ANZCTR search results

Preschool wheeze is among the most common causes of hospital admission in young children worldwide. Current prevention strategies are ineffective and parents and paediatricians identify developing effective treatments to prevent hospital admission as a research priority. Compelling evidence from animal, laboratory and clinical studies support the hypothesis that OM-85 has the potential to reduce the risk of hospital admission due to preschool wheeze. This trial has been designed and powered to address this question, which is critical to both consumers and the health system.

Endometriosis is a common yet under-recognised chronic disease. Endometriosis occurs when cells similar to those that line a persons uterus grow in other parts of their body, usually around the pelvis. Although endometriosis is often effectively managed, it can lead to debilitating chronic and persistent pelvic pain and compromised fertility. It can also significantly impact the social and economic participation and psychosocial health of those affected. it is estimated that 11.4% (more than 830 000) Australian people are living with endometriosis; however, delays in diagnosis and lack of definitive research on the domestic burden of disease suggest the number could be far higher. Surgery for endometriosis is a common procedure and randomised, placebo controlled trials have shown a benefit at 6 and 12 months following surgery, with variable changes noted in these studies in the first few months. People with endometriosis frequently report a worsening of pain following their surgery, however there are no data reporting immediate outcomes, effect on menstruation or the likely changes to expect in these first few months. Our aim is to investigate the immediate effect of surgery on people's symptoms and provide that information in publicly available forums to improve the education and understanding of how women experience symptoms in the immediate post-operative phase of care. It is important to note that we are not establishing the long-term outcomes since these are reported in other studies.

We do not fully understand why Type 2 Diabetes (T2D) risk is, disproportionately higher in people from culturally and linguistically diverse backgrounds. Because of this knowledge gap, opportunities for early intervention are reduced and more lives will be lost. This study will identify if impaired non-fasting lipid metabolism is an early feature of T2D risk in Chinese immigrants in Australia. The metabolic phenotype of Chinese immigrants at risk of T2D is distinct from other ethnic groups. People from China develop T2D at a lower body mass index (BMI) and younger age than Caucasians. Traditional Western-based screening measures may not adequately capture the risk factors for T2D in this population. Chinese immigrants are Australia’s largest group of non-English speaking migrants. Recent evidence supports assessment of lipid profiles in T2D risk assessment in Chinese populations. We propose this mechanistic study as the first step in addressing the knowledge gap. We will conduct an acute high fat meal challenge to assess post-prandial lipid metabolism in Chinese adult participants. A group of age-matched Caucasian participants will be recruited as a comparison and we will employ a cross-over design. Each participant will attend two testing days, the first where they will be given a high-fat meal challenge and then second where they will be given a high-carbohydrate meal challenge. Aim: To demonstrate that Chinese-immigrants at risk for T2D have (a) an exaggerated lipid response to a high fat meal challenge and (b) a unique lipid phenotype compared with Caucasians. Hypothesis: Chinese-immigrants will exhibit a different post-prandial lipid profile compared with age and weight-matched Caucasian controls.

Transgender individuals seeking feminisation (transfeminine individuals) are treated with estrogen and anti-androgen (testosterone blocker) to align their physical appearance with their gender identity. There has been increasing interest in the potential use of progesterone for transfeminine individuals, given anecdotal reports of improved mood and breast development. This randomised placebo-controlled cross-over trial is a trial of micronised progesterone in transfeminine individuals treated with estradiol therapy. We aim to establish the influence of progesterone on sleep, psychological distress and total testosterone concentration.

PARTICIPANTS: Children (> 5 years) and adults with pulmonary fibrosis (PF) related to short (<10th centile) telomere length (PF-ST) (n=50). This subgroup have mutation/s in the telomerase enzyme which maintains telomere length. PF-ST patients have a prognosis far worse than their long telomere counterparts. Survival is worse than most cancers, with death within 2 years. INTERVENTION: A synthetic androgen, danazol (400mg capsule bd), or placebo (2:1 randomisation) for 12 months, administered in addition to standard of care. Danazol is a synthetic hormone which augments telomerase activity and hence lengthens telomeres. In a small group of haematology patients with short telomere syndromes (Townsley et al. NEJM 2016) danazol impressively attenuated telomere attrition, and in the subgroup of patients with PF (n=10) there was apparent stabilisation of lung function for up to 2 years, completely at odds with expected PF-ST natural history. COMPARATOR: Identical placebo. OUTCOMES: Change in absolute telomere length (base pairs) and lung function (forced vital capacity) over 12 months; safety (treatment emergent adverse events); survival.

Irritable bowel syndrome (IBS) is a very common condition that has a big impact on quality of life. IBS and common mental health disorders (like anxiety and depression) are strongly linked. In fact, more than 30% of people with IBS also have anxiety and more than 20% have depression. Changing diet can be very helpful for improving IBS symptoms but some specific diets can be difficult to follow. An alternative dietary approach, which will be investigated in this study, has been found to improve depressive symptoms. The diet may also have positive affects for the gut microbiome (the micro-organisms found in the gut), which is also important in IBS, and for other health outcomes. This study aims to test if this diet can be followed and is acceptable for people with IBS and current symptoms of anxiety or depression. It also aims to understand whether this diet could improve gut as well as mental health symptoms, and how it might do this. The results of this study may contribute to the clinical management of people with IBS and mental health problems.

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.