ANZCTR search results

Effect of Palmitoylethanolamide (PEA) and Resveratrol compared to a placebo on menstrual pain symptoms in an Adult Population – A double blind, randomised controlled trial. The aim of this study is to assess the effectiveness of a combination of PEA and resveratrol on alleviating menstrual pain symptoms in otherwise healthy women.

Although internet interventions can effectively address key eating disorder symptoms, it is not yet known whether the mode of content delivery impact engagement, outcomes, and dropout. This randomized controlled trial will compare a static (i.e., written text content online) versus interactive (i.e., multimedia content with embedded activities) internet intervention on eating disorder symptoms. This trial is nested within a larger RCT (ACTRN12619001437156), in which participants originally randomized to the wait-list arm of that trial will be subsequently randomized to either the static or interactive intervention at post-test (once the wait-list period ends). The two interventions are identical in content, with the only difference being the mode of delivery.

The purpose of this study is to test the safety and tolerability of a new medication (called FTP-637) in healthy volunteers. FTP-637, an investigational drug, is a small molecule inhibitor of tyrosine kinase 2 (TYK2) being developed for the treatment of psoriasis and other autoimmune diseases. The study will consist of 2 parts; Part A - multi-cohort Single Ascending Dose (SAD), and Part B – multi-cohort Multiple Ascending Dose (MAD).

Lichen sclerosus (LS), also known as balanitis xerotica obliterans (BXO), is a chronic relapsing inflammatory dermatosis of cryptic aetiology. LS, which usually occurs in the anogenital region of men or women, may cause destructive scarring that can lead to devastating urinary and sexual problems. Clinically it presents as symptoms of itching, pain, dysuria, urinary retention and sexual dysfunction. Specifically, in males, lichen sclerosus may present as phimosis or urethral stricture disease, requiring the involvement of urologists in their care. One third of men were found to have signs of lichen sclerosis without symptoms on examination for other conditions. Lichen sclerosus is a clinically and histologically diagnosed pathological condition with very little understanding of the underlying genetic and proteomic changes that lead to the development and progression of this condition. Skin samples of affected and normal skin will be taken from affected men undergoing circumcision for the treatment of lichen sclersus and analysed to determine the genetic and proteomic profile. The purpose of this study is to investigate the gene and protein expression profile changes in skins affected by LS as compared to normal skin in order to discover the mechanism of the LS, and to further develop targets for diagnosis and effective drugs to treat the condition.

This trial is investigating the efficacy and feasibility of a personalised risk assessment for breast and ovarian cancer, through offering a polygenic risk score. Who is it for? You may be eligible for this trial if you are a woman aged 18 years and above undergoing a predictive test for a known familial mutation in a gene associated with increased risk of breast cancer - BRCA1, BRCA2, PALB2, CHEK2, ATM, RAD51C or RAD51D at a participating Familial Cancer Clinic. You may also be eligible if you have previously completed predictive testing that detected PALB2, CHEK2, ATM, RAD51C, or RAD51D at a participating Familial Cancer Clinic. Study details Participants will be randomly allocated to either the intervention arm, or a waitlist control that will be eligible to receive the personalised risk assessment after 1 year. The intervention arm will receive an integrated, personalised risk assessment and risk management advice, whereas the control arm will receive risk management advice based on the standard risk assessment incorporating the results of single gene testing and family cancer history. Information from this trial will be used to optimise targeted risk management of breast and ovarian cancer, whilst minimising the burden and cost to the health system

Indirect calorimetry is a device used to measure energy requirements by measuring oxygen use and carbon dioxide production. Indirect calorimetry is the recommended method of guiding energy provision in critically ill patients in key nutrition guidelines. However, indirect calorimetry is not widely available in Australia and there is minimal data describing measured energy expenditure during Intensive Care Unit (ICU) admission in a modern setting. The primary aim of this study is to describe measured energy expenditure in adult mechanically ventilated critically ill patients in a modern Australian ICU.

Research has shown differences exist in gut bacteria between people with Parkinson’s disease and those without Parkinson’s disease. This research indicates that specific bacteria, capable of producing beneficial compounds called Short Chain Fatty Acids (SCFAs), are reduced in individuals with Parkinson’s disease. Additional research indicates that the start of Parkinson’s may be in the gut, where it then spreads toward the brain. We wish to investigate this further and want to see if people’s lifestyle factors, like diet, physical activity and sleep, contribute to the difference in gut bacteria between people with Parkinson’s, and people without Parkinson’s. For example, does higher levels of physical activity relate to better gut bacterial health? And how might this differ between the groups? Additionally, we wish to determine what relationship gut bacteria has to participants capability to think, termed cognition, and to participants ability to learn motor tasks, referred to as neuroplasticity, as both factors can be affected in Parkinson’s disease. Overall, we aim to investigate if/how gut bacteria contributes to Parkinson’s disease progression and what impact lifestyle factors may have on this relationship. Specifically, the primary objective of this study is to assess if differences exist in terms of gut bacteria characteristics, meaning the types and amounts of gut bacteria present, across healthy young and healthy old groups and in PD. Additionally, the relationships between participants gut bacteria and scores of cognition and neuroplasticity will be assessed for any relationships that may indicate involvement of gut bacteria in these factors. Finally, lifestyle factors including diet, physical activity and sleep will be measured to see what effect they have on individuals gut bacteria. We expect there to be different gut bacteria characteristics across the groups, with lower amounts of specific and beneficial SCFA producing gut bacteria in the Parkinson’s disease individuals. In addition, we expect healthier lifestyles, based on the three factors measured, to relate to better gut bacteria characteristics, namely an increased number of SCFA producing bacteria. Cognition and neuroplasticity scores will be lower in the older adult groups, and we expect them to be less again in the PD group.

In view of the expected epidemic of type 2 diabetes, there is an urgent need for large-scale interventions that can prevent the progression from pre-diabetes to diabetes through encouraging change in health-related behaviours. We have set out to test the acceptability of receiving daily physician’s feedback informed by wearable continuous monitoring of subjects’ activity, food choices and glucose profiles with the aim of encouraging healthier behaviours in subjects with diabetes. Fifteen subjects with type 2 diabetes wore a continuous glucose monitor and an Apple Watch for 12 days. Uploaded data were integrated into an App which also enabled the recording of activity and food consumed. A physician provided text-based daily feedback to each individual, based upon their data from each day of the study. At the beginning and the end of the study,data was collected on health related-behaviour, such as eating and exercise, and diabetes control assess the acceptability of the intervention.

This is a Phase 1 ,Single arm open label clinical trial. The objective of this clinical trial is to test an alternative treatment to antibiotics in a small group of Chronic Rhinosinusitis (CRS) patients to evaluate safety, efficacy of a 4 strain lactobacilli probiotic nasal rinse. The study population will consist of up to 40 patients with a diagnosis of CRS. Patients will be invited to participate in a 14-16-week program from screening to End of Study. At the screening visit the patient will be reviewed and perform assessments to ensure the suitability of the patient to partake in the trial. The suitability will be checked using inclusion /exclusion criteria. Before any assessments take place the patient will asked to sign a patient information and consent form. This form will have been sent to patient to review prior to screening day. The subject if suitable for enrolment will attend a baseline visit 2-4 weeks after screening. At the Baseline visit the patient will have inclusion/exclusion criteria rechecked before being enrolled and commenced on the intervention ( Probiotic powder administered via nasal rinse) . Each patient will be trained under supervision in the clinic on how to self-administer the probiotic nasal rinse. The patient will then administer the probiotic rinse once daily at home for 4 weeks when they will attend an end of treatment visit at the ENT clinic. The patients will then be followed up for a further 8 weeks then will attend an End of study visit. The overall aim of this study is to improve quality of life by reducing the pathogen load and increasing beneficial bacteria in the nasal microbiome of Chronic Rhinosinusitis sufferers.

This is a dual centre, randomised, double blinded trial of two pulmonary vein isolation systems for paroxysmal AF. Participants will be screened from all participants referred for pulmonary vein isolation aged between 17 and 80 years. Randomisation will occur after consent is obtained and on enrolment into the study. Participants will be randomised to pulmonary vein isolation with the Arctic Front Advance™ Cryoballoon or the POLARx™ Cryoablation System. It is planned that 110 participants will be randomised in a 1:1 ratio to one of two treatment arms: • 55 will undergo pulmonary vein isolation via the Arctic Front Advance™ Cryoballoon. • 55 will undergo pulmonary vein isolation via the POLARx™ Cryoablation System. Primary non-inferiority endpoints • Total procedure time • Total ablation time Secondary safety and tolerability endpoints • Complications of Pulmonary Vein Isolation. • Major adverse cardiac and cerebrovascular events (MACCE) (non-fatal MI, non-fatal stroke, CV death, cardiac hospitalisation due to heart failure). Secondary efficacy endpoints: • Burden of recurrent symptomatic documented AF episodes. • Burden of recurrent documented AF episodes. • Time to recurrence of AF. • Any symptomatic AF recurrence. • Hospitalisation.