ANZCTR search results

The purpose of the study is to demonstrate the safety and efficacy of the LensOne device, which allows surgeons to implant a single piece, posterior chamber IOL in patients with aphakia. It is hypothesized that the LensOne device can provide surgeons and patients a safe and stable solution for fixating a posterior chamber IOL when there is insufficient capsular and zonular support. This study aims to establish the safety of the LensOne device and to provide surgeons with a consensus method of securing a posterior chamber IOl when there is insufficient capsular or zonular support.

ECMO is a form of advanced life support that is used in patients with heart or lung failure when other forms of medical treatment have failed. These patients are some of the sickest within Australian and New Zealand Intensive Care units (ICUs) and often remain unconscious for weeks. Whilst provision of nutrition via feeding tube into the stomach (enteral nutrition) is an accepted standard of care there remain crucial gaps in our understanding of the best way to provide nutrition to this population. Available data indicates that these patients consistently receive less nutrition than they are prescribed, and they experience frequent interruptions to nutrition delivery. Moreover, the outcomes in these patients are poor with significant losses of muscle mass and strength resulting in disability that persists well beyond hospital discharge. It is thought that nutrition delivery across hospitalisation may influence recovery, however this needs to be understood, with no information currently available for the period on the hospital ward. This study is designed to describe current nutrition provision and practices across hospitalisation for the first time in patients receiving ECMO. It is expected that the findings from this study will enable the develop of strategies to improve the delivery of nutrition in this high-risk population and inform the design of future research.

Trans young people often have poor mental health outcomes and high rates of depression and anxiety. These poor mental health outcomes have been shown to be associated with the abuse, rejection and discrimination that many trans young people experience due to anti-trans attitudes in broader society, referred to as minority stressors. This study will evaluate the Trans Adolescent Group ThErapy for Alleviating Minority stress (TAG TEAM) intervention, which is a group cognitive behavioural therapy (CBT) program that focuses on experiences of minority stress and aims to improve symptoms of depression and anxiety. The results of the study will be used to inform the clinical care of trans young people.

This will be a phase 1, first-in-human, open-label, 3-period, 3-treatment crossover design study to evaluate the food effects and relative bioavailability of 2 formulations of PTC607 in 8 healthy participants.

This is an observational tele trial to determine the effectiveness of Sambucol in the management of the symptoms of the common cold and flu-like illnesses in children and adolescents aged between 2 years and 17 years who are already committed to consuming Sambucol as part of their own routine self-care (with parental consent and monitoring). Sambucol Black Elderberry Cold & Flu is a liquid that has an extract of Elderberry that is safe for children and teens to consume to help relieve their cold and flu symptoms. This same Elderberry extract has been shown to be useful in helping to resolve cold and flu symptoms like coughing, sneezing and headaches in adults. This study is testing if the same extract in Sambucol Black Elderberry Cold & Flu is useful for children and adolescents with cold and flu symptoms or not. The study will be conducted online via a study app and will measure the duration and severity of cold symptoms of participants who are taking Sambucol Black Elderberry Cold & Flu, until the illness resolves. The researchers expect that Sambucol will significantly reduce the severity of the symptoms of the common cold in comparison to existing data on children with cold and flu symptoms. It is also expected that Sambucol will reduce the severity of the symptoms of the common cold in children comparable to reductions observed in clinical trials with adults taking Sambucol, and significantly greater than adults taking placebo.

This is a double-blind, randomised, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics (PK) of a single administration of AXN-001 at increasing dose levels in the range of 1 mg to 16 mg. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence. Dose administration will be performed by the subcutaneous (SC) route for Cohorts 1 to 5. To enable determination of the bioavailability of the investigational product following SC administration, dose administration for Cohort 6 may be performed by the intravenous (IV) route. Cohort 7 may proceed via subcutaneous injection upon completion of cohort 5. The decision by the Safety Review Committee (SRC) to escalate between dose levels will be based on review of all available safety and PK data from previous cohorts. Up to 56 healthy male and female volunteers aged 18 to 55 years of age (inclusive) and with a body mass index between 18.0 kg/m2 and 32.0 kg/m2 are planned to be enrolled. Healthy volunteers will be screened between Day -28 and Day -2, inclusive. Participants will be admitted to the clinical facility on Day -1 with dosing to occur on the following day (Day 1). All participants will be dosed under fasted conditions. Seeking to address unmet medical needs for the acute treatment of migraine, Axon Therapeutics is developing AXN-001, a peptide CGRP-R antagonist as a subcutaneous (SC) formulation for the acute self-administered treatment of migraine.

Finding people with chronic liver disease and silent liver cirrhosis (scarring) who are at risk of liver failure and liver cancer is a critical public health issue. The AST-to-platelet ratio index (APRI) determines the risk of liver cirrhosis and is calculated using routine blood tests. In this study, we determine whether an innovative cirrhosis screening program of automated APRI calculation and provision of liver disease education information including a weblink for Fibroscan referral on routine pathology blood test results increases liver cirrhosis diagnosis and linkage to specialist care. We hypothesise that the inclusion of automated fibrosis scores will lead to an increased recognition of individual's at risk of significant fibrosis and improved linkage to care.

Brief summary: The purpose of this pilot study is to assess Skin Tear healing trends with the use of two differing wound dressing types (adhesive silicone foam dressing versus meshed silicone interface dressing), the dressing performance outcomes and the patient and staff satisfaction with the use of these two products. These two products are currently in use for the treatment of Skin Tears within the TPCH based on a standardised treatment regime. This regime is based on best available evidence, which included expert opinion and a regime generated by a dressing product manufacturer. Although the two options are based on a review of the evidence, there is minimal evidence in regards to their skin tear treatment efficacy. In practice, the decision to use one or the other is based on individual staff preference. The hypothesis is that one of the dressings advantages versus disadvantages, in comparison to the alternative will result in improved healing outcomes, patient and staff satisfaction. The design of the study is a randomised study of TPCH patients sustaining upper limb skin tears. A consecutive, convenience sample of 126 adults (aged 18 or over) will be recruited. Following consent patients will be randomised into two treatment arms with their Skin Tears dressed either with the adhesive silicone foam dressing or the meshed silicone interface dressing. Baseline data will be collected when the skin tear is first assessed and dressed, with follow up data will be collected at 7 days, 14 days, and 21 days.

This study will explore how diet and lifestyle, as well as age and gender (and other non-modifiable risk factors), are involved in the development of bowel cancer and pre-cancerous lesions (adenomas) in people considered at above average risk for bowel cancer due to either family history of bowel cancer or prior history of colorectal adenoma. Who is it for? Individuals are eligible to join this study if they are aged 18 years or older, and are currently enrolled in the Southern Cooperative Program for the prevention of colorectal cancer (SCOOP) Program for a surveillance colonoscopy. Study details: All individuals enrolled in the SCOOP program will be invited to complete and return an online or paper survey at years 1, 2 and 3, which will ask questions on diet, exercise, sleep and other lifestyle factors. The results from each survey and the changes in lifestyle over the 3 years will be compared to the findings at the regular surveillance colonoscopies, in particular the presence of advanced colorectal neoplasia (adenoma or cancer). It is hoped that the results of the study will improve the understanding of the interactions between diet and lifestyle behaviour, with the non-modifiable risk factors on the development of advanced neoplasia. It is hoped that this will be useful for identifying high-risk individuals who may benefit from targeted interventions to reduce their risk of developing bowel cancer and reducing the need for unnecessary colonoscopies for lower risk patients.

The 2-ASSURE trial will be a multi-centre Phase II rolling cohort study examining the optimal conditioning regimens of Autologous Stem Cell Transplant (AHSCT) for patients with severe systemic sclerosis. Patients will be stratified based on cardiac screening, age and co-morbidities. Those who have normal cardiac screening (as outlined in inclusion criteria), age less than 60 and no major co-morbidities will receive a standard dose of 200mg/kg cyclophosphamide in their conditioning in two separate cohorts. Those who have heart disease (as defined in inclusion criteria), age greater than or equal to 60 years or significant co-morbidities/poor performance status will receive a low dose regimen utilizing cyclophosphamide 140mg/kg +/- rituximab in two cohorts. This study aims to illustrate which low dose of cyclophosphamide is as effective in achieving remission compared to patients who received standard dose as part of their conditioning therapy for AHSCT.