ANZCTR search results

This Phase 1, randomised, placebo-controlled, double-blind study will evaluate the safety, tolerability, PK, and PD of PXS-5505A in a single ascending dose (SAD) and multiple ascending dose (MAD) fashion in healthy male volunteers. The study will be conducted in 2 parts: Part A (SAD) and Part B (MAD). The MAD portion of the study will commence after all cohorts of the SAD portion of the study have been completed.

Frailty is common in older hospitalised patients and leads to adverse consequences like increased risk of death, prolonged length of hospital stay and frequent unplanned hospital readmissions but may be missed by the clinicians in the absence of proper screening. Currently, all hospitalised patients are not routinely screened for frailty. The currently available frailty tools need a face to face interaction with the patient and are time consuming. Recently a new tool called the Hospital Frailty Risk Score (HFRS) has been developed that can detect frailty taking into account only the administrative data of the patients and this tool does not need a face to face interaction. However, this tool needs to be tested for accuracy in different hospital settings and needs comparison with already established frailty tools before it can be incorporated into routine clinical practice. If this tool is found to be accurate then it may help in early detection of frail patients and thus an early intervention can be started to target these patients. The purpose of this study is to compare and test the new tool against an existing frailty tool to diagnose frail hospitalised patients. This research is not funded.

Women who had preeclampsia are at greater risk for cardiovascular and related diseases and their infants are at risk of being born too small or dying. Although many aetiological risk factors have been identified for preeclampsia, at present it is not possible to effectively predict which women will develop pregnancy complications, particularly in first time pregnancies. This study aims to compare the UK developed fetal medicine foundation test with the locally developed Lyell McEwin Hospital preeclampsia screening test in all first-time pregnancies at the Lyell McEwin Hospital. Prevention of preeclampsia is an important goal of obstetrical care. The current study is needed to determine which test most effectively predicts onset of preeclampsia in nulliparous women so the introduction of this test can translate into routine antenatal care in Australia.

Alzheimer’s disease is the most common cause of dementia in older adults and affects millions of people in Australia and worldwide. Alzheimer’s disease causes loss of memory, difficulty in thought and reasoning, and behavioural changes. There are currently no effective treatments that slow or stop the progression of Alzheimer’s disease. In an effort to address the need for medications that treat Alzheimer’s disease, Samumed, LCC (the sponsor) has developed a new investigational drug, SM07883. SM07883 is a novel small molecule inhibitor of DYRK1a which has been tested in a number of non-clinical studies. This study is a first-in-human, single dose, dose-escalation safety study in healthy subjects 18-70 years old. Subjects who provide written informed consent for this study will undergo baseline evaluations at the Screening visit. Subjects will participate in a screening period of up to 21 days and a 28-day observation period. Sequential dose cohorts of healthy subjects will receive a single fixed dose of SM07883 at 5, 10, 15, 30, 60, 120 and 180 mg. Each cohort will consist of 4-6 subjects. Safety data from each cohort will be reviewed by a Safety Review Committee prior to continuing to the next cohort. The purpose of this study is to learn more about the safety of SM07883, how well it is tolerated, and what happens to it in the body when given as a single dose oral tablet to healthy subjects. The findings from this study will support future studies in Alzheimer’s patients.

Students’ ability to regulate their attention and emotions and comply with teacher instructions during the early years of school predicts school adjustment, participation and success. Many schools are looking for ways to support students during the transition to school to ensure they have the appropriate skills to navigate this period. Mindfulness is an approach that has rapidly gained popularity in Australia and internationally. Mindfulness-based interventions aim to improve student skills in areas such as attention, self-regulation and executive functioning. Although there has been rapid uptake of mindfulness-based interventions, there are a glaring lack of robust randomised intervention trials examining whether mindfulness interventions lead to improved long-term outcomes for students. We hypothesis that a teacher-led mindfulness intervention is effective in improving student and teacher outcomes using objective and self-reported measures, when compared our usual teaching practice group.

The purpose of this observational study in participants with Asthma is to: - Collect exhaled nitric oxide, exhaled breath temperature, lung sounds, asthma medication and its usage, asthma symptoms, asthma control questionnaire, and air quality data over the course of four (4) weeks. -Analyse the collected data for trends and correlation(s), if any.

This research aims to demonstrate safe function of SureflO2 device and efficacy of the device in alerting staff to adequacy of oxygen flow through a standard face mask. The SureflO2 indicator is incorporated into a standard oxygen mask and reveals a bright orange indicator to carers when oxygen flow is present which changes to white when oxygen flow is inadequate. The developers of the SureflO2 indicator contend that this extra alert as to absence of adequate oxygen flow will prompt healthcare workers to carry out further checks to the oxygen provision system when oxygen flow is inadequate.

The purpose of this study is to evaluate the potential for different blood transfusion strategies to assist with the treatment of thrombocytopenia that has occurred as a result of blood-related cancers, chemotherapy or bone marrow failure. Who is it for? This study is for adults with either a blood related cancer or has been diagnosed with aplastic anaemia and who has low pletelets which would usually be treated with platelet transfusion. Study details Participants will take part in one of two treatment options: 1. The transfusion of cryoprecipitate (a frozen product derived from healthy blood donors), followed by a platelet transfusion, or 2. A frozen platelet transfusion In each case, participants will receive these transfusions in lieu of an expected platelet transfusion, but will be able to continue on with all other therapies. Blood tests will be measured before each transfusion and for up to two days afterwards. Blood tests will be repeated if participants require additional regular platelet transfusions as part of their standard of care. This study is non-randomised. Potential participants will be able to choose a strategy provided that arm remains open. This study will provide information on the effect of these alternative transfusion strategies in this patient group. It is hoped that this may provide a basis for treatment in regions where fresh platelets are not available to treat or reduce the risk of bleeding and enhance our understanding of how this might be best measured.

This study is a 12-week, randomised, double-blind, placebo controlled, clinical trial to assess the effectiveness and safety of a novel herbal formulation, consisting of Curcuma longa (Turmeric), Boswellia serrata (Indian Frankincense) and Zingiber officinale (Ginger) for the management of osteoarthritis of the knee. The study will assess if taking this formulation helps reduce knee pain and improves function and wellbeing from osteoarthritis of the knee. It is expected that the herbal formulation will reduce pain from osteoarthritis of the knee over the course of 12 weeks compared to placebo medication.

KER-047 is being developed by Keros Therapeutics Australia Pty Ltd as a potential treatment for Fibrodysplasia ossificans progressive (FOP). FOP is a rare genetic condition where the muscles, tendons and ligaments of the body slowly turn into bone. There are no approved treatments for FOP; This study aims to recruit healthy volunteers to determine the safety and pharmacokinetics of single and multiple dose of KER-047.