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A prospective observational study exploring association between Fractured Neck of Femur (#NOFF) patient's cardiovascular state and postoperative brain oxygen levels and mental state
This study primarily aims to see how patients having surgery for a common type of hip fracture have the oxygen levels in their brains affected after the operation by changes in their heart strength during the operation. We also want to see how other factors during the operation (blood pressure, and related factors) affect these same patients’ thinking after the operation; as well as seeing how common and how severe abnormally low readings in these factors (and other related heart factors) occur during the operation. We believe that intraoperative reduction in heart strength is related to reduced postoperative brain oxygen levels.
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mi.spot (supportive, preventative, online and targeted): a moderated online intervention for young adults who have a parent with a mental illness and/or substance use concern: A study protocol for a randomised controlled trial
The transition to adulthood can be a vulnerable period for emerging adults who have a parent with mental illness or substance use concern. Compared to their same aged peers, this group of youth face increased risks to their own mental health and commonly do not engage with traditional face-to-face health services or have access to age-appropriate, targeted interventions. Increased engagement may result through providing an online intervention. This controlled trial examines the utility of mi.spot (mental illness: supportive, preventative, online, targeted) online intervention for emerging adults aged 18 to 25 years who have a parent with a mental illness or substance use concern. The research will investigate the impact of the mi. spot intervention on the mental health and wellbeing of an intervention group compared to a control group waiting to participate in the intervention. The two groups will be compared pre, post and 6 weeks follow-up after the intervention period.
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Parent and Child Cognitive Behavioural Therapy for Anxiety Disorders
The purpose of this study is to determine the acceptability and effectiveness of a newly developed parent-child cognitive behaviour therapy protocol for parents and their children who both have an anxiety disorder diagnosis. Ten separate parent and child group treatment sessions will be delivered. Treatment sessions will include relevant psychological education and the development of skills to best treat anxiety symptoms. It is anticipated that parent and child participants will find the treatment acceptable and show improvement in symptoms from pre-treatment to post-treatment. Findings from this study are expected to advance current understanding of effective treatment for parents and children with anxiety.
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Evaluating the update of acupressure in the management of post-operative nausea and vomiting through auditing
About one in two to three surgical patients suffer from nausea and vomiting after operation (PONV) and PONV greatly impacts on patient surgical experience and can prolong the hospital stay. Acupressure, a form of non-invasive acupuncture, can safely and effectively reduce the incidence of PONV by up to 30%. The current project aims to assess if acupressure could be incorporated into the routine management of PONV in a public hospital in Victoria to provide a non-drug option for surgical patients; what factors may impact on the adoption of acupressure; and if this non-drug option could reduce PONV and / or the use of medications. The acupressure tested is a wristband, called Seaband, and is applied to Nei Guan, an acupuncture point on the wrist of patient, about 30 min prior to surgery. The band can be in place for 24 hours. The band can be easily removed by patient if it becomes uncomfortable and can be applied later. We expect to see that this band can be easily integrated into the standard PONV management plan, and acupressure may reduce PONV or the use of anti-emetics post-operatively. Both staff and patients would be happy to have a non-drug option to complement the existing PONV management plan.
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A Single Ascending Dose and Multiple Ascending Dose Phase 1 Study of PXS-5505A Administered Orally in Healthy Adult Males
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.
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Validation of the Hospital Frailty Risk Score in predicting clinical outcomes in older hospitalised patients in Australian health care settings.
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.
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Screening for preeclampsia in pregnancy, a prospective, observational, cohort study.
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.
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A Phase 1, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of SM07883, a Novel DYRK1a Inhibitor, Following Oral Administration to Healthy Subjects
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.
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Minds@Play: Understanding whether mindfulness in the classroom can improve student outcomes
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.
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Observation of breath measurement in Asthmatics
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.