You can narrow down the results using the filters
-
Clinical validation of circulating cell free DNA [ccfDNA] as a biomarker of metabolic health
Obesity and its associated diseases have rapidly risen to become a significant burden on health systems across the world. Australia is not immune to this upheaval, with nearly 2 in 3 adults in this country classified as overweight or obese. In line with rising obesity, rates of diabetes have also risen dramatically. In the 2017-2018 Australian Bureau of Statistics Health Survey, 4.9% of respondents reported a diagnosis of diabetes. Furthermore, it is estimated that diabetes was an associated or underlying cause for 11% of deaths in the year 2018. Even without progression to diabetes, obese individuals are at risk of a host of other health issues such as the development of Nonalcoholic fatty liver disease (NAFLD). There is an urgent need for new ways to manage the metabolic diseases of obesity. However, there is a lack of diagnostic tests that can accurately predict diabetes before to the appearance of the symptoms that indicate that the first steps into full disease have already occurred. New evidence shows that inflammation of the deep fat stores that surround our organs plays a key role in health and obesity. It is now known that fat tissue is not just a passive storage site for excess energy but rather a complex organ that can disrupt the healthy hormonal and metabolic profile of obese patients. This inflammatory process occurs very early on in the development of disease, before the onset of diabetes and pre-diabetes symptoms. Ongoing inflammation of organ fat results in high rates of cell death in this tissue and the release of unwanted cell free DNA into the surrounding tissues and blood circulation. This free DNA can actually increase the level of inflammation via a negative feedback loop that serves to strengthen this unwanted response. At CSIRO, we have developed a new blood test that can measure the amount of DNA being released by these fat cells. This new test may provide a window into health for obese patients that can help doctors predict and monitor long-term health well before a diabetes diagnosis could be determined using current measures. This study will test the validity or our new blood test, in a group of patients who will be profiled for a well defined set of biomarkers that measure metabolic and liver health. This study is funded by CSIRO.
-
The CareNET trial: Caring for carers of people with advaNced cancer at hospiTal discharge
CareNET is an intervention that is integrated into existing discharge processes and uses the Carer Support Needs Assessment Tool- Intervention (CSNAT-I) to identify and meet the carers needs preparing for the person they care for to return home from hospital. This study aims to determine whether it is feasible to deliver the CSNAT-I to carers both in the hospital setting and in the first few days when they person they care for returns home. Who is it for? You may be eligible for this study if you identify as a carer for someone who has advanced cancer. For this study a carer is someone who is in a close supportive role who share in the illness experience of the patient and who undertake vital care work and emotion management for the patient. Patients with advanced cancer who are currently in-patients at a specialist cancer centre will also be invited to participate. Study details Patients who choose to participate in this study will be asked to meet with an occupational therapist to determine their needs related to achieving discharge home. While the patient is still in hospital, carers who choose to participate in this study will also be asked to meet with the occupational therapist (OT) to identify and prioritise their caring needs using the CSNAT-I tool. Following this initial assessment, the OT will meet again with the carer to develop an action plan for prioritised needs prior to the patient being discharged. Within 3- 7 days after the patient has been discharged home, the carer and OT will review and discuss whether the identified needs have been addressed, including review of any new needs identified by or referring to relevant service providers (e.g., GP, community palliative care service, nurse coordinators). It is anticipated that these meetings may occur face-to-face or via video- or teleconference per the carer's preference. Meetings should take no more than 30-40 minutes. Carers and patients will be asked to complete a series of surveys regarding their experience with the intervention and their health, they may also be asked to participate in a one-on-one interview with a member of the research team to discuss their experiences of the study. It is hoped this research will determine whether it is feasible to deliver the CSNAT-I intervention to carers of patients with advanced cancer. This includes understanding what is required to conduct a larger trial that can test how effective it is in benefiting the patients and carers and how we can translate it into everyday practice. The results of the larger trial may then lead to improved health and wellbeing for future carers and patients.
-
A Randomized Controlled Trial of a Smartphone App for addressing distress and wellbeing in a high-trauma risk population
This project aims to examine the efficacy of a smartphone application [the Build Back Better app] in providing evidence-based prevention strategies for psychological distress, anxiety, depression, and posttraumatic stress (PTS) symptoms in people who have experienced potentially traumatic experiences. Based on user feedback of a previously conducted feasibility pilot study (Meuldijk et al. 2022, in preparation) within a sample of Emergency Service Workers (ESWs) (n=63) the Build Back Better app has been refined and a fully functional version is ready for formal testing in a randomized controlled trial (RCT).
-
Nutritional biomarkers comparing a healthy versus a typical Australian diet: a Feeding Study in Australian Adults.
A randomized cross-over feeding study conducted in free-living healthy adults aged 18 years and older old recruited from the local Hunter region. Participants will be enrolled in an 8-week dietary intervention consisting of a 2-week run-in period (habitual/usual diet) followed by 2 x 2-week dietary intervention periods that include a 2-week washout between them. The 2-week diet periods will consist of a ‘Healthy Australian Diet’ that aligns with Australian recommendations and a ‘Typical Australian Diet’. These will be allocated in a randomized order. During the 2-week washout period the participant returns to their / usual diet). The entirety of the diet (i.e., 3 main meals and snacks per day) will be provided to participants during dietary period 1 and 2. Participants will supply their own meals and foods during the run-in and washout periods. Study participation involves completing self-administered questionnaires (e.g., food frequency, health. demographic, physical activity questionnaire); collection of biosamples (fasted blood sample, urine and faecal sample) and physical measurements such as blood pressure, arterial stiffness, anthropometry and body composition. Researchers hypothesise that distinct nutrition biomarkers will be detected that are representative of each diet phase.
-
Brain Pulse Monitoring Study in patients with or at risk of developing stroke to provide earlier detection of stroke
The brain pulse monitor is a new non-invasive method that uses light to monitor brain oxygen levels and blood flow. The purpose of the study is to determine if the brain pulse monitor accurately detects falls in brain oxygen and blood flow associated with stroke. The study will enrol adult patients with or at risk of developing a stroke. The target group are patients presenting to hospital with stroke, patients with sub-arachnoid haemorrhage that develop vasospasm and patients undergoing surgeries associated with a risk of stroke, such as carotid and cardiac surgery. The major outcome is to assess the accuracy of the brain pulse monitor to detect reduced brain oxygen and blood flow changes associated with stroke.
-
A Phase III study to investigate the effect of EMD-RX5 on symptoms of psychological distress in adults with chronic pain
Symptoms of psychological distress, also described as acute stress, anxiety or nervous tension are particularly common in patients suffering chronic pain. EMD-RX5 is a cannabidiol (CBD) capsule. Some research indicates that CBD affects receptors (a group of cells that control the movement of chemicals and molecules) in the brain, that may alter a key hormone (serotonin) relating to mood, happiness and feelings of well-being. The purpose of this study is to determine whether EMD-RX5 improves symptoms of psychological distress in patients experiencing chronic pain.
-
Walk-and-Talk Psychotherapy for Men with Low Mood: A Pilot Study
Background Depression is a highly prevalent mental illness that affects over 109 million men worldwide and one in eight Australian men every year. Characterised by persistent feelings of sadness and hopelessness, untreated depression is devastating for individuals, families, and communities. Due to COVID-19, the Australian prevalence of depression increased by 10% in 2020 alone. In Australia, men with depression are often referred to psychotherapy (also known as counselling). However, while effective for treating depression, psychotherapy often fails to engage men who most often report that the process ‘doesn’t feel right’. Given the dominant form of masculinity in Australia encourages men to suppress emotions, it is unsurprising many find it hard to be vulnerable with a relative stranger, in a formal and unfamiliar environment, for a substantive period of time. Recently, the Australian National Men’s Health Strategy highlighted the need to tailor existing mental health services to be more engaging for men. In contrast to traditional psychotherapy, which almost exclusively takes place indoors, ‘walk and talk’ therapy in natural settings has potential to engage men for several reasons. First, walking outdoors may represent a less confronting context (e.g., less direct eye contact, shared ownership of physical space). Second, the biophilia hypothesis suggests humans have a ‘biological attraction to natural environments’, and gain health benefits by simply being in nature. Finally, physical activity has a known anti-depressant effect, that can enhance the benefits of psychotherapy. Despite these benefits, no studies have examined the value of walk-and-talk therapy for supporting men. Study aims Primary aim: To test the feasibility of outdoor, walking-based psychotherapy for men with depression compared to usual care (seated indoor therapy). Secondary aim 1: To investigate the preliminary efficacy of outdoor, walking-based psychotherapy for improving the mental health of men with depression compared to usual care. Secondary aim 2: To investigate differences in perceptions of therapy and the therapeutic alliance between men who participant in outdoor, walking-based psychotherapy compared to usual care.
-
Measuring the efficacy of sending personalised, mobile-accessible discharge instructions for opioid pain medicines to patients going home from the hospital ED and surgical outpatient clinic.
In Australia between 2015 and 2019, there were 2731 unintentional deaths due to prescription opioids1. Many consumers are unaware of how to use opioids safely and that opioids can cause addiction and harm. Many consumers are not receiving adequate instructions about opioids from doctors. When instructions are poor, consumers are less likely to receive the benefits of opioid medications and more likely to become opioid dependent. Hospital settings such as the emergency department (“ED”) and the surgical outpatient department (“OPD”) are key risk areas for initiating treatment with opioids for acute pain after injury or surgery. Approximately 16% of patients who received their first opioid medication from a WA hospital between 2014 and 2015 were still taking opioids one year later. The OPIOIDS Trial will be run as a multi-site intervention trial to assess the efficacy of personalised, mobile-accessible patient instructions for opioid medications at discharge from the ED and surgical OPD with patients and doctors.
-
Exploring the Utility of Non-Invasive Coronary Angiography in Suspected Acute Coronary Syndromes with Low Level Troponin Elevation. (EN-ACT): A national study
High sensitivity troponin assays have led to increased numbers of patients presented to the emergency department (ED) for suspected acute coronary syndrome (ACS) now having detectable troponin levels. For those with low level troponin elevated, there is limited evidence to guide care. It is suggested that individuals in this zone, have a higher risk of poor outcomes and the risk versus benefit of invasive coronary angiography (ICA) is less clear as the likelihood of an evolving heart attack is lower. Computed tomography coronary angiography (CTCA), being a less invasive alternate approach, may provide useful information to inform subsequent care to these lower risk patients. This randomised clinical trial aims to investigate CTCA vs. ICA in suspected ACS with low level troponin elevations in the ED. Outcomes will be assessed at 30 day, 6 months and 12 months.
-
An open label study to evaluate the safety, tolerability, and subjective effects of two dimethyltryptamine (DMT) and harmala alkaloid containing formulations in healthy volunteers
The primary purpose of this study is to assess the safety and psychedelic effect of two orally administered DMT and harmala alkaloid formulations provided in separate sessions to healthy volunteers with prior use of these substances. This data will inform the decision to chose one of the formulations for use in a future phase 2 study involving participants with dual diagnosis and major depressive disorder. The potential dose escalation element will focus on determining the psychedelic properties and safety at a range of doses.