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Healthy Mums and Bubs - Birthing in Our Community (BiOC): Gold Standard Indigenous Maternal & Infant care
Expand descriptionBirthing in Our Community (BiOC) is an Aboriginal and Torres Strait Islander-designed and led maternity care and family support program initially established in 2013 in South Brisbane (QLD, Australia) by the Institute for Urban Indigenous Health (IUIH), together with its partner organisations, the Mater Mothers Hospital and the Aboriginal and Torres Strait Islander Community Health Service Brisbane (ATSICHS Brisbane, a member organisation of IUIH). An initial evaluation of BiOC’s outcomes from 2015 - 2019 has shown a significant reduction in preterm births (between 43% and 50%) and increases in healthy-weight babies, antenatal visits, and exclusive breastfeeding at hospital discharge. Building on the success of BiOC Brisbane South, IUIH and its member Aboriginal Community Controlled Health Services have secured resources to support the expansion of the BiOC Model into three new locations: Brisbane North, Logan, and Brisbane Bayside. The intent is to eventually enable all Aboriginal and Torres Strait Islander families across the urban Southeast Queensland region to have the BiOC model available as an option for their birthing care.
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Supporting Mental Health in Regional and Rural Communities: Developing and Testing SOLAR-R apps
Expand descriptionThis triple-blind randomised controlled trial will compare an AI-enhanced mental health app (SOLAR-R+) with an otherwise identical version without AI enhancement (SOLAR-R). We will recruit 650 adults aged 18 years and older who live or work in regional, rural, or remote Australian communities, or who have strong family, personal, or community ties to one. Both apps are adapted from the Skills fOr Life Adjustment and Resilience (SOLAR) program and deliver evidence-based psychosocial skills designed to support recovery and wellbeing following stress or trauma. The study will examine whether the addition of an embedded AI assistant improves symptoms of posttraumatic stress, depression, and anxiety, as well as quality of life, user engagement, and health service utilisation compared with a standard, non-AI-enhanced version of the same app. Participants will complete self-report measures at baseline, end-of-treatment (7 weeks), and 3-month follow-up (19 weeks).
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A study to evaluate the activity and safety of pembrolizumab in combination with sacituzumab tirumotecan in mismatch repair proficient advanced or recurrent endometrial cancer
Expand descriptionBrief description of the study purpose The IMPACT study is a Phase 2 clinical trial investigating whether a combination of pembrolizumab (an immunotherapy) and sacituzumab tirumotecan (Sac-TMT, a targeted chemotherapy delivery treatment) can safely and effectively treat endometrial cancer that has returned or spread. The study aims to determine whether this combination can improve tumour control while remaining well tolerated. Who is it for? You may be eligible for this study if you are aged 18 years and older with recurrent or advanced endometrial cancer that cannot be treated with curative surgery or radiotherapy. Participants must have mismatch repair proficient (pMMR) disease, measurable cancer on imaging, good physical functioning, and adequate organ function. Study details All those who are eligible will receive the combination treatment. Pembrolizumab will be given as an intravenous (IV) infusion every 6 weeks for up to 2 years, and sacituzumab tirumotecan will be given as an IV infusion every 2 weeks for up to approximately 3 years, or until the cancer progresses or side effects become unacceptable. All enrolled participants will receive the same treatment combination. Participants will attend regular study visits and undergo assessments including physical examinations, blood tests, imaging scans to measure tumour response, and monitoring for side effects and overall health. It is hoped that this research will help determine whether combining pembrolizumab with sacituzumab tirumotecan is an effective treatment option for people with recurrent or advanced endometrial cancer and may contribute to improved treatment outcomes in the future.
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Validation of Biobeat Wearable Patch for Blood Pressure Monitoring in Pregnant Women
Expand descriptionThe assessment of blood pressure (BP) is the cornerstone of antenatal, intrapartum, and postnatal care. Accurate measurement of BP enables the diagnosis and management of hypertensive disorders of pregnancy, including chronic hypertension, gestational hypertension, and preeclampsia. In recent years, a range of cuffless, non-invasive technologies have emerged for blood pressure measurement. A key advantage of these devices is that they can capture blood pressure frequently – either at short, repeated intervals or continuously—without the discomfort and practical limitations of cuff inflation. By avoiding arterial occlusion, they may offer a more convenient and acceptable approach to blood pressure monitoring in both hospital and ambulatory settings. Further, these devices may offer advantages in the setting white coat hypertension. Many of these systems rely on photoplethysmography (PPG) signals, and several have already obtained commercial regulatory clearance in the United States and/or Europe and Australia. PPG-based monitoring is a means of beat-to-beat BP monitoring. In PPG-based monitoring, a light source is applied to the skin, and a photodetector measures the reflected light from the tissue. The detected light can be used to measure blood volume changes and thus BP. The aim of this study is to prospectively evaluate the accuracy of BP measurements obtained from a novel, commercially available cuffless, non-invasive PPG-based chest patch monitor (Biobeat, Biobeat Medical Smart Monitoring) during pregnancy. BioBeat is a 3cm x 3cm diameter sensor which can be applied to the upper torso and relies on PPG-based monitoring to provide beat-to-beat BP readings. The device requires 1-3 blood pressure entries from a cuff-based calibration for initialisation. The patch can be applied by the research team, and patients can continue to go about their day as normal. Should the clinical efficacy of this monitor be proven in pregnant women, there is room for it to be adopted for use in antenatal and postnatal care and optimise monitoring of women with HDP.
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A Phase Id, Randomised, Double-Blind, Placebo-Controlled, Multiple-Dose Bridging Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of XKH001 in Healthy Adult Caucasian Participants
Expand descriptionThis study will evaluate XKH001, a recombinant anti-IL-25 humanised monoclonal antibody given as subcutaneous injections, in healthy adult Caucasian volunteers. The main purpose is to describe the pharmacokinetics, safety and tolerability of repeated XKH001 doses and to compare drug exposure with existing Chinese clinical data to support ethnic bridging. Sixteen participants will be enrolled into two sequential dose cohorts. Participants will receive either XKH001 300 mg or 600 mg, or matching placebo, on Day 1, Day 29 and Day 57, with follow-up to Day 169. The study will also evaluate immunogenicity and exploratory laboratory biomarkers related to type 2 inflammation.
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A Study in Adult Volunteers to Understand the Safety and Effects of a New Drug, PTC612 with Food Effect (Part2)
Expand descriptionThis study is an early-stage clinical trial to check whether a new medicine called PTC612 is safe for healthy adults to take. The study will also look at how the medicine moves through the body and whether eating food before taking it changes how the body absorbs it. Some participants will receive a single dose, others will receive the medicine for several days, and some will take it with or without food. Blood samples will be collected to measure the amount of medicine in the body and to look at substances related to inflammation. The study is based on the idea that PTC612 can be taken safely and may help reduce inflammation, supporting its future use in inflammatory diseases.
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A Study in Adult Volunteers to Understand the Safety and Effects of a New Drug, PTC612 - Part 1 (Single Ascending Dose) and Part 3 (Multiple Ascending Dose)
Expand descriptionThis study is an early-stage clinical trial to check whether a new medicine called PTC612 is safe for healthy adults to take. Blood samples will be collected to measure the amount of medicine in the body and to look at substances related to inflammation. The study is based on the idea that PTC612 can be taken safely and may help reduce inflammation, supporting its future use in inflammatory diseases.
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Effect of a circadian-informed light intervention on depression in individuals taking an antidepressant
Expand descriptionBy the year 2030, depression is projected to the leading cause of disease burden worldwide. Although 1 in 10 Australians are currently taking an antidepressant medication, as many as 45% of patients will not respond to the beneficial effects of antidepressants. Depression is commonly associated with disrupted sleep and circadian ('body clock') rhythms, which rely on light from the environment. Previous research has found that there are individual differences in the sensitivity towards light, especially in patients taking Selective Serotonin Reuptake Inhibitors (SSRIs; the most common antidepressant medication). The increase in the effect of light from antidepressant medication on patients with depression may depend on the individual’s light exposure patterns. Individuals who tend to expose themselves to irregular light patterns especially at night, report poorer responses to SSRI treatment and increased depression during SSRI treatment compared to those that tend to seek bright light during the morning. Therefore, reducing evening home lighting and encouraging increased daylight exposure may enhance antidepressant efficacy. We aimed to investigate the ability of a circadian-informed light intervention to increase the beneficial effects of light and reduce the adverse effects of light on depressive symptoms and insomnia symptoms for individuals taking an SSRI.
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Attitudes, Drivers and Opportunities for Long-Acting Injectable Antiretroviral Therapy: Australian Healthcare Practitioner Perspectives
Expand descriptionLong-acting Antiretroviral Therapy (LAI ART) for the treatment of HIV infection has been available in Australia since April 2022, when long-acting injectable cabotegravir and rilpivirine (CAB + RPV) became available on the PBS (Pharmaceutical Benefits Scheme). LAI ART represents a new era of HIV treatment as previous regimens all required a commitment to life-long adherence to daily oral therapy (tablets). In both pre- and post-registrational studies, LAI ART demonstrated efficacy, safety, and tolerability equivalent to standard of care oral therapy with significant transformative benefits in multiple patient reported outcomes, including experience of stigma and wellbeing. Despite this, uptake of LAI ART is highly variable across states and health services. ADOPT LAI seeks to understand the attitudes and drivers of oral versus LAI ART uptake among HIV healthcare services across Australia.
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Can Eye Movement Desensitisation and Reprocessing (EMDR) therapy work in public mental health services? A pilot study
Expand descriptionMany people who get help from mental health or drug and alcohol services have PTSD or have been through trauma. Eye Movement Desensitisation and Reprocessing (EMDR) is a type of talking therapy that helps with trauma. It often takes fewer sessions than other therapies. This study will look at how helpful and easy to use EMDR is for people in Brisbane public mental health and drug and alcohol services. 50 participants will be screened and 30 will choose to take part in EMDR therapy. We will monitor their trauma symptoms, how many sessions they attend, their service duration, if they stay in the study, and if they go to hospital or the emergency department. We hope the study shows that EMDR is helpful, easy for people to take part in, improves symptoms, reduces hospital visits, and improves daily life.