ANZCTR search results

In this randomised, double-blind, placebo-controlled study, 80 peri- or early post-menopausal women aged 40 to 65 years who believe that their cognitive function has worsened since the transition into menopause will be randomly assigned to receive either a curcumin extract (Curcugen) or a matching placebo for 12 weeks. Changes in cognitive performance, self-reported menopausal symptoms, brain fog, and general wellbeing will be assessed over time. Moreover, to examine potential mechanisms of action, changes in blood markers associated with inflammation, glucose regulation, and appetite markers will be evaluated.

Brief description of the study purpose This study aims to evaluate whether a structured psychological skills program (the MyWell program) can improve mental health and wellbeing for people living with multiple myeloma. Who is it for? You may be eligible for this study if you are an adult living in Australia aged 18 years or older who have been diagnosed with multiple myeloma or smouldering myeloma and are able to participate in an online program. Study details Participants who are eligible will be randomly assigned to one of two groups. One group will take part in a seven session online psychological wellbeing program delivered via Zoom, where they will learn practical skills such as mindfulness, coping strategies, and ways to manage thoughts and emotions. Sessions are delivered in small groups by experienced myeloma nurses, and participants will also receive a workbook to support their learning. The other group will receive usual support resources, such as information sheets and access to support services, during the first phase of the study, and may access the program later. Participants will complete questionnaires about their mental health, including symptoms of anxiety and depression, as well as overall wellbeing and quality of life. It is hoped this research will show whether a structured, nurse led psychological program can improve mental health outcomes and provide better support for people living with myeloma.

This study aims to compare two commonly used pain-relief techniques given during anterior cruciate ligament (ACL) reconstruction surgery using hamstring tendon grafts. After ACL surgery, some patients experience significant pain and require opioid pain medicines, which can have unwanted side effects. Participants undergoing ACL reconstruction at Hornsby Hospital will be randomly assigned to receive one of two regional anaesthetic techniques in addition to standard pain management: an adductor canal block with local anaesthetic infiltration, or an IPACK block with local anaesthetic infiltration. Both techniques are routinely used in clinical practice. The main aim of the study is to determine whether one technique leads to lower opioid use in the first week after surgery. The study will also compare pain levels, patient satisfaction, and knee-related recovery outcomes over the first three months following surgery. We hypothesise that patients receiving the IPACK block will require less opioid medication and experience better early pain control compared with those receiving the adductor canal block.

The trial aims to assess the associations between the personality trait Extraversion and preferences for social physical activity (“we-exercise”) versus solitary physical activity (“me-exercise”), and between Extraversion and changes in affective responses in social physical activity versus solitary physical activity. The research question underpinning this trial is "Does the level of person-environment fit in facet Gregariousness moderate the relationship between moderate intensity exercise and affect?" It is hypothesised that person-environment fit will moderate the relationship between moderate intensity exercise and affect.

This study investigates whether playing recorded maternal heartbeat sounds to babies after surgery can improve their recovery. The researchers hypothesise that this familiar, soothing sound will reduce pain, improve physiological stability (such as heart rate, breathing, and oxygen levels), and decrease the need for pain medications. The main outcome will be differences in pain scores over the first 48 hours after surgery, while secondary outcomes include cardiorespiratory stability, analgesic use, stress hormone levels, and parent satisfaction. Overall, the study aims to test a simple, low-risk intervention that could enhance comfort and recovery for vulnerable newborns.

Hearing loss in midlife is one of the biggest modifiable risk factors for a dementia diagnosis in later life. Sleep issues are also associated with both hearing loss and dementia but the link between hearing device use, cognitive decline and sleep is poorly understood. HAVENS will address this knowledge-gap in an Australian-first prospective study that uses a combination of innovative sensing techniques to assess cognition (electroencephalogram and functional near infrared spectroscopy sensing technologies), brain health (magnetic resonance imaging), sleep (domestic sleep sensing mattress), and physiological measures (wristband oximetry sensor for heartrate, breathing rate and oxygen saturation) in adults using hearing devices (103 hearing aid and 37 cochlear implant users). This project represents a paradigm shift as it will advance understanding of the impact of hearing interventions on human health.

In this randomised, double-blind, placebo-controlled study, 120 men aged 40 to 65 years experiencing self-reported stress and fatigue will be randomly assigned to receive Shatavari extract 300 mg plus BioPerine 5 mg, Shatavari extract 500 mg, or placebo once daily for 8 weeks. Changes in self-reported stress, fatigue, mood, sleep, and interest in sexual activity will be assessed over time. Changes in hand grip strength, heart rate variability, bioimpedance phase angle, testosterone, and high-sensitivity C-reactive protein will also be examined.

The purposes of this study are to clinically screening for developing Alzheimer’s disease in ageing populations using recently validated macrostructural biomarker of entorhinal cortex to test if human milk supplements, Lactoferrin, could slow down the process of developing Alzheimer’s disease, and to test if macrostructural changes are correlated with microstructural changes within the entorhinal cortex.

Admission to the Neonatal Intensive Care Unit (NICU) can be a stressful and challenging experience for families. The Neo Bloom study aims to explore the experiences of parents and the perspectives of neonatal healthcare professionals to better understand families' educational, communication and emotional support needs. Participants will complete an online survey, and some will be invited to participate in a collaborative workshop to help co-design concepts for a future digital support resource. We hypothesise that understanding parent and staff experiences through a co-design approach will identify opportunities to improve family-centred care and inform development of a practical digital support resource for NICU families.

Ulcerative colitis (UC) is an immune mediated disease that causes sores in the large bowel and symptoms such as diarrhoea, passage of blood and abdominal pain. Acute severe ulcerative colitis (ASUC) is the most severe form of this condition, which requires admission to the hospital for treatment with intravenous steroids as their first line of treatment. In this randomised open label trial, we will aim to explore whether the addition of Upadacitinib, a medication belonging to family of drugs known as janus kinase (JAK) inhibitors, to intravenous steroids is effective, feasible and safe. The primary aims of this pilot study are to determine if, in patients admitted to hospital with ASUC, upadacitinib in addition to steroids is more effective than steroid treatment alone in inducing clinical response and reducing the need for rescue therapy by Day 5 of admission, and whether this strategy is feasible, and safe. The secondary aims include evaluation of efficacy of upadacitinib in improving symptomatic and biochemical response at day 5; likelihood of colectomy during index hospitalisation; cost and duration of index hospitalisation. We hypothesise that upadacitinib in addition to corticosteroids will be more effective that corticosteroid treatment alone in inducing response and reduce need for rescue therapy, and will be a feasible and safe strategy.