ANZCTR search results

This study aims to understand how gum inflammation (gingivitis) may affect the immune system in people with rheumatoid arthritis (RA) or those at risk of developing it. Participants will temporarily stop brushing and flossing for up to three weeks under supervision, allowing researchers to observe changes in the gums and immune responses. The study will compare these changes across three groups: people with RA, those at risk, and healthy individuals. We hypothesise that people with RA will show a stronger immune and bacterial response to gingivitis than healthy individuals. The results may help identify early warning signs of RA and improve strategies to prevent joint flare-ups linked to oral health.

The primary aim of this research study is to investigate the effect of resistance training on body composition in females in or approaching the menopausal transition. The aim of the second study is to investigate if an exercise care management model can maintain physical activity levels in this population. The entire study will be followed by a semi-structured interview to qualitatively assess differences in experiences across the study between participants who finish the trial as either insufficiently active, moderately active and active.

Waiting at least 60 seconds before clamping the umbilical cord ("delayed cord clamping") is recommended in uncomplicated pregnancies to reduce anaemia, death and disability. However, babies with a heart defect diagnosed before birth have not been included in the studies on which these recommendations were based. This study will examine whether delayed cord clamping improves the proportion of red blood cells ("haematocrit”) in the blood of babies born after 34 weeks of pregnancy with a serious heart defect ("critical congenital heart disease") that was diagnosed before birth, compared to early cord clamping. It will also examine the feasibility of a larger definitive trial that would examine whether delayed cord clamping improves health outcomes for these babies in the longer term. Data will be collected to approx. 3-4 months of age, or to approx. 12 months of age subject to further funding. A total of 90 infants will be recruited.

The purpose of this study is to evaluate the effectiveness of an evidence-based peer coaching online parenting intervention (PiP-P2P) as compared to the non-coached self-guided online parenting intervention (PiP) in parents of adolescents aged 12-17 years with emerging mental health problems. The program aims to build parenting skills and confidence by equipping parents with evidence-based parenting strategies that are associated with reduced risk and impact of depression and anxiety disorders in adolescents. The PiP program comprises up to 10 self-guided, online modules covering different topics related to parenting and adolescent mental health. In this trial, we aim to evaluate: 1) the effectiveness of PiP-P2P compared to self-guided PiP in improving parenting skills, parental self-efficacy, parental anxiety and depression symptoms, caregiver strain, carer burden, carer gains, adolescent depression and anxiety symptoms, and adolescent perceived quality of parental support, and 2) whether intervention engagement (percentage of PiP modules and PiP goals completed) mediates the effects of the intervention on parent and adolescent outcomes. We hypothesise that compared to PiP, PiP-P2P will produce greater improvements in parent and adolescent outcomes from pre- to post-intervention and at follow-up. It is also hypothesised that greater improvements in outcomes from PiP-P2P compared to PiP will be explained by greater intervention engagement in PiP-P2P.

This study is testing a new dosing schedule of Lutetium-177 PSMA (177Lu-PSMA), a radioactive treatment for men with prostate cancer that has spread and no longer responds to standard hormone therapy. The aim is to see whether giving 177Lu-PSMA more frequently at the start of treatment can overcome early resistance and improve outcomes. Who is it for? You may be eligible for this study if you are a male aged 18 or over who has prostate cancer that has spread to other parts of the body and is no longer controlled by standard hormone therapy (castration-resistant). You must have evidence of metastatic disease on imaging, a reasonable general health status (ECOG 0–2), a life expectancy of at least 12 weeks, and adequate blood and organ function. Men who have previously received modern hormone therapies such as abiraterone or enzalutamide may be eligible. Study details All participants will be randomised to either arm 1 or arm 2 with different dosing schedules. Depending on when you join the study, you will either receive 7.5 GBq or 8.5 GBq. The first 40 participants randomised on the study (both arms 1 and 2) will all receive 7.5 GBq of 177 Lu-PSMA at each dosing visit. For the next 80 participants (participants 41 – 120), anyone randomised to arm 1 on the study will receive 8.5 GBq of 177 Lu-PSMA at each dosing visit. Participants will receive 177Lu-PSMA treatment according to either the standard schedule or a more frequent dosing schedule. You will have PSMA PET/CT scans, blood tests, and other routine health checks to monitor your response and side effects. It is hoped that this study will help provide important information on whether a new dosing schedule can improve the effectiveness of 177Lu-PSMA and guide future treatment for men with advanced prostate cancer.

The aim of this study is to evaluate the acceptability and feasibility in a real world setting of a tailored intervention developed to assist CSOs of treatment-refusing or non-help-seeking individuals with gambling problems, to encourage the gambler to enter treatment.

The objective of this RCT is to evaluate whether arthroscopically administered local anaesthesia in patients undergoing an anterior cruciate ligament reconstruction and posteromedial meniscal repair results in significant effects on acute pain relief and lower consumption of oral analgesia.

In intensive care units (ICUs), patients are subject to many treatments, which may limit mobility and result in sensory overload and disorientation. More importantly, they have reduced social interaction, which can result in substantial emotional distress. The extended ICU stay often results in long-term psychological consequences, including anxiety, depression, and post-traumatic stress disorder. Although medications can be used, there is increasing uptake of non-pharmacological interventions (i.e. other than medications) to manage these stressors, with Virtual Reality (VR) emerging as a promising solution. VR offers immersive, interactive environments that temporarily distract patients from their surroundings, promoting calmness and emotional regulation. While VR has been used in healthcare (e.g. medical training, pain distraction), it has not been used in ICU. Early studies suggest that VR may reduce stress and anxiety, but its implementation is not standardised, making it difficult to make a clear stand. As such, a structured evaluation of VR’s therapeutic potential in ICUs is needed. This study will help develop standardised VR protocols for ICUs and support future innovation by involving early-career researchers across health, design, and technology. Findings will be shared at conferences and published in high-impact journals to guide future clinical adoption and large-scale implementation.

Myofunctional Research Company have recently developed a novel CPAP connection to their MyOSA S1H oral device. Airflow from a CPAP machine can now be ported into the oral device while a patient with OSA is sleeping. Initial trials in 4 CPAP-compliant OSA patients (during wakefulness) have shown that is possible to deliver CPAP at different pressures without leaks. Furthermore 2/4 of these patients reported that they found it so comfortable that they wanted to take it home immediately after the trial (indicating a potential patient preference over their existing interface). However, to date the efficacy and tolerability of this mode to deliver CPAP has not been tested in OSA patients during sleep. The aims of this study are therefore to; 1. Assess patient comfort and tolerability using the MRC device and compare it to the comfort/tolerability when the patients use their existing nasal/oronasal mask 2. Assess the therapeutic pressure requirement using the MRC device and compare it to the pressure required when the patients use their existing nasal/oronasal mask. We hypothesize that CPAP provided via the MyOSA S1H oral device will be more tolerable and require a lesser therapeutic CPAP level compared to a regular CPAP interface.

The primary purpose of this study is to evaluate if treatment with epcoritamab plus pirtobrutinib will improve outcomes for patients than standard of care R-(mini)-CHOP in patients with previously untreated Richter transformation. Who is it for? Patients over 18 with confirmed CLL and diagnosis of Diffuse Large B-cell Lymphoma (DLBCL)-type Richter's transformation (RT) who have not received prior treatment for RT. Study details This is a randomized, open-label, phase-III study. Arm A consists of patients that will receive standard of care (SOC) R- CHOP or R-(mini)-CHOP. R-CHOP regimen consists of cyclophosphamide, doxorubicin, vincristine, rituximab, and prednisolone. Given in 6 cycles, with each cycle being 21 days. Arm B consists of patients that will receive epcoritamab plus pirtobrutinib. Given in 12 cycles (each cycle is 21 days). Additional treatments will be stem cell transplant and radiation if deemed necessary by treating physician. There will be a cross-over option. If the standard treatment doesn't work, patients can switch to the other treatment arm. To monitor treatment response and safety, several diagnostic tests will be performed, including Positron Emission Tomography (PET)-Computed Tomography (CT) scans, bone marrow biopsies, electrocardiograms (ECG), and laboratory evaluations. These tests help assess disease progression, organ function, and potential adverse effects. It is hoped this research will determine if epcoritamab and pirtobrutinib can improve outcomes for patients previously untreated for RT.