ANZCTR search results

What the study is about: This study will evaluate whether a fixed-duration combination of Sonrotoclax, BGB-16673 (A Bruton Tyosine Kinase (BTK) chimeric degradation activation compound (CDAC)), and Rituximab can achieve deep and durable responses in patients with Waldenström Macroglobulinaemia (WM). The goal is to assess safety, tolerability, and efficacy, focusing on achieving Very Good Partial Response (VGPR) and measurable residual disease (MRD) negativity. Who is it for: It is for adults with histologically confirmed WM who are either treatment-naïve or BTK inhibitor-naïve relapse refractory (RR) and meet criteria for requiring therapy. Study details: This is an open-label, multicentre Phase II trial with two cohorts (treatment-naïve or relapsed and refractory patients with no prior BTK inhibitor treatment). Participants will receive 25 cycles (28 days each) over approximately two years: • BGB-16673 from Cycle 1 • Sonrotoclax added from Cycle 2 • Rituximab introduced from Cycle 4-Cycle 7 and then every 3 cycles. The study aims to recruit 80 patients across Australia, UK, and Canada. The primary endpoint is the rate of VGPR at end of treatment. What is hoped from it: This 2 year fixed-duration, targeted treatment strategy aims to achieve deep and durable responses while reducing long-term toxicities compared to continuous Bruton Tyrosine Kinase inhibitor (BTKi) therapy or chemoimmunotherapy, which is the current standard of care for WM. The goal is to improve both clinical outcomes and quality of life for patients with WM.

Physical inactivity is a global health problem causing 5.3 million deaths per year and costing healthcare systems $53.8 billion worldwide in 2013. Those who are most profoundly inactive account for a disproportionately high percentage of the deaths and healthcare costs that are attributable to physical inactivity, thus strategies which target those with low activity are required. People with moderate to severe traumatic brain injury (msTBI) are particularly inactive in the long-term, increasing the risk of preventable disease and compounding the primary effects of TBI in this typically young adult population. Our team was funded by the Medical Research Future Fund TBI Mission to develop the first Physical Activity Clinical Practice Guideline for people living with msTBI (Stage One). Our guideline was developed for the Australian context in collaboration with key stakeholders, including people living with msTBI, their families, carers and health professionals. It includes 10 recommendations for children, adolescents, adults, and older adults living with moderate to severe TBI for the delivery and promotion of physical activity across the continuum of care. The next phase of this work is to conduct implementation research to support national adoption of clinical guidelines for people with msTBI. We plan to conduct a hybrid type III implementation-effectiveness cluster RCT in 20 rehabilitation services across Australia. The trial aims to evaluate the effectiveness of implementation support to teams of health professionals working in rehabilitation services to increase concordance with the Australian Physical Activity Clinical Practice Guideline recommendations for people with msTBI (immediate-implementation sites) compared to services who do not receive implementation support (waitlist sites). Qualitative and economic sub-studies are embedded within the trial. We will initially collect service-level data and work with sites to identify implementation support strategies for each participating site during a service mapping process for all teams. Sites will then be randomised into either immediate implementation support or delayed implementation support (waitlist control). Teams in the immediate implementation support will receive a tailored implementation strategies for 3-months to support the prescription and promotion of physical activity interventions consistent with the guideline recommendations. Teams in the delayed group will receive the implementation strategies after collection of the primary outcome (6-months). We hypothesise that health professionals in the immediate implementation support group will demonstrate higher levels of concordance with the guideline recommendations compared with health professionals in the delayed group.

This project will determine whether the codesigned, MOVE Together: Reduce Falls program is effective at improving walking, balance and leg strength (physical function), evaluate the cost-effectiveness and explore issues around implementing the program. Participants who take part in the research will be people over 65 years of age from Italian, Greek, Vietnamese, Chinese (Cantonese- and Mandarin- speaking) and Arabic-speaking communities. Participants will be randomly assigned to either receive the MOVE Together: Reduce Falls Program or educational resources around exercise and falls prevention in their preferred language. The MOVE Together: Reduce Falls program is delivered by a physiotherapist over 10-12 sessions and includes exercise prescription and behaviour change strategies to support long term engagement. Participants will undergo three assessments to asses walking, balance and strength and record falls they have during the 12 months period.

Mental health disorders are seen in up to 30-50% of people involved in traffic accidents. Post-traumatic stress disorder (PTSD) and depression are common mental health disorders experienced by survivors of traumatic incidents and are predictive of poor recovery. Research suggests that providing psychosocial rehabilitation programs and early intervention/identification is paramount. This study will involve providing Social work and psychology input to patients who report anxiety following a traumatic injury. This will occur at 4-6 weeks post acute hospital discharge. The outcome will be their self reported anxiety/distress at 6 months post injury.

The MyPREP-ED trial is a hybrid randomised controlled effectiveness and implementation feasibility trial of a of a peer supported self-management intervention “My Personal REcovery Plan for young people in Early psychosis services who are approaching Discharge” (MyPREP-ED). The goal of this study is to see how well the MyPREP-ED program works to help young people to learn how to manage their own mental health condition. The program is delivered with the support of a Peer Support Worker who also has experience living with a mental health condition. Our aim is to get feedback from participants about whether MyPREP-ED is more helpful than ‘usual care’. MyPREP-ED is a program made by members of this research team with the help of people with lived-experience of mental ill-health. MyPREP-ED is a personal recovery plan and supports people to map out the strategies that help to keep people well, manage those ups and downs, move on from a crisis if one comes their way, and make active, meaningful and purposeful plans for now and the future.

The main goal is to gather basic information on how body composition and blood sugar control are connected after a kidney transplant. This information will help in developing future strategies, such as diet, lifestyle changes, or medications, to prevent early metabolic issues and enhance the success of the transplant and the health of the patient

Preterm infants often struggle to maintain body heat immediately after birth, and the standard practice is to transfer them to the neonatal intensive care unit (NICU) inside a pre-warmed incubator. Skin-to-skin care or kangaroo care, holding the baby skin-to-skin against a person's chest, has proven benefits for temperature control and bonding, but it has not been widely tested during the actual transport from the delivery room to the NICU in high-resource settings. This non-inferiority trial will compare skin-to-skin care transport, using a secure parent-worn vest, against the standard incubator method. The primary outcome will be the neonate’s temperature at NICU admission. Secondary outcomes will assess safety, feasibility, and parental experience. If kangaroo care transport is shown to be non-inferior to transport incubator in maintaining thermal stability, without additional risks, it could provide a more family-centred alternative that keeps infants close to their parents from the very first moments of life.

This study is evaluating the feasibility of Can Walk Can Run, a program that was co-developed to support physical activity and healthy lifestyles in people affected by cancer. Who is it for? You may be eligible for this study if you are a community dwelling adult living with or beyond any type of cancer and are able to walk independently. Study details The intervention will include a ‘couch to 5k’ style walking and running program delivered in outdoor locations, in-person for up to 12-weeks, supported by education and social support. Audit of study records, surveys/questionnaires, and participant interviews will determine feasibility. It is hoped that findings from this study will provide insight into how to support physical activity and healthy lifestyles in people affected by cancer.

The purpose of this clinical trial is to compare a custom made (3D-printed) biodegradable (polymer called polycaprolactone or PCL) mesh with a custom made (3D-printed) metal (titanium or Ti) mesh in the reconstruction of jaw bone deficiency. Currently there is no ideal technology for the treatment of large or complex jaw bone deficiencies. We have developed a biodegradable, customizable, 3D printed mesh to regenerate alveolar (jaw) bone (the part of the skull bone that houses the teeth) to allow for dental implant placement. The use of a biodegradable, customized and accurate device may lead to advantages such as reduced surgical time, improved patient recovery and improved ridge contour when compared to the control device. This specific material called Polycaprolactone (PCL) is already approved in Australia for use in sutures, screws and dermal fillers. However, it is not approved to treat jaw bone deficiency. Therefore, it is an experimental treatment for jaw bone regeneration.

This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of NAV 242 in healthy participants. Approximately 48 healthy adult volunteer participants, in Part A and Part B (up to 6 cohorts with 8 participants per cohort). Each part of the study will include a screening period of up to 6 weeks, a treatment period of 4 days (Part A), 32 days (Part B Cohort B1), or 60 days (Part B Cohort B2) and a follow up period of 24 weeks. The approximate total study duration is 30 weeks for each participant in Part A, 34 weeks for each participant in Part B Cohort B1, and 38 weeks for each participant in Part B Cohort B2.