ANZCTR search results

The purpose of this study is to find out if BEL536is safe and tolerable in healthy adults. BEL536 is a synthetic protein called a bispecific antibody which can recognise and block pathways to help reduce inflammatory responses in the body. Bispecific means that BEL536 can attach to two different targets at the same time. This is the first time BEL536 has been tested in humans and aims to assess the effects of BEL536 on healthy volunteers. 

Resair 3 is a phase 3 pragmatic multicentre, consent waiver, cluster randomised cross-over study of 51 hospitals in 9 countries that will recruit 481,774 term or near term infants (gestation >35 weeks) within 12 months to initial respiratory support with either air (21% O2) or pure (100% O2). O2 concentrations will be titrated according to preductal O2 saturations (SpO2) of healthy, full-term infants (1). The primary outcome is the need for advanced resuscitation interventions (one or more of the following: 1. Endotracheal intubation/supraglottic airway 2. Cardiac compressions 3. Adrenaline) and death before hospital discharge. Resair 3 will use interventions and data collection methods that are part of routine care. The hypothesis is that initiating resuscitation of term/near term infants with 100% oxygen and then titrating according to clinical condition and oxygen saturations will lead to reduction in the need for advanced resuscitation interventions and death before hospital discharge, compared to initiating resuscitation with 21% oxygen and then titrating upwards.

OV329 [(S)-3-amino-4-(difluoromethylene) cyclopent-1-ene-1-carboxylic acid hydrochloride salt] is a gamma aminobutyric acid (GABA) aminotransferase (GABA-AT) inhibitor that is being developed as an antiseizure medication for seizure disorders in adults and pediatric patients. Part A will consist of up to 2 cohorts, comprising 8 participants each. Dosing will be initiated at 7 mg/day. Subsequent cohorts will be dosed as recommended by the Data Review Committee (DRC) based on the safety, tolerability and PK of OV329 from the previous cohort. Part B will consist of 2 planned cohorts comprising 8 participants each. Subsequent cohorts will be dosed as recommended by the DRC based on the safety, tolerability and PK of OV329 from the previous cohort (based on review of the Day 30 data, including ophthalmological assessments). Participants will be dosed for a total of 7 days.

This study aims to understand how a new anti-cancer drug ATNM-400 ([²²5Ac]-barecetamab-DOTA) behaves in the body, to determine a safe dose range, and to assess its early signs of anti-tumour activity. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with metastatic prostate cancer that has not responded to surgery and you have undergone at least one previous round of chemotherapy. Study details Participants who choose to enrol in this study may be invited to participate in one of three parts. Part A - participants will have a dose of [89Zr]-barecetamab-DFO injected into a vein and will then undergo PET-CT imaging. These participants will also be asked to provide blood samples for up to 6 hours after their injection. Part B - participants will be given a dose of ATNM-400 ([²²5Ac]-barecetamab-DOTA) injected into a vein once every 6 weeks. If participants don't experience any extreme side effects, they may have this treatment repeated up to 4 times. Different groups of participants will be enrolled to assess higher doses of ATNM-400 ([²²5Ac]-barecetamab-DOTA) for this part. Part C - participants will be give a dose of ATNM-400 ([²²5Ac]-barecetamab-DOTA) injected into a vein once every 6 weeks. If participants don't experience any extreme side effects, they may have this treatment repeated for up to 1 year. Participants in Part B and C will also be asked to provide further blood samples while receiving ATNM-400 and to undergo additional PET-CT and possibly MR imaging. It is hoped this research will determine if ATNM-400 anti-cancer treatment could be developed further for patients with advanced prostate cancer who have limited treatment options.

Community acquired pneumonia is a common cause of hospital admission and can be life-threatening. Despite effective antibiotics, some patients develop complications, need intensive care, or die. Vitamin C is a natural antioxidant important for immune function and healing. Patients who require hospitalisation with infections like pneumonia often have low vitamin C levels. Giving vitamin C may help recovery, but this has not been tested in a large clinical trial in pneumonia. The purpose of this study is to determine whether vitamin C supplementation improves outcomes in patients hospitalised with pneumonia. We believe that Vitamin C supplementation in people who have pneumonia will lead to improvement in outcomes. We will be studying if the use of Vitamin C will reduce the time to recovery, affect length of hospital stay and improve post-discharge quality of life.

The aim of this study is to evaluate and compare the efficacy and cost-effectiveness of online and in-person delivery of a staff professional development program for the promotion of physical activity and healthy eating in outside of school hours care (OSHC) services. Services will be randomly assigned to one of three groups: a high-intensity support group, a low-intensity support group, or a control group. We expect that services receiving the professional development program will show greater improvements in children’s physical activity levels and healthy eating practices compared with the control group.

The purpose of this research study is to assess the safety and practicality of using wearable devices to monitor vital signs, such as heart rate, temperature and blood pressure, in patients receiving chemotherapy and/or immunotherapy for relapsed/refractory myeloma. Who is it for? you may be eligible for this study if you are an adult who has been diagnosed with relapsed/refractory myeloma. Study details Participants will wear remote monitoring devices for 30 days following the administration of chemo-immunotherapy or CAR-T cell therapy. Vital signs will be checked 4 times a day for 30 days, participants will complete some quality-of-life questionnaires at the end of the monitoring phase and follow-up data will be collected for 100 days. This study is to inform current clinical practice incorporating wearable device technology with a goal to assist patients into the earliest, and safest, timeframe for community-based care while receiving chemo-immunotherapy and cellular therapies.

The WoundView pilot study responds to the urgent need to develop a digital solution bringing together wound analysis within video telehealth and increase access to wound care in Residential Aged Care Homes. A set of digital tools that use simple and affordable technology to collect, analyse, and track wound images will be tested, and included in an existing secure video telehealth platform (Coviu). The tool, WoundView, will allow for timely access and improved wound care. The aim of this study is to assess the benefits and costs of WoundView and identify factors associated with successful implementation of WoundView.

This is a prospective interventional clinical study which evaluates the reliability of the Nutromics Sensor Device measurements of vancomycin concentrations in interstitial fluid (ISF) that correlate with its serum concentrations under varying environmental and physiological conditions. The study will enrol up to 70 healthy participants in this clinical study.

Emergency care settings are high-stress environments that affect both patients and healthcare workers, with acute stress responses influencing recovery, morbidity, and long-term mental health. If unmanaged, physiological stress reactions can escalate into chronic conditions such as PTSD, depression, and anxiety. This study evaluates the WeCare program, a wearable-integrated stress management intervention that provides real-time physiological feedback to enhance self-regulation and resilience. Using a single-case experimental design, the WeCare program will be tested for feasibility, effectiveness, and economic impact across four vulnerable groups: (i) mild-to-moderately injured patients, (ii) severely injured patients, (iii) individuals with acute medical symptoms, and (iv) emergency healthcare workers. Findings will inform scalable, early interventions to improve mental well-being and health outcomes in emergency care settings.