ANZCTR search results

Falls are a major cause of preventable injury, hospitalisation, morbidity, and mortality in older adults. 1 in 3 people aged 65 years or greater living at home experience a fall annually. Emerging evidence indicates obstructive sleep apnea (OSA), a common sleep breathing disorder (~50%) in older people, may be an independent contributor to fall risk. Balance and gait decline with time awake and can vary across the circadian cycle with specific periods of vulnerability (e.g., transition in posture, standing up and toileting). In addition, the severity of OSA varies significantly from night to night, which may exacerbate gait abnormalities and fall risk in older people. There is currently a lack of robust evidence that OSA treatment reduces fall risk, hence, OSA is currently ignored in falls prevention and reduction strategies. To address this knowledge gap, our internationally recognised team of clinicians and researcher experts in sleep health, fall risk prevention and rehabilitation will build on our successful uncontrolled pilot study and propose to conduct a randomised controlled trial (RCT) to : (1) establish if treatment of OSA with 6 months of CPAP reduces fall risk markers and improves daytime gait quality, (2) provide first in field insight into the temporal relationship between night-to-night variation in OSA with next day gait quality to identify periods of potential increased vulnerability to falls. We hypothesise that 6 months of CPAP treatment will reduce fall risk markers and improve walking and balance.

We plan to explore the feasibility of providing human albumin infusions in the home setting by community nurses.

This 3 year study will observe longitudinal changes to vision in glaucoma using two different visual field testing (perimetry) methods. Glaucoma is a disease of the optic nerve in which peripheral vision is lost. Visual damage in glaucoma is typically measured using a visual field test, which measures the ability to see small white-light targets at various locations spread across the visual field. Current visual field tests use the same test pattern for all people with glaucoma. The primary aim of this study is to observe whether alternate test grids enable earlier detection of progressive damage to the visual field. Clinicians use visual field test information in combination with information from imaging of the eye to make decisions regarding whether people need more treatment. The secondary aim of this study is to combine the information from the visual field tests with information from retinal imaging to improve understanding of how glaucoma progresses.

This study is evaluating the safety and properties of 177Lu-RAD204, a PD-L1 antibody joined to a radioactive lutetium isotope. Who is it for? You may be eligible for this study if you are an adult patient with confirmed PD-L1 positive solid tumours including non small cell lung cancer (NSCLC), small cell lung cancer (SCLC), triple negative breast cancer (TNBC), cutaneous melanoma, head and neck squamous cell carcinoma (HNSCC) and endometrial cancer that is unresectable, progressive and for which standard treatment measures are no longer effective. Study details Participants will undergo a Screening Period of up to 4 weeks, followed by a Phase 0 (Imaging) Period for imaging and receiving a single injection of 177Lu-RAD204. If they are able to tolerate this in the following 2 week period, they will then proceed to a Phase I (Treatment) Period where they will be assigned a dose of 177Lu-RAD204 delivered every 6 weeks for 3 cycles. Blood sampling and imaging studies will be performed to determine how the participant is responding to 177Lu-RAD204. Additional treatment cycles (beyond 3 cycles) will be considered if participant is deemed to receive clinical benefit from 177Lu-RAD204 and approved by study Sponsor. Findings from this study will help determine a recommended dose of 177Lu-RAD204 for future exploration

Lower respiratory tract (chest) infections are a common complication in patients placed onto mechanical ventilation (life support) in the intensive care unit (ICU). Patients with brain injuries who require invasive mechanical ventilation may be particularly susceptible to chest infections – the consequence of which may be worsening of their neurological injury. A recent multi-centre randomised clinical trial showed a significant reduction in ventilator associated pneumonia in mechanically ventilated patients after out of hospital cardiac arrest who received prophylactic (preventative) antibiotics starting within 6 hours of cardiac arrest. It is possible that patients with acute brain injuries would also benefit from this strategy as indicated by small pilot studies but it is not known whether this will lead to patient important outcomes such as increased survival with a favourable neurological outcome. This study aims to answer the question, do prophylactic antibiotics reduce the occurrence of lower respiratory tract infections in adults with acute neurological injuries requiring mechanical ventilation. This will then inform the design of a phase 3 trial testing the hypothesis that this treatment regime will increase survival with a favourable outcome at day 180 in these patients.

This study will be conducted in two parts to assess the safety of AT-0174, how the treatment interacts within the body and to determine the maximum safe dose that may be administered to patients with advanced solid cancers. Who is it for? You may be eligible for this study if you are aged 18 years or older and you have been diagnosed with a solid cancer, including but not limited to: non-small cell lung carcinoma, small cell lung carcinoma, triple-negative breast carcinoma, malignant melanoma, gastric carcinoma/gastroesophageal junction carcinoma/oesophageal cancer, colorectal carcinoma, pancreatic ductal adenocarcinoma, epithelial ovarian carcinoma (fallopian, ovarian, primary peritoneal carcinoma), endometrial carcinoma, thyroid carcinoma (non- medullary) or moderate-high grade astrocytoma (brain cancer). Study details This study will be conducted across two parts. In the first sub-study (Part 1), participants who choose to enrol in this study will be allocated to the next available dosing cohort. The first cohort will be asked to take a daily oral capsule of AT-0174 for 7 days, followed by 3 weeks of no treatment. The second cohort will be asked to take a daily oral capsule of AT-0174 for 14 days, followed of 2 weeks of no treatment. The third cohort will be asked to take a daily oral capsule of AT-0174 for 28 days with no breaks. In the second sub-study (Part 2), participants who choose to enrol in this study will be allocated to the next available dosing cohort. This sub-study will ask all participants to take a daily oral capsule of AT-0174 for 28 days with no breaks. The dose of AT-0174 may increase in amount or frequency (e.g., twice per day) with each successive cohort in Part 2, based on a careful assessment of the safety and tolerability of each dose. All participants will have their vital signs (heart rate, blood pressure, temperature, etc) checked and will provide blood and urine samples for testing. In addition, participants will have their cancer assessed using CT, MRI or CT/PET scans during the study. Participants may continue taking AT-0174 for as long as they and their doctor agree. It is hoped this research will determine the maximum dose of AT-0174 that can be administered safely without causing severe reactions. Once the safest maximum dose of AT-0174 has been determined, a larger trial investigating the efficacy of AT-0174 as a treatment for a greater number of cancer patients may proceed.

Currently we are not meeting glycaemic targets using standard care models. This provides the opportunity to review models of care to maximise outcomes. The use of continuous glucose monitor (CGM) data to detect changes in glycaemic control provides an opportunity to adapt our model of care to deliver more personalised and targeted care for young people with diabetes. This trial will test a new model of care, aiming to use CGM data to detect early adverse changes in glycaemic control and provide targeted and tailored intervention to those individuals needing more intensive support. Aim: This study aims to investigate if using fortnightly review CGM for early identification of adverse markers in glycaemic control, with implementation of targeted intervention improves glycaemic outcomes and patient reported outcomes in children living with diabetes compared to those receiving care using the current standard model of care. Objectives: 1) To investigate if targeted intervention based on adverse glycaemic control on CGM metrics improves glycaemic control compared to standard models of care 2) To investigate if patient and family reported satisfaction and outcomes are improved with targeted intervention based on CGM metrics 3) To conduct cost-benefit analysis of targeted intervention compared to standard models of care 4) To conduct post study consultation with consumers and health care professionals for feedback on the study and relevant comments on next stages of digital dashboard development Hypothesis: 1. Using fortnightly review of digital CGM upload for early identification of adverse changes in glycaemic control with targeted personalised clinical intervention can improve overall glycaemic control and patient and family satisfaction compared to 3-monthly review at multidisciplinary appointments.

Individuals with Cerebral Palsy who are reliant on wheelchairs for mobility have significantly reduced options for participating in physical activity and movement. For those with significant disabilities encompassing not only the musculoskeletal system but also cognition, behaviour and communication face a unique set of challenges requiring new and novel treatment options. In addition to the barriers of access and transport consideration also needs to be given to the timing of medications and feeds. The MOTOmed is a motorised movement (cycling) device, accessed from a person’s wheelchair that provides an option to move for non-ambulant adults with CP. The passive rhythmical cycling motion provides movement at the hip, knee and ankle joints that is otherwise not possible for those with a lack of independent and functional active movement. This movement opportunity may be beneficial given that adults with CP are otherwise in static postures for the majority of their day and night. The primary study aim is to investigate the effects of physical activity on cardiometabolic biomarkers in non-ambulant adults with CP. Commonly used measures of increased physical activity such as strength, walking speed and distance are not able to be used in this group of adults. Blood markers offer a way to measure the effects of physical activity with change possible within 1 to 3 months of moderate intensity exercise training in able-bodied individuals. Changes are anticipated to occur in the proposed population as participants are beginning from an extreme low or non-existent level of activity. The secondary study aim is to explore the experience of MMT including any perceived benefits and burdens.

The primary aim of this project is to evaluate the efficacy of shoe inserts in the treatment of pain associated with osteoarthritis of the midfoot. This study is a parallel group, participant- and assessor- blinded, randomised controlled trial with a 12 week follow-up. One-hundred and forty participants will be randomised to receive one of two types of shoe inserts. All participants will receive clinical guideline-based information and support. Primary and secondary outcome measures will be collected at baseline and at 4, 8 and 12 weeks. The primary outcome measure will be the severity of average pain in the midfoot whilst walking in the last 7 days, scored using an 11-point numerical rating scale (NRS). Secondary outcome measures will include function, self-reported global rate of change, level of physical activity, general health-related quality of life, use of co-interventions and adverse events.

Assessing whether applying a different technology to access the inside of the oocyte is beneficial for patients with previous poor fertilisation or high number of degenerate oocytes after using conventional ICSI. Use of piezo-ICSI will be determined by the IVF specialist after consultation with the patient. Monitoring of fertilization rates, utilisation rates and pregnancy / birth rates will be assessed.