ANZCTR search results

The purpose of this Phase 1 study is to evaluate the safety, tolerability and PK profile of Smartech Aspirin, applied daily to the skin for 10 days, compared to topical vehicle control and orally administered immediate release (IR), low dose aspirin in healthy adult participants. The study will be initiated with 2 treatment cohorts as follows: 1. Topical Cohort (randomized, double-blind, vehicle-controlled): up to 10 evaluable participants will be enrolled and randomized to receive Smartech Aspirin (2 pumps of a nominal 179 mg per pump; 358 mg total per day) or vehicle control in a 4:1 ratio (8 active: 2 vehicle control), to be applied topically once daily (QD) for 10 days. 2. Oral Cohort (open-label): up to 8 evaluable participants will be enrolled and treated with oral, IR, low dose aspirin (81 mg) dosed QD for 10 days. Up to 2 additional cohort(s) of 10 participants each; i.e., Cohort A2 and Cohort A3, may be enrolled to further investigate the safety, tolerability and PK/PD of Smartech Topical Aspirin gel.

This study aims to directly compare the laboratory findings from samples collected from 10 healthy volunteers with results from a laboratory bladder infection model, using similar antibiotic therapy dosing. Laboratory testing involves measuring concentrations of amoxicillin and clavulanate in urine, assessing the activity of the antibiotic against E. coli uropathogens, and studying how the antibiotic affect the healthy microorganisms in the urinary tract, called the urobiome. Results from this study will validate the utility of the laboratory bladder infection model and help guide future research. This includes finding the best doses of antibiotics and testing other types of antimicrobials.

Piano training using creative improvisation provides opportunities for autonomy-supportive learning where participants can self-direct and express themselves through their musical play. Piano training using traditional methods often requires precise replication of music notation. This study aims to investigate the cognitive and wellbeing benefits experienced by older adults who participate in piano improvisation training compared to those who engage in traditional piano instruction, with particular attention to individuals who report memory concerns, formally referred to as subjective cognitive decline.

This study aims to improve how anticancer drugs and blood transplant and cellular therapy (BTCT) treatments are given to patients. Many of the medications used—such as chemotherapy agents and immune-modulating drugs—can affect people differently depending on their age, body composition, organ function, and genetics. Some of these drugs stay in the body for a long time and may cause serious side effects or influence how well the treatment works. Who is it for? You may be eligible for this study if you are a male or female of any age scheduled to receive precision medicine drugs as part of cancer treatment or BTCT therapy for both malignant or non-malignant disease. Study details For those who chose to participate in this study no changes will be made to the prescribed treatment regimen by the study team. Drug infusion rates are guided by drug-specific prescribing information, clinical guidelines, and may also be protocol-driven. This study will measure drug levels in the blood over time (called pharmacokinetics) and look at how those levels relate to side effects and treatment success or failure. Researchers will also study how a person’s genes affect how their body handles these medications (called pharmacogenomics). By combining drug level data with genetic information, the study hopes to find better ways to personalize treatment—so each patient gets the right dose for their body from the beginning of treatment. It is hoped that the results from this study will help to reduce harmful side effects, improve transplant success, and help doctors make more informed decisions about dosing. Ultimately, this research will support safer, more personalised cancer and transplant care for future patients.

The purpose of this pilot study is to preliminarily evaluate the efficacy of Integrative Attention and Somatic Processing (IASP), a customised therapeutic approach, developed to support women who have received a diagnosis of ADHD in adulthood. It is hypothesised that this therapeutic approach will reduce the psychosocial burden of ADHD and increase psychological wellbeing of women with a late diagnosis of ADHD.

Motor neurone disease (MND) is a progressive neurological disorder that results in profound disability and eventual death. Respiratory failure is the leading cause of death in MND due to declining respiratory muscle strength. Non-invasive ventilation, to support breathing, is the most effective treatment available for people living with MND. Polysomnography (PSG) is currently the gold standard for diagnosing sleep-disordered breathing and determining when to commence non-invasive ventilation in people living with motor neurone disease (MND) as it offers comprehensive monitoring of cardiac, respiratory, musculoskeletal, and neurological functioning. However, PSGs pose a significant challenge for people with MND as they require significant effort to travel to hospital and stay overnight. Also, as PSGs only collect data on the night they are conducted, they are not able to monitor the deterioration in respiratory status that is synonymous with MND. This study aims to explore the feasibility and acceptability of the use of a minimally invasive on-mattress device capable of recording body position, acoustic, respiratory and cardiac signals to identify breathing issues during sleep by people with MND and carers of people with MND. If feasible and acceptable to people with lived experience of MND, use of this device may simplify and improve the monitoring of sleep-disordered breathing in people living with motor neurone disease.

Poor balance and mobility are consistently associated with increased risk of falling among people in hospitals. This study aims to implement and evaluate SureStep, an evidence-based group standing balance exercise program designed to help hospital patients improve their balance, mobility and reduce their risk of falls. The program is delivered by physiotherapists as part of new standard care and involves supervised group exercise sessions held on the recruited wards. Using a stepped wedge type III hybrid design, recruited hospital wards will begin the program at randomly assigned times, allowing comparison between the original usual care and the SureStep program as new standard care primarily on the exercise dose and physical level of patients on ward. The study will assess feasibility, acceptability, cost-effectiveness and sustainability of the program. We hypothesise that SureStep will be feasible, safe and cost-effective to deliver, which will be sustained over time to support better mobility for hospitalised adults.

The Body Project is an ED prevention program targeting young females with self-identified body dissatisfaction, aiming to challenge and reduce the unrealistic pursuit of thin idealisation. This study will implement and evaluate the Body Project in the Queensland tertiary environment, by recruiting females aged equal to or greater than 18 years up to 30 years of age enrolled at Griffith University with self-reported body image dissatisfaction (n=80). Participants will be randomised into either 4 sessions of the Body Project or a control group directed to watch a documentary. All participants will be asked to complete online surveys that measure changes in body dissatisfaction, psychosocial functioning, quality of life, service use and dietary intake before and after the intervention, 4 weeks apart for both groups. The groups will be facilitated by trained female peer educators. Following completion of all sessions, participants, peer educators and counsellors will be invited to take part in an individual interview to discuss their participation experiences, perceptions of the Body Project and its value.

The study hypothesis is that implementation of a nursing program in hospital to reduce noise and interruptions overnight will improve patient's sleep. To investigate the effect of a nursing program to reduce noise and operational interruptions (measurement of vital signs, administration of medications) overnight on a cardiorespiratory ward in an Australian tertiary hospital. Observational study before and after implementation of nursing program. 1. Baseline data collection hospital ward- noise levels overnight, patient sleep duration and quality. 2. Data collection hospital ward after implementation of nursing program- noise levels overnight, patient sleep duration and quality.

The AMLM28/A3 study is part of the ADAPT platform trial (ACTRN12623000900617), which is testing new ways to treat acute myeloid leukaemia (AML). The ADAPT trial will enroll patients unfit for intensive chemotherapy and planned to receive Venetoclax and Azacitidine (VEN-AZA) as standard of care. This study is looking at whether ambulatory management for fever related hospitalisation is more effective than the current standard of care. Who is it for? Patients enrolled on the ADAPT platform trial who have achieved a remission of their AML after VEN-AZA treatment and require hospitalisation due to a fever. Study Details. This is a randomised study where patients will be randomised 1:1 to either receive the ambulatory management compared to the standard of care for fever-related hospitalisation in AML patients enrolled in the ALLG ADAPT platform trial. A total of 100 patients will be recruited across Australian sites. This study aims to determine if ambulatory management can reduce the duration of the time spent in the hospital when AML patients are readmitted due to a fever, after responding to treatment VEN-AZA.