ANZCTR search results

This research project is looking at whether sugammadex interacts with progesterone assay testing, and therefore affects the reliability of progesterone concentration measurements. An interaction at 104micromol/L is reported by the manufacturer of Sugammadex. This research project will look at the accuracy of progesterone assay testing in the presence of various sugammadex concentrations.. This study is important to assess the reliability of data that utilising progesterone assay testing when using sugammadex.

Delayed umbilical cord clamping after 60 seconds improves outcomes for preterm infants born before 37 weeks. However, delayed clamping is neither reliably recorded nor routinely implemented across Australian hospitals. This study will investigate whether funded basic, accurate data collection and sharing between sites together with a funded, locally adapted quality improvement program increases the rate of delayed cord clamping more than 60 seconds (DCC60) by 10%, compared to funded basic, accurate data collection and sharing alone.

In this prospective, 2 stage interventional pilot study we aim to evaluate the safety and feasibility of FMT as a therapeutic intervention for dysbiosis associated with persistent critical illness, in patients who have been admitted to the intensive care unit (ICU) at a tertiary hospital in Western Australia. Subsequent preliminary evaluations of the efficacy of FMT at restoration of microbial diversity, richness and evenness in the recipient together with important clinical outcomes including the incidence of infection and burden of MDRO colonisation will be secondary endpoints.

This is an open-label study to evaluate the effect of food and drug-drug interaction with tinlarebant. This study will assess the effect of omeprazole, itraconazole,rifampin and food on the pharmacokinetics of tinlarebant.

This is a proof of concept trial of a phone application with patient self-monitoring of biometrics in patients with heart failure and kidney disease. This patient population is at high risk of recurrent hospital admissions and require careful monitoring of their health and fluid status at home. The trial will involve the use of a wearable device (smart watch), digital scales and blood pressure machine, in combination with a phone application, to aid patients to self-manage their condition at home. They will be provided with a 24-hour phone service to call for advice and also provides triage to services based on need. The proof-of-concept study will run for 6 months and will evaluate usability, feasibility and acceptability of the model of care.

This study will be a feasibility intervention-based Randomised Controlled Trial (RCT) study in menstruating and hormonal contraceptive user sportswomen who experience cycle-related symptoms. The proposed study will consist of a screening stage, an initial stage, a baseline stage covering two menstrual/hormonal contraceptive cycles, and an intervention stage covering two menstrual/hormonal contraceptive cycles. This study will involve dietary supplementation with chocolate with high or low cocoa solids, questionnaires on menstrual and reproductive health, self-monitoring of cycle-related symptoms, training and nutrition, monitoring of body composition, inflammatory markers and sex hormones, and an interview. The investigators hypothesise that chocolate supplementation will help ameliorate cycle-related symptoms, as reported on the Menstrual Distress Questionnaire, and reduce serum inflammatory markers (C-reactive protein).

Complications due to frailty and injury after falls are a significant problem in Residential Aged Care Facilities (RACFs) in Australia. Over 65% of people living in RACFs have dementia which poses an additional challenge when dealing with frailty and falls. The recent Royal Commission into Aged Care Quality and Safety received many submissions highlighting these problems and the lack of allied health and other services available to address these challenges. This project directly relates to addressing recommendations 37, 38, 61 and 69 made in the Royal Commission calling for increased allied health intervention to meet the unmet need in residential aged care. This project will deliver evidence-based allied health interventions to people living with dementia in residential aged care facilities specifically related to frailty and preventing falls. This will be done by utilising existing General Practice networks based at a selected RACF in Canberra to coordinate a suite of evidence-based allied health services, including occupational therapy, physiotherapy, speech pathology, dietetics and optometry to residents in the RACF. We will recruit 60 residents at a RACF in Canberra to be a part of this project who will receive a transdisciplinary allied health intervention consisting of an occupational therapist, physiotherapist, dietitian, speech pathologist, pharmacist and optometrist and allied health assistants. The outcomes of this project will provide a guide for other RACFs in Australia to follow to implement evidence-informed allied health interventions to improve the quality of life of their residents. We will also provide an economic evaluation which will provide evidence to inform funding models for the provision of allied health into RACFs.

Brief description of the study purpose This study will examine the safety and efficacy of romosozumab (a drug to treat bone loss) in patients with multiple myeloma who have had a skeletal related event despite bisphosphonate therapy. Who is it for? You may be eligible to join this study if you are aged 18 years and older, have been diagnosed with multiple myeloma and had a skeletal related event despite previous treatment with bisphosphonate therapy Study details All participants who choose to enrol in this study will receive an Romosozumab subcutaneously every 28 days for 12 cycles. Patients will also receive calcium and vitamin D supplementation. During and after completion of the treatment participants will be assessed for safety and effect of romosozumab. This will include monthly blood tests. A bone marrow biopsy will also be performed during screening for the study, following 12 months of treatment and at disease progression if this occurs during the study period. A CT skeletal survey will also be performed at screening and following 12 months of treatment and 12 months following completion of treatment. It is hoped that this research project will demonstrate that romosozumab is safe to administer to patients with multiple myeloma and identify any potential bone modifying effects of this drug in these patients

Despite the clear physical and mental health benefits of physical activity, as few as 13% of Australian women aged 45-64 years meet both the physical activity (150 minutes of moderate to vigorous activity per week) and strength (muscle strength twice per week) guidelines. Middle-aged and older adults are a priority for targeted physical activity programs, since physical capacity starts to decline at around age 50. This project aims to test the effectiveness of the Active Women over 50 program (intervention) on physical activity, over 6 months compared with a no intervention waitlist (control), among women aged 50 years and over. The intervention includes: 1) two health coaching sessions with a health coach, 2) behaviour change messages delivered by email or SMS over 6 months, 3) access to the Active Women Over 50 website, 4) access to a private Facebook group with other participants.

In the era of disease-specific treatments improving life expectancy for adults with Cystic Fibrosis (CF), we face new challenges in their metabolic health. Our project focuses on the highest-risk group, specifically adults with CF-related diabetes. We will use continuous glucose monitoring to gather detailed blood sugar data, along with body metrics, clinical information and patient-reported outcomes. Research evidence will be used to advocate for access to diabetes technology, inform management to prevent diabetes-related complications, and profile metabolic status. This endeavor will deliver novel insights that will also be foundational in informing strategies to optimise metabolic health in this population.