ANZCTR search results

This study will look at the effects on muscle protein synthesis (rates of building new muscle) when people undertake resistance training while consuming 2 different types of diet for 2 weeks. One will restrict energy intake using an intermittent fasting restriction (2 days per week of severe dietary restriction), and the other will meet individual energy requirements. Generally, energy restriction results in lower muscle protein synthesis, however energy restriction is usually undertaken every day, rather than over 2 days per week. It is hypothesised that that rates of muscle protein synthesis rates will not be significantly different between groups.

EMVision’s EMView study is a 3 stage, multicentre, study of the EMVision Gen 1 Brain Scanner to collect clinical data for hardware verification and software advancement for the imaging of acute stroke. The imaging software, once finalised, will be able to differentiate between stroke/no stroke, classify stroke as either haemorrhagic or ischaemic and localise the stroke event to a specific quadrant of the brain. The first stage of the study will gather data from 30 healthy participants, to establish an age-matched baseline against the target stroke patient population for ‘healthy brain’/no stroke. The second stage will gather data on 150 patients presenting to hospital emergency with symptoms suspected to be stroke, including a minimum of 15 haemorrhagic stroke, 15 ischaemic stroke, 10 stroke mimics with migraine, 10 stroke mimics with seizure and other stroke mimics. Data from the second stage will be used to estimate the final sample size necessary to advance the software algorithms to clinically useful performance levels. The third stage will gather data on up to 30 patients presenting to hospital emergency with symptoms suspected to be stroke and who are confirmed to have had a haemorrhagic stroke. Due to the nature of streamlined code-stroke protocols and timing of diagnosis and EMVision scan, other patients who present to hospital with suspected stroke will continue to be recruited until the haemorrhagic stroke group minimum target is met. The data from all stages of the study will allow the EMVision to finalise software algorithms that identify, classify and localise stroke. It is anticipated that EMView Study will enroll approximately 320 patients with stroke and stroke mimics in the second and third stages of the study.

Background & Aim: Myofascial pain or jaw muscle pain is a common orofacial pain resulting in impairment of jaw function, and high health-care costs. It is most common in the 20–40-year age range. The aim of this study is to evaluate the feasibility, acceptability, and effectiveness of yoga in adult students experiencing myofascial pain. Methods: Subjects were recruited from a university student population and invited to learn more about the study through advertisements by email. Those interested were provided a jaw health screening questionnaire and if self-reporting facial pain they were invited for clinical examination to confirm orofacial myofascial pain (using standardised Research diagnostic criteria for Temporomandibular disorders [RDC/TMD]). 25 students with diagnoses of myofascial pain volunteered for this double-blind randomized controlled study. Participants undergoing other management for facial pain and TMDs were excluded. Participants were randomized to one of two interventions, either a yoga inclusive management programme or an active control standard care programme. Both groups received the intervention for 28 days. The outcome measures analysed were the change in pain intensity on an 11-point numerical rating scale and change in pain location and distribution using digitalized pain mapping software. Jaw mobility, oral health related quality of life and cognitive factors related to the participant’s understanding of pain were determined at baseline, at 14 days and at the end of 28 days. Change in outcome measures between baseline and (outcome points) were analyzed using Mann- Whitney test. Hypothesis That there will be a statistically significant difference in the treatment benefits between a yoga exercise inclusive management program as compared to active control standard care for the management of jaw muscle pain.

This study is evaluating the quality of cancer shared follow-up care for colorectal and breast cancer using an e-care plan. Cancer shared follow-up care is shared between the patient’s specialist and their GP. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older who has completed their active treatment for colorectal or breast cancer at a cancer service in South Eastern Sydney Local Health District within the past 4 years. You will also need to discuss whether you are suitable for this study with your cancer specialist. Study details The study is being implemented at cancer services in the South Eastern Sydney Local Health District. Participants who choose to enrol in this study will be allocated to one of two treatment groups. Participants who are allocated to the first treatment group will be given access to a new shared follow-up care service provided through an electronic care plan (e-care plan). The e-care plan sets out the schedule of appointments, what needs to be done and who is responsible. Results and other information can be shared through the e-care plan. The participant, specialist and GP have access to it and other care team members can be added. Participants who are allocated to the second treatment group will continue to receive their usual follow-up care which is often provided directly from their specialist and will not access the e-care plan for the duration of 9 months. After enrolling, participants in the second group will then be given access to the e-care plan for shared follow-up care. All participants will be asked to complete a questionnaire at the start of the study, at 9 months and the second treatment group at 18 months. A sample of participants will be asked to complete an interview at 9 months and 18 months after enrolling. It is hoped this research will determine whether implementing a shared follow-up model of care for colorectal and breast cancer patients provides any changes to the participants' quality of care and health outcomes. If this study finds that the shared follow-up model of care is beneficial for patients, it may be expanded for use in more cancer patients in the future.

Motor neuron disease (MND) is a rapidly-progressive and fatal neurological condition. There is no cure. Riluzole, the only available treatment, has a very modest benefit at best. Diagnosis is often delayed. CuATSM (‘copper ATSM’) is a compound that has been shown to protect against a type of newly-described cell death known as ferroptosis in animal models of MND. The results of a recent phase 1 trial of CuATSM in humans with MND were promising. Additionally, radiolabelled CuATSM was detected via PET imaging in parts of the brain involved in MND in a pilot study. CuATSM may therefore be disease modifying as well as localising to areas of active disease, showing promise both as a treatment and diagnostic agent. This project is an imaging study which aims to further explore the role of CuATSM in diagnostic imaging. We aim to use radiolabelled 64CuATSM PET in conjunction with a type of MRI scanning called quantitative state mapping, which detects iron in the brain, another potential marker of ferroptosis. Participants will have these scans at baseline. Clinical data, including neurological examination and cognitive testing results, will be collected. We aim to explore whether both types of imaging demonstrate involvement of the same brain regions. Positive results would 1) provide evidence that the type of cell death known as ferroptosis is occurring in humans with MND, 2) support ongoing clinical trials of anti-ferroptotic agents such as CuATSM, and 3) support future exploration of these imaging techniques in diagnosis and monitoring of disease progression.

The study will be a prospective, randomised placebo controlled 3x6x3 cross over trial that will examine the effect of an isometric wall squat on pain sensitivity and clinical pain intensity when compared to a true control (quiet rest) in 30 individuals with non-specific chronic low back pain. Participants will receive each of the three interventions over a period of three weeks. The sequence of intervention exposure will be randomized according to the Williams randomised allocation sequence. This study will also evaluate the suitability of a novel placebo exercise intervention for maintaining participant blinding of intervention allocation. The hypothesis is that the isometric exercise intervention will lead to reduced pain sensitivity (exercise induced hypoalgesia) and reduced low back pain intensity when compared to the control group. A total of 4 individuals have been screened as potentially eligible. As of 09/01/2023, 3 participants have been enrolled. It is anticipated that data collection for the first participant will commence on the 16/01/2023.

• The aim of this study is to evaluate the impact of contact lens disinfectants on ocular physiology, tear film characteristics, and symptomatology that might occur during contact lens wear. Participants will wear Comfilcon A contact lenses over a 6-week, changing their lenses every two weeks, a commonly recommended wear schedule and use new contact lens disinfectants (Cleadew MPS,Ophtecs Corp., Japan) • The primary endpoint is the changes in the ocular surface and tears of contact lens wearer over the first six weeks of lens wear using new lens care product. • The secondary endpoint is changes in factors that have been reported to be different between comfortable and uncomfortable contact lens wearers.

Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have symptomatic malignant pleural effusion that requires treatment, you are currently being looked after by the Pleural Medicine Service at Northern Health, and have recently undergone a procedure to manage the fluid around the lung. Study details: The trial aims to include 114 participants, 57 who will be cared for with the Specialised Ambulatory Pleural Service digital health care model at Northern Health. The hospital records of a further 57 individuals receiving standard care will be reviewed from Melbourne Health and Western Health to compare hospital admissions, emergency presentations, and outcomes. Participants in the intervention group will receive aftercare by a treating physician and a pleural nurse. The pleural nurse will visit at home, to provide care for the indwelling pleural catheter. At each visit a lung ultrasound will be performed. The treating physician will view the ultrasound remotely (tele-ultrasound) and do a video call (tele-health) to provide an assessment of the fluid around the lungs. The visits will occur at days 14 & 28, and months 2, 3, 4, 5 and 6. Being involved also requires completion of a logbook to monitor symptoms for 28 days and participation in surveys at during the routine home visits. Participants will also be asked about health care outcomes, such as whether they have recently been to hospital or emergency department. Participants may be selected for an interview via telephone or internet video call that should take approximately an hour. Hospital records will be accessed related to hospital admissions, emergency presentations, and outcomes for the purpose of comparing the benefits and risks of this model of care to standard care at other health services. It is hoped this research will demonstrate that a specialised pleural service where participants may receive treatment at home is safe and can be achieved in a practical manner. If this initial study shows that this service is feasible, it may be rolled out to additional hospitals and could lead to improved quality of life for patients who are being treated for malignant pleural effusion.

Ventricular tachycardia (VT) is a heart rhythm abnormality which typically affects people with underlying heart disease (cardiomyopathy). There are a number of patients who do not have any alternative treatment options. Stereotactic ablative radiotherapy involves the delivery of high-dose radiation non-invasively with high precision and will be used to treat the part of the heart that is causing VT. In this study, we will investigate whether the use of cardiac stereotactic ablative body radiotherapy (SABR) reduces the number of ventricular tachycardia events in the patient. The effectiveness the radiation treatment will be done by assessing the toxicity and quality of life both before and after the radiation delivery.

A Phase 1, Single Centre, Randomised, Double Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, of NeuroDirect Ketamine in Healthy Adult Volunteers