ANZCTR search results

This is a randomised, double-blind, placebo-controlled, single ascending dose (SAD), multiple ascending dose (MAD) multi-cohort study to assess the safety and tolerability of SKY-0515 and how this drug acts in the body in healthy volunteers. SKY-0515 may be indicated for use in patients with Huntington’s Disease, but a trial of the drug in healthy volunteers is needed before trials in patients with Huntington's Disease can proceed. Who is it for? You may be eligible for this study if you are a healthy male or female volunteer aged 18 to 70 years of age who has met all inclusion criteria and do not meet any exclusion criteria will be eligible to be enrolled. Study details All healthy volunteer participants who choose to enroll in this study will be assigned by chance to receive either a single dose of SKY-0515 or placebo once daily for 14 days. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. If the drug appears safe, additional participants will be assigned by chance to receive a larger single dose of SKY-0515 or placebo once daily for 14 days, followed by blood and urine testing. This will continue until a maximum safe dose is determined. It is hoped this research will determine the maximum dose of SKY-0515 that can be administered safely without causing severe reactions. Once the dose of SKY-0515 has been determined in healthy volunteers, a trial investigating the safety of SKY-0515 as a treatment for patients with Huntington's Disease may proceed.

Patient data, including demographics, health information, and treatment outcomes, is routinely collected by MindSpot in accordance with Australian Privacy Principles for highly sensitive health information. This information is used to provide services to patients and their health professionals; report to funders; and for quality assurance and service development. The primary purpose of the MindSpot Research Databank is to allow data that is gathered as part of the routine operations of MindSpot to be stored in deidentified format for research purposes.

The influence of amitriptyline on critical thermal limits. Primary objective is to assess whether oral ingestion of amitriptyline influences critical thermal limits and thermal and cardiovascular strain during an acute heat stress. With a secondary outcome to assess whether oral ingestion of amitriptyline influences heat and thirst perception during an acute heat stress. Participants will be asked to complete a humidity ramp heat stress test 7 hours after oral ingestion of either i) 75 mg placebo (PLA) or, ii) 75 mg amitriptyline hydrochloride (AT). The heat stress test involves participants being exposed to 43°C, 20% relative humidity (RH) for 30 minutes before a stepwise increase in relative humidity occurs (4% every 8 min until 64% RH). The heating protocol is a standard methodological approach within the field of human thermoregulation. We anticipate that amitriptyline, an anticholinergic, may decrease sweat output, and as a result exacerbate the rectal temperature and heart rate response to a given heat stress.

This study is investigating a new agent to be used in PET imaging for prostate cancer, called 68Ga-NTA-476. It aims to find out where 68Ga-NTA-476 goes in the body once it is injected into a person and whether there are any side effects or issues with tolerating the compound. This will be compared to an existing imaging compound which is currently used in Australia called 68Ga-PSMA-11. 68Ga-NTA-476 has been developed and tested in the laboratory; however, this is the first time that it will be tested in humans. Who is it for? You may be eligible for this study if you are an adult older than 18 years of age, you have been diagnosed with prostate cancer and do not have any significant other health issues. Study details All participants who choose to participate will complete a Screening Visit to make sure that they meet the eligibility requirements for the study. Procedures completed during this visit will include demographic details, medical history, physical examination, vital signs, ECG, blood samples to check overall health status and a 68Ga-PSMA-11 PET scan. Following confirmation of eligibility, participants will complete an Imaging Day Visit. During this visit, single dose of 68Ga-NTA-476 will be injected via a vein into the body. Following this, PET scans will be completed at about 1 hour and 2-3 hours. Participants will be observed in the clinical for a total of 4 hours to check vital signs and record any side effects. Between 7-9 days after this, a final study visit will be completed. Blood samples will be collected to check overall health status and the research team will check to see if any side effects were experienced. A total of 10 participants will be enrolled in this study at GenesisCare Murdoch in Australia.

Many older adults complain of cold feet, but little is being done to alleviate this problem because it is generally not considered limb-threatening. Fabrics functionalised with inorganic additive minerals reflect far-infrared (FIR) rays. Socks made from these ‘FIR’ fabrics have thermo-regulating properties in-vitro. They could reduce discomfort and complications related to cold feet in older adults, resulting in benefits such as reduction of thermal injuries from placing cold feet too close to a heat source or falls from wearing thick socks. We hypothesize that ‘FIR’ socks are effective in thermo-regulation and keeping feet warm.

Flucloxacillin is the treatment of choice for proven or suspected Methicillin-susceptible Staphylococcus aureus (MSSA) infections in Australian Therapeutic Guidelines. However, it needs to be given at least four times a day, which can be difficult for patients to adhere to. In this study, we would like to determine whether the use of probenecid or ibuprofen can reduce flucloxacillin dosing frequency. Healthy adult volunteers will be enrolled into two parallel groups (10 people in each group), and prescribed probenecid or ibuprofen, in combination with flucloxacilin.

The Virtual Reality Insertion of Chest-drain Outcomes Research (VICTOR) study will compare the traditional teaching of chest drain insertion against an immersive Virtual Reality (VR) training system. Junior and senior anaesthetic registrars will be the targeted study population and will be randomly assigned to one of the two study groups. The traditional education group will receive instruction on chest drain insertion via written text and an instructional video. The VR education group will receive instruction via the VR software training programme. After instruction, both groups will be assessed by two blinded researchers using a validated chest drain insertion assessment tool. Assessment of chest drain insertion will be done by utilizing a simulation mannikin fitted with a chest drain insertion module. Any differences between the traditional training group and the VR group will be assessed by measuring the following outcomes; Scores recorded on a validated checklist for chest drain insertion proficiently, the number of deviations from the checklist. Self-reported participant confidence will also be recorded

This project is testing the safety and pharmacokinetics of single and multiple oral doses of a new drug called FP-100. FP-100 is being developed for the treatment of patients with Lyme disease You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 55 years old. In Cohorts 1a through 1f, participants will be randomised (assigned randomly, like flipping a coin) to receive single oral dose(s) of either the active study drug or placebo. In Cohorts 2a through 2c, participants will be randomised (assigned randomly, like flipping a coin) to receive multiple oral dose(s) of either the active study drug or placebo. For subjects in Cohorts 1a, 1b, 1c, 1e and 1f, study participation will require 22 calendar days which will include 4 days (3 nights) in the CRU. For subjects in Cohort 1d, study participation will require 22 calendar days which will include one stay of 7 days (6 nights) in the CRU. For subjects in Cohorts 2a, 2b and 2c, study participation will require 22 calendar days which will include 9 days (8 nights) in the CRU. It is hoped that this research will help determine the safety of FP-100 when given to healthy men or women so that it can be tested in patients with Lyme disease

During continuous renal replacement therapy in critically ill patients with acute kidney injury, electrolyte imbalances, including phosphate imbalances, may occur. Prismocal B22 and Phoxilium® are two routinely used replacement fluids during continuous renal replacement therapy for critically ill patients admitted to the Austin Hospital's Intensive Care Unit. In our 30-patient, single-centre, sbefore-and-after study study, we will investigate whether, compared with Prismocal B22, Phoxilium® replacement fluid achieves higher phosphate levels during continuous renal replacement therapy in critically ill patients with acute kidney injury.

Neurological disorders are the leading cause of disability world-wide. Due to our aging population and population growth, this burden will inevitably increase over time. To add to this burden, our capacity to detect and treat many neurological disorders is hampered not only by gaps in our knowledge but by a lack of appropriate and cost-effective biomarkers to measure and monitor change in function. The study of eye movements is an established and widely used methodology in experimental research, the assessment of eye movements already an integral part of the clinical examination with distinctive eye movements characteristic of almost all neurological conditions. However, eye movements cannot currently be measured with precision outside of the research setting. This research aims to establish the utility of the BioEye eyetracking application in measuring aberrant function in some of the most common neurological diseases. By measuring simple eye movement parameters in patients with various neurologic conditions we will ascertain WHETHER the application can be used by the individual to self monitor change or by a physician to monitor change in function and adjust or implement treatments at the earliest possible timepoint.