ANZCTR search results

KER-050 is being developed by Keros Therapeutics Australia Pty Ltd as a potential treatment for anaemia in patients with very low, low or intermediate risk myelodysplastic syndromes (MDS). KER-050 is a therapeutic protein designed to increase red blood cell and platelet production by inhibiting the signaling of a subset of the TGF-ß family of proteins to promote hematopoiesis. The main purpose of this study is to test how safe the study drug is and how well the body can handle taking it (called tolerability). The study will also look at whether the study drug works (called efficacy), the amount of the study drug in the blood (called pharmacokinetics) and how the study drug affects the body (called pharmacodynamics).

The purpose of this study is to compare various artificial intelligence algorithms used for the diagnosis and management of skin tumours against clinician diagnosis and management. Who is it for? You may be eligible for this study if you are an adult and either have previously had taken whole body photographs or have been assessed as requiring a biopsy of a skin lesion by your attending specialist.. Study details Following your routine examination by your attending specialist you will be examined by two other doctors and have images taken of some of your skin lesions by a mobile phone. None of this will effect your management and any tests performed will only be related to your attending specialist's requests. It is hoped that this study will help determine if artificial intelligence can accurately be used for the diagnosis and management of skin tumours.

This study examines the hypothesis that the proposed link between obstructive sleep apnea (OSA) and stroke is mediated through abnormalities of: 1) small blood vessels in the brain and 2) the main large artery (carotid) supplying blood to the brain. Retinal blood vessel size (mirrors the cerebral circulation) can be measured via retinal photographs while carotid artery wall thickness (intima media thickness – IMT) can be measured using ultrasound. Patients attending a sleep clinic were recruited and, after retinal photography and ultrasound examination, underwent an overnight sleep study to assess sleep disordered breathing severity. A sub-group then used continuous positive airway pressure (CPAP) at night with repeat vascular examinations at 12 months.

This research project is being conducted to look at the effect and safety of PRN473 topical on skin reactions of otherwise healthy participants with allergies to 2 common allergens - when PRN473 topical is applied to the skin both prior to and following a skin prick with 2 of the allergens.

The study is a pilot randomised controlled trial of a mindful parenting program for community-recruited parents who have concerns about their child’s emotional well-being. The study is being conducted to investigate (1) the feasibility of the program, as a way to improve child emotional well-being by assisting parents to manage their own emotions and anxiety-related beliefs and behaviours; and (2) the acceptability of the program to parents.

We are currently facing a global pandemic of COVID-19, caused by the novel coronavirus, SARS-CoV-2. Frontline healthcare workers, especially anaesthetic staff, are particularly vulnerable because of frequent performance of aerosolized-generated procedures, such as bag-mask ventilation and intubation. N95 filtering facepieces are recommended for use by healthcare workers who come into contact with airborne or aerosolized infectious diseases. The protection that is provided by these devices is dependent on the filter’s efficiency and seal quality. According to the recommendations by Standards Australian (AS/NZS 1715-2009), healthcare workers should undergo regular fit testing. Australian Guidelines for the Prevention and Control of Infection in Healthcare (2019) recognises that fit testing is a valuable practice, which provides an opportunity to educate healthcare professionals. There are two types of N95 mask examinations — fit check and fit test. Fit checks, also known as the user seal checks, are fast and simple. It is performed by the wearer, who detects if a gross leak is present. Quantitative fit tests are more objective but require the use of specialised equipment by a trained operator. We would like to compare the fit testing results between the two types of N95 masks, namely the Halyard* N95 Particulate Filter Respirators and the ProShield® N-95 masks. There has been no published literature on the performance of these two types of masks. We would also like to compare the fit check with the fit testing results.

An advanced hybrid closed-loop (A-HCL) insulin delivery system has shown safety and high time-in-range in a previous study. The use of a faster acting insulin aspart (FiASP) with a more rapid onset and shorter duration of insulin action compared to standard insulin aspart could improve the responsiveness of a HCL system. Limited data is available regarding the use of FiASP in HCL systems, in particular in 'free-living' conditions. The aim is to compare glucose control using A-HCL delivering FiASP vs. insulin aspart in this observational study. All participants will undertake the study over a 12-month study duration in a 'free-living' protocol with A-HCL active. Participants are free to undergo their normal daily activities. There will be no specific interventions from the study team. Participants will be free to utilize insulin aspart or FiAsp with the pump based upon their personal preference. Outcome measures include CGM time-in-range and time in hyperglycaemic and hypoglycaemic ranges; safety and system performance outcomes.

STUDY AIM This study will evaluate the feasibility of a web-based system of patient reported outcomes (PROs) assessment to identify and address unmet needs of cancer patients. WHO IS IT FOR? Patients: You may be eligible to join this study if you are aged 18 years or more, and have been diagnosed with any type of cancer for which you are receiving care from Flinders Medical Centre. Staff: You may be eligible to join this study if you are employed by Flinders Medical Centre and provide care for patients with cancer. STUDY DETAILS: Patients and staff participants in this study will provide feedback via a survey and interview or focus group regarding their experience using a web-based portal, called iScreen, to provide PRO data. Patients will be asked to engage in qualitative interviews and complete a survey at least 3 months after their first use of the system to indicate its acceptability. Data on feasibility, cost and safety will also be collected throughout the 16 month implementation period. It is hoped that results from this study will indicate that the iScreen system is feasible, safe and acceptable. It is anticipated that further funding will be sought in order to evaluate the effectiveness of the system and to ultimately roll out the system permanently within Flinders Medical Centre and perhaps across other health institutions.

This project is testing the safety, tolerability, pharmacokinetics (PK, the amount of study drug in your blood) and pharmacodynamics (PD, how the study drug affects your body) of both single and multiple oral doses of a new drug called NT-0167. Up to eighty (80) healthy men or women of non-child-bearing potential (WNCBP), aged between 18-55 will be enrolled in this study in up to six SAD and up to four MAD cohorts comprising 8 subjects each. This study will enrol approximately 80 participants, in two parts: Part A: will involve a single ascending (increasing) dose (SAD) where approximately 48 participants (6 groups of 8) will be randomised (assigned randomly, like flipping a coin) to receive a single dose of the study drug or placebo. The placebo will look the same as the study drug but will not contain any medicine. Part A (Food Effect): One group from Part A will return for an additional dose to determine the effect of food on the pharmacokinetics (PK) of the study drug. Part B: will involve a multiple ascending (increasing) dose (MAD) where approximately 32 participants (4 groups of 8) will receive one dose of the study drug or placebo daily for 14 consecutive days (14 doses in total). The study is placebo controlled, meaning that some participants will receive capsule(s) containing the active study drug, and some will receive capsule(s) containing placebo. For Part A your total participation will last about 8 weeks, of which you will spend 4 days (3 nights) in the clinic. For Part B your total participation will last about 10 weeks, of which you will spend 17 days (16 nights) in the clinic.

Background: The aim of this study was to explore the impact of exercise intensity on aerobic fitness and autonomic cardiac regulation (heart rate variability (HRV)) and salivary biomarkers of the stress systems (HPA-axis, cortisol; sympathetic nervous system, a-amylase) and mucosal immunity (secretory(s)-IgA), in breast cancer survivors. Methods: Seventeen participants (62 ± 8 years) were randomly assigned to; 1) high intensity interval training (HIIT; n = 6); 2) moderate-intensity, continuous aerobic training (CMIT; n = 5); or 3) a wait-list control (CON; n = 6) for a 12-week (36 session) stationary cycling intervention. Cardiorespiratory fitness (VO2peak), resting HRV and salivary biomarkers were measured at baseline 2-4 d pre-intervention and 2-4 d post the last exercise session. Results: A significant improvement (p = 0.05) was observed for VO2peak in the HIIT group; 19.3% (B = 3.98, 95%CI = [1.89 ; 4.02]) and a non-significant increase in the CMIT group; 5.6% (B = 1.96, 95%CI = [-0.11; 4.03]), compared with a 2.6% (B = -0.64, 95%CI = [-2.10; 0.82]) decrease in the CON group. Post intervention improvements in HRV markers of vagal activity (log(ln)LF/HF, LnRMSSD) and sympathetic nervous system (a-amylase waking response) occurred for individuals exhibiting outlying (> 95% CI) levels at baseline compared to general population. Conclusion: High intensity interval training improved cardiovascular fitness in breast cancer survivors and improved cardiac regulation, and sympathetic nervous system (stress) responses in some individuals. High-intensity interval training was safe and effective for breast cancer survivors to participate in with promising results as a time efficient intensity to improve physical health and stress.