ANZCTR search results

Exercise is known to support mental well-being during and after pregnancy as well as in times of grief. However, there is very little research on how exercise may support individuals after pregnancy loss. This study will explore the safety and feasibility of a personalised, in-person exercise program aiming to support the mental and physical health of bereaved parents in Australia. Twenty parents who have recently experienced stillbirth will be invited to take part in a 10-week program run by an accredited exercise professional, combining physical activity with education and peer support. The aim of this research is to better understand how exercise and connection with others can help to improve emotional well-being and reduce isolation after pregnancy loss, and to address critical gaps in current research and practice.

This double-blind, placebo-controlled, first-in-human (FIH) study will assess the safety, tolerability, PK, and immunogenicity of TX002100. This study seeks to establish doses of TX002100 that are safe, well tolerated, and exhibit an appropriate PK profile to warrant further clinical investigation. Six cohorts of 8 participants each are planned. Participants will be randomized in a 3:1 ratio to receive a single dose of TX002100 or matching placebo. Planned evaluations will include approximately 48 healthy men or healthy women of non–childbearing potential

Primary objective To quantify pre- to post-season changes in ACL tissue properties using quantitative MRI in youth female rugby league athletes. Hypotheses 1. ACL quantitative MRI indices and morphology will demonstrate measurable changes across the season. 2. The intervention group will show greater favourable changes in ACL morphology and quantitative MRI indices compared with controls. 3. Improvements in strength/power and favourable landing/deceleration mechanics will be associated with favourable ACL MRI changes. 4. Hormonal concentrations will explain inter-individual variability in ACL MRI outcomes and adaptation, consistent with mechanobiological and endocrine influences reported in prior literature .

This research is testing if telling a person their risk of melanoma based on either their clinical risk factors or their genetic risk factors influence their skin screening behaviours. Who is it for? You may be eligible for this study if you are a healthy adult aged between 51 and 75 years old (inclusive) at the time of informed consent with no history of invasive or in situ melanoma. You must have also previously participated QSkin Sun and Health Study. Study details Participants will be randomly allocated to either of the two intervention groups who will receive one of the personal melanoma risk scores along with general skin health education, or the control group who will not be given a risk score and will only receive general education. Data on their screening habits and behaviours will be followed up over a one-year period. It is hoped that findings from this study will help inform potential screening programs for melanoma.

G-DISCOTEQ is testing how well two cancer drugs (Gemcitabine and Docetaxel) work when they are given directly into the bladder at the same time. Who is it for? You may be eligible for this study if you are a male or female age 18 or above with either carcinoma in situ with or without papillary tumours or papillary tumours. Study details Participants will receive intravesical chemotherapy consisting of Gemcitabine (1 g) and Docetaxel (37.5 mg) combined in 50 mL of saline per instillation. Treatment begins with an induction phase of weekly instillations for six weeks, followed by a maintenance phase of monthly instillations for ten months. After the intervention, participants will undergo cystoscopy, cytology, and biopsy. Medical records will be reviewed to evaluate key outcomes, including complete response rate, recurrence-free survival, progression-free survival, cystectomy-free survival, cancer-specific survival, overall survival, and safety. Quality of life will also be assessed through patient-reported outcome measures. It is hoped that the results from this study will contribute to the field of non-muscle-invasive bladder cancer.

This study will evaluate the effect of a high-fat meal on the pharmacokinetics of a single oral dose of ACE-2223-1 in healthy adults. Participants will receive the solid formulation of ACE-2223-1 in a fasted state and after a standardized high-fat meal in a randomized, two-period crossover design. The study aims to determine how food intake alters the absorption, peak concentration, and overall exposure of ACE-2223-1. Up to 8 healthy male or female adults aged 18–65 years with a body mass index of 18–30 kg/m² will be enrolled. Safety, tolerability, and pharmacokinetics will be monitored throughout each intervention period.

This is a single ascending dose study of ACE-2223-1 in healthy adult participants. You may be eligible for this study if you are aged 18 to 65 years and have a body mass index greater than or equal to 18 kg/m² and less than or equal to 30 kg/m², without any clinically significant medical history. Part C will determine the relative bioavailability (RBA) of an ACE-2223-1 solid formulation compared with the liquid formulation used in Parts A and B. Participants will receive both formulations in a randomized sequence with a washout period between doses. This part of the study aims to determine whether the new solid formulation of ACE-2223-1 is absorbed into the body in a similar way to the liquid formulation. We expect that the solid formulation will have comparable levels in the blood as the liquid, indicating it can be used interchangeably.

This study aims to test whether ACE-2223-1 is safe and well tolerated when given as single or multiple oral doses to healthy adults, and to understand how the body absorbs and processes the drug at different dose levels. This is a Single and Multiple-Ascending Dose Study of ACE-2223-1 in Healthy Adult Participants. Who is it for? You may be eligible for this study if you are aged 18 to 65 years living and have a body mass index of greater than or equal to 18kg and less than or equal to 30kg without clinically significant (CS) medical history. Study details: Part A and Part B will consist of up to 6 cohorts of 8 healthy male or female adults, randomized 3:1 to receive ACE-2223-1 or placebo. Part B may be initiated after satisfactory review of safety and data from at least the first 3 cohorts in Part A.

This study investigates if the addition of a molecule, platelet derived growth factor (PDGF) produced by the body in the normal healing process of a tooth extraction socket will improve the amount of bone formed. At the time of extraction a bone graft will be placed in the socket with PDGF as the test and saline as the control. Six to eight weeks later the extraction site will have an implant placed. The dimensions of the jaw will be measured clinically and radiography at the time of extraction and implant placement. In addition a bone sample will be taken to analyse the amount of new bone formed.

Sepsis is a leading cause of death and disability in children globally accounting for over >3 million childhood deaths per year. Beta-lactam antibiotics are the most commonly used antibiotic to treat sepsis in children. Rather than giving a large dose of antibiotics intermittently, giving antibiotics over a longer time-period may improve outcomes, as seen in adult trials. To date, there is no high-grade evidence to support this practice in children. The BUILD trial is multicentre, multinational, open-label, type 1 adaptive hybrid effectiveness-implementation trial with an in-built pilot that will investigate if prolonged infusions of beta-lactam antibiotics increase survival for children with sepsis, while also checking safety and feasibility.