ANZCTR search results

Follitropin delta is a safe and effective medication to use in ovulation induction prior to intrauterine insemination or frozen embryo transfer with acceptable pregnancy, cycle cancellation, ovarian hyperstimulation syndrome and multiple pregnancy rates. The purpose of the retrospective observational cohort study is to report patient and treatment characteristics and outcome for patients where follitropin delta was used.

This phase I study aims to recruit healthy volunteers. Participants will be enrolled in 2 groups of 6 each (3 men and 3 woman). Each participant will attend 2 treatment sessions and receive two different formulations of Keticap®. In Period 1, Participants will be randomised to receive either a single dose of KET-IR (160 mg) or single dose of KET-AD (160 mg) in the first study session. Following at least 7 days wash-out period the participants will receive the alternate formulation to the one received in period 1second formulation in the final study session.

Patients recovering from heart surgery in the ICU often experience high stress, anxiety, and confusion, which can lead to lasting psychological effects like PTSD or depression. While medications are commonly used, they can have side effects and may not be fully effective, prompting interest in non-drug approaches such as music or guided imagery. Virtual Reality (VR) offers an immersive and calming experience and has shown promise in reducing anxiety in healthcare settings, but its structured use in ICUs remains limited. This Australian study will be the first to prospectively test an interactive, gamified VR program for heart surgery patients in the ICU. It will evaluate the intervention’s safety, effectiveness, usability, and acceptability from both patients and staff, with findings to be published and shared widely.

Psychological distress affects over one in five university students, harming their study, work, relationships, and wellbeing. Brief, smartphone-based programs targeting mindfulness, sleep, and physical activity can reduce distress, but not all students benefit equally. This study will explore whether “amotivation” – including low drive, loss of interest, and reduced social engagement – helps explain why some students respond less well to these interventions. Using our MindGRID digital phenotyping app, we will collect passive smartphone and wearable data (e.g., movement, location, phone use) alongside brief self-reports to identify digital patterns linked to amotivation. We will then test whether these digital profiles can predict and help personalise the delivery of smartphone interventions to improve mental health in university students.

The extent to which caffeine disrupts subsequent sleep depends largely on the amount and timing of intake relative to bedtime, with more pronounced reductions in sleep quantity and quality as caffeine is consumed closer to bedtime. However, a common limitation of the current evidence is its applicability to females with varying hormonal profiles. Oral contraceptive use can slow caffeine metabolism, with greater caffeine exposure potentially altering the effects of caffeine on subsequent sleep. Understanding the influence of hormonal profile will improve the applicability of caffeine-related sleep recommendations for females. This study has three key objectives: 1) Investigate the effects of caffeine dose on subsequent sleep in healthy adult females; 2) Investigate whether the time course of caffeine metabolism differs according to hormonal profile; and 3) Examine whether differences in caffeine metabolism alter the effects of caffeine on subsequent sleep.

In this project, we will explore the clinical utility of novel integrated E-Tattoo surface EMG sensors by measuring the activity of spastic muscles in the arm or leg at a participant’s first and follow-up appointments at the Spasticity Clinic at the Royal Park Rehabilitation Centre. Electrodes will be placed over the overactive muscle and its opposing muscle and the data about the activity of each muscle during some tests of physical function. Participants will be asked about their experience of wearing the E-Tattoo electrodes. The project explores the application of E-Tattoo electrodes for the first time in the measurement of spasticity, as an example of their potential use for personalized health care. We hypothesis that these electrodes will be comfortable for participants to wear and will provide data on muscle activity comparable to that obtained from traditional electrodes.

This global clinical trial which evaluates the efficacy and safety of TLX101-Tx, a potential new treatment for patients with recurrent glioblastoma, The purpose of the study is to assess the safety and tolerability of TLX101-Tx given alone or in combination with standard care chemotherapy, called lomustine. Between 6 to 18 patients are expected to be enrolled. Who is it for? To be eligible for this study you must be 18 years or older with a confirmed diagnosis of IDH-wildtype glioblastoma showing first recurrence or progression after standard first-line treatment. You must have measurable disease with increased [18F]FET PET uptake, adequate organ function, ECOG performance status of 0–2, and be able to comply with study requirements. Stable steroid use and appropriate contraception measures are also required. Study details If you participate, you will be assigned to a study arm (a group of patients receiving the same treatment), to test different doses of the study drug either alone or in combination with lomustine. Your time on this study will be about 52 weeks. You will be required to return to the study site for multiple visits over the course of the study. This study is divided into four periods. Depending on which arm or study you are assigned, your schedule may look different. Screening period (up to 21 days) Treatment period (up to 127 days) Maintenance period Follow up period (every 12 weeks) This study may have up to three arms. All study participants will receive the study drug. However, depending on when you enter the study, you could be assigned to a study arm without lomustine. Arm A: Receive TLX101-Tx and lomustine at 90 mg/m2 in combination. Then lomustine alone in Maintenance Therapy. Arm B: Receive TLX101-Tx and lomustine at 70 mg/m2 in combination. Then lomustine alone in Maintenance Therapy. Arm C: Receives TLX101-Tx alone. Then lomustine alone in Maintenance Therapy. This arm will only open when Arms A and B are closed. During the Treatment Period, you will need to attend the study site for at least 8 visits over 12 weeks. Your study doctor will explain what you must do, and which tests you will have during the study. Each visit may be different in length depending on what tests will be done and will take between 2-3 hours. TLX101-Tx will be given as an intravenous infusion (IV), which means it will be injected through a vein in your arm. You will receive 3 equal doses over 85 days. If you are assigned to Arm A or B, you would also take lomustine by mouth on the same day (Days 1, 43 and 85). If you are assigned to Arm C, you will receive only TLX101-Tx on Days 1, 29 and 57. During the study visits, you will have the required tests and procedures as described by a protocol and will include: Physical examination, Measurement of vital signs, Medications Review, Blood tests, Dosimetry Imaging (SPECT/CT scans), Tumour Assessment (MRI and PET scans), Urine Test, ECG, QOL and Neurological assessments

The aim of this cross-sectional national survey is to explore the early life feeding practices of infants and cwCF in Australia, with a focus on exclusive and partial breastfeeding rates throughout infancy, determinants to breastfeeding cessation, infant formula introduction and the timing and practices associated with transition to solid foods.

There are no standardised guidelines to inform how to wean patients from high-flow nasal oxygen (HFNO) once clinical status has improved which can lead to inconsistent practice, prolonged length of stay and increased healthcare costs. We are testing a new approach to reducing the use HFNO for patients recovering from acute respiratory illness admitted to hospital. Clinical staff will follow a medically supervised step-by-step weaning protocol to safely reduce and transition patients from HFNO to low flow nasal oxygen. Outcomes will be compared between two separate wards, one following the protocol and one continuing usual care. We aim to assess if this protocol shortens the time patients need HFNO and therefore length of stay.

This study represents an examination of a novel iCBT-based self-management program for people who use methamphetamine, ‘IMPACT’. The primary objective of the study is to examine the feasibility of the IMPACT program. Feasibility is defined as uptake, acceptability (participant satisfaction, perceived usefulness, and ease-of-use), participant safety, completion rates, and drop-out. The secondary objective of the study is to examine pre-post changes in methamphetamine use and psychological wellbeing, assessed via validated self-report measures. There is a clear need for further exploration of the feasibility and potential clinical utility of digital health interventions specifically for people who use methamphetamine; and whether a product tailored for people who use methamphetamine - such as the IMPACT program - will lead to better engagement and ultimately improved outcomes.