ANZCTR search results

In this Phase 2 trial, we are trying to assess the safety and tolerability of a potential new treatment for MS with established spasticity known as MRX-4TZT. MRX-4TZT is what is called a transdermal delivery system (TDS), which is a method of getting medication into the body through the skin using a patch or other device that sticks to the skin which then allows the drug to be absorbed into the body. MRX-4TZT contains a formulation of drug called tizanidine and is being tested to see how the body absorbs, distributes and breaks down tizanidine administered through the skin compared to oral capsule containing tizanidine. The results of this study will also be used to determine effective, safe and tolerable dose levels of MRX-4TZT for future studies.

Background: Perinatal depression (PND) affects up to 20% of mothers and can lead to pregnancy complications and impairments in child health, development, and mother-infant bonding. Blood-based biomarkers capable of predicting PND prior to symptom onset will enable timely and unbiased screening, early treatment, and improved outcomes. Aims: The current study will test the efficacy of blood-based biomarkers as a predictor for PND, and will evaluate the feasibility of using Dried Blood Spot (DBS) devices in clinical practice. user satisfaction of the DBS will also be assessed. Methods: Online surveys will collect information related to mothers' perinatal depression, distress, quality of life, and DBS satisfaction. Venous blood collection will be conducted at usual second trimester appointments. Finger prick blood samples using DBS devices will be collected at 24 weeks gestation, 6 weeks postpartum, and 6 months postpartum. Outcomes: We expect that blood-based biomarkers will predict PND, and that the DBS device will be feasible and acceptable to participants.

We have previously enhanced slow wave sleep and cognition by playing acoustic tones during sleep. We aim to test whether we can enhance slow wave sleep and improve memory, cognition, and clearance of brain toxins such as amyloid and tau with a wearable device in the home. We hypothesise that acoustic stimulation will improve the quality of deep sleep with an at-home headband device, and that percentage of sleep enhancement will be correlated with percentage improvement in cognition and clearance of toxins.

Previous research has shown deep sleep may contribute to Alzheimer’s disease risk through the clearance of chemicals from the brain and body. The present research aims to test whether slow wave sleep is associated with chemical clearance by measuring how overnight levels change in blood, and comparing this to chemical levels in the brain assessed using a MR-PET scan. Participants completed 3 days of at-home monitoring of their sleep and wake habits, followed by an overnight stay in the laboratory. In the laboratory, participants' sleep was measured and regular blood samples were taken overnight without disturbing participants' sleep. An MR-PET scan was completed to assess how chemical levels in the brain impact clearance during deep sleep.

The purpose of this study is to assess in Part 3 (Itraconazole Drug-drug Interaction [DDI]) the effects of itraconazole on the pharmacokinetic (PK) of JNJ-90858638. Part 4 (Midazolam DDI) will assess the effects of JNJ-90858638 on the plasma PK of midazolam and its metabolite.

This retrospective cohort study compares ketamine- versus propofol-based induction for emergency intubation in critically ill adults. We will analyse Monash Health ICU data (2018-24) using causal inference methods. Primary outcome is hospital mortality; secondary outcome is a composite of haemodynamic collapse or severe hypoxaemia within 30 minutes. We hypothesise ketamine is associated with lower peri-intubation complications and improved survival.

This single-centre before-and-after retrospective cohort study is being conducted to evaluate the dose–exposure relationship of ß-lactam antibiotics administered by continuous infusion in critically ill patients with sepsis. This has been brought about by a change in practice in the administration of beta-lactam antibiotics at our site following the publication of the BLING III multi-centre randomised trial (doi:10.1001/jama.2024.9779). We anticipate 400 patients will be evaluated.

The purpose of this research is to investigate a new heart therapy device for the treatment of acute decompensated heart failure (ADHF) with worsening renal function (WRF), to evaluate the device for providing support and recovery during unscheduled hospital admissions. This type of heart failure occurs because the heart is not pumping blood effectively leading to a sudden deteriorating or worsening heart failure, often requiring emergency hospital admission. Typically, a patient presents to hospital in an emergency with congestion and fluid retention, resulting in shortness of breath and lower limb swelling. Diuretics are used to remove fluid and reduce congestion which is only effective in around half of the patients treated. The QHeart TARR heart therapy device is a new treatment aiming to support patients who do not respond in a timely manner to diuretics. The QHeart TARR heart therapy device is a small balloon that is deployed inside the descending aorta, the large blood vessel running from of the heart supplying blood to organs and tissues throughout the body, including the kidneys. The TARR balloon device has shown very promising performance and safety data in pre-clinical studies. The TARR heart therapy device uses a small diameter balloon sized for low risk within the aorta. The device is inserted using a standard interventional procedure in under 30 minutes and can be safely removed at any time during use. The device balloon is inflated which then automatically works with your heart allowing your heart to pump more effectively. The study aims to show the TARR device therapy: 1) Provides a clinically significant improvement in heart performance during treatment, and 2) The TARR device and procedures for its insertion, use, and retrieval are as expected and without any adverse events.

This study aims to investigate whether a supervised, online, home-based eccentric resistance exercise program can reduce liver fat and improve liver health in adults with metabolic dysfunction–associated steatotic liver disease (MASLD). Participants will complete five supervised exercise sessions each week for eight weeks, delivered live through Google Meet. Liver fat, liver stiffness, liver enzymes, metabolic markers, and physical fitness will be measured before and after the program. We hypothesise that this home-based eccentric exercise program will be safe, feasible, and effective in reducing liver fat and improving MASLD-related health outcomes.

Fatigue is a common and debilitating symptom of primary biliary cholangitis (PBC), yet no approved treatments currently exist. Creatine, through its beneficial effects on mitochondrial function, muscular metabolism, and neuroprotection, represents a biologically plausible therapeutic option to treat symptoms associated with PBC. This is the first study of its kind with aims to assess whether creatine supplementation improves fatigue, quality of life, liver biochemistry, and muscle function in patients with PBC. If effective, creatine could offer a safe, accessible, and cost-effective strategy for managing fatigue in this population.