ANZCTR search results

Many people with hypothyroidism do not feel well, even when their blood tests say their thyroid levels are normal. Apart from thyroxine, there are no other approved medications available to treat hypothyroidism. Naltrexone, a medication typically used to treat other conditions, may help people with hypothyroidism feel better when taken at a low dose. The purpose of this study is to determine whether naltrexone is beneficial when used in addition to thyroxine for the treatment of hypothyroidism. Our proposed study will test if naltrexone improves quality of life and other health related measures versus a placebo tablet. This will help us to understand whether this medication (naltrexone) should be studied further as a potential treatment for hypothyroidism. Medications must be approved for use by the Australian Federal Government. Naltrexone is currently approved in Australia to treat alcohol and opioid dependence. However, it is not approved to treat hypothyroidism. Therefore, it is an experimental medication for treatment of hypothyroidism secondary to Hashimoto’s thyroiditis. This means that it must be tested to see if it is effective for this indication.

The purpose of this study is to test the hypothesis that it is feasible and safe to use the Nutromics Sensor Device (investigational device; further called ‘Device’ in the protocol) to continuously monitor vancomycin concentrations in the interstitial fluid of intensive care unit (ICU) patients. This is a multi-site, mixed methods study consisting of a prospective observational study (Part 1) and survey with healthcare professionals (Part 2). The overall study duration is expected to be 18 months. Part 1 involves the application of two Devices over a period of 24 hours, and the comparison of the vancomycin concentrations measured by the device to those measured in plasma from blood samples. This 24 hour period of observation will be repeated on two occasions. These 24 hour periods of observation do not need to be sequential. In addition, assessment of Device safety will be determined. Associations between vancomycin concentrations measured by the Devices and treatment efficacy/safety up to 30 days post cessation of the course of therapy or post ICU discharge; whichever is sooner, will be determined from medical records. Part 2 involves the completion of a survey by stakeholders (physicians, pharmacists and nurses) involved in the use of the Device and thematic analysis of responses.

In this randomised, double-blind, placebo-controlled study, 60 generally healthy adults aged 18 to 65 experiencing high stress will be randomly assigned to receive an ashwagandha extract (NRAHG001) or a placebo for 28 days. Changes in self-reported stress, mood and fatigue will be measured over time. Moreover, changes in the stress response using subjective and physiological measures after exposure to an experimental stress procedure (Socially Evaluated Cold-Pressor Test) will be investigated. The effects of ashwagandha supplementation on metabolomic markers will also be investigated to help understand the mechanism of action associated with ashwagandha supplementation. It is hypothesised that ashwagandha will be associated with a reduction in self-reported stress, and improvments in overall mood and fatigue.

This is a double-blind, randomized, placebo-controlled study to assess XW10508 safety, tolerability and efficacy in patients with Major Depressive Disorder. Patients will be randomized to receive 200 mg once per week for 4 weeks. The hypothesis is that oral XW10508 tablets will rapidly improve and maintain the treatment of depression symptoms without significant adverse effects and with good patient tolerability.

This study’s importance is drawn primarily from its focus on an under-represented demographic, which presents distinct and unique health needs. Postmenopausal women, as any other specific population, require tailored interventions to address physiological issues of importance. Assessing the efficacy of APP supplementation to induce favourable protein metabolism and hydration outcomes can advance scientific knowledge, as well as contributing to developing targeted strategies for health adaptations. Further to this, the findings of this study may offer insights of practical importance to practitioners working with postmenopausal women. Specifically, these results could inform public health programs that seek to improve the health and quality of life of postmenopausal women.

This is a prospective study with an Umbrella Protocol, where each sub-Protocol investigates a particular condition(s) and challenges to various Vancomycin biosensors and electrode properties. The study will enrol up to 50 healthy participants in the community. The Sub-Protocol described in this registration form is Sub-Protocol #2: Impact of physical activity, mobility, and physiological interferences on the Limit of Blank (LoB) of Vancomycin Biosensors used in the Nutromics Sensor Device.

Stroke affects approximately 1 in 4 people in their lifetime, but is highly preventable through effective management of risk factors such as smoking, inadequate diet, high blood pressure and physical inactivity. Love Your Brain is a digital platform that aims to help people identify and manage their risk factors for stroke. There are three sequential stages of the Love Your Brain digital platform development and evaluation: Co-design (Stage 1), Implement (Stage 2), and Evaluate (Stage 3). This Stage 3 trial will evaluate whether Love Your Brain helps people identify and manage their risk factors, for example: by seeing a medical practitioner (GP or specialist) for assessment or management of their risk factors; having increased knowledge of risk factors and signs of stroke; and adopting healthy behaviours for controlling risk factors of stroke. We hypothesise that participating in Love Your Brain will improve stroke knowledge, leading to more discussions with healthcare professionals and prevention of stroke in Australia.

The prospective observational study aims to evaluate the clinical performance of the ZiP-CoVx-P2 point-of-care test for detecting the SARS-CoV-2 virus in oro-naso-pharyngeal swab samples from patients presenting to the emergency department with respiratory infection symptoms. Participants will provide combined nose and throat swabs at a single time point, in addition to samples collected as part of routine clinical care (e.g., RT-PCR test and/or RAT test). These samples will be tested using the ZiP-CoVx-P2 point-of-care test within the emergency department. The performance of the ZiP-CoVx-P2 test will be compared to a lab-based RT-PCR test, focusing on clinical sensitivity and specificity. Furthermore, the clinical performance of the ZiP-CoVx-P2 test will be compared to the RAT test, and the study will also assess the potential impact of this test on emergency department care outcomes.

The objective of this randomized controlled clinical trial is to compare the efficacy of a patient specific 3D-printed manufactured medical grade polycaprolactone mesh with a collagen membrane that are loaded with particulate anorganic porcine bone mineral and autogenous bone in the reconstruction of alveolar ridge defects. Lay public hypothesis: We anticipate no significant differences when using customized 3D-printed polymer (polycaprolactone) mesh or the current technique of using animal derived collagen membranes trimmed chair-side to reconstruct lost jaw bone. The trial will report results for a extensive range of outcomes including; graft volume, post-operative recovery/morbidity, implant feasibility, histology, peri-implant parameters and patient reported outcomes

In hospitals, mechanical ventilation is crucial for critical conditions, commonly initiated in intensive care units through intubation. Unfortunately, about half of patients undergoing this process may suffer acute laryngeal injury, with limited information on its impact on post-ventilator speech. Our study focuses on how ventilator use for over 48 hours affects the voice in adult ICU patients. Utilising the vocal handicap index (VHI-10) and voice-related quality of life (V-RQOL), we measure the impact on voice and overall well-being at 8 weeks following ventilation. The VHI-10, a 10-question questionnaire, assesses the impact of voice problems, with scores above 11 indicating a significant impact. The V-RQOL questionnaire gauges the burden of these issues. Our findings are crucial for identifying predictive factors, enabling early intervention strategies like check-ups, speech therapies, and psychological support for those with voice issues, significantly improving their well-being.