ANZCTR search results

Alyra Biotech Pty Ltd is an Australian-owned biopharma company that wishes to develop an optimal intrauterine contraceptive device (IUD) for people with period or pelvic pain. The use of IUDs globally is increasing, however some people experience increased pelvic pain in the 3-6 months following insertion, causing them to have the device removed. They then miss out on the benefits that IUDs can provide, such as; reducing your lifetime exposure to synthetic hormones; decreasing the amount of blood loss at each period; as well as decreasing intense period pain, over time with continual use. Alyra Biotech Pty Ltd has developed and patented a novel IUD designed to reduce the severity of post-insertion pain in those that experience it, giving them access to the benefits of IUD use. The objectives of this study are: 1. To determine how the device performs at releasing the appropriate medicinal drugs (pharmacokinetics). 2. To compare the tolerability of the new Alyra device with the currently approved for use in Australia, the Mirena 'Trademark" device. 3. To establish the expected number of days of bleeding following insertion 4. To determine the number of days and intensity of pain experienced following insertion

This project aims to test a multi-dimensional physiotherapy intervention for dysfunctional breathing in people with difficult asthma. The intervention involves breathing exercises and education, and may involve manual therapy, relaxation therapy and physical exercise depending on the individual assessment findings. We believe a targeted, individualised program will be feasible and acceptable to people with difficult asthma.

Tremors are uncontrollable shaking movements. Organic tremors are usually the result of structural damage to the parts of the brain that coordinate muscular movement. Current treatments for organic tremors are mainly medication based. Up to 30% of tremor patients do not respond to medication and therefore need alternative treatment options. For some of these patients surgical treatment options can be considered. These treatments are invasive (with significant risks of complications), expensive and difficult to access for many patients. Also, many patients cannot undergo surgery for treatment of their tremors due to age or unacceptably high surgical risk. Functional Neurological Disorder (FND) is one of the most common diagnoses in general neurology clinic. Functional tremors are not caused by structural damage to the brain, but are due to a problem with communication between different brain areas. Functional tremors can often be treated by teaching patients strategies to retrain control over their movements. In this study we want to test if this approach can also work for patients with organic tremor disorders. Acute flares of organic tremors share many features with functional tremors. We hypothesized that it will be possible to use the physiotherapy-based treatment approaches that have been shown to be beneficial in patients with functional tremors to help patients with organic tremors to manage their acute tremor flares.

We are determining, as a pilot study, if we are able to reduce the duration of labour associated with induction of labour, when oxytocin is provided in a pulsatile (intermittent) fashion as opposed to the existing continuous infusion. Furthermore, by the use of paired blood samples, we are determining if restriction, as opposed to a liberal fluid strategy, changes baseline serum osmolality and serum copeptin levels, which may be impacting upon the birth outcomes.

The PANDA (Personalised Add-on Acupuncture Service at Northern Emergency Department for Acute Pain) project is a feasibility study aimed at integrating acupuncture into the emergency department (ED) to manage acute pain and improve patient outcomes. This interdisciplinary research investigates the effectiveness of acupuncture in reducing pain intensity, minimizing opioid use, improve the key performence index of hospital and enhancing overall patient satisfaction. The study involves non-randomized allocation of patients to either receive standard care or additional acupuncture treatment, with key outcomes measured through various clinical and patient-reported metrics. Ethical approval for the project has been granted by the St Vincent’s Hospital (Melbourne) Human Research Ethics Committee (HREC).

LOTUS is an investigator-initiated and nurse-led trial with a two-arm, open-label, randomised, multicentre design. Low dose combination therapies for treatment of hypertension and (optional factorial arm) hypercholesterolaemia will be compared to usual care in stroke survivors over 26 weeks. The primary aim of LOTUS is to assess whether an innovative model of care involving low dose antihypertensive (and optionally) lipid lowering treatment underpinned by team-based, telehealth-supported care will reduce BP over 26 weeks when compared to usual care in survivors of ischaemic stroke/transient ischaemic attack (TIA). Secondary aims include if this new model (when compared to usual care): reduces cholesterol, is acceptable to patients and clinicians, is cost-effective, improves medication adherence and patient acceptability, and is safe.

This study is seeking to investigate the commercially available and TGA approved drug Tirzepatide in obese asthmatics with uncontrolled symptoms. The trial will be a pilot phase 3 placebo controlled randomised trial. The trial is seeking to determine if this drug improves asthma symptoms over a 36 week period in the setting of weight loss. Furthermore, secondary and exploratory outcome measures are seeking to determine how these benefits, if they are observed, can be explained. For example it might not just be about weight loss that improves asthma symptoms. Maybe other changes in the bodies inflammatory pathways can explain any improved symptoms observed in asthmatics. It's very important for doctors to understand how drugs work as this allows improved prescribing practices and improves the ability to identify patients who are most likely to benefit from any drug intervention.

This is an open-label study to evaluate the safety/tolerability and pharmacokinetics of RECCE327 topical gel in the systemic circulation when applied to intact human skin. The study will also evaluate the safety and tolerability of RECCE327 topical gel when applied to intact human skin. All participants must meet all inclusion criteria and not meet any exclusion criteria. Study medication will be applied once daily for seven (7) days to normal intact skin. The location of the gel administration will be on the ventral mid-section of the forearm. Participants will be treated in an inpatient setting at the clinical site for 8 days, and return to the clinic for a follow-up visit on Day 14 (+/- 3 days).

Bone loss is a common health problem in older people, particularly women, and can significantly affect their quality of life. Progressive resistance training has been shown to be effective in preventing bone loss. However, several questions remain regarding the optimal design of such interventions. One such aspect is movement velocity. The aim of this project is to investigate whether faster movement velocities are more effective in improving bone mineral density.

This Phase 1, first-in-human, open-label, fixed-sequence, 3-period, 3-treatment study is designed to assess the skin safety, tolerability and PK of MRX-7MLL compared to the oral reference product, Namenda® (Memantine HCl oral tablet) or generic equivalent. This pilot study will also assess TDS adhesion, validate analytical methodology, assess inter- and intra-participant variability, and/or optimize PK sample collection timepoints for MRX-7MLL and oral memantine HCl tablets. The results of this study will support dose selection in future bioequivalence studies with MRX-7MLL and oral reference product or may be used to identify candidate formulation(s) for the pivotal study.