ANZCTR search results

A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Intravenous Dose Study to Assess the Safety, Tolerability and Pharmacokinetics. VGL101 or placebo will be administered to healthy volunteers to test if VGL101 is safe and can be explored as a treatment for Adult onset leukoencephalopathy with axonal spheroids and pigmented glia.

This study aims to understand the feasibility and cost of allied health assistants delivering a structured falls prevention education script for patients in the first 48 hours of admission to a rehabilitation hospital. We hypothesise that this project will help patients to reduce their rate of falls and injuries arising from a fall whilst in hospital. Findings from this study will contribute to society new knowledge on the effects of using different health workforce approaches to educating patients about how to reduce their risk of falls whilst in hospital. The findings may also contribute to future workforce redesign. We will seek to measure any changes in patient views and knowledge about falls prevention from before and after the education. The views of the allied health assistant staff delivering and those supervising them will also be sought via focus groups and interviews. We aim to analyse the costs of delivering patient education via allied health assistants versus: (i) an occupational therapist (ii) a physiotherapist and (iii) a registered nurse. Finally, we will track falls rates and any associated injuries during the trial and compare these to the historical data for the rehabilitation hospital.

The primary objective is to evaluate the safety and tolerability of a single dose of PMX205 in individuals with ALS. The secondary objectives are: to determine the plasma pharmacokinetics (PK) of PMX205, evaluate PMX205 levels in the cerebrospinal fluid (CSF) after dosing at a single level, and to evaluate PMX205 pharmacodynamic (PD) activity by measuring cytokine levels following C5a challenge in peripheral immune cells. It is important to determine the extent to which PMX205 crosses the blood-brain barrier and enters brain tissue in individuals with ALS. PMX205 is to be administered as a subcutaneous (SC) injection into the anterior abdomen. Patients who have ALS or are likely to have ALS will be selected by the investigators based on history, examination, imaging and laboratory results. A total of up to 8 participants will be enrolled and assessed for safety (physical exam and clinical laboratory pathology), PMX205 PK and PMX205 PD during the study.

The Frailty Reduction via Implementation of Exercise, Nutritional support and Deprescribing Project (FRIEND) Project is a pilot implementation study that aims to establish integrated processes and pathways within a residential aged care facility to enable early identification and effective reduction of frailty in residents with Mild Cognitive Impairment (MCI) or Dementia. The study involves the evaluation of current practices within a large, regional aged care facility (The Good Shepherd Home Townsville) and the delivery of a multicomponent intervention which aims to reduce frailty in residents living within this facility over a six-month period. Outcomes collected will include not only those relating to improvements in the clinical status within the residents including frailty, nutritional status, quality of life, depression, physical function and cognition, but also facility level outcomes relating to the implementation of the intervention including adoption, acceptability, fidelity, cost, and safety. As part of the study, the research team including the study geriatrician, dietitian, exercise physiologist, and pharmacist will work together with the Clinical Nurse Manager and relevant staff members at TGSH, including the resident’s general practitioner (GP), to design individualised treatment plans for the residents that aim to reduce frailty via the implementation of an exercise, nutritional support and medication review intervention. To sustain these interventions, educational modules for residents and families (face-to-face), as well as pharmacy, nursing, GPs, and other relevant staff (online modules) will also be delivered and integrated into the intervention to educate on the role that exercise, nutrition and deprescribing has on reducing frailty and improving resident’s overall health, as well a build capacity within the facility to continue with this evidence-based care model. Ultimately, the modules and education materials developed and implemented during this study will be refined and disseminated widely to be freely accessible for all aged care facilities nationwide.

The MAP-APS registry has been established to assess the feasability and utility of populating a standardised longitudinal dataset on participants with atypical parkinsonsian syndromes at a single site. The protocol has been devised to acquire enough clinical-biological data to perform deep clinical phenotyping while maintaining brevity and minimising allocation of resources and burden on participants.

This study aims to investigate the effect of a combined exercise training program, compared to a sham-placebo control group on skeletal muscle microvascular blood flow and exercise intolerance in adults living with atrial fibrillation. Secondary to this, the study aims to determine the effect of combined exercise training on quality of life, symptom severity and traditional cardiovascular risk factors. It is hypothesised that participants in the combined exercise training group will have an increase in skeletal muscle microvascular blood flow and exercise tolerance when compared to the sham-placebo control. Additionally, those randomised to the combined exercise training group will have an improvement in quality of life, lower symptom severity and improved cardiovascular risk factors.

Most ICU patients who need a breathing machine (ventilator) to help them breathe require sedation and pain relief with one or more sedative (calming) and analgesic (pain reliever) drugs given as continuous drip into a vein. Combinations of sedative and analgesic drugs are usually used in the ICU to make patients on ventilators comfortable. The focus of this study is on the analgesic component of this management. Analgesic drugs will treat a patient’s pain, but may also provide some sedation. The type and the manner in which analgesic agents are used will vary. The type of analgesic drug and the way they are given may determine whether or not a patient is deeply or lightly sedated (more or less responsive to voice or physical stimulation). Currently, there is no agreement amongst doctors around the world about the best choice of analgesic drug or the best way to manage pain in patients receiving mechanical ventilation. Many of the commonly used analgesic drugs have side effects and may be associated with longer time on the ventilator, longer stay in the ICU, leading to delirium (a confused state often including hallucinations) and decreased mental awareness after recovery from critical illness. Clinical guidelines recommend a multi-modal approach to pain relief in patients who are being treated with a breathing machine (mechanical ventilation). This approach is to try and minimise the amount of pure analgesic agents used and theoretically minimise side effects of these agents. The purpose of this study is to evaluate a drug which has both analgesic and sedative properties, ketamine (Ketalar®), that might decrease the need for other analgesic agents and improve survival and recovery (reduce delirium, time on a ventilator and time in ICU) for patients who are receiving mechanical ventilation in the ICU.

Aortic stenosis(AS) is the most common valvular condition with an increasing prevalence in an ever-ageing population. Historically, the only treatment was surgical valve replacement, but transcatheter aortic valve replacement(TAVR) has emerged as the treatment of choice for those patients at high or intermediate surgical risk. Coronary artery disease(CAD) is common in patients with AS. But the assessment of CAD severity is challenging as our usual physiological tools are not reliable in this group. One of their problems is that they do not assess coronary microcirculation, which is altered in severe AS. A potential solution would be to measure absolute coronary flow to better understand the microcirculation and lead to more reliable estimates. This project seeks to validate absolute flow in patients with severe AS using a novel catheter, Rayflow(Hexacath, France), that measures coronary flow using thermodilution. Once validated, we would then ascertain if this can translate into routine practice with serial measurements pre and post TAVR.

Uterus transplantation involves taking the uterus (womb) from one woman and transplanting it into another with the sole purpose of allowing the second woman to have a baby. Up until recently women with no womb (called absolute uterine factor infertility or AUFI) could only use surrogacy, adoption or fostering if they wanted to become mothers. The prevalence of AUFI among women of childbearing age is not exactly known. Women can either be born without a womb called congenital AUFI (affecting 1:4500 women) or have it removed (hysterectomy) called acquired AUFI. A woman’s womb might be removed due to cancer, large growths in the womb or severe bleeding after a previous childbirth. The most common form or AUFI is called Mayer–Rokitansky–Küster–Hauser syndrome (MRKH), these women are born without a womb but have otherwise normal ovaries. This means they can create embryos but without a womb, can’t carry the baby. Currently the only options for women with AUFI in Australia are surrogacy, adoption and fostering but these options can sometimes be difficult to achieve. Therefore, uterus transplant could give women with AUFI a third option should they wish to become biological parents. Internationally, subsequent to the Swedish UTx trial, more than 60 donor UTx procedures have been performed. The procedure has proven to be successful with more than 40 babies having already been born after a uterus transplant in countries such as Sweden, USA, Brazil and Germany. An International Society for Uterus transplantation (ISUTx) has been established to help countries collaborate and share clinical de-identified data through a secure data registry. However, deciding to put a woman (and her living donor) through a long surgery and short-term immunosuppression (medication to support the womb transplant) needs to be thoroughly explored prior to it becoming a mainstream option in the Australian setting.

During the COVID-19 pandemic there was a rapid move to telehealth use (either via phone or video) in the delivery of pregnancy care. There have been mixed findings from research conducted during the COVID-19 pandemic in Australia and elsewhere. One local study found the use of telehealth at Monash Health showed no compromise to pregnancy outcomes, however women didn’t receive telehealth for all of their pregnancy as some care was provided prior to the start of the COVID-19 pandemic. Another multi-centre cohort study including all public maternity services in metropolitan Melbourne found an increase in preterm stillbirths during lockdown periods and a decrease in medically required preterm births, which could be related to there being fewer episodes of in-person pregnancy care during lockdowns. This two-arm pilot randomised controlled trial (RCT) aims to develop and implement an agreed pregnancy care schedule that combines video-based telehealth care (referred to as telehealth hereafter) with face-to-face visits, and test it against a schedule of all face-to-face visits, with the ultimate aim of testing these in an adequately powered RCT. This study will be conducted at the Women’s and Mercy Hospital for Women. We will recruit 200 pregnant women who are obstetrically low-risk, with approximately 100 women randomised to receive all face-to-face pregnancy care, and 100 to receive combined telehealth and face-to-face care. Participants will complete a survey at recruitment and at two months post birth. Clinical data for each participant will be collected from their medical record. A second component of this pilot study is to evaluate obstetric and midwifery staff views and experiences of providing pregnancy care via telehealth. An online survey will be sent to all obstetric and midwifery staff to explore their views. Findings from this study will help to inform the development of a larger trial investigating the use of telehealth in providing pregnancy care.