ANZCTR search results

A Trans-Esophageal ElectroPhysiological Study (TE-EPS, TEEPS), uses an oesophageal probe to sense and pace the heart together with an electrocardiogram to perform a limited electrophysiology Study. For adults it is potentially a less invasive, more rapid and more cost-effective strategy for some heart rhythm disorders. TEEPS provides a diagnosis of SVT (supraventricular tachycardia) comparable to that an invasive electrophysiology study and can terminate the arrhythmia. Historical TEEPS systems require at least three interconnected systems, limiting applicability and ease-of-access. In this pilot study using a novel integrated system, fifteen patients scheduled to undergo EP Study will first undergo an additional 20-30 minute TEEPS study before proceeding to a routine invasive EP study. Fifteen further patients will be recruited from emergency department presentations with suspected SVT. TEEPS data will be evaluated for operator- and patient-related qualitative criteria to inform a future study of TEEPs to improve arrhythmia management in the emergency department.

A first in human, single and multiple-ascending dose study to determine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SIR4156 in healthy adult and elderly participants. Results of this study will inform dose selection and design of studies to assess the efficacy and safety of SIR4156 in muscle degenerative diseases. The study hypotheses are that SIR4156 is safe and well tolerated in Adult and elderly healthy volunteer subjects; SIR4156 has a well acceptable PK profile with or without food effects and formulation difference; and SIR4156 could potentially increase the NAD+ level in adult and elderly healthy subjects

This study aims to assess the tolerability and efficacy of the ChezLeon DP-Tx product (neck wrap) for patients with head and neck lymphoedema (HNL) after radiotherapy. Who is it for? You may be eligible for this study if you are an adult patient who has completed adjuvant or definitive radiotherapy for a head and neck cancer, at least 3 months prior to enrolment into this study, and have visible and/or moderate grade external and internal lymphoedema. Study details Participants will be asked to wear the neck wrap as much as possible over a 6-week period and will be asked to provide feedback on tolerability of the neck wrap. HNL measurements will be taken at various timepoints to determine efficacy. It is hoped that findings from this study will help inform future clinical trials to develop this treatment device for head and neck lymphoedema after radiotherapy.

Without adequate ambient humidity, extremely preterm babies lose water through their skin, causing dehydration and hypernatraemia (high blood sodium concentration), which is associated with death, brain injury and disability. Skin water loss and hypernatraemia are reduced by increasing incubator humidity. However, there is worldwide variation in practice due to lack of high-quality clinical trials. Clinicians in Japan routinely use 95% incubator humidity compared to 80% in Australia. The HUM-TE study hypothesis is that in extremely preterm infants, initial incubator humidity of 95% compared with 80% reduces the risk of any hypernatraemia (serum sodium >=150 mmol/L) and/or mean sodium concentration in the first three days after randomisation and reduces the risk of skin injury, sepsis, IVH and brain damage. The concurrent process evaluation will explore context, uptake, acceptability and parent experience of starting incubator humidity at 95%. Skin integrity substudies will assess the effects of incubator humidity on skin barrier function.

Nutrition impact symptoms (NIS) are symptoms that affect food intake or choice and increase the risk of undernutrition. Contributing to the high prevalence, burden, and suboptimal management of NIS is the lack of a patient-reported tool that comprehensively assesses NIS. Therefore, in people undergoing cancer treatment, a cross-sectional survey will aim to assess nutrition impact symptom (NIS) incidence, frequency, and severity; frequency of NIS interference with eating and drinking; met and unmet NIS needs; and perceived importance of NIS. In a minimum of 100 participants, 27 patient-reported NIS will be assessed using a researcher-developed survey due to the lack of a comprehensive NIS tool existing. The comprehensiveness, relevance, and comprehensibility of the NIS survey will be assessed to aid in the further development and validation of the NIS tool.

This study aims to gather evidence on the mechanisms of action and optimal dose of ginger for chemotherapy-induced nausea and vomiting (CINV), one of the most distressing and common side-effects for people undergoing chemotherapy. Who is it for? You may be eligible for this study if you are an adult scheduled to undergo intravenous (IV) chemotherapy for any type of cancer, and have been deemed to be at moderate to high risk of nausea and vomiting. Study details Participants will be randomly allocated to receive either standard care, or low dose or high dose oral ginger supplements at the beginning of chemotherapy infusion. This will occur on a single test day, with outcome data collected using a novel technique called Body Surface Gastric Mapping (BSGM) in the baseline (fasting) states as well as during chemotherapy infusion. It is hoped that findings will guide the optimal ginger dose to improve the management of CINV and assist in the future application of BSGM as a non-invasive, low cost, and quick measure of CINV treatments.

Depression is a mental illness which is the leading cause of disease burden in middle and high-income countries. It is characterised by low mood (i.e., feeling sad), loss of interest in or pleasure from things that were previously enjoyable, changes in appetite or weight, fatigue and sleep disturbances. Up to 90% of people with depression experience sleep problems, which often precede the onset of mood symptoms. Problems with the circadian system, or 'body clock' can contribute to sleep problems and may play a role in the development of depression. It has been found that antidepressants increase the effect of light on the body clock, which may contribute to variability in treatment outcomes. For example, increased light sensitivity may be beneficial for patients who were previously insensitive to light, or for those who exhibit healthy light exposure patterns (as the positive effects would be enhanced). However, for patients with unhealthy light patterns, or who are already hypersensitive, increased sensitivity due to antidepressant treatment may lead to the exacerbation of symptoms. Better understanding the impacts of antidepressants, and light exposure, on treatment outcomes in depression may lead to simple ways for improving the efficacy of those very common medications. We aim to investigate the effect of citalopram use on the response of the circadian system to light and test the hypothesis that increased light sensitivity is predictive of better SSRI treatment efficacy for depression.

More than 20,000 heart operations are carried out each year in Australia. While many patients survive the operation, many spend long periods in hospital recovering. Common complications that can occur include a rapid and irregular heart rate (atrial fibrillation) and damage to the kidneys (known as acute kidney injury). These each occur in as many as one in four patients. Preventing or reducing the severity of these complications could improve the health of patients. Previous studies have suggested that acute kidney injury or atrial fibrillation may be reduced by using a drug known as ‘vasopressin’ to preserve blood pressure during surgery. Drugs to preserve blood pressure are often needed in cardiac surgery. However, the research studies that showed that vasopressin was a superior choice to noradrenaline were small, and the largest was conducted in a hospital and group of patients with a higher rate of complications. In this study we aim to assess whether a trial comparing vasopressin to a placebo infusion (inactive substance) is feasible in a Australian population.

We have highly effective psychological therapies for post-traumatic stress disorder (PTSD), however, individuals face multiple barriers to receiving gold-standard treatments. Most prolific of these is long waiting times or no access at all, due to the limited number of professionals trained in specialist PTSD treatments. Here, we aim to evaluate a simple, digital, memory-based program MemFlex, which has been demonstrated to improve PTSD symptoms, and ameliorate cognitive difficulties that predict prognosis and impede the efficacy of psychological therapy. It is expected that offering MemFlex to individuals with PTSD will improve both a) cognitive predictors of PTSD, and b) PTSD symptoms, relative to treatment as usual.

Chest physiotherapy (CPT) is regarded as an important contributor to the management, and potentially long-term outcomes, of preterm infants with lung disease. Delivering CPT in this population is not without risk, however, and the decision to undertake CPT interventions rely on effective assessment (Hough, 2008). Preterm infants present with multiple lung pathologies, (Gallacher et al, 2016) however not all of these are best treated using CPT. In preterm infants, CPT is thought to be most efficacious in treating alveolar collapse and consolidation, and not useful, or potentially harmful, in the management of interstitial lung disease (Hough, 2008). Differentiating between pathological processes using existing assessment tools such as auscultation and chest radiograph is challenging as these tools only provide subjective, non-specific and surrogate measurements of lung aeration and pathology (McAlinden et al, 2020). Physiotherapy- led lung ultrasound (LUS) has been recently proposed as a more accurate and objective way to image both regional lung aeration and lung pathology by the bedside without the potentially harmful radiation associated with other imaging techniques (Hansell et al, 2023; Hayward et al, 2021). Such imaging makes it theoretically possible to deliver individualised and targeted CPT, thereby improving effectiveness and minimising physiological burden. (Le Neindre et al, 2023) Despite its promise, physiotherapist-led LUS is considered an extended scope skill in Australia and further training and knowledge is required before it can be used safely and effectively. To date, physiotherapist-led LUS has been investigated in paediatric (Myszkowski, 2019; Shkurka & Nolann 2023) and adult cohorts (Hansell et al, 2023; Le Neindre et al, 2023) but similar research has yet to be undertaken in preterm infants. This study aims to investigate the use of LUS as a neonatal physiotherapy assessment tool to measure the effect of CPT in premature infants with lung collapse.