ANZCTR search results

• The aim of this study is to evaluate the impact of contact lens disinfectants on ocular physiology, tear film characteristics, and symptomatology that might occur during contact lens wear. Participants will wear Comfilcon A contact lenses over a 6-week, changing their lenses every two weeks, a commonly recommended wear schedule and use new contact lens disinfectants (Cleadew MPS,Ophtecs Corp., Japan) • The primary endpoint is the changes in the ocular surface and tears of contact lens wearer over the first six weeks of lens wear using new lens care product. • The secondary endpoint is changes in factors that have been reported to be different between comfortable and uncomfortable contact lens wearers.

Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have symptomatic malignant pleural effusion that requires treatment, you are currently being looked after by the Pleural Medicine Service at Northern Health, and have recently undergone a procedure to manage the fluid around the lung. Study details: The trial aims to include 114 participants, 57 who will be cared for with the Specialised Ambulatory Pleural Service digital health care model at Northern Health. The hospital records of a further 57 individuals receiving standard care will be reviewed from Melbourne Health and Western Health to compare hospital admissions, emergency presentations, and outcomes. Participants in the intervention group will receive aftercare by a treating physician and a pleural nurse. The pleural nurse will visit at home, to provide care for the indwelling pleural catheter. At each visit a lung ultrasound will be performed. The treating physician will view the ultrasound remotely (tele-ultrasound) and do a video call (tele-health) to provide an assessment of the fluid around the lungs. The visits will occur at days 14 & 28, and months 2, 3, 4, 5 and 6. Being involved also requires completion of a logbook to monitor symptoms for 28 days and participation in surveys at during the routine home visits. Participants will also be asked about health care outcomes, such as whether they have recently been to hospital or emergency department. Participants may be selected for an interview via telephone or internet video call that should take approximately an hour. Hospital records will be accessed related to hospital admissions, emergency presentations, and outcomes for the purpose of comparing the benefits and risks of this model of care to standard care at other health services. It is hoped this research will demonstrate that a specialised pleural service where participants may receive treatment at home is safe and can be achieved in a practical manner. If this initial study shows that this service is feasible, it may be rolled out to additional hospitals and could lead to improved quality of life for patients who are being treated for malignant pleural effusion.

Ventricular tachycardia (VT) is a heart rhythm abnormality which typically affects people with underlying heart disease (cardiomyopathy). There are a number of patients who do not have any alternative treatment options. Stereotactic ablative radiotherapy involves the delivery of high-dose radiation non-invasively with high precision and will be used to treat the part of the heart that is causing VT. In this study, we will investigate whether the use of cardiac stereotactic ablative body radiotherapy (SABR) reduces the number of ventricular tachycardia events in the patient. The effectiveness the radiation treatment will be done by assessing the toxicity and quality of life both before and after the radiation delivery.

A Phase 1, Single Centre, Randomised, Double Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, of NeuroDirect Ketamine in Healthy Adult Volunteers

The purpose of this study is to identify whether fast track cardiac anaesthesia is superior to usual care anaesthesia for patients undergoing primary coronary artery bypass grafting surgery. Who is it for? The study will include adult patients undergoing coronary artery bypass grafting surgery. This is a retrospective analysis of patients who underwent primary coronary artery bypass grafting (CABG) surgery via midline sternotomy who were managed by a fast-track protocol (fast-track group) or via usual care (usual care group). Fast track cardiac anaesthesia is a program using methadone with non-opioid adjuvant infusions (magnesium, ketamine, lidocaine, and dexmedetomidine) in patients undergoing CABG. Study details This study will evaluate the total mechanical ventilation time in hours adjusted for the hospital, body mass index, category of surgical urgency, cardiopulmonary bypass (CPB), and European System for Cardiac Operative Risk Evaluation (EuroSCORE II). We will evaluated other outcomes such as time taken to tracheal extubation, pain within the first 24 and 48 hours postoperatively, and postoperative opioid requirements within the first 24 and 48 postoperative hours. We will evaluate postoperative complications. It is hoped that this study will be hypothesis generating and provide valuable data for power calculations for future studies on evaluating the use of fast track surgery in patients undergoing primary coronary artery bypass grafting surgery.

This trial will utilise information from Boston Scientific Cardiac Implantable electronic Devices remote monitoring and Heart Logic Algorithm and the NOTIFY-HF smart phone web-application to assist in the early identification of fluid overload. Evidence shows that heart failure decompensation events begin 4-6 weeks before the development of symptoms such as breathlessness or fluid retention. The aim of this research project is to use this information obtained from your device via remote monitoring to provide feedback via push notifications to participants on their heart failure status. The app, NOTIFY-HF, will provide a weekly update in an easy-to-understand manner with the hope of instigating behavioural changes that result in improvements in heart failure management. The central hypothesis of the study is that push notifications guided by HeartLogic data will promote behavioural change that leads to improvements in heart failure.

Prospective questionnaire following paediatric tonsillectomy at 3 and 12 weeks determining presence, impact and risk factors of pain following paediatric tonsillectomy.

This is a Phase I/II proof-of-concept study of RECCE®327 topical anti-infective therapy for mild skin and soft tissue diabetes foot infections (DFIs). It is designed to establish effect size, patient tolerability and ease of use of a topical application in an ambulatory sample of patients. The study has been designed to provide proof of concept regarding the effect and tolerability of the study drug. We hypothesise that this will provide pilot data to guide sample size for future trials in the same patient group using the same assessment tools.

Background: Skeletal muscle alterations significantly contribute to exercise intolerance in heart failure (HF). Small muscle mass training, localised to the quadriceps femoris muscle group, has been proposed as an intervention to target these HF-related changes. The application of this training paradigm in HF is supported by a recent literature review that found improvements in whole-body exercise capacity, quadriceps muscle strength and health-related quality of life (QoL) in those with reduced ejection fraction. Since this training involves only one muscle group, it places a lower demand on the central circulation than whole-body exercise, thereby permitting a near-maximal intensity protocol. Hence, this proposed study will evaluate high-intensity small muscle mass training (HISMT) isolated to the knee extensor muscles in a conventional clinical context, with the aim to determine the additive effects of integrating HISMT within a standard HF rehabilitation program. Methods: This randomised, controlled, single-blind trial will aim to recruit 70 clinically stable participants aged 18 years and over with a HF diagnosis and New York Heart Association class I to III. Participants will be randomly allocated to either: (i) standard training (ST) alone: combination of upper and lower extremity cardiovascular and resistance-based exercises; or (ii) HISMT plus modified ST: bilateral, isolated knee extensor HISMT in addition to a modified version of the ST, so that the total volume of work will be similar to ST alone. The training interventions will be conducted twice weekly for 12 weeks in an outpatient setting. Outcome measurements will be performed at baseline and following the 12-week intervention period. The primary outcome measure will be exercise capacity (six-minute walk test), with secondary measures being physical performance (timed up and go test and 30-second sit-to-stand test), muscle strength (quadriceps maximal voluntary isometric contraction, knee extensor five-repetition maximum and hand grip strength), and health-related QoL (Kansas City Cardiomyopathy Questionnaire). Discussion: This study will assess whether there are greater improvements with incorporating knee extensor HISMT within a traditional HF rehabilitation program. It is hypothesised that the addition of HISMT will confer superior outcomes. In addition to extending current knowledge relating to small muscle mass training, the study will provide a unique perspective on the effects of HISMT within routine clinical practice, thus enabling the optimisation of exercise prescription for the HF patient population.

This study is a comparative study investigating how ILO chest x-ray compares to low dose high resolution computed tomography (LD HRCT) for early diagnosis of occupational lung disease. As part of this study participants will be asked to undergo a LD HRCT scan, which is new technology using very low levels of radiation. HRCT scans are better at diagnosing early stage of occupational lung diseases than chest radiography. This study will answer the question about whether the low radiation dose HRCT scan used in this study picks up more early stage lung diseases such as black lung, emphysema and silicosis. No Australian evidence has been collected to demonstrate the use the use of LD HRCT in the screening of occupational lung diseases.