ANZCTR search results

This was a pilot randomised controlled trial that examined the feasibility of a three months ‘internet-based intervention’ as a possible tool to enhance recovery and to examine how the intervention be perceived and if potential benefits can be identified. The potential effect of the internet-based intervention on knee pain, function, self efficacy and fear of pain were also assessed. The study would provide preliminary results, which could then help to determine whether such intervention is appropriate for further testing on a larger scale

It is known that modern Australian society is trending towards an ageing population combined with a poor intake of foods rich in dietary fibre such as wholegrains, fruits and vegetables. Therefore, as diverticulitis is highly prevalent in older adults, it is predicted to become even more prevalent in the future. In addition, it is also suggested that the disease is now occurring more commonly in younger ages. Furthermore, the evidence that is in existence to support current dietary managements is inconsistent, of poor quality and lacking in Australia. Therefore, observational research is warranted to explore the impact of current clinical practice in Australia upon patient and healthcare related outcomes. In adults admitted to an acute-care hospital with acute, uncomplicated diverticulitis in South-East Queensland, Australia, it is hypothesised that: 1). Participants who are prescribed and adhere to liberalised diets during hospital admission have less healthcare use and no difference in gastrointestinal symptom scores compared to those prescribed restricted (fluid only) diets. 2). Participants who follow a high fibre diet following discharge have lower healthcare use and gastrointestinal symptom scores than those following a standard diet. A Low or Negligible Risk (LNR) research application for ethical approval has been submitted as this study intends to be of low risk to research participants as the likelihood and severity of any risks to the patient is low. Possible risks include using vulnerable, sick patients as the study population as well as fatigue, inconvenience or discomfort of talking about personal issues. To minimise risks, high risk patients will be excluded from the study, patient involvement will be as minimal as possible by accessing medical records and eligible participants will be asked to provide informed consent. Data will also be gathered and kept in a de-identifiable format where possible with identifiable data stored in password protected electronic files or a locked filing cabinet. Researchers will be the only ones to have access to this information. The intended outcomes of this study include a greater understanding of acute uncomplicated diverticulitis. Future research that can stem from findings of this study, may then help to formulate best practice guidelines for the dietary management of acute, uncomplicated diverticulitis as such is currently non-existent. This would help to achieve cohesion across treating doctors and dietitians. It is believed that theses outcomes and associated potential benefits that this study can provide will far outweigh the possible minimal risks.

Background: Despite the high burden of mortality of sepsis, there are no clearly effective strategies to suppress the underlying inflammatory response. Studies have suggested that low-dose aspirin - a cost-effective and safe medication - has a potential role in the prevention and treatment of sepsis. This trial aims to measure the effects of low-dose aspirin on target inflammatory markers; activation of NF-KB, increases in aspirin triggered lipoxins (ATLs) pathway, platelet activation indices, immune cellular markers and the rate of organ dysfunction in septic patients. Method: The MATHS trial is a single-centre, randomised, open label, phase II trial. One hundred and thirty-five septic patients (Sepsis-3 definition) will be randomised to one of three treatment groups: aspirin 100mg, aspirin 300mg both given daily for two days or no treatment. Blood samples will be taken at regular set intervals and assays will be performed to quantify the inflammatory response via NF-KB activation, expression of aspirin triggered lipoxins (ATLs) and various other inflammatory markers. Initial SOFA and APACHE II scores will be calculated, with repeat SOFA scores at 24 and 48 hours. Exploratory analyses, such as the correlation between ATL levels at 24 hours, and deterioration in SOFA scores/mortality/length of stay in ICU, will involve exact tests for comparisons of categorical outcomes (SOFA), log ranked tests for non-parametric data (APACHE II) and ordinal logistic regression for multivariable analysis. Conclusions: The results of this this trial could add further evidence to support the use of low-dose aspirin in sepsis.

An exercise rehabilitation program based in the hospital or home is commonly used to manage patients with congestive heart failure to improve their quality of life. However, the proportion of patients who follow these programs is low. In this project the researchers will assess the use of regular motivational text messaging in keeping you motivated towards your exercise program. This will be looked at using questionnaires about your health and quality of life, and by measuring your walking distance in a 6 minute walking test. The use of physical activity trackers, Fitbits, will also be used to assess your ability as a way of monitoring your health (heart rate and level of exercise) remotely. We will also be measuring your waist circumference and level of key biomarkers in your blood samples at the beginning and end of the study to help monitor your progress, At the end of this study, we hope to have improved our understanding of using these new technologies as a means of improving a patient’s motivation for their rehabilitation programs.

This Phase 1 study entails administration of GS-5801 to subjects with chronic hepatitis B (CHB) for the first time with the objective of evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GS 5801, and thereby determining the clinical pharmacology profile and antiviral activity of GS 5801 to evaluate if it is suitable for further clinical development as a treatment for CHB. The results from this study will form the basis for further evaluation of GS 5801 and dose selection for upcoming studies in subjects with CHB. The study will proceed in two parts, with the first part (Part A) evaluating the safety, tolerability, PK and PD of GS-5801 administered once daily for 7 days in the fasted state via a pre specified dose escalation through 2 cohorts. The second part (Part B) is designed to evaluate the safety, tolerability, PK, and PD of GS-5801 with adaptive dose selection (up to 100 mg administered once daily for 7 days). The doses evaluated in the adaptive cohorts (Part B) will be selected based on safety and available PK and PD data (up to day 14) from Part A (Cohorts 1-2) and available safety, PK and PD data from previously conducted cohorts from Study GS US 405 2064

Utilization of wearable technology in estimation of heart rate has wide reaching implications. Firstly, validation of heart rate measurement using this technology in healthy individuals at rest and exercise is vital for any future research going forward. Secondly, if smart watches prove to be accurate in monitoring heart rate trends among patients with arrhythmias, it could be a useful tool in guiding and monitoring response to pharmacological therapy. Smart watches and wearable technologies also have the ability to provide longer term monitoring of heart rate compared to 24 hour ECG holter monitoring also called ambulatory monitoring or telemetry - the current standard of care. It may be a cost effective and non-invasive method for patients to remotely assess their heart rate trends and communicate any abnormalities with their cardiologist or general practitioner. This would ensure timely assessment and an earlier change in management strategy that could lead to reduced presentations to the emergency department and improve overall patient satisfaction. Moreover, the ability for patients to accurately track their biometric indices may empower them to be more engaged in their health leading to improved clinical outcomes and quality of life. In addition to heart rate analysis, a versatile and validated mobile platform for heart rhythm analysis through the use of a mobile single lead ECG device may lead to more widespread adoption of this technology by the clinician. Methodology Patients that consent for the study will be provided with two smart watches that use wrist PPG technology as well as a hospital grade pulse oximeter for heart rate assessment. The two smart watches intended for use in this study are the Apple Watch and the FitBit Blaze given their popularity and global market share. Heart rate readings in all patients will be documented using data from an ECG linked with the ward telemetry unit (in the case of inpatients) or an ECG ambulatory monitor (in the case of outpatients undergoing stress echo or ECG) as per standard ward or stress testing protocol. Each patient will be monitored for a period of approximately 30 minutes with heart rate data being recorded every fifteen seconds among each different modality. Additional parameters recorded include a blood pressure reading at the start and end of the period of monitoring. Baseline characteristics including cardiovascular risk factors, history of arrhythmias and medication use will be noted. For patients when using the mobile smart phone electrocardiogram, three heart rate recordings using a single lead mobile ECG device (each lasting approximately 30 seconds) will be taken. These readings will be compared to a 12 lead ECG which will be performed during this period as a comparator. For patients undergoing cardioversion, this will be repeated after the cardioversion procedure.

Trial of a procedure specific consent form for laparoscopic cholecystectomy with a set of significant complications listed for discussion vs a standard consent form with no complications listed for discussion. To signify that a complication was discussed on the procedure specific consent form, surgeons/doctors had to tick the complication. We aimed to assess if documentation of these specific complications improved following the introduction of a procedure specific consent form. Participants were randomized to either a procedure specific or standard consent form. Outcomes measured were proportion of consent forms in each cohort with documentation of specific complications.

Our aim is to test the effect of a new wearable device (a continuous glucose monitor) on the achievement of evidence-based targets for overall glucose levels (glycemic targets). The general way of measuring glycaemic targes is to measure HbA1C in the blood, which gives an average of the glucose levels over the last 3 mths. Based on this measure about half of people with T2D in the community are not in the glycemic target of 53 mmol/mol.. We think knowing more about the day-to-day variation in glucose levels may be important, because that sort of information might help GP and patient to make more personalised and rational changes in treatment (including lifestyle changes and medicines). Our research question are: 1. Does the judicious use of intermittent retrospective continuous glucose monitoring (r-CGM) in primary care improve glycaemic control as measured by HbA1c? 2. Is intermittent r-CGM cost-effective? This is an individually randomised controlled trial set in General Practices in Victoria. Up to 60 practices and up to 300 patients will participate. Eligible patients are people with T2D who are out of glycaemic target despite moderately intensive therapy. People will be asked to complete a survey and have a blood test at the beginning and at 12 months. Patients randomised to the intervention group are asked to wear the r-CGM device every three months for a period of 2 weeks then to meet their GP to discuss it. Patients in the control group just continue to have usual diabetes care.

Mazabraud’s syndrome is a rare syndrome in which benign intramuscular myxomas occur in association with fibrous dysplasia of bone. (Macfarlane, Lew et al. 2007) There is increased risk of developing osteosarcoma or fibrosarcoma in Fibrous Dysplasia with Mazabraud syndrome. The recognition of this entity is important for appropriate management of the patient. In this project, we will perform genetic tests on 4 patients with Mazabraud syndrome to look for any genetic link between Fibrous Dysplasia (FD) and Intramuscular Myxoma (IM). In order to do genetic study, we need to arrange taking blood sample from these patients.

Ambulatory surgical procedures are increasingly being performed worldwide; patient complexities such as obesity, advanced age along with other medical conditions will be frequently encountered. Major perioperative morbidites or mortalities are reported to occur once in every 1000-day surgical cases according to a recent large review on approximately 250,000 cases. One of the significant predictors for adverse outcomes was hypertension. Increasing number of patients on ACEI and ARBs are seen undergoing day surgery procedures. While we have strong recommendations about preoperative beta-blockers, the evidence on these antihypertensives that act on the renin- angiotensin pathway is insufficient and controversial There is insufficient evidence on whether ACEI and ARBs should be continued or ceased before ambulatory surgeries. As there have been limited data in terms of recommendations on ACEI/ARB agonist in ambulatory surgeries, more research seems necessary to provide evidence on the risks of continuation these drugs, in terms of both high and low blood pressure responses. Primary aim: To investigate the association between i)Preoperative angiotensinogen converting enzyme inhibitor (ACEI) and ii)angiotensin II receptor blocker (ARB) therapy and perioperative blood pressure changes in patients undergoing ambulatory surgical procedures Secondary aim: 1. To study the haemodynamic influence of continuation of other antihypertensive agents. 2. To examine the effect of hemodynamic fluctuations on the quality of recovery and complication rates Following ethics committee approval, preoperative data from the consented patients that undergo day surgery procedures will be collected from patient records and face-to-face interview. Patients are allowed to follow their medication order as per the surgical/ anaesthetic teams’ instructions. No specific instruction on the antihypertensive treatment shall be given for this study. The preoperative data collected include but not limited to the antihypertensive therapy details and the time of last dose of medication. Management of the case will be left to the anaesthetic team involved. The details on the anaesthetic management, intraoperative hemodynamic changes and postoperative recovery details will be collected at the end of surgery. Endpoints measured: Primary: Significant hypotension b. Change in mean perioperative systolic blood pressure from mean pre-operative measures. c) Variability in systolic blood pressure d) Preoperative hypertensionSecondary outcomes: Length of stay in recovery room. Unplanned readmission or any major surgical or medical complications, quality of recovery within 24 hours of the day-surgery procedure, correlation between the primary outcome measures Vs type antihypertensive agents and the timing of discontinuation in patients on monotherapy.