ANZCTR search results

Approximately 17000 colonic cancers are diagnosed in Australia each year. The majority of patients will undergo surgery. Large sessile lesions are traditionally removed surgically. In recent years advances in Endoscopic Mucosal Resection (EMR) emerged as a safe, effective, minimally invasive technique for removal of large sessile polyps and can be performed as an ambulatory procedure in special Gastroenterology units. This has potentially a much smaller impact on the patient and allows a faster recovery. However, one of the main risk factors of EMR is delayed bleeding. Clinically significant post-endoscopic bleeding [CSPEB] occurred in 6.2% of patients. The underlying cause for the bleeding is unclear. We suspect that there is a possibility the clotting system gets disturbed slightly during the procedure in some patients. A special blood test looking for clotting abnormalities may help us evaluate if this theory is true or not. This study will test for clotting abnormalities before and after endoscopic mucosal resection (EMR). Who is it for? You may be eligible to join this study if you are aged 18 years or above and are undergoing EMR for large sessile colonic polyps. Study details All participants will have a blood test immediately before and after the EMR to check for clotting abnormalities. Participants will be asked to return to the clinic for post-procedure follow-up 2-3 days after the procedure to determine any occurrences of post-endoscopic bleeding.

Parkinson’s disease (PD) is a chronic, progressive, incurable, and disabling neurological condition. In addition to the many physical symptoms at least 75% of people with PD experience impaired speech production and various mental health issues, such as depression and anxiety. This mixed-methods study aims to explore the experience of group singing for people with PD and examine the effects of long-term participation on communication and health outcomes. We will assess speech and voice function, speech-related quality of life, and communication participation, as well as wellbeing outcomes such as depression, anxiety and fatigue for both participants with PD and their caregivers.

The study is a randomised controlled treatment (RCT) trial over 8 weeks in individuals with Major Depressive Disorder, with a 6 month post-RCT trial period, where study participants have the option to continue Vortioxetine. The purpose of the study is to investigate the effectiveness of using a simple blood test, prior to treatment of depression, to guide the use of anti-inflammatory medication as an addition to antidepressant medication. The study aims to find out whether adding the anti-inflammatory medication Celecoxib (also known as Celebrex) to the antidepressant medication Vortioxetine (also known as Brintellix) can improve symptoms of depression. There is evidence that raised levels of inflammatory markers in the blood are associated with depression. The study measures the inflammatory marker C-reactive protein (CRP) prior to commencing treatment, with study participants assigned to a study "arm" based on CRP levels. Within each study "arm", participants receive treatment for 6 weeks, with either Vortioxetine plus Celecoxib, or Vortioxetine plus placebo. Levels of circulating inflammatory markers, tests of cognitive function, and depression symptoms are measured at baseline (before treatment) and again at the end of this 6 week treatment period.

The primary purpose of this trial is to evaluate the efficiency of two endoscopic imaging techniques for detecting colonic adenoma during colonoscopy. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over, and are scheduled to undergo a colonoscopy. Study details All participants enrolled in this trial will receive colonoscopy using both standard white light (WL) and linked colour imaging (LCI). LCI is a new endoscopic image enhancement technology that is built-in within scopes and activated by a push-button and highlight mucosal abnormalities within the gastrointestinal lumen. LCI uses different band widths and filters and is hypothesized to improve detection of subtle gastrointestinal pathology. Participants will be randomly allocated (by chance) to receive WL imaging first, followed immediately by LCI to detect any polyps missed by WL, or to receive LCI imaging first, followed immediately by WL to detect any polyps missed by LCI. This will allow researchers to investigate which technique results in less missed adenomas during colonoscopy.

A ‘hybrid closed-loop (HCL)’ system or ‘hybrid artificial pancreas’ provides automated control of basal insulin delivery, with ongoing requirements for manual boluses of insulin for meals. These systems offer the potential to reduce significant glycaemic excursions outside of a healthy glucose range compared with standard therapy. Small, short-term pilot studies have shown superior glucose control and lower rates of hypoglycaemia with use of a hybrid artificial pancreas compared with manual insulin delivery. Closed-loop insulin delivery has the potential to revolutionise type 1 diabetes therapy. The primary study rationale is to fill a knowledge gap regarding the efficacy of glucose control with long-term use of an HCL system vs standard manual insulin therapy, including % time in target glucose range, as well as glucose excursions (both hypoglycaemia and hyperglycaemia). This study will explore the impact of the HCL system on fear of hypoglycaemia, treatment satisfaction, psychological outcomes, sleep quality and cardiac rhythm, and the economic impact of using HCL. Any improvement in glycaemia may also be reflected in biomarkers associated with the risk for long-term complications of diabetes. One sub-study will explore the efficacy of the HCL system vs. standard therapy in regards to hypoglycaemia awareness and the counter-regulatory hormone response to hypoglycaemia of participants with severe hypoglycaemia and impaired hypoglycaemia awareness. A second sub-study will compare glucose control with different types of exercise using the HCL system vs. standard therapy.

Clients attend Alfred Health Community Rehabilitation Program for goal-oriented rehabilitation following a change in their health status (i.e. stroke, joint replacement, falls). Many of these clients are elderly and/or suffer from one or more chronic health conditions (i.e. osteoarthritis, diabetes, heart disease). Rehabilitation is targeted to address current goals and concerns, however no formal education is given about the benefit of adherence to a long-term physical activity program. This study will assess the feasibility of delivering a single session intervention of physical activity education and counselling, geared towards encouraging long-term physical activity. The intervention will be delivered at the end of the client’s community rehabilitation program encounter. On completion of baseline measures, clients will be allocated to either the intervention or usual care group. Usual care group clients will receive standard care with the addition of being provided with written physical activity educational material. The intervention group will receive one additional session to their usual therapy regimen, for the provision of physical activity education and counselling. They will also be provided with written educational material and a personalised written walking program. The intervention will be tailored to the participant's stage of change and self efficacy in relation to exercise. These items will be assessed using questionnaires, completed both at baseline and at three-month follow up. The primary outcome will be assessing the feasibility of this intervention, considering the rate of recruitment, completion of the intervention, and follow up rates. Physical activity levels will be assessed using an activity monitor at baseline and three-month follow-up. Participants will need to wear the activity monitor armband for one week at each assessment point. This will collect data about energy expenditure, sedentary time and time spent in moderate and vigorous physical activity. Quality of Life will also be assessed, using a questionnaire.

Amendment to the effects of a stretching programme on anterior humeral head translation and acromio-humeral distance, this study aims to evaluate the effects of a manual therapy technique - Mulligan's glenohumeral mobilisation-with movement on humeral head translation and glenohumeral translation in healthy subjects using diagnostic ultrasound

Optical enhancement with magnification is a new modality of colonoscopy offered by Pentax Medical (Pentax EPK i-series). It uses optical filters that limit light of certain wavelengths to increase resolution and image contrast of mucosa and underlying blood vessels seen at endoscopy, similar to narrow band imaging technology. The concept is to use pre-image processing by means of filters whilst retaining post-image processing to digitally enhance the image. This dual enhancement (optical and digital) allows for better clarity of the endoscopic image. The technology has also improved on the major barrier encountered in previous iterations of optical filters (reduced illumination), by connecting the peaks of the haemoglobin absorption spectrum (415, 540 and 570mm) allowing a continuous wavelength spectrum. This achieves a higher overall transmittance of the optical filter and an increased level of illumination. Using the optical filter increases the ability to assess microvascular patterns and surface structures, which is vital in assessing mucosal healing in ulcerative colitis patients Study type Prospective, interventional study investigating the ability of a new optical enhancement endoscopic technology to accurately assess mucosal inflammation and develop predictors of disease relapse. Study population and recruitment This study will prospectively recruit patients, aged 18 years and older, with ulcerative colitis to investigate their risk of relapse using a new optical enhancement technology from Pentax Medical. This will be done by scoring a patient’s degree of rectal mucosal inflammation using this optical enhancement technology and correlating it with the current gold standard- histopathologic examination of biopsy specimens. If the patient is to be included in the study, a thorough endoscopic examination of the rectum will be performed. This will be done using the optical enhancement feature of the Pentax endoscope. The rectal mucosa will be examined and the pit pattern of the rectal mucosa will be recorded. Details of the vascular pattern and surface structures will be recorded. The area with the most severe mucosal changes will be biopsied for histology. Biopsies will be examined by a pathologist who is blinded to the patient’s clinical history and endoscopic pit pattern grade. The biopsies will be analysed according to the Robarts index, which is a validated score for assessing the degree of mucosal inflammation in ulcerative colitis based on histologic features including architectural change, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction, and erosion or ulceration.

Overweight and obesity represent major health problems facing middle-aged men in Australia. In WA, four out of five men risk the quality and length of their lives by being overweight or obese. Middle-aged men are less likely than women to recognise that they are overweight or obese, less likely to know about the links between diet and health, and appear reluctant to participate in weight loss programs. This may be because such programs are typically marketed toward women and are often considered ‘female territory’. A new project led by researchers at Curtin University and Glasgow University offers a promising solution to the problem of how to engage men in weight loss and physical activity programs in WA. Building on the highly successful ‘Football Fans in Training’ (FFIT) program delivered in premier league soccer clubs in Scotland, a new, adapted, Aussie version (Aussie-FIT) will capitalise on men’s passion for AFL as a ‘hook’ to engage them in a physical activity and weight loss program based on sound scientific evidence. The research team will recruit 120 overweight and obese AFL fans to join a 12- week program which will be delivered at the ground of their favourite WA AFL team. The program will be delivered by club coaches trained by the project’s researchers. The men will be put through their paces on the hallowed turf of their favourite team and in the classroom, discuss important issues such as healthy eating and cutting back on drinking. A key part of the program is to educate and support the men to make sustainable changes that will improve their physical activity, eating and drinking habits for the better, and for the long term. The researchers will take a range of measures before and after the program, including physical activity levels, diet, mental health and weight, to assess the program’s effectiveness. When delivered in Scotland, FFIT was highly popular with middle-aged males from all walks of life, and very successful in helping them lose weight. In the future, the Aussie-FIT team aim to customise this program for other sports and groups of fans (e.g., females, families).

Objective: To examine the effectiveness and cost-effectiveness of real-time video counselling compared to: proactive telephone counselling; and self-help materials (control) in achieving smoking abstinence among smokers living in regional and remote areas. Design: A three-arm, parallel, randomised controlled trial will be conducted with 1,842 smokers residing in regional and remote areas of NSW. Participants will be randomised into one of three conditions: 1) real-time video counselling delivered by smoking cessation advisors; 2) proactive telephone counselling delivered by smoking cessation advisors; or 3) written self-help materials (control). Online assessments will occur at baseline and 4-months, 7-months and 13-months post-baseline to measure smoking cessation. Methods: Smokers will be recruited via traditional and online ads and other promotions. The Accessibility and Remoteness Index of Australia (ARIA+) will be used to recruit smokers living in regional and remote areas of NSW. Eligibility criteria are: 1) daily tobacco use; 2) aged 18 years or older; 3) access to a mode of video-communication (e.g. Skype, Face Time); 4) telephone access; 5) internet access; 6) a current e-mail address; and 7) reside in a regional or remote area of NSW. Potential participants will be asked to complete an online screening survey and those who meet eligibility criteria will be automatically redirected to the online baseline survey. At the end of the baseline survey, a random number generator will randomly allocate the participant to one of the three conditions. The hyperlink to online follow-up surveys will be e-mailed to participants, 4-, 7- and 13-months post-baseline. Real time video-counselling condition: Participants in the video counselling condition will be contacted via video communication (e.g. Skype or Face Time). Smokers in the video counselling condition will receive from a smoking cessation advisor up to six video counselling sessions to assist smokers to quit. Proactive telephone counselling condition: Smokers allocated to the proactive telephone counselling condition will receive from a smoking cessation advisor up to six telephone counselling sessions to assist smokers to quit. Control condition: Participants allocated to the control condition will be mailed self-help materials (i.e. a quit kit). Measures: Point prevalence abstinence (primary outcome): The primary outcome will be self-reported 7-day point prevalence abstinence and will be measured at 4-, 7- and 13-months post-baseline. Prolonged abstinence (secondary outcome): Prolonged abstinence will be measured from a 1-month post-recruitment grace period (to give smokers opportunity to quit) to each follow-up and between surveys, resulting in 3-, 6-, 9- and 12-months prolonged abstinence. Quit attempts (secondary outcome): Participants will be asked if they quit for one day or longer since the last survey.