ANZCTR search results

The aim of this project is to investigate the effectiveness of an Australian designed cognitive behavioural therapy intervention for insomnia called Sleep-e. Insomnia is a very common sleep problem but many people do not access available treatment. Online interventions that are delivered via the internet, such as Sleep-e, can increase the communities’ access to treatment, and improve health outcomes. 70 participants with insomnia related sleep difficulties will be recruited into the study. Participants will be recruited either through completing the e-PASS online assessment on www.mentalhealthonline.com or through advertisements on mental health websites such as beyondbue and Reconnexion. Participants will initially complete a range of questionnaires via the internet about their sleep, and also complete sleep diaries outlining their current sleep patterns. Participants will then complete Sleep-e, a 7 week online program based on cognitive behavioural therapy for insomnia. Every week, participants will be asked to read one module, complete homework activities based on the module, and also complete weekly sleep diaries. Participants will be given questionnaires and sleep diaries to re-assess their sleep and insomnia immediately after the program has been completed, as well as three months following completion. Twenty participants will also be interviewed by telephone regarding their program experiences and satisfaction.

Endoscopic ultrasound can obtain fluid using a technique known as fine needle aspiration (FNA). This involves a needle entering a pancreatic cyst and sucking fluid out. However, this test risks introducing gut bacteria into a normally sterile space. As such antibiotics may be effective to prevent infections. We aim to test whether Tazocin or Ciprofloxacin if penicillin allergy is present, prevents infections or is associated with increased harm.

To document in major centres in Australia and New Zealand the current practice for achieving haemostasis in patients who present with significant haemorrhage or require anticoagulant reversal for urgent surgery and/or a procedure whilst on new (dabigatran, rivaroxaban, or apixaban) or established (warfarin) oral anticoagulants. In patients whilst on oral anticoagulants who present with embolism, determine the circumstances and level of anticoagulation at the time of presentation.

Arteriovenous fistulae continue to function in patients who have had a successful kidney transplant. This adds to the cardiovascular burden in this group of patients. Closure of these fistulae have been shown to improve cardiovascular outcomes in observational studies. If this is demonstrated in a randomised controlled trial, this could help guide nephrologists to form definite opinion as practice varies widely among hospitals.

Heart Failure (HF) is a debilitating and chronic disease that is associated with a high rate of comorbid mental illness. Depression is associated with increased risk of mortality and cardiac events. Cognitive Behaviour Therapy (CBT) is recommended as a preferred treatment in HF and cardiovascular disease (CVD) management. However determining the effect of CBT in CVD and HF patients is implicated by a history of limited randomised controlled trials, confounded sampling issues and reduced functioning ability. Furthermore, research in the field of anxiety management in cardiac patients is lacking although emerging research indicates that clinical anxiety is as prevalent as depression. This study seeks to investigate the therapeutic impact of a CBT intervention targeted to both depression and anxiety on HF outpatients in managed care. The treatment model “mood management” has been trialled and evaluated to be efficacious in depressed and anxious nonmedical clients. Participants (n=5) will be offered the program as a treatment option from a HF nurse and self refer to the study. It is hypothesised that participants will display improved scores on measures of depression and anxiety. Results will help inform current and future research on effective therapeutic treatment of CBT group therapy and the utility for depressed and anxious HF outpatients.

The primary aim of this study is to investigate the efficacy and safety of SAMe versus a combination nutraceutical (SAMe + 5-HTP, EPA and zinc) as adjunctive treatments in adults (n=300) with major depressive disorder in an 8-week, double-blind, randomised, placebo-controlled trial. The primary outcome measure is severity of depressive symptoms using the Montgomery-Asberg Depression Rating Scale (MADRS).

The primary aim of this study is to investigate the efficacy and safety of SAMe versus a combination nutraceutical (SAMe + 5-HTP, EPA and zinc) in the monotherapy treatment of adults (n=60) with major depressive disorder in an 8-week, double-blind, randomised, placebo-controlled trial. The primary outcome measure is severity of depressive symptoms using the Montgomery-Asberg Depression Rating Scale (MADRS).

The study is investigating the effectiveness of pelvic floor muscle (PFM) training plus general multidisciplinary rehabilitation in patients who have undergone bowel cancer surgery. Who is it for? You may be eligible to join this study if you are aged 18 years and over, have undergone anterior resection for stage I – III bowel cancer, and are able to walk and manage self-care, out of bed more than 50% of waking hours (Eastern Cooperative Oncology Group performance status 0 – 2). Trial details Participants in this study will be randomly (by chance) divided into one of two groups. Participants in one group will receive general multidisciplinary rehabilitation and PFM training program. The general multidisciplinary rehabilitation will consist of a multidisciplinary group education and exercise program, which will be provided twice weekly for 8 weeks. Each session will last approximately one hour. The education component will include advice about nutrition, exercise, fatigue management and coping with stress. Information will be delivered by a range of clinicians (physiotherapists, occupational therapists, psychologists, and dieticians). The exercise component will include a general (combined aerobic and resistance) exercise training program supervised by a physiotherapist. The PFM training program will consist of physiotherapy-supervised pelvic floor muscle training sessions, and bladder and bowel function advice over 12 sessions. Biofeedback will be used to facilitate pelvic floor muscle function. The training sessions will be approximately one hour long. The duration of intervention is eight weeks. Participants in the second group will only receive the general multidisciplinary rehabilitation twice weekly for 8 weeks. All participants will be required to complete some questionnaires and tests (e.g. transperineal ultrasound, six-minute walk test, etc) at the end of the intervention, and at 6, 12, 24 and 60 months from baseline to evaluate their pelvic floor symptoms and outcomes.

Fifty patients undergoing liver transplant will be included in the study. The participants will be randomized in two groups using a software application. In SR group, simultaneous portal vein and hepatic artery reperfusion, while in IPR group an initial portal reperfusion and the hepatic artery reperfusion is subsequently performed. Both techniques are used in the clinical practice, it is based on the personal preference of the surgeon the type of perfusion technique used. There is no evidence that one technique of reperfusion is superior to another or harmful.Data regarding preoperative variables, intraoperative and postoperative variables are prospectively collected. A non-invasive device (called Sidestream Dark Field imaging), that allow for clinical observation of the microcirculation will be used. It is hand-held probe with a sterile extension for direct contact with liver parenchyma. Liver biopsies are performed to assess Immunohystochemical intensity of ET-1 and other markers. The tissue to be acquired in this study will be obtained from surgical specimens taken from consented participants having routine hepatic surgery or liver transplantation. The study additionally requires the provision of a blood sample for the serum assessment of ET-1 and other markers. This blood sample will be taken at the time of clinically indicated vensection. The risks involved in drawing blood from the arm include discomfort at the site of insertion of the needle and possible bruising/swelling around the injection site. There is a very rare risk of infection. There is also a remote possibility of fainting while blood is being drawn.

Forty patients undergoing major liver resection will be included in the study. Data regarding preoperative variables, intraoperative and postoperative variables are prospectively collected. A non-invasive device (called Sidestream Dark Field imaging), that allow for clinical observation of the microcirculation will be used. It is hand-held probe with a sterile extension for direct contact with liver parenchyma. Portal vein and hepatic artery flow will be measured intraoperatively. Liver biopsies are performed to assess Immunohystochemical intensity of ET-1 and other markers. The tissue to be acquired in this study will be obtained from surgical specimens taken from consented participants having liver resection.