ANZCTR search results

The purpose of this trial is to investigate the dose-related effects of intragastric administration of the bitter agonist, quinine, a non-nutritive (calorie-free) compound, on gastric emptying, gut and gluco-regulatory hormone, postprandial blood glucose and appetite responses to a subsequent meal.. The relationship between outcomes and the ability to detect bitter in the oral cavity will also be investigated. We have found previously that specific dietary nutrients, when given into the small intestine in small amounts (and so not contributing significantly to overall energy intake) have the unique ability to substantially stimulate gastrointestinal functions leading to marked energy intake suppression and improvements in postprandial blood glucose. There has been a recent interest in the effects of bitter compounds, some of which also occur in the diet, including thio-urea compounds in certain vegetables or fruit, or quinine in tonic water, with reported effects on gut functions and energy intake suppression. This study aims to characterise the dose-related effects of quinine, when delivered intragastrically, in an effort to identify an optimal dose for beneficial effect on the outcomes mentioned herein. This may then guide future research to evaluate hypotheses that observed effects may be further enhanced by combining nutrients with quinine

Inflammatory bowel diseases (IBD), comprising Crohn's disease (CD) and ulcerative colitis (UC), are chronic incurable inflammatory disorders of the gastrointestinal tract that cause a global health burden. A major advance in the management was the development of biological therapies to treat IBD. This class of drugs, in the form of monoclonal antibodies, target the proinflammatory cytokine tumor necrosis factor (TNF). Several randomised controlled trials (RCT) have shown that infliximab, adalimumab, certolizumab pegol are efficacious in inducing and maintaining clinical remission in moderate-to-severe Crohn’s disease, and for ulcerative colitis, infliximab, adalimumab, and golimumab are effective in inducing and maintaining clinical remission in patients with moderate-to-severe disease activity in whom conventional therapy has failed. Despite the high effectiveness, rates of primary non-response to TNF-a inhibitors in RCTs range between 20 and 40%. Moreover, up to 40% of patients initially responding to TNF-a inhibitors develop intolerable side-effects or lose response overtime. Thus new treatment strategies are needed. The concept of leucocyte migration into inflamed intestinal tissue has been the target for the development of new biologic therapies. a4ß7-integrin is an adhesion molecule expressed on the surface of gut-specific lymphocytes; by binding to mucosal vascular addressin cell adhesion molecule-1 (MAdCAM-1) on intestinal venules it plays a critical role in the mediation of leukocyte trafficking to the gut. Vedolizumab selectively binds to the a4ß7 integrin. The efficacy and safety of vedolizumab in UC and CD has been demonstrated in three pivotal phase III RCTs (GEMINI 1, GEMINI 2 and GEMINI 3) evaluating patients with moderate-to-severe UC or CD who had previously failed at least one prior therapy (e.g. corticosteroids, immunomodulators, TNF-a inhibitors). The combination of an immunosuppressive agent (e.g. azathioprine or its metabolite, 6-mercaptopurine ) with TNF-a inhibitors has proven to be more effective than monotherapy with an immunosuppressive agent or monotherapy with the TNF-a inhibitors. The main role of concomitant immunosuppressive agents is to suppress antibody formation to biological therapies and maintain adequate circulating drug levels. Because of concerns on adverse effects (infections, skin cancers and lymphomas), safety and costs of combination therapy, clinicians always consider withdrawal of therapy once remission is achieved. A recent systematic review on de-escalation of an immunomodulator from combination therapy in IBD showed that in patients discontinued an immunomodulator after combination therapy in CD the rates of relapse did not differ from those of patients who continued taking the drug (55%–60% had disease relapse 24 months after they stopped taking the immunomodulator). The only study in patients with ulcerative colitis supported continued immunomodulator use. Although no difference in efficacy

The purpose of this study is to test the safety and tolerability of the medication ‘enoxaparin’ for the prevention of blood clots in patients receiving anti-cancer treatment. Who is it for? You may be eligible for this study if you are an adult patient with lung or gastrointestinal cancer that is planned to commence anticancer therapy as an outpatient. Study details All consenting patients will have blood tests to assess their risk of developing a blood clot. Patients identified as ‘high risk’ will be randomised to their usual cancer treatment with or without enoxaparin for clot prevention. Patients identified as ‘low risk’ will be observed and then re-assessed one month after commencement of cancer therapy, and if fulfilling requirements for ‘high risk’, will be randomised and included in the study. Participants will be followed up at 1, 3, 6 and 12 months after randomisation, and yearly thereafter until the study is closed. Study aims It is hoped that this research will demonstrate that routine clot risk assessment and personalised preventative interventions can reduce the incidence of blood clots and improve patient outcomes.

This study is examining the use of general practice point-of-care prompts to increase participation in the National Bowel Cancer Screening Program (NBCSP). Who is it for? Tasmanian general practices located in Remoteness Areas 3 and 4 may be eligible to participate and the study will apply to patients turning 50, 60 and 70 during the study timeframe. Study details Five participating general practices will have a prompt added to the electronic files of eligible patients. This message will pop-up when patients attend their consultation, and will prompt general practitioners (GPs) to encourage participation in the NBCSP. Additional resources will also be provided to the GPs in the 5 participating practices. Another 5 general practices will not receive the prompts, and will provide usual care. NBCSP participation rates will then be compared between the two groups of practices The findings from this research may have implications for the NBCSP in terms of engaging GPs in the screening invitation process, increasing participation in the program, and ultimately decreasing mortality from bowel cancer in Tasmania and nationally.

This research study aims to recruit 82 patients following an admission for chest pain or heart attack. The patients will be randomised to Colchicine 0.5mg daily or placebo for 12 months. This study aims to see how Colchicine acts on the coronary plaque. This medication is currently used for inflammatory conditions such as gout. It has a broad anti-inflammatory effect and previous research has shown that Colchicine helps to reduce adverse cardiovascular events in patients with coronary artery disease.

This study is testing a website-based intervention to encourage survivors of prostate cancer to increase their physical activity which has previously been shown to be effective in relieving cancer survivor burden Who is it for? You may be eligible for this study if you have previously been diagnosed with prostate cancer (non-metastatic) and are currently in remission. Study details Participants will be randomised (by chance) into three groups. One group will be offered the website in a stepped fashion, with modules being unlocked as the previous one is completed. The second group will be offered the complete website in a free-choice manner. The third group will be offered the website after a brief wait (4 weeks). The modules will be delivered over a 4 week period. All participants will complete a number of questionnaires about their physical activity and their experience of the website. This study aims to lay some groundwork for the use of web-based interventions targeting physical activity in prostate cancer survivors.

It is well established that physical inactivity leads to a wide range of poor health outcomes. Physical inactivity is highly prevalent in Australia, and the direct cost of physical inactivity to the Australian economy is $1.5 billion per year. Numerous physical and psychological health benefits can be reaped if more individuals engage in regular moderate intensity physical activity across all life domains, including at work. Effective, sustainable and scalable evidence-based physical activity interventions are therefore urgently needed. We propose an innovative peer-led workplace walking intervention designed to empower employees to gradually take ownership of their physical activity behaviours, thereby facilitating sustained engagement. Our research plans involve training peer leaders in the workplace, i.e. existing employees, to facilitate long-term capacity in each worksite. Our proposed research plan is based on a solid theoretical framework that involves isolating motivation effects from group-based effects on walking behaviour, and testing mediators (motivation) of intervention effects via a thorough process evaluation. We propose a pragmatic 16-week pilot cluster randomised controlled trial targeted at physically inactive employees to examine the feasibility and preliminary effects of the intervention on walking, health, well-being and work performance. Eight worksites and a total of 121 employees from these worksites will be recruited from worksites in Perth, WA. The results of the research could have direct translational potential for workplace health practice and policy with great potential for roll out across a range of work sites and sectors.

We are assessing the occurrence of bile reflux in patients who have undergone weight-loss operations. Bile reflux can predispose to oesophagitis, Barrett’s oesophagus and even oesophageal cancer. A new surgical technique has been developed and shows excellent results with regard to weight loss, remission of diabetes and safety. This technique is controversial, however, with an increased theoretical risk of bile reflux. Our study will provide additional data on the safety of weight loss operations, both generally and specifically relating to bile reflux, impacting surgical decision making in bariatric surgery. The results from our study will provide clinicians with clear evidence from which they can make informed decisions about the safety of the 'new' surgical technique. With current data showing favourable results, including improved efficacy and decreased risk of complications, increased utilisation of the technique will result in improved short-term and long-term patient outcomes. Awareness of the incidence of bile reflux post-operatively will allow clinicians to treat any reflux early, preventing or at least delaying potentially detrimental health outcomes. These interventions will translate into decreased health expenditure, providing net health and economic benefit.

The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of single doses of CSL112 after intravenous administration in healthy Japanese and Caucasian subjects. Japanese subjects enrolled in the study will be assigned to Cohorts 1, 2, or 3 in a sequential manner. Caucasian subjects will be enrolled in the study and assigned to Cohort 3 only after subject matching by weight within 15% of the median weight of Japanese subjects in Cohort 3. All subjects will be randomized to treatment (CSL112 or placebo) within their cohort and within their race (Cohort 3 only).

This is a phase 1 study of a new molecule (called CEND-1) designed to enter cancer cells and increase the uptake of chemotherapy drugs. Who is it for? You may be eligible for this study if you are aged over 18 and have histologically confirmed metastatic pancreatic ductal cancer. Study details Participants in the phase 1a of the study will take the study medication CEND-1 alone initially for one week, before commencing a combination therapy with CEND-1 and the 28-day cycle of chemotherapy. Participants in the phase 1b of the study will receive the combination therapy with CEND-1 and the 28-day cycle of chemotherapy directly. Treatment may continue as long as there is perceived benefit or until disease progression. All participants will provide blood samples and undergo imaging studies. All participants will receive standard doses of chemotherapy, nabpaclitaxel and gemcitabine, approved in Australia. The primary goal of this research study is to find the correct dose of the study drug, CEND-1, that can be given alone or in combination with standard chemotherapy to patients with pancreatic cancer that has spread. Another goal is to measure the levels of CEND-1 in the blood over time. Researchers also want to learn if the study drug combinations can help to control the disease.