ANZCTR search results

The proposed study is designed to (i) compare the glycaemic and incretin hormone responses after administration of glucose into the duodenum vs. ileum, and (ii) evaluate the incretin effect (IE) and gastrointestinal-mediated glucose disposal (GIGD) induced by intraduodenal (ID) and intraileal (II) glucose infusion using intravenous (IV) ‘isoglycaemic’ clamp, in both healthy subjects and patients in type 2 diabetes. Secondary objectives are to evaluate the effects of intraduodenal vs. intraileal glucose on blood pressure (BP), heart rate (HR) and superior mesenteric artery (SMA) blood flow.

The proposed study is designed to determine, in patients with type 2 diabetes, (i) whether blood glucose, incretin hormone (ie. glucagon­like peptide­1 (GLP­1) and glucose­dependent insulinotropic polypeptide (GIP)), insulin, glucagon, and fibroblast growth factor­19 (FGF­19) concentrations in response to a small intestinal glucose infusion (2 kcal/min) are modified by intrajejunal infusion of taurocholic acid (TCA), (ii) the effect of TCA on small intestinal glucose absorption, and (iii) the relative contribution of the actions of GLP­1 to the lowering of glycaemia by TCA, using the specific antagonist, exendin (9­39). Additionally, changes in blood pressure (BP), heart rate (HR) and superior mesenteric artery (SMA) blood flow in response to intrajejunal glucose infusion will be evaluated, in the presence and absence of intrajejunal TCA and intravenous exendin (9­39).

The primary purpose of this study is to determine the feasibility of using cardiac MRI scans, cardiac ultrasound and blood tests to detect changes in heart function following completion of chemotherapy and/or radiation therapy for cancer. Who is it for? You may be eligible to join this study if you are aged 18 or over, and have been diagnosed with breast cancer, Hodgkin's lymphoma, Non-Hodgkin's lymphoma, leukaemia or other intra-thoracic/upper gastrointestinal malignancies such as cancer of the oesophagus or thymoma, for which chemotherapy and/or radiotherapy have been prescribed. Study details All participants in this study will undergo additional cardiac screening tests at timepoints before and after chemotherapy/radiation therapy up to 12 months following the end of therapy. These tests will include MRI scans, cardiac ultrasound scans and blood samples being taken. Results from these tests will be used to assess changes in cardiac function caused by the cancer therapy. It is hoped that the findings of this feasibility trial will ultimately aid early identification of heart injury due to cancer therapy, and thus enable prevention strategies and early treatment options in these patients.

The aim of this research is to evaluate the functionality, efficacy, and utility of a new safety planning smartphone application. The trial will involve including the use of the smartphone application into existing Monash Health mental health services. Participants will include 60 patients who have experienced recent suicidal ideation or behaviours. Participants will be recruited by their treating mental health clinician. First, research staff will train the treating clinicians and participants in the use of the smartphone application, and conduct baseline measurement of suicide ideation and/or behaviour, as well as suicide resilience using self-report measures. Participants will then undergo 'treatment as usual' under the management of their treating clinician for a period of two months. Research staff will then conduct post trial measurement of suicide risk and resilience along with qualitative data on smartphone application functionality and utility. Data on smartphone application usage will be collected via Google analytics software. This information will not include personal information stored in the application.

Patients who present with an acute coronary syndrome remain at high risk of further events in subsequent years. Better identification of individuals at high risk can allow better targeting of novel therapies and resources. This study will create an imaging bio-bank that enables testing of multiple novel strategies involving new imaging, image analysis and biomarker approaches alone or in combination for improved risk stratification and targeting of prevention. Prospective follow-up in the cohort for outcomes enables the predictive value to be tested in a pilot data setting.

The project will use both a randomised control trial and prospective cohort design. Participants will be Western Australian travellers planning to depart for Bali. Half of participants will be randomly allocated into an intervention group and receive prepared online travel health information. After returning from Bali, both the intervention and non-intervention group will be invited to complete an online survey with questions concerning any communicable disease symptoms and health impacts.

The aim of the study is to obtain an understanding of mechanisms of action and the biological and psychosocial effects of an Endoluminal Bariatric Intervention (Endobarrier-DJBS) in an obese diabetic population. Hypothesis: Implantation of the Endobarrier device will reduce: 1. Body weight as compared to the baseline values and compared to control interventions, 2. Intraluminal digestion of triglycerides as measures by the 13C triglyceride breath test in patients with EB device as compared to baseline and controls; 3. Fasting insulin and fasting glucose during the intervention and improvement will be greater in actively treated subjects. In addition the implantation of the Endobarrier device will: 4. Alter the mucosal and stool microbiome, 5. Improve liver function and parameters of fibrosis (elastography, blood tests, liver biopsy ). 6. Improve cardiopulmonary reserve and exercise capacity, 7. Improve quality of life, self-image, anxiety and depression will improve in actively treated subjects as compared to baseline.

This trial is conducted to evaluate the Safety, Pharmacokinetics and Haemodynamic Effect of CRD-102 in a Fasted and Fed state in Healthy Adult Volunteers. 8 Healthy Adult volunteers will be administered a single dose of CRD-102 in a fasted state, followed by a single dose of CRD-102 in a fed state 7 days later. PK samples, blood pressures, ECGs will be taken to assess the PK and haemodynamic profile of the medication following administration in a fasted and fed state. Healthy volunteers will be screened up to 28 days prior to trial enrolment, Following enrolment, 8 healthy volunteers will be dosed with CRD-102 in a fasting state on day 1, followed by administration of CRD-102 in a fed state following a 7 day wash out. Subjects will return to clinic for a follow up 5 days after administration of the last dose of investigational product for a safety visit.

This study aims to determine - the effectiveness of using a CPP-ACP toothpaste in preventing dental caries in children - the microbial changes in plaque such as the reduction in decay causing bacteria Participants will attend routine dental examination appointments at public oral health services. In addition to standard examination a sample of plaque will be taken by swabbing selected teeth with a small brush. A questionnaire will be completed by the participant's parents regarding medical, social, toothbrushing and dietary histories. Dental radiographs will be taken at the recruitment appointment. All identified treatment will be undertaken. At the first appointment, a participant's toothbrushing group will be randomly allocated. The allocation is either the CPP-ACP toothpaste or the placebo toothpaste (blinded groups) or commercial fluoridated toothpaste (non blinded). For the blinded groups (CPP-ACP and placebo), the toothpaste packaging will be marked with a digital code, but the content will not be known to the participants, the clinicians or the investigator. The codes will be provided to the chief supervisor of the study. Only after the statistical evaluation is completed will the decoding occur. All the toothbrushes and toothpaste will be provided free of charge for the duration of the study. Participants are asked to brush twice daily will the allocated toothpaste. Compliance will be monitored by a phone call questionnaire at 3 and 9 months and in person at 6 and 12 month . The examination appointment will be repeated at 6 months and 12 months. Dental radiographs will be taken at 12 months.

Osteoarthritis (OA) is a leading cause of disability in developed nations. Total knee arthroplasty (TKA) is the mainstay of treatment for people with end-stage knee OA, and represents one of the highest volume medical interventions globally. Despite a high overall success rate with this operation, up to 1 in 3 patients remain dissatisfied following TKA. The reasons for this dissatisfaction include ongoing pain and functional limitation, which patients view as markers of poor outcome following surgery. Research indicates that the strongest predictor of patient dissatisfaction following TKA is unmet expectations. This is known to occur when patients and surgeons have different expectations of surgery. Decision making aids have been effective in aligning patient and surgeon expectations of surgery and improve health outcomes. This study will use a discrete choice experiment (DCE) as a type of decision making aid applied to patients prior to surgery to improve patient knowledge and realistic expectations of TKA. This study will test if this leads to greater health outcome and satisfaction amongst patients following TKA. 132 people with end stage OA on the waiting list for TKA will be recruited and randomly allocated to one of 2 groups using computer-generated block randomisation. A randomised controlled trial (RCT) adhering to CONSORT guidelines will evaluate the effect of applying a DCE prior to surgery on patient expectations, health outcomes and satisfaction following TKA. Patients in the intervention arm will complete a survey containing the DCE decision aiding tool, compared to the control group who will complete a modified survey that does not contain the DCE activity. Participants in both groups will be required to complete the survey prior to surgery during their routine pre-admission appointment at SVHM. Patients will also be required to complete a brief patient expectation survey 1-week prior to scheduled TKR. In addition, orthopaedic surgeons will complete a brief expectations survey for patients consented to TKA to compare matched surgeon and patient expectations for recovery following TKA. Primary outcomes will be evaluated by a blinded examiner at 12 months post-surgery using a validated self-reported pain and physical function scale. Secondary outcomes will include a range of validated measures of health and psychological wellbeing. All analyses will be conducted on an intention to treat basis using linear regression models. This study is the first of its kind to use this approach to elicit risk-benefit tolerance in surgery and to evaluate if guiding patients through a decision making process in the form of a DCE-based survey prior to surgery will improve patient expectations, health outcomes and satisfaction following TKA. Reducing the rate of patient dissatisfaction commonly seen in patients following TKA will help to reduce the burden associated with poor outcomes on the health system.