ANZCTR search results

This parallel group, blinded, placebo-controlled randomised trial will determine whether 1500mg/day of metformin administered for 6 months improves walking ability in PAD patients. Based on sample size calculations focused on the minimal clinically important difference, 250 PAD patients that do not have diabetes, renal or cardiac failure will be included. The trial will employ an independently run minimisation randomisation system and identical appearance, weight and packaging of drug and placebo to ensure blinding of investigations, patients and assessors, along with balancing of important determinants of outcome. The primary outcome measure will be the 6-month maximum walking distance during a six minute walk test. Secondary outcomes will include physical activity assessed over 7 days with an accelerometer, health-related quality of life, leg blood supply assessed with ankle-brachial pressure index and circulating concentrations of key markers of angiogenesis. Adverse events will be monitored by an independent data monitoring committee. Previous trials indicate metformin is safe for patients without diabetes.

The study aims to evaluate the combined effect of a cognitive rehabilitation group (CRG) with intake of Queen Garnet plum (QGP) juice, to optimise cognition in adults with mild cognitive impairment (MCI). Biomedical measures would contribute to an understanding of the mechanisms of action associated with cognitive improvements. The study would include an 8week, doubleblind randomised controlled trial with two arms, CRG plus placebo, and CRG plus 250mL QGP juice, using MCI patients referred to the ISLHD Geriatric Outpatient Services or Rehabilitation and Medical Psychology Department. Recruitment and research consent of participants will occur within ISLHD clinics, with an aim of 72 subjects. Participants will attend a data collection session at baseline, conducted by Clinical Neuropsychologist and a Research Assistant, where participants will undergo the neuropsychological test battery, collection of demographic data, a food frequency questionnaire and instructions for a 4day food record, and blood collection. Subjects will be provided a 24hour Blood Pressure monitoring device, a urine and faecal sample collection kit, and their supplement/placebo to commence. These assessment procedures will be repeated at 8 weeks.

The objective of this study was to determine the effect of age, prolonged bypass and deep hypothermia on perioperative levels of cefazolin in children undergoing cardiac surgery.

The primary goal of this study is to determine the effects of two drug combinations (known as AD047 and AD282) on sleep apnoea severity (the apnoea/hypopnoea index) compared to a placebo (sugar pill). Other measures of sleep apnoea severity, upper airway function, breathing and symptoms will also be assessed as secondary outcomes.

Congenital aortic stenosis is a lifelong disease often requiring multiple interventions. Valvuloplasty refers to the procedure by which the valve obstruction is relieved by either incising the valve during a surgical procedure or utilising balloon to stretch the valve during an interventional cardiology procedure. We are seeking to determine the early and late outcomes of surgical or balloon aortic valvuloplasty and whether the technique use, influences the long term risk of re-intervention, other morbidities, or death.

The study investigates the absorption characteristics and safety of Medlab’s NanoCelle D3 (Vitamin D3 as cholecalciferol) administered to 8 healthy individuals. The dose to be administered in 10 sprays/5000 I.U./1.5mL. A total of four 10 mL blood samples will be collected from each participant at 0, 60, 180 and 360 minutes. The total study duration per participant is approximately 7.5 hours.

As many as 1 in 4 Australians experience chronic pain. There is a critical need for the development and evaluation of fast-acting non-pharmaceutical treatments that have the capacity to target the multidimensional nature of chronic pain. This study will compare the effects and mechanisms of mindfulness meditation against placebo and no-treatment control groups. Results will ultimately lead to targeted interventions that more effectively engage cognitive mechanisms associated with pain attenuation.

A double-blind (allocation concealed) randomised controlled trial conducted among Indigenous mother-infant pairs in the Northern Territory. To determine whether weekly vitamin D supplementation (compared to placebo) given to mothers (between 28 to 34 weeks gestation (inclusive) until birth) and their infants (birth until age 4 months) reduces the incidence of acute respiratory infection (hospitalisations or primary care presentations) in the infants first 12 months of life.

Globally children's intake of unhealthy foods and beverages is excessive, contributing to weight gain and risk of obesity. There is a lack of research focusing on unhealthy foods with majority of past research focused on increasing healthy foods in the hope that unhealthy foods will also decrease, which has not been the case (Johnson et al., accepted). Parents play a key role in what children eat (Yee et al. 2017). Understanding the physical and social opportunity influences on parents’ food provision will help to guide future intervention content to support parents to make healthy food choices for their children. This project aims to explore the influence of physical* and social^ opportunity on parents’ unhealthy food provision choices for their 3-7 year old children. The project is focused on understanding the influence of parents’ physical opportunity, in terms of cost and time, and social opportunity, in terms of support from their child, co-parent and friends. The project will also determine whether the influence of physical and social opportunity on parental food provision differs in social occasions. To achieve the project aim a discrete choice experiment will be administered via an online survey to investigate parents’ hypothetical food provision in social and everyday occasions, where the food options vary in terms of the cost, time to prepare, support from child, significant family members and friends, and type of food (nutritional value). The discrete choice experiment contains a number of choice tasks (a type of single-answer question) which involves parents choosing between two hypothetical snack options or the neither (opt-out) option. The two snack options will vary in their attributes (e.g. cost, time, support from child, co-parent and friends, and the type of food). * Physical opportunity = the physical resources a parent has available, such as money (cost) and time. ^ Social opportunity = what is afforded by the social environment, such as support (or resistance/opposition) from the child, co-parent, extended family and friends.

Key Research question(s) 1. Will the proposed MMMP model, using a risk tool to stratify patients (The Intervention) increase access to medication management services post discharge compared with those receiving usual care? 2. Will the proposed MMMP model using a risk tool to identify “at-risk” patients (The Intervention) reduce the hospital health utilisation (emergency department visits, hospital admission and length-of-stay) at 30 or 90 days post discharge compared with those receiving usual care? This project aims to reduce the risk of medication misadventure across care transitions by increasing identification of patients at-risk, and hence referral to pharmacist led medication management services. Hypothesis: The routine application of an easy to use, bedside tool can facilitate identification of at-risk patients and trigger referral to an appropriate medication management pathway in the community following hospital discharge. Improving medication management across the continuum continues to be one of the greatest challenges in modern health care. A report to Government on the Home Medicines Review (HMR) declared strong ‘widespread’ unconditional support for hospital-initiated medication review (HIMR) early post-discharge, acknowledging this gap in care. Yet nearly a decade on, there is no nationally accepted pathway for HIMRs to ensure our most vulnerable patients are supported following a hospital admission. A recent Australian systematic review highlighted those most in need of medication review remain underserved, including indigenous and Culturally and Linguistically Diverse populations, and those recently discharged from hospital. Application of the risk tool will facilitate identification of “at-risk” patients and ensure handover to a community medication management service most suited to the individual patient. ‘Risk Stratification’ uses a process to identify people likely to suffer an unplanned hospital admission. There are currently no international or national risk stratification solutions, focused on medication misadventure that can be readily applied to the Australian context. By identifying patients at risk, appropriate coordinated care can be provided to them. The period 7-10 days after hospital discharge is a particularly vulnerable time, and associated with a significant risk of medication related problems. Studies have shown about half of the patients discharged from hospital experience a medical error, with 19% - 23% suffering an adverse event, most commonly an adverse drug event. Through use of a structured framework, actively assessing risk, hospital staff will identify and triage high-risk patients for pharmacist-led medication management services in the community setting. This should improve identification of those at risk and improve care across the continuum.