ANZCTR search results

In this randomised, double-blind, placebo-controlled study, 120 adults who are currently experiencing unsatisfactory sleep will be randomly assigned to receive tablets containing either a high-dose saffron extract (28mg a day), low-dose saffron extract (14mg a day), or placebo for 28 days.. We will assess change in sleep quality, quality of life, and mood via several validated self-report measures (to be completed at various time points throughout the study). We will also examine changes in evening salivary concentrations of cortisol and melatonin.

The purpose of this trial is to investigate the dose-related effects of intraduodenal administration of the bitter agonist, quinine, a non-nutritive (calorie-free) compound, on gastric emptying, gut and gluco-regulatory hormone, postprandial blood glucose and gastrointestinal symptoms in people with type 2 diabetes. 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 improvements in postprandial blood glucose. There has been an increasing 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.

General Objective To introduce uniform use of vaginal antiseptic wash immediately prior to Caesarean section and to determine the best antiseptic wash material in reducing post-operative infections or complications. Specific Aims 1. To determine the number of post-CS infections among women that will undergo pre-operative vaginal cleansing with either 1% povidone iodine or chlorohexidine or no toileting (control) during elective CS 2. To determine the number of post-CS infections among women that will undergo pre-operative vaginal cleansing with 1% povidone iodine or chlorohexidine or no toileting (control) during emergency CS 3. To compare the rate of infections among the three groups that receiving either 1% povidone iodine or chlorohexidine or no toileting for vaginal irrigation prior to any kind of CS 4. To identify the best antiseptic wash and methods for vaginal irrigation prior to CS for developing a uniform guideline through locally generated evidence 5. To determine the factors that may influence the outcomes such as post-CS infections or related complications

Artificial sweeteners, also known as non-nutritive sweeteners (NNS) are used worldwide. A significant proportion of the Australian adult population consume NNS especially those on weight loss diets and by diabetics to control their glycaemia. However, no study till date has evaluated the impact of NNS consumption in diabetic population. The purpose of this study is to investigate the impact of 12 week NNS consumption on blood sugar levels in people with Type 2 diabetes.

The Chronic Conditions Course is a remotely-delivered psychological treatment that has been designed on the principles of cognitive behavioural therapy. It is designed for adults with a chronic health condition and associated impact on their emotional wellbeing. It involves five lessons and other additional materials delivered online over an 8 week period. Participants also receive telephone support from trained psychologists. The efficacy of the Chronic Conditions Course has been examined in a randomised controlled trial, with promising results (long-term follow-up data collection is ongoing). The aim of our study is to evaluate the efficacy of the course in a larger group of participants. We hypothesise that, compared to a delayed treatment waitlist group, participants in the Chronic Conditions Course will report greater symptom improvements (in terms of mood, anxiety and level of disability). By recruiting a large group of participants, we are also aiming to understand what particular groups of people (or what participant characteristics) may benefit most from the Chronic Conditions Course.

The study will investigate whether a diet high in foods rich in Resistant Starch (RS), with or without the addition of a RS supplement, changes the gut microbial composition and blood glucose control compared with usual dietary advice (control) in women with newly diagnosed Gestational Diabetes (GDM). Data will be collected at Baseline, Day 7 of intervention, and 36-weeks of gestation and include dietary RS consumption, stool microbial analysis and short chain fatty acid content, fasting and post-meal blood glucose levels, time in optimal glycaemic range, the requirement for glucose-lowering medication, maternal and neonatal health outcomes, and health care costs. We hypothesise that, compared with standard GDM dietary advice, women with a high dietary intake of RS beginning at the diagnosis of GDM will show a reduction in fasting blood glucose levels and other measures of blood glucose control.

This is a prospective double-blind cross-sectional cohort study, assessing the difference in knee stability in the sagittal (forwards and backwards) between two commonly used implants, and the effect that this has on patient satisfaction. Patients with a primary diagnosis of knee osteoarthritis who are over 18 years of age and are booked for a TKA at Fremantle Hospital receiving either an AttuneTM or TriathlonTM primary knee replacement will be recruited. Patients will be recruited at their booking visit, and consenting participants will be asked to complete validated Patient Reported Outcome Measure (PROM) questionnaires. Sagittal stability will be objectively measured by a device called a GNRB arthrometer at 30 degrees and 90 degrees of knee flexion. 134N of force will be applied to the top of the shin bone whilst the thigh bone is held steady and anterior displacement of the tibia will be measured. Clinical evaluation of stability will occur through physical examination. Sagittal stability is defined according to the amount anterior translation of the tibia with <5mm deemed stable, 6-10mm partially unstable and >10mm unstable. Range of movement in flexion and extension will be assessed with a goniometer and recorded. Radiological assessment prior to their surgery will be routine as per all joint replacements; pre-operative alignment and post-operative alignment will be assessed with long-leg alignment views. Each surgeon involved will use only 1 prosthesis type for all participating patients under their care (TriathlonTM or AttuneTM) in line with current practice. Participants and the examiner performing assessment of sagittal stability will be blinded to implant type. All implant details (size, side, patella, polyethylene type, polyethylene thickness and patella resurfacing) will be explicitly recorded and tracked. Patients are randomly assigned to each surgeon according to the participating hospital's outpatient referral system, as is current practice. Pre-operative demographic analysis of patient characteristics will be used to screen for selection bias. TKA will be performed as per the surgeon’s preferred technique according to the manufacturer’s recommendations. Plain radiographs, PROMs and assessment of sagittal stability will be repeated at 6 weeks and 12 months follow up.

The primary objective of this study is to evaluate whether an adaptive cognitive control program is able to reduce attention difficulties in children with ADHD. It is expected that children with ADHD who complete the intervention training program will show greater improvements in selective attention, sustained attention, interference control and response inhibition compared to children with ADHD who complete a control program. We also expect that children with ADHD who complete the intervention program will demonstrate greater improvements in behavioural inattention, everyday functioning, working memory, executive functioning and social impairment compared to children with ADHD who complete a control program.

This is a seamless Phase 1b multicentre study to evaluate safety, tolerability, and efficacy of SER-301 in adult participants with active mild-to-moderate UC. SER-301 is a live microbiome therapeutic – a designed set of diverse, human-commensal bacterial strains, administered as oral capsules. This study has a seamless design, as it is composed of two study parts, each with different objectives, with an operationally seamless transition in between. Participants will be enrolled into either Part 1 or Part 2 of the study, but not both. This record describes Part 1 only. Part 1 is open-label. Approximately 15 participants will be enrolled in 2 sub-cohorts to receive 10 weeks of once-daily open-label induction treatment with SER-301 following 6 days of vancomycin pre-conditioning (4 times daily). o Part 1A: 5 participants will be dosed with SER-301 after vancomycin pre-conditioning. If no significant safety concerns are reported after all 5 participants have completed pre-conditioning and 7 days of SER-301 dosing, enrollment in Cohort 1B will proceed. o Part 1B: The remaining 10 additional participants will be dosed with SER-301 after vancomycin pre-conditioning. If no significant safety concerns are reported after all 10 participants have completed pre-conditioning and 7 days of SER-301 dosing, enrollment in Cohort 2 will proceed.

The technical difficulty each individual operation creates for a surgeon is difficult to measure. Each surgeon knows after an operation how easy or hard it was, but there are no accurate measures of this difficulty. In a research setting and in a teaching setting it would be valuable to be able to accurately measure this degree of difficulty. Any new surgical technique or intervention needs to be measured for improvements in clinical outcomes. It would also be beneficial to measure any improvement in technical difficulty for the surgeon. The ability of a trainee to learn a new operation, and the ability to measure a trainees progress is also beneficial. This project will measure the NASA Task Load Index (NASA TLX) and correlate this against other current, relatively weak, measures of technical difficulty. The NASA TLX produces a numerical score for each operation, and this can be measured against clinical outcome parameters. The study does not alter the clinical or operative management of the patient, but merely has the surgeon complete a survey immediately after the operation, along with other clinical outcome parameters. The project will study eight surgeons from both upper gastrointestinal and colorectal surgery, and at two levels of experience: consultant surgeons and post-fellowship advanced trainees. Each surgeon will enrol 20 patients to the study, giving an adequate volume per surgeon to detect a correlation, plus a total of 160 operations overall to produce overall power of the study.