ANZCTR search results

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.

A foot orthosis is an insert worn inside shoes to help realign the foot and ankle to reduce excessive movements that lead to pain, stress, and strain in the lower limb during functional tasks. The traditional process of orthotic fabrication is time consuming and labour intensive with the quality and effectiveness of the final product largely dependent on the skill level of the podiatrist fabricating the device. The use of computer aided design and manufacture (3D printing) has the potential to reduce the time and cost of orthotic manufacture, and reduce dependence on podiatrist's skill. Despite the reported benefits of the technology driven foot orthoses, the efficacy of 3D printed orthoses in changing gait kinematics, compared to traditionally made orthoses, has not been adequately investigated. This project will compare the immediate effects of traditionally manufactured orthoses and 3D printed orthoses in regards to: (1) manufacturing specifications (e.g. size and shape of the orthoses), (2) lower limb kinematics and kinetics, and (3) comfort levels in patients with clinically diagnosed heel pain. The results of this study will show how orthoses made using new technology compare with those made using traditional methods. Paired t-tests and repeated measures analysis of variance (ANOVA) will be used to examine the differences in outcome measures between conditions.

This randomised controlled trial seeks to investigate the adherence rates and efficacy of an internet-delivered program for repetitive negative thinking immediately following treatment and at 3-months follow-up, and compare outcomes for clinician-guided versus self-guided online program.

High blood pressure, also known as hypertension, is a disease where the blood inside the heart and blood vessels is pumped with more force than normal. This adds stress to these important tissues, increasing the chance of a heart attack, stroke and, as we age, heart failure. Hypertension affects one in three people in Australia, and is known as a ‘silent disease’ as it usually does not produce any symptoms until it might be too late. It is well known that our diet influences the risk to high blood pressure. While salt intake is associated with higher blood pressure, consumption of fruit, vegetables and other food rich in fibre is usually associated with lower blood pressure. New evidence from our laboratory has emerged that this may be due to the tiny microorganisms that live in our gut. While our bodies are incapable of digesting some types of fibre, they are fermented in gut, where they feed the community of ‘good’ bacteria. This results in the release of substances that can be detected in our blood and might be beneficial in lowering our blood pressure. The present study will expand our knowledge about the gut bacteria in the setting of normal and high blood pressure, to help us understand the types of bacteria present in hypertensive subjects and whether they could be contributing to the increase in blood pressure. This research has implications for cardiovascular health due to the relatively benign and cost effective nature of diet treatments. It will also inform on future intervention strategies and food guidelines.

This is an open-label single ascending dose (SAD), and randomized, double-blind, placebo-controlled, multiple-ascending dose (MAD) study to evaluate the safety, PK and pharmacodynamic effects of oral doses of CST-2032 in healthy adult participants. In addition, an optional cohort of patients with Mild Cognitive Impairment (MCI) or Parkinson’s disease may be enrolled to evaluate the effects of a single dose of CST-2032. The study will additionally evaluate whether peripheral effects that may emerge with CST-2032 can be inhibited by CST-107. Up to 17 cohorts are planned for this study, with approximately 4-8 subjects per cohort following confirmation of study eligibility during the screening period.

This study will investigate the feasibility of using oestradiol vaginal tablets (Vagifem Low) for women on adjuvant aromatase inhibitors for breast cancer Who is it for? You may be eligible to join this study if you are female, aged 18 and above, have early breast cancer (stage I-III), on an aromatase inhibitor for at least 3 months and are experiencing genitourinary symtoms Study details All participants in this study receive estradiol vaginal pessaries (Vagifem Low) for 12 weeks (daily application for the first 14 days, then twice a week application for the next ten weeks). Feasibility/adherence to treatment will be assessed using a participant diary. This study will also assess symptom response, quality of life and sexual function using questionnaires and the effect of this treatment on blood levels of oestrogen. We hope this study will further medical knowledge and may improve treatment of genitourinary symptoms for women in the future.