ANZCTR search results

An therapeutic diet targeting naturally-occurring bioactive chemicals has been suggested to relieve gastrointestinal symptoms. A major focus of this diet is salicylates. This study aimed to address a potential role of dietary salicylates in causing symptoms in patients with irritable bowel syndrome (IBS). A pilot, double-blind, randomised, cross-over trial of two-week low-versus high-salicylate diets was undertaken. All food was provided containing minimal quantities of other potential food triggers. Gastrointestinal and extra-intestinal symptoms were measured daily using a 100-mm visual-analogue-scale. We hypothesised that a low salicylate diet would improve symptoms compared to the high salicylate diet in the 10 patients with IBS who conducted the study.

Since emerging in late 2019, the coronavirus disease 2019 (COVID-19) has rapidly spread across the world, including Australia. The World Health Organisation (WHO) declared COVID-19 a pandemic on 11 March 2020. The virus responsible for COVID-19, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a positive sense single-stranded RNA virus which predominantly causes respiratory tract infection, with a wide spectrum of disease severity from mild upper respiratory tract symptoms to respiratory failure. Health care workers (HCW), the elderly and immunocompromise have a higher risk of developing COVID-19. This clinical trial will establish whether a hyperimmune intravenous immunoglobulin (HIVIG) preparation concentrated with antibodies to SARS-CoV-2 is safe when administered to healthy adults. The trial will also assess whether the anti-SARS-CoV-2 antibodies in the immunoglobulin preparation are pharmacokinetically equivalent to naturally generated antibodies when infused in the trial subjects. This is an open label, active control Phase 1/2 study to assess the safety, tolerability and pharmacokinetic (PK) profile of hyperimmune IG (HIVIG) to SARS-CoV-2 compared with SARS-CoV-2 convalescent plasma (CP) following a single IV infusion of antibodies at a titre of = 1:160 in healthy adults aged 18 years and over. Fifteen participants will be allocated to each study arm, with matching of participants occurring based on sex and age (18-29, 30-49 and greater than or equal to 50 years). The first 3 participants from each arm will comprise a sentinel group, subject to 24hr confinement post infusion. Safety assessment of the sentinel group will occur prior to subsequent enrolment within the arm. All participants may have up to 13 scheduled clinic visits from Screening until Day 182 (end of study). Participants will be subject to safety blood sampling and for PK at Day 1, Day 2, Day 3. Day 7, Day 14, Day 28 and Day 42. This trial will address a gap in current knowledge by investigating a new agent manufactured by a novel Australian technology in the prevention of COVID-19. If successful, this approach can be rapidly scaled up for implementation into clinical practice and contribute to the sustainability of the Australian healthcare system during the current pandemic.

A novel prebiotic product, targeted for microbiome modulation in patients with low levels of fibre intake and those prone to constipation.

The study will provide a full cognitive assessment of patients with MCI to confirm their diagnosis and likely underlying cause. There are three specific aims of the project: 1. Establish a cohort of well-characterised patients with neurodegenerative diseases presenting as mild cognitive impairment (MCI). 2. Create a repository of blood, brain imaging (MRI & PET) and CSF data for biomarker studies. 3. Implement a clinical model to increase physician referrals to clinical trials, through access to advanced imaging, neurocognitive screening, and cognitive neurologist assessments for people residing in the South Eastern part of Melbourne and rural areas in Victoria. The study will allow us the opportunity to collect a large database of MCI patients to gain greater insights in to risks, diagnosis and prognosis of the disease. Simultaneously it will provide patients with a clearer understanding of their disease (through use of research only tools) and increase referrals in to clinical trials of potentially beneficial treatments for patients with MCI.

LEGO® therapy is a proven intervention that uses a child’s natural interest to motivate learning and to collaboratively build a LEGO® set with others through the social division of labour.. It has been found to be effective in increasing social skills and reducing maladaptive behaviours in younger children with autism spectrum disorder (ASD), however, there is limited information about the effectiveness of LEGO® therapy for children over the age of 13 years. LEGO® robotics therapy – which uses the principles of LEGO® therapy applied to LEGO® robotics – may be an age-appropriate intervention to reduce anxiety and increase social skills in adolescents with ASD. The primary aim of this Phase 1 clinical trial is to investigate whether LEGO® robotics therapy can reduce anxiety and increase social skills and school engagement in adolescents aged 13-16 years with ASD. The second aim is to measure the engagement, utility, and acceptance of LEGO® robotics with this cohort, while the third aim is to formally gather the views and perceptions of the intervention from all stakeholders (adolescents with ASD, parents, teachers, and LEGO® therapist/facilitators). The fourth and final aim is to develop a training manual for school staff and parents to support adolescents with ASD. The manual would support the reach, generalisation and longevity of the LEGO® robotics therapy program across educational, clinical, home and community settings. The findings of this study will inform the development of a larger randomised controlled trial.

This is a phase 1, single-center, randomized, open-label, 3-way crossover study to evaluate the pharmacokinetics of PBT434 after administration of a tablet formulation in the fed and fasted states and a powder in capsule formulation which has been utilized in previous Phase 1 investigations

Proximal hamstring origin tendinopathy (PHT) is a common condition in the active and sporting population, particularly in sports involving sprinting, jumping, kicking or distance running. It was first described in 1988 (Puranen & Orava, 1988) as ‘Hamstring Syndrome’. The condition presents as localized lower buttock pain, and is typically aggravated by prolonged sitting, running or walking (particularly uphill), lunging and squatting. The primary aim of this study is to compare the immediate effect of isometric and isotonic exercise on pain and strength in individuals with proximal hamstring tendinopathy. A secondary aim of this study is to examine force steadiness in isometric contraction in a population with proximal hamstring tendinopathy compared to a matched population without the condition.

The aim of this project is to examine the influence of different anatomical structures on knee kinematics in total knee arthroplasty (TKA), with focus on condylar movement over the tibia (pivot and rollback through flexion). The study will examine the hypotheses that tibial internal rotation in balanced Kinematic Alignment (KA) Cruciate Retaining (CR) Computer Assisted Surgery (CAS) is synonymous with a medial pivot. Patients will be prospectively recruited to undergo KA CR CAS TKA. Values obtained from CAS intraoperatively will be validated using additional values measured using an Orthosensor, Versasense device.

We will conduct a multi-centred, double-blind randomised sham-controlled trial on 50 people with chronic SCI. The primary outcome will be walking ability measured using the Walking Index for SCI II (WISCI II). Participants will be randomised to either the Stimulation group or the Sham group. All participants will receive the same intensive locomotor training consisting of three one hour sessions per week, over 12 weeks, in combination with either stimulation or sham stimulation. The secondary outcomes will capture different aspects of recovery, strength, spasticity, and bowel function. Outcome measures will be taken at baseline, 12 weeks and 16 weeks after randomisation.

Impact Diabetes Bump2Baby is a study to test whether women at high risk of developing diabetes can reduce that risk through a healthy eating and physical activity smartphone app and tele-health coaching. Women presenting to the maternity service for the first time will be assessed, using a validated set of questions, to determine the likelihood that they will develop gestational diabetes during their pregnancy. Women identified as at high risk will be invited to take part in a study study, to see if a personalised tele-health coaching service can help women with the self-management of modifiable lifestyle risk factors compared to women who will receive usual care. The tele-health coaching is provided through a smartphone application (app) called “Bump2Baby & Me”. This will guide a woman through the journey from pregnancy to birth and the end of the baby’s first year. Trained health coaches will optimise engagement with the app and help to personalise the behaviour change experience. The app is supported by a developed and tested commercial platform, that uses a health coach dashboard to coordinate and tailor engagement for each woman. The platform will integrate seamlessly with a woman’s smartphone and each site will have their own dedicated health coach. Our study will involve a woman during pregnancy and after birth will include her baby. During the first antenatal visit, all women will be screened for their risk of developing gestational diabetes using standard information collected at this visit such as age, body mass index, family history of diabetes. Women scoring 3 or higher will be eligible to take part. At the start, we will take blood samples, measure weight and height and ask the woman to fill out some questionnaires. Women in the intervention group will have access to the Bump2Baby & Me app and tele-health coach during pregnancy and for the first 12 months after their baby is born. At 12 months we will ask women to come in for a follow-up visit where we will repeat the blood samples, body measurements and questionnaires. We will ask a random sub-sample to take part in a short exit interview.