ANZCTR search results

This is an exploratory study testing the Atmo Gas Capsule in 5 patients aged 18 years or over with active inflammatory bowel disease. The Atmo Gas Capsule is a novel swallowed capsular technology which measures gas concentrations (eg. oxygen, carbon dioxide, hydrogen, methane) in the gastrointestinal tract and sends data to an external receiver kept within 1.5 metres of the body. Intestinal gas composition is expected to reflect the gut microbiome composition. We will first exclude any intestinal strictures in patients with Crohn’s disease as strictures might increase the risk of capsule retention within the bowels. This will be done by demonstrating no strictures on a magnetic resonance enterography (MRE) scan within the past 3-6 months, or by first successfully passing a swallowed wax capsule containing a radiofrequency identifier. An externally held radiofrequency detector will be used to detect whether the wax capsule has passed out of the body after 5 days. If it does not pass within 5 days, the wax capsule will melt by itself and cause no harm, but these patients will not proceed with the study. Patients with Crohn’s disease who have a recent MRE with no strictures or have successfully passed the wax capsule will be able to proceed with the rest of the study. Patients with ulcerative colitis will not need this initial screening for strictures as ulcerative colitis does not predispose patients to intestinal strictures. Measurements will then be taken using the Atmo Gas Capsule before and after (8-12 weeks later) initial treatment of active inflammatory bowel disease and correlated with inflammatory bowel disease activity before and after treatment assessed clinically and by various means such as serum inflammatory markers, faecal calprotectin, or endoscopy. This will allow us to see if certain intestinal gas patterns can be correlated to disease activity and also see if gas patterns can help predict response to treatment.

This study aims to investigate whether priming intravenous administration sets with monoclonal antibodies reduces chair time. Who is it for? You may be eligible for this study if you are an adult being treated with the single agent monoclonal antibodies: Obinutuzumab, Daratumumab, Nivolumab, Pembrolizumab at the Royal Brisbane and Women's Hospital. Study details Participants will randomly be allocated to one of two groups: one which has their IV line primed with the treatment drug, and one which is primed with diluent only before administration of the drug. Information on treatment duration, adverse reactions and patient experience will be collected on the day. Information from this trial will inform the optimisation of patient flow and decreased hypersensitivity reactions in oncology care.

This study will evaluate the feasibility of Human Microbiota Transfer Therapy (HMTT) for depression in adults. We will aim to recruit 15 participants to recieve a HMTT enema (n=10) or placebo enema (n=5). We will follow up participants for 8 weeks for primary outcome, measures including recruitment, retention, acceptibility, tolerability, and 6 months for safety data. We hypothesise that HMTT will be a safe and feasible treatment for depression in adults. This pilot data will inform a larger randomised controlled trial evaluating efficacy of HMTT for depression, scheduled to commence in 2022.

The aim of this study is to examine whether Neisseria gonorrhoeae bacteria from the oropharynx will grow after using a mouthwash over a two-hour time period.

The purpose of this research is to explore the effect of stopping heart medication in cancer patients whose hearts have recovered from chemotherapy-related cardiac dysfunction (CTRCD). Who is it for? You may be eligible for this study if you are aged 18 or older, you have been previously diagnosed with asymptomatic CTRCD and you are currently taking CTRCD medications including Angiotensin Converting Enzyme inhibitors (ACEi) and/or Beta Blockers (BB). Study details All participants who choose to enrol in this study will be randomly divided into one of two groups by chance (similar to flipping a coin). One group will continue their heart medications as prescribed. The second group will cease their heart medications (Angiotensin Converting Enzyme inhibitors (ACEi) and/or Beta Blockers (BB)) under medical supervision, this will occur over a staged period. All participants regardless of their group allocation will undergo monthly clincial review. An echocardiogram (heart ultrasound, approximately one hour), Electrocardiogram (ECG), blood tests and cardiac magnetic resonance imaging (CMR) will be taken at the start and end of study involvement. It is hoped this research will determine whether completely stopping cardiac medications including ACE inhibitors and beta blockers is safe and whether this has any negative impacts on patients with previous chemotherapy related cardiac dysfunction. If this treatment cessation is safe it may be used to improve health outcomes for future cancer patients who are affected by chemotherapy related cardiac dysfunction.

Percutaneous coronary intervention (PCI), also known as coronary angioplasty, is a nonsurgical procedure that improves blood flow to your heart. After a PCI, it is recommended in medical guidelines that everyone should receive physical activity advice and referral to a cardiac rehabilitation program prior to discharge. However, physical activity levels have been found to be low in people following a PCI. The aim of this research is to investigate whether a 30-minute physiotherapist-led physical activity counselling session prior to discharge improves physical activity levels early in individuals recovery (first 3-weeks) compared to brief physical activity advice provided by nursing staff. Findings from this study will inform further investigation of physical activity advice after a PCI, to determine how we should deliver this information, and whether this has an impact on physical activity levels early in people's recovery.

Depression is a common form of mental distress that affects 1 in 7 Australians in their lifetime. People who are depressed not only feel depressed and sad, but often find they sleep poorly, experience a change in appetite, have low energy, poor concentration and have lowered self-esteem. Sometimes, they might think of harming themselves. Often, they find it hard to enjoy life or be productive. Recovery from depression is possible and treatment for depression includes psychotherapy (talking therapy), cognitive behavioural therapy and medication. In fact, almost 10% of Australians use antidepressants each year. Finding the right medication and the right dose can be challenging, often requiring several trial-and-error attempts. Approximately two thirds of people do not get better with the first medication they’re prescribed and one third of people do not recover even after four different medications are tried. Pharmacogenomics is a new, simple genetic test which can determine the way a person’s body will respond to medication. The ALIGNED Study (AustraLIan trial of GeNotype-guided pharmacothErapy for Depression) is looking at how pharmacogenomics can help to find the right antidepressant medication for people with depression. This may improve the likelihood of recovery from depression.

This project aims to evaluate the feasibility and acceptability of an intervention to improve the feeding practices of parents concerned for the fussy eating behaviours of their toddlers. The program will be delivered via a mobile web-based application with text-message prompts.

The aim of the Novoglan-01 clinical trial is to conduct a scientific study in compliance with good clinical practice in order to confirm the safety, efficacy and tolerability of the Novoglan product as a conservative treatment for adult phimosis. This study is expected to provide evidence for the use of the Novoglan product as an alternative to steroid creams in the conservative treatment of adult phimosis. The study is an investigator-initiated running in two sites at Macquarie University Hospital in NSW and Princess Alexandra Hospital in QLD. The Novoglan-01 study is a single arm, non-randomised, observational, prospective study that plans to recruit 24 participants starting in September 2019 and concluding in February 2022.

The primary objective of this study is to use machine learning methods to examine autonomic, cardiorespiratory and sleep function in patients with epilepsy to determine whether this data can be used to detect seizures. We will also examine seizure classification and prediction as secondary objectives using the same approach. We will examine whether autonomic, cardiorespiratory and sleep function can be used to differentiate between epileptic seizures and non-epileptic events. Further, we will also examine the prevalence and risk-factors for sleep-disordered breathing in patients who undergo video-EEG monitoring.