ANZCTR search results

Aim: The overall aim of this research is to report on maternal weight status prior to pregnancy and nutrition status (weight gain, oral intake, micronutrient deficiencies) during pregnancy after bariatric surgery and its association with maternal and offspring outcomes.

Children can sometimes have pulsed dye laser procedures for birthmarks and scars without a general anesthetic. Instead of having a general anaesthetic, they instead have pain relief (paracetamol/ibuprofen) before their procedure and have access to additional pain relief during the procedure if required. It is unclear if, in this situation, children might benefit from having a numbing cream (topical anaesthetic) applied to their birthmark or scar before the laser. Any medications have their own risks associated with them, so we want to make sure that if we do start routinely using numbing cream in these situations, that it brings enough of a benefit for children that it would outweigh any associated risks with using numbing cream. We would like to do a study that looks at children's pain scores during and after laser procedures, and whether there is a difference in pain scores of children who have had numbing cream compared to children who receive a placebo (non-active) cream. The first step of doing such a study would be to check that it is feasible to do, and acceptable to everyone who might participate. That is what this feasibility pilot study will aim to do.

To examine the feasibility and acceptability of a 12-week VILPA intervention to increase physical activity (PA) in insufficiently physically active adults who are transitioning to retirement. This study will be a pilot randomised controlled trial with two groups of participants using the adapted Consolidated Standards of Reporting Trials (CONSORT) statement. Eligible participants will be randomised to either a waitlist or intervention group. The intervention group will receive the intervention for 12 weeks. The waitlist group will receive current physical activity recommendation by the World Health Organization until the intervention group has completed their 12-week trial.

FMT has been proven to be a safe and effective treatment for recurrent and refractory C. difficile infection and is now available within Australia for this purpose. There is also significant and growing evidence that FMT can effectively treat gastrointestinal disorders such as ulcerative colitis, Crohn’s disease, irritable bowel syndrome, immune checkpoint inhibitor-associated enterocolitis and functional constipation, and practitioners may now request access to FMT for patients with these conditions under the TGA managed Special Access Scheme-B (SAS-B) or authorised prescriber schemes. However, there is a dearth of evidence on the safety and efficacy of FMT in gastrointestinal disorders in a real-world setting. In this a real-world, prospective, observational study, we aim to track the real-world safety and efficacy of FMT treatment in patients with gastrointestinal disorders within Australia. The results of this study may inform standard clinical care for patients with gastrointestinal disorders.

This study will assess the safety and tolerability of a single dose of Erwinaze, and how this drug acts in the body in healthy volunteers. Erwinaze is indicated for use in patients with acute lymphoblastic leukemia (blood cancer), but a trial of the drug in healthy volunteers is needed to obtain additional information to potentially make Erwinase available in more countries. Who is it for? You may be eligible for this study if you are aged 18 to 40 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Study details All participants who choose to enrol in this study will be screened for eligibility within the 28 days prior to being admitted to a clinical research unit for up to 5 days. Eligibility will be confirmed within the 24 hours prior to participants receiving a single intramuscular (injected) dose of Erwinaze. Participants will then be asked to provide a series of blood and urine samples to assess the effect of the drug on their body. After 5 days, participants will be discharged home and will be asked to attend two further study visits to provide blood samples. It is hoped this research will determine whether Erwinaze can be safely administered without causing severe reactions. Once the safety and tolerability of Erwinaze has been determined, further studies to assess the effect of Erwinaze in people with leukemia may proceed.

The current study aimed to demonstrate an acute cortisol response following a single high salt meal. While studies to date show an association between high dietary salt-intake over several days and 24-h urinary cortisol, no studies have investigated the acute relationship between salt-intake and cortisol production. The primary aim of our study was to demonstrate salt-induced cortisol production in an acute setting. Our secondary aim was to demonstrate this cortisol production in the absence of an adrenocorticotropic hormone (ACTH) response. We hypothesized that urinary cortisol but not plasma ACTH will increase following a single high-salt meal. To further characterize the role of high salt intake, we measured salivary cortisol, heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and blood glucose.

Peripheral Intravenous Catheters (PIVCs) are the most frequently used vascular access device in Australia, with Queensland Health spending $41 million purchasing over 2.6 million PIVCs in 2016 alone. Currently, peripheral intravenous (IV) device choice consistently defaults to short-PIVCs (<4cms) to meet most patients’ IV treatment needs. This is largely due to the current workforce model in which most PIVC inserters are doctors and nurses (generalist) inserting PIVCs within their existing roles. Over the last decade, PIVC insertion teams made up of Vascular Access Specialists (VAS) have been disbanded in many hospitals due to budgetary constraints. The ‘generalist’ approach has been adopted instead putting pressure on already-stretched frontline clinicians, particularly junior medical officers in the after-hours space. Inherent inefficiencies in the current generalist workforce model are not sustainable. More efficient, innovative service provision is urgently needed. Our research project aims to compare the clinical effectiveness of peripheral intravenous device selection and insertion by (i) VAS compared with (ii) generalist model (standard practice). We will conduct a single-centre, two-arm, parallel, randomised controlled trial recruiting 196 patients who are 18 years of age or older and requiring IV therapy for 24hrs or more. All participants enrolled in this trial will be randomly allocated (by chance) to have their IV device inserted by either a VAS or a generalist inserter. Daily follow up checks will then be carried out by a (blinded) Research Nurse until the time of device removal. We the investigators hypothesise that devices selected and inserted by a VAS, compared to those inserted by a generalist inserter, will result in: • Reduced peripheral IV device failure and complications • Fewer attempts to achieve successful peripheral IV device placement • Fewer devices to complete the prescribed peripheral IV therapy • Improved patient satisfaction and less self-reported pain on insertion

IVF remains a difficult process – physically and emotionally - in part due to the ovarian stimulation protocols that stimulate the ovaries. It has been established that there is crosstalk between female gonadal hormones and the vaginal microbiome. This research aims to look at how the vaginal microbiome will respond when exposed to the physiologically abnormal doses of reproductive hormones introduced during Assisted Reproductive Technology treatment. The purpose of this project is to investigate whether fertility treatment used to stimulate ovulation, changes the amount, or type, of microbes usually present in your vaginal microbiome. This study wants to know what a person's vaginal microbiome looks like prior to commencing gonadotropin fertility treatment, during treatment, and once the person has finished treatment.

This study aimed to identify MBSR-related changes in depression, anxiety, and stress and various subcomponents of mindfulness using a longitudinal design over an 8-week MBSR course.

More than two million Australians report an antibiotic or penicillin allergy. Patients’ reports are not always accurate, which may lead to them receiving second-line antibiotic therapies. It has been found that 85% of reported allergies are false and can be removed by testing: in fact, more than 95% of low-risk penicillin allergies. The International Network of Antibiotic Allergy Nations (iNAAN) is a health services program that seeks to improve access to direct oral penicillin challenge for Australian patients. This will reduce the burden and cost of antibiotic allergies in healthcare. At present, many of the patients carrying an antibiotic allergy label remain undiscovered with 50% of these patients not having access to vital testing. We seek to prospectively audit this clinical program to assess safety and the impact on reducing the burden of penicillin allergy in hospitalized patients and the subsequent effects on antibiotic prescribing and patient outcomes.