ANZCTR search results

The overall research aim is to reduce the burden of functional gastrointestinal disorders (FGIDs) in children with Autism Spectrum Disorder (ASD) with possible amelioration of ASD-associated behaviours and anxiety disorders. Children diagnosed with ASD and comorbid FGIDs aged 5.00-10.99 years (n=40) will be recruited through community and clinical settings and randomised (1:1) to one of two 12-week treatment groups: 1) synbiotic or 2) synbiotic + gut-directed hypnotherapy. The primary outcome will be changes in GI symptom severity as measured by the 6-item gastrointestinal severity index (6-GSI). Secondary measures include changes to ASD severity (ATEC questionnaire) and anxiety scores (PRAS-ASD questionnaire) and biological measures to characterise the gut microbiome (metagenomic DNA sequencing) among participants. It is hypothesised that a combined treatment approach (synbiotic + GDH) will be more effective than a synbiotic alone at reducing GI symptoms in the target population.

Patients referred to orthopaedics outpatients commonly face long wait times for outpatient appointments and surgery. This study intervention supports advanced physios- funded through Cairns Hospital - to offer assessments to referred chronic musculoskeletal patients within community Queensland Health (QH) facilities. they will collaborate with other QH allied professionals and create an individual Plan for patient management- which will be sent to the patient's GP for discussion on how to access existing community allied health services to complete the recommended planned sessions.

This project builds on a previous randomised controlled trial (RCT), which demonstrated beneficial alcohol and anxiety outcomes compared to control following delivery of the therapist-supported "Inroads" CBT-based early intervention program. This study seeks to extend those findings to evaluate the acceptability and preliminary efficacy of a self-guided version of the Inroads program, which provides automated, personalised eHealth features in place of therapist support. The present study will conduct a large, single-group naturalistic trial (i.e., a noncontrolled clinical trial) of a 5-session cognitive behavioural therapy (CBT)-based self-guided early intervention for anxiety and alcohol use. The self-guided version of the Inroads program incorporates additional eHealth features to provide troubleshooting, accountability and motivational support via customised, responsive auto-messaging in place of therapist involvement. In view of increasing rates of anxiety and concerning levels of binge-drinking among young Australians (AIHW 2017; Dooley et al., 2018), it is critical that we provide young people with effective tools to help them manage anxiety and alcohol use, when problematic symptoms first emerge. This is particularly important at present, as experts predict there will be further increases in the incidence and severity of anxiety and hazardous alcohol use as the result of recent and ongoing global crises, such as bushfires, droughts and the COVID-19 pandemic. Benefits associated with the self-guided Inroads program will be measured immediately post-intervention (2-months post-baseline) to assess short-term intervention effects and at 6-months post-baseline to examine the durability of the intervention effects. Primary outcomes will include symptoms of anxiety (social anxiety, generalised anxiety) and alcohol use (frequency of binge drinking and hazardous consumption). Secondary outcomes will include alcohol consumption and negative consequences from drinking, existential anxiety and anxiety about global threats (e.g. COVID-19), depression, and functional impairment. We hypothesise that: 1. Participants will show significant reductions in primary anxiety and alcohol use outcomes from baseline to 2-months post-baseline; 2. Participants will show sustained improvements in these outcomes until 6-month follow-up (primary end point); 3. These changes will be reflected in clinically significant improvements on alcohol and anxiety symptom measures; and 4. Participants will rate the Inroads program as acceptable.

The current novel coronavirus (COVID-19) pandemic has highlighted the importance of safety for healthcare personnel particularly in relation to PPE. There are few studies in healthcare comparing user seal checks to the reference standard of formal fit testing. Better evidence is urgently required to guide current practice. Epworth ICUs use of one of two brands of disposable N95 respirators or a Powered Air Purifying Respirator (PAPR). Staff receive training in the use of the various masks, and are expected to perform a user seal check on each occasion. Fit testing has not previously been performed. This study aims to assess the adequacy of the user seal check, compared to the reference standard of fit testing for various models of N95 respirators.

Android artificial pancreas system (APS), uses an algorithm housed on an android phone in association with a Dexcom continuous glucose monitoring (CGM) system. An insulin pump that communicates with both the android APS software and Dexcom continuous glucose monitoring system is required and we will be using a modified Ypsopump in this trial. The aim of this study is to assess the safety and efficacy of a hybrid closed loop Android Artificial Pancreas System compared with conventional pump therapy using a standard Ypsopump. All participants will trial both the Android APS system and conventional insulin pump therapy for 4 weeks each.

Tonsillectomy is one of the most common procedures in childhood in Australia. Despite this, the incidence of minor bleeding, pain, nausea and vomiting and respiratory complications are very common (overall up to 70% of children). This study will improve the peri-operative evaluation of paediatric Obstructive Sleep Apnoea (OSA) and help to identify patients who can have tonsillectomy (+/- adenoidectomy) as a day case. This is a single centre, explorative observational study.

The focus of this project is on improving mental health outcomes among Australian young adults (18-25 years) who are lesbian, gay, bisexual, trans and gender diverse, and questioning or queer (LGBTQ). The main aim of the project is to determine whether participants in an 8 week self-compassion group program (MSC) report improved mental health outcomes compared to a group of participants on a waiting list. We expect that participants in the MSC group will show improvements in self-compassion and emotion regulation as well as reductions in self-stigma and symptoms of depression, anxiety, stress. A second aim of the project is to look at the relationship between those health outcomes to see whether the changes in self-compassion and emotion regulation lead to changes in depression, anxiety and stress. Finally, we will determine whether the program is acceptable to participants and the people delivering the program. To do this, we will conduct interviews with participants, program facilitators and peer facilitators.

This study will investigate the effect of topical polaprezinc mouthwash on the incidence of oral mucositis in cancer patients undergoing haematopoietic stem cell transplantation Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with blood cancer and will receive high dose chemotherapy with or without total body irradiation (TBI) followed by autologous or allogeneic haematopoietic stem cell transplantation Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive polaprezinc mouthwash 4 times daily from hospital admission until neutrophil recovery (approximately 20 days). Participants in the other group will receive sodium bicarbonate mouthwash 4 times daily from hospital admission until neutrophil recovery (approximately 20 days). Daily oral assessment will be conducted by nurses and oral mucositis severity will be graded according to the WHO mucositis scale. Patients will be asked to complete an oral mucositis daily questionnaire that evaluates their oral pain and functional difficulties. Patients’ compliance, acceptability of the mouthwashes, total opioid and patient controlled analgesia (PCA) use, enteral nutrition (EN) and total parenteral nutrition (TPN) use will be collected. If polaprezinc lower the incidence and severity of oral mucositis, it may be used in the future as an effective, inexpensive and safe prevention of oral mucositis.

Lyndra Therapeutics is currently developing extended release (ER) capsules for weekly administration across therapeutic areas with certain medications for which consistent pharmacokinetics (PK) or enhanced adherence may translate to improved efficacy, and possibly better safety. LYN-045 (Lyndra code for dapagliflozin) ER capsules are intended to provide comparable dapagliflozin exposure to daily treatment affording better accessibility and tolerability for the treatment of type 2 diabetes mellitus (T2DM). This Phase 1 study is intended for execution in healthy individuals due to its exploratory nature. Data from this study will be a key indicator of feasibility of the product concept and will inform formulation optimization and dose selection for further development. This study will be conducted in up to 10 healthy volunteers (including 2 sentinels) who meet all of the inclusion criteria and none of the exclusion criteria. This is a single-center, open-label study of dapagliflozin 70 mg ER capsules (LYN-045) to evaluate its safety, tolerability, and PK administered as 2 weekly doses in healthy male and female volunteers. All subjects will receive 3 doses of IR dapagliflozin 10 mg in the inpatient unit, Dose 1 on Day -3, Dose 2 on Day -2, and Dose 3 on Day -1. Following that, all subjects will receive 2 doses of LYN-045 70 mg; on Day 1 and Day 8. After completion of Day 10 assessments, subjects will be discharged from the inpatient unit. Thereafter, subjects will attend study center visits on an outpatient basis on Days 14 and 15. All subjects will attend an End-of-Study (EOS) visit on Day 21 for final study assessments.

This study aims to assess the cardiovascular risk in people with acute gout treated with anakinra through performing imaging the heart at baseline and at 9 months. We will determine the impact of having an acute flare of gout on the scans, which is a surrogate of cardiovascular risk. We will also determine the impact of a drug (anakinra), which is increasingly being used in acute gout, on its effect on these heart scans. This will help us understand the effect of acute inflammation on cardiovascular risk in gout. The use of anakinra for acute gout will also be assessed in terms of its effectiveness, safety and tolerability.