ANZCTR search results

This is a multicentre Phase I clinical trial to establish if Deflexifol is safe and effective in children, adolescents and young adults with recurrent or refractory brain tumours. Who is it for? Participants may be eligible for this study if they are older than 12 months and up to 21 years old and have a recurrent or refractory brain tumour; or newly diagnosed diffuse intrinsic pontine glioma (DIPG) or diffuse midline glioma (DMG) participants after completion of radiotherapy. Study details Participants will receive Deflexifol every 2 weeks for up to approximately one year, if there is ongoing clinical benefit. Deflexifol will be administered via an injection over 3-5 minutes (bolus), followed by a continuous intravenous infusion over 46 hours. Pharmacokinetics will be measured during the first 4 weeks and safety will be assessed throughout the course of treatment and during follow up visits. Participants will have physical examinations, blood tests, urine tests, echocardiogram, electrocardiogram (ECG) and MRI scans. This study will test the safety and effectiveness of this new drug in children and adolescents in cases where treatment options are limited.

Problem: Goals of Australian antenatal education include promoting appropriate parenting, enhancing parental capacities for relationship with their child and supporting parents with their preparation. Although many programs exist there has been limited examination of effectiveness. Background: ‘Bringing Baby Home’ (BBH) is one such program. Designed as antenatal education, the US developers’ 2005 randomised control ‘efficacy’ study demonstrated benefit on multiple measures at 12 months post-birth. Aim: In the original study participants were American. While that study demonstrated very positive workshop outcomes, in that study the workshop was run by its creators who are recognised world experts, supported by their research team. The current study was run to see if the workshops were still effective when run by a general antenatal educator with no additional back-up, and delivered to Australian rather than US participants.. The current study also had longer follow-up than the original. Methods: 60 couples attending a suburban public hospital maternity service were randomised to either a) the then-standard antenatal education program or b) standard program + BBH workshop. Measures were self-report surveys used in the US study, collected on recruitment and time points up to 8-10 years later.

The primary purpose of the study is to investigate if we can individualise treatment for non-underweight eating disorders in response to initial changes in dietary restriction. We hypothesise that: (1) Single session interventions tackling growth mindset or behavioural activation (both which will reinforce a message of decreasing restriction delivered in assessment) will significantly reduce dietary restriction over a waitlist period before participants receive cognitive behaviour therapy for eating disorders (CBT-ED) compared to a non-suicidal self-injury single session intervention. (2) Those people whose dietary restriction decreases by 50% over the waitlist period and receive the less intensive version of CBT-ED (online guided self-help) will benefit commensurately to those whose dietary restriction does not decrease and who receive a more intensive form of CBT-ED (CBT-T).

The use of low-calorie (or “non-nutritive”) sweeteners has increased greatly in recent decades because they are perceived as healthy replacements for sugar. However, large population studies suggest that regular intake of these sweeteners can increase the risk of developing type 2 diabetes. This study is designed to investigate whether different low-calorie sweeteners are more or less prone to affect blood glucose control. We will also test which sweeteners affect glucose absorption from the intestine, and whether they alter the types and amount of bacteria present in the intestine.

Chronic wet cough (CWC) is among the commonest symptoms of chronic lung disease. In children, it is associated with bronchiectasis (BE), recurrent doctor visits and impaired quality-of-life (QoL). Early diagnosis/treatment leads to decreased cost and, improved QoL and clinical outcomes. Yet, there is currently there are no published data on treatable traits in children with child CWC or intervention that prevents BE. Our primary question is: In children with CWC and with ‘high-risk traits’ (recurrent antibiotics for CWC, airway H. influenzae infection or cough duration >6-mo), does 9-mo of azithromycin (vs controls) reduce the risk of future recurrent protracted bacterial bronchitis (recPBB) and BE? Our secondary aims are to determine if 9-mo of regular azithromycin (vs. controls) improve other clinical outcomes (lung function, time-to-next exacerbation, recurrence rate, and time off work/school) and its cost-effectiveness, in children with CWC and with ‘high-risk traits’.

Participants with Posttraumatic Stress Disorder will engage in a 4 week inpatient program that includes individual and group cognitive behaviour therapy. This study aims to test whether trauma-focused CBT with minor modifications based upon memory reconsolidation research findings (CBT-MR) can improve patient outcomes compared with a standard trauma-focused CBT (CBT-S). Hypothesis 1 = Participants assigned to our standard trauma-focused CBT (CBT-S) will experience at least equal patient outcomes to published standard trauma-focused CBT patient outcomes. Hypothesis 2 = Participants assigned to our trauma-focused CBT modified based upon memory reconsolidation research findings (CBT-MR) will experience better patient outcomes to participants assigned to our standard trauma-focused CBT (CBT-S). Hypothesis 3 = Participants will find both version of the therapy equally acceptable in terms of similar levels of attendance, attrition from the study, and self-report of acceptability at the end of the program. Hypothesis 4 = Participants with higher levels of endocannabinoids, neuropeptides, peptides, oxytocin, and cortisol will respond significantly better to treatment compared to participants with lower levels of these analytes (in both hair and blood samples before, during, and after treatment).

This study aims to evaluate a new approach to the treatment of patients with lower grade glioma that has started to grow again (i.e. is recurrent) following your initial treatment. Who is it for? You may be eligible to join this study if you are aged 18 years or older, with histologically-confirmed grade 2 or 3 glioma at initial diagnosis, and with evidence of progressive disease after initial treatment. Study details For each participant, the study will involve taking a sample of tumour tissue during surgery, which will be screened for biomarkers. The results of this testing will then be used by a panel of experts who will make a treatment recommendation. If you have a mutation that matches one of the treatment arms, this will be recommended to you. If you do not have a mutation that matches one of the treatment arms, you will be randomised (i.e. allocated by chance) to one of the treatments that does not require a matching mutation. The study treatments available in LUMOS2 are: the oral medication Paxalisib administered once daily, the intravenous infusion AK104 administered once every 2 weeks, the oral medication Selinexor administered once weekly, or the oral medication Niraparib administered once daily in combination with the intravenous infusion AK104 administered once every 2 weeks. Treatment will continue until disease progression is documented or until participants experience intolerable toxicity or withdraw from the study for another reason. During treatment, participants will undergo an MRI scan every 8 weeks to assess for disease progression and response to treatment, and will complete questionnaires regarding their quality of life. It is hoped that screening tumour tissue for specific biomarkers to direct targeted treatment will be effective, safe, and cost-effective for the management of patients with recurrent lower grade glioma.

Low-calorie sweeteners (LCS) have been widely used in food and beverages in recent decades. However, a recent World Health Organisation (WHO) report highlighted that people who consume LCS regularly have an increased risk of developing type 2 diabetes (T2D). Acesulfame potassium (Ace-K) is a widely used low-calorie sweetener that is absorbed from the gut and excreted in the urine. We want to find out whether Ace-K consumption, as compared with water and a poorly absorbed LCS, sucralose, reduces the amount of glucose excreted in the urine in people with T2D, which would promote higher blood glucose levels.

This Post-Market Clinical Follow (PMCF) study will evaluate clinical performance and safety outcomes of primary total hip arthroplasty surgeries using MobiliT™ cup and Paragon™ stem over a ten-year period. Participants will be selected for recruitment into the study from the general population of patients requiring a dual mobility total hip arthroplasty surgery and considered suitable to be implanted with MobiliT™ cup and Paragon™ and Taperfit stem (Corin Ltd). After the surgery, participants will be required to return for follow up visits and radiographic controls at specific timepoints and complete questionnaires for a period of 10 years. This PMCF prospective study is being initiated to collect performance and functional results of dual mobility procedures performed in primary THA surgery using the MobiliT™ cup and the ECiMa (highly crosslinked UHMWPE with Vitamin E) insert that received the CE mark at the end of 2020 and was recently approved by the TGA in 2022 for dual mobility procedures in primary THA surgery.

Sleep Intervention for Adults Presenting with Insomnia (SLEAPI) is a novel ACT-I/behavioural therapy (BT) intervention originally developed to increase behavioural and psychological flexibility around sleep in autistic adults (Lawson et al., 2022). Behavioural methods aimed at reducing sleep difficulties and improving sleep involve sleep hygiene, self-monitoring, relaxation, and sleep restriction. This trial aims to investigate whether SLEAPI delivered in an individual format for non-autistic adults promotes significant improvements on insomnia symptomology severity. This study will investigate the efficacy of the SLEAPI intervention on improving (1) quality of life; (2) acceptance of sleep issues; (3) individual sleep components; (4) perceived sleep quality; and reducing (5) anxiety and depression and (6) pre-sleep arousal among non-autistic adults. A non-concurrent multiple baseline design will be used to track the effects of the intervention. The use of a multiple baseline design allows participants in the longer baseline phases to act as controls/comparators for those in the intervention phase. In this design all participants will receive the same intervention.