ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31380 results sorted by trial registration date.
  • Long-term treatment with azithromycin to prevent bronchiectasis and recurrent cough (LEAP-Cough)

    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’.

  • A Pilot Randomised Controlled Trial Comparing Cognitive Behaviour Therapy-Standard vs Cognitive Behaviour Therapy-Memory Reconsolidation for Inpatients with Post-Traumatic Stress Disorder

    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).

  • LUMOS2: Low & Anaplastic Grade Glioma Umbrella Study of Molecular Guided TherapieS

    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.

  • Acute effect of the renally excreted low-calorie sweetener, acesulfame potassium (Ace-K), on urinary glucose excretion in people with type 2 diabetes.

    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.

  • Clinical, radiographic and patient-reported outcomes using MobiliT™ cup with ECiMa™ insert in primary total hip arthroplasty surgery.

    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.

  • Multiple Baseline Clinical Trial Investigating the Efficacy of an Acceptance and Commitment Therapy (ACT)-Based Sleep Intervention for Adults Presenting with Insomnia (SLEAPI) on Sleep, Mental Health, and Quality of Life

    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.

  • Disability and Frailty in People Living with HIV in regional Australia

    The primary purpose of this study is to find out how much difficulty people living with HIV (PLHIV) who live in a regional area have with everyday tasks, hobbies, sports, jobs, memory, emotion, or participating in social events. These difficulties are known as ‘Disability’ and ‘Frailty’, and we will measure them using three questionnaires. Also, because one of the disability questionnaires is relatively new, we want to compare it with the established disability questionnaire we are using, to test how suitable it is to use for PLHIV in regional Australia. The study will recruit 54 volunteers (over 18 years) living with HIV. Disability due to HIV leads to a reduced quality of life, so knowing what difficulties exist will tell us what changes are needed in health and community services to improve their quality of life. Without better understanding of disability and frailty, best services and funding to improve health, function, inclusion in society, and quality of life cannot be provided. This cross-sectional study with a nested reliability and validity study will use quantitative methods of 3 self reported written questionnaires measuring disability and frailty in PLHIV. Recruitment will be conducted at the Sexual Health Service study site. Initially, participants will be recruited through leaflets and posters advertising the study available on notice boards and in reception areas at the study site.

  • Evaluating the impact of using a novel patient prompting document on communication in the surgical outpatient clinic

    Presenting to a surgical outpatient clinic can be a stressful experience for patients. Disparity in education levels, perceived power imbalances and other factors can result in the patient feeling unsatisfied or confused at the completion of the consultation. We propose a randomised controlled study; whereby, the participant is placed into either the intervention group and will receive a pre-designed patient prompting document, or they are placed in the control group. The outpatient consultation will be audio-video recorded. Within 7 days of the consultation the participant will be contacted by telephone to discuss their experience. The purpose is to analyse the utility of a patient prompting document in improving patient understanding, increased patient empowerment and facilitating successful outpatient consultations.

  • Role of Left Bundle Branch (LBB) pacing in heart failure - An Observational Study

    This is a prospective cohort study to observe the efficacy of LBB pacing, a newer pacing modality to the current gold standard of BiVentricular Pacing (BVP). All patients with heart failure and an indication for pacing/CRT will be selected and categorized into two cohorts. Intervention under study cohort - patients who will undergo LBB pacing CRT Comparator cohort - patients who will undergo biventricular pacing CRT It is a multicentre cohort study and those undergoing CRT at two centres - the Canberra hospital and the National capital private hospital will be enrolled. CRT is cornerstone of heart failure management apart from optimal medical treatment. BVP is current gold standard of delivering CRT but LBB pacing is a new modality which recruits conduction system and physiologically depolarises LV and could be more efficacious in improving LVEF, QRS duration and symptoms.. However, literature regarding this is scarce. We aim to compare these two cohorts in terms of primary outcomes including effect on LVEF and QRSd on follow up and secondary outcome including LV end diastolic and end systolic volumes and effect on NYHA class and QoL. The outcome data will help us understanding whether LBB pacing is more efficacious and will support conduction of prospective Randomized Control Trial.

  • Comparing the Effect of Two Prolonged Fasting Protocols on Short-term Outcomes in Healthy Individuals

    This project will carry out a controlled randomised crossover trial, enrolling up to 20 healthy volunteers from ages 18-70 years over the next 3 years. The intervention involves a 3-day water-only fasting, with or without a single bout of glycogen depleting exercise on cycle ergometer. We and others have shown that prolonged fasting, turns on autophagy and proteostatic pathways via up-regulation of several “longevity genes”. However, we do not yet understand the timing and the dose-response of these beneficial cell and metabolic signalling adaptations in humans. The proposed study will determine the effects of a 3-day fast on activation of autophagy and associated stress-resistance pathways, and test the hypothesis that a single bout of exercise enhances this effect. This study is part of an ongoing research effort at the University of Sydney multidisciplinary hub ‘Charles Perkins Centre’ and Sydney Local Health District on healthy ageing and prevention of cardiometabolic diseases.

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