ANZCTR search results

Self-Regulated Learning (SRL) is described as a process whereby learners actively take control of their learning by setting goals, planning, monitoring, evaluating, and adjusting their learning strategies to improve performance and achieve desired outcomes. SRL proficiency has been shown to predict educational success and lifelong outcomes, such as income and health. While SRL is recognized as a key lifelong competency, there remain questions regarding how educators can best develop and promote SRL in school settings. A scalable, low-cost intervention targeted at grade 1 students (6-7 years old) in Germany was found to have substantial effects on impulse control and self-regulated learning, with sustained impacts on long term academic success. This study seeks to adapt the Schunk et al (2022) randomised trial to the Australian content and extend it to grades levels 2, 4 and 6

This study will be a single-site, randomized, controlled, blinded study at the Royal Prince Alfred Hospital to examine changes in High definition-electroencephalogram (HD-EEG) correlates of cognition and consciousness during waking and sedation. Our study will address the neural correlates of consciousness and modulate these neural correlates through low frequency Transcranial alternating current stimulation (tACS).

Since Tinlarebant has not yet been approved, the purpose of this study is to continuously provide Tinlarebant to patients who have completed the 24 months of treatment with Tinlarebant in the previous study (i.e., LBS-008-CT02) with no safety issues.

Epilepsy is one of the most common, complex, and disabling neurological conditions worldwide. Mental health conditions are highly prevalent among people with epilepsy (PWE), with approximately 1 in 3 developing lifetime diagnoses of depression and anxiety disorders. However, there are significant barriers to accessing effective psychological treatment for PWE, including high costs, travel and mobility restrictions, cognitive difficulties (e.g. poor memory), and low involvement of mental health professionals in the routine care of PWE. As a digital mental health intervention, the Wellbeing Neuro Course offers an innovative solution to these barriers and aims to improve access to effective psychological care for adults with epilepsy within the Australian healthcare system. The Course uses the principles of cognitive behaviour therapy and compensatory cognitive rehabilitation to target several domains of mental health and cognitive function, and was designed specifically for people with neurological conditions. Digital mental health can be provided in both clinician-guided and unguided models, each with their own potential strengths and weaknesses. Guided models may be more expensive and complex given that trained clinicians must be recruited, yet previous research suggests they may be more efficacious than unguided models. In contrast, unguided models have more public health potential as they involve lower costs and are easier to implement into routine care settings, but may be less efficacious for those with complex presentations who would benefit from clinician support. The primary aim of this research project is to examine the comparative efficacy, cost-effectiveness, acceptability, safety, and long-term outcomes of the Wellbeing Neuro Couse when delivered under two different models of care (clinician-guided vs. unguided) for PWE experiencing emotional difficulties. The secondary aim of this research is to provide critical data of the characteristics of patient’s response to treatment to inform the wider dissemination of the program, including examination of the demographic and clinical predictors and moderators of treatment acceptability and efficacy. Consistent with previous trials, we hypothesise that: 1. Both the guided and unguided groups will result in substantial improvements in primary outcomes of depression and anxiety compared to the treatment-as-usual waitlist control (TAI-WLC) group. 2. There will be non-inferiority in clinical efficacy between the guided and unguided groups across the primary outcomes. 3. Both the unguided group and guided group will be cost-effective compared to TAU-WLC, but the unguided group will be more cost-effective relative to the guided group due to lower intervention costs.

This is an open-label, non-randomised pilot study to evaluate the safety and infectivity of a Plasmodium knowlesi parasite bank. Up to 4 participants will be enrolled in cohorts of 1 participant each. The monkey parasite Plasmodium knowlesi is an important cause of human malaria in South East Asia. This parasite now accounts for all cases of locally-acquired malaria in Malaysia, and has prevented Malaysia from being able to eliminate malaria. Malaria volunteer infection studies (VIS) have provided key insights into the biology of other causes of human malaria, including P. falciparum, P. vivax and P. malariae, and have provided a model for evaluating antimalarial therapeutics against these species. However, a VIS for P. knowlesi has not been established. Using similar methods utilized for other Plasmodium parasites, we have recently developed a P. knowlesi parasite bank. In this pilot study, we will now evaluate the safety and infectivity of this new P. knowlesi parasite bank in up to 4 healthy human volunteers. This study will provide valuable information on P. knowlesi replication rates, host response to disease, and pharmacodynamic response to artemether-lumefantrine, in addition to establishing a model to evaluate novel antimalarials and vaccines against this emerging parasite.

This will be a phase 1 first-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PTC607 at various doses in healthy volunteers. Participants will be undergo screening for up to 28 days. Eligible participants will then be admitted to an inpatient unit for up to 19 days, where they will be taking study medication as directed by the unit staff and will undergo the following but not limited to procedures: vital sign measurements, physical examinations, collection of blood and urine samples, electrocardiograms. Once discharged from the unit, participants will have a follow up phone call approximately 30 days after the last dose of study drug.

This study aims to explore how whether Restorabite, a device used to assist with stretching of the jaw, can help improve jaw function during radiotherapy for head and neck cancer and whether this has any impact on adherence to head and neck cancer treatment. Who is it for? You may be eligible for this study if you are aged 18 or older, you have a diagnosis of head and neck cancer, and you will be treated using radiotherapy. Study details Participants will be, by chance, provided one of three different treatments [in addition to standard care]: - Group 1: a jaw stretching program using standard stacked tongue depressors - Group 2: a low intensity stretching program using the Restorabite device - Group 3: a high intensity stretching program using the Restorabite device Participants will be asked to complete these jaw stretching exercise daily prior to starting radioatherapy upto 12 months after completing radioatherapy.. Information on jaw function and quality of life will be collected a total of 12 times at different timepoints via phone interviews and in person appointments for 12 months post radiotherapy. It is hoped that this study will be able to show whether Restorabite can be used to improve jaw function and quality of life during radiotherapy treatment for those with head and neck cancer.

The HOPE program is an new online pain management program for people with hypermobile Ehlers-Danlos Syndrome or Hypermobility Spectrum Disorder. This aim of this study is to assess its feasibility, acceptability and effectiveness. We will be comparing the intervention group to a treatment-as-usual group. Outcomes will include online surveys asking about the program's feasibility and acceptability, and interviews with participants in the HOPE program on their experience with it.

We will test a smartphone app that delivers a type of cognitive training designed to reduce impulses to drink alcohol to see if it is an effective intervention for people drinking at harmful levels, but who are not otherwise engaged in treatment for alcohol problems. We will test outcomes including alcohol use, cravings, severity of dependence, quality of life, and cognitive biases. We also aim to determine the cost-effectiveness of the app. We predict that the version of the app that includes the cognitive training will lead to better outcomes than the control versions of the app.

This is a Phase 1, single centre, open-label study to investigate the PK profile, safety and tolerability and pharmacodynamics (PD) of single ascending doses of nicotine administered in single and multiple inhalations via a Miist Nicotine Inhaler in healthy male smokers. Study participants will receive 3 inhaled doses of the investigational nicotine replacement therapy (NRT) product. The doses will be administered via the novel Miist Nicotine Inhaler in increasing order of strength of nicotine, starting from 0.08 mg and increasing to 0.16 mg then 1.15 mg with a 120 minute (+15 minutes) washout period between each dose level.