ANZCTR search results

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.

The purpose of this study is to evaluate whether strength or balance exercises leads to greater improvements in outcomes in patients who complete a 6-week falls and balance program in outpatient setting at St John of God Berwick Hospital. We hypothesised that both interventions will reduce risk of falling and improve quality of life.

Theta tACS is a potentially efficacious treatment for depression that warrants development. However, there are inconsistent findings in the tACS literature making the optimal selection of stimulation parameters challenging. In our proposed research, we aim to explore several tACS protocols to identify an optimal procedure that can be used to modify theta activity. We aim to explore 2 stimulation approaches to modify theta oscillations (as well as mood and performance on working memory task to explore behavioural correlates of changes in theta activity) in healthy individuals. Specifically, we aim to investigate whether theta-tACS produces greater effects when applied at individualised theta frequency (i.e., matched-ITF tACS) or at 1Hz below the ITF (offset-ITF tACS) with both compared to a sham tACS condition. We will investigate effects on theta power, working memory and mood. We hypothesise that: 1.Matched-ITF tACS will increase theta power to a greater degree than offset-ITF tACS and sham tACS 2.Matched-ITF tACS will increase working memory to a greater degree than offset-ITF tACS and sham tACS 3.Matched-ITF tACS will transiently increase positive mood to a greater degree than offset-ITF tACS and sham tACS

We will establish a person-centred approach to health service monitoring in aphasia services. Our team has developed a minimum aphasia dataset in partnership with stroke survivors with aphasia, their families, clinicians, and researchers. We will evaluate its implementation using a prospective, multi-centre, observational cohort study and a mixed-methods process evaluation.

Very few studies have investigated the use of Assisted Reproductive Technology (ART), such as in vitro fertilization (IVF), in multiple sclerosis (MS) or Neuromyelitis optica spectrum disorders (NMOSD). This study will provide a comprehensive overview of ART use in women with MS or NMOSD and look at if ART affects disease activity, if MS or NMOSD affects a woman's ability to fall pregnant through ART. Additionally we plan to evaluate blood based tests that might be able to predict both ART success or increased disease activity in women with MS or NMOSD while using ART.