ANZCTR search results

Acute severe behavioural disturbance (ASBD) is an emergency situation where a patient experiences severe agitation or aggression. One of the common strategies used to manage those presenting to the emergency department (ED) with ASBD is the provision of medications. Medications assist in allowing the young person to gain control over their behaviour. In most instances, oral medications are used. For a small proportion of young people with ASBD, their emotional dysregulation is so extreme that they are unable or unwilling to accept oral medication and, therefore, IM medication is required to de-escalate their behaviour. In individuals less than 18 years of age, there is no evidence available to guide doctors about which medications are the most effective, despite them being commonly used to manage ASBD. It is also not known how well these medications are tolerated by young people. Therefore, the primary aim of this study is to determine whether, in children and adolescents with ASBD, IM olanzapine is more effective than IM droperidol at achieving successful sedation (i.e.: a state of calm) at 1 hour after randomisation. These medications were chosen as they are the two of the most commonly used medications in Australia. This study will be a randomised, open label, multi-centre effectiveness trial which will enrol young people aged 9 to 17 and 364 days presenting to participating EDs with ASBD. We hope to determine which medication is most effective and to assess the side effects of these medications. We hypothesise that 15% more children will achieve successful sedation 1 hour after randomisation to olanzapine compared to those children who were randomised to droperidol.

When hospitalised, patients with infective pulmonology often require some form of breathing support: oxygen administered using different delivery modes (nasal prongs, high flow nasal cannula, The currently limited data suggests that each of these strategies increase the spread of exhaled droplets, with the distance and direction-dependent upon the specific strategy, resulting in an increased viral transmission risk if this patient is still infective. Therefore, it is necessary to determine droplet spread from human patients with each of the respiratory support strategies administered to patients with a viral infection, so that protective measures can be adapted accordingly to protect staff and other patients in the hospital. We hypothesise that the administration of respiratory support will increase the number of detected respiratory aerosol particles detected around the study subject.

Acute severe behavioural disturbance (ASBD) is an emergency situation where a patient experiences severe agitation or aggression. One of the common strategies used to manage those presenting to the emergency department (ED) with ASBD is the provision of medications. Medications assist in allowing the young person to gain control over their behaviour. In most instances, oral medications are used. In individuals less than 18 years of age, there is no evidence available to guide doctors about which medications are the most efficacious, despite them being commonly used to manage ASBD. It is also not known how well these medications are tolerated by young people. Therefore, the primary aim of this study is to determine whether, in children and adolescents with ASBD, oral olanzapine is more effective than oral diazepam at achieving successful sedation (i.e.: a state of calm) at 1 hour after randomisation. These medications were chosen as they are the two most commonly used medication in Australia. This study will be a randomised, open label, multi-centre effectiveness trial which will enrol young people aged 9 to 17 and 364 days presenting to participating EDs with ASBD. We hope to determine which medication is most effective and to assess the side effects of these medications. We hypothesise that 15% more children will achieve successful sedation 1 hour after randomisation to olanzapine compared to those children who were randomised to diazepam.

This Phase 1a study will be a randomized, placebo-controlled, double-blind, single-center, ascending dose, first in human trial of an inhaled antibody vs. placebo in normal, healthy volunteer (NHV) men and women. The study will assess safety and pharmacokinetics, in initial single ascending doses (SAD) portion, followed by a multiple dose cohort..

The unprecedented rise in synthetic drugs, many containing unknown toxic agents, has made timely analytical diagnosis more difficult, and has reduced the confidence of clinicians providing Emergency Department (ED) management to this population of patients. This has also impacted the quality of evidence informing harm reduction responses. The Emerging Drugs Network of Australia (EDNA) brings together emergency physicians, toxicologists and forensic laboratories to establish a national system of surveillance and reporting of illicit and emerging drugs causing acute toxicity. EDNA will improve coordination between clinicians and analytical services by way of its standardised approach to surveillance and reporting. Blood analysis of intoxicated patients will be conducted by forensic laboratories to enable precise identification of the substances causing acute toxicity. This will be linked with clinical data collected at the time of ED presentation to enable analysis of the clinical effects and outcomes associated with different illicit and emerging drugs. Standardisation of data collection recorded in a national clinical registry will provide more robust data on epidemiology and associated harms. This will facilitate the translation of clinical and toxicological evidence into timely, appropriate harm reduction and policy.

Lennox-Gastaut syndrome (LGS) is a treatment-resistant form of childhood-onset generalised epilepsy, defined by multiple seizure types including tonic seizures, specific EEG abnormalities, and cognitive impairment. Anti-seizure medications are only partially effective and resective surgery is rarely an option, meaning new treatment approaches are needed. Deep brain stimulation (DBS) is an emerging treatment for drug-resistant epilepsies, which aims to modulate neuronal excitability across the distributed networks that underpin generalised epilepsies. Prior uncontrolled studies have reported seizure reductions following Deep Brain Stimulation (DBS) in patients with Lennox-Gastaut syndrome (LGS), but data from randomised controlled studies are lacking. We aimed to formally assess the efficacy and safety of DBS to the centromedian thalamic nucleus (CM) for treatment of LGS. Electrical Stimulation of the Thalamus for Epilepsy of Lennox-Gastaut Phenotype (ESTEL) is the first randomised, double-blind, controlled study to evaluate the efficacy and safety of CM-DBS in a carefully characterised group of young adults with LGS. Due to the poor correlation between diary seizure counts and objective seizure frequencies, we also measure electrographic seizures (on 24-hour ambulatory EEG) at key timepoints (baseline, post-implantation/pre-stimulation, and post-stimulation. We perform cognitive assessments at these same timepoints and report safety outcomes in the 20 participants. We hypothesise that the proportion of participants with a 50% or greater reduction in seizures will be higher in those receiving 3-months of CM-DBS, compared to control participants (i.e., no stimulation).

This study aims to investigate the use of newly developed magnetic resonance imaging (MRI) prototype sequences (different settings on the MRI scanner that results in different image appearances) to be used in parallel with standard MRI sequences to compare the usability and potential benefits for cancer patients undergoing radiotherapy treatment. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with any type of cancer and you are receiving radiotherapy that requires a MRI scan for radiotherapy treatment planning purposes. Study details Participants who agree to enroll in this study will be asked to undergo additional MRI sequence(s) on top of the standard MRI sequences that are part of their regular radiotherapy treatment. Your doctor will review and discuss with you whether additional MRI sequence(s) will be of benefit to the planning of your radiotherapy treatment. If this is the case a maximum of 15minutes may be added to your standard radiotherapy planning MRI scan to allow these sequences to be obtained. It is hoped this research will allow engineers to further refine and design more specialised MRI sequences that will allow clinicians to improve personalised care for cancer patients who are undergoing radiotherapy.

The purpose of this study is to determine incidence and clinical outcomes of KRASG12C mutated advanced non-small cell lung cancer patients in Australian cancer therapy centres. Who is it for You may be eligible for this study if you, were diagnosed with advanced NSCLC with the presence of a KRAS G12C mutation between Jan 2018 and Dec 201 , and are a patient at one of the participating sites. Study Details Participants in this study will continue to receive routine clinical care, which will not be impacted by involvement in this study. Enrolled participants will have clinical data collected from one time point from their medical record. Data captured will include patient characteristics, disease characteristics, surgical and or drug treatments administered, survival, and treatment outcomes. Data will be collected at a single point by study personnel from the patient medical record. This study aims to help Oncologist better understand the incidence, demographics, disease characteristics and survival outcomes of KRASG12C mutated advanced NSCLC in Australia. This may ultimately lead to improved standard of care practices which will improve patient outcomes.

This project will evaluate the feasibility of the use of a mobile health application (mHealth app) as an effective secondary prevention program for people in remote and rural Queensland who have experienced a cardiovascular event. This study will evaluate feasibility of methods and procedures for a large trial, using pre-defined criteria for recruitment (>80% approached recruited), retention (>80% participants complete study phases), protocol fidelity (>90% of participants receive allocated intervention for entire study). This study will provide information on the resources and management required for a larger efficacy RCT. Secondary prevention outcomes (i.e., depression, quality of life, cardiovascular clinical and lifestyle risk factors, functional capacity, & medication adherence) will be collected. Participants will be randomised to receive either standard care (nurse telephone follow-up and referral to secondary prevention program 8-12 weeks), or the mHealth program (mHealth app [includes weekly nurse mentoring] & standard care). Approximately 60 participants will be recruited to the study.

The purpose of this phase I open-label safety trial is to assess the safety of a traditional Chinese medicine (TCM) herbal formula, containing Alisma orientale, Prunus armeniaca, Cyperus rotundus and Atractylodes macrocephala, in healthy adults aged 18-60 years old. Twenty participants will be recruited, 10 will receive 1 capsule per day, 10 will receive 2 capsules per day for a 15 day period. We hypothesize that the TCM herbal formula is safe and will not cause serious side effects.