ANZCTR search results

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.

This pilot cluster randomised controlled trial (CRCT) will examine the use of smoking cessation training and the dissemination of cessation resources by participating Health Professionals (HPs). In addition, surveys of Aboriginal patients will seek to understand their experience and feelings following their smoking cessation counselling from trained HPs. Health Professionals consult with large numbers of patients each year and are perceived as influential sources of information for smoking cessation (Zwar et al., 2009). The literature shows that individual counselling from smoking cessation specialists increases the chances of successful abstinence compared with less intensive support (Fiore et al., 2008, Lancaster and Stead, 2008). This is supported by a Cochrane meta-analysis, where the Coordinating Primary Investigator (CPI) identified that even training of short duration (a one-off session of 2-3 hours) can have substantial implications for quit attempts amongst patients of HPs (Carson et al., 2012, & unpublished data). Furthermore, research articles report that training HPs in smoking cessation counselling programs enhances the knowledge, skills and confidence required to deliver optimal smoking cessation advice and support to patients (Carson et al., 2012). Essentially, smokers are more likely to quit if asked, and HPs are more likely to ask if trained. This project contains a pilot CRCT to assess impact of the ‘Kick the Smokes’ culturally safe smoking cessation training and resources on Health Professional practices. This CRCT itself is nested within a larger feasibility study to determine whether the method developed can be upscaled in to a larger full-scale CRCT

To investigate the acute effect of the UnderCool 2.0 cooling vest during high-intensity exercise in a heat sensitive MS population on; i) body temperatures and sweating, ii) feelings of exertion and hotness, iii) MS symptoms that are aggravated by heat, and iv) Concealability, comfort and functionality. With a controlled, cross-over design, 20 participants diagnosed with MS will complete four high-intensity interval cycling sessions on separate days including familiarisation and three experimental trials with participants wearing either; i) an UnderCool 2.0 cooling vest, ii) a CryoVest Comfort cooling vest (current evidence-informed practice), or iii) no vest. The exercise sessions will be high-intensity interval cycling sessions of 45 minutes in controlled conditions (22°C, 40% relative humidity). Exercise intensities will be standardised across all trials. It is hypothesised that compared to control, during high-intensity exercise, the UnderCool 2.0 cooling vest will: 1) Attenuate the increase in gastrointestinal temperature, mean skin temperature, sweat rate and heart rate 2) Attenuate the increase in perceived exertion, thermal discomfort and thermal sensation, and 3) Reduce perceptions of fatigue, pain, difficulty concentrating and urinary urgency It is further hypothesised that compared to the CryoVest Comfort, during high-intensity exercise, the UnderCool 2.0 cooling vest will: 4) Improve perceptions of concealability, comfort, functionality and intention to use 5) Similarly attenuate the increase in gastrointestinal temperature, mean skin temperature, sweat rate and heart rate 6) Similarly attenuate the increase in perceived exertion, thermal discomfort and thermal sensation, and 7) Similarly reduce perceptions of fatigue, pain, difficulty concentrating and urinary urgency

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of durvalumab plus chemotherapy in patients with with extra-pulmonary small cell carcinoma. Who is it for? You may be eligible to join the study if you are aged 18 years and older and have recently been diagnosed with extra-pulmonary small cell carcinoma. Study details Participants will receive durvalumab and chemotherapy. Durvalumab is given by infusion every three weeks, and chemotherapy will be given by infusion every three weeks for the first 4 doses. After the combination completes, you will receive durvalumab every 4 weeks, for as long as you are tolerating the treatment well and the cancer is under control. Participants will undergo clinical assessments at 3-4 weekly intervals from first treatment until end of treatment. Safety and tolerability of treatment will be assessed at 3-4 weekly intervals. Health related quality of life during treatment will be assessed at 3-4 weekly intervals while on treatment and then every 8 weeks after end of treatment until progression. We cannot guarantee that participants will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that durvalumab and chemotherapy will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.