ANZCTR search results

This project is testing the safety and pharmacokinetics of single and multiple oral doses of a new drug called FP-100. FP-100 is being developed for the treatment of patients with Lyme disease You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 55 years old. In Cohorts 1a through 1f, participants will be randomised (assigned randomly, like flipping a coin) to receive single oral dose(s) of either the active study drug or placebo. In Cohorts 2a through 2c, participants will be randomised (assigned randomly, like flipping a coin) to receive multiple oral dose(s) of either the active study drug or placebo. For subjects in Cohorts 1a, 1b, 1c, 1e and 1f, study participation will require 22 calendar days which will include 4 days (3 nights) in the CRU. For subjects in Cohort 1d, study participation will require 22 calendar days which will include one stay of 7 days (6 nights) in the CRU. For subjects in Cohorts 2a, 2b and 2c, study participation will require 22 calendar days which will include 9 days (8 nights) in the CRU. It is hoped that this research will help determine the safety of FP-100 when given to healthy men or women so that it can be tested in patients with Lyme disease

During continuous renal replacement therapy in critically ill patients with acute kidney injury, electrolyte imbalances, including phosphate imbalances, may occur. Prismocal B22 and Phoxilium® are two routinely used replacement fluids during continuous renal replacement therapy for critically ill patients admitted to the Austin Hospital's Intensive Care Unit. In our 30-patient, single-centre, sbefore-and-after study study, we will investigate whether, compared with Prismocal B22, Phoxilium® replacement fluid achieves higher phosphate levels during continuous renal replacement therapy in critically ill patients with acute kidney injury.

Neurological disorders are the leading cause of disability world-wide. Due to our aging population and population growth, this burden will inevitably increase over time. To add to this burden, our capacity to detect and treat many neurological disorders is hampered not only by gaps in our knowledge but by a lack of appropriate and cost-effective biomarkers to measure and monitor change in function. The study of eye movements is an established and widely used methodology in experimental research, the assessment of eye movements already an integral part of the clinical examination with distinctive eye movements characteristic of almost all neurological conditions. However, eye movements cannot currently be measured with precision outside of the research setting. This research aims to establish the utility of the BrainEye eyetracking application in measuring aberrant function in some of the most common neurological diseases. By measuring simple eye movement parameters in patients with various neurologic conditions we will ascertain WHETHER the application can be used by the individual to self monitor change or by a physician to monitor change in function and adjust or implement treatments at the earliest possible timepoint.

Neuro Optica is an Australian company that has developed a proprietary eye-tracking platform, using an application via a smartphone, to assess brain function (BrainEye). The application is currently categorised as a wellness device (non-medical) and as such does not fall under the Therapeutic Goods Administration as regulated under the Therapeutic Goods Act. Accordingly, fundamental research studies of the application have not been conducted to Good Clinical. Practice (GCP) or ISO 14155 standards. Neuro Optica is now proposing that the device be classified as a low risk SaMD (Class 1 medical device), capable of measuring and analysing ocular movements, although with results used for information only, i.e., not for clinical diagnosis. Although clinical trials are not required to support this proposal, Neuro Optica wish to substantiate its labelling claims to the market by conducting a clinical trial on a small number of participants (n=30), validating its smooth pursuit and pupillary light reflex measures against gold standard device measures. We hypothesis that all BrainEye measures of latency, velocity, amplitude and accuracy will correlate significantly with gold standard device measures.

Eye movements have been used for decades to interrogate neurological function, and we have an extensive understanding of the consequences of a broad range of neurological disorders on eye movements. BrainEye is a smartphone application that uses AI, machine learning, and cloud based technology to record and anlayse the location of the eye in space over time, with a view to providing a snapshot of neurological function in an individual over time. In patients diagnosed with concussion or a mild traumatic brain injury, the BrainEye application will be used to record and measure smooth pursuit eye movements (SMP) and the pupillary light reflex (PLR) as an indication of brain function. Data will be collected at 4 timepoints: firstly within 24 hours of a post concussive event within the emergency department (ED) by an ED occupational therapist, and then 2, 7 and 30 days post event by the individual in his/her own home. Data will include measures of latency, velocity, amplitude and accuracy for both SMP and PLR. From these data BrainEye will determine a concussion algorithm that sensitively identifies and tracks recovery from concussion. We hypothesise that this algorithm will sensitively identify an individual with (a diagnosed) concussion and may assist in monitoring recovery .

Gastric emptying (GE) is believed to be a potential mechanism causing individual differences in insulin requirements. However, the role of GE in personalising diabetes management is not well understood, and feasible ways to assess GE in children with T1D in a clinical setting are needed. This project aims to study GE in adolescents with type 1 diabetes (T1D) to examine the relationship between GE and blood glucose levels (BGLs) after eating a mixed meal, and to determine if continuous glucose monitoring (CGM) can be helpful in identifying rates of individuals GE. Thirteen T1D participants using a hybrid close loop system (HCL) will consume a standard meal, and both GE using the breath test technique, and BGLs will be monitored over the subsequent 4 hours. Changes in glucose levels will be monitored by CGM and regular blood sampling throughout the study. CGM traces will be assessed in its potential to use as a marker of GE. The outcomes will provide important information about GE characteristics in young people with T1D and its potential to optimise current strategies of insulin delivery.

The Methylphenidate in Children with ADHD+Autism (MICAA) Trial will use N-of-1 trial methodology to individually test the effectiveness of MPH-IR in ~40 children (aged 6-15 years) with ADHD+autism. Participants will include children who have been taking a stable dose of MPH-IR for at least one month prior to trial enrollment. The children will cycle through 12 randomised weekly periods of “on” (MPH-IR) or “off” (placebo) medication, with allocation concealment. There will be weekly monitoring of primary outcomes (ADHD symptoms), and secondary outcomes, including autistic traits, functional behaviour, emotion regulation, anxiety and medication side effects. Study findings will identify those children who are not responding to their prescribed medication, prompting a review of treatment decisions.

Anorexia nervosa (AN) is a serious psychiatric condition with high morbidity and mortality, for which existing treatment paradigms demonstrate suboptimal therapeutic efficacy and duration of treatment effect. Through the repeated application of focussed electromagnetic energy, Repetitive Transcranial Magnetic Stimulation (rTMS) can modulate cortical neural activity and connectivity downstream, along the brain circuits that the cortical target is connected to. rTMS has the added benefits of being non-invasive, has high degrees of patient acceptance and tolerability, as well as being relatively economical to apply. As an evidence-based treatment for depression, rTMS has received little research attention in AN. Clinical trials to date indicate therapeutic optimism, particularly in relation to subjective anorexia-related experiences and comorbid mood, anxiety, stress, and quality of life symptoms. This study protocol proposes the conduct of a single-site, proof-of-concept, open-label trial to evaluate if this individualised rTMS targeting and stimulation approach is effective in improving the low body mass and psychological symptoms in anorexia nervosa from baseline to the end of week 4, and the durability of these effects at 6- and 12-month follow-up.

This study aims to investigate the feasibility of utilising a smartphone app (Oto) in tinnitus management as determined by trial acceptability, deliverability, and effectiveness. Oto is a novel multimodal app-delivered approach to tinnitus available for iOS and Android. It combines patient education, cognitive behavioural therapy (CBT), relaxation, mindfulness, and sound therapy in a customisable package. Oto has received Medicines and Healthcare products Regulatory Agency (MRHA) certification as a Class 1 medical device in the UK. We hypothesise that the utilisation of Oto in tinnitus management is feasible and deliverable. This study will also test the hypothesis that the use of Oto will significantly reduce tinnitus severity compared to receiving no tinnitus intervention.

This prospective comparative trial embedded in population-based screening, at Maroondah BreastScreen, Eastern Health, will examine screening outcomes of hybrid digital breast tomosynthesis/mammography compared to digital mammography screening (standard of care) in women presenting for routine breast screening. Who is it for? You may be eligible to join this study if you are a woman aged 40 years or above and are attending a BreastScreen service at Maroondah BreastScreen. Study details Current standard of care for breast screening is bilateral two-view (MLO and CC) digital mammography screening which represents 2-dimensional (2D) imaging. Intervention in this study is digital breast tomosynthesis (DBT, quasi-3D-mammography) acquisition for the MLO view only (2D-mammography images will be reconstructed from the DBT to provide synthetic 2D). Standard digital mammography will be acquired for the CC-view. This is referred to as ‘hybrid tomosynthesis/mammography’ screening or the ‘intervention screen’ in this trial. Other aspects of screening and assessment, and any required follow-up, will be based on standard BreastScreen protocols and quality assurance processes. The trial will assess initial detection measures (cancer detection, and recall for further testing) as well as outcomes at follow-up (to determine interval cancer rates).