ANZCTR search results

A) Aims and Objectives This project aims to investigate the role of the neurotransmitter dopamine in complex decision making, and how three prescription stimulant medications that modulate dopamine levels in the brain in slightly different ways can affect the quality of complex decision making. These medications (dextroamphetamine, methylphenidate and modafinil) are increasingly used by healthy people for non-medical, cognitive enhancement purposes, however their effects on basic cognition are often found to be inconsistent, and their effects on more naturalistic, complex optimisation behaviours are not known. B) Key Question(s) Do stimulant medications, that increase dopamine in the brain, enhance, or have a deleterious effect, on the completion of a complex decision making task. More specifically do they; * Affect the amount of time taken to solve a problem? * Increase or decrease the likelihood that a participant will find the correct solution to the problem (the computational performance)? * Increase or decrease the computational distance between the participant’s solution and the correct solution (the economic performance)? * Affect the variety of search paths that participants take through the space of possible solutions? C) Research Design This study will utilize a double-blinded placebo-controlled crossover design. We will recruit 32 healthy participants with no history of neurological, psychiatric or heart conditions. Each one will participate in an initial assessment session and four testing sessions, each at least one week apart to allow for pharmaceutical washout. At each session, the participant will receive either a single dose of the three pharmaceuticals or the placebo. After a 90-minute waiting period, during which the participant fills out number of demographic and personality surveys, the participant will complete a series of computerised complex optimisation tasks and basic cognition tasks. Data collected includes the sequence and timing of the selection of items for each task solution, key variables from the more basic cognitive tasks and the answers to the survey questions.

Q-122 is being developed by QUE Oncology as a treatment for vasomotor symptoms (hot flashes) in female breast cancer patients/survivors. Q-122 has been studied in three Phase 1 clinical trials in cancer patients, healthy volunteers, and breast cancer survivors taking anti-estrogen therapy who were experiencing VMS. This study is designed to determine the effect of food on Q-122 pharmacokinetic (PK) parameters (Part 1) and PK parameters following a once daily or twice daily dosing regimen.

The main purpose of this study is to determine whether or not patients that are treated by spinal cord stimulation have the same or different treatment outcomes as patients that undergo spinal fusion in a group of patients that have received no treatment in the past for chronic low back pain. The outcomes are measured by pain scores, depression, anxiety and stress scores, patient impression of change, patient functionality, health outcomes assessments and disability scores. The patients' belief in the efficacy of the treatment will also be collected. There is also an aspect of the study that will look at whether spinal cord stimulation in conjunction with spinal fusion leads to better patient outcomes. Eligible subjects will be randomised to either the spinal cord stimulation arm or the fusion arm. Subjects randomised to the spinal cord stimulation arm will undergo an initial spinal cord stimulation trial. If this trial is positive (relieves pain by at least 50%), the subject will then be offered a spinal cord implant. If the trial is not positive, the subject will be withdrawn from the study and offered spinal fusion. If the implant is positive (pain relief of at least 50% is maintained) 6 months post implant, a subject will be followed for a further 12 months. If the implant is negative, the subject will be offered spinal fusion. Outcomes of the fusion will be assessed 6 months after surgery. If the fusion is positive (pain relief of at least 50% is maintained), the subject will be followed for a further 12 months. If the fusion is negative, the subject will be offered reactivation of the spinal cord stimulator. The subject will then be followed for 18 months post reactivation. Subjects randomised to the spinal fusion arm will be assessed 6 months post procedure. If the spinal fusion is positive (pain relief of at least 50% is maintained) , subjects will be followed for a further 12 months. If the spinal fusion is negative, subjects will then be offered a spinal cord stimulation trial. If this trial is positive (at least 50% of pain relief is obtained), subjects will be offered a spinal cord stimulation implant. Subjects will be followed for 18 months post implant (whether positive or negative). If the spinal cord stimulation trial is negative, subjects will be followed for 18 months post the spinal fusion procedure.

The purpose of this study is to determine whether baseline cognitive screening tests, Montreal Cognitive Assessment (MoCA), Addenbrooke’s Cognitive Assessment-III (ACE-III), Oral Trail Making Test-B (oTMT-B), reliable Digit Span predict functional outcomes in patients following a traumatic brain injury and whether they correlate with neuropsychological testing. In addition, the study aimed to determine the accuracy and validity of baseline cognitive screening tests in the detection of those patients with cognitive impairment on neuropsychological testing.

This randomised controlled trial seeks to compare the adherence rates and efficacy of internet-delivered cognitive behavioural therapy and internet-delivered mindfulness skills training for the treatment of adult depression and anxiety disorders immediately following treatment and at 6-month follow-up.

Delirium is an acute confusional state that is a medical emergency and is associated with significant morbidity and mortality. Delirium can often disrupt the times when someone is sleeping or awake. Although the main management of delirium is based on treatment of the underlying causes, specific medications are sometimes necessary to manage delirium-related behaviours. These interventions include the use of sedating medications that are associated with an increased risk of substantial harm. Melatonin is a natural-occurring substance made in the brain that helps regulate the timing of sleep and wakefulness. It is a well-established treatment for insomnia, has a good safety profile and has a potential theoretical benefit in the management of delirium by correcting the sleep-wake cycle disruption commonly seen in delirium. Although it has been used to manage delirium in hospitals around the world for some years, there have been no scientific trials to examine its effectiveness. Melatonin is approved in Australia to treat insomnia. However it is not approved to manage delirium. Therefore, it is an experimental treatment for delirium. This means that it must be tested to see if it is an effective treatment for delirium. This study aims to examine the effect of melatonin on delirium.

Introduction: This study aimed to measure the prevalence of dehydration and diuretic use in older patients presenting to the Emergency Department of a large metropolitan hospital with falls. Materials and Methods: Subjects were recruited as a convenience sample from all patients aged over sixty years presenting with falls. The mean age of the 204 recruits was 81 years and 65% were female. Demographic, clinical, medication and falls information were collected on admission and the subjects were classified as either robust (101 subjects) or frail (103 subjects) utilising the Edmonton Frail Scale. Results and Conclusions: Compared to robust subjects, frail fallers were more likely to use diuretics (34% frail, 14% robust, p=0.001), to be dehydrated (20% frail, 7% robust, p=0.001) and to have both diuretic use and dehydration (13%, 3% robust, p=0.01). These findings suggest that dehydration, potentially exacerbated by diuretic use, is common amongst older patients admitted after a fall, particularly amongst the frail. These two factors, in the frail elderly in particular, merit further study as potentially modifiable causes of falls.

This is a randomised, parallel, open-label study for patients with hypertension, conducted by George Medicines. Ethical approval has been sought in November 2017, shortly followed by regulatory acknowledgement. This research project aims to understand whether a single pill containing 3 types of blood pressure lowering medications at quarter-standard doses will more effectively lower blood pressure and have fewer side effects compared to a standard dose of a single type of hypertensive medication. This research project will assess two different pill combinations for the treatment of high blood pressure, they are: • Ultra-low dose: telmisartan (10 mg), amlodipine (1.25 mg), and indapamide (0.625 mg) • Low-dose: losartan (25 mg), amlodipine (2.5 mg), and hydrochlorothiazide (12.5 mg)

The burden of end stage kidney disease is growing globally. Much of this growth since the turn of the century has been in elderly patients, a group in whom the outcomes from both dialysis and non-dialysis treatments are poor. Optimal therapy for these older patients with end stage kidney disease is not clear and practice varies widely. Recent literature shows high mortality rates in older patients receiving dialysis, with an average mortality of 27% in the first year. Data on the outcomes from non-dialysis treatment, usually referred to as supportive care, is much less clear. This is because: • There are no registries of patients receiving supporting care • It is difficult to define a clear start-in point for supportive care, as opposed to dialysis initiation • Dialysis patient groups compared to supportive care patients have large differences in co-morbidities • There is crossover between the two patient pathways The only effective way to better understand the effects of the dialysis and the supportive care treatment approaches is to randomly apply the treatments in a clinical trial. This approach allows the issues of lead-time bias, residual confounding and cross-over to be eliminated or managed, thereby producing findings of the highest clinical and scientific value. It is the view of the investigators of the DISCERN Trial that, where clinicians and patients have equipoise around the relative benefits and risks of dialysis and supportive care, to randomly allocate patients to either of these treatment approaches is an appropriate and ethical approach. In a setting for scarce healthcare resources, understanding this balance arising from a resource-intensive treatment such as dialysis is the appropriate path to guide resource allocation. Objectives: The primary null hypothesis of the DISCERN study is that, in highly co-morbid patients aged over 75 years with stage 5 chronic kidney disease, medical management including maintenance dialysis compared to medical treatment alone is associated with no differences in the outcome of mortality. Secondary null hypotheses will examine the effect of the same comparison upon the outcomes of quality of life, burden of hospitalisation and cost-effectiveness. Study Design: The DISCERN study is a randomised, controlled trial with blinding of outcome assessment. Participants will be randomised on a 1:1 basis to the two study arms: Medical treatment with maintenance dialysis, OR medical treatment (with no maintenance dialysis).

People with dementia often experience difficulty in recognising the emotions of other people, such as fear, anger and sadness. This can impact upon relationships and social interactions thus causing distress for the individual living with dementia as well as for family members and friends. This study investigates whether a naturally occurring hormone in the body, oxytocin, can help people with Alzheimer's disease and/or Vascular dementia recognise the emotions of other people better. It is hypothesised that patients who receive the oxytocin nasal spray will demonstrate improved accuracy of emotion recognition, following a single dose and repeated administration over one week. Furthermore, it is also hypothesised carers of patients who receive the oxytocin nasal spray will report improved interactions and reduced caregiver burden.