ANZCTR search results

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 If the trial is not positive, the subject will be withdrawn from the study and offered spinal fusion.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.

This is a trial of a capacity building program to build the self-efficacy of Early Childhood Intervention Service staff (known as key workers) to support parental mental wellbeing and therefore their own wellbeing. Strategies to improve the mental health of parents of children with a disability are urgently needed, and are timely given the current rollout of the National Disability Insurance Scheme (NDIS) in Australia. This program is needed to break the vicious cycle of poor mental health in parents of children with a disability that leads to poorer short and long term outcomes for themselves, their child and their family. Staff will receive the program as part of organisational change to improve both parent and staff mental wellbeing. Applying a capacity building framework and assessing changes in self-efficacy of professionals this program was developed to not only benefit the wellbeing of parents of children with a disability but also the wellbeing of their Key Workers.

Surgical site infections are recognised as a common surgical complication, and the use of antibiotic prophylaxis has become an important method of reducing the risk of infection. However, given increasing concerns regarding antibiotic resistance, it is important that the use of antibiotic prophylaxis be evidence based. Local and international guidelines attempt to aid clinicians by outlining the evidence available for prophylaxis for various gynaecological procedures. The current Australian Therapeutic Guidelines recommend antibiotic prophylaxis for hysterectomy, termination of pregnancy and caesarean delivery, with no specific reference to non-hysterectomy complex laparoscopic procedures. Although anaphylactic reactions to cephalosporins are reported to be rare (0.001 to 0.1%), skin reactions such as urticaria, rash, exanthem and pruritis occur in 1-3% of patients. Other reported reactions include serum-sickness-like reaction, fever and immunohematologic reactions. Additionally, the potential costs of antibiotic resistance mean all clinicians have a heightened responsibility to ensure administration of antibiotics is for appropriate indications. Medicare data shows that at least 25000 non-hysterectomy, operative laparoscopic gynaecological procedures were performed in Australia last year. In view of the frequency with which such surgery is performed, there is a clear need for an appropriately powered study to examine whether there is a role for antibiotic prophylaxis for non-hysterectomy laparoscopic surgery in gynaecology. To ensure this a study of this magnitude can be carried out correctly, it is essential to perform this pilot study to assess the feasibility of future studies. Given the potential costs to both patients and the health-care system of post-operative infectious morbidity, as well as the costs of using antibiotics, including the actual cost of drug administration, adverse reactions in individual patients, and potential increases in antibiotic resistance, the results of this study have the potential to significantly impact both local and international policy in this area.