ANZCTR search results

Update This study aims to assess if dexamethasone influences the development of symptoms, if any during stereotactic radiotherapy (SRT) to brain metastases. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have 1-5 brain metastases with at least one lesion planned for SRT, and not on dexamethasone for at least 7 days prior to SRT. Study details: There are no clear guidelines on who would benefit from prophylactic (ie. as a precaution before any symptoms develop) dexamethasone during SRT to brain metastases. Some clinicians may choose to prescribe prophylactic dexamethasone to prevent or minimize any local swelling during radiotherapy. Others may not, as not all patients will develop symptoms. To evaluate this, we are randomising patients to having 4 mg oral dexamethasone (on days of SRT and 1 day after) or placebo. We are also studying the effect of treatment on patient’s quality of life. It is hypothesised that patients in the placebo arm may develop symptoms following SRT. The results of the study will guide clinicians whether prophylactic dexamethasone is beneficial in a selected group of patients having stereotactic radiation for brain metastases.

This study aims to evaluate the effects of an individually-tailored web-based parenting program on parenting behaviours associated with adolescent depression and anxiety disorders. The program is designed to provide parents with (1) personalised feedback about their current parenting, including what they are doing well and areas that they can improve in order to reduce their teenager’s risk of depression and anxiety, and (2) specific modules of the web-based parenting intervention recommended based on their survey responses to support them in making changes to identified areas for improvement in their parenting. We aim to find out whether this program can help improve parenting behaviours associated with adolescent depression and anxiety, and in turn reduce risk of depression and anxiety in teenagers.

Insulin therapy for people with Type 1 Diabetes has the risk of hypoglycaemia when insulin administration is in excess of their requirements. This hypoglycaemia is a major contributor in the failure to achieve glycaemic targets in Type 1 Diabetes. The Investigational Device is a non-invasive device designed to detect warning signs of hypoglycaemia. The device consists of a wrist band connected by a flexible wire to a ring. Parameters monitored by this device include wrist and finger tremor and temperature. The study aims to collect overnight exploratory data regarding the relationship of the above parameters to hypoglycaemia. Having a device that has the potential to provide an early warning of impending hypoglycaemia may have a positive impact upon the wellbeing of the person with Type 1 Diabetes.

Psychological injury is a common outcome following a motor vehicle crash (MVC) and the claims process can result in further deterioration of mental, social and physical health. The provision of brief psychological or healthy lifestyle interventions soon after people who have experienced an MVC and who engage in the compensation scheme should improve wellbeing by reducing risks of psychological and physical distress. Improved wellbeing should also result in reduced scheme costs, for instance, by preventing the development of severe psychological injury and enhancing return to normal daily functioning. This Project will investigate the efficacy, using a randomised control trial design, of two email-delivered interventions designed to improve and maintain physical health and strengthen mental health. It is hypothesised that participants receiving one of the two brief interventions will exhibit less psychological distress compared to control particpants 6 months after the road accident.

Healthcare associated infections (HAI) are a major cause of avoidable costs, morbidity and deaths among hospital patients. In Australia 200,000 cases of HAI arise each year and 1.9 million hospital bed days are diverted to treat them. Reducing important HAI requires multiple evidence-based approaches. This study will evaluate the effectiveness and cost-effectiveness of improving environmental cleaning, using an evidence-based bundle, to reduce HAI.

The aim of this study is to evaluate the safety and efficacy of two herbal formulations in reducing menopausal symptoms in otherwise healthy women. Participants will be enrolled in the study between September 2014 and October 2015 and provided treatment for 3 months. All participants are provided with the treatment pack – which includes the product (active intervention 1, active intervention 2 or placebo), a daily symptom diary and a pre-prepared QML pathology form for safety profiling and hormone assessment. Participants take the medication daily and complete the symptom diary daily for 1 week/month. At month 1 and month 2, a telephone interview is conducted to confirm compliance and complete the QOL questionnaires. At month 3, participants repeat the blood test at a QML collection centre and they return to the clinic for final assessment. There will be regular communication with all participants during the study. There will be supervision of the trial by a qualified Medical Practitioner / Endocrinologist, A/Prof Warrick Inder who will monitor any adverse events associated with the trial.

The primary purpose of this study was to determine the concentrations of the drug paracetamol in the plasma and cerebrospinal fluid after intravenous and oral administration to adult patients having surgery under spinal anaesthesia.

Labour is perhaps the most hazardous time in pregnancy for the fetus. Uterine contractions can contribute to more than a halving of blood flow to the uterus and placenta and this in turn may lead to fetal distress. In most pregnancies, the placental blood supply and function is adequate but it may not be sufficient to tolerate the extra demands of labour. Up to 63% of babies who become distressed and suffer oxygen deprivation in labour have no prior risk factors. Furthermore, events in labour account for as many as 20% of cases of cerebral palsy in term infants. Recent research demonstrates that the changes in blood flow to the fetus can be detected by ultrasound and that these changes are highly predictive of identifying fetuses at risk of becoming distressed in labour, as well as reliably excluding those that were not at risk. With this in mind, investigating ways to preserve and promote the blood supply and in turn, the oxygenation to the fetus has the potential to significantly change intrapartum care. Sildenafil is a vasodilator (opens blood vessels) and based on previous research may play a role in enhancing blood flow to the fetus. This clinical trial will investigate if having sildenafil in labour improves the blood flow to the fetus and reduces the need for emergency operative delivery (either caesarean section or operative vaginal birth) for fetal distress.

Background: Postoperative complications and delayed physical recovery are significant problems following emergency abdominal surgery. Physiotherapy aims to aid recovery and prevent complications in the acute phase after surgery and is commonplace in most first-world hospitals. Despite ubiquitous service provision, no well-designed, adequately-powered, parallel-group, randomised controlled trial has investigated the effect of physiotherapy on the incidence of respiratory complications, paralytic ileus, rate of physical recovery, ongoing need for formal sub-acute rehabilitation, hospital length of stay, health-related quality of life, and mortality following emergency abdominal surgery. We hypothesise that an enhanced physiotherapy care package of additional education, breathing exercises, and early rehabilitation prevents postoperative complications and improves physical recovery following emergency abdominal surgery compared to standard-care alone. Methods: The Incidence of Complications following Emergency Abdominal surgery: Get Exercising (ICEAGE) trial is a pragmatic, investigator-initiated, multicentre, patient and assessor-blinded, parallel-group, active-placebo controlled randomised trial, powered for superiority. ICEAGE will compare standard-care physiotherapy to an enhanced physiotherapy care package in 288 participants admitted for emergency abdominal surgery at three Australian hospitals. Participants will be randomised using concealed allocation to receive either standard-care physiotherapy (education, single session of coached breathing exercises, and daily early ambulation for 15-minutes), or an enhanced physiotherapy care package (education, twice daily coached breathing exercises for a minimum two days, and at least 30-minutes of daily supervised early rehabilitation for at least five postoperative days). The primary outcome is respiratory complications during the first seven postoperative hospital days assessed daily with standardised diagnostic criteria. Secondary outcomes include referral for sub-acute rehabilitation services, discharge destination, paralytic ileus, hospital length of stay and costs, intensive care unit utilisation, 90-day patient-reported complications and health-related quality of life and physical capacity, and mortality at 30-days and at one year following surgery. Discussion: The morbidity, mortality, and fiscal burdens following emergency abdominal surgery are some of the worst within surgery. Physiotherapy may be an effective, low-cost, low-harm intervention to improve outcomes and reduce hospital utilisation following this surgery type. ICEAGE will test the benefits of this commonly provided intervention within a methodologically robust, multicentre, double-blinded, active-placebo controlled randomised trial.

The aim of this study is to gather information about the effectiveness of a foam dressing to prevent the development of sacral pressure injuries (PI). Currently, preventative dressings are not used routinely. In this study,of adult patients who are at high risk of developing a PI, half of the sample of 126 patients will be randomly allocated to receive the sacral foam dressing and half will receive standard care i.e. no sacral dressing. The dressing will remain in place for the duration of each participant's hospital stay. It will be replaced routinely after 7 days, or before if needed. In all patients, the sacral skin will be inspected on a daily basis to observe for the presence of PI, for a maximum period of 4 weeks. The main outcome measure will be the occurrence of sacral PI. Dressing comfort will be evaluated from the patient's perspective, and its utility will be evaluated by nurses. A cost analysis will also be undertaken. It is anticipated that patients treated with the foam dressing will have a lower incidence of pressure injuries than those receiving standard care.