ANZCTR search results

The purpose of this project is to explore whether a clinician-guided treatment program can help to reduce anxiety symptoms in a population of mature adults (aged 60-75), when administered over the internet. A secondary purpose is to determine how acceptable people find this form of treatment. The study will inform how services can best improve future treatment programs for mature adults with anxiety.

The purpose of this project is to explore the efficacy of a clinician-guided treatment program for symptoms of depression in older adults (aged 60-75), administered over the internet in a Ramdomised Controlled Trial. A secondary purpose is to determine the acceptability of the treatment protocol and materials to older adults with symptoms of depression. A tertiary purpose of this project is to explore the efficacy of a self-guided version of the program, with participants from the Waitlist Control Group.

Currently, patients who are suspected of having obstructive sleep apnea (OSA) need to be seen by a sleep specialist and undergo a full sleep study in a laboratory to confirm the diagnosis. A full sleep study involves monitoring of brain waves, eye and chin muscle movements to determine different stages of sleep, breathing patterns, oxygen levels, heart rate and leg movements. Waiting lists to see a specialist and have a laboratory sleep study can often be long, even up to 6-12 months in some centres. To address this problem, increasing numbers of simplified sleep recording devices designed to be used in the patients’ own home are being developed, and have a smaller number of channels recording only breathing patterns and/or oxygen levels overnight, without recording of brain waves to determine stages of sleep. It is currently unclear whether patients who undergo simplified sleep study recordings to test for OSA have treatment results (for example, in the degree of improvement in their symptoms) compared to patients who undergo full sleep studies. In this study, patients referred to a sleep specialist for investigation of possible OSA will be randomly assigned to one of three groups for diagnosis: (1) an overnight sleep study with full monitoring of brain waves, eye and chin muscle movements, breathing patterns, oxygen levels, heart rate and leg movements; (2) an overnight sleep study with monitoring of only breathing patterns, oxygen levels, and heart rate or (3) an overnight sleep study with monitoring of only oxygen levels. The aim of the study is see whether patients who receive treatment from a sleep specialist on the basis of a simplified sleep study recording will do as well (in terms of improvement in symptoms and ability to perform usual daily activities) as patients who have had a full sleep study after 3 months of follow-up.

This study examines the potential of a web-based tool to help cancer doctors explain survival time to their patients with advanced cancer who wish to receive information about their likely survival time. Who is it for? You may be eligible for this study if you have been diagnosed with incurable cancer, you wish to receive information on your prognosis and you are able and willing to complete a written study questionnaire about your attitudes to the web-based tool anfd the information you received. The study will also collect information from medical oncologists and other health professionals involved in the care of the cancer patients, along with family members and carers of the patient in order to build an overall picture of the usefulness of the tool. The overall duration of the study is 6 months but if you participate you are only required to complete one questionnaire that takes less than 10 minutes to complete. Trial details: The aim of this study is to find out if patients and their family members find the information provided by the web-based tool helpful and if cancer doctors find using the web-based tool helpful. We will also be providing information on likely survival time to other doctors and nurses helping to care for these patients to find out if they find receiving this sort of information on their patients helpful. The overall duration of the study will be for 6 months and each participating cancer patients will be given 2 weeks to complete and return a written questionnaire.

Spinal cord injury results in loss of motor, sensory and autonomic function below the level of the lesion. This has serious implications on activities of daily living and psychological well being. Specifically, significant loss of lower limb motor control leads to marked changes in peripheral circulation, increasing the risk of skin breakdown, pressure ulcers and limiting footwear options. Functional electrical stimulation (FES) cycling is an increasingly popular part of rehabilitation programs following recent spinal cord injury. The functional electrical stimulation cycling unit uses electrodes on the main muscle groups in the lower limbs to cause contractions of paralysed muscles to generate a cycling motion. There is mounting anecdotal evidence to support the use of FES cycling to improve urine output, and reduce lower limb swelling and spasticity. However, there is little good quality research to confirm these claims. Thus the purpose of this study is to determine the effect of FES lower limb cycling on urine output, lower limb swelling and spasticity. The results of this study will have implications for the rehabilitation of people following spinal cord injury. In particular, they will provide high-quality evidence to guide clinical practice and assist with prescription and recommendations for FES cycling.

Herpes labialis (cold sores) caused by herpes simplex virus type 1 (HSV-1) is a common condition affecting millions of people worldwide. The pathogenesis of the disease suggests that brief and early immunogenic therapy may be a logical approach. Abalone Haemocyanin (AH) derived from live abalone. The literature and clinical data generated by the sponsor of this study, indicate that AH has the potential for prophylaxis and therapeutic treatment of all stages of oral herpes. The proposed study is to look at the safety and effectiveness of topical AH for 5 days compared with placebo.

This project will compare patients 16 years and under with simple appendicitis (appendicitis that is not perforated or gangrenous). Patients will be randomly divided into two groups; - Group one will receive a single pre-operative dose of antibiotics (metronidazole 12.5mg/kg up to 500mg and cefazolin 25mg/kg up to 1g) and two ‘doses’ of normal saline (placebo) eight and sixteen hours after the initial dose, respectively. - Group two will receive one pre-operative dose of antibiotics (metronidazole 12.5mg/kg up to 500mg and cefazolin 25mg/kg up to 1g) and two post-operative doses, eight and sixteen hours after the first dose, respectively. Group allocation will be concealed from the patient and their guardian, the treating surgical team and outcome assessors (triple blinded). A process to rapidly reveal group allocation if required will be in place. The aim of the study is to determine if a single dose of antibiotics is as effective as three doses in preventing post-operative infection. This will be assessed by comparing: - Duration of hospital stay from operation until discharge, based on a standardised discharge criteria. - Development of wound infection or requirement of antibiotics in the six weeks post-operation - Need for re-admission. Information will be collected prospectively from each patient’s hospital notes and from a follow-up phone call six weeks after the operation.

We intend to evaluate the efficacy of 14 days of the triple antibiotics listed above in eradicating Blastocystis infection in symptomatic patients.

Research question: Does administration of exogenous surfactant using a minimally-invasive technique improve outcome in preterm infants 29-32 weeks gestation treated with continuous positive airway pressure (CPAP)? A multicentre, randomised, masked, controlled trial will be conducted in preterm infants 29-32 weeks gestation, aged less than 12 hours, requiring CPAP because of respiratory distress, with an FiO2 of >=0.32 (CPAP pressure 5-6) or >=0.28 (CPAP pressure 7-8). Infants randomised to surfactant treatment will receive 100 mg/kg of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter, followed by reinstitution of CPAP. Controls will continue on CPAP. The intervention will be masked from the clinical team. Care thereafter will be as per usual in both groups, other than the requirement to adhere to intubation criteria. The primary outcome will be duration of respiratory support (all hours of intubation, CPAP and high flow nasal cannula). Secondary outcomes will include Need for intubation and surfactant therapy; durations of intubation, CPAP, intubation and CPAP, HFNC, oxygen therapy, intensive care stay and hospitalisation; hospitalisation cost; incidence of death, major neonatal morbidities, pneumothorax and patent ductus arteriosus; and applicability and safety of the MIST procedure. The sample size will be 227/group, allowing detection of a 25% reduction in duration of respiratory support with 90% power. The trial will commence at Royal Hobart Hospital and Royal Women's Hospital during 2011, and will ultimately be conducted over 5 years in multiple centres nationally and overseas.

Does administration of exogenous surfactant using a minimally-invasive technique improve outcome in preterm infants 25-28 weeks gestation treated with continuous positive airway pressure (CPAP)? A multicentre, randomised, masked, controlled trial will be conducted in inborn preterm infants 25-28 weeks gestation, aged less than 6 hours, requiring CPAP because of respiratory distress, with an FiO2 of >=0.3 and CPAP pressure 5-8. Infants randomised to surfactant treatment will receive 200 mg/kg of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter, followed by reinstitution of CPAP. Controls will continue on CPAP. The intervention will be masked from the clinical team. Care thereafter will be as per usual in both groups, other than the requirement to adhere to intubation criteria. The primary outcome will be incidence of death or BPD. Secondary outcomes will include incidence of death, major neonatal morbidities (BPD, intraventricular haemorrhage, periventricular leukomalacia, retinopathy of prematurity, necrotising enterocolitis), pneumothorax and patent ductus arteriosus; need for intubation and surfactant therapy; durations of mechanical respiratory support, intubation, CPAP, intubation and CPAP, high flow nasal cannula (HFNC), oxygen therapy, intensive care stay and hospitalisation; hospitalisation cost; applicability and safety of the MIST procedure; and outcome at 2 years. The sample size will be 303/group, allowing detection of a 33% difference in the primary outcome with 90% power. The trial commenced at Royal Hobart Hospital December 2011 and Royal Women's Hospital during 2012, and will ultimately be conducted over 7 years in multiple centres nationally and overseas. Followup: at 2 years corrected age, parents of each infant will complete a brief health assessment and a validated child development assessment (PARCA-R, Dev Med Child Neurol 2004;46:389–97) administered as a web-based questionnaire located on a secure server. No identifying details will be revealed in the completion of the questionnaire. Health information to be collected will include duration of oxygen therapy at home, details of hospitalisations in the first 2 years (age, duration and classification of illness [respiratory/non-respiratory]), whether immunized against respiratory syncytial virus and influenza, family history of asthma, details of respiratory symptoms (respiratory distress and wheezing) and medications, details of feeding, vision and hearing capabilities, and presence and severity of motor problems. The PARCA-R questionnaire will seek information on the child’s development and speech.