ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31276 results sorted by trial registration date.
  • A Retrospective Review of Intra-operative Anaesthesia Management during Fractured Neck of Femur (IAM-NOF) Surgery and Mortality

    This is a retrospective study of the influence of intra-operative blood pressure management and depth of anaesthesia on mortality after fractured neck of femur (NOF) surgery. Hospital admission and surgery for hip fractures is very common, and is associated with a high mortality rate. To date, finding anaesthesia interventions which could influence mortality has been unsuccessful. This study will review the medical, surgical, and anaesthesia records of patients admitted for NOF surgery in a 4 year period (2012 – 2016) in Liverpool Hospital. Relevant anaesthesia data, such as blood pressure pre- and intra-operatively, as well as depth of anaesthesia levels, will be collected. NOF patients will be identified through the Department of Orthopaedics database of surgical operations records for the same period. This also records 30- and 120-day mortality. This will allow researchers to analyse the impact of anaesthesia management on post-operative mortality.

  • Whole body vibration training in Congenital Myopathies

    Congenital myopathies refers to a group of muscle disorders that appears in infancy. It results in muscle weakness due to abnormalities within the muscle cell. Congenital myopathies as a group are one of the most common neuromuscular disorders. There are no effective medicines or exercise regimes that currently exist to improve the muscle weakness for these children. Their muscle weakness leads to difficulty in doing normal physical activities, like getting dressed, walking, climbing stairs or opening jars. We think that a home exercise program could increase their muscle size and strength, to help them perform physical activities better. We think the home exercise programme could also improve the strength of their bones, reducing the chance of a fracture, and improve their quality of life. The home exercise programme will use Whole body vibration training (WBVT). To use WBVT, children stand on a specialised vibration platform that moves like a see-saw, a few millimetres at a time, exercising the muscles, for a few minutes a day. WBVT is an emerging, simple and safe training method, which has been shown to improve muscle function and fitness in adults and children, and we think could help children with congenital myopathies also. Children in the study will undergo comprehensive clinical assessments at baseline and after the 3 month WBVT treatment period. This will then be compared with an observation period of 3 months. Children will then repeat the WBVT treatment for another 3 months, followed by a further observation period of 3 months with assessments after each stage. This novel therapy is non-invasive, simple, and potentially could help affected children maintain their ability to walk, perform physical activities, and improve their quality of life.

  • Translating research evidence from the Healthy Beginnings Trial to prevent childhood obesity at the beginning of life: feasibility, effectiveness and cost-effectiveness

    Childhood obesity is a serious public health challenge. About one in five Australian children aged 2 to 3 years is now either overweight or obese. Early intervention is important as excess weight and fast weight gain in early childhood are related to being overweight later in life with considerable impact upon health and health services. Over the past 7 years we have developed, implemented and evaluated an early obesity intervention program funded by NHMRC. The project tilted Healthy Beginnings Trial (HBT) was designed to improve infant feeding practices, eating habits, active play, and reduce TV viewing time to prevent childhood obesity in the first two years of life through staged home visiting. However, the high cost associated with home visits potentially limits population reach. To translate the successful evidence from the HBT into scaled-up practice applicable across the state with low-cost and broad-reach approaches, we propose this study to promote healthy infant feeding and active play using telephone support and Short Message Service (SMS). The proposed study aims to test the effectiveness of telephone support or SMS with mail-outs in reducing child BMI z-score, promoting healthy infant feeding practice and active play in the first 24 months of life; and examine the cost-effectiveness of these interventions. We hypothesise that the staged early intervention using either mailed self-motivating written materials plus SMS or plus telephone support delivered in the antenatal period and over the first 24 months of life, relative to usual care, will: 1) lead to reduced child BMI z-score and rapid weight gain at age 12 and 24 months compared to usual care. 2) improve infant feeding practices and decrease the prevalence of obesity-related behaviours at 12 and 24 months compared to usual care. 3) be more cost-effective compared to usual care, and SMS will be more cost-effective than telephone support. Both qualitative and quantitative methods will be used in this study. A total of 1155 women at late pregnancy were recruited from main hospitals in four Local Health Districts. They were randomly allocated to one of three arms. Randomisation was stratified by Local Health District. Telephone surveys were used to collect data at baseline, 6 months, 12 months, and will be used at 24 months. Children’s weight and length at 24 months will be measured by research nurses.

  • Early rehabilitation after traumatic brain injury (TBI)

    Following emergence from coma individuals with traumatic brain injury (TBI) experience a period of confusion, amnesia, and sometimes agitation, termed post-traumatic amnesia (PTA). Guidelines for management of patients in PTA have traditionally recommended that these patients not receive active therapy during this phase. However, this management strategy has never been empirically tested and anecdotal evidence implicates potential benefits from rehabilitation during PTA. Retraining of daily living skills such as personal care activities (e.g., dressing) and domestic tasks (e.g., meal preparation), known as activities of daily living (ADLs), is a core focus of the rehabilitation program in the post-PTA phase. Efficacy of commencing ADL retraining during the PTA phase has never been systematically assessed. The proposed randomised controlled trial is designed to evaluate the efficacy of commencing ADL retraining during the PTA phase after severe TBI (treatment group), as compared to introducing ADL retraining after emergence from PTA (treatment as usual control group).

  • Exercise Training in Pulmonary Hypertension.

    The aim of the study is to provide guidance to clinicians in relation to the safety and effectiveness of exercise training for pulmonary hypertension (PH) patients. More specifically, the study will have the following aims: 1) To examine the short-term outcomes and safety of exercise training in patients with PH 2) To examine the impact of exercise training on cardiac function at rest and during exercise using cardiac magnetic resonance imaging 3) To examine the long-term outcomes including adverse events and clinical worsening following exercise training. The study hypotheses are: 1) Exercise training will have beneficial effects in terms of improved exercise capacity, quality of life and a reduction in disease severity, with no increase in adverse events 2) Exercise training will result in improved cardiac function as measured using cardiac MRI, both at rest and during submaximal exercise 3) Participants who undertake exercise training will have a longer period without clinical worsening, using a minimum 2-year follow-up period

  • SMS reminders promoting influenza vaccines in general practice

    Immunisations are an important public health intervention for reducing the morbidity and mortality caused by vaccine-preventable diseases in the community. Certain individuals are at higher risk of serious complications following influenza infection, and unfortunately, influenza vaccine has the lowest uptake of any routine vaccination program in Australia. Studies from overseas have shown the use of text message reminders (also called short message service [SMS] reminders) can be an effective method of promoting vaccines to priority groups. The Western Australia Department of Health (WA Health) is interested in creating a program for general practitioners to use during the influenza vaccination season to remind patients they are eligible for government-funded influenza vaccine. To assess whether this activity is an effective and efficient use of resources, WA health intends to evaluate the impact of a prototypic reminder system in a subset of practices.

  • Success rate of upper gastrointestinal endoscope insertion directly into the oesophagus through a dedicated channel in the laryngeal mask airway (LMA) called the LMA GASTRO (Trademark)

    The overall aim of the project is to demonstrate the utility of the newly developed novel laryngeal mask airway (LMA) device called the LMAGastro (Trademark) which is a first for laryngeal mask airway (LMA) use in upper gastrointestinal endoscopy procedures. The device’s novel design features include firstly a dedicated endoscopic channel for entry into the oesophagus and secondly, a dedicated airway channel and cuff to protect the airway. The hypothesis is: the LMAGastro (Trademark) will have a high endoscopic success rate and provide a clinically satisfactory protected airway during upper gastrointestinal endoscopy procedures under anaesthesia. Gastroenterologists won’t change practice unless endoscopic success rates are very high. We are anticipating that the modified airway device (being developed with TELEFLEX and in collaboration with the Gastroenterology Department of the RHH) will not only provide reliable and superior upper gastro-intestinal access, but also provide airway protection and better anaesthesia monitoring of the patient, both significantly enhancing patient safety leading to a change in practice.

  • Accelerated Rehabilitation After Anterior Cruciate Ligament (ACL) Hamstring Reconstruction

    This is a prospective randomized controlled trial (RCT) investigating the graft stiffness of a Double Bundle (DB) remnant sparing Anterior Cruciate Ligament Reconstruction. The patients receiving this graft configuration will be randomized to either an accelerated rehabilitation program or a conventional rehabilitation program. Six months and one and two year graft laxity measures will be used as the primary outcome measure of the graft stiffness and its response to two forms of rehabilitation loads. Our overall hypothesis is that accelerated rehabilitation culminating in a return to sport at 6 months post-surgery will have no adverse effects on the graft laxity after ACLR, evaluated primarily by graft laxity measures at 1 and 2 years and secondarily by the time taken to return to sport, patient satisfaction, validated functional scores and patient-reported outcome (PRO) measures.

  • The SEED Project (Sleep, Eat, Emotions, and Development): Enhancing sleep and wellbeing in mothers and infants.

    Sleep disturbance is experienced by the majority of child-bearing women during the pregnancy and post-partum periods. Physiological changes related to pregnancy and birth-giving (e.g., hormonal changes), and post-partum nighttime infant care are common factors that reduce/disrupt sleep opportunity. In addition, some women (~17%) experience clinically significant insomnia symptoms. The resulting sleep complaints have been associated with a range of poor maternal outcomes (e.g., mood disturbance, worse birth outcomes, poorer maternal-infant attachment). Integrated behavioral and educational interventions have been consistently shown to improve sleep, and have lasting effects on sleep and wellbeing. Cognitive Behavioral Therapy for Insomnia (CBT-I) is an effective insomnia treatment, and recently has been tailored to, and piloted on, women with comorbid postpartum depression and insomnia with significant improvements to sleep and mood. Given the proven efficacy of CBT-I and the need to prioritize treatment accessibility in the community, the lack of a flexible delivery service platform for healthy sleep strategies represents a significant gap in clinical translation. Given the high prevalence of sleep disturbance in perinatal periods, a platform that can be easily integrated into routine perinatal care, as well as being accessible to a broad community is desirable. However, expectant mothers in most of Australia are not currently receiving evidence-based information and recommendations to prepare and support them through the many changes to sleep/wake cycles during the transition into motherhood. This study will adapt an existing evidence-based perinatal sleep intervention for use in an Australian public hospital setting and include features that allow for sustainable integration into routine care, promoting eventual wider dissemination. The primary aims of the study are to obtain pilot data on 1) the feasibility of integrating this adaptation in outpatient perinatal care, and 2) its treatment effect on sleep and wellbeing in mothers and infants. To achieve this aim, a comparison group, Diet SEED will be used. A secondary aim of the study is exploratory, and assesses potential benefits of Diet SEED on participants' diet. From a diet perspective, the Sleep SEED group will be treatment as usual (as outpatients). Currently, diet related information is given to women in a text-dense booklet. By adapting content of this booklet to digestible sizes that are delivered at important perinatal milestones, Diet SEED has the potential to improve women's diet behaviors significantly compared to treatment as usual. Therefore, to achieve this aim, dietary measures will be compared between Sleep and Diet SEED groups.

  • ‘Caring for the Carer’: implementing a comprehensive support service model for family caregivers looking after persons with age-related macular degeneration.

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