ANZCTR search results

This study will measure the direct impact of an exercise program on the health outcomes of people with chronic kidney disease on dialysis. The health outcomes that will be measured include: physical function, quality of life, uptake of community exercise programs, self-reported falls, and biochemical markers. This work is significant given the effects of end stage kidney disease on musculoskeletal health in this group. There is a current absence of exercise programs in haemodialysis clinics globally, leading to a decline in dialysis patients’ physical function and increased costs to health services. Study Hypothesis: Accredited exercise physiologists providing a resistance exercise program will improve the physical function of people with chronic kidney disease receiving haemodialysis.

The purpose of this study is to investigate the potentially beneficial effects of Vitamin D supplementation on platelet aggregation and endothelial function, in patients who have proven vitamin D insufficiency and a known history of either Coronary artery disease (CAD) or Peripheral Vascular Disease (PVD).

The inhalation of gastric (stomach) contents in to the lungs (pulmonary aspiration) has significant morbidity and mortality and can attribute to up to 9% of anaesthetic related deaths. [1] [2] In a large retrospective analysis, pulmonary aspiration occurs between 1:900 emergency patients and one in 3900 elective patients [3] A key risk factor for pulmonary aspiration is the volume of the aspirated gastric content. In certain subgroups of patients such as those with trauma, pulmonary aspiration can be as high has 34%. [4] Preoperative fasting guidelines aim to reduce the risk of pulmonary aspiration for the majority of patients undergoing anaesthesia. This is normally 6 hours for solid food and 2 hours for clear fluids in our institution (Royal Perth Hospital). Despite these guidelines there remain high risk groups in whom significant residual gastric volumes can remain despite adequate fasting - this is because they take longer to clear their gastric contents. These include patients with diabetes, liver or kidney dysfunction or pregnancy and trauma patients. [5] Previous methods for determining gastric content preoperatively have been invasive and lengthy procedures. Non-invasive gastric ultrasound however can now reliably estimate gastric volume and content. [5] [6] Ultrasound represents a convenient bedside portable tool that can be used to help guide anaesthetists managing the anaesthetic risk for these high risk groups. This prospective cohort study aims to quantify the risk of aspiration by gastric volumes for those with renal dysfunction, emergency or urgent surgery, diabetes, gastro-oesophageal reflux disease (GORD) and obesity as indicated by preoperative gastric ultrasound using a standardised technique [1, 5] 1. Perlas, A., et al., Ultrasound assessment of gastric content and volume. Anesthesiology. 111(1): p. 82-9. 2. Landreau, B., I. Odin, and N. Nathan, [Pulmonary aspiration: epidemiology and risk factors]. Ann Fr Anesth Reanim, 2009. 28(3): p. 206-10. 3. Warner, M.A., M.E. Warner, and J.G. Weber, Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993. 78(1): p. 56-62. 4. Lockey, D.J., T. Coats, and M.J. Parr, Aspiration in severe trauma: a prospective study. Anaesthesia. 54(11): p. 1097-8. 5. Perlas, A., et al., Gastric sonography in the fasted surgical patient: a prospective descriptive study. Anesth Analg, 2011. 113(1): p. 93-7.

Adverse fetal growth is strongly associated with adverse pregnancy outcome for the fetus and newborn. Close monitoring of fetal growth is an essential component of antenatal care in order to try and reduce the resultant risks associated with adverse growth. It is standard practice to assess fetal growth by measuring symphyseal fundal height (SFH) at each antenatal visit and assessing the growth in line with a standard non-individualised growth chart. We have developed a customised growth chart that we hypothesise that when compared to a standard growth chart, reduces the risk of adverse pregnancy outcome through increased detection of adverse growth. Therefore, this study is a single centre, blinded, two-arm, randomised controlled trial to compare the detection rates of adverse growth (both slowed growth and accelerated growth) and adverse fetal and neonatal outcomes when using a customised fetal growth chart compared with a standard growth chart. The study will be run at the Mater Mothers’ Hospital Antenatal Clinic, with women randomly allocated to receive either the standard chart or customised chart. This chart will then be used throughout pregnancy to plot serial measurements of SFH to monitor fetal growth. We aim to reduce the rate of our composite perinatal morbidity outcome measure from 10% to 7.5%, which will require randomising 4,010 women. If our study hypothesis is proven, the low cost nature of this tool allows for the possibility of implementation into developing countries, as well as rural and remote Australian settings, that do not have sophisticated monitoring equipment. By implementing such a low cost solution to the difficult task of monitoring growth, there are potentially very large human and economic benefits from this research.

To cross-validate the second generation EyeMapper (EyeMapper Gen 2) against the previously validated prototype instrument, EyeMapper Gen 1.

The study is designed to evaluate the effects of intrajejunal taurocholic acid on the release of glucagon-like peptide 1 (GLP-1) from the small intestine, and the glycaemic response to concomitant intrajejunal glucose infusion in healthy subjects.

The study involves the addition of skin glue to the insertion site of a routinely inserted peripheral intravenous line (IVL) which is expected to reduce the IVL failure rate, by reducing the combined poor outcomes of Infection, Phlebitis, Occlusion and/or Dislodgement, in those patients that are admitted to hospital.

Lung cancer is the fifth most common cancer in Australia and the leading cause of cancer deaths. The majority of lung cancers are of the Non Small Cell Lung Cancer (NSCLC) histological type and most patients present with inoperable Stage III or IV disease. The population to be studied in this trial are patients with inoperable NSCLC who have a good PS but locally advanced or limited metastatic disease for whom radical CT-RT (=60Gy) is not feasible either due to tumour extent or patient factors. In these patients, the aim of therapy is to achieve symptom control and maintain Quality of Life (QOL). However, the optimal treatment regimen for this group is uncertain. Hypothesis- The hypothesis is that the addition of chemotherapy to high dose palliative radiotherapy in these patients will maximises intrathoracic symptom palliation (both the extent of improvement and its duration), which will lead to an improvement in QOL, and is associated with acceptable toxicity, compared with high dose palliative radiotherapy alone. Objectives- The Primary objective is to compare, in this group of patients, high dose palliative radiotherapy (HDPRT) versus concurrent chemotherapy and HDPRT (C-HDPRT), with respect to - The relief of dyspnoea, cough, haemoptysis and chest pain as assessed by change in total symptom burden from baseline to six weeks after the completion of treatment. - Response for each component symptom separately (dyspnoea, cough, haemoptysis, chest pain) The secondary objectives are to compare the two regimens in terms of; Dysphagia during treatment, Thoracic symptom response rate, Duration of thoracic symptom response , QOL, Toxicity, Progression-free survival and Overall survival. The exploratory/tertiary objectives are; - to determine how much improvement in QoL and symptom palliation would be necessary to make the inconvenience due to the longer duration of radiotherapy of C-HDPRT worthwhile, relative to HDPRT. This objective will be addressed in the Patient Preferences Substudy. - Analyse serum protein glycosylation changes and exosomes to identify potential biomarkers of disease response and progression - Prospectively collect and bank tumour tissue and blood samples from this cohort of patients for future evaluation of potential biological markers End Points- Primary - - Change from baseline at 6 weeks after treatment in the Intrathoracic Symptom Burden Index - Change from baseline at 6 weeks after treatment in each of the component symptoms, dyspnoea, cough, haemoptysis and chest pain. Secondary - - Profile of change from baseline of Intrathoracic Symptom Burden Index, and of component symptoms, by time (6 weeks, 3, 6, 12, 24 months) - Thoracic symptom response rate and response duration - Physician’s rating of cough, dyspnoea, haemoptysis and chest pain, summed into a symptom index and performance status (Karnofsky) and QOL (Spitzer) - Toxicity measured by NCIC CAE v 3.0 - Tumour response, Progression-free survival and Overall survival Trial Design- This is a multi-centre, two-arm, randomised (1:1) Phase III trial to compare high dose palliative radiotherapy (HDPRT) versus concurrent chemotherapy and HDPRT (C-HDPRT) in patients with inoperable NSCLC. 1) ARM A (control arm): High dose palliative RT (HDPRT) alone (36Gy/12 fractions, 4-5 fractions/week) or 2) ARM B (investigational arm): Chemotherapy + HDPRT (40Gy/20fractions, 4-5 fractions/week + IV cisplatin 20mg/m2 days 1, 8, 15, 22 + IV vinorelbine 25mg/m2 days1, 8, 22). (C + HDPRT) All eligible patients will be stratified according to tumour stage, histology, major chest symptoms and treating institution. The total participant accrual for this trial will be 130. The accrual period is expected to be 41 months and total study duration 55 months.

Many smokers who try to quit fail in their attempt. Medicinal nicotine is currently only used as a short-term quit aid. This trial will test if offering smokers the option of using these products as long-term substitutes for cigarettes will help more smokers to successfully quit. We will also determine if offering smokers electronic nicotine delivery systems in addition to medicinal nicotine products further increases the number of smokers who quit successfully.

Single fasting blood samples will be collected from each study participant for analysis of endogenous plasma L carnitine, acylcarnitine and free fatty acid concentrations. Results will be utilised for the determination of indices of fatty acid/carnitine homeostasis, calculated as the ratio of plasma free fatty acid – acylcarnitine. At the time of blood sample collection, each study participant will complete validated questionnaires for assessment of fatigue severity (Fatigue Severity Scale) and quality of life (Medical Outcomes Study Short-Form 36, SF 36). 13C oleic acid breath testing will be conducted in a subgroup of participants. After an overnight fast, participants will be administered a single 50 mg oral dose of 13C oleic acid. Expired air samples will be collected prior to dose administration (baseline) and then at hourly intervals until 8 hours post-dose for analysis of 13CO2 content. Baseline-corrected expired air 13CO2 concentration-time data will be kinetically modelled to determine the rate and extent of oxidation of oleic acid. Results of fatty acid/carnitine profiling and 13C oleic acid breath testing obtained from patients with CFS/ME will be statistically compared to those obtained from healthy controls using analysis of variance (ANOVA). Statistical examination of the relationship between the determined indices of fatty acid oxidation and fatigue severity/quality of life will be conducted using linear regression.