ANZCTR search results

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.

The prevalence of autism spectrum disorder (ASD) is currently estimated at 1 in 88, but there is a distinct lack of validated biomedical treatments that target the core symptoms. Non-invasive brain stimulation techniques, including repetitive transcranial magnetic stimulation (rTMS), have been established as safe and efficacious treatments for a range of psychiatric disorders, particularly depression. We conducted a pilot, placebo-controlled study of deep rTMS (a form of rTMS providing stimulation of brain structures further away from the scalp) among individuals with ASD (n = 28) that involved a conservative two-week course of stimulation, and found evidence of improved social relating among those undergoing active deep rTMS. Following on from our pilot research, this study will examine the underlying mechanism of deep rTMS, and the safety and efficacy of a stronger course of deep rTMS in ASD. There will be two phases to this study. Phase 1 will involve 20 individuals with ASD aged 18 or older. They will undergo positron emission tomography (PET) and clinical assessment before and after receiving 30 minutes of active deep rTMS each weekday for 3 weeks, and for 2 weekdays of the following week. This phase will help to understand the underlying brain mechanism of deep rTMS. Phase 2 will involve 60 individuals with ASD aged 15 or older. They will receive 30 minutes of either active (n = 30) or sham (placebo) (n = 30) deep TMS each weekday for 3 weeks, and for 2 weekdays of the following week. Clinical assessments will be conducted at five points: (1) before the first treatment, (2) immediately after the last treatment, (3) 1 month after the last treatment, (4) 3 months after the last treatment, and (5) 6 months after the last treatment. These assessments will comprise self-report and parent-report (or significant other-report) questionnaires assessing ASD symptomatology and short experimental measures assessing distinct aspects of social relating (e.g., perception of other’s emotions). Individuals must have been assessed to have an IQ of 55 or above (i.e., mild intellectual disability, average intelligence, or above average intelligence). Capacity to provide informed consent will be evaluated and monitored for all adult participants. Child participants will require parental consent to participate. For Phase 1, it is expected that deep rTMS will enhance activity within the brain’s ‘mentalising network’ (i.e., a series of connected regions devoted to understanding others thoughts, beliefs, intentions, and feelings) and result in clinical improvements to social relating symptoms. For Phase 2, it is expected that active deep rTMS will improve social abilities in ASD, and that these will be maintained after 6 months. Should our hypotheses be supported, it will indicate the possibility of deep rTMS as a neurobiological intervention for ASD.

The purpose of this study is to determine whether rLCAT, when given to patients can lead to changes in the composition of plaque in the leg arteries and to changes in the amount of cholesterol and inflammation in the blood. From laboratory studies, rLCAT shows promising outcomes in terms of its ability to remove cholesterol from cells and animal models. Hence, we hypothesize it will have a similar effect in patients.

This retrospective study aims to evaluate the role of hip arthroscopy in patients who have undergone hip resurfacing surgery and who continue to have symptoms in the same hip. Symptoms may include pain, stiffness, clicking, giving way episodes or weakness. Pathologies causing these symptoms, which reside within the hip joint can be more accurately assessed and treated by the insertion of an arthoscope within the hip joint capsule. The study involves reviewing patient files and operating notes and subsequently conducting a phone call or a follow up visit, if possible, to evaluate current patient status. There will not be follow up appointments made specifically for fulfilling the purposes of the study. However, if the patient is attending a pre-booked follow up visit, then evaluation of patient functional status will be carried out concurrently. By analysing our series of hip arthroscopies used to treat symptomatic resurfacing arthroplasties, we hope to better define and categorise causes of persisting problems. This will help improve patient outcomes. Arthroscopy after hip resurfacing may assist in final diagnosis and address symptoms, yielding good clinical results.