ANZCTR search results

In order to validate the sepsis-3 quick Sequential Organ Dysfunction Assessment (qSOFA) score in a remote ED population and setting, it will be compared retrospectively by case note review against the Systemic Inflammatory Response Syndrome (SIRS), Remote Early Warning Score (REWS) and Medical Emergency Warning Score (MEWS) for rates of Intensive Care Unit/High Dependency Unit (ICU/HDU) admission and in-hospital mortality. A prospective introduction of the qSOFA score with and without point of care lactate as an early warning tool at the first point of contact with ASH ED triage and its use as an alert for early senior medical staff involvement, will attempt identify the most efficient way to shorten the time to treatment of patients with severe infections.

The primary purpose of this trial is to evaluate whether endoscopic examination of the chest is useful for identifying disease sites in non-small cell lung cancer, which are not visible on standard care PET scans. Who is it for? You may be eligible to participate in this trial if you are aged 18 to 80 years, with known/suspected non-small cell lung cancer (NSCLC) and suspected/known mediastinal metastases (stage III A-B based on mediastinal nodal involvement). Study details All participants enrolled in this trial will receive the endoscopic staging procedure in addition to the standard care PET scan. The endoscopic staging procedure will involve an endoscopy procedure (performed under deep intravenous sedation) where examination of all lymph nodes in the mediastinum will be performed, and sampling of any identified nodes perfomred. The procedure is required on the basis of your PET findings. The procedure lasts 20-30 minutes and is usually performed as a day procedure. The results of the staging procedure will be used to guide planning the dose of radiotherapy received. Researchers will compare the results obtained from the endoscopic staging procedure with the results from the PET scan to evaluate whether the staging procedure may be able to detect additional cancer sites which are not detected on the PET scan. If so, this will improve targeting of radiation treatment in non-small cell lung cancer patients with mediastinal metastases by ensuring that all disease sites receive adequate radiation doses, thereby minimizing the risk of under-treatment and disease recurrence.

Based on a pilot study conducted in England the New Medicines Service (NMS) was introduced under the NHS community pharmacy contract in the UK in October 2011 as an “Advanced Service” to provide support for people newly prescribed a medicine for a chronic condition including: asthma/chronic obstructive pulmonary disease; type 2 diabetes; hypertension; and conditions requiring antiplatelet/anticoagulant therapy. The primary aim of the service is to improve medicines adherence and a randomised controlled trial demonstrated that the service was effective at improving patients’ adherence to their new medicine by 10%. NPS MedicineWise piloted this service to determine how it could be adapted for delivery in Australia and integrated into the workflow of community pharmacy. Evaluation of the pilot demonstrated that implementation in pharmacies across Australia is feasible and that the service was valued by both pharmacists and consumers. Following the successful pilot, this service is now being extended to a larger number of pharmacies. It aims to improve health outcomes by increasing patient adherence to new medicines for chronic conditions. This second phase will explore the ability to scale the service up to a larger number of pharmacies and measure consumer adherence to newly prescribed medicines through a randomised controlled trial.

The primary purpose of this trial is to evaluate the safety of rivaroxaban for the treatment of thrombosis associated with cancer, in comparison to the standard care treatment with low molecular weight heparin (LMWH). Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have active cancer and require therapeutic anticoagulation for a new diagnosis of deep vein thrombosis or pulmonary embolism. The duration of anticoagulant treatment should be for at least 6 months. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either treatment with rivaroxaban or treatment as per standard care with LMWH for at least 6 months. Patients can either be enrolled within 72 hours of diagnosis, or at day 30 +/- 2 days. Participants will be assessed six months later for side effects of treatment, including any bleeding which has occurred. It is hoped that the findings from this trial will provide information on whether rivaroxaban is a safe alternative to LMWH for the treatment of cancer-associated thrombosis.

The Gala Therapeutics Airway Treatment System for Chronic Bronchitis in Australia will evaluate the safety and efficacy of the technology in up to 24 adult patients across three sites in Australia, Patients with chronic bronchitis for a minimum of 2 years will be enrolled. Patients with a history of pacemaker / implantable defibrillator and cardiac arrhythmias as well as prior lung surgery, such as lung transplant, LVRS, lung implant/prosthesis, metal stent, valves, coils, bullectomy, segmentectomy, or lobectomy will not be considered for the trial Exception to this is patients who have had a valve removed greater than 30 days prior to being enrolled in the trial provided that the airway is sufficiently accessible for the Gala treatment.. The trial is single arm / non randomised (it is intended that each patient enrolled in the trial will receive the treatment under investigation) and is non blinded (patients and clinicians will be aware that the treatment is being delivered). The trial will subject consented participants to treatment by the Gala Therapeutics Airway Treatment system over 2 bronchoscopies that will be performed by trained respiratory physicians (interventional pulmonologists) in tertiary teaching hospitals. Patients will be anaesthetised for these procedures. A third bronchoscopy will be performed in order to take airway biopsies to assess the effect of the treatment on the cells that produce mucous in the airways. Subjects will also be required to undertake several tests during the study including 2 CT scans (Lung), respiratory function tests, exercise testing and blood tests. Subjects will be followed for 1 year following the second bronchoscopy.

Despite cigarette smoking being the leading cause of preventable death in the western societies, around 15% of people over the age of 14 are daily cigarette smokers in Australia (Australian Institute of Health and Welfare, 2011). The high prevalence of cigarette smoking can in part be attributed to the fact that they are legal and can be readily purchased and in part to their content of nicotine, which is more addictive than both amphetamines and alcohol (Nutt et al., 2007). For regular cigarette smokers, attempts to abstain from smoking result in an unpleasant withdrawal syndrome, symptoms of which include depressed mood, irritability, frustration, difficulty concentrating, anxiety, insomnia and increased appetite (American Psychiatric Association, 2013). Success rates for quitting smoking for at least one year without pharmacological intervention are quite low, at around 10% (Silagy et al., 2004). Of the pharmacotherapies available to aid with quitting cigarettes, varenicline is the most effective, with as abstinence rate of 30.5% at 12 months. While varenicline is more effective than other available therapies such as nicotine replacement and bupropion, the poor outcome for the majority of smokers demonstrates a clear need for a pharmacotherapy with greater efficacy. In moderate and heavy smokers, cravings and anxiety begin to occur within 1 hour of the last cigarette smoked (Hendricks et al., 2006). Given that heavy smokers are known to have an average interval of around 40 minutes between cigarettes, this supports the idea that smokers use cigarettes to relieve these early symptoms (Hatsukami et al., 1988). Flumazenil has been reported to reduce feeling of anxiety, while naloxone has been shown to have anti-craving effects. This had led to the development of a pulsatile fast-acting delivery system for flumazenil and naloxone which may be administered at the time of craving. It is hypothesised that this pharmacotherapy will provide immediate relieve of withdrawal cravings and anxiety which are normally a precursor to on-going smoking and will therefore increase the rates of success for people attempting to quit cigarettes. The proposed pilot study aims to assess the efficacy of combined flumazenil and naloxone in the form of a nasal spray which is to be administered at the time of craving or feelings of withdrawal symptoms to promote cigarette and cannabis smoking abstinence.

This study aims to assess the effect co-administration of pre- and probiotics has on cardiovascular risk in patients with chronic kidney disease, and, whether this is a potential treatment strategy targeting the deleterious side effects of uraemic toxins.

Obesity is a global health problem that is reaching epidemic proportions. Since the 1970’s the rates of overweight and obesity in reproductive-age men has nearly tripled such that 70% of Australian adult men (>18 years) are now overweight or obese. Male obesity alters the physical and molecular structure of sperm which both reduces fertility and increases obesity risk of the next generation. There is emerging evidence from work in mice that that these effects might be reversible for example in response to an antioxidant rich high quality diet and diet and exercise but also that some interventions, for example weight loss with a nutritionally insufficient diet, may be deleterious. Bariatric surgery is increasingly used to treat obesity. The 2 most commonly used procedures: sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB), differ in regards to the magnitude of weight loss, resolution of co-morbidities and impacts on nutrient intake and absorption. For example RYGB is associated more immediate and more patients with resolution of type II diabetes and control of metabolic syndrome with a greater reduction in triglyceride levels, greater improvements to LDL levels and lower HOMA index compared with SG. Poor diet quality is a common outcome after SG as patients experience difficulties in eating certain foods which may contribute to these reduced outcomes. In terms of fertility, following RYGB, hormone profiles (testosterone, inhibin B, SHBG and estrogens) and erectile dysfunction improve in obese men. However less is known about the effects of SG. The effects of surgical weight loss procedures on sperm structure and function really remain unclear, and it cannot be assumed that these procedures necessarily result in beneficial or even similar effects on reproductive potential and outcomes. Therefore, we aim to determine the effect of these procedures (SG and RYGB) on the structure and function of sperm.

Bronchopulmonary dysplasia (BPD) is a chronic inflammatory lung disease characterised by disordered alveolar and vascular development, most commonly affecting extremely preterm infants exposed to mechanical ventilation and oxygen therapy for respiratory distress syndrome (RDS). BPD is associated with mortality, and adverse long-term pulmonary and neurodevelopmental outcomes. Despite advances in neonatal care including antenatal corticosteroids, exogenous surfactant, and the increasing use of ‘non-invasive’ ventilation, the incidence of BPD is not decreasing. BPD remains the most important pulmonary complication in extremely preterm infants occurring in about 50% of survivors to 36 weeks post menstrual age, with no new therapies shown to prevent it. Laboratory and clinical studies suggest a crucial role for lung inflammation (pre- and post-natal) and host immune response in the pathogenesis of BPD. A subcommittee of perinatal experts of the National Health, Lung, Blood Institute summarised the current state of knowledge regarding BPD and identified potential points in its pathogenesis susceptible to therapeutic interventions. One recommendation was to study the use of selective anti-inflammatory therapies, to attenuate the inflammatory response in the developing lung to potentially prevent BPD. As inflammation is a primary mediator of injury in the pathogenesis of BPD, anti-inflammatory agents such as postnatal corticosteroids have long been the focus of preventive interventions. Whilst systemic (intravenous or oral) corticosteroids reduce inflammation and improve respiratory function, their early use may be associated with many side effects. Given the serious adverse effects of systemic corticosteroid administration, safer alternatives are sought.Inhaled or nebulised corticosteroids are technically challenging to deliver with conflicting results from trials as the dose, optimal timing of initiating treatment and the duration are unknown. Local administration of corticosteroids to the lung via the intra-tracheal route has the potential to maximise anti-inflammatory effects on the distal airway, minimise systemic absorption and decrease the risk of adverse effects. Exogenous surfactant is a proven effective therapy for RDS in preterm infants. Combining budesonide with surfactant is a simple intervention that may prevent BPD in the high-risk population of extremely preterm infants. The aim of the PLUSS trial is to evaluate the safety and efficacy of early intratracheal corticosteroid (budesonide) combined with exogenous surfactant as the vehicle for distribution compared with exogenous surfactant alone to increase survival without BPD at 36 weeks’ PMA in extremely preterm infants born <28 weeks’ gestation. This is a multicentre, double-blind, two-arm, parallel 1:1 placebo-controlled randomised trial. Families, healthcare providers, outcome assessors and data analysts will be blinded to the randomisation group. Infants enrolled in the study will be randomised to receive intratracheal surfactant and budesonide or surfactant alone.

The aim of this research project is to test the preliminary feasibility, effectiveness and possible mechanisms of change of a CPT-C treatment program that is tailored to incorporate cultural differences in self-concept and trauma related appraisals for use among South East Asian trauma survivors. The primary aim of the research project is to (1) determine the efficacy of a group culturally-modified CPT (cm-CPT) protocol for the treatment of individuals from a South East Asian Background with moderate-high levels of PTSD symptomatology (2) assess feasibility, treatment adherence and client satisfaction of cm-CPT (3) examine moderators, mediators, and mechanisms of change.