ANZCTR search results

Colonoscopic polypectomy reduces morbidity and mortality from colorectal cancer. A proportion of patients undergoing colonoscopic polypectomy are on antiplatelet agents such as clopidogrel/prasugrel and ticagrelor. Current recommendations about peri-endoscopic management of these medications is individualized with guidelines generally recommending temporary interruption although the evidence behind this is poor. This randomized controlled trial aims to determined whether these antiplatelet agents can be continued for screening colonoscopy, mitigating the cardiovascular risk of temporary interruption of clopidogrel/prasurgrel or ticagrelor.

The primary purpose of this trial is to evaluate the safety and efficacy of a combination of ixazomib, thalidomide and dexamethasone (ITD) for the treatment of multiple myeloma which has progressed despite one to three lines of previous therapy. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over, and have been diagnosed with relapsed/refractory multiple myeloma for which 1-3 prior therapies have been administered. Study details All participants enrolled in this trial will receive ITD therapy, which involves taking a specific regime of oral tablets across four 28-day cycles. Participants will be assessed for adverse events and progression and survival outcomes until all patients remaining on study have been followed up for at least 12 months. . It is hoped that the findings of this study will provide information on whether the addition of ixazomib to thalidomide and dexamethason (TD) therapy is safe and effective for the treatment of relapsed/refractory multiple myeloma. Individual patients will remain on study until disease progression, unacceptable toxicity or consent withdrawal, whichever occurs first.

Post-operative care usually includes an overnight hospital stay, to ensure adequate analgesia, satisfactory haemostasis. Patients with an abscess drained will stay until the next morning with examination of the wound and the removal of the haemostatic pack. It is the fact that there is a logistic reason to keep the patients postoperatively. Baker et al illustrated their similar experience in NZ about theatre access (Baker 2009). Drainage of an abscess received a relatively low priority since it can be done by more junior staff after hours. Patients tend to have prolonged stays if access to theatre is an issue. There is currently no evidence to keep post abscess drainage patient in the hospital otherwise (Akkapulu 2014). It is time to encourage a better use of hospital resources in managing this common condition. The proposed change is to perform the drainage procedure early at the start of the ASU theatre list with minimal anaesthesia. There is evidence that for lower torso procedures, a smaller dose of spinal anaesthesia enables early ambulatory and shorter recovery period from anaesthesia. The patient is then referred to Acute Care at Home service for observation and to be discharged on the next day. Adequate analgesia and antibiotics will be dispensed prior the patient is being discharge from recovery. The ASU team can be contacted if concerns are raised by the Acute Care at Home service. The patient is then referred to Community Wound services for post-operative wound care. The complication and re-admission rate post drainage are very low (<1%) in the current management of abscesses, according to the ASU internal audit. It is important to ensure this low complication and re-admission rate continue in the new management model. The purpose of this trial is to demonstrate the safety of this new management.

AIMS To investigate the effectiveness of ketamine for the treatment of pain associated with red-back spider envenoming HYPOTHESES Ketamine will result in a significant change in the level of pain experienced by patients envenomed by red -back spider. RESEARCH DESIGN This pilot study will test the effectiveness of subanesthetic, intravenous ketamine infusions for red-back spider envenoming in a small single centre pilot trial. All patients will also receive standard opioid and nonopioid analgesia. Patients will be over 18 years old with moderate to severe red-back spider envenoming. The primary outcome will be clinically significant reduction in pain 30 minutes after administration of the ketamine infusion (compared to baseline). Informed written consent will be obtained from the patient using usual procedures prior to trial entry. All participants will receive analgesia according to a standardised protocol, commenced prior to administration of the trial drug. Patients will be cared for in an acute care area with physiological monitoring and if required intravenous parenteral analgesia as rescue medication. STUDY INTERVENTION A standard analgesia protocol will be followed prior to receiving the study intervention. The analgesia protocol will be as follows in all patients: paracetamol 1g orally PLUS oxycodone 10 mg orally. After the standard analgesia has been administered, the trial drug will be given to the patient. Subjects will be given an IV infusion with ketamine 15 mg in 100 mL of normal saline over 15 minutes. Clinical observations and patient pain score will be recorded at baseline and then post treatment at 30 minutes, one hour, two hours, four hours and on discharge. OUTCOMES: The primary outcome will be a clinically significant reduction in the severity of pain 30 min after the commencement of the ketamine infusion using the VNRS

Improving support for people with bipolar disorder is an important priority. Worldwide, bipolar disorder causes more pain and suffering than well-known conditions like heart disease and Alzheimer's. Feedback from people with bipolar disorder tells us that recovery is a personal journey about hope, understanding, empowerment and living a meaningful, satisfying and purposeful life alongside their experience of mental health conditions. Even with the right medication, people often have symptoms that continue to affect their everyday lives. Research is needed on an approach that improves individual recovery outcomes and that is useful and easy to access. This study will develop and test an eight session recovery focused group therapy programme for adults with bipolar disorder. An important focus of the project is combining what is currently known about what works with feedback from experts, including consumers. Being recovery focused, the group is an opportunity to learn from one another. Group discussion, activities and at-home tasks will be used to help group members a) increase their awareness of what matters to them; b) strengthen their ability to notice the things they are already doing that bring meaning to their life; c) identify the way(s) they respond when strong thoughts, feelings and/ or sensations show up (to help decide when/ whether these things are useful) and d) take steps towards changing the things that are less helpful in the long run and doing more of the things that bring meaning, purpose and direction. This initial study will involve 24 people with bipolar disorder. All participants will be offered the new group treatment alongside any other treatment they are already using. We will measure key signs (recovery, quality of life, symptoms) several times before and after treatment (baseline, post-treatment and 3 months post-treatment). We will also ask people to give feedback on their experience of participating in the study and the treatment they received. This will help to improve the treatment and inform a larger trial of its use in practice.

Neuropsychiatric symptoms like depression are common in people with Alzheimer's disease (AD), as are a frequent cause of distress and reduced quality of life. Pharmacological treatments are only modestly effective in treating these symptoms but are largely ineffective for depression people with AD, and are frequently associated with unacceptable side effects. It is therefore essential that we are able to identify safe and easily accessible therapies for these debilitating symptoms. Cognitive bias modification (CBM) is a simple, novel and safe intervention that targets attentional and interpretative biases associated with anxiety and depression. CBM has been shown to be effective in reducing depressive symptoms in younger adults but studies in people with cognitive impairment and their carers are lacking. Our preliminary research has indicated that CBM is well tolerated by people with AD and could be easily accessed at home, making it a potentially invaluable intervention for depression in this population. The aims of this study are to determine the effect of CBM in preventing clinically significant depressive symptoms from occurring in patients with AD. This study will also investigate the impact of CBM on quality of life and cognitive decline, as well as investigating factors that may predict the development of depression in AD. People with AD will be randomly assigned to an active or control CBM intervention group in a double-blind parallel design. The intervention will be conducted over 24 months. Incidence of clinically significant depressive symptoms will be compared between groups across the duration of the trial, and will be the primary outcome of interest. Changes in quality of life, carer burden, and cognitive ability will also be compared between groups across the duration of the trial, and will serve as secondary outcomes of interest. The capacity of demographic, lifestyle, and neurophysiological factors to predict depressive symptom change in AD will also be assessed across participants, and will serve as secondary outcomes of interest. Dementia is a common condition and is frequently associated with a diverse range of neuropsychiatric symptoms, including depression and anxiety. Our current understanding of the cause and management of these symptoms is far from optimal. The proposed study trials a simple and safe treatment that could be easily implemented into everyday clinical practice. This study will provide high quality evidence for the efficacy of CBM in improving the quality of lives of people with AD.

This study aims to examine the efficacy of a training program at the University of Sydney. The training program is run each semester by the Counselling and Psychological Services. It aims to train students to respond effectively to situations where friends or family are experiencing emotional difficulties.

Flexible video fibreoptic bronchoscopy (FOB) is an important component of the airway skills required by doctors in the area of critical care, including anaesthetists, intensive care physicians, and in emergency medicine. Speed and accuracy of performance, as well as causing no trauma to the patient's airway, is essential to secure the airway for adequate oxygenation and ventilation. However, FOB skills are often learnt in an unstructured format by trainees, and clinical exposure is limited by their relative rarity, causing skills decay after initial training. In this study, we are examining if training in FOB skills can be improved based on the innate visuospatial and psychomotor abilities of doctors. Other procedural tasks in medicine, similar in complexity to FOB, have previously been shown to be associated with these cognitive abilities as they influence hand-eye dexterity and motor skills. An educational intervention will be provided to those novices identified with lower visuospatial and psychomotor abilities, to determine if these novices can be brought up to the same level of FOB performance as their higher ability colleagues. This training is based on mental rehearsal of the procedure, which has been used by professional athletes, musicians, and by surgeons where they "practice" the performance in their heads before they actually perform it in real life. This study will recruit doctors rotating into critical care areas where FOB skill is necessary (anaesthesia, intensive care, emergency medicine). Visuospatial and psychomotor ability will be assessed by a standardised test battery. For doctors stratified into the low ability cohort of visuospatial and psychomotor ability, mental imagery training will be provided. FOB performance is measured using an anatomically correct, benchtop manikin of the human airway. Primary endpoint of performance is time taken to successfully perform a FOB task, and secondary endpoint is proficiency as evaluated by blinded assessors using a validated global rating scale.

There will be three treatment groups: Group 1: 15 subjects receive 2 A/Cal Nanopatches delivering a total of 15 mcg of A/Cal Haemagglutinin (HA) protein and 5 subjects receive 2 placebo-coated Nanopatches to the volar forearm Group 2: 15 subjects receive 2 A/Cal Nanopatches delivering a total of 15 mcg of A/Cal HA protein and 5 subjects receive 2 placebo-coated Nanopatches to the deltoid. Group 3: 15 subjects receive intramuscular Fluvax containing 15 mcg of A/Cal HA protein and 5 subjects receive an intramuscular injection of sterile saline. Sentinel Group: The study will begin with sentinel dosing, with 2 subjects (1 active, 1 placebo) from each treatment group, with evaluation to day 7. After 7 days the subjects will be assessed for safety by adverse events, physical exam, vitals and local injection site reactions (halt criteria). In the absence of safety concerns the remainder of the subjects will be enrolled and randomised into the study. Safety assessments include: Blood pressure, aural temperature, heart rate, respiratory rate, biochemistry, haematology, pregnancy testing for females, serology (human immunodeficiency virus (HIV), Hepatitis B and C), adverse event monitoring and local tolerability and pain assessment of the Nanopatch application site and intramuscular injection site. The study is designed to test the hypothesis that Nanopatch application to the skin with a well characterised influenza vaccine antigen (A/California/7/2009 (H1N1)-like) results in comparable safety / local skin reaction to conventional intramuscular vaccination.

The proposed study would investigate the effectiveness of the graphic warning labels currently featured on tobacco products and whether they can be enhanced by adding messages which target self-efficacy. Self-efficacy can be understood as the level of confidence to which a person believes in their own capacity to carry out a given action, despite potentially arising difficulties. Manipulating self-efficacy beliefs and has been observed to enhance the effectiveness of confronting or threatening health messages (‘fear-appeals’), which are often found to backfire. The current tobacco warning labels used in Australia make extensive use of fear-appeals. This study would measure whether sticking self-efficacy messages onto current warning labels (while ensuring the graphic images remain visible) can influence intentions and behaviours observed to be related to quitting smoking among a group of sixty tobacco smokers. A study-provided smartphone would be used to assess perceptions of personal health risks due to smoking, intentions and behaviours several times a day over a three week period. The first week of the study would be a baseline phase in which all participants report their risk perceptions, intentions and behaviours while continuing to smoke from the standard tobacco packaging. The second and third week would be the experimental phase, during which participants would be randomly divided into two groups. The experimental group would smoke from packages with self-efficacy messages attached and the control group would smoke from packages with current warning labels. All participants would continue to report their risk perceptions, intentions and behaviours, allowing researchers to assess changes between the two groups as well as changes within individual participants by comparing the baseline phase to the experimental phase. Participants would visit the laboratory three times during the course of the study: an induction visit at the beginning; a visit at the end of the baseline phase during which randomisation will take place, and a visit at the end of the experimental phase. At each visit they would be required to give a sample of exhaled breath for the measurement of carbon monoxide content. Carbon monoxide levels provide an indication of how much a person smokes and allows researchers to check how reliably participants report their smoking behaviour. Moreover, they will complete a brief assessment of their overall risk perceptions, intention and smoking behaviour during the last week. This will allow us to compare stable measures of the proposed determinants of behaviour with real-time measures. During the final visit, participants will be debriefed and asked to provide feedback. Moreover, at this time, participants in the control group will receive the same set of study-specific labels the experimental group received during the experimental phase, thus they will have access to the same intervention material after the study is completed.