ANZCTR search results

For patients on warfarin, the safety of having dental extractions while continuing to take the drug has been well established. Bleeding rates are not significantly different between patients who continue warfarin and those who temporarily discontinue warfarin for their dental extractions. Warfarin interruption for dental extractions has been associated with a 1% risk of blood clots, which can be fatal. International and local guidelines therefore recommend warfarin be continued for simple dental extractions. There are currently no published studies to guide the management of new oral anticoagulants (NOACs, i.e. dabigatran, rivaroxaban and apixaban) around dental extractions. We hypothesise that the amount of bleeding post-extraction will be similar between patients who continue NOACs and patients who continue warfarin. By providing evidence that NOAC therapy can be safely continued for dental extractions, we believe that fewer patients will be exposed to the undue risk of developing blood clots by unnecessary interruption of anticoagulant therapy.

The aim of this study is to test a novel cannula that permits blood flow up and down the leg (called bi-directional) when placed in the femoral artery for the purposes of connecting patients to cardiopulmonary bypass during cardiac surgery. As the cannula needs to be large to allow for a large volume of blood that must pass through the ECMO machine, the diameter of the cannula is almost the same as the diameter of the femoral artery so there is little room around the cannula for the blood to flow down the leg. Complications can arise due to poor blood flow down the leg which may result in irreversible damage to structures in the leg. The use of a second downstream cannula or sewing a side graft are methods used to prevent complications from poor blood supply to the lower leg by providing a dedicated blood supply. These techniques are cumbersome, time consuming and require additional equipment. As a result current standard practice involves the use of an upstream femoral cannula only, relying on the very small amount of blood that will flow downstream around the cannula to keep the leg viable. It is hoped that the use of the novel bi-directional femoral perfusion cannula in cardiac surgery will lead to an improvement in current practice by providing a more reliable continuous blood flow down the leg during cardiopulmonary bypass. The aim of this study is to evaluate the safety and performance of the MTMM bi-directional cannula in the cardiac surgery setting and to determine whether this cannula provides adequate downstream blood flow to the limb to avoid complications from poor blood supply.

The primary purpose of this study is to evaluate the role of socioeconomic disadvantage on the needs and experiences of care of cancer patients. Australians experiencing socioeconomic disadvantage have poorer cancer-related outcomes than their counterparts. To ensure cancer care is equitable it is imperative that steps are taken to reduce disparities in care related to socioeconomic status. However, in order to achieve this aim and to make improvements where they are most needed, we must first understand where the greatest disparities in cancer care exist. Who is it for? You may be eligible to join this study if you are aged 18 or over, have been diagnosed with any form of cancer, are attending the clinic for an outpatient medical or radiation oncology appointment at any of the recruitment hospitals and have attended the clinic on at least one previous occasion in the last 6 months. Study details All participants recruited to this study will be asked to complete a survey while waiting for their outpatient appointment. A follow-up survey will be mailed to participants 4 weeks post-recruitment. Surveys will contain questions relating to patients' experiences with cancer care, quality of life, socio-demographics, disease and treatment related characteristics will also be included. A sub-sample of at least 15 participants whose survey responses indicate they are experiencing socioeconomic disadvantage, will also be contacted by the research team 8 weeks post-recruitment to participate in a telephone interview. This study will help to identify the gaps in care for cancer patients experiencing socioeconomic disadvantage, which may assist in informing the Cancer Institute NSW as to which specific areas should be targeted to improve care for this vulnerable population.

Background. Various lines of evidence indicate that negative metabolic consequences follow when a person regularly drinks a large quantity of sugar-sweetened beverages (SSBs). What is not known is whether SSBs also produce negative psychological effects, such as impairments in short-term memory and increased impulsiveness. Switching from SSBs to ‘diet’ beverages (non-nutritive sweetened beverages; NSBs) would seem to offer a relatively easy dietary change. However, it has been claimed that this can be counter-productive in at least some circumstances. Aims. 1. To test whether SSB consumption produces impairment on psychological tests, relative to NSB consumption and a water control condition; 2. To test whether the effects of NSB consumption depends on other aspects of a person’s diet (e.g. consumption of sweet energy-rich foods). Design. In a non-blinded 3-group parallel design over a 12-week period the Sugar group is given SSBs, the Diet group is given NSBs and the Water group is given water. Metabolic and cognitive/behavioural measures are taken at the outset of the intervention (Initial test), after 6 weeks (Midway test), at the end of the intervention (Completion test) and approximately 12 weeks later (Follow up test). Main predictions: 1. In the Completion test the primary psychological outcome measure, scores on the Logical Memory test, will be lower in the Sugar group than in the other two groups. 2. In the Completion test the primary metabolic outcome, waist:hip ratio will be larger in the Sugar group than in the other two groups.

The purpose of this proposed project is to replicate the efficacy of, and assess the cost-effectiveness, an established internet-delivered self-management program, the Pain Course, for chronic pain, when administered with optional clinician guidance versus a waitlist control. Participants in this research trial will be randomly allocated to receive the Course with optional telephone guidance from a clinician, or to a delayed-treatment control group. Hypotheses: 1. The Pain Course will result in statistically and clinically significant improvements in symptoms of disability, anxiety and depression from pre-treatment to post-treatment compared to the treatment-as-usual Waitlist Control Group. 2. The Pain Course will be more cost-effective at common willingness-to-pay thresholds compared with treatment as usual. 3. Observed clinical improvements in symptoms of disability, anxiety and depression will be maintained at 3-month follow-up.

Description: Post-herpetic neuralgia (PHN) is a condition in which there are few effective therapies, and most of those which do show some efficacy have an unfavourable side effect profile. This study will explore whether a widely used clinical complementary therapy may have a role in the treatment of PHN. In addition to confirming whether SJW is effective in PHN, this research will help to build an evidence base for complementary therapies. Despite being widely used, most complementary therapies remain unstudied. This research will help to uncover the effectiveness, or lack thereof, of SJW in PHN. Objectives: Primary – The effectiveness of a herbal treatment on clinical measures of post-herpetic neuralgia. Secondary – Tolerability of a herbal medicine treatment in the treatment of post-herpetic neuralgia Study design: Double-blind randomised cross-over clinical trial Planned sample size: 40-60 (pilot) Selection criteria: Persons with a confirmed diagnosis of herpetic neuralgia. Study procedures: The design of the study is a randomised, placebo controlled pilot trial recruiting 40-45 adults (18-65) with post-herpetic neuralgia (PHN). The clinical trial will be conducted over 9 weeks in 3 phases. All the participants will receive placebo application for the 1st phase (washout-placebo phase - 1 week), then group 1 (determined via randomisation) will continue to take placebo for 4 weeks, while group 2 will receive the active St. John’s Wort topical application (SJW). The next phase involves both groups 1 and 2 crossing over for 4 weeks. The topical application will be applied to the area affected by PHN twice daily, this will differ depending on the severity and extent of PHN in individual patients. Statistical considerations: As a pilot study of a treatment in common clinical use, but with no data to calculate effect size, a pilot trial of 40-60 persons will be conducted. Study duration: 4 weeks (participant). Recruitment will last for 1 year (12 months)

The purpose of this project is to evaluate the usability, acceptability and impact of the Mindfulness and Gamification eTool and its capacity to promote wellbeing. The eTool is designed to improve user engagement with an existing program, Smiling Mind, by increasing gamified features and elements.

Asthma is a major health problem globally. Clinical research and management mainly focus on moderate to severe asthma, however most adults with asthma have mild disease. Short Acting Beta Agonist (SABA) reliever therapy alone is currently the internationally recommended treatment in mild asthma. However, there is substantial morbidity in this population and previous studies have shown that those with intermittent or mild persistent asthma who were Inhaled Corticosteroid (ICS) free experienced severe exacerbations. Evidence suggests that a combination Inhaled Corticosteroid/ Long Acting Beta Agonist (ICS/LABA) inhaler used as reliever therapy may be preferable to SABA only reliever therapy and represent an alternative to maintenance ICS and SABA reliever therapy. The major advantage of the combination ICS/LABA as needed over SABA monotherapy is the ICS therapy is being self-titrated according to symptoms in a group of patients that would not otherwise receive ICS. It may improve adherence to ICS use and enable high dose ICS therapy to be promptly delivered by patients with worsening asthma. We are therefore investigating the safety and efficacy of 3 treatment regimens in mild asthma: 1. A combination inhaled corticosteroid (ICS) and Long Acting Beta Agonist (LABA) as required 2. SABA only as required 3. Regular ICS maintenance, and SABA as required.

Currently, opinion amongst obstetric anaesthetists is divided as to whether an intravenous (IV) route is superior to the per rectum (PR) route for perioperative mangagement of post caesarean section pain. Recently, a prospective audit was conducted at the Northern Hospital. This audit assigned 50 women to receive IV analgesia and a further 50 women received PR analgesia post caesarean section, which was either an elective or an emergency procedure. Analysis of the data revealed that the group who had received IV analgesia had a lower 48 hour oxycodone usage of 148.9 +/- 36.7 compared to the PR analgesia group, which had a 48 hour oxycodone usage of 170.0 +/- 47.5 mg. This difference is a 12.4% reduction. Despite this apparent difference in opioid requirements, there did not appear to be a difference in pain scores as reflected by the fact that for three of the four pain questionnaires, all of which were unidimensional measurements of pain, there was no statistical difference between the two groups. For the fourth pain questionnaire, which measures the multidimensional aspect of pain, a statistical difference was found favouring the group who had received IV analgesia. Therefore, we wish to expand upon these findings and would like to propose a non-blinded randomised controlled trial comparing the IV route to the PR route. Based on data previously obtained, if the IV route provided better analgesia, we propose that there should be a 20% reduction in the total pain score as determined by the multidimensional pain questionnaire (SF-MPQ).

This study aims to look at the effectiveness of rehabilitation for improving prospective memory in everyday life. Prospective memory refers to remembering to carry out things you intend to do in the future, like remembering to attend an appointment or to take medication. Previous research has shown that people with traumatic brain injury often have prospective memory difficulties which can impact on their independent living, social participation and work. Compensatory rehabilitation approaches which involve training people to use a range of strategies to circumvent the problem (i.e. diaries, note-taking, alarms) are successful in improving prospective memory function. However, research has also shown that strategy use and everyday memory performance can be enhanced by using a 'metacognitive' treatment approach designed to improve self-awareness of changes post injury. This study will compare two treatment approaches: a compensatory rehabilitation approach and a compensatory plus metacognitive rehabilitation approach designed to develop self-awareness of prospective memory problems and train strategy use to improve everyday prospective memory function. The study will also explore whether improvements are maintained (3 months and 6 months) after the rehabilitation is finished.