You can narrow down the results using the filters
-
A Phase I/IIa Study of the Efficacy and Safety of ASN-002 Alone and in Combination with 5-Fluorouracil (5-FU) in Adult Patients with Low-Risk Nodular Basal Cell Carcinoma
The primary purpose of this study is to determine whether ASN-002 alone or in combination with 5-FUis safe and effective in the treatment of nodular basal cell carcinoma (nBCC). Who is it for? You may be eligible to join this study if you are aged 18 or over, have been diagnosed with nBCC. Study details ASN-002 is a vaccine-like product that is injected into the BCC spot to be treated. It is made from modified adenovirus serotype 5 (also called Ad5). Adenoviruses are common in nature worldwide and can cause mild colds and respiratory infections from which people usually recover without treatment. The Ad5 used in this study has been modified so that it cannot grow in the body or cause an infection. The modified Ad5 in this study will deliver artificially made genetic material into the cancerous and surrounding cells. This genetic material will produce human interferon which is normally produced by the body to stimulate the immune system. It is hoped that injected ASN-002 will cause the body’s own cells to produce interferon and stimulate the immune system to attack the cancerous cells and reduce the size of or eliminate the nBCC. 5-FU is a chemotherapeutic agent approved to treat many types of cancer. Participants will attend the study centre weekly for an injection of ASN-002 alone or in combination with 5-FU into the nBCC. The participants recruited will have 3 injections over 3 weeks, and then undergo surgical excision of the tumour. Patient outcomes will then be assessed using a tumour sample collected during surgery and by the incidence of adverse events which occur throughout the study. It is hoped that the findings of this trial will provide information on the safety and efficacy of using ASN-002 alone and in combination with 5-FU for nBCC, particularly for patients in whom the standard treatment of surgery is not possible or not recommended.
-
Improving access for community health and sub-acute outpatient services.
This study aims to find out if this evidence-based alternative to the traditional use of triaged waiting lists reduces waiting time for a variety of community health and sub-acute ambulatory care services. It is hypothesised that this will be achieved without detrimental effects on service quality, patient outcomes, patient satisfaction or service cost.
-
A randomised controlled trial and consumer characteristics of iChooseWell eHealth: A comprehensive biopsychosocial online wellbeing program to decrease stress.
A randomised controlled trial will be used to investigate the effectiveness of the iChooseWell program. The iChooseWell program will be placed within the Federation eHealth Platform. People visiting the website, in response to advertisements or through self interest, will be informed of the availability of the iChooseWell program and invited to participate in the study. People who consent to take part in the study will be randomly allocated to either an immediate access to the program condition or a delayed access condition (8 week delay). The iChooseWell eHealth program consists of forty biological, psychological, social, and wellness strategies, all designed to increase mind and body health (e.g., brain & gut nutrition, emotional regulation strategies, problem solving, sleep hygiene, social connectedness, practising gratitude). Participants will be able to choose from the array of biopsychosocial strategies available within iChooseWell. Background information is also provided on health and wellbeing (e.g., the stress response, brain/neural plasticity) and useful resources are provided (e.g., self monitoring, ‘On the Go’ mobile tools). Each individual wellness strategy is 2-6 web pages in length (taking between 5-20 minutes to read) and its user friendly and interactive components are designed to keep the user engaged. To consolidate learning, participants will be given activities (10 minutes per day on average) to complete offline to practise the principles of the chosen wellness strategies. Participants will also receive automated emails (e.g., to remind them to log on, when to complete post/follow-up questionnaires) and will be asked several questions during the study period to monitor their progress. The iChooseWell program includes text, graphics, audio, video, quizzes, and downloads. iChooseWell can be accessible via web, mobile or tablet devices. Participants randomised to the iChooseWell eHealth immediate access group will complete a pre-intervention assessment (Week 0), during intervention (Week 3) assessment, post-intervention assessment (Week 5) and a 1 and 3 month follow-up assessment (Week 9 and Week 17). Participants randomised to the delayed access group will complete the same assessment phases and will be given access to the iChooseWell eHealth program following the 1 month follow-up assessment (Week 9). However the delayed access group will be asked to complete the post intervention assessment after they have completed the iChooseWell program (Week 13) and a 1 month follow-up (post program) (Week 17). Access to iChooseWell will be provided for the entire trial period. Adherence will be measured by the number of strategies visited by post assessment (measured via passive analytics) as well as questions regarding engagement levels. It is expected that people who undertake iChooseWell will show increases in mental health and wellbeing and optimism and reductions in negative affect at post and the 1 month follow-up time points.
-
A comparison of the force required for removal of intravenous cannulae using two taping methods
A comparison of two commonly used methods for securing intravenous cannulas Objective: There is a wide variety of techniques to secure intravenous cannulas but little objective evidence to support their relative efficacy. This study compares the security of the two most common methods used within a major Australian Emergency Department. Methods: The plastic sheaths of four needle-less intravenous cannulas were secured to the skin surface (not intravenously) of 40 volunteers using two different taping styles, an ‘under and over’ method with one of the tapes applied to the posterior surface of the hub then crossed anteriorly to adhere to the opposite skin surface or ‘horizontal’ taping with the tapes applied horizontally across the anterior surface of the hub. The peak force required to dislodge the taped cannulas using each of these different methods was then measured in both an anterograde and retrograde direction of force using a force transducer. In more detail, the force of dislodgement was measured in antergrade and retrograde directions with a force transducer and these forces compared. The "under and over" technique was the intervention arm being compared to the more standard "two horizontal tape" method. The plastic sheaths of four needle-less intravenous cannulae were secured to the skin surface (not intravenously) using an ‘under and over’ method with one of the tapes applied to the posterior surface of the hub then crossed anteriorly to adhere to the opposite skin surface or ‘horizontal’ taping with the tapes applied horizontally across the anterior surface of the hub. The peak force required to dislodge the taped cannulae using each of these different methods was then measured in both an anterograde and retrograde direction of force using a force transducer. Each participant had two cannulae for each of the two techniques ie four cannulae in total. The cannulae were applied sequentially to the cubital fossae (2 per arm)of the body. The first cannula was placed in one cubital fossa using the control technique and removed in an anterograde fashion, followed by the second cannula on the same cubital fossa utilising the intervention technique, again dislodged using anterograde force. The process was repeated on the opposite cubital fossa using retrograde force. Cannulae were left in place 5 mins before removal and there was approximately five minutes again until the next cannula removal. Anterograde / retrograde removal is defined as the hub is pulled in direction of cannula removal (anterograde) and against the direction of removal (retrograde) until dislodged. A senior clinician grade operator (often PI) applies the force transducer to the cannula hub whilst blinded to the technique utilised. A second senior clinician grade applies the cannulae without revealing this to the operator attempting removal. There were no adherence monitoring process applied. Results: The force required to dislodge a cannula taped in an ‘under and over’ taping style was significantly higher than that required for the horizontal taping in both anterograde and retrograde directions of force. (p <0.001) Conclusion: The results of this study suggest that the ‘under and over’ taping technique offers significantly more security than ‘horizontal’ taping and should be considered as a more effective method for securing intravenous cannulas.
-
Patient adherence to physiotherapy exercise programs: effect of a web-based exercise programming system compared to usual physiotherapy exercise delivery.
Exercise is an integral component of the conservative management of most musculoskeletal conditions. However, adherence to exercises is often low and this impacts on treatment effectiveness. The aim of this randomised controlled trial is to evaluate whether the addition of a web-based system, Physitrack, to usual physiotherapy treatment improves patient adherence levels to exercises compared to the usual non web-based methods physiotherapists use to deliver exercise programs to people with musculoskeletal conditions. Secondary aims are to evaluate whether Physitrack improves patient satisfaction with the delivery of an exercise program and whether patient confidence changes with Physitrack. The primary hypothesis is: The level of patient-reported adherence to a prescribed exercise program will be greater in the group receiving Physitrack in addition to usual physiotherapy treatment (Physitrack group) than in the group receiving non web-based usual physiotherapy treatment alone (Usual care group) after 3 weeks. Secondary hypotheses are: i) The level of patient satisfaction with the delivery of the prescribed exercise program will be greater in the Physitrack group than in the group receiving non web-based usual care after 3 weeks; and ii) The level of patient confidence with exercises will be greater in the Physitrack group than in the group receiving non web-based usual care after 3 weeks.
-
MEDINA: Mediterranean Dietary Intervention Study in Nonalcoholic Fatty Liver Disease (NAFLD) patients
The aim of this study is to determine if the Mediterranean Diet (MD) compared to standard care (low fat diet), can reduce the severity of NAFLD and other symptoms often associated with NAFLD namely the Metabolic Syndrome (MetS). The components of the MetS which this study aims to monitor and potentially reduce includes: high blood pressure, increased waist circumference, elevated triglycerides (bad fats in the blood), reduced HDL cholesterol (good fats in the blood) and elevated glucose levels. These symptoms are referred to as the Metabolic Syndrome (MS).
-
Safety of Dental Extraction on New Oral Anticoagulants (NOACs) withouT Stopping Therapy (DENTST study)
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.
-
A Phase 1 Study of a Novel Bi-Directional Arterial Cannula in Patients requiring Peripheral Cannulation for Cardiac Surgery.
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.
-
Understanding the role of socioeconomic disadvantage on the needs and experiences of care of cancer patients
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.
-
Effects of sugar-sweetened drinks on psychological and metabolic outcomes.
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.