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Cervical Ripening Using Misoprostol vs Dinoprostone: A randomised, triple-blinded, interventional study comparing safety and efficacy in primiparous women
Expand descriptionMisoprostol and Dinoprostone are both medications used to ripen a woman's cervix in preparation for labour. In a phase III trial by Wing et al misoprostol vaginal insert, when compared to dinoprostone vaginal insert, was thought to reduce the time from insert to vaginal delivery and decrease the number of women needing further intervention by oxytocin for induction of labour by 26% without an increase in the complications of caesarean section or neonatal morbidity. Misoprostol was found to increase the rate of tachysystole (too frequent uterine contractions) to 13% compared with 4% for dinoprostone. Wing et al used both primiparous women and multiparous women in their study. We hypothesize that by using misoprostol in primiparous women only we may still be able to achieve the significant reduction in need for other interventions for induction of labour but without the significant increase in rates of uterine tachysystole. Women admitted to the study will have either the misoprostol or dinoprostone inserted for cervical ripening and data collected on whether or not they then needed to have a cervical ripening balloon for further ripening, whether they needed oxytocin for induction of labour, whether they had too many contractions that required intervention to control, what their mode of delivery was, what the time interval between when the pessary was inserted and when they delivered and whether or not there were any neonatal complications.
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The EXPRESS pilot study: EXercise and PRotein Supplementation Supporting Autonomy in Prefrail & Frail Community Residing adults aged 65 years or older
Expand descriptionThis proposed research will examine the feasibility of the FRAIL Screen in general practice as a screening tool for frailty and determine the impact of a high- as compared to low-quality protein supplement in combination with a centre- and home-based exercise intervention on muscle strength, physical function parameter and quality of life in frail older people who live in the community. Aims: 1. To examine, the feasibility of recruiting 120 community-dwelling older people, aged 65 years and older who have screened frail (>1) using the FRAIL SCREEN tool to a 6 months intervention study involving nutrition and exercise; 2. To determine the effects, over a period of 6 months, of exercise in combination with either (i) high-quality whey protein supplements or (ii) lower-quality rice protein supplement, on the primary outcomes of gait speed, leg press and grip strength, and physical performance, and other secondary outcomes including frailty, muscle mass, nutritional intake, physical activity, and quality of life. Hypotheses: 1. It is feasible to recruit 120 community dwelling frail older people using the FRAIL SCREEN tool through the ACH referral system and multiple proposed referral strategies. 2. It is feasible for participants to participate in the proposed nutritional and exercise supplementation program for a period of 6 months. 3. The higher-quality whey protein supplement combined with a pragmatic exercise program will result in greater improvement of gait speed and grip strength, physical performance and quality of life, and the other secondary outcomes at 3 months and 6 months than a lower quality rice protein combined with pragmatic exercise program, in older people who are frail or at-risk of frailty as determined by the FRAIL Screen.
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Evaluation of glyceryl trinitrate ointment as treatment for leg ulcers
Expand descriptionThe proposed research plans to examine the application of an ointment (Rectogesic 0.2% GTN), a pharmaceutical agent approved for human use, on venous leg ulcers. GTN ointment works in part by releasing nitric oxide (NO) into the wound, which acts to improve blood flow to the area and has the capacity to kill unwanted bacteria in the wound. The product to date has not been used routinely for the treatment of venous leg ulcers. A previous study by the chief investigator demonstrated the enzyme (iNOS), which drives the production of NO, was elevated in patients with faster healing leg ulcers, suggesting that application of a topical GTN donor (the ointment) might accelerate this healing process. The trial will be double blinded with half of the recruited patients receiving a placebo and the other half receiving the GTN donor. Neither the patients nor the research nurse involved in treatment will know if the product is the placebo or the GTN donor. The trial will run only for 4 weeks for each patient so rates of healing will be determined by planimetry (ulcer tracing) as complete healing of the ulcer will most likely not be achieved in the time frame being examined. If a statistically significant difference exists between the two groups the treatment will deemed successful. It is hoped that a subsequent larger trial will be planned based on the findings from this study. Hypothesis: Participants receiving the Rectogesic (GTN donor) will have a statistically higher linear healing rate (LHR) compared to patients that receive only the placebo.
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Biomarkers in Pancreatic Cancer
Expand descriptionPancreatic cancer is a devastating disease that is set to become the 2nd leading cause of cancer-related deaths worldwide by 2020. Over 80% of pancreatic cancer patients are diagnosed with unresectable locally advanced or metastatic disease. Through data collection and correlation with analyses of archival tumour specimens and blood collections, this trial aims to identify and validate novel diagnostic and monitoring methods; novel predictive and prognostic biomarkers and to use these to inform studies of novel therapeutic opportunities that will improve the management of pancreatic cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with pancreatic ductal adenocarcinoma (PDAC). Study details This protocol aims to enrol at least 500 consecutive eligible patients over 10 years. Enrolled patients will undergo collection of clinical data and archival tumour specimens. Where applicable, patients will also undergo collection of blood and/ or urine at several time points. Once a sufficient cohort has been enrolled, selected molecular analyses will be conducted on each specimen, thus, allowing for batching of specimens. Enrolled patients will undergo collection of clinical data and archival or fresh tumour specimens as part of routine clinical management, with all patients will be treated as per standard of care. When applicable, archival tissue samples from the primary pancreatic cancer, matched normal pancreas tissue and/or resected metastases will be obtained, upon enrolment. to study. Where possible, current biopsy specimens (fresh tissue) will be collected by either Victorian Cancer Biobank or local pathology laboratories at the time of standard of care procedures. Patients that consent to the “liquid biopsy” (blood and urine collection) sub-study will undergo collection of blood/plasma and urine at the beginning and during each systemic therapy. Blood (upto 60 ml) and urine (upto 60 ml) will be collected for research purposes on the following occasions: 1. Before and after surgical removal of pancreatic cancer (if applicable) 2. Before and after any chemotherapy regimen (if applicable) 3. Every 6 months while you are on active surveillance (if applicable) Follow up will occur until the end of active surveillance, death or 5 years post enrolment, whichever occurs first.
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Clinical Trial of Group counselling and support online using Kids Helpline Circles on a secure social network.
Expand descriptionThe research aims to provide evidence of efficacy of social support to young clients (13-25) who utilise the projects secure social network community site for peer-to-peer support supervised by a counsellor at Kids Help Line. This will validate that the best way to support and manage young peoples mental health issues is through extending solution focused one-on-one counselling practice to incorporate group counselling with peers, of the same age and problem, in a supportive, private and secure social network environment.
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Designing physical activity interventions based on user’s need for cognition: impact on attention and persuasion among healthy adults
Expand descriptionProviding individuals with physical activity advice and guidance can help to improve their physical activity behavior. This is especially the case when individuals are motivated to read the information and are able to understand it and consider it thoughtfully. There is some evidence that providing people with information that is matched to their cognitive processing style, known as need for cognition, increases motivation and ability to read the messages presented. Further, there is evidence that this in turn is associated with greater improvements in attitudes and behaviors. This has been shown in a health context before (e.g., mammogram utilization), but evidence in the physical activity field is lacking. Given that interventions matched to participant’s need for cognition are more resource intensive to develop than unmatched interventions (requiring at least double the intervention materials), research examining the impact of matching to need for cognition in the physical activity domain is needed before this technique is adopted en masse in this area. We aim to examine how stimuli optimized for central route (deep thinking) processing compared to peripheral route processing (use of simple cues) are processed by individuals with higher and lower need for cognition and the impact of this on the persuasiveness of the materials. This will be achieved in a mixed method laboratory-based study, with outcomes assessed using eye-trackers, combined with brief questionnaires and qualitative interview. We hypothesize that individuals who are shown materials that best match their cognitive processing style will show greater attention to the materials and less distraction when processing them (assessed by eye tracking devices) compared to individuals who are shown materials that do not match their cognitive processing style. Further, we anticipate that greater attention will be associated with more positive ratings of the intervention materials and greater motivation for physical activity participation (assessed via self-report; quantitative and qualitative methods). Overall, this study will provide valuable insights into how to develop physical activity messages and in doing so may help to inform the development of more effective physical activity interventions in the future.
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Medicinal Cannabis for Anorexia in Advanced Cancer
Expand descriptionThe primary purpose of this trial is to evaluate whether a vaporised form of medicinal cannabis is feasible and effective in increasing appetite in cancer patients with anorexia. Who is it for? You may be eligible for this trial if you are aged 18 or over, have an advanced cancer and have been suffering from anorexia for at least two weeks. Study details: Participants will receive a range of doses of vaporised botanical cannabis flower bud one hour before your meals (three times a day) for 7 days unless side effects occur. Each dose may be different from the previous dose, but they will all be made up to the same weight of plant material by adding different amounts of inactive plant material (‘placebo’, which has the same characteristics of leaf cannabis with the active components removed). Participants will have blood samples taken at multiple timepoints up to 4 hours following each morning dose and will complete a number of questionnaires and a daily food record to determine the concentration of the drug in the blood, and to monitor its effect on appetite, mood and other factors. It is hoped that the findings from this trial will provide information on whether inhalation of medicinal cannabis is feasible for achieving a safe and effective blood concentration for the treatment of anorexia in cancer patients.
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A prospective study conducted in an adult intensive care unit to measure the plasma concentration of citrate during continuous renal replacement therapy.
Expand descriptionThe primary aim of the study is to quantify to plasma concentration of citrate when using RCA with CRRT. We expect to establish a mean and standard deviation for the plasma concentration. Our secondary aim is to measure citrate clearance across the haemofilter over time. We hope to show that this measure is sensitive enough to predict filter failure.
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Physical activity levels in Sydney Local Health District (SLHD) allied health professionals.
Expand descriptionPhysical inactivity has been linked to increases in morbidity and mortality, with major implications for the general health. Participation in sufficient physical activity levels throughout the day is associated with significant health benefits. The study aims to evaluate the physical activity levels of allied health staff working in Sydney Local Health District (SLHD) to determine the contribution of workplace to daily physical activity levels. Specifically, the aims of the study are to: 1. Quantify the number of steps taken and the amount of moderate to vigorous physical activity of allied health professionals during work time and outside work time. 2. Determine how the physical activity levels of allied health professionals employed within the SLHD compare to recommended physical activity levels for Australian adults. 3. Investigate how physical activity levels vary between allied health professionals working in different allied health disciplines. This study will be an observational cross sectional study. A recruitment flyer will be distributed to all allied health departments (physiotherapy, speech pathology, occupational therapy, psychology, nutrition and dietetics, pharmacy, radiography, and social work, podiatry, orthotics) across the SLHD (Royal Prince Alfred hospital, Concord hospital, Balmain Hospital and Canterbury Hospital). Interested participants will be given a participant information sheet and will be required to sign a consent form. Inclusion Criteria - Allied health professionals (aged 20 - 70 years) employed in the SLHD and who are working within their usual professional capacity during the data collection period (7 days). Exclusion criteria – Allied health professionals who are unable to perform their usual work duties over the seven day study period. Methods Allied health professionals who agree to participate in this study will have the following baseline measurements collected: - Demographic information - age, gender, occupational classification, work department. - Basic anthropometric measurements - weight, height, body mass index (BMI), - Administration of validated physical activity questionnaires: Activity Australia Questionnaire, International Physical Activity Questionnaire (IPAQ), Occupational Sitting and Physical Activity Questionnaire (OSPAQ). Participants will then be fitted with a physical activity monitor (uniaxial Actigraph GT1M accelerometer) and asked to wear for 7 days. Participants will also be asked to keep an activity diary. Physical activity data will be analysed and presented as means and standard deviations of daily step count and amount of moderate-to-vigorous physical activity. Physical activity during work time will be compared with physical activity outside work time. Physical activity levels will be compared with recommended guidelines for Australian adults.
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Understanding the negative effects of prolonged sitting: investigating the impact on musculoskeletal discomfort and cardiovascular parameters
Expand descriptionAdvances in technology, while providing a wide and varied range of benefits, have had the effect of engineering an environment where humans are continually encouraged to sit. This shift toward a more sedentary lifestyle has been linked to a myriad of poor health outcomes, including increased risk of cardiovascular disease, diabetes, and all-cause mortality. Compelling evidence indicates that the global burden of chronic disease and premature deaths attributable to physical inactivity is comparable to smoking. Over the past decade, our lab has revealed that sedentary behaviour (sitting) is associated with elevated markers of cardio-metabolic risk, and premature all-cause and cardiovascular disease mortality. Expanding on the evidence provided from observational studies, we have shown a beneficial effect of breaking up prolonged sitting time with light intensity physical activity on postprandial glucose and insulin metabolism, blood pressure and fibrinogen; and that some of these effects are being mediated by changes at the gene and protein expression level. Despite the progress that has been made, there still remains the question “how much sitting is too much”? This is likely to involve a complicated interplay between several different metabolic processes, and requires the ability to use continuous measures to determine the point at which negative effects occur. Teasing out the mechanisms and time-course of the negative impact of prolonged uninterrupted sitting is a vital next step which could help to inform future intervention strategies and activity guidelines. In this pilot trial, we aim to assess the impact of 5 hours of prolonged, uninterrupted sitting on various physiological and metabolic parameters in overweight adults with type 2 diabetes (n=5). These parameters include: (i) muscle activity and posture, leading to musculoskeletal discomfort (ii) the baroreflex and orthostatic intolerance (iii) sympathetic nervous system activity via microneurography One of the main aims of this pilot trial is to test the feasibility of measuring all of these parameters at once, using our standard sitting intervention and musculoskeletal protocols. In particular, we aim to establish whether we can get useful EMG and posture measures with the other equipment and furniture being used; and also determine if we can get clear and meaningful microneurography measurements in the sitting position. We hypothesise that reduced variation in muscle activity resulting from prolonged sitting and poor posture will lead to musculoskeletal discomfort. Moreover, prolonged sitting will lead to baroreflex dysfunction and orthostatic intolerance. Sympathetic nervous system activity will be tested only for feasibility in this pilot study.