ANZCTR search results

Providing 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.

The 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.

The 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.

Physical 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.

Advances 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.

The aim of the project is to examine if changes in the maternal diet can reduce the colicky symptoms of infants with infantile colic, resulting in a more settled baby and reduced parental stress and exhaustion. There is limited evidence to support that changes in the mother's diet can lead to a more settled baby despite this being common practice by breastfeeding mothers and health professionals. This study will use rigorous and controlled methods to investigate if the properties of breast milk and infant faeces changes when the mother's diet is altered, which is currently unclear.

The primary purpose of this trial is to investigate the efficacy of StrataXRT in reducing the incidence and rate of onset of radiation dermatitis in head and neck cancer patients undergoing radiotherapy. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over, and have been diagnosed with a head or neck cancer for which you are receiving radiotherapy (>50Gy) with or without concurrent chemotherapy or biotherapy. Study details Participants enrolled in this trial will be randomly allocated (by chance) to receive either StrataXRT gel or 10% Glycerine (Sorbolene). The allocated dressing will be applied to the irradiated skin, twice a day until the skin reaction subsides, up to 4 weeks post treatment. Participants will complete a range of questionnaires by interview every week from the start of radiotherapy and four weeks following the completion of radiotherapy, in addition to collecting data on radiation dermatitis symptoms, healthcare costs and side effects. It is hoped that results from this trial will provide information on whether StrataXRT is more safe and effective than Sorbolene for the prevention and treatment of radiation dermatitis in head and neck cancer patients undergoing radiotherapy.

This study aims to investigate the effectiveness, safety, tolerability and blood levels, of twice daily ZYN002, in addition to regular seizure medication, for 12 weeks in 180 adults with partial onset seizures. This will be done by analysing a daily seizure and skin irritation diary, drug levels in the blood at various times following drug administration, and side effects. Skin at the application sites will be checked to see if there is any irritation or reactions present after applications. Who is if for? You may be eligible to join this study if you are aged between 18 and 70 years, have epilepsy with partial onset seizures and are currently on a stable regimen of AED(s). Study details: This study will investigate two doses of ZYN002 compared to a placebo gel (a treatment with no active ingredients which looks like the real thing but it is not). This study is ‘double-blind’ which means you and your study doctor, together with the study staff will not know whether you are receiving ZYN002 or placebo gel. What does study participation involve? Your participation in the study includes a screening visit; a baseline period of up to 8-weeks; a 12 week study treatment period; dose reduction at Week 13 and 14; and an end of study (EOS) visit at Week 15. Participants should fast prior to four study visits. Participants will be instructed to record their seizure frequency and type in their daily diary. During the baseline period, participants will record seizures in the daily diary, and blood samples will be collected at two visits. During the treatment period four clinic visits are required for: blood sampling; review of daily diary, medications, AEs and skin irritation; measurement of blood pressure, heart rate, breathing rate and temperature ; suicide risk; and possibly, a brief physical and neurological exam, pregnancy tests (females only, if applicable) and an ECG. Participants withhold their morning application until after blood sample collection at these visits. Two additional clinic visits are also required for blood sampling. Additional out-patient visits may be required if there is skin irritation present at the application site.

The study will compare the safety, tolerability and pharmacokinetics (the levels of drug in the blood) of 3 drugs when given intravenously (into a vein). The drugs tested are: *a new drug called ABP 959, *a marketed drug called Eculizumab (Soliris registered trademark) approved in United States (US) *a marketed drug called Eculizumab (Soliris registered trademar) approved in European Union (EU) The study is to test that these drugs behave the same in the body, for example, produce the same drug levels in the blood. who is it for? You may be eligible to join this study if you are a healthy male 18 to 45 years of age, inclusive. Non-Japanese subjects will have a BMI of 18.0 to 30.0 kg/m2, inclusive, at screening and check-in. Japanese subjects must have a BMI of 18.0 to 25.0 kg/m2, inclusive, at screening and check-in. Trail Details Participants in this study will be randomly (by chance) allocated into one of three groups to receive either: - ABP 959 300 mg intravenously once only. - US approved Eculizumab 300 mg intravenously once only. - EU approved Eculizumab 300 mg intravenously once only. All participants will be followed-up at 50 days post allocation to one of the three drugs used in this trial.

This study aims to obtain a real-time gas profile of the entire gastrointestinal tract of healthy human volunteers on a standardised diet using a novel medical device entitled “human gas capsule”. The clinical trial will also evaluate the viability of the gas capsule in the human body, accessibility of the graphical user interface for the data acquisition system and the reliability of the data analysis.