ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32707 results sorted by trial registration date.
  • Promoting walking, improving psychological wellbeing and enhancing work outcomes in physically inactive employees

    It is well established that physical inactivity leads to a wide range of poor health outcomes. Physical inactivity is highly prevalent in Australia, and the direct cost of physical inactivity to the Australian economy is $1.5 billion per year. Numerous physical and psychological health benefits can be reaped if more individuals engage in regular moderate intensity physical activity across all life domains, including at work. Effective, sustainable and scalable evidence-based physical activity interventions are therefore urgently needed. We propose an innovative peer-led workplace walking intervention designed to empower employees to gradually take ownership of their physical activity behaviours, thereby facilitating sustained engagement. Our research plans involve training peer leaders in the workplace, i.e. existing employees, to facilitate long-term capacity in each worksite. Our proposed research plan is based on a solid theoretical framework that involves isolating motivation effects from group-based effects on walking behaviour, and testing mediators (motivation) of intervention effects via a thorough process evaluation. We propose a pragmatic 16-week pilot cluster randomised controlled trial targeted at physically inactive employees to examine the feasibility and preliminary effects of the intervention on walking, health, well-being and work performance. Eight worksites and a total of 121 employees from these worksites will be recruited from worksites in Perth, WA. The results of the research could have direct translational potential for workplace health practice and policy with great potential for roll out across a range of work sites and sectors.

  • Bile Reflux after Weight-Loss Surgery

    We are assessing the occurrence of bile reflux in patients who have undergone weight-loss operations. Bile reflux can predispose to oesophagitis, Barrett’s oesophagus and even oesophageal cancer. A new surgical technique has been developed and shows excellent results with regard to weight loss, remission of diabetes and safety. This technique is controversial, however, with an increased theoretical risk of bile reflux. Our study will provide additional data on the safety of weight loss operations, both generally and specifically relating to bile reflux, impacting surgical decision making in bariatric surgery. The results from our study will provide clinicians with clear evidence from which they can make informed decisions about the safety of the 'new' surgical technique. With current data showing favourable results, including improved efficacy and decreased risk of complications, increased utilisation of the technique will result in improved short-term and long-term patient outcomes. Awareness of the incidence of bile reflux post-operatively will allow clinicians to treat any reflux early, preventing or at least delaying potentially detrimental health outcomes. These interventions will translate into decreased health expenditure, providing net health and economic benefit.

  • Assessing the pharmacokinetics, safety, and tolerability of CSL112 in healthy Japanese and Caucasian adults

    The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of single doses of CSL112 after intravenous administration in healthy Japanese and Caucasian subjects. Japanese subjects enrolled in the study will be assigned to Cohorts 1, 2, or 3 in a sequential manner. Caucasian subjects will be enrolled in the study and assigned to Cohort 3 only after subject matching by weight within 15% of the median weight of Japanese subjects in Cohort 3. All subjects will be randomized to treatment (CSL112 or placebo) within their cohort and within their race (Cohort 3 only).

  • CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

    This is a phase 1 study of a new molecule (called CEND-1) designed to enter cancer cells and increase the uptake of chemotherapy drugs. Who is it for? You may be eligible for this study if you are aged over 18 and have histologically confirmed metastatic pancreatic ductal cancer. Study details Participants in the phase 1a of the study will take the study medication CEND-1 alone initially for one week, before commencing a combination therapy with CEND-1 and the 28-day cycle of chemotherapy. Participants in the phase 1b of the study will receive the combination therapy with CEND-1 and the 28-day cycle of chemotherapy directly. Treatment may continue as long as there is perceived benefit or until disease progression. All participants will provide blood samples and undergo imaging studies. All participants will receive standard doses of chemotherapy, nabpaclitaxel and gemcitabine, approved in Australia. The primary goal of this research study is to find the correct dose of the study drug, CEND-1, that can be given alone or in combination with standard chemotherapy to patients with pancreatic cancer that has spread. Another goal is to measure the levels of CEND-1 in the blood over time. Researchers also want to learn if the study drug combinations can help to control the disease.

  • Improving treatments for brain metastases through advanced imaging

    This study is examining brain tumour blood flow and drug uptake in patients with brain tumours originating from breast cancer. Who is it for? You may be eligible for this study if you are aged 18 or over and have a history of breast cancer, with radiologically diagnosed metastatic brain disease. Study details All participants will have an intravenous infusion containing a chemical tracer used in a PET scan. On the day of administration, plus an additional one or two occasions in the following week, participants will have a PET-MR scan. The study aims to use imaging to examine the uptake of the chemical tracer in brain metastases originating from breast cancer. It will provide new information about how treatment could be affected by unique blood flow patterns in the brain.

  • The Impact of Branched Chain Amino Acids (BCAA) Supplementation in Patients with Advanced Liver Disease

    Advanced liver disease, or cirrhosis, is associated with increased morbidity and mortality and patients suffer frequent complications. Sarcopenia, defined as the the loss of muscle mass as well as muscle function, is among the commonest complications, with an estimated prevalence of up to 70%. Sarcopenia is independently associated with reduced survival, increased infection risk and higher rates of hospitalisation in this cohort. Despite this, little is known about how to increase muscle mass in this population. Branched chain amino acids (BCAAs) include three essential amino acids which are used as building blocks for protein and energy in muscle. In addition to being the primary energy source for skeletal muscle, they are also used to help clear toxins that build up in liver disease. Patients with cirrhosis have reduced levels of BCAAs, which is thought to be a major contributing factor that contributes to low muscle mass in these patients. Treating patients with oral BCAA supplements, in the form of a soluble powder, may improve quality of life and overall nutrition in patients with cirrhosis. However, the impact on muscle mass is unknown. Our study aims to investigate the effect of oral BCAA powdered supplements on sarcopenia in patients with cirrhosis. Our randomised trial will compare BCAAs to a control protein supplement to assess whether replacing dietary protein deficit as a whole or BCAAs specifically can influence outcomes. Our primary outcome will be an increase in muscle mass and strength in treated subjects. If we can improve sarcopenia, we anticipate we may also improve other outcomes. Therefore, our secondary outcomes of this study will be improved muscle function, hepatic encephalopathy, insulin resistance, rates of hospitalisation, health care costs, quality of life and overall mortality. Given the higher rates of infections seen in patients with sarcopenia, the second focus of our study will be on immune function through monitoring blood samples and infectious complications.

  • Muscle Energy Technique for Chronic Obstructive Pulmonary Disease

    The aim of this research is to evaluate whether it is feasible to add a manual therapy technique, called Muscle Energy Technique, to a Pulmonary Rehabilitation program for people with COPD. Muscle Energy Technique is a gentle manual technique used by osteopaths, physiotherapists and massage therapists to improve joint motion and stretch the muscles. Muscle Energy Technique is commonly used in clinical practice in Australia and around the world. Recent studies have shown positive effects when Muscle Energy Technique are used with Pulmonary Rehabilitation. These benefits include improved ability to exercise. This research is important to help us understand what effects Muscle Energy Technique may have in people with COPD. Participants will be enrolled for a total of 12 weeks. Participation in the research will involve participants attending a Pulmonary Rehabilitation program twice per week for 8 weeks. In weeks 1, 2 and 3 and 5, 6 and 7 they will also receive a Muscle Energy Technique treatment before the Pulmonary Rehabilitation session once per week. These will be conducted in the physiotherapy department at Austin Health. In week 12 participants will receive a follow up phone call from the researcher. The follow up phone call in week 12 should take no longer than 10 minutes.

  • The impact of cognitive training on cognitive outcomes following coronary artery bypass grafting surgery in older adults.

    Older adults are increasingly having operations on their heart, which improves heart function however often leads to problems with learning and memory (cognitive impairment). These adults are already at high risk of dementia due to poor heart health, therefore this cognitive impairment after surgery puts them at even greater risk of late-life dementia. This project aims to decrease future dementia risk following heart surgery, in 120 patients 65 years and older, using cognitive training interventions. Learning and memory will be measured at the beginning of the study, so any changes can be assessed following surgery. The cognitive interventions will take place both before and after surgery in half of the patients. Cognitive impairment (such as delirium) will be monitored in hospital and learning and memory will be tested 4 and 6 and 12 months, and 1 and 3 years post-surgery. It is expected that patients who undertake cognitive training will demonstrate better learning and memory after surgery compared to patients who did not.

  • Single Troponin Accelerated Triage of Chest Pain (STAT-Chest Pain) Study: Assessment of the safety and efficacy of an innovative pathway used to triage patients presenting to the Emergency Department with chest pain.

    Acute chest pain is one of the commonest causes of presentation to Emergency Departments (EDs) locally (~7.5% of all attendances to Royal Perth Hospital ED in 2015), nationally and worldwide. The majority (>75%) of these individuals are at low risk of serious complications, with only a small proportion ultimately diagnosed with an acute coronary syndrome (ACS) or other major pathology. The consequences of misdiagnosis are, however, potentially catastrophic. Thus, considerable time and resources are expended to ensure the accurate triage of such patients. Recent data from Shah et al suggests that patients with very low levels of high sensitivity troponin (hs-cTn; a very sensitive and specific blood marker of cardiac injury) on arrival to ED (the majority of all those with presenting with chest pain) are at extremely low risk and could be safely and quickly discharged. They found that of all patients presenting with suspected acute coronary syndromes, 61% had a high sensitivity troponin I of <5 ng/L which had a negative predictive value of 99.6% (95% CI 99.3-99.8) for index myocardial infarction and subsequent myocardial infarction or cardiac death at 30 days. If their serum troponin measurement was taken more than 2 hours after the onset of symptoms then this increased the negative predictive value to 99.8% (95% CI 99.6-100%). Based on this research and current best practice, our group has developed a rapid assessment “single troponin” chest pain pathway that will be introduced at Royal Perth Hospital in early 2018. Using a pre/post cohort study design we will observe the efficacy and safety of this innovative pathway, which offers the most accelerated triage of patients with chest pain currently available, and compare it with the current National Heart Foundation of Australia / Cardiac Society of Australia and New Zealand Guidelines based “Suspected ACS Pathway” which represents current best practice. We hypothesise that using a combination of hs-cTnI levels, careful clinical assessment, objective risk scores and structured, evidence-based, early follow up and investigation will greatly reduce the length of stay for low risk patients without any increase in adverse outcomes. If this proves correct this novel pathway will result in considerable efficiencies and cost savings that can be easily replicated in other hospitals.

  • On-line cooking tips for Sleevers

    We previously recruited 506 adults (mean age 38.8 ± 11.8 years; 18% male) who completed a nutrition questionnaire. Included were individuals with different classes of obesity and past weight loss surgery (11%, n=55). The relationship between demographic characteristics, nutrition knowledge, and diet quality were explored. Those with obesity (BMI >30 kg.m-2) had lower levels of nutrition knowledge and those with a BMI >40 kg.m-2 had the lowest diet quality of the BMI groups studied. The lowest diet quality was reported for individuals with past weight loss surgery. Our findings provide evidence that individuals who have undergone weight loss surgery should be targeted for nutrition interventions aimed at assisting in the adoption of higher quality diets. This study aims to evaluate cooking skills and diet quality of individuals who previously had a Sleeve Gastrectomy (at least 12 months ago) using a cross-sectional questionnaire. In addition, to conducting an on-line intervention that encourages cooking from fresh and basic ingredients delivered via a Closed Facebook group. The intervention will consist of healthy cooking tips and recipes specially developed for individuals 12 months post Sleeve Gastrectomy, delivered over 10 weeks.

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