ANZCTR search results

Nutrition delivery to critically ill patients is largely inadequate, resulting in muscle wasting and reduced physical function in the long-term. While factors such as delayed gastric emptying and reduced glucose absorption are relatively well described early in critical illness, there is a paucity of data on the resolution of these derangements. Further, nutrition intake post-extubation and on the post intensive care unit (ICU) ward are also inadequate. Whether factors that are known to influence nutritional intake in ICU are still prevalent post-ICU requires exploration.

Marketing of unhealthy foods through elite sport sponsorship is pervasive in Australia, with massive audience reach. This study aims to examine spectator responses to unhealthy food sponsorship and investigate the utility of alternative, pro-health sport sponsorship options to promote healthier food choices to young adults. The four sponsorship scenarios tested will be: (A) non-food sponsorship (control); (B) unhealthy food sponsorship; (C) healthier food sponsorship; and (D) obesity prevention campaign sponsorship. Participants will be exposed to their assigned sponsorship stimuli; complete a distractor task; then answer a series of questions assessing their brand awareness, attitudes and image perceptions, event-sponsor-fit perceptions, and their preference for food sponsor products. The findings from this study will lay the foundation for developing public health-oriented sport sponsorship policies targeted toward healthy eating and obesity prevention.

We will test the safety and efficacy of N-Acetyl-Cysteine (NAC) as a pharmacotherapy for methamphetamine dependence using a double-blind placebo-controlled randomised controlled trial (RCT). The trial will involve 180 participants receiving either 12 weeks of take-home oral NAC (2,400 mg daily) or equivalent placebo. There are three trial sites (Wollongong, Geelong and Melbourne). This is a Phase 2b trial that is powered to confirm whether NAC has a clinically relevant benefit on methamphetamine use and a range of related clinical outcomes. Primary hypothesis: Daily oral NAC delivered as a take home medication will reduce methamphetamine use measured as (a) days of methamphetamine use, and (b) methamphetamine in weekly saliva tests, during 12 weeks of active treatment relative to placebo. Secondary hypotheses: Daily oral NAC delivered as a take home medication will, relative to placebo: - reduce the severity of methamphetamine dependence, craving for methamphetamine, methamphetamine withdrawal symptoms and psychiatric symptoms (affective symptoms, positive psychotic symptoms and hostility), - have an acceptable adverse event profile, and - not significantly increase the use of other substances (including alcohol, tobacco, cannabis, heroin and cocaine).

This is a phase 1 study in healthy subjects. It is planned to develop the drug for reducing pressure in the brain of patients with a traumatic brain injury (TBI). Increased pressure following TBI can lead to death or can cause permanent disability. There are currently no medications that are approved for improving outcomes after TBI. The drug will also be tested for improving clinical outcome in patients that suffered a concussion. The study drug being evaluated is called EU-C-001 and is being developed by an Australian company called PresSura Neuro. Studies in animals have shown that EU-C-001 may reduce pressure in the brain. Therefore, it is thought that EU-C-001 may improve outcomes in patients with TBI by increasing the amount of oxygen available to brain tissue. In other studies it was shown that the EU-C-001 may also have potential to improve outcomes in patients with concussion. Single oral administrations up to 180 mg EU-C-001 and single intravenous administrations up to 90 mg EU-C-001 have been administered to healthy male subjects. The safety, tolerability and pharmacokinetic information is not yet available in females. Therefore, the present study is planned to investigate the safety, tolerability and the pharmacokinetic characteristics of the medication given intravenously in healthy female subjects and will compare the result from a historical data set obtained from studies in healthy male subjects.

The purpose of this study is to determine if new blood testing methods are effective in determining Calreticulin mutation status. Who is it for? You may be eligible for this study if you are over the age of 18, have a known myeloproliferative disorder and are currently undergoing regular blood tests at St Vincent’s Hospital. Study details Participants will continue to undergo regular testing by clinicians. However, an additional 10mL of blood will be collected during your routine venesection. This sample will then be tested for Calreticulin mutation using both of the following tests: 1. Flow cytometry 2. Immunohistochemistry The results will then be compared to results from the current gold standard method used for testing for Calreticulin mutations. It is hoped that results from this study would allow testing for Calreticulin mutation to be done rapidly, locally and non-invasively.

Albumin and dexamethasone are often administered to patients undergoing major surgery. Despite these drugs being commonly used, it is not known how they impact on the stress response to surgery. Albumin is an intravenous fluid made up of a normal physiological protein (albumin) in a salt solution, that is routinely administered to patients having major surgery. It is TGA approved and readily available in Australia. Dexamethasone is a steroid medication, often used in many types of surgery to reduce the risk of nausea and vomiting. It also has anti-inflammatory and pain relieving effects. It is also TGA approved and readily available in Australia. This pilot study aims to determine if giving albumin and dexamethasone immediately prior to surgery can reduce the stress response from surgery. Stress, or the inflammatory response during surgery can result in damage to the microvasculature (the smallest blood vessels in the body). By protecting these small vessels with dexamethasone and albumin, we hope to reduce the effects caused by the systemic inflammatory response that accompanies major surgery. The study is a collaboration between 5 major hospitals that specialize in major abdominal surgery. These are Austin Health, Peter MacCallum Cancer Center, Warringal Private Hospital, Knox Private Hospital and Auckland City Hospital. Importantly, for all patients in the study, standard of care will be maintained during anaesthesia, surgery, and the entire perioperative process and there will be NO deviation at any stage from acceptable routine care. For this pilot study, patients undergoing 3 different types of major abdominal surgery will be randomized (allocated by chance) into two groups. The ‘Treatment Group’ will receive 16mg of dexamethasone and 100ml of 20% albumin solution 30-60minutes prior to the start of surgery, and a solution of 4% albumin to meet their ongoing fluid requirements during surgery. The ‘Control Group’ will receive no dexamethasone and 100ml of a standard balanced salt solution, with further balanced salt solution to meet their fluid requirements during surgery. We will compare levels of Syndecan-1 (a marker of microvascular function) between the two groups at 5 different time points during and up to 48 hours after the operation to assess if microvascular function differs between the groups. A total of 72 subjects will be included in the study.

The main aim of this study is to assess whether consuming a mix of almonds, dried grapes and dried cranberries daily for four weeks can improve recovery from fatigue and exercise performance compared with a control snack. The secondary aims are to investigate the relationship between consumption of these foods and blood and urinary markers of training-induced stress/damage and choice reaction time at rest and during exercise. Additionally, this study aims to evaluate the whether changes in heart rate can be used to predict changes in endurance exercise performance. Almonds are a rich source of arginine and antioxidants, while grapes and cranberries are also rich sources of antioxidants and nitrates. Studies have shown that dietary antioxidants improve endurance exercise performance by reducing exercise-induced damage to muscle. In addition, an increased dietary intake of arginine, nitrates and nitrites has been shown to improve endurance exercise performance in recreational athletes due to increases in blood flow to muscles. Thus, combining almonds, which are a good source of antioxidants and arginine, with grapes and cranberries, which are good sources of antioxidants and nitrates, may reduce exercise-induced damage to contracting muscle and promote increased muscle and brain blood flow. This in turn might reduce fatigue and promote improvements in endurance exercise performance. The period of heavy training is designed to produce negative changes in all of the outcomes discussed above, thus it is desirable for AGC to reduce the magnitude of these negative changes, in addition to resulting in superior changes in the outcomes following the taper training, when measures should be at their peak values.

the study sought to determine whether Cognitive Therapy or Mindfulness-based therapy better assists participants with primary insomnia. Participants were allocated to each treatment or a wait-list control. Those in the wait-list were allocated to an active treatment after the wait-list period. Outcome measures included quality of sleep and amount of time asleep.

This project is a world first and vital step towards developing an effective falls prevention intervention for the large numbers of Australian stroke survivors. Fifty people aged over 50 years old with a diagnosis of first ever stroke will be recruited and monitored for 12 months for falls, falls injury, serum levels of vitamin D, parathyroid hormone, highly sensitive C-reactive protein and triglycerides, and strength, balance and walking in people after stroke. This project will produce detailed information and understanding about the link between vitamin D and falls in stroke survivors, an essential step in enabling the development and evaluation of effective falls prevention interventions (e.g. Vitamin D supplementation) for stroke survivors. The outcomes will enable clinicians and researchers to develop evidence-based interventions that will be implemented and tested in future projects in order to reduce falls and falls injury in older people after stroke and to improve their quality of life. The data produced by this project will mean that future phases of this work will attract government and other funding, such as National Health and Medical Research Funding. Overall impact will be measured by the development of a successful intervention that reduces falls in people with stroke. Aims 1. Describe the trajectory of vitamin D levels in people in the first twelve months after stroke. 2. Describe the relationship between vitamin D levels, physical function (strength and balance), falls and injury in people in the twelve months after stroke. 3. Determine the relationship between other related biochemical markers (parathyroid hormone, C reactive protein and triglycerides) and falls in the twelve months after stroke. Research Questions: 1. What is the trajectory of vitamin D levels in the first 12 months after stroke? 2. What is the current use of vitamin D supplementation in first 12 months after stroke? 3. Is vitamin D deficiency associated with physical function and falls in the twelve months following stroke? 4. Is vitamin D deficiency associated with injury severity following a fall in the twelve months after a stroke? 5. What is the relationship between other biochemical markers (parathyroid hormone, highly sensitive C-reactive protein and triglycerides) and falls in stroke survivors in the first twelve months?

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. The purpose of this is to investigate whether gene or CD31 protein profiles may be used to select the best treatment for participants with advanced cancer. Who is it for? You may be eligible for this study if you are over 18 years old and have CD31 positive advanced and/or metastatic angiosarcoma OR have CD31 positive advanced and/or metastatic sarcomas. Study details All participants will be given eribulin via intravenous administration on Day 1 and Day 8 of a 21 day cycle. Participants will continue to be given the medication in 21 day cycles until the disease has progressed or there are adverse reactions that are not tolerated or the participant withdraws for any reason. Participants will undergo assessments at 6 weekly intervals or as clinically indicated in order to evaluate tumour response. Safety and tolerability of treatment and health related quality of life during treatment will also be assessed via clinical assessment, blood tests and questionnaires prior to each treatment with eribulin. It is hoped that this study will help increase treatment options for participants with advanced metastatic cancer. We cannot guarantee that participants will receive any benefits from this study.