ANZCTR search results

This study aims to investigate the interactions and effects of salt and fat on ad libitum intake. The objective is to quantify the contributions of different concentrations of salt and fat in food on satiation in humans classified according to fatty acid taste sensitivity. Fifty participants, aged 18-60 will participate in the study and consume a lunch either low or high in salt and low or high in fat after a fixed breakfast, on four different testing days. Participants will be classified according to fatty acid taste sensitivity, which will be assessed in two different sessions.

Intensive Care Unit (ICU) services cost the Australian economy at least $1.1 billion annually, excluding the cost of longterm morbidity. In particular, patients with a long length of stay in ICU (> 10-14 days) consume a disproportionate amount of resources. A quarter of these patients suffer a severe weakness syndrome defined as ICU-acquired weakness (ICUAW). This catastrophic syndrome results in significant limitations to people being able to perform their usual activities required for living (e.g. standing, walking, brushing teeth, showering, toileting or feeding themselves). People who suffer ICU acquired weakness are more likely to die and experience worse physical function and quality of life up to ten years following their ICU admission. The specific cell level interactions that influence this weakness syndrome are yet to be fully understood. The protein activin limits muscle growth and causes severe muscle wasting. It has recently been shown to not only have strong regulatory effects on muscle mass in mice with cancer, and when blocked, beneficial effects such as reversal of muscle loss. It is known that blood activin levels are significantly higher in people with critical illness who have infection, however the effect this has on muscle mass and weakness has not been established in this setting. There is also emerging evidence that there may be differences in the genes that turn on and off in people within the first 5 days of an ICU stay. It is logical that genes might also turn on and off differently in people who develop severe weakness in ICU compared to those who don‘t. However no studies have looked at differences in these gene patterns and compared them with changes in weakness or the ability to breathe independently. The project will compare levels of the protein activin and gene expression patterns (i.e. differences in genes turning on and off) in people admitted to the ICU with and without severe weakness. The investigators will also test muscle strength and the ability of the patient to do functional tasks (e.g. stand up, walk) and the project aims to provide proof-of-concept of an association between protein and gene measurements with muscle strength and function in ICU patients. the results will be used to design future projects investigating i) mechanisms associated with the development of clinically significant weakness and possible therapeutic pathways and ii) prevention strategies to reduce exposure to agents associated with severe weakness in ICU.

Aerobic energy powers endurance exercises e.g. jogging, long distance running etc. and it is used as a measure of fitness. On the other hand, initiation of any activity (e.g. rushing for a bus, climbing stairs) relies on anaerobic energy that is provided by preformed energy in form of phosphocreatine and glycolysis (breakdown of glucose) that occurs in absence of oxygen. Hence, individuals with inadequate anaerobic energy levels usually struggle to carry out their activities of daily living and suffer from chronic fatigue. What regulates the Anaerobic Energy System (AES) is not well studied and the factors that enhance AES apart from physical training are not known. Adults with Growth Hormone Deficiency (GHD) typically suffer from chronic fatigue and loss of vitality, symptoms suggesting impairment of the AES. These symptoms improve with GH replacement. However, the mechanisms underlying the symptomatology and how it is improved are poorly understood. New research shows that GH plays a vital role in energy provision. A recent study showed that administration to healthy subjects with GH enhanced sprinting, which is a marker of anaerobic capacity. However, GH did not improve any other measures of physical performance. Another research studied the effects of GH treatment in GHD subjects at a cellular level and found that GH favored the use of glucose (anaerobic glycolysis) over fat as a fuel for energy provision in muscle cells. These studies indicate that GH may have a positive role in regulating the AES. The main aims of this study are to investigate the effects of GH on anaerobic capacity and genes governing energy metabolism in skeletal muscle, and study the relationship between the AES and physical function.

The Pharmacokinetics of Testosterone Cream Applied to Scrotal Skin study is a dose finding study to determine the effectiveness of absorption of testosterone cream when applied in an alternative way to current practice. Long-term compliance with testosterone replacement therapy requires convenience in the delivery system to facilitate continuation of treatment with minimal intrusion or disruption to daily life. Current product information for transdermal( via the skin) application of testosterone states it is not to be administered to the genital area. Transdermal application of testosterone depends on the stratum corneum, the layers of dead skin cells which limit permeability of small molecules through the skin. Skin varies widely in thickness and steroidal (cortisol) permeability. The thinnest stratum corneum and highest steroidal permeability is scrotal skin. The study will determine the absorption rate of testosterone cream when applied to scrotal skin. The study will be conducted at the Department of Andrology, CRGH and will aim to recruit 12 healthy male volunteers from the local community. Eligible and consenting participants will visit the study centre 5 times. The men will receive 2 separate intramuscular injection of nandrolone decanoate to temporarily suppress testosterone levels. They will self-administer 3 dose applications (in random order) of testosterone cream to their scrotal skin. Venous and capillary dried blood spots will be collected before and over a 24 hour period before and after application of the cream to monitor hormone levels.

This study aims to use recent advances in PET scanning techniques, in particular Amyloid scanning to assist in the detection of Preclinical, Prodromal and Mild Alzheimer's disease.

This is a 30 patient single-centre, open-labeled, randomised pilot study assessing the effectiveness of a cyclooxygenase (Cox)-II specific inhibitor, Celecoxib, in reducing perioperative inflammation associated with thoracic and major abdominal surgery as assessed by blood and urinary markers. Information regarding Celecoxib's capacity to reduce perioperative pain and morphine consumption will also be sought. Patients will receive standard dosing of Celecoxib in accordance with on-license use. Demonstration of effect and feasibility of inflammation suppression is intended to lead to a multi-centre study investigating the use of perioperative Celecoxib to delay cancer recurrence following Non-Small Cell Lung Cancer (NSCLC) resection surgery.

The elderly population in Australia is continuing to increase with the number of people over 65 years of age increasing from approximately 2.7 million in 2006 to 3 million in 2011. As people living longer they are exposed to a higher risk of trauma. Studies have shown that the elderly trauma population (over 65 years of age) have significantly higher mortality, increased ventilator days and longer ICU and hospital length of stay (LOS) compared to a younger population. Frailty is a widely used term to classify a multi-factorial syndrome comprising of physical and cognitive changes leading to increased vulnerability. Frailty is associated with increased risk of adverse events which are associated with higher cost of health care and care needs of patients. The prevalence of frailty amongst the critically ill population has been reported as 13% of all patients and 32.8% in patients over 50 years of age. Frail patients admitted to the intensive care unit (ICU) have been shown to have higher in-hospital mortality and lower quality of life at 6 month follow up. During the ICU admission, frail patients had more major adverse events and longer ICU and hospital LOS. There is no clear consensus on how to measure frailty, however two methods have been utilised in ICU research, the Phenotype Frailty (PF) and the Clinical frailty score (CFS). Historically elderly trauma patient outcomes have been investigated in relation to age and co-morbidities. This study aims to determine whether frailty is predictive of mortality and functional outcomes, which of two frailty measures is more effective at predicting mortality and functional outcomes and whether frailty is more effective at predicting mortality and functional outcomes compared to other patient measures (i.e. age, co-morbidities or injury severity score). METHODS: Prospective observational study, in 2 Australian ICUs (the Alfred Hospital and Royal Perth Hospital). We aim to recruit 200 patients admitted to ICU under the trauma unit, 50 years of age and over. Primary outcome measures include mortality (in ICU, hospital, 6 months and 12 months) and function using the GOS-E. Secondary outcome measure include (but not limited to) frailty, pre-morbid function, level of treatment in ICU, functional ability at ICU discharge.

This study involves measuring the blood levels of the medication, treosulfan, to improve the way we adjust the dose in children. Who is it for? Children and adolescents with either malignant or non malignant (genetic) diseases can join this study if they are receiving the medication, treosulfan, prior to undergoing blood or marrow transplantation. Trial details A series of blood levels will be collected after the treosulfan dose to see how well their body breaks down and gets rid of the medication. This study does not replace other studies, but simply investigates key medication widely used in the treatment of children's cancer. Participants will be studied for several years after the study to monitor their health. This study will define the best way to adjust the dose of the drug, treosulfan, a key medication in blood or marrow transplantation conditioning regimens. Too much causes toxicity and too little risks the disease being more likely to return.

Obstructive Sleep Apnoea is a common sleep-related breathing disorder and can be treated using a Mandibular Advancement Splint (MAS), an oral device worn during sleep which protrudes the mandible, improving airway calibre. Approximately two thirds of patients adequately resolve their sleep apnoea with this conventional therapy however; clinical trials have shown that the addition of a tongue restraining device significantly increases MAS effectiveness. This study will investigate the Tongue Tamer (TT) system, designed to be reversibly added to the conventional SomnoMed MAS to passively restrain the tongue. Safety, efficacy, tolerability and compliance of the TT MAS will be investigated in patients not demonstrating a complete response to conventional MAS treatment.

The primary purpose of the study is to develop and test a motivating communication/teaching style for Les Mills International instructors. More specifically the study will examine the feasibility and fidelity of delivering a motivation-based communication training intervention with Les Mills International instructors and test the effects of the intervention on clients’ perceptions of the instructors’ motivational style.