ANZCTR search results

The design of the study is a phase IV, 2-arm, 8-week, randomised, double-blind, placebo-controlled trial using one 3.2 gram tablet of Kava (Piper methysticum), twice per day equal to 120mg of kavalactones (but in non-responders at week 3 this will be doubled to two tablets twice per day equal to 240mg of kavalactones), or matching placebo, in 100 currently anxious participants with diagnosed generalised anxiety disorder (GAD). Participants are required to fill out assessment forms throughout the study and to have 3 blood tests (liver function tests and a genetic test providing information on liver enzyme function and neurochemistry). Assessment will occur at Healthscope hospital sites in Victoria and at Swinburne University of Technology, Hawthorn VIC. Data collection will occur during week 0 at baseline and at weeks 1,2,4,7,8 by trained research assistants. Assessment tools used: Compulsory a) Structured Clinical Interview for DSM disorders (automated version) b) HAM-A (primary outcome) c) MADRS d) Weekly safety checklists (for adverse reactions) e) Current health & medications questionnaire to assess their current health and any medications they are currently taking f) Drug Check to assess alcohol and other drug use g) Demographics questionnaire to assess age, education, marital status, employment h) The Arizona Sexual Experience Scale (ASEX) to assess the difference in sexual dysfunction between paroxetine, placebo, and Kava. i) Addiction assessment scale to observe whether any perceived addictiveness to the interventions is occurring j) Three blood tests (liver function test and a genetic test providing information on liver enzyme function and neurochemistry). Participants will be required to attend 6 visits at the Brain Science Institute, Hawthorn. The first visit is a baseline session. Participants will be asked to complete all tests: screening assessments, consent forms, mood and anxiety questionnaires. Testing for all subsequent visits will follow the same outline of their baseline session (excluding consent forms and including an adverse effects safety questionnaire). Participants will be given $100 each at the completion of the study to compensate for their time and to cover travel expenses if required. The recruitment, data collection and analysis period will be approximately 1 year. Data will be analysed by research team using SPSS 17.0. Repeated measures ANOVAs will be used to assess any changes between groups across time.

A majority of the falls prevention interventions shown to effectively reduce the risk of falling in community dwelling older people, such as Tai Chi, or programs such as ‘Stepping On’ and the ‘Otago exercise program’, involve specialised training or instruction. This specialised activity places limits on the accessibility of such interventions: due to a lack of qualified instructors, the costs involved in joining programs, or the barriers inherent in attending physical activity classes. Only a small proportion of older people benefit from these interventions. In contrast, walking is a simple activity that can be done by virtually anyone, any time and anywhere without the need for specialised training or equipment. However to date only two studies have examined the effect of walking on falls; one study as a secondary outcome measure the other study combined walking with a home-based exercise program. No studies have explicitly looked at the impact of walking of falls in older people. The Easy Steps to Health study is a randomised controlled trial investigating the effectiveness of a self-managed one year (48-week) walking program in reducing the number of falls in sedentary, community-dwelling people aged 65 years and over. People will be excluded if: they are already physically active (i.e. engage in physical activity for more than 120 minutes per week or on more than three occasions per week); they cannot communicate in English, and; they have any conditions that limit their ability to participate in a physical activity program. A total of 484 participants will be randomised into either the intervention or control group. Participants randomised into the intervention group will receive instruction in the walking program via mail and telephone coaching at week 0, 12, and 24 with additional telephone support at weeks 2, 8, 18 and 36. The control group will receive the self-managed walking program at the end of the study period. During the study period the control group will receive healthy lifestyle information. Falls during the study will be recorded prospectively using a daily calendar. Baseline and end-of-study telephone interviews will be conducted using structured questionnaires assessing ‘Quality of Life’, levels of Physical Activity, confidence in avoiding a fall, confidence in ability to walk, and the ‘walkability’ of their neighbourhood. Baseline interviews will also gather basic demographic information, falls history, and a brief description of current medical conditions and medications being used. In addition, a sub-sample of 194 participants will receive physical performance assessments. These assessments will gather data on lower limb functionality (using the Short Physical Performance Battery), quadriceps strength and lower limb reaction time (using choice step reaction time). Accelerometers will also be used as a more objective measure of participants’ levels of physical activity. These measures on a sub-sample of participants will occur at weeks 0 (baseline), 12, 24, and 48.

The purpose of this study is to characterize the safety, pharmacokinetics, and pharmacodynamics of CEP 37251 following single ascending doses in healthy postmenopausal women. This study is intended to identify a dose of CEP-37251 having a sustained effect on biomarkers of bone resorption.

This study has been designed to investigate how the load and duration of Whey Protein Hydrolysate effects gut motility, gut hormones, and appetite sensations. Volunteers are required to visit the clinic on 4 occassions no less than 3 days apart. Visits will last for approximately 5 hours. A long felxible tube will be inserted through an anaethetised nostril and passed through into the small intestine to monitor stomach and small intestinal contractions. Through this tube, a whey protein or saline solution will be infused over a 60 minute period (4mL/min). Blood samples will be taken (through a cannula, which is a long flexible tube inserted into a vein) and questionnaires on appetite sensations will be completed every 15 minutes. At the end of the 60 minute infusion, a buffet meal will be provided. This meal will be consumed over 30 minutes until the volunteer is comfortably full.

This study aims to demonstrate that an immunotherapy made from a patient's own blood cells, (known as Rheumavax) can safely modify (reduce or desensitize) the body’s immune response to a specific rheumatoid arthritis antigen.

This project involves the evaluation via a randomised control trial (RCT) of an on-road Assisted Ride Program for Victoria based on best practice rider training and education for newly licensed motorcycle riders. Qualified and experienced motorcycle rider training instructors will provide coaching and feedback to newly licensed rider participants on their riding skills and behaviours over the course of a 4 hour supervised on-road ride. The anticipated benefits of the project are safer on-road riding by participants, and reduced engagement in risk taking behaviours and crash involvement. If the program produces road safety benefits for participants, then it may be introduced on a state-wide basis to reduce road trauma among this vulnerable group of road users.

Investigation of the brain activation patterns of 4 acupoints ( LR14, CV14 HT7 and LR8) found to be highly significant in the treatment of unipolar depression in a double blind randomised controlled trial and an additional acupoint KI3 considered useful in associated anxiety and fatigue in depression.

While it is known that patients with Parkinson’s disease (PD) lose more weight and have a higher risk of decreased bone mineral density and increased inflammation when compared with age-matched controls, and deep brain stimuation of the subthalamic nucleus (STN-DBS surgery) in PD is followed by weight gain, there has been limited research that has investigated specific factors that impact upon nutritional status in PD. There has also been limited research in regards to the measurement of nutritional status in Parkinson’s disease. The overall aim of this project is to determine the influence of motor and non-motor symptoms and inflammation on nutritional status in people with Parkinson’s disease and how deep-brain stimulation modifies the severity of symptoms and inflammation and therefore their impact on nutritional status. The specific aims of the proposed project are to: *Identify potential factors influencing nutritional status changes in Parkinson’s disease. *Evaluate the effectiveness of available subjective and objective tools in the assessment of nutritional status in Parkinson’s disease. *Provide evidence to inform effective nutritional interventions aiming to address the decline in nutritional status associated with Parkinson’s disease.

An experimental study to investigate the brain effects of laser acupuncture on 4 acupoints found to be highly significant in a pilot study on the use of laser acupuncture in mild to moderate depression- using functional magnetic resonance imaging.

The aim of the research is to evaluate the effectiveness of the following treatments for lifelong Premature Ejaculation (PE): (a) Priligy alone, (b) Cognitive-Behavioural Therapy (CBT) alone, and (b) Combined Priligy and CBT. The effectiveness of the interventions will be measured by pre and post treatment measures including intra-vaginal ejaculation latency time (IELT), distress, satisfaction with treatment, sexual satisfaction, relationship satisfaction, self-esteem, self confidence, masculinity, and partner sexual dysfunction. It is expected that all three treatments will be effective, but that the combination therapy will be more effective than Priligy alone or CBT alone in improving all of the above variables.