ANZCTR search results

The aim of the project is to investigate the usefulness of novel markers (‘biomarkers’) in predicting the risk of experiencing a CVE (defined as a composite of STEMI or NSTEMI, stroke, or death) during or after vascular surgery in patients with severe peripheral vascular disease (PVD) who require surgical correction or bypass. The risk of a CVE in this group of patients is typically about 20-25%. The prevalence of coronary artery disease in this select group of participants approaches 50% and increases with age. Current risk assessment methods, although useful, may not necessarily detect all at-risk patients, especially those without pre-existing symptoms of ischaemic heart disease such as angina or previous myocardial infarcts. This study will assess if newer methods can help detect at-risk patients who may not have symptoms of heart disease but who are still at risk of developing a CVE peri-operatively. Examples of novel biomarkers measured preoperatively include endothelial function testing by fingertip arterial tonometry, iron studies, myeloperoxidase, matrix metalloproteinase, and lipidomic profiling.

This trial seeks to investigate if providing a small financial incentive ($30) will increase the uptake and completion of the hepatitis B vaccine among injecting drug users.

The purpose of this study is to establish the efficacy and safety of alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with Rebif (registered trademark for interferon beta-1a). The study will enroll patients who have not previously received treatment to suppress MS, except steroids. Patients will have monthly laboratory tests, and comprehensive testing every 3 months. Every patient will receive active treatment; there is no placebo. Patients who qualify will be randomly assigned to treatment with either alemtuzumab or Rebif (registered trademark) at a 2:1 ratio (ie, 2 given alemtuzumab for every 1 given Rebif (registered trademark). Patients will not be able to guess which treatment will be randomly assigned to them. Alemtuzumab will be administered in two annual cycles, once at the beginning of the study and again 1 year later. Rebif (registered trademark) will be self-injected 3 times per week for 2 years. All patients will be required to return to their study site every 3 months for neurologic assessment. In addition, safety-related laboratory tests will be performed at least monthly. Participation in this study will end 2 years after the start of treatment for each patient. Additionally, all patients who receive alemtuzumab will be followed in an extension study for safety and efficacy assessments. Patients who receive Rebif (registered trademark) and complete 2 years on study may be eligible to receive alemtuzumab in an extension study.

This study will determine whether the antidiabetic medicine, sitagliptin, has the capacity to increase intestinal hormones called glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP), decrease blood glucose levels and reduce appetite in healthy subjects and people with type 2 diabetes. We will also determine, in the people with diabetes, whether these effects are enhanced when sitagliptin is given together with another diabetes drug, metformin.

The aim of this project was to reduce falls risk in people 65 years and older living in the community in retirement villages, independent living units and hostels or in their own homes and attending a respite centre, day therapy or other supported program for older people, eg. Senior Citizens’ Centres. The geographical area involved was the Brisbane metropolitan region including bayside. The process involved implementation and evaluation of a sustainable model of service delivery based on best practice falls prevention interventions, including individualized risk assessment and a specific targeted intervention. The objectives of the Project were to: encourage best practice falls prevention interventions in the community; increase access to falls prevention information, strategies, and activities for community dwelling older persons and the multidisciplinary team including the GP; build partnerships to reduce falls in older people within selected facilities and for the target population in metropolitan Brisbane and environs; and recommend a sustainable model of service delivery taking into consideration the emerging workforce issues in the future. The strategies employed to deliver the objectives were to increase participation in the target population by offering group exercise programs to 500 participants in the Brisbane metropolitan (including bayside) area;ensure the program is targeted to the risk factors of the individual participants by a screening process followed by referral for appropriate assessment and management; measure the impact of the risk reduction interventions; ensure a coordinated approach by all involved in the project; build capacity in community service providers to consistently assess and manage people at risk of falling; and develop and describe a sustainable model of activity promotion, implementation and evaluation for this target population. The outcomes from this intervention study may provide information to address the development of future programs to reduce the risk of falls in people over 65 years of age. The project will identify and describe the nature and level of risk factors of falls in the target population and will assist program planners to determine the appropriate workforce combination required for the program to continue.

Operations of the spine, when performed from the front of the neck can cause problems like sore throat, difficulty in swallowing and voice change during postoperative period. Often these problems are temporary, but they are common. Most of the patients feel these symptoms are very uncomfortable. These symptoms are attributed to the retraction of structures like wind pipe and food pipe during the operation. The retraction causes pressure on to these structures and results in direct damage as well as damage due to reduced blood flow during the period of retraction. The more the pressure the more will be the damage and the worse will be the symptoms. Conventional retractor systems are designed to mount directly on to the soft tissues during the operation, causing direct transmission of retraction pressure on to them. A novel retractor system (Seex retractor system) has been introduced in to surgical practice. The new system is mounted/fixed directly on to the bones (vertebrae) during the procedure so that the amount of direct pressure transmission to wind pipe or food pipe is theoretically much less than the conventional retractors. Cadaver studies conducted by the researchers agree with that. In this pilot study the researchers prospectively measure the pressure variations on windpipe and food pipe in the two groups of patients under going neck operations with conventional retraction system and the new system. They will also assess sore throat, difficulty in swallowing and voice change in patients of both the groups during postoperative period using rating score chart. Data collected in this unblinded pilot study will be used to design a subsequent randomized controlled trial, if the new system appears to be a better one.

A 26 week study to assess the effects of transdermal testosterone spray on cognitive function in healthy postmenopausal women aged 45-60 years.

Glucagon-like peptide-1 (GLP-1) is a naturally occurring hormone in the human body that has the effect of stimulating insulin secretion and slowing stomach emptying, helping to limit the rise in blood glucose after a meal. Exenetide is a drug that mimics GLP-1, and has recently been approved in Australia for the treatment of diabetes. However, there is little information on how GLP-1 can affect the small intestine. The aim of this study is to see what effect exenatide has on the contractions and flow of contents inside the small intestine and how it affects glucose absorption. The findings will help us understand how sugar is absorbed in the small intestine in health and in people with diabetes, and whether the effects of exenatide on small intestinal function would benefit people with diabetes.

The aim of this project is to examine whether a particular level of physical activity while in hospital leads patients to have faster or better recovery of walking when they leave hospital. This is important, as many older people admitted to hospital may have problems with their walking. The results of this research may help us develop treatments to help older people recover faster and more completely.

The purpose of this study is to establish the efficacy and safety of two different doses of alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with Rebif (Registered trademark for interferon beta-1a). The study will enroll patients who have received an adequate trial of disease-modifying therapies but continued to relapse while being treated, and who meet a minimum severity of disease as measured by MRI. Patients will have monthly laboratory tests and comprehensive testing every 3 months. Every patient will receive active treatment; there is no placebo. The 24 mg alemtuzumab dose is closed to enrollment so newly enrolled patients will be randomly assigned to treatment with either 12 mg alemtuzumab or Rebif (registered trademark) at a 2:1 ratio (ie, 2 given 12 mg alemtuzumab for every 1 given Rebif (registered trademark)). Patients will not be able to guess which treatment will be randomly assigned to them. Alemtuzumab will be administered in two annual cycles, once at the beginning of the study and again 1 year later. Rebif (registered trademark) will be self-injected 3 times per week for 2 years. All patients will be required to return to their study site every 3 months for neurologic assessment. In addition, safety-related laboratory tests will be performed at least monthly. Participation in this study will end 2 years after the start of treatment for each patient. Additionally, all patients who receive alemtuzumab will be followed in an extension study for safety and efficacy assessments. Patients who receive Rebif (registered trademark) and complete 2 years on study may be eligible to receive alemtuzumab in an extension study.