ANZCTR search results

Medical evidence suggests that the right ventricular (RV) apex and right atrial (RA) appendage may be suboptimal lead locations for providing chronically effective pacing therapy. Over recent years alternate pacing sites, or ‘selective sites’, have been proposed and evaluated. These are sites other than the traditional Atrial Appendage and RV Apex pacing. Such sites are suggested to reduce ventricular dysfunction, atrial arrhythmias, and influence morbidity resulting from asynchronous Left Ventricular (LV) activation associated with traditional RV apex pacing. The Medtronic SelectSecure Deflectable Catheter Delivered Lead System was developed to assist physicians implanting a pacing lead in an RV or RA selective site such as the RVOT or the ventricular septum, the Bachman bundle area or the atrial septum. PASSES is a prospective, randomised, multicenter clinical trial to assess the ease of implant in targeting alternate pacing sites with a catheter delivered lead compared with the stylet lead. The chronic aspect of the study will enable analysis of the long-term lead performance and will provide a first estimation of economic benefits for pacing with a new therapy and tool. This study compares the novel approach of new therapy of pacing selective sites with new tools to the traditional pacing therapy and tools. During the follow-up period information will be collected on lead performance (electrical and clinical data), adverse events, health care utilization, and progression of HF and AF. This is expected to provide information on the long-term lead performance, and the clinical and economic benefits for implanting alternate sites with the SelectSecure lead.

This study will evaluate the efficacy of adding the drug, nitroglycerin, to first line chemotherapy for advanced non-small cell lung cancer. Who is it for? You may be eligible to join this study if you are 18 years or above and have a confirmed diagnosis of stage III or IV non-small cell lung cancer. Radiotherapy should have been completed at least one week before commencing treatment in this study. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Both groups undergo 6 x 3 week treatment cycles of standard chemotherapy determined by their doctor. In addition, participants in group one will receive nitroglycerin administered as a 25mg patch for 12 hours each day for 2 days before, the day of, and for two days after each chemotherapy injection. Participants will undergo regular visits to the hospital and undergo CT scans prior to treatment, every six weeks during chemotherapy, and every two months after chemotherapy until the lung cancer has progressed. This will help determine which treatment is more effective in terms of progression-free survival and overall survival.

Research has shown that people with Type II Diabetes are at increased risk of developing depression, and the combination of both disorders increases the likelihood of the development of diabetes related complications. Diabetes related complications often means increased need for medical interventions, increased hospitalizations and generally poorer health outcomes for patients. This research projects aims to evaluate interventions for depression in patients with Diabetes type II. Minimal intervention (self help resources and regular monitoring) single focused intervention (depression alone treatment) and integrated treatment (depression intervention and diabetes education) will be compared. Participants in the depression focussed or integrated treatments will attend small group sessions for 90 minutes each week over eight weeks. Outcomes (depressive symptoms, self care beahviours and HbA1c) will be measured post treatment, three and six months.

The GAP study is a research study which looks to compare a combination heart medicine called the "polypill" with existing treatments. The polypill has 4 different types of medicine in the one tablet. It contains aspirin, a cholesterol lowering medicine and two blood pressure lowering medicines. All four medicines have been available in Australia for a long time; the only difference is that they have been put into one tablet rather than four separate tablets. We think that this will make it easier for clients to take their medicine every day. We also think that by making these medicines easier to take it will be better at lowering blood pressure and cholesterol levels than taking many different tablets. This has not been proven and that is why we are conducting this important research to see if this is true. There is a merge of this trial with the Kanyini Polypill trial (of identical protocol and study design) into one trial to be renamed as 'Kanyini Guidelines Adherence with the Polypill (GAP)' trial under the ACTRN 12608000583347.

The Kanyini Guidelines Adherence with the Polypill study is a research study which looks to compare a combination heart medicine called the "polypill" with existing treatments. The polypill has 4 different types of medicine in the one tablet. It contains aspirin, a cholesterol lowering medicine and two blood pressure lowering medicines. All four medicines have been available in Australia for a long time and are known to be very safe; the only difference is that they have been put into one tablet rather than four separate tablets. We think that this will make it easier for clients to take their medicine every day. We also think that by making these medicines easier to take it will be better at lowering blood pressure and cholesterol levels than taking many different tablets. This has not been proven and that is why we are conducting this important research to see if this is true.

The PROMUS Element clinical trial – PLATINUM, is a prospective, multi-centre trial to evaluate the safety and effectiveness of the PROMUS Element Everolimus-Eluting Coronary Stent System compared with the PROMUS Everolimus-Eluting Coronary Stent System. Treatment will be in participants with up to 2 de novo (new or untreated) atherosclerotic coronary artery lesions. A separate coronary artery (de novo) narrowing is able to be treated with a commercial treatment (eg: stent such as PROMUS, balloon angioplasty, excluding brachytherapy) during the initial procedure. Up to 160 sites enrolling up to 1,532 patients. Follow up at hospital clinics 30 days, 6 and 12 months. Participants enrolled who did not receive the PROMUS Element or the PROMUS stent will complete follow up at this point. The Primary Endpoint is Target Lesion Failure at 12 months defined as ischaemia-driven Target Lesion Revascularisation (repeat treatment of narrowing), Myocardial Infarction (heart attack) related to the target vessel, or Cardiac Death (participant death) related to the target vessel.

PLATINUM QCA is a prospective, multicenter trial to assess PROMUS Element for the treatment of patients with a maximum of 1 de novo atherosclerotic coronary artery lesion of up to 34 mm in total length (by visual estimate) in native coronary arteries =2.25 mm to =4.25 mm in diameter (by visual estimate). Approximately 100 non-randomized patients at up to 20 sites are proposed to obtain clinical outcomes data for the PROMUS Element stent system. Follow up occurs at 30 days, 9 months and 12 months with both QCA and IVUS assessments at 9 months. The Primary Endpoint is Cardiac events at 30 days post-index procedure (Myocardial infarction (MI, Q-wave and non-Q wave) rate; Cardiac death rate; Target lesion failure (TLF) rate; Target lesion revascularization (TLR) rate; Stent thrombosis (ST) rate (definite or probable by Academic Research Consortium [ARC] definitions) with an efficacy endpoint of 9 month in-stent late loss and post-procedure incomplete apposition.

To determine the short term effects of a High Intensity Functional Exercise (HIFE) group program on clinical outcomes in older people in the sub-acute setting. Clinical outcomes include mobility, balance, length of stay and discharge destination.

Adequate nutrition is important to allow patients in the Intensive Care Unit the best chance of recovery from their illness. This is usually provided by feeding through a tube into the stomach. Unfortunately, many patients do not get enough nutrients from feeding into the gut, as the stomach and small intestine does not work normally. In these patients, symptoms such as diarrhoea and bloating are also common. We are doing research in this Intensive Care Unit to understand why the gut does not work normally in some patients and how this affects their absorption of nutrients. A greater understanding of how the gut functions during illness is important for treatment and to devise ways to improve the feeding of patients in Intensive Care.

The project will evaluate an injury assessment and treatment referral service for those injured in motor vehicle crashes in the ACT. This service will consist of a musculoskeletal specialist, supported by an education program. The primary research hypothesis for the program is that the provision of multidisciplinary musculoskeletal referral service will lead to improved health outcomes for injured people and reduce the duration of illness and associated costs. This will be established through a comparison with a control group of people injured before the service is established.