ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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33103 results sorted by trial registration date.
  • Prospective Double Blind randomised controlled trial assessing the effects of the cough-test versus no cough-test during the tension free vaginal tape procedure on post operative voiding difficulties.

    The Tension Free Vaginal Tape Procedure (TVT) is the most commonly used procedure for women with stress incontinence worldwide. The cough-test (involving asking the patient to cough during TVT placement until no further leakage is seen) was originally described as being integral to the TVT procedure to improve outcomes and reduce post-operative voiding difficulties. Many gynaecologists now perform TVT insertion without the cough-test claiming similar outcomes, The proposed study is the first randomised trial comparing the differences in post-operative outcome between the TVT performed with an intra-operative cough-test and the same procedure without a cough test

  • Cystocele and Stress Urinary Incontinence(SUI):Simultaneous repair (Sim-Pair) by a modified surgical technique using transobturator mesh -Prospective study

    This is a study to assess the efficacy and safety of using one single mesh to treat both bladder prolapse and stress urinary incontinence as one operation. We hope the cure of stress urinary incontinence(SUI) will be comparable to other meshes used to treat SUI alone.

  • Pilot project for a randomised controlled trial of exercise coaching for general practice patients.

    Lack of physical activity (PA) is a major cause of ill health and disability, and increasing physical activity is one of the national health priority areas. The Australian Institute of Health and Welfare estimates that 6.7% of the total disease burden in Australia is due to insufficient physical activity, and two of the three higher ranked causes are also related to PA: Overweight 8.6% and high blood pressure 7.3% of disease burden respectively. PA is protective against cardiovascular disease, osteoporosis, several cancers, and diabetes, and forms part of the treatment plan for many diseases including depression. General practitioners are aware of the benefits of exercise but do not currently have effective ways to get patients motivated and active, and generally do not make use of allied health staff in this area. If this project successfully demonstrates a PA intervention that is acceptable to GPs and patients it could have wide spread public health benefits.

  • Study of the effectiveness of Probiotics and Peanut Oral Immunotherapy (P-POIT) in inducing desensitisation or tolerance in children with peanut allergy

    A two arm randomised-controlled trial to test a novel therapy (Peanut Oral Immunotherapy with a Probiotic adjunct) against placebo. The findings of this study will provide much needed evidence on whether OIT combined with a probiotic adjunct can induce tolerance in children with peanut allergy.

  • Pacing Alternate Sites using SelectSecure (PASSES Study): To assess the ease of implant in targeting alternate pacing sites with a catheter delivered lead compared with the stylet lead.

    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.

  • A Phase III, randomised trial of adding nitroglycerin to first line chemotherapy for advanced non-small cell lung cancer

    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.

  • Innovative ways of treating comorbid diabetes type II and depression: the "MADE-IT" Program

    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.

  • Guidelines Adherence to the Polypill Study. A clinical trial of a fixed dose combination medication (Polypill) versus usual care for improved adherence to indicated pharmacotherapy among individuals at high risk of a cardiovascular event.

    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- A clinical trial to investigate whether a fixed dose combination 'Polypill' Medication is better than existing treatments for people at high risk of cardiovascular disease.

    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.

  • Evaluation of the Safety & Effectiveness of the PROMUS Element Everolimus-Eluting Coronary Stent System compared with the PROMUS Everolimus-Eluting Coronary Stent System in patients with new or untreated atherosclerotic coronary artery lesions

    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.

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