ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Antenatal Asthma Management Service (AAMS)

    Background: Pregnancy presents a unique situation for the management of asthma as it can alter the course of asthma severity and its treatment, which in turn can affect pregnancy outcomes. Despite awareness of the substantial adverse effects associated with asthma during pregnancy, little has been done to improve its management and reduce associated perinatal morbidity and mortality. The aim of this randomized controlled trial is to evaluate the clinical and cost effectiveness of an Antenatal Asthma Management Service (AAMS). Methods/design: Design: Multicentre, randomized controlled trial Inclusion criteria: Women with physician diagnosed asthma, which is not currently in remission, who are less than 18 weeks gestation with a singleton pregnancy and do not have a chronic medical condition. Trial entry and randomization: Eligible women with asthma, stratified by disease severity, will be randomized into one of two study groups: either the ‘Standard Care Group’ or the ‘Intervention Group’ Study groups: Both groups will be followed prospectively throughout pregnancy. Women in the ‘Standard Care Group’ will receive routine obstetric care reflecting current clinical practice in Australian hospitals. Women in the ‘Intervention Group’ will receive additional care through the nurse-led Antenatal Asthma Management Service, based in the antenatal outpatient clinic. Women will receive asthma education with a full assessment of their asthma at 18, 24, 30 and 36 weeks gestation. Each antenatal visit will include a 60-90 min session where asthma management skills are assessed including: medication adherence and knowledge, inhaler device technique, recognition of asthma deterioration and possession of a written asthma action plan. In addition, subjects will receive education about asthma control and management skills including trigger avoidance and smoking cessation counseling when appropriate. Primary study outcome: Asthma exacerbations during pregnancy. Sample size: A sample size of 378 women will be sufficient to show an absolute reduction in asthma exacerbations during pregnancy of 20% (alpha 0.05 two-tailed, 90% power, 5% loss to follow-up). Discussion: The integration of an adapted model of an asthma education program within the antenatal clinic setting has the significant potential to improve the participation rate of pregnant women in the self-management of their asthma, reduce asthma exacerbations and improve perinatal health outcomes.

  • Tenecteplase versus Alteplase for Stroke Thrombolysis Evaluation (TASTE) Trial

    This research is comparing two clot dissolving medications tenecteplase and alteplase. Tenecteplase is not currently licensed and approved for use in acute stroke care, but has shown very promising results in recent stroke studies. Alteplase is the approved medication for ischaemic stroke. Despite the clear benefits of alteplase at reducing brain damage and disability, we would like to find a medication that has similar clot-dissolving effects with a lower risk of brain bleeding. This would result in an even greater reduction in long-term stroke disability. The aim of this study is to compare alteplase with tenecteplase for stroke treatment to determine which will help more patients have less disability at 3 months following their stroke.

  • Sampling Antibiotics in Renal Replacement Therapy, A Multinational Prospective Pharmacokinetic Study.

    Inadequate antibiotic therapy is a critical determinant of survival in patients admitted to an Intensive Care Unit (ICU) with overwhelming infection requiring renal replacement therapy (RRT). Guidelines for effective dosing are not available because RRT can be vastly different between ICUs, resulting in significantly different antibiotic pharmacokinetics. Developing an evidence-based antibiotic dosing guideline is of global significance and should be considered a priority to improving clinical outcomes for patients requiring RRT that have infections.

  • Prevention of Deep Vein Thrombosis (DVT) in Patients undergoing Total Knee Replacement (TKR)Surgery with Low Molecular Weight Heparin (LMWH) or outpatient Calf Compression Device (CCD) after a short course of LMWH: a randomized prospective study

    This study hypothesises that shorter duration low molecular weight therpay is as effective as standard therapy in post operative orthopaedic DVT prophylaxis. There will be no significant difference in the incidence of post operative thrombotic events such as DVTs and PE. There mat be added advantages of reduced leg swelling and hence pain with the use of mobile calf compressor device as an outpatient.

  • Phase II Feasibility Study of Lipidiol Markers for Radiation Therapy Localisation and Response Assessment in the Multi-Disciplinary Team Management of Oesophageal-Gastric Cancer

    Patients involved: Those patients with oesophageal-gastric cancer. Intervention: Insertion of lipiodol markers under endoscopic guidance that will allow improved response assessment with imaging such as CT, surgical resection and pathological assessment of the tumour in the surgical specimen. Intervention will also allow image guided radiotherapy for candidates who are suitable for radiotherapy. Outcomes of this study: The outcomes include success of lipiodol marker insertion which will be classified endoscopically and or radiologically on follow up imaging. Visibility of markers for radiotherapy planning Cost analysis of lipiodol markers in comparison to alternative methods such as fiducial/endoclip placement. The rate of successful anatomical correlation of both pre and post neoadjuvant therapy lipiodol images. The rate of successful (RECIST) assessment of tumour response post neoadjuvant therapy. The quantitative improvement in RECIST reporting with lipiodol. The quantitative improvement in correlating metabolic response with pathologic response rate with lipiodol. The rate of successful spatial correlation of pathologic margin (macro and micro) correlation with conventional imaging. (CT, EUS and FDG-PET/CT) Spatial correlation of CT, EUS and FDG-PET/CT and oesophagectomy specimens with radiotherapy volumes in definitive and postoperative settings

  • Effect of Transfusion of Washed Reed Blood Cells on Neonatal Outcome: A Pilot Randomised Controlled Trial

    Extremely low gestational age newborns represent the smallest and most immature newborns and are at greatest risk of dying or surviving with significant morbidity particularly neurodevelopmental disability. Over 90% of these newborns receive at least one packed red blood cell (PRBC) transfusion whilst in neonatal intensive care with the majority receiving between 3 and 5 transfusions during their primary hospital admission. There is increasing evidence that PRBC transfusions are independently associated with more frequent and severe cardiopulmonary, gastrointestinal and neurodevelopmental morbidities. Indeed, in comparison to other populations, these transfusion associated adverse events are more common in the preterm newborn. Packed red blood cells are biologically active. We have shown that PRBC transfusion results in endothelial activation, inflammation and oxidative stress in preterm neonates. This transfusion related immunomodulation (TRIM) might contribute to the recognised association between allogeneic PRBC transfusion and adverse clinical outcomes. It is unclear if TRIM is a response to red blood cells themselves, the time-dependent accumulation of bioactive substances in the supernatant (storage lesion), or both. However, in adult and childhood populations significant benefit is gained from modifications in blood product processing such as PRBC washing, though this has never been studied in the preterm neonate. Any reduction in PRBC transfusion related harm would be of substantial clinical benefit in this at risk population. This pragmatic clinical trial aims to identify if transfusion with washed PRBCs reduces harm from transfusion in high-risk newborns.

  • Faecal transplant for the treatment of active ulcerative colitis

    This study aims to test faecal transplant as a potential new therapy for active ulcerative colitis. Patients with ulcerative colitis have a restricted diversity of bacteria in the bowel and faecal transplant aims to replenish the diversiy of the bowel bacteria. Faecal transplant involves the delivery of stool from a faecal donor into the bowel of a patient with the aim of improving symptoms and reducing mucosal inflammation.

  • Improving help seeking and peer support for substance use and emotional problems: a cluster randomised controlled trial

    Adolescence is a high-risk time for the development of mental health and substance use problems. Evidence shows that young people who experience these issues typically turn to their peers for support rather than seeking professional help. While there are numerous programs that endeavour to improve student knowledge about mental health and substance use, there are few programs that provide students with the practical skills required to encourage their friends to seek help. MAKINGtheLINK is a school based education program that equips young people with correct information and the opportunity to practice assisting a friend at risk. The program teaches students practical skills regarding: signs of problematic substance use and emotional issues, what to say to a friend that you are concerned about to encourage them to seek help, the types of helpers that exists and how to access them. By comparing the knowledge and behaviours of Victorian year 9 students who receive the program with those that do not receive the program, we will be able to measure whether there are improved rates of help seeking and confidence to assist a friend to seek help amongst the group that receive the program.

  • TRialing Individualised Interventions to prevent FunctionaL decline in at-risk older adults (TRIIFL): A nested randomized controlled trial

    The project will focus on older adults living independently in the community, and who are on the cusp of Functional Declune (FD). We will conduct a nested RCT within a 13 month longitudinal observational study. In the observational study we will apply a simple, previously untested quality of life screen to detect incipient Functional Decline, one month following an Emergency Dept presentation that did not result in an inpatient admission. Those individuals with low scores at the point of screening will enter the RCT, which will test the effectiveness of a novel, early, home-based, personalised program (compared with ‘usual care’) in arresting or slowing Functional Decline.

  • The effect of delivery method, supervised versus home-based, on outcomes of core strengthening programs

    Poor core stability is associated with dysfunction and weakness of muscles of the trunk, pelvis and hip (core muscles) and the development of lower limb pathology and low back pain. Core strengthening programs aim to prevent injury and increase stability through improved strength and co-ordination of core muscle activity (Faries & Greenwood, 2007). However, the delivery method of training programs is highly variable and despite widespread use, the evidence for injury treatment and prevention with core strengthening programs is inconclusive. This may be due to the heterogeneity of delivery methods of programs used as the intervention. Investigation of the most effective delivery method of core strengthening programs is required to enable accurate evaluation of efficacy core strengthening interventions. The aim of this project is to compare the effect of supervised core strengthening classes, a home-based core strengthening program and no intervention on specific measures of core stability. It is hypothesised that supervised classes will 1) result in a greater improvement in performance in tests assessing core strength, and 2) increased transversus abdominus (TrA) hypertrophy when compared to a home-based program and no intervention.

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