ANZCTR search results

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

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32814 results sorted by trial registration date.
  • PRE-BABE: Pre-conception weight loss for women above a healthy weight: a pilot randomized controlled trial

    BACKGROUND: High preconception BMI is the single most important modifiable risk factor for adverse perinatal outcomes and offspring obesity. Trials to limit weight gain during pregnancy have not lived up to the promise of reducing this burden. There is increasing recognition that targeting obesity before pregnancy might improve outcomes for mother and baby. However, there are no current guidelines to suggest which preconception health programs and interventions are of benefit to women above a healthy weight and their infants. Thus, there is urgent need to establish the effectiveness of preconception weight loss, in order to improving short and long-term maternal and child health. AIM: To assess the feasibility and acceptability of a 10 week online weight loss program in women with a BMI >25 kg/m2 who are planning pregnancy. Intervention: Women will be randomly allocated to one of the following programs for 10 weeks: 1. An online weight loss program 2. Recommended weight loss advice delivered in a clinic setting RECRUITMENT: recruitment will occur over the next 6 months. Eligible women will be recruited from the RPA pregnancy planning clinic, Charles Perkins Centre. OUTCOMES: Weight loss: Measured in kilograms at 10 weeks

  • Progesterone after mifepristone, for women whose decision has changed after commencing a medical termination of pregnancy - a pilot clinical trial

    Medical termination of pregnancy (MTOP) is a two stage process, women take mifepristone first, then take misoprostol 36 to 48 hours later. If women do not take misoprostol after taking mifepristone the continuing pregnancy rate varies from 0 to 25%.[1] There is evidence that some women decide they want to continue their pregnancy after initiating a MTOP. Currently there are no clinical guidelines for managing these women. The PAMper Trial aims to assess the efficacy of progesterone after mifepristone as % of viable pregnancies 2 weeks after initiation of progesterone, as determined by ultrasound, and % of live births. It will also report on relevant clinical factors associated with the use of progesterone after mifepristone and explore the experiences of women who take mifepristone then decide they want to continue their pregnancy. Participants will be women who have taken mifepristone then contact the trial centre because they now want to continue their pregnancy. It is expected that the pregnancy continuation rate 2 weeks after commencing treatment will be statistically greater than 25% and could be be over 50%. [1] Davenport ML, Delgado G, Harrison MP, Khauv V Embryo survival after mifepristone: a systematic review of the literature. Issues in Law & Medicine. 2017;32(1):3-18.

  • Australian and New Zealand Multicenter trial of Extended (6-8 hours) Non-Ischemic Heart Preservation (NIHP) of Donor Hearts for Transplantation

    The time from when a heart is removed from a brain dead organ donor and transplanted into a recipient is known as the ischemic time. This is a critical period of time since the donor heart is not receiving any blood supply, oxygen or nutrition and if the ischemic time becomes prolonged (beyond approximately 4 to 6 hours), the heart may be damaged to the point that it does not work well in the recipient (known as primary graft dysfunction). For the last 50 years of heart transplantation, transportation of the heart during the ischemic time involves stopping the heart by paralysing it chemically and then putting it in ice slush to cool it down and reduce its energy requirements, a technique known as cold static storage (CSS). Recent advances in donor heart preservation have led to the development of a mechanical perfusion system called non-ischemic heart preservation (NIHP). With this system, during the ischemic time, the heart can be continuously perfused with a solution containing hormones, oxygen and some nutrition. Protecting the donor heart using NIHP substantially increases the ischemic time while minimizing the risk of primary graft dysfunction. The aim of the current trial is to investigate the effectiveness of NIHP to increase the ischemic time of donor hearts to 6 to 8 hours. Findings from this study may demonstrate that NIHP is beneficial in preventing primary graft failure. Additionally, countries the size of Australia and New Zealand where donor hearts are often declined because the ischemic time is unacceptably long, NIHP of the donor heart may allow longer ischemic times and hence increase donor heart availability.

  • Partnering with General practitioners to Optimise Survivorship for PatiEnts with Lymphoma: A Phase II randomised controlled trial.

    The purpose of this study is to test the feasibility of a care model involving haematologists and GPs for lymphoma follow-up care. Who is it for? You may be eligible for this study if you are aged 18 or older, and have lymphoma. Study details Participants in this study will be randomised by chance (like flipping a coin) into two groups. One group will receive standard follow-up (haematologist-led) care and information from Cancer Council Australia. The other group will undergo the share-care model. This involves a series of 20 to 60 minute appointments with specialist nurses, GPs and haematologists for up to 2 years. As part of the study all participants will answer a series of questionnaires every 6 months for 12 months. It is hoped this research will demonstrate the feasibility and usefulness of the new model of care which could influence future lympjhoma follow-up care.

  • Has the threat of SARS COVID-19 increased influenza vaccination rates in pregnant women?

    Seasonal influenza infection is a significant cause of morbidity and mortality which can be prevented by vaccination. Notably, pregnant women and babies under 6 months are at significant risk of hospitalisation and adverse health outcomes if infected with influenza. In a retrospective audit, seasonal influenza vaccination rates in pregnant women at the Centenary Hospital for Women and Children at the Canberra Hospital were found to have increased from 35% in 2017 to 79.8% in 2017 with the introduction of a mandatory field in an electronic health record. This study aims to investigate compliance of pregnant women with seasonal influenza vaccination rates at the Centenary Hospital for Women and Children during the Covid-19 pandemic using a follow-up audit.

  • Phase I Dose Finding Study in Patients with HER2-Positive Advanced Solid Tumors

    This purpose of this study is to determine a safe dose for GQ1001 in patients with HER-2 Positive Advanced Solid Tumors Who is it for? You may be eligible to join this study if you are aged 18 years and older, and have pathologically documented solid tumor with HER2 expression Study details All participants in this study will receive the study drug (called GQ1001). There will be 5 groups of patients who each receive a different dose. The drug will be given once intravenously (through the vein) on Day 1 of a 21-day cycle. Participants will be monitored for reactions and treatment effectiveness, and provide blood and urine for analysis. It is hoped that this research will improve the health outcomes of patients with HER2-positive advanced solid tumors.

  • Individualised Theta Burst Transcranial Magnetic Stimulation (TBS) for Depression

    This study is a randomised controlled trial investigating whether response to TBS can be substantially enhanced through the application of TBS at an individualised frequency. We hypothesised that treatment with an individualised TBS (Ind TBS) protocol will result in greater improvement in depressive symptoms, compared with standard TBS. So we will compare an individualised TBS intervention to standard TBS to evaluate its relative effectiveness in regards to antidepressant effects. Participants will take part in assessments of depression severity before, during and after four weeks of TBS and at another follow-up review at week 8. They will receive a course of 20 treatments of either Ind TBS or standard TBS. All assessments and treatments will take place at Epworth Camberwell.

  • Psychological impact of COVID-19 pandemic on perioperative staff at the Royal Melbourne Hospital – a longitudinal study

    This study will investigate the psychological impact on healthcare workers who work in the operating theatre environment during the COVID-19 pandemic. This is an important study because operating theatre staff are frontline healthcare professionals, who are working under enormous pressure during this challenging time. There is potentially a significant risk of mental health burden as a result of the pandemic. This study will help to identify any risk factors which may be associated with worse psychological outcomes. This study is a time-series online survey. Participation is voluntary. Data collected are anonymous and unidentifiable. The survey will be repeated every 4 weeks until the end of the pandemic or for 8 months from commencement, whichever is the sooner. Psychological support strategies will be provided to each individual at the end of each survey in the form of written information.

  • Can metacognitive training (MCT) improve treatment outcomes for adolescents with anorexia nervosa?

    Metacognitive training (MCT) targets ‘thinking errors’ underlying different forms of mental illness and is effective at reducing symptom severity in people with psychosis, depression, borderline personality disorder, and obsessive-compulsive disorder. Importantly, the literature suggests that MCT is not only effective at reducing the severity of a diverse range of psychiatric symptoms (e.g., delusions, depressed mood, compulsive thoughts), but that participants consistently report that the training is engaging, with high applicability to daily life and low attrition rates. However, the approach has not yet been applied to people with anorexia nervosa (AN), despite the high prevalence of ‘thinking errors’ in this population (e.g., belief inflexibility; weak central coherence or difficulty seeing the ‘forest for the trees’). MCT may be particularly beneficial to adolescents with AN, as it aims to improve cognitive flexibility in a non-confrontational manner by targeting the biased thinking styles that contribute to disordered eating symptoms. This project, the first randomised controlled trial to investigate MCT in individuals with eating disorders, specially aims to: 1) determine the feasibility of the MCT programme for adolescents with anorexia nervosa (e.g., subjective evaluation of the programme’s effectiveness and applicability to daily life). 2) determine the therapeutic benefit of MCT for adolescents with AN when added to an inpatient refeeding program, including eating disorder symptom severity (e.g., concerns about weight, shape, and eating). 3) generate knowledge of the psychological processes that contribute to the onset and maintenance of AN (e.g., belief inflexibility, perfectionism). By developing a greater understanding of the psychological processes responsible for disordered eating, this project is expected to improve current models for preventing and treating this serious mental health condition. As the study is a feasibility trial, we are primarily interested in the qualitative feedback participants in the MCT condition provide. We are also interested in group (MCT/control) differences across several secondary measures. We hypothesise that the MCT group will experience greater improvements on biased thinking styles associated with eating disorders (e.g., improved cognitive flexibility, lower perfectionism) and greater increases in global eating disorder psychopathology than the control group at 3-month follow-up.

  • The safety and efficacy of STC3141 in patient with COVID-19 Acute Respiratory Distress Syndrome

    The pathophysiology of ARDS and sepsis involves a dysregulated response of the immune system to infection. NET-associated proteins, particularly histones play very important role and cause significant tissue damage, which correlate highly with death as an outcome. Our hypothesis is to use STC3141 to neutralize the extracellular histone/NETs. Continuous infusion STC3141 up to 5 days while the patients are on ventilators in ICU compare to standard care.

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