ANZCTR search results

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

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32103 results sorted by trial registration date.
  • Tongue injury among patients with epilepsy undergoing video-encephalographic monitoring

    In this study, we plan to investigate the effectiveness of mouthguards to prevent or minimise tongue injury among epilepsy patients who are undergoing VEEG or Stereotactic EEG (SEEG) monitoring.

  • The International Glaucoma Surgery Registry

    Glaucoma is the most common cause of irreversible blindness in the world, affecting more than 70 million worldwide, of whom approximately 7 million are blind. The only proven treatment for glaucoma is to lower intraocular pressure (IOP). There are various treatment options for lowering IOP including medicine, laser, or surgery. More recently, new minimally invasive surgical devices and procedures have been introduced that aim to lower IOP and reduce dependence on medical therapy and/or avoid the need for invasive surgery. The International Glaucoma Surgery Registry (IGSR) is an observational, non-interventional, study of people who have undergone or are going to have a laser or surgical procedure for glaucoma. The inclusion criteria are a history of glaucoma or ocular hypertension requiring treatment with a laser or surgical procedure. The registry only collects information and does not influence the choice of treatment in any way. As part of routine clinical care, data will be collected on patients undergoing glaucoma procedures annually for 5 years or more with the goal of providing high-quality longitudinal data on outcomes, treatments patterns, quality of life, and cost-effectiveness. The IGSR aims to make a major contribution to understanding the clinical effectiveness of glaucoma procedures, as well as guiding evidence-based decision making and providing data to support future clinical trials.

  • SMARTscreen: A randomised controlled trial to measure the impact of SMS messages sent to patients from their general practice on participation in the National Bowel Cancer Screening Program.

    This study is assessing whether a mobile phone SMS prompt will affect how many people choose to complete the National Bowel Cancer Screening Program (NBCSP) test among 50 to 60-year-old patients in Victoria. Who is it for? You may be eligible for this study if you are aged between 50 to 60 years, you are eligible to receive the free National Bowel Cancer Screening Program test kit, your GP has agreed to participate in the study and you have access to a smartphone. Study details Participants in this study will be randomly assigned to one of two groups. The first group will receive a single SMS message sent by their GP's practice one month prior to receiving their NBCSP test kit in the mail. The SMS message will include web links to a number of resources, including a message from their GP endorsing the free home test kit; a link to a narrative video of someone describing their positive experience of doing the test; a link to information about bowel cancer; and an animation showing how to do the test. The second group will not receive a SMS message but will still receive the NBCSP test kit in the mail. Participants in the second group will be able to discuss the test with their GP as part of their usual care. It is hoped this research will determine whether an SMS prompt about completing the NBCSP test kit impacts on the number of people choosing to take up the screening test at home, which could increase early detection of bowel cancer.

  • A Phase 1 Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Selgantolimod upon Co-administration with a Representative Proton Pump Inhibitor or H2-Receptor Antagonist

    A Phase 1 Study to Evaluate the Pharmacokinetics and Pharmacodynamics of GS-9688 upon Co-administration with a Representative Proton Pump Inhibitor or H2-Receptor Antagonist in healthy adults

  • Exploring the effectiveness of policy options for simultaneous displaying multiple added sugar labels in Australian adults

    This project aims to generate experimental evidence from one online randomised controlled trial to determine the relative effect of simultaneously displaying multiple added sugar labels to facilitate healthier choices by consumers. We hypothesise that displaying multiple added sugar labelling on food and beverage items will reduce the proportion of intended purchases of products that are high sugar, compared to no added sugar labels or only one added sugar label. Further we hypothesise participant characteristics including age, gender, education, income, and usual levels of sugar consumption alter the effect of added sugar labelling on intended purchasing. This new evidence will be critical to the development of effective labelling policies to reduce added sugar consumption for all Australians and New Zealanders.

  • Double-Blind Randomised Investigation of Bazedoxifene and Conjugated Estrogen for Depression in Menopausal Women

    The purpose of this study is to investigate the use of the medication combination Bazedoxifene and conjugated estrogen, a hormone replacement therapy, in the treatment of depression with a first onset or relapse during the peri-menopausal phase that is still persisting. The study will employ a 12-week, double-blind, randomised, two-arm parallel-group design. Participants will be randomised to one of two groups: (1) Daily oral Bazedoxifene and conjugated estrogen (20mg/0.30mg), (2) Placebo (sugar pill). The aim is to compare, in a twelve-week double-blind randomised controlled trial, the psychological and physical outcomes of women experiencing a first-onset, relapse or persistent depressive symptoms that commenced during the peri-menopause in four groups: i) women taking Bazedoxifene and conjugated estrogen (20mg/0.30mg oral/day) in adjunct to standard antidepressant treatment, ii) women taking placebo in adjunct to standard antidepressant treatment, iii) women taking Bazedoxifene and conjugated estrogen (20mg/0.30mg oral/day), iv) women taking placebo alone (i.e. women not using any psychotropic / hormone treatment). It is hypothesized that women receiving Bazedoxifene plus conjugated estrogen alone, and Bazedoxifene plus conjugated estrogen in adjunct to standard antidepressant medication will have the same as or significantly greater improvement in depressive symptoms compared with women receiving placebo in adjunct to standard SSRI and women not using any psychotropic/hormone treatment.

  • Perioperative oxygen administration in patients undergoing major non-cardiac surgery under general anaesthesia in Australia and New Zealand: study protocol for a prospective multi-centre observational study.

    The aim of the proposed study is to determine the proportion of patients who are administered oxygen therapy in accordance with the current World Health Organisation (WHO) guidelines by anaesthetists in Australia and New Zealand. The primary outcome of this study will be to determine the proportion of cases where time-weighted average intra and postoperative inspired oxygen concentration (FiO2) was at least 0.8 in accordance with WHO guidelines. We hypothesise that among the population group studied, fewer than 5% of patients will be administer intraoperative oxygen therapy as recommended in the WHO guidelines.

  • Australian Myelodysplastic Syndromes (MDS) Patient Registry

    The primary purpose of this study is to provide long-term patient follow-up, and review of clinical and correlative data outside of clinical trials. Who is it for? The registry will collect information on patients age 18 years or older, with a new diagnosis of Myelodysplastic syndrome (MDS). Study details Treating clinicians at sites will identify patients at the time of referral and enrol them to the study. The following categories of data items will be collected to the Myelodysplastic syndrome database using a web portal: • Health at diagnosis • Demographic details • Laboratory and bone marrow biopsy results at diagnosis including cytogenetics and molecular studies if available • Therapy decisions including pharmacological agents, transfusion practice and supportive therapy, and side effects of treatment • Outcomes (overall and progression free survival, duration of response and time to next treatment and quality of life measures – EORTC QLQ-C30, QUALMS) • Long-term outcomes (through linkage with Cancer and Death Registries) Patients are asked to completed both questionnaires 6 monthly up to 3 years either at their hospital appointment or send to them via email. It is hoped that the data collected for this registry will identify patterns of treatment and variation in outcomes, for survival and quality of life. Findings will be valuable in informing optimal treatment strategies for Myelodysplastic syndrome and will assist with monitoring patient access to care, as well as monitoring trends in Myelodysplastic syndrome incidence and survival in Australia.

  • A Prospective multicentre, phase 2b randomised controlled double-blind trial, to determine the safety and efficacy of perispinal etanercept on quality of life at 28 days post treatment

    The participant is invited to take part in this research project. This is because the participant has had a stroke within the last 15 years and has ongoing disability and impairments. The research project is testing a new treatment for stroke called Etanercept. Stroke survivors often have lifelong, disabling effects as a result of their stroke which impact daily life. Because current treatment options for post-stroke impairments are limited, stroke survivors sometimes try out therapies that may not be scientifically proven. The use of Etanercept injected at the base of the neck, is one treatment that has received a lot of attention in the media as it has been linked with improvement of stroke symptoms. It is unclear whether these improvements are due to the drug or other factors, as many of the effects have been seen in small observational case studies. Etanercept is approved in Australia to treat joint conditions (such as rheumatoid arthritis) or skin conditions (such as psoriasis). However, it is not approved to treat stroke. Therefore, it is an experimental treatment for stroke. This means that it must be tested to see if it is an effective treatment for stroke. This trial is aiming to properly test to see whether this medication is an effective treatment. The participant will be randomly assigned to receive an injection of Etanercept or an injection of a placebo at two timepoints in the study. The study will be double-blinded. This means that neither you, the participant nor their study doctor will know which treatment they are receiving. However, the study doctor can find out which treatment they are receiving if necessary, for safety reasons.

  • The impact of individualised post-exercise blood flow restriction on exercise performance and perceived recovery following strenuous resistance exercise in trained adults.

    Post exercise blood flow restriction (PE-BFR) appears to offer a novel, ecologically viable, and practical method of enhancing recovery that is becoming increasingly common in athletic settings. In brief, PE-BFR consists of repeated brief alternating periods of blood flow restriction and reperfusion on targeted limbs, most commonly applied via an inflatable pneumatic cuff placed on the proximal most portion of the limb. However, the effect of PE-BFR on recovery have been conflicting. In certain settings, PE-BFR has been shown to attenuate decrements in physical performance, measures of muscle damage, and perceptual measures of recovery between 24 and 72 hours after exercise. Conversely, in others, no positive effects on recovery have been observed. Irrespective of outcomes, it is important to highlight that methodological differences exist between previous studies regarding the implementation of BFR. For example, all previous methods of application used either standardised arbitrary pressures, pressures based on thigh girth, or pressures based on a percentage of systolic blood pressure – none of which align with the current recommendations of restricting blood flow using a percentage of limb occlusion pressure (LOP) As such, this study aims to explore the effects of individualised post exercise blood flow restriction, based upon a percentage of LOP, on measures of physical performance and perceived recovery following heavy resistance training exercise.

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