ANZCTR search results

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

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31102 results sorted by trial registration date.
  • Evaluation of mega-dose Vitamin C for patients with severe infections who are admitted to the intensive care unit

    Septic shock, which is a state of severe infection, triggers a complex response by the body (the inflammatory response) that causes a decrease in blood pressure and subsequently one or more organ systems to fail when blood supply to these organs is reduced. When patients are admitted to intensive care with sepsis and/or septic shock they receive a range of therapies including antibiotics, intravenous fluids and strong drugs to improve blood pressure, known as vasopressor drugs.. However, these therapies have significant side effects and it would be desirable to restore a safe blood pressure quickly. Over the last few years, evidence has emerged that high dose Vitamin C administered via infusion may help to restore blood pressure with almost no side effects. This makes treatment with Vitamin C potentially desirable in patients with on-going low-blood pressure due to septic shock. However, this effect might be dose dependent and we do not know the effect of mega dose Vitamin C. In response, we will perform a clinical research project, known as a randomised controlled trial, to evaluate whether giving intravenous mega-dose Vitamin C (total of 60 grams) compared to placebo, improves physiological outcomes in a population of 30 patients admitted to intensive care with a diagnosis of suspected or confirmed sepsis.

  • Training Inhibitory Control in Adolescents in Attention-Deficit/Hyperactivity Disorder

    Children who are inattentive or impulsive often have difficulties in a range of areas including academically and socially. For many children with ADHD, these difficulties will continue on through adolescence and into adulthood, yet there are currently few tools available for those experiencing impulsivity and inattention. The Alfi VR program uses Virtual Reality (VR) to create a novel and engaging platform for teenagers to practice cognitive skills that are associated with impulsivity and inattention. The aim of the study is to determine whether VR cognitive training is associated with improvements in impulse control, and related domains such as attention, social skills and ADHD symptoms. It is hypothesised that adolescents who complete the Alfi VR program will show significant improvements in inhibitory control when compared to adolescents in the control group.

  • The RAP clinical trial: Safety of a novel endoscopic technique for post laparoscopic sleeve gastrectomy patients with severe reflux

    The primary purpose of the clinical trial is so establish a safety profile for the RAP (resection and plication) technique in patients who are experiencing severe reflux symptoms post laparoscopic sleeve gastrectomy. Endoscopic anti-reflux therapy is an emerging treatment considered for selected patients with gastro-oesophageal reflux disease that have a history of ongoing symptoms despite standard treatment. Additionally, the trial will measure quality of life measures, effects on reflux symptoms,endoscopic data points, medication usage and weight changes.

  • An online mindfulness program for fear of cancer recurrence in people with prostate, breast or bowel cancer.

    The purpose of this study is to determine the effect of an online mindfulness program (MindOnLine) on fear of cancer recurrence, anxiety and depression. Who is it for? 400 adults who have completed treatment for breast, prostate or colorectal cancer and who experience significant fear of cancer recurrence will be invited to participate. Study details People will be allocated to one of two groups by random chance: the intervention group with immediate access to MindOnLine, or a usual care group who will receive the intervention after the follow up period. MindOnLine is a 9 week program where a new theme is introduced each week with a new meditation practice. People will be encouraged to practise mindfulness every day. At the end of the 9 weeks, participants will be asked to complete a series of surveys. It is hoped that this research will help determine whether mindfulness will be an effective method of assisting people in managing fear of cancer recurrence, anxiety, and depression.

  • FluBub Study: Early influenza vaccination in infants

    Young children, particularly those younger than six (6) months are at increased risk of severe influenza infection. Influenza vaccination is recommended for all children 6 months of age or older, but not for younger children. This is despite their risk of severe disease. The safety and immune response to previously available trivalent influenza vaccines (TIV; conferring protection against three influenza strains) has already been demonstrated in infants under 6 months of age, yet these reassuring data have not translated into routine use. There are no data on the safety and immune response in infants under 6 months of age to quadrivalent influenza vaccines (QIV; conferring protection against four strains; routinely used in Australia since 2016), nor is anything known about the impact of the now recommended maternal influenza vaccination on vaccine responses in infants under 6 months of age. We will conduct a phase 2, prospective randomised open-label feasibility study to assess both the safety of early (under 6 months) influenza vaccination in healthy young infants and its ability to generate a protective immune response via antibody production (immunogenicity). This will be compared with infants vaccinated according to the currently recommended schedule. Approximately 160 infants will be randomised to a vaccination strategy which will either have an early start to the schedule or commence according to the currently recommended schedule. Arm 1: Early vaccination and booster (receipt of QIV at 6 to <12 weeks; booster at least 4 weeks later); Arm 3: [Control] Standard vaccination (QIV at 6-7 months of age; booster at least 4 weeks later); Solicited and unsolicited adverse events will be monitored. Antibody responses will be assessed using the standard haemagglutination inhibition and focal reduction assays. The strength of immune responses will be assessed across the different arms, and impact of amount of maternal antibody present will be considered in the analyses. Additional testing using a systems serological approach will be performed on remaining samples to generate new knowledge on the mechanisms determining vaccine efficacy. Surveillance for influenza infection will occur during the influenza season with episodes of acute respiratory infection confirmed through nasopharyngeal samples. This is a pilot study that will tell us whether a larger, more informative study will be worthwhile.

  • Integrating a mobile health device into a community youth mental health team to manage severe mental illness: A randomized controlled trial

    Symptoms of mental illness are often triggered by stress and individuals with mental illness are sensitive to these effects. This study uses a mobile health device to monitor physiological signs of stress in youths with severe mental illness, as reflected by changes in their activity and arousal. Participants from community mental health services will be allocated to standard case management combined with an integrated mHealth device (information is viewed by both participant and case manager) or an unintegrated mHealth device (participant alone views information; control). We hypothesize that participants and case managers using the integrated mHealth device will be better able to engage and respond to early signs of mental deterioration.

  • Ventricular Arrhythmias in Implantable Cardioverter Defibrillator Patients During the COVID-19 Pandemic

    PRIMARY PURPOSE OF STUDY & STUDY HYPOTHESIS: The primary purpose of this study is to assess the incidence of life-threatening heart rhythms in patients with an implantable defibrillator during the early coronavirus pandemic, compared with the months prior. Physical activity and illness, emotional distress and significant world events (including earthquakes, major sporting matches, and the 9/11 World Trade Center attack) have all been shown to correlate with a increase in life-threatening heart rhythms. We hypothesise that the COVID-19 pandemic will similarly be associated with a rise in life-threatening heart rhythms in defibrillator patients, who have a predisposition to such heart rhythms. To establish this, we plan to to assess all life-threatening heart rhythms in defibrillator patients during the first 100 days of the COVID-19 pandemic in the United States of America, compared with a 100-day period at the end of 2019, prior to the pandemic.

  • A phase II, open label non-randomised clinical trial of the safety and efficacy of the CovidCare app to support self-monitoring for COVID-19 symptoms in self-isolation and to determine the impacts on mental health

    CovidCare provides patients with symptoms and/or a diagnosis of COVID-19 with self-monitoring support during self-isolation. CovidCare is also providing researchers with critical information about emotional needs and the impact on mental health of self-isolation due to Covid-19. The aim of the study is to make sure that CovidCare is safe to use and that it performs accurately. From this study we also hope to better understand the mental health impacts and well-being of people who have received a positive diagnosis for COVID-19

  • Characterising Left Atrial Function and Compliance in Atrial Fibrillation

    This study will investigate the association between left atrial compliance on AF type (paroxysmal versus persistent), patient symptoms, exercise tolerance, left ventricular function and long-term prognosis. The hypothesis is that left atrial compliance will be increased in patients with persistent AF compared with those with paroxysmal AF and may be correlated with patient symptoms, exercise tolerance and long-term outcomes of AF ablation. This will be the first study to assess left atrial compliance using direct measurements of the left atrial dimensions and pressure and direct infusion of saline into the left atrium.

  • “SWIPE”: A Personalised brain-training app to reduce alcohol cravings and consumption

    "Approach bias modification" (ABM) is a computer-based, behavioural "brain-training" intervention that has been shown to help prevent relapse in people receiving residential treatment for alcohol use disorder (AUD). However, very few studies have tested whether ABM can be delivered as a smartphone app, and whether an ABM app can benefit heavy drinkers in the community who are not engaged in residential treatment. There have also been no studies examining whether it is useful to "personalise" ABM by allowing participants to select the stimuli used in the training task. We have developed "SWIPE", an ABM smartphone app, in which participants are trained to avoid alcohol-related images by "pushing them away" (which causes the image to shrink and then disappear), and approach positive images by "pulling" them, causing them to enlarge, Unlike previous alcohol ABM tasks, which use a standard set of images for all participants, SWIPE is personalised. Participants are prompted to select alcohol-related and positive images that are most relevant to them to use as training stimuli before commencing training. Additionally, SWIPE is "gamified", awarding points to participants for the speed and accuracy of their response, and encouraging them to try to improve their score on subsequent training sessions. We aim to test the feasibility and acceptability of SWIPE in people reporting hazardous alcohol use, recruited from the general community. In addition, we aim to gather data on drinking, alcohol craving, and alcohol dependence outcomes following training to assess whether these decrease after using SWIPE, since that would help determine if it is worth proceeding to a controlled trial testing its efficacy. We hypothesise that: 1. We will recruit 500 participants within 3 months of launching the app, supporting the feasibility of this programme. 2. At least 60% of participants will complete 8 sessions of ABM, supporting its feasibility and acceptability. 3. Mean ratings of the app will be greater than 3 on each subscale of the Mobile Acceptability Rating Scale, demonstrating adequate acceptability. 4. There will be statistically significant decreases in number of standard drinks per week, number of days on which alcohol was used in the past 7 days, alcohol craving, and Severity of Dependence Scale scores at the end of the 4-week intervention, relative to pre-training scores, suggesting its potential effectiveness. 5. The more sessions of ABM that participants complete, the larger will be the reductions in alcohol drinking, craving, and dependence symptoms. 6. The reduction of drinking over the intervention period will be larger in those with more severe baseline alcohol use/problems, and also larger in those with greater motivation and confidence to reduce alcohol use. We also intend to explore participants’ reaction time and error rate data from their ABM sessions as this will inform further refinement of the app after this study is completed.

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