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.
  • Associations between diet quality and common mental disorders in emerging adults: results from a nationally representative sample

    This study is a secondary analysis of cross-sectional, nationally representative data from the Australian National Health Survey 2017-18. Data will be obtained from the Australian Bureau of Statistics (ABS) in the form of a Confidentialised Unit Record File (CURF). The aim of this study is to investigate the associations between indicators of diet quality as an exposure of interest, and common mental disorders as outcomes of interest, among a large, nationally representative cohort of emerging adults in Australia. It is hypothesised that 1) indicators of high healthy and low unhealthy diet will be independently associated with lower rates of common mental disorders, and 2) indicators of low healthy and high unhealthy diet will be independently associated with higher rates of common mental disorders.

  • Internet-delivered dialectical behaviour therapy (iDBT) skills training to reduce difficulties in emotional dysregulation and pain in people with chronic pain

    Difficulties in emotional regulation is one important factor in the development and maintenance of chronic pain. Some evidence already supports the potential for internet-delivered Dialectic Behaviour Therapy (iDBT) to reduce difficulties in emotional regulation and pain intensity. However, further studies are needed to provide bolster evidence regarding the effectiveness of iDBT in the chronic pain context. A single-case experimental design (SCED) with multiple baselines will be used to examine the effectiveness of iDBT-Pain skills training intervention to reduce difficulties in emotional regulation and pain intensity in people with chronic pain. Three participants with chronic pain will be recruited. Each participant will be randomised to a different baseline phase (i.e., 5, 9 or 12 days), which will then be followed by 6 sessions of 60-90min iDBT skills training intervention over a 4-week period including unlimited usage of the iDBT-Pain skills training web application. The Difficulties in Emotional Regulation Scale (DERS) will serve as the primary outcome measure. The visual analogue scale assessing average pain intensity will serve as the secondary outcome measure. Generalisation measures will assess sleep quality, coping, temperament and anxiety and depressive symptoms as well as medial prefrontal cortex glutamate concentration. SCEDs are considered a viable alternative approach to randomised clinical trials to identify evidence-based practices when recruitment of large samples is not feasible.

  • Development of customised distraction techniques for managing acute behavioural disturbance in patients aged 65 years or older in the emergency department

    This is a pilot study using technologically advanced customised distraction techniques to prevent and manage acute behavioural disturbance (ABD) in elderly patients in the emergency department (ED). Acute behavioural disturbance is a common problem in EDs, particularly in elderly patients and even more so in those with cognitive impairment, for example people with delirium or dementia. This behaviour endangers the patients themselves, their companions, other patients and ED staff, and hampers timely delivery of their care. Current treatment options, including psychotropic medication and mechanical restraint remain of limited benefit, confer risk and are of limited efficacy. Despite recognition that they are preferred practice, distraction techniques are rarely used in the management of patients with ABD in the ED setting; with the vast majority of cases managed using psychotropic medications, often administered parenterally, and often without patient consent under the Principle of Necessity. These medications have significant adverse effect profiles; complications can include over-sedation with hypoxia or hypotension, falls and subsequent injuries as well as prolonged lengths of stay and increased mortality. In the ED, available non-pharmacological options are limited, rendering the investigation of distraction techniques such as the use of virtual reality (VR) and other multimedia approaches in this setting an important initiative. We aim to perform an iterative process of testing, adaptation and refinement of devices and media to develop customised distraction techniques for elderly patients who exhibit ABD in Cabrini ED.

  • Post-Intensive Care Nutrition Status in Patients with COVID-19

    Patients with COVID-19 admitted to intensive care are at high risk of nutritional concerns such as high fevers, increased energy utilisation, impaired glucose utilisation, and increased catabolic state and protein breakdown. Post-ICU there may be significant effects on appetite, taste sensations and direct gastrointestinal affects resulting in diarrhoea, nausea, and vomiting. While no data exist on nutritional intake post-ICU in patients diagnosed with COVID-19, significant nutritional deficits in other cohorts of ICU survivors have been demonstrated. Further, similar conditions, such as Acute Respiratory Distress Syndrome, are associated with substantial acute weight loss during hospitalisation, with long-term muscle weakness and functional impairments. If they survive, patients with COVID-19 are likely to have prolonged recovery and stay in hospital for a significant length of time. Coupled with stretched healthcare resources, this cohort of patients may be particularly susceptible to nutritional deficits, declining nutritional status, and poor functional recovery. Given there is limited available data to guide the optimal nutritional management of patients with COVID-19, we aim to quantify nutrition intake and process in survivors of COVID-19 after ICU discharge. Therefore, we are conducting a multi-centre observational study, across participating sites in Australia. As this is a descriptive study the following (but not limited to) outcomes are of interest: - Nutrition service delivery - Nutrition provision at the patient level - Nutrition information on patients with COVID-19

  • Examining yoga as a complementary therapy for anxiety and depression

    This is a pragmatic, proof-of-concept study which aims to explore yoga as an adjunct treatments to cognitive behavioural therapy (CBT) for adults with anxiety and depression. Up to 60 participants will be recruited from an existing eight week group CBT program for treatment of anxiety or depression at a primary mental health clinic and invited to take part in a tailored yoga program in addition to their usual treatment, consisting of weekly group classes and an individualised home practice. Mixed-methods data will be collected at pre post and follow up time points. It is expected that individualised who complete yoga in addition to CBT will experience significantly greater reduction in clinical symptoms compared to those engaged in CBT alone. Furthermore, it is expected that qualitative findings will provide insights into whether yoga is an acceptable adjunct treatment to CBT, if adults with anxiety and depression experience yoga as complementary and how.

  • Seizure Detection Using Kaoskey TRIO Software

    This is a single-centre, prospective post-market study using a TGA approved Class IIa medical device (“eMotion Faros Sensor”), which records electrocardiogram (ECG) through Kaoskey’s prototyped developed software suite (“TRIO”). Adult (18 years or older) participants admitted for inpatient video-EEG monitoring at The Alfred Hospital meeting eligibility criteria will be invited to participate in the study. Enrolled participants will be asked to wear the eMotion Faros Sensor during the monitoring period. High-resolution ECG recordings will be recorded during the patient’s admission and assessed using the TRIO software suite.

  • Topical corticosteroid for treatment of hand osteoarthritis

    Aim: To assess, using a parallel-group randomized controlled design, the effect of topical Diprosone OV ointment administered 3 times daily compared to placebo in reducing pain and improving function in participants with hand osteoarthritis over 6 weeks. Hypothesis: Topical Diprosone OV ointment administered 3 times daily would be more effective than placebo in reducing pain (visual analogue scale) and improving function (assessed using validated questionnaires and grip strength) in participants with hand osteoarthritis over 6 weeks.

  • A double-blind randomised controlled study to evaluate the effectiveness of orally-dosed Palmitoylethanolamide (PEA) compared to placebo for reducing pain severity and duration of migraines in otherwise healthy participants aged 18 years and older

    A double-blind randomised controlled study to evaluate the effectiveness of orally-dosed Palmitoylethanolamide (PEA) compared to placebo for reducing pain severity and duration of migraines in otherwise healthy participants aged 18 years and older. The aim of this study is to assess the effectiveness of Levagen+ for reducing pain severity and duration of migraines compared to a placebo.

  • 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.

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