ANZCTR search results

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

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31130 results sorted by trial registration date.
  • Cradle to Kinder: A Qualitative and Quantitative Evaluation of a Maternal and Child Health Intervention for Disadvantaged Young Mothers

    Young disadvantaged mothers are at a higher likelihood of having their child/children removed from their care, which results in poor psychosocial outcomes for the mother and the infant. Therefore, a prospective cohort study will be conducted to evaluate the efficacy of the Cradle to Kinder program on psychosocial outcomes among young and vulnerable families. An anticipated sample of 50 young at-risk women and their families will receive the Cradle to Kinder program, commencing from pregnancy up until the child turns four years old, Cradle to Kinder is a targeted, intensive and long-term ante- and postnatal support service for vulnerable young mothers (aged less than 25 years with one or more risk factors) and their families. Cradle to Kinder practitioners will conduct weekly to fortnightly home visits and engage families in a range of different interventions to support and facilitate health outcomes. Assessments will be conducted by the practitioner at baseline and then every six months over the four years of the intervention. Maternal health outcomes (i.e., mental health, parenting capacity) will be measured using the North Carolina Family Assessment Scale, and infant outcomes (i.e., attachment style, social and emotional development) will be assessed by the Brigance. It is expected that families who engage in the program for its entire duration will demonstrate better psychosocial outcomes at the conclusion of the program compared to the beginning.

  • Effect of breaking up sitting on health and cognition in sleep-restricted and non-sleep restricted individuals

    Our modern 24h society means that sleep and waking activities are changing. Ten million Australian workers sit at work, eleven million Australians are sleep restricted and 1.9 million Australians are shiftworkers. This is problematic, as prolonged sitting and sleep restriction have negative impacts on health and safety at work and contribute to a huge burden on public health. Although sleep restriction and prolonged sitting have been investigated separately, to date, no study has investigated how these factors jointly impact health and safety. To investigate the combined effects of prolonged sitting and sleep restriction in different shiftwork types, this study measures cardiometabolic outcomes and cognitive performance in healthy adults doing dayshifts or nightshifts under different levels of sleep restriction and in conditions of prolonged sitting and conditions of breaking up sitting. We propose that breaking up sitting will improve cardiometabolic health and cognitive performance compared to prolonged sitting, but this effect will be lessened under conditions of sleep restriction. These results inform the development of workplace policy and public health guidelines targeting prolonged sitting at work and the impacts on health and safety.

  • Lung function, quality of life and handgrip strength in adults with heart disease

    Previous research has showed a reduced lung function after cardiac surgery and this has been associated with increased mortality and morbidity. The aim of this prospective, observational study is to determine if a cheap and simple tool like HGS could be an indicator of lung function and health-related quality of life after cardiac surgery. It is hypothesized that HGS will be a simple and valid method to monitor lung function and health-related quality of life during post-hospital recovery in cardiac patients.

  • Herbagut® for the Treatment of Digestive Complaints in Adults

    In this randomised, double-blind, placebo-controlled study, 50 adults who are currently experiencing digestive complaints will be randomly assigned to receive capsules containing either a herbal combination or placebo for 8 weeks. We will assess change in digestive symptoms, intestinal bacteria, vitamin D and B12 concentrations, and overall quality of life.

  • Pharmacokinetics and Safety of Rivastigmine Nasal Spray versus Exelon (Registered Trademark) Capsule in Healthy Men

    Rivastigmine (RIV) is an acetylcholine esterase inhibitor which prevents neurotransmitter breakdown. As such it is currently approved for the treatment of neurological disorders such as Alzheimer's and Parkinson's disease dementia. RIV is available in two forms, oral (capsule) and as a transdermal (through the skin) patch. The latter was developed as a consequence of the oral forms causing nausea, vomiting and diarrhoea predominantly caused by the low oral bioavailability of this drug. Although the transdermal patch overcomes a lot of these side effects, a high percentage of people suffer from skin irritation and possible sleeplessness. This study will investigate whether delivering RIV nasally (into the nose) provides RIV therapeutic levels in the blood plasma that are comparable to Exelon (Registered Trademark) oral capsule and whether nasal RIV results in lower side effects. Each intervention will be as a single dose with thorough blood sampling over 24 hours to assess drug levels; each intervention will be separated by a 2 day washout period. This is a phase 1 trial in 16 young healthy males aged 18 to 55 years. While comparing the two delivery methods, this study will also investigate the safety and tolerability of Rivastigmine nasal spray.

  • Does stopping folic acid at 12 weeks of pregnancy reduce the amount of unmetabolised folic acid in the blood of pregnant women - The Folic Acid in Pregnancy Study

    Australian women receive 0.15-0.2 mg/d of folic acid from food containing fortified bread flour. In addition, >80% of Australian women take a multivitamin during pregnancy, with one of the most popular brands containing double the amount of folic acid recommended for pregnant women until 3 months gestation. (0.8 mg/d). There is no question that taking folic acid in early pregnancy is important to prevent neural tube defects. However, there is no proven benefit and potential harm from taking folic acid after neural tube closure at approximately 28 days post conception. We aim to determine if removing folic acid from prenatal supplements after 12 weeks of gestation results in lower blood concentrations of unmetabolised folic acid, a biomarker of excess folic acid, at 36 weeks’ gestation. We will also determine if removing folic acid from prenatal supplements after 12 weeks’ gestation allows women to maintain red blood cell folate concentrations >905 nmol/L at 36 weeks’ gestation.

  • The impact of reminiscence therapy using virtual reality in residential aged care to improve quality of life.

    Apathy is one of the most common of the behavioural and psychological symptoms of dementia and can have devastating effects on quality of life for older adults, particularly those in residential aged care. People with apathy are at greater risk of cognitive decline and reduced quality of life. Pharmacological interventions can have limited effectiveness and side effects, therefore, non-pharmacological interventions are a preferred approach. This projects aims to reduce levels of apathy in older adults living in residential aged care using virtual reality as a tool for reminiscence therapy. It is expected that greater improvements in apathy will be found in a virtual reality reminiscence group compared with a traditional reminiscence therapy and no treatment group.

  • The impact of thought processes on sleep outcomes in adults aged 60 - 80 years

    Sleeping well is an essential part of good health, but about 60% of people over 60 years of age report that they have trouble sleeping. Whilst some research suggests that sleep problems are due to age-related changes, other studies have proposed that cognitive or thought processes may contribute to poor sleep. This study will examine sleep quality in adults aged 60 - 80 years residing in Western Australia. It will investigate whether thought processes influence treatment outcomes of online CBT in people with and without sleep problems.

  • The BEKind Study: Psychological Wellbeing of Women with Endometriosis

    This research aims to assess and measure various aspects of psychological wellbeing, self-compassion and body image disturbance in women with endometriosis over a six-month period. A secondary aim includes mapping and exploring the trajectories of psychological distress this duration of time. It is hypothesized that women with endometriosis will report high levels body image disturbance, anxiety and depression, and that this will correlate with reduced levels of self-compassion. In order to be able to mitigate these issues and help women cope with the day-to-day challenges of living with endometriosis, the crucial first step is quantifying the level of body image distress and its relationship to other psychological variables. Through a longitudinal design, we may be able to firstly identify the trajectory of psychological distress in this population, and furthermore delineate predictors of psychological distress over time. This research will form a foundation on which development of interventions that can address body image concerns and improve coping in women with endometriosis.

  • A trial to see how educational websites for cancer doctors, nurses, patients and family carers affect family carer involvement medical consultations.

    The purpose of this study is to test some online training modules for those involved in cancer consultations. Who is it for? You may be eligible for this study if you are aged over 18 and any of the following: a) a hospital-based medical/radiation/surgical nurse or oncologist treating cancer patients. b) a person diagnosed with cancer of any type, whose nurse/oncologist is participating in the study c) a person related to a participating patient who supports the patient inside and outside a consultation. Study details Medical staff in this study will be randomised by chance (like flipping a coin) into two groups. one group will use the eTRIO resources, and the other will use existing NSW Health resources. Patients and carers will use separate resources, based on which group their medical staff are allocated to. The use of these resources involves reading websites, watching videos and completing activities. As part of this study, participants will answer questionnaires and have their consultations recorded. It is hoped this research will contribute to increased carer involvement in cancer consultations, and improved psychological outcomes through better communication.

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