ANZCTR search results

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

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32856 results sorted by trial registration date.
  • A double-blinded randomised controlled trial of daily use mouthwash to reduce the detection of pharyngeal gonorrhoea among men who have sex with men

    Men who have sex with men tested positive for pharyngeal gonorrhoea at Melbourne Sexual Health Centre (MSHC) who volunteer will be randomised to rinse and gargle the study mouthwash every day within the next 12 weeks. The primary outcome is the proportion of MSM with diagnosed with pharyngeal gonorrhoea within 12 weeks.

  • Delivering a very early nutrition intervention for patients with upper gastrointestinal and lung cancers at home using technology: a pilot randomised trial.

    This study will investigate the impact of early nutrition counselling delivered electronically on health-related quality of life and nutritional status in patients diagnosed with stomach or oesophageal or lung cancer compared with both early nutrition counselling delivered via the telephone and standard nutrition care. You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with upper gastrointestinal (GI) cancer or lung cancer and are being treated at Monash Health and your consultant is agreeable. Participants in this study are randomly allocated (by chance) to one of three groups. Participants in one group will receive early nutrition counselling delivered electronically via a mobile device (ipad). Participants in another group will receive early nutrition counselling delivered via telephone. Participants in the third group will receive standard nutrition care as deemed necessary by their health professional. Participants with early nutrition intervention will receive contact from the dietitian for the first 18 weeks of the study. Health-related quality of life and nutritional status will be assessed by questionnaires throughout the study up to 26 weeks.

  • Effect of skin-to-skin care compared with incubator care on cerebral oxygenation in preterm infants

    Skin-to-skin contact (SSC) has advantages for newborn babies. It increases weight gain, reduces mortality, severe infection, and length of hospital stay. There are, however, conflicting results from studies, which measured physiological parameters (heart rate, breathing frequency and oxygen saturation) of preterm babies. This uncertainty is a barrier to implementation of SSC especially in very immature preterm babies. Both too much and too little oxygen supply to the brain contributes to morbidity and mortality in very preterm babies. Regional brain oxygenation (rcO2) can now be measured by a technology called near-infrared spectroscopy (NIRS). There is a lack of knowledge about brain oxygenation during SSC. If stability in rcO2 during SSC could be demonstrated this would provide reassurance that SSC is “safe” and could be used in immature babies. The primary objective of this study is to measure rcO2 during SCC compared with measurements when the baby is being cared for in their incubator or cot. We aim to include 40 very preterm babies with a gestational age at birth less than 33 weeks. We hypothesise that rcO2 remains stable during SSC (noninferiority trial). The brain oxygen levels will not be visible to the medical and nursing staff. The primary outcome will be changes (mean of the differences) in rcO2 between SSC (intervention) and incubator care (baseline) (1 hour period for each observation). Secondary outcome will be changes (mean of the differences) in physiological parameters e.g. peripheral oxygen saturation (SpO2), fractional tissue oxygen extraction (FTOE) equal to (SpO2 – rcO2)/SpO2) heart rate (HR), and respiratory rate (RR), axillary body temperature and sleep status (quiet sleep vs. active sleep) between SSC (intervention) and incubator care (baseline), the number of hypoxemic (SpO2 less than 80%) and bradycardic episodes (bradycardia: fall in instantaneous HR by one third of the infants’ baseline HR lasting for at least 5 seconds between SSC (intervention) and incubator care (baseline), changes (mean of the differences) in rcO2, SpO2, fractional tissue oxygen extraction (FTOE) equal to (SpO2 – rcO2)/SpO2, HR, RR, number of hypoxemic and bradycardic episodes, axillary body temperature, and sleep status (quiet sleep vs. active sleep) between post intervention incubator care and pre-intervention incubator care (baseline) (1 hour period for each observation). Further sub group analysis will be changes (mean of the differences) in rcO2 obtained during washout period with those obtained during the main observation period for all three periods (baseline, intervention, postintervention) and changes in rcO2 (mean of the differences) obtained during feeding periods with the rest of the observation period for all three periods (baseline, intervention, post-intervention).

  • Pilot study evaluating the Every Moment program for foster and kinship carers of children with challenging behavioural and/or mental health needs

    In 2013-14 18,950 children and young people were in out-of-home care (OOHC) in NSW. A substantial proportion of those in foster or kinship care arrangements are, or have been in foster or kinship care arrangements that have broken down. Approximately 60 per cent of those placed in foster care placements are placed with two or more foster families following their removal from their birth parents, a portion were placed with significantly more (FACS, 2013-14). A significant proportion of children in foster and kinship care arrangements have experienced some form of maltreatment. Reviews differ but some find children in foster care have social and emotional problems at between three and ten times those of children in the general population (Dorsey, Burns, Southerland, Cox, Wagner, & Farmer, 2012).Fisher, Gunnar, Dozier, Bruce & Pears, 2006; Nilsen, 2007). Their behaviour has significant implications for their social, emotional and academic development, and the stability of their living arrangements (Cook et al, 2005; Nilsen, 2007). Children who have suffered abuse &/or neglect present with a cluster of symptoms currently known as Complex Trauma (Cook et al, 2005, van der Kolk, Bessel,2005). The outcomes for these children include social, emotional behavioural and cognitive challenges. This is important as childhood behavioural and emotional difficulties are among the best predictors of mental health difficulties in adolescence and adulthood. Foster and kinship care arrangements provide an immensely important opportunity to change the trajectories of children who have had their development impacted by early maltreatment (Fisher et al, 2006; Nilsen, 2007). Given the emotional and behavioural challenges that children in foster and kinship care can display, this potential can be very difficult and foster and kinship care placements often break down as a result of these pressures (Nilsen, 2007). Currently neurodevelopmental science and clinical psychological treatment evidence identifies a range of treatment components that has the potential to both inform foster and kinship carer training and allow foster and kinship carers an opportunity to understand and engage characteristics of presentation of children in their care. UTS: familychildbehaviour has developed Every Moment, an innovative program of trauma informed Foster and Kinship Care for carers looking after children with challenging behavioural &/or mental health needs. The primary purpose of this study is to evaluate whether the Every Moment program can contribute to reductions in difficulties experienced by foster and kinship carers in looking after children who have experienced early maltreatment and also whether Every Moment can contribute reducing difficulties for children that commonly follow early maltreatment.

  • Effectiveness of Dialectical Behaviour Therapy (DBT) Group Skills Training for Borderline Personality Disorder (BPD) in Community Mental Health

    This research will examine the effectiveness of 25 weeks of DBT group skills training in a community mental health setting for improving symptoms and functioning in individuals with BPD. The primary outcome to be assessed is borderline-related symptomology. Secondary outcomes of interest include quality of life, client satisfaction with services and health services utilisation. Findings will evidence the utility of DBT skills training in delivery effective group treatment for BPD in the public mental health system.

  • Lifestyle intervention for metabolic syndrome

    One quarter of the world’s adults have metabolic syndrome. Lifestyle modification appears to be the key to reduce the risk of heart disease and diabetes in this population but there are no established, replicable program guidelines that can be used by health services to promote healthy lifestyle habits for people with metabolic syndrome. There is also no research to support the effect of such lifestyle programs for people with metabolic syndrome in terms of avoidable hospital presentations. This retrospective study aims to evaluate the effects of a novel multidisciplinary lifestyle intervention program, embedded in a health service, which aims to empower adults with metabolic syndrome to make behavior changes to reduce metabolic risk factors to prevent progression to chronic disease and reduce associated potentially avoidable hospital presentations. This program has been running at the health service for 2 years. This retrospective study will analyze routinely collected data to evaluate the effectiveness of the program.

  • INtegrated combination Therapy, Electronic General practice support tool, phaRmacy led intervention And combination Therapy Evaluation (INTEGRATE): An integrated general practice and pharmacy-based intervention to promote the prescription and use of appropriate preventive medications among individuals at high cardiovascular risk

    Despite the strength of evidence about the benefits of medicines for the prevention of cardiovascular events, particularly in those at high-risk, there are substantial evidence-practice gaps. This study will test the hypothesis that an integrated intervention combining three evidence based approaches: (1) a CVD polypill (fixed dose-combination of generic blood pressure lowering and lipid modifying, with or without antiplatelet drugs), (2) a GP focused point-of-care electronic decision support and (3) a pharmacy-led medication adherence intervention will increase prescription and long-term use of recommended medications, leading to improvements in CVD risk factor levels compared to usual care. This will be done using a pragmatic cluster randomised control trial of 70 general medical practices.

  • A Randomised Controlled Trial (RCT) of iCanADAPT, an internet Cognitive Behavioural Therapy (iCBT) program for the treatment of depression and anxiety in early stage cancer patients and cancer survivors.

    The primary purpose of this trial is to evaluate the efficacy of an internet program, iCanADAPT, for depression and anxiety in adults diagnosed with cancer. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, suffer from anxiety or depression and have an early stage cancer, or have survived an early stage cancer in the past. Study details All participants enrolled in this study will be randomly allocated (by chance) to receive the iCanADAPT program soon after enrolment or 16 weeks later. The iCanADAPT program is a 16 week online program which involves learning about tackling depression with a form of therapy called Cognitive Behavioural Therapy (CBT). CBT looks at improving how we manage our thoughts, actions and feelings. There are 8 lessons, each one taking up to an hour to complete, with the recommendation to do a new lesson every 1 – 2 weeks. There will also then be additional activities to do for around 3 hours per week. The program is tailored to unique aspects of the cancer context, such as fear of cancer recurrence and adapting to illness, side effects, and survivorship. Participants will complete a number of important questionnaires to assess their depression and anxiety levels among other psychological factors, at the beginning of the program, mid-way through, then again at the end of the program and the last time is 3 months after finishing the program. Participants will also be asked to complete a short questionnaire before every lesson. It is hoped that the findings of this trial will provide information regarding the efficacy of the iCanADAPT program in reducing depression and anxiety in cancer patients and cancer survivors.

  • The effectiveness of a stretching intervention in lowering plantar pressures related to reduced ankle range of motion in people with diabetes.

  • The Management to Optimise Diabetes and mEtabolic syndrome Risk reduction via Nurse-led intervention (MODERN) Study

    People can have many risk factors, but when a combination group together at the same time, including high blood pressure, obesity, blood glucose (sugar) and lipids (cholesterol and triglyceride), it forms what is called the “metabolic syndrome” and exposes individuals to diabetes and cardiovascular disease. People living in regional areas have higher levels of these risk factors than people living in metropolitan areas. One reason for this is less access to health care. Therefore, a health and lifestyle intervention program led by nurses for participants with metabolic syndrome may be beneficial for preventing these diseases. The aim of this study is to develop a regional health care program that reduces the risk of developing diabetes or cardiovascular disease (such as a heart attack or stroke) by managing risk factors that cause these diseases better.

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