ANZCTR search results

Infants born prematurely (< 30 weeks gestational age) have a higher risk of developing cerebral palsy than infants born at term, due to immaturity of the developing brain at birth, and potential brain injuries that can occur in the neonatal period. Cerebral palsy is frequently not diagnosed till the second year of life, delaying the start of early intervention treatments which may be of benefit in minimising functional limitations and providing key family supports. To date magnetic resonance imaging (MRI) at term equivalent age and general movement assessment provide the most accurate prediction of neurodevelopmental outcome at 12 months corrected age. This project aims to investigate the relationship between earlier brain MRI and neuromotor/neurobehavioural assessments at 30 weeks gestational age, and their ability to predict outcomes of cerebral palsy and motor difficulties at 3 and 12 months corrected age. We aim to achieve this in a longitudinal prospective cohort study of 80 infants born at less than 30 weeks gestational age, at the Royal Brisbane and Women’s Hospital. Infants will undergo a brain MRI scan at 30 and 40 weeks gestational age to develop our understanding of very early brain structure at 30 weeks; and maturation that occurs between 30 and 40 weeks gestational age. A combination of neurological (Dubowitz neurological assessment), neuromotor (General Movements, Test of Infant Motor Performance, visual functions) and neurobehavioural assessments (the NICU Network Neurobehavioural Scale) will be performed at 30 and 40 weeks GA to understand the relationship between brain structure and function. These data will be compared to motor assessments at 12 weeks post term and 12 months corrected age. These data will be compared to outcomes at 12 months CA including a developmental assessment by a paediatrician (Bayley scales of Infant and Toddler Development), motor assessments (Alberta Infant Motor Scale, Neurosensory Motor Developmental Assessment) to differentiate atypical development (including cerebral palsy and/or motor delay). At a time of increasing demand on health care resources, reliable ways of predicting neurodevelopmental outcome in premature infants is desirable to determine those that may benefit most from early intervention.

This study aims to compare radiation treatment combined with either cetuximab or cisplatin in patients with locoregionally advanced HPV positive oropharyngeal squamous cell carcinoma (OPSCC) (located at the base of tongue or tonsil) Who is it for? You may be eligible to join this study if you are aged 18 years or more, and have been diagnosed with locoregionally advanced HPV positive oropharyngeal squamous cell carcinoma (OPSCC). You should not have received any prior treatment for this cancer. Trial details; Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will receive radiation treatment 5 days a week over 7 weeks, in conjunction with weekly doses of a drug called cetuximab. This drug is administered intravenously, i.e. directly into the vein. Participants in the other group will receive radiation treatment 5 days a week over 7 weeks in combination with the chemotherapy drug cisplatin, which is also administered intravenously. Participants will be assessed weekly during treatment, then at 1, 3, 5, 9, 13 weeks post-treatment and at months 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 42, 48, 54, and 60 post-completion of treatment. Assessments will involve blood tests, questionnaires, clinical examination, hearing tests, swallowing tests, and radiological examination. The main research question being answered is whether those treated with weekly cetuximab and conventionally fractionated radiotherapy will experience less acute symptom severity than patients receiving weekly cisplatin and conventionally fractionated radiotherapy.

The aim of this study was to conduct a pilot randomised study into the efficacy of omalizumab in allergic bronchopulmonary aspergillosis.

Survival from breast cancer has improved significantly over the past 30 years. This has been due to the coordinated approach of surgery, chemotherapy and/or radiation therapy with each member of your treating specialist team contributing to your treatment recommendation. For each of these three disciplines of treatment, the conduct of clinical research has led to more effective ways of performing surgery and delivery of the best drug combinations and radiation therapy. In addition, research has also aimed to reduce side effects and therefore make each of these treatment approaches, safer and less intrusive to the quality of your life. However, it is still likely that patients will experience side effects of some kind as a result of their surgery, chemotherapy and/or radiation therapy. Currently, it is not known how often the specialist treating team or the patient’s general practitioner is managing these side effects; and how successful the treatment recommended is. Understanding the frequency of side effects that lead to an unplanned visit with a member of your specialist treating team or GP and how these side effects are managed, will allow us to plan more effective ways of coordinating the care, to ultimately improve the well-being of breast cancer patients as they undergo the various stages of their breast cancer treatment.

Submitted on 29 Jan, 2013, [Dr. Deborah Zion, the Chair of the Victoria University Human Research Ethics Committee informed this ANZCTR is required before final approval is given.] (Office for Research, Victoria University, PO Box 14428, Melbourne, VIC, 8001 or phone (03) 9919 4781.)

The purpose of this study is to find a new way of treating central sleep apnoea and drug tolerance caused by opioid medication prescribed for chronic pain. The medication tested in this study is Minocycline, a commonly used antibiotic with effects on the central nervous system's immune system. Hypothesis Minocycline will reduce the severity of central sleep apnoea in patients prescribed opioids for chronic pain. Minocycline will increase the analgesic efficacy of opioids prescribed to chronic pain patients.

There is evidence that exercise capacity is reduced in patients with type 2 diabetes. Beta-alanine has been shown to increase exercise capacity in younger, apparently healthy individuals and in elderly subjects. To date, no previous exercise trials have evaluated the effects of B-alanine supplementation on exercise capacity in a cohort of patients with T2DM. An improvement in exercise capacity in this population is valuable in that it may translate to an improvement in GLUT4 translocation and, consequently, an increase in glucose uptake. Further increases in exercise capacity secondary to B-alanine supplementation may yield significant improvements in insulin sensitivity, resulting in an overall improvement blood glucose management (HbA1c) and possibly a reduction in diabetes medications or dosages.

A 16 week intervention using encapsulated Caralluma fimbriata extract and Morosil extract in combination with lifestyle intervention to investigate whether or not Caralluma fimbriata extract and Morosil extract decrease the risk factors of metabolic sydrome

This research project is a Phase I pilot study which aims to develop and manualise a version of Mindfulness-Based Stress Reduction (MBSR) suitable for individual administration to Head and Neck Cancer (HNC) patients during the active stage of cancer treatment of curative intent. Members of our research team have previously demonstrated that HNC patients receiving treatment of curative intent reach a threshold of clinically significant distress both immediately prior to and during treatment, and also experience a decline in health-related quality of life (HRQoL) in the weeks following treatment. These findings are consistent with previous research which has shown that patients experience high levels of distress following the chronic functional impairment and disfigurement that is a common outcome of treatment for HNCs, and points to the need for effective psychological interventions to assist coping during and following treatment for HNCs. MBSR, as demonstrated by another of our team members, has shown success in reducing psychological distress associated with other forms of cancer, including breast and prostate cancer. As no reported studies exist that use MBSR with HNC patients, we intend to evaluate whether MBSR may be suitable for use in this population. We also aim to establish whether participants’ levels of psychological distress, HRQoL, mindfulness attention and awareness, intrusive cognitions, self-compassion and shame can be effectively measured in this setting. We plan to examine the feasibility (assessed through the feasibility of and compliance and fidelity to the intervention) and acceptability of MBSR therapy to participants through examining the accrual and attrition rates for this pilot study, and further explore participant’s experiences, both positive and negative, of MBSR through a post-intervention semi-structured interview. Finally, we aim to see whether MBSR delivered by a suitably qualified and experienced mental health professional is applicable and feasible for use in a hospital context.

This study looks at the effectiveness of a psychological therapy designed to support parents and carers of children and young people with cancer to make a positive transition to life after treatment completion. Who is it for? You can join this study if you are the parent of a young cancer survivor aged under 18 years who has finished treatment for either a primary or secondary cancer. Trial details: Participants will be divided into three groups. One group will take part in 'Cascade', a cognitive-behavioural program designed to help people build skills to return to normality after cancer treatment. This will take place in four 90-minute group sessions, delivered weekly over the internet. The second group will take part in an open discussion forum with the same schedule. The third group will be allocated to a waitlist before participating in one of the interventions. The study aims to monitor the distress, psychological adjustment and coping after cancer treatment. Participants complete several questionnaires and will be followed up for 6 months after participating in the online groups.