ANZCTR search results

This study will determine if rehabilitation programs for people with ankle pain and stiffness following immobilisation for ankle fracture produce clinically worthwhile effects and are cost-effective.

The objective of this trial is to examine whether 14 week administration of lyprinol(registered trademark) improves a range of cognitive, mood, behavioural and psychophysiological measures in children aged 6-14 years with symptoms of inattention and hyperactivity relative to placebo. Children will be enrolled into the study if they have elevated inattention or hyperactivity whether or not they have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and whether or not they are currently medicated for their ADHD. As there is no evidence that Omega 3 intake interferes with current ADHD medications, providing children or adolescents who are currently taking ADHD medication with Lyprinol should be safe and well tolerated (Whitehouse et al, 1997). Their inclusion in the trial will be based on their level of hyperactivity and impulsiveness. If participants are included in the trial and are currently taking stimulant or other medications then this indicates that their current medication is not efficacious, as they are still presenting with high levels of inattention and hyperactivity. We will not include participants who have started stimulant medication for ADHD within the past two weeks as the medication may not have had sufficient time to reach maximum effectiveness. As this is a randomized trial there will be equal probability of the control (placebo) and active (Lyprinol) groups to have the same numbers of participants who are currently on medication. All participants will receive a 14 week supply of Lyprinol(registered trademark) once they finish the study. This is to ensure participants who are allocated to the placebo group also have the opportunity to take the Lyprinol for the same duration as the study.

This project aims to compare the outcomes of two different formats of Cognitive Behavioural Therapy for insomnia (CBT-i) programmes implemented by our team in real life clinic populations. Key components of these education-based programmes include: - teaching about sleep mechanisms and factors contributing to the development and maintenance of insomnia - challenging current beliefs about sleep - structured behavior modification - strategies to cope with anxiety and mood disturbances CBT-i can be used in different formats, with individual sessions, group sessions or both. This study will compare two formats of CBT-i presented in a standardised slide presentation: - The CBT-i4 Programme which involves 4 group sessions - The CBT-i2-2 Programme which involves 2 group sessions with 2 subsequent individual follow-up sessions focussing on the participant’s implementation of the behavioural strategies learnt during the group session and allowing individual guidance and support. These two programmes will be conducted at the Woolcock Institute of Medical Research with individuals who have at least a one month history of insomnia symptoms (DSM-IV criteria). Voluntary participants will be recruited by sleep psychologists and sleep physicians at the Woolcock Insomnia Clinic after completing an assessment for sleep disorders. To quantify improvements in subjective sleep quality assessments, participants will be asked to complete questionnaires and sleep diaries between the assessment visit and the first CBT-i session, at the end of the programme (4th group session or 2nd individual session) and 6 months after the last session. The current study will also include data from a CBT-i4 Programme previously run at Royal Prince Alfred Hospital’s Sleep Unit through a project that has been approved by the SSWAHS Ethics Review Committee (RPAH ZONE). Results from the current study are likely to provide empiric evidence on ways to optimize cognitive-behaviour therapy for insomnia in real world clinical settings.

Aboriginal children living in remote areas of the Northern Territory have the world’s highest rates of eardrum perforation reported in the medical literature. The disease can have significant effects on a child’s hearing, language, education and associated social disadvantage. Studies show that a child with chronic suppurative otitis media (CSOM) requires frequent daily ear cleaning and antibiotic drops. This may be needed for many months. Regular review of the eardrum is required to monitor progress and provide treatment. Families living in remote communities struggle to provide the level of care needed for effective cure of perforations. Our research will look at ways to increase the rates of Aboriginal children with a history of eardrum perforation participating in follow-up exams. We will randomise families caring for a child with CSOM to receive regular reminders by mobile phone calls, text messages or standard practice. Clinic attendance rates will be the primary outcome.

This study will investigate whether providing cognitive behaviour therapy provides better reduction of postconcussive syndrome symptoms than education about postconcussive syndrome in patients following mild traumatic brain injury. Patients will be randomly allocate patients with postconcussive syndrome to either (a) cognitive behavior therapy, or (b) education, and assessed for postconcussive symptoms following treatment.

A randomised controlled trial (RCT) will be used to evaluate the effectiveness of the BO program; an internet-based CBT program for BN. Participants will be randomly assigned to one of three conditions; (1) BO with therapist assistance (BO-TA); (2) BO automated self help (BO-ASH); or (3) a wait-list control (WLC) group. Participants in the BO-TA condition will be allocated an online therapist (who will be a fully or provisionally registered psychologist) who will email them once per week and whom they can email as often as they wish. Participants in the BO-ASH condition will be sent a weekly automated email reminding them to complete the modules and encouraging them to think about important points from each module. Participants in the WLC condition will have access to the BO-ASH condition after three months. Participants randomised to the intervention conditions (BO-TA and BO-ASH) will complete online assessments at pre, post- and 3-month follow-up. Participants randomised to the waitlist control condition will complete online assessments at pre and post waitlist, as well as post and 3- month follow-up BO. This study is a repeated measures design with three time points. We will employ multi-level modelling to allow for the comparison of the two BO programs and waitlist control condition in terms of changes in clinical diagnosis, BN specific symptomatology, general psychological functioning and quality of life, drop-out, and program engagement while controlling for and testing for any important participant variables such as age, gender and education. In addition, pre-, post- and follow-up variables will be subjected to correlational and multiple regression analyses to determine significant correlates of treatment adherence and attrition and potential predictors and discriminators of successful intervention outcome.

The incidence of bacteria in the urine after radical prostatectomy when patients still have their catheters is not known. How qucikly the bacteria clears after the catheter is removed is also not known. Presence of bacteria is a risk for infection which can increase patient morbidity. We want to investigate the rate of bacteria in the urine before and after catheter removal and the incidence of symptomatic urinary tract infection

This project aims to determine if 12 weeks (three times per week) of high intensity intermittent exercise (HIIE) and green tea consumption leads to significant fat loss and improvements in metabolic markers for diabetes and cardiovascular disease in overweight men. We have shown that HIIE leads to significant fat loss and increase in insulin sensitivity in women and now want to demonstrate this effect in men. The ability of HIIE to increase catecholamline secretion may be the reason why this form of exercise combined with green tea consumption results in more fat loss compared to exercise such as walking and jogging. We hypothesize that exposure to 12 weeks of HIIE and green tea will result in: - significant subcutaneous and visceral fat loss - significant increases in insulin sensitivity - significant increases in aerobic and anaerobic fitness We also hypothesize that: - greater hepatic fat loss will occur when green tea is consumed with HIIE

Due to the results of previous studies both in vivo and in vitro, we hypothesised that curcumin may decrease paraproteinemia and bone turnover in MGUS and indolent myeloma patients. A pilot study conducted by us showed a reduction in paraprotein levels and the uNTX bone turnover marker in a select group of MGUS patients. This trial is a continuation of the pilot study and we aim to prove that curcumin may act to prevent the progression of MGUS to active myeloma.

This study is designed to evaluate the pharmacokinetics, safety and tolerability EMA401 in healthy elderly subjects (56 years and over) after two single oral doses of EMA401 Sodium Salt administered on the same day with a 10 hour interval between doses, for a total daily dose of 200 mg.