ANZCTR search results

Background summary: Refugees experience a higher incidence of posttraumatic stress disorder (PTSD) and increased levels of chronicity. Effective treatment is a challenge worldwide and is likely to require a multifaceted approach. Neurofeedback (EEG biofeedback) is utilized to enable individuals to modulate and retrain brain electrical activity through training new pathways of activation that can increase the brain’s capacity to self-regulate. STARTTS’ neurofeedback program was developed to complement counselling for refugee related PTSD and has had good clinical success. However, evidence from a randomized controlled trial is needed. Objectives: The primary aim of this project is to examine the efficacy of neurofeedback training for alleviating chronic posttraumatic stress symptoms in adult refugees. We hypothesize a reduction in symptoms, accompanied by changes in functional brain activity reflecting improved cognitive control and emotion regulation. Study Plan: Willing and eligible, existing STARTTS clients will be randomized to participate in neurofeedback integrated with counselling (NFT) or to an active control “lifestyle enhancement intervention” (LEI) involving sessions focusing on nutrition and physical activity in addition to counselling. Both interventions will involve 30 bi-weekly sessions over 15 weeks. A total of eighty participants will be enrolled over two years and will complete questionnaire and EEG assessments pre- and post-intervention and at 3-month follow-up.

The purpose of this study is to see if a 5 session psychological therapy program delivered after bone marrow transplantation can have a positive impact on quality of life and psychological distress in these patients. Who is it for? You may be eligible for this study if you are aged 18 or older and have received a bone marrow transplant in the last 3 to 12 months. Study details All participants in this study will receive 5 individual sessions of face-to-face cognitive behavioural therapy targeting mental adjustment and coping strategies. Participants will also need to do approximately 10 minutes of ‘homework’ every day following each of the first 4 sessions. As part of the study, participants will complete questionnaires about their quality of life, psychological distress, mental adjustment, coping and self-efficacy before and after the 5 session intervention. Participants will also be asked to complete questionnaires about their psychological distress and homework completion at each session. It is hoped this research will provide evidence this program improves mental health outcomes in this patient population.

The qNox monitoring System (Conox Monitor; Fresenius Kabi) is an electroencephalogram-based (sticky electrode on forehead) dimensionless score (0-100) which claims to reflect levels of analgesia in anaesthetized patients. Higher levels of the score may reflect higher levels of noxious stimulation, or a higher likelihood of a patient to respond to noxious stimuli. Aim of the current study is to investigate whether a higher qNox score during, and at the end of surgery may be associated with a higher likelihood of significant postoperative pain. 150 patients scheduled for non-emergency surgery under sevoflurane/opioid anaesthesia and state entropy depth of anaesthesia monitoring will be included. In addition to standard monitoring, a row of sticky electrodes (similar to the ones used for monitoring the long-established state entropy monitor) will be placed on the patients’ forehead. No other intervention is done for the trial. QNox will be monitored specifically at the end of surgery before patient arousal. Once awake in recovery, patients’ pain will be rated on a numeric rating scale (0-10) every 5 minutes (as per recovery room routine). The first 4 pain ratings will be used to analyse any relationship between qNox and postoperative pain. No other study-related intervention will take place. Participating patients will neither be inconvenienced nor harmed in any way by inclusion in this trial.

Perioperative lignocaine infusions have significant benefits for patients undergoing major abdominal surgery in regards to analgesia, reduced opioid requirements, earlier return of normal bowel function and potentially even enhanced recovery and discharge after surgery. Currently there is significant heterogeneity in the various suggested lignocaine dosing regimens and a real paucity of evidence in regards to optimal dosing in the bariatric population. As a result, despite the benefits of perioperative lignocaine infusions particularly in the bariatric population, clinicians cannot be confident about the efficacy and safety of currently suggested lignocaine infusion regimes in this population group. As a result our objective is to develop a pharmacokinetic model of lignocaine infusion including patients at the extremes of BMI and thus develop a regimen for bariatric patients that achieves safe but effective therapeutic dosing.

The purpose of this study is to compare a new product (called Herceptin biosimilar) to two existing Herceptin products. Who is it for? You may be eligible for this study if you are a healthy male aged between 18 and 45 years old. Study details Participants in this study will be randomised (by chance) into three groups. All participants will have a single infusion of either the new product or one of the two existing products. The infusion will be delivered through a needle in the arm over 90 minutes or less. After the infusion, participants will provide a number of blood samples so the products can be compared. It is hoped this research will be used to improve health outcomes, by providing lower priced treatments to larger numbers of cancer patients.

We propose that treating patients with inflammatory knee osteoarthritis with the anti-inflammatory drug, diacerein, will reduce pain and joint damage. The aim of this study is to compare, using a multi-centre, randomised, placebo-controlled double-blind design over 24 weeks, the efficacy of diacerein (50 mg twice daily) vs. identical placebo to reduce pain and effusion-synovitis in 260 knee osteoarthritis patients with effusion-synovitis. We hypothesise that diacerein treatment will decrease knee pain and joint inflammation by more than identical placebo over 24 weeks.

Preeclampsia is a condition of pregnancy that causes serious health problems to women and their babies. It is important to investigate new medications that could help these women and there babies. One possible option is a natural antioxidant found in broccoli sprout. This study aims to determine the appropriate dose of broccoli sprout extract for pregnant women, so that we can conduct a larger clinical trial investigating this compound.

The aim of this research is to see whether a self-guided online mindfulness intervention leads to an increase in mindfulness and reductions in anxiety/depressive and stress symptoms in parents of children with DD. Based on previous research involving online mindfulness interventions with the general population, we expect that parents of children with DD will experience increases in mindfulness and reductions in anxiety, depressive and stress symptoms as a result of the intervention. If this intervention leads to increases in mindfulness and reductions in symptoms of distress, and parents rate the intervention as acceptable, then these preliminary results would suggest e-treatment as a possible alternative to current face-to-face treatments.

In this single-centre study, two groups of women who were normal weight prior to a recent pregnancy will be recruited at 12 months post-partum: women who have already returned to their pre-pregnancy weight (group A) and those who remain 10% or more above their pre-pregnancy weight (group B). Women in group B will be prescribed a hypocaloric diet until they return to their pre-pregnancy weight. Hormones involved in appetite regulation and DNA methylation state in peripheral blood mononuclear cells in weight-relevant genes will be compared between groups. We hypothesise that in women who remain 10% or more above their pre-pregnancy weight 12 months post-partum (group B), the elevated weight is ‘defended’, and that compensatory changes in hormones involved in appetite regulation will occur when they lose weight.

The purpose of this study is to evaluate two different recall methods for cervical screening and mammography in Aboriginal women. Who is it for? Women aged between 25 and 74 who attend the Illawarra AMS and who are due for routine cervical screening and breast cancer screening, are eligible for involvement in this study. Study details Participants in this study will be randomised (by chance) into two groups. One group will receive a phone call reminding them that they are due for screening and encouraging them to make an appointment for screening, followed by two reminder SMS's if they do not respond. The second group will receive a recall letter reminding them that they are due for screening and encouraging them to make an appointment for screening, followed by two further reminder letters if they do not respond. We will measure whether women attend for cervical screening, and whether they make an appointment for screening. We also will measure relative costs of each intervention. It is hoped this research will provide evidence as to which recall method is most successful and cost-effective for cervical screening and mammography.