ANZCTR search results

This study is examining the safety, tolerability, persistence and immunogenicity of Tafuramycin-A (TF-A) attenuated purified P. falciparum 7G8 blood stage parasites. Participants will receive a single inoculum of purified malaria parasites attenuated with either 200nM or 400nM of Tafuramycin-A. Following administration of the inoculum, we will measure the level of malaria parasites in the blood-stream and then administer anti-malarial treatment (Riamet) at D28. We will also be assessing the safety of the inoculum and the way the immune system responds to it. Determining the safety, persistence and immunogenicity of the Tafuramycin-A attenuated purified malaria parasites is important as they form the basis of a novel malaria vaccine approach.

The primary purpose of this study is to investigate the acceptability, usability and comprehensibility of a decision aid which aims to help parents make a decision about nutrition support to treat malnutrition during their child's cancer treatment. Who is it for? You may be eligible to participate in this study if you are the parent, carer or clinician of a child who has been diagnosed with cancer or a haematological condition at the Kids Cancer Centre at Sydney Children's Hospital, and have had to consider nutrition support in the past five years. Study details: All participants recruited in this study will be asked to read the decision aid and then complete a questionnaire regarding its acceptability, usability and comprehensibility. It is hoped that the findings of this pilot study may be used to support the implementation of the decision aid to inform parents and carers facing choices regarding their children's nutrition support during cancer treatment.

Whilst CBT has been validated as an effective psychological treatment for depression, efficacy rates of treatment still indicate the need for improvement. Emerging evidence indicates that the relationship between the gut and the brain can be harnessed, so that changes in gastrointestinal health can have positive or negative effects on mental health, and vice versa. This trial investigates whether administration of a probiotic is effective in reducing levels of depression in a population of depressed adults. Participants will consume the probiotic daily, and provide measures of mood throughout the study period. We will measure baseline and post-intervention levels of depressive symptoms, and compare changes in levels of depression between a group provided with the probiotic, and a control group given a placebo.

Low back pain (LBP) is a highly prevalent health condition affecting up to 80% of individuals at some point in life. It is acknowledged that abnormal clinical findings, such as structural alterations of the spine found from imaging, poorly correlate with clinical status. Further, current prediction models that take into account psychological, demographical and physical factors explain only a small proportion of the variance in clinical outcomes. In recent years, evidence has accumulated that abnormal somatosensory processing occurs in people with chronic LBP. Psychophysical studies have commonly found pain hypersensitivity to various sensory stimuli in people with chronic LBP compared with healthy controls, not only at the back, but also at non-painful remote sites (e.g. at the hand). These changes in pain sensitivity in areas remote from the low back implicate abnormal central mechanisms. At present, it is not yet established to what extent these sensory alterations contribute to the generation and maintenance of LBP. Also, the temporal aspects of these changes are unknown. However, recent research has shown that somatosensory abnormalities can be detected early (i.e. within 4 weeks) after the onset of LBP. These include augmented spinal cord excitability as well as pressure pain hypersensitivity. Further, longitudinal studies in acute whiplash injury cohorts have shown that widespread pain hypersensitivity persisted only in subjects who did not recover at 6 months. Cold pain threshold was found the sensory parameter that most significantly predicted non-recovery at 6 months. The primary aim of this study is to investigate whether psychophysical measures of pain sensitivity contribute to predicting non-recovery in low back pain and to evaluate the time course of somatosensory changes from the onset of low back pain to 4 months.

Survivors of critical illness experience significant physical, psychological and cognitive compromise during recovery. ICU diaries have been proposed as one intervention that may be effective in helping survivors recover psychological function. Despite support by some members of the intensive care community, there is a lack of empirical work investigating diaries and subsequent concern regarding the potential harm of such an intervention exists. This study is designed to determine feasibility of two proposed psychological interventions for survivors of critical illness: (1) the use of ICU diaries and (2) the provision of an individualised summary of the ICU experience prepared by ICU staff and based on the User Centred Critical Care Discharge Information. The effect size of each psychological intervention to reduce psychological compromise (anxiety, depression, posttraumatic stress symptomatology) will also be determined to inform sample size calculations for a larger efficacy randomised control trial. Other aims of this pilot study are to determine the feasibility of early screening for psychological health for survivors of critical illness, and to validate the Intensive Care Psychological Assessment Tool (IPAT) against recognised depression and anxiety screening instruments in an Australian ICU population.

This randomised controlled trial will compare the effect of an 8-week well-being and performance enhancement program with a wait-list control group for Australian Para athletes with a physical impairments who are competing at a national level or above and aged 18 years and over. Athletes will be asked to complete electronic questionnaires and semi-structured interviews in addition to completing the well-being program.

This project will recruit pregnant women to receive either a prebiotic supplement or a placebo supplement. They will be asked to take the supplement from 18-20 weeks gestation until their baby is 6 months of age. We will then examine whether supplementing the mother’s diet during pregnancy and breastfeeding with the prebiotic powder will reduce the development of allergies in her child. Both study groups will include children deemed to be at high risk of allergic disease (based on family allergy history).

This study aims to invesitgate the neuroprotective effects of ketamine in elderly patients undergoing cardiac and major vascular surgery. Delirium and depression are common effects of cardiac and major vascular surgery. Ketamine is believed to have a protective effect against delirium and depression. Participants will undergo neuropsychological testing prior to surgery and again at day 7 and 3 months postoperatively. Deliriuma and depression will be measured during patient hospital stay. Additionally, inflammatory bloods will be taken to assess the role inflammation plays in the role of postoperative cognitive dysfunction.

UBWELL is a smart-phone app-based continuous, real-time data tracker which can link to current available wearable technology (i.e. Fitbit) and other smart software systems (i.e. HealthKit, Google Fit and Project Synergy) to collect physiological and experiential measures and then monitor, analyse and report these results. Currently, UBWELL can measure physical activity, sleep, mood, anxiety, energy, substance use (alcohol, tobacco), functional engagement (relationships, work, study), healthy eating and weight. This data can be used by an individual to help maintain good health and wellbeing; as well as by health professionals to more effectively plan, implement and monitor treatment to patients, thus providing enhanced, personalised healthcare. The use of this innovative technology has the potential to empower young people to actively engage in their general health and wellbeing (including mental health) by reliably tracking the metrics that are important to them. Unfortunately, the majority of apps for mental health that are currently available lack scientific evidence about their efficacy, and few (if any) have the capacity for the continuous comprehensive integrated assessment that UBWELL offers. This project aims to evaluate the engagement, efficacy and effectiveness of UBWELL (as compared to Recharge and OzHealth) among the Australian general population to improve general health and wellbeing outcomes.

This study investigates whether addition of the drug acetazolamide to a dexamethasone treatment for controlling raised intracranial pressure symptoms, related to high grade glioma brain tumour (such as headache, nausea and vomiting), will allow the dexamethasone dosage to be reduced, and whether this leads to less dexamethasone-related side-effects. Who is it for? You can join this study if you are required to restart or increase a dexamethasone treatment to control recurrent or increased symptoms of intracranial pressure, that may be related to your brain tumour, high grade glioma. Study details: If you like to join this study you will first be screened by your specialist to see if you meet the eligibility criteria to participate in this study. If you are deemed eligible to participate you will be randomly (by chance) assigned to one of two possible treatment groups: Group 1 will receive 1 tablet of 250mg acetazolamide twice per day for 8 weeks, in addition to the dexamethasone treatment. Group 2 will receive 1 tablet of placebo twice per day for 8 weeks, in addition to the dexamethasone treatment. Your chance to receive the group 1 treatment is equally high as to receive the group 2 treatment. You cannot choose to which group you are assigned and both you and your doctor will not know which treatment you received until the study is finished. Participants will be asked to attend clinic visits every 2 weeks during the treatment period and then 1 more time (about 1 month after having received the last treatment). During these visits the specialist will assess your physical and mental health, and ask you about your well-being. Participants will also be asked to undergo tests and procedures, such as blood testing, scans, and questionnaire completion.