ANZCTR search results

Patients with persistent or chronic pain often have underlying chronic conditions that can be overlooked such as anaemia, which can have significant effect on the quality of life of patients. A recent pilot study involving patients who have persistent pain for greater than 12 months have shown that 59% have iron deficiency. This study will follow on from the pilot study to examine if intravenous iron infusions do improve this cohort of patients fatigue levels, their health-related quality of life, pain levels and reduce pain medication use. This study will be conducted at a Quaternary hospital in Brisbane as a single-site, single-blinded, parallel-group randomised controlled trial. We plan to recruit 160 participants who will be randomised to receive either intravenous iron infusion or placebo. The outcomes will be measured using specific validated surveys and questionnaires related to fatigue (FACIT), health-related quality of life (SF-36) and pain (ePPOC).

This study is a randomised open-label trial of the Moderna Omicron-containing bivalent booster candidate mRNA-1273.214 (mRNA-1273.214) vaccine. Participants who have received 2-3 prior doses of the any COVID-19 vaccine will be randomised into two arms: to receive a 3rd dose of the Moderna Bivalent Omicron vaccine on enrolment or 3 months later. Both groups will be followed-up for six months after enrolment.. We hypothesise that there will be a difference in measurable SARS-CoV-2 antibody responses in people who receive a Moderna Bivalent Omicron COVID vaccine booster immediately on enrolment in the study compared to those who wait an additional three months before receiving a booster dose. A booster dose of the Moderna Bivalent Omicron r vaccine will be administered intramuscularly. One dose (0.5 mL) contains 50 micrograms of mRNA-1273.214 (25-µg each ancestral Wuhan-Hu-1 and omicron B.1.1.529 spike SARS-CoV-2 mRNAs) (embedded in lipid nanoparticles). This is a single-site study with interested potential participants attending the Royal Melbourne Hospital for recruitment, the consenting process and study visits. A total of 64 participants will be recruited (32 per arm).

Traditionally, combination therapy has not proven to be effective in Myelodysplasia (MDS) given the increased toxicity of drugs used in combination with standard therapies. The aim of this master platform trial is to test a range of novel treatments aimed at targeting MDS to find safe and effective drug combinations. You may be eligible to participate in this study if you are aged 16 or older (depending on the study, this may be limited to 18 and older) and you have a diagnosis of either MDS or acute myeloid leukemia (AML) with less than 30% blasts. If you choose to enrol in this trial you will undergo a screening process where blood and bone marrow samples are taken prior to starting any treatments. The study doctors will assess your samples for specific MDS markers and will then prescribe a combination treatment that may be effective. Participants who do not respond to treatment or whose disease worsens may be removed from treatment and be reassessed for the next best treatment option to receive. During treatment participants will be assessed regularly which will include physical exams, blood tests, ECG (heart monitoring), bone marrow biopsies, toxicities to the treatment, quality of life. After treatment, disease will continue to be monitored and if participants have MDS progression or morphological relapse they will be assessed for the next best treatment option. It is hoped that the results of this trial will help us to determine which drug combinations are safe (minimal side effects/toxicity) and effective for treating MDS.

This study aims to evaluate the effectiveness of a new online treatment for body dysmorphic disorder (BDD) in adolescents. BDD is an underrecognised and undertreated mental health condition, characterised by a preoccupation with perceived flaws in physical appearance. There is a paucity of research exploring the disorder among youth. In adults with BDD, cognitive-behavioural therapy (CBT) has been shown to be an effective treatment. There is some evidence that CBT can be effective for some youth with BDD, however many young people remain impaired by their BDD following treatment. Therefore, this study aims to test a developmentally-tailored CBT approach to treating adolescent BDD. The therapy will be delivered via videoconference to families, to increase accessibility to the study.

This is Part B of a 2-part, Phase 2, Clinical Trial Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of PRAX-944 in Adults with Essential Tremor. Each participant will complete 3 study periods: Screening, Treatment Period (21 or 28 days) and Safety Follow-up.

In recent years significant interest has been shown in the role of contact heat evoked potentials (CHEPs) in the assessment of spinal cord damage. A single study comparing CHEPs with dermatomal somatosensory evoked potential (dSSEP) and clinical sensory testing found CHEPs to be the most sensitive measure of spinal cord damage. In subjects with spinal cord injury (SCI), peripheral sensitisation with topical capsaicin was found to improve the detection of “silent” fibres using quantitative sensory testing (QST). Given that QST is a psychophysical test (dependent on patient report) more objective neurophysiological tests would be valuable. Several methods have been explored to improve the acquisition of potentials in patients with and without nerve damage. The two most promising methods are the use of chemicals to achieve peripheral afferent sensitisation and raising the baseline temperature of the stimulation. This study assesses whether increased baseline temperatures and peripheral sensitisation using topical capsaicin improves the detection of “silent” spinal cord fibre tracts using contact heat evoked potentials (CHEPs) in people with spinal cord injury (SCI) and below-level neuropathic pain (BLNP). Given the onset of SCI BLNP is often delayed identification of partially preserved fibres may be a risk factor that can be identified early in an individual. The detection of a potential peripheral contributor to the pain will also influence the treatment options pursued. Primary Objective: Determine whether CHEPs are able to detect subclinical spinothalamic fibre (STT) preservation following SCI. Secondary Objective: Determine whether CHEPs taken from an area of pain (below the SCI) are more frequently observed when peripheral sensitisation with capsaicin and baseline temperatures up to 42°C are used in subjects with clinically complete spinal cord injuries and BLNP.

The aim of this randomised controlled trial is to increase adoption of the lunchbox nutrition program ‘SWAP IT ’ in primary schools located in the Mid North Coast Local Health District. This trial will evaluate whether a theory-based multi-component dissemination strategy targeting barriers to adoption can improve the adoption rates of the nutrition program. Schools will be randomly allocated to receive either a multi-component dissemination strategy over a four month period, or a minimal intervention control group. Intervention effectiveness will be determined by comparing, relative to control, the absolute difference in the proportion of schools adopting the program at 6-month follow up. The trial aims to generate evidence regarding the effectiveness of strategies to inform broader dissemination of the lunchbox nutrition program.

Peripheral vasopressors are safe and effective to use in pre-hospital and retrieval medicine with a similar risk profile to administration in Emergency departments Prospective data collection on the use of peripheral vasopressors in prehospital and retrieval medicine. Studying patients transported by Lifeflight retrieval medicine who operate across Queensland in Australia. Primary outcome is safety with secondary endpoints including monitoring and indication as well as site and type of access.

Undiagnosed or unrecognised Coeliac disease is associated with a 3-fold increased risk of autoimmune disease (such as type 1 diabetes), osteoporosis and malignancy (such as lymphoma), decreased quality of life and a 2 to 4-fold increase in mortality. Early diagnosis and treatment of Coeliac disease reduces or avoids many of these complications and reduces health care expenditure. In Australia it is estimated that Coeliac disease affects 1 in 60 females and 1 in 80 males based on serological testing. Despite this, the rate of diagnosis through routine medical care is very low, resulting in 4 out of 5 Australians with Coeliac disease remaining undiagnosed. There is currently insufficient data to support population-wide screening for Coeliac disease. As such, screening is based on active case finding of high-risk individuals, such as first-degree relatives of Coeliac disease sufferers and other high-risk populations such as those with developmental defects of enamel in the teeth. Coeliac disease is known to be associated with dental developmental defects of enamel in children. They appear as bilateral, symmetrical and chronologic white or yellow opacities with or without grooves and structural defects. It is thought to be caused by an immune mediated reaction affecting the cells that form enamel and possible nutritional disturbances. Delayed diagnosis and increased exposure to gluten is likely to result in more significant enamel defects over time. Therefore, screening for Coeliac disease in high-risk individuals with developmental defects of enamel could decrease the amount of future enamel and structural defects. This research study is a prospective exploratory study which aims to assess how many children with developmental defects of enamel have undiagnosed Coeliac disease . The study is being conducted at the Paediatric Dental Group, Wesley Medical Research (WMR) and St Andrew’s War Memorial Hospital (SAWMH) in Brisbane, Australia

There are many types of orthodontic appliances with the most common fixed appliance consists of brackets bonded onto the enamel of the teeth and wires that provide the force for tooth movement. The more recent method is with a series of customized clear appliances, called "aligners". The purpose of the study is to compare the outcomes Invisalign® System to the fixed orthodontic appliance; and especially for subjects who have moderate malocclusion (greater than 5mm of crowding in either the maxilla or the mandible). The secondary outcome measures are treatment efficiency and patient satisfaction.