ANZCTR search results

Patients with acute traumatic brain injury (TBI) requiring admission to the ICU, commonly receive sedative drugs to reduce the brain’s demand for oxygen and glucose. These patients often also require pain-relieving (analgesic) medications. Ketamine is a combined sedative and analgesic medication that is not currently used in acute TBI but has the potential to benefit this patient group for several reasons: 1. It can reduce the need for high doses of other sedatives and analgesic drugs which may accumulate or cause low blood pressure 2. It can reduce or eliminate the need for other drug infusions which are required to maintain a normal or high blood pressure during the treatment of TBI 3. It has been shown to reduce the incidence of damaging waves of brain activation that travel across the surface of the brain after severe TBI (Spreading Depolarizations). This pilot feasibility study aims to demonstrate that using Ketamine sedation is safe in acute TBI patients admitted to the ICU and will establish the methodology for a larger randomised controlled trial.

Physical inactivity is estimated to cause almost one in ten premature deaths worldwide. A pilot clinical trial conducted by the Lambert Initiative (University of Sydney) and scientists at Griffith University found that the non-intoxicating phytocannabinoid, cannabidiol (CBD), had an effect to increase ratings of pleasure during aerobic exercise; specifically, in endurance-trained males running at a fixed, moderate intensity. This initial finding suggests that CBD has the potential to support physical activity (PA) participation. However, further research is required to confirm and better understand the observed effect. The overall objective of this trial is to determine whether CBD can enhance affective responses to self-paced aerobic (running) exercise in recreationally active individuals – and, thus, support PA participation. Participants will complete two treatment sessions involving the oral administration of CBD (150 mg) or a placebo in a randomised, double-blind, crossover design. Affective valance will be measured at baseline (pre-treatment), pre-exercise, at 6-lap intervals throughout a 25-lap run (~10 km) on a standard outdoor athletics track, and post-exercise using validated scales. Exercise enjoyment, motivation to exercise, and exercise self-efficacy will also be assessed. We hypothesise that CBD will increase ratings of pleasure during self-paced aerobic exercise – as well as exercise enjoyment, motivation, and self-efficacy.

Sulforaphane is a naturally occurring organophosphur able to upregulate phase II detoxification enzymes resulting in anti-inflammatory and antioxidant effects. Sulforaphane has been widely investigated outside of pregnancy in a wide variety of clinical trials including cancer, autism spectrum disorder and gastroesophageal reflux disease. Sulforaphane is generally administered in the form of glucurophanin via broccoli sprout supplements and has variable formulations and manufacturing pathways. It is hypothesised that sulforaphane will provide beneficial effects to various pathological states of pregnancy. It is important to compare the various formulations of sulforaphane commercially available to inform decisions for clinical trial design and analysis of sulforaphane trial outcomes. This study will compare three different commerically available broccoli sprout extracts and their circulating concentrations in healthy pregnant participants.

Broccoli sprout extracts contain glucurophanin which converts into a compound called sulforaphane. Sulforaphane is a natural inducer of nuclear related ECH-like related factor 2 (Nrf2) activity which promotes production of endogenous anti-oxidant enzymes and anti-inflammatory cytokines. Numerous disorders of pregnancy result in states of oxidative stress and inflammation including fetal growth restriction and preeclampsia with risks of resultant neuroinflammation on the fetus and possibly adverse neurodevelopment. This study aims to investigate the possibility of sulforaphane transfer via the placenta and in expressed breast milk.

The current randomised control trial (RCT) aims to investigate the impact of a single session online intervention aiming to reduce self-harm cognitions and behaviours in young adults aged 18-25. The online intervention (Project SAVE: Stopping Adolescent Violence Everywhere; Dobias et al., 2021) has been previously evaluated with adolescents in the United States, whereby participants are invited to take part in a 30-minute self-administered psychoeducation intervention presented online using Qualtrics software. The online intervention aims to normalise and de-stigmatise feelings of self-hatred and aims to empower young adults to select alternative coping strategies in the face of self-hatred. Participants are randomised to either receive the project SAVE intervention or an alternative online single session intervention called “Share your feelings”, which is a 30-minute self-administered program that uses components of supportive therapy to encourage feelings sharing (Dobias et al., 2021). The current study aims to expand on previous work conducted with adolescents to investigate the impact of project SAVE on decreasing the frequency and likelihood of non-suicidal self-injurious behaviours in young adults, who either report previous month self-harm behaviours and/or cognitions.

Thiamine deficiency manifests as two conditions: cardiac (wet) beriberi, or Wernicke’s encephalopathy. Furthermore, it can potentiate lactic acidosis through failure of pyruvate to enter the Kreb’s cycle. Patients who are malnourished are at risk of thiamine deficiency, and traditionally, replacement is given for patients at risk (patients on TPN without micronutrients, those with history of alcohol abuse, starvation states). Thiamine levels are not routinely checked in usual practice, but instead, supplementation is provided based on risk. The current guidelines give different recommendations (excluding for treatment of beriberi/Wernicke’s, in which the dose is 200-500mg intravenously three times a day for 5-7 days followed by 100mg for 1-2 weeks) 1. For those at high risk of thiamine deficiency, therapeutic guidelines suggests giving 300mg intravenously for 3 days and then 100mg daily for 1-2 weeks 2. In re-feeding syndrome 100mg intravenously for 7-10 days Clinical Question Is 3 days of intravenous thiamine replacement in patients receiving TPN AND at risk of refeeding syndrome, sufficient to restore and maintain thiamine levels when measured at day 7? Hypothesis In patients at risk of refeeding syndrome, thiamine levels are sufficiently restored with 3 days, as opposed to 7 days, of supplementation. Methodology Patients randomized to receive 3 days of intravenous thiamine or 7 days of intravenous thiamine. Standard dose will be given, 250mg b dose forte intravenous. Thiamine levels will be measured at day 0, 3 and 7 to ensure adequate blood levels are reached.

Fifty five percent of all spinal cord injuries result in tetraplegia and with impaired motor and sensory function of arms, hands, legs and respiratory muscles. For people with tetraplegia, restoration of hand and arm function ranks highest of all functional recovery targets, closely followed by improved breathing and coughing. Exercise training is the main treatment for improving upper-limb and respiratory function after spinal cord injury. Emerging evidence from pre-clinical and clinical studies suggest transcutaneous spinal cord neuro-stimulation (TSS), increases spinal cord excitability through increased reflex input. The aim of this study is to explore the efficacy, safety, and acceptability of TSS combined with exercise training for chronic tetraplegia, targeting hand and respiratory function in a multi-centre community-based adaptive Bayesian Optimal Phase (BOP) II trial design across Australia and New Zealand. A BOP trial design allows for early analysis, identifying and ceasing trial arms that prove to be futile to continue. We hypothesise participants with complete SCI may improve in their strength and breathing outcome measures, however, it is not known whether the improvement will reach the pre-determined signal of benefit.

This clinical trial aims to investigate the effectiveness of a Cognitive Behavioural Therapy for Insomnia (CBT-I) program delivered via a smartphone application (called Sleep Ninja®) for improving sleep and mental health outcomes in Australian children (aged 10 to 11 years) with disrupted sleep relative to an active control. A. Primary Aim: To determine whether the Sleep Ninja app reduces insomnia symptoms at post-intervention compared to an active control. B. Secondary Aims: To determine the effects of the Sleep Ninja on depression, anxiety, sleep quality and daytime sleepiness compared to an active control. C. Subsidiary and Exploratory Aims: To examine whether the reduction in depressive symptoms is mediated by changes in sleep, and to explore the possible mediating role of cognitive processes including repetitive thinking, dysfunctional beliefs about sleep and pre-sleep arousal. To explore the emergence of new cases of MDD at the tertiary endpoint. Hypotheses: Participants receiving the Sleep Ninja app, relative to the active control will report: A1: Improved insomnia symptoms at post-intervention (primary endpoint). B1: Improvement in depression and anxiety, daytime sleepiness and sleep quality at post-intervention. C1: In the Sleep Ninja condition, reductions in depressive symptoms will be mediated by improvements in insomnia symptoms. C2: In the Sleep Ninja condition, reductions in depressive symptoms will be mediated by improvements in insomnia symptoms.

In a total hip replacement (THR), also called total hip arthroplasty, the damaged bone and cartilage is removed and replaced with prosthetic components. Secondary stability of the femoral stem is a prerequisite to secondary bone ingrowth and proper long-term fixation. Initial or primary stability of uncemented stems depends either on filling the proximal femur with intimate contact between the stem and the anatomic shape of the proximal femur (an anatomic fit) or filling the femoral diaphysis. The MasterLoc HA femoral stem is a cementless flat dual tapered wedge stem, designed to restore the anatomy of the patient enhancing mediolateral stability with reduced removal of bone. The stem features a shortened stem length and reduced distal geometry. It is coated, using a proprietary technology, called Mectagrip, with plasma sprayed titanium and hydroxyapatite to to assist with biological fixation. The aim of this study is to assess patient satisfaction and clinical outcomes following placement of a MasterLoc Stem for Total Hip Arthroplasty.

The aim of this trial is to compare the effectiveness of a vapocoolant (rapidly cooling) spray to a chemical ice pack to usual care for reducing the injection pain experienced by labouring women when water injections are used to manage back pain in labour. Participants will be women in labour at term with a single, head down fetus and requesting analgesia for back pain in labour. Labour back pain occurs in approximately one third of all labours and sterile water injections, which is standard care at all participating sites, has been shown in placebo controlled trials conducted by members of our team, to provide significant pain relief. However, the administration pain experienced by women receiving water injections is significant and in known to act as a deterrent to use. We will randomise eligible women who have elected to have water injections for labour back pain and consent to participate to receive either vapocoolant spray, application of cold packs for 10 minutes prior to injections, or a control group of usual care in which neither the vapocoolant spray or cold packs are used. We expect the study to provide data on the best approach to mitigating the pain of water injections