ANZCTR search results

This study is an open-label trial investigating the safety, feasibility, and tolerability of photo-biomodulation Therapy (PBMT) on healthy participants aged 50 to 70 years. Photo-biomodulation (PBMT) employs red or near-infrared (NIR) light (600-1100nm) to stimulate healing, protect tissue from dying, increase mitochondrial function, improve blood flow, and tissue oxygenation (Dompe et al., 2020; Hamblin, 2018). PBMT can also act to reduce swelling, increase antioxidant defence, decrease inflammation, protect against apoptosis, and modulate microglial activation states (de Freitas & Hamblin, 2016; Hamblin, 2017). All these mechanisms of action strongly suggest that PBMT delivered to the head could be beneficial in cases of mild cognitive impairment and dementia (Hamblin, 2016; Hennessy & Hamblin, 2016). The study will also determine the relevant parameters of PBMT that will be used to design a larger randomised blinded trial. We hypothesize that the (1) PBMT intervention will be safe and tolerable for an older adult population and (2) the treatment will result in discernible changes in MRI measures and these will be correlated to improvements on neuropsychological assessment outcomes on the CANTAB that reflect decision making and working memory constructs, as well as EEG measures of attention and working memory. The 12-week intervention will include participants undergoing pre-treatment assessments (week 0), 12 weeks of PBMT (week 1-12), and post-treatment assessments (week 12). The PBMT trial will be evaluated against baseline verse follow up cognitive, psychological, and neuroanatomical changes, along with participant safety and tolerability (number and severity of adverse events) and program completion (actual treatment completed).

Craniosynostosis is a condition where the bones in a baby’s skull fuse too early causing an unusual head shape. Most children with this condition undergo cranial vault remodeling surgery within the first 2 years of life. This operation is generally effective in normalising the overall shape of the skull, however, a common issue after surgery is hollowing of the temples just in front of the hairline (temporal hollowing). The current way that temporal hollowing is corrected involves using artificial materials (for example, a bone substitute putty or plastic-like implant) but they have some limitations and can only been used when the child is in their teenage years and their skull has stopped growing. A new approach to fix this problem uses a specially made, degradable tissue scaffold. This scaffold is designed to fit in the affected area and can be placed through a smaller incision. The benefits of using this scaffold include the potential for further growth, which is not possible with current materials used for correction. The scaffold is made of a material called Polycarprolactone (PCL) which is the same material that some dissolving sutures are made of and is known to support tissue growth. The scaffold will also have a compound called Tricalcium Phosphate added which encourages bone to form. Eventually the scaffold will be replaced by the patient’s own bone as the scaffold slowly degrades. These scaffolds have been studied extensively and are currently being used in Australia in trials for other types of reconstruction (eg skull defects, leg bone defects, and jaw bone defects). Aims of the study: The main aim of the study is see how effective a tissue scaffold is at improving the appearance of the temporal region and forehead in children with temporal hollowing. The study will also investigate how much new bone forms within the scaffold. Importance of the findings: Tissue scaffolds have been used in other parts of the face, but this will be the first time they have been used in the temporal region, laid on top of the bone. This study will therefore tell us how effective scaffolds are at augmenting bone. This is relevant for many children with congenital conditions that affect the face, where the facial bones do not grow normally and may need to be augmented.

A trial in healthy adults to evaluate how AR882 may interact with common drugs such as fluconazole, carbamazepine, celecoxib, and sulfasalazine.

We aim to determine if maternal oxygen supplementation 5-10 min prior to birth of term and near-term infants (32 weeks gestation or above at birth) utilising heated humidified high flow nasal cannula with 100% oxygen at 30-70L/min is feasible at both caesarean section and vaginal births. The information gained from this feasibility study will inform the planned randomised controlled trial of maternal oxygen in very preterm infants.

Four in five (80%) older Australians report having one or more long-term health condition. Older frail patients who undergo cardiac surgery have poorer postoperative outcomes. There is some evidence that multidisciplinary prehabilitation may reduce the number of postoperative complications in older patients undergoing abdominal cancer surgery. There is a need for the current pilot study to demonstrate the feasibility of the multidisciplinary prehabilitation program in frail older persons and to investigate any potential risk, adverse events, compliance to exercise program and satisfaction in this patient population who has higher likelihood of unwanted postoperative outcome after cardiac surgery.

The aim of this study is to evaluate the impact of a personalised skin cancer prevention strategy on UV exposure in adults with a history of skin cancer. Who is it for? You may be eligible for this study if you are aged 18 years and over, and have previously been diagnosed with skin cancer (including melanoma, basal cell carcinoma, squamous cell carcinoma). Study details Participants will be randomly assigned to either an intervention or control group. The intervention comprises 10-days wear of a Sun Watch, which displays the real-time UV Index and the wearer’s daily cumulative UV exposure alongside receiving personalised SMS sun protection reminders, and educational information on skin cancer prevention, early detection and treatment. The control arm will receive the educational information only. Participants will be asked to complete questionnaires on their sun protection behaviours, physical activity, psychosocial outcomes and their perspective on the intervention. It is hoped that findings from this study will help researchers understand the effect of a personalised skin cancer prevention strategy on primary prevention behaviours.

Borderline Personality Disorder (BPD) is a common, yet complex, mental illness. People with a diagnosis of BPD experience significant distress due to difficulties relating to other people and the world around them, disruptions to family, social and work life. Symptoms of BPD may include difficulty regulating emotions, impulsive behaviours, self-harm, suicidal ideation/attempts, feelings of detachment from their own experiences, and/or intense and unstable relationships. Additionally, parents with BPD may face challenges responding to and bonding with their infants, which may negatively impact children throughout their lifespan. Although BPD is a long-term condition with high rates of relapse and crisis, recovery is possible with suitable therapy. Treatment approaches for people living with BPD are often intensive and lengthy, which can mean long waiting periods for patients to enter programs. Helen Mayo House and Borderline Personality Disorder Collaborative (BPD Co) have collaborated to develop a ten-week group therapy program (Lifeboat) for parents with DBT informed by the principles of Dialectical Behavioural Therapy (DBT) and Mentalization Based Therapy (MBT). Lifeboat aims to help parents living with BPD understand and connect their emotional, cognitive and behavioural experiences. The present pilot study will assess the appropriateness, feasibility and effectiveness of the program by comparing the severity of parental psychological symptoms and parenting attitudes and behaviours before and after attendance to the program, as well as six months post-intervention. Interviews with participants will also be conducted to explore the experiences of parents with BPD engaging with the Lifeboat program. Participants will be asked to complete an electronic survey and participate in an evaluation and interview before, after, and six months post-intervention. It will be made clear to participants that participation is voluntary and refusal to participate will in no way affect eligibility for the Lifeboat program, or any other health service.

Study Title: The IDEAS-B STUDY Evaluating whether nebulized dexmedetomidine can be used for pain management in burn injury dressing changes.: A phase III pilot feasibility, randomized controlled crossover trial. This is a pilot phase III randomised controlled crossover trial that will be conducted in the burn’s unit at the Royal Brisbane and Women’s Hospital. The drug, Dexmedetomidine, will be used for its registered purpose, sedation and analgesia, however this study will be investigating the use of an alternative method of administration (nebulisation). Patients suffering from burns undergo procedures (dressing changes, de-stapling and burns baths) associated with pain and discomfort requiring analgesia/sedation. Inadequate analgesia/sedation causes complications such as patient discomfort, distress, noncompliance, difficulty nursing, and prolonged procedural time, adversely affecting wound healing and increasing hospital length of stay. Therefore, optimal procedural analgesia/sedation is vital for these patients. Currently, in RBWH burns patients, analgesia/sedation is provided by oral oxycodone 10mg and sublingual lorazepam 1mg with breakthrough inhaled nitrous oxide, but this is associated with several adverse effects (nausea, vomiting, and dizziness), and suboptimal clinical effect. Dexmedetomidine, a centrally acting Alpha 2 agonist with analgesic, anxiolytic and sedative properties commonly administered by intravenous route is also able to be administered via the inhaled route using a nebulizer. Due to its pleiotropic effects, intravenous dexmedetomidine is used as an analgo-sedative in clinical medicine. However, Intravenous dexmedetomidine is associated with side effects such as hypotension and bradycardia. Nebulization is a viable and effective alternative mode of drug delivery for systemic effects including analgesic agents due to the extensive surface area and perfusion of the lungs. Moreover, nebulized dexmedetomidine has been reported to have been used safely and effectively in other conditions. Nebulized dexmedetomidine can potentially achieve therapeutic plasma concentrations with lower peak (minimising adverse effects) and larger area under the plasma concentration-time curve, achieving adequate analgesia for a longer duration which is ideal for burns procedures in non-mechanically ventilated patients. However, currently there is no data supporting the use of nebulized dexmedetomidine for analgesia-sedation in burns patients. We plan to recruit 20 participants per for this study.

The ALLEVIATE study aims to determine what level of levetiracetam concentrations are achieved in the blood and brain, in ICU patients with bleeding in the brain due to severe traumatic brain injuries or ruptured aneurysms. Although research suggests that there needs to be a certain amount of levetiracetam in the blood to stop or prevent seizures, it is currently unclear, whether the amount in the blood results in the right level in the brain (the site of injury). The purpose of this study is to determine how best to dose levetiracetam so that adequate levels are achieved in the brain in patients at high risk of seizures. We hypothesise that there may be significant differences in levetiracetam brain fluid concentrations between the two groups of patients. Patients who are receiving Levetiracetam for the treatment or prevention of seizures as part of their standard care for bleeding in the brain will be considered for participation. Participation will involve sampling of blood and brain fluid over one dosing interval on one day only, to measure the concentration of levetiracetam. Blood samples will be collected from an existing arterial line. The brain fluid is collected from an external ventricular drain that is already in place as part of usual care to relieve pressure in the brain. A prolonged electroencephalogram (EEG) recording will be undertaken prior to administration of levetiracetam dose and continuing until the next dose on the day of sampling. EEG is a non-invasive procedure that studies the brain’ electrical activity and is used to evaluate seizures.

This pilot study aims to examine the efficacy of the Spaced Retrieval and Montessori-based activities (SPREMON) mealtime intervention on eating difficulties, mealtime engagement, and affect in individuals with dementia living in an Australian nursing home. A quasi-experimental design (single group) will be undertaken for the pilot study. The pilot study will recruit 35 individuals who are in the mild to moderate stage of dementia, have eating difficulties, and scored above 5 on the Edinburgh Feeding Evaluation in Dementia Questionnaire. The intervention will consist of Spaced Retrieval and Montessori-based activities, 45 minutes per session, three times per week, for a total of 20 sessions over seven weeks. The outcomes will be measured three times: prior to first intervention session, immediately after completion of the intervention program and 3 months follow-up post-completion of the intervention program.