ANZCTR search results

The purpose of this study is to explore the differences in a type of tumour marker, called a carcinoembryonic antigen, in two different blood sample sites. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with cancer of either the colon or appendix. Study details All participants in this study will be asked to provide consent for venous blood samples to be taken as part of your peritonectomy surgery. Five ml of blood will be taken from a vein in your arm as well as another 5 ml of blood from the vein near your appendix or right colon that is located in the right lower side of the abdomen during the initial stages of your peritonectomy surgery. All participants will also give access to medical records to collect the relevant study data such as demographic details, diagnosis, treatment, blood and histopathological results. It is hoped that this research will form part of the eventual outcome where we hope to identify patients at risk of developing liver metastases from their colorectal cancer and develop a suitable drug to prevent these patients from developing liver metastases - Improving their prognosis and disease free survival.

This is a multicentre non-randomized clinical trial looking to examine the benefit of implementing a decision aid named Pregnancy IBD Decision Aid (PIDA). Access to dedicated pre-conception counselling sessions within both metropolitan, regional and rural Australia and Canada however can be limited, given the restricted number of specialised ‘pregnancy in IBD’ clinics. A decision aid, to be utilised in conjunction with outpatient clinical appointments, may provide a method by which to overcome such limitations in access. Each site will have study outcomes collected over a six month period during the implementation of the current standard of care of preconception counselling; in the following six months the intervention (PIDA) will precede this standard of care. Sites will comprise a combination of tertiary centres with dedicated pregnancy in IBD Clinics, in addition to non-tertiary centres which provide non-specialised IBD care. An improvement in the quality of the decision-making process as measured by the Decisional Conflict Scale will be the primary outcome variable. The secondary outcome variables are: 1. Quality of decision-making process (as assessed by PrepDM scale questionnaire) 2. Quality of decision comprising knowledge and congruence of values (as assessed by CCPKnow; SWD questionnaires)

Function of the cardiac left atrial chamber is known to be impaired in people with atrial fibrillation, a condition principally related to this structure. In people who have an ischaemic stroke, roughly one quarter will have no definite cause found despite extensive imaging and other tests, though up to 30 percent of these will have atrial fibrillation diagnosed on implantable cardiac monitoring in the 3 years after stroke. The purpose of this study is to determine if a proportion of this group with stroke of undetermined source have signs of left atrial cardiomyopathy, evidenced by low left atrial reserve at rest and during exertion seen on echocardiographic imaging, and if this is reflected by impaired exercise tolerance, altered blood test biomarkers, or left atrial structure and epicardial fat abnormalities on computed tomography.

Nasal capsaicin is the standard of care for the treatment of non-allergic rhinitis. The capsaicin receptor (TRPV1) is widely present through the human body (Nobel Prize in Medicine 2021) and is related to pain and noxious stimuli. Nothing is published on the systemic availability of capsaicin after nasal administration.

This is open label, cross over study to evaluate the safety, tolerabitity, pharmacokinetics (PK) food effects of AC-201 following oral single ascending dose administration in healthy male and female participants. The impact of food (high-fat breakfast) on the rate and extent of absorption will be evaluated.Food Effect (FE)study enrolling 1 cohort of subjects (Part 2) to receive AC-201 under both fasted and fed conditions for investigating the effect of food. In this part of the study the dose given in Fed Period will be administered 30 minutes after starting a high-fat breakfast. A high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal will provide to the subject 30 min prior to dosing. This test meal should derive approximately 150.250,and 500-600 calories from protein, carbohydrate, and fat, respectively.

Early intervention to slow the onset of dementia is a crucial topic warranting investigation, however, to date there has been insufficient research in this field. There is evidence suggesting that older adults with memory difficulties are particularly vulnerable to developing dementia and that music training programs could have a positive effect on cognition and potentially harness the brain's ongoing ability to form new and/or reorganise existing neural pathways – 'neuroplasticity' – as well as contribute to increased wellbeing in this population. Nevertheless, there remains a paucity of research investigating the neuroprotective effects of music training in people with memory difficulties. The unique pairing of experts from the Brain and Mind Centre and the Sydney Conservatorium of Music perfectly position us to develop, pilot and translate a ground-breaking intervention to reduce risk of cognitive decline and dementia whilst improving quality of life for older people with MCI. Thus, the main objective of this NeuroMusic study is to evaluate the efficacy of keyboard and choral singing interventions in comparison to a control condition on improving verbal memory performance. We hypothesise that in older adults with memory difficulties, our music-based training program will improve memory performance, supported by structural and functional brain changes. This study is a 12-week, single blind, randomised-controlled trial in which 216 community dwelling older Australians (60-90 years), with memory difficulties. Participants will be randomised (1:1:1) to either the keyboard intervention, choral singing intervention or an active control condition (i.e. film-viewing sessions). Data collection points will be baseline (weeks 0-2), post-intervention (week 16) and 6 months after intervention completion (week 36).

Hearing loss is prevalent in later life and associated with increased risk of depression, social isolation, loneliness, mental illness and reduced quality of life. Additionally, the Covid-19 pandemic has brought about restrictions in social interaction and face to face contact, which has further impacted on the social isolation and mental health status of adults, particularly those with hearing loss. Treatment of hearing loss can be relatively simple but traditional hearing aids are expensive and uptake is often sub-optimal. Personal sound amplification products (PSAPs - 'hearables') offer a simple, cost-effective alternative to conventional hearing aids, but no current evidence exists to determine if they improve the psychosocial consequences of age-related HL. Psychological therapies can be effective in treating mental distress in the elderly but factors such as availability of suitably trained therapists, cost and difficulties delivering the therapy in a socially isolated, hearing-impaired population pose challenges. Behavioural activation (BA) is a pragmatic and fairly simple psychological intervention aimed at improving mental health by increasing cognitive, physical and social activities. BA has been shown to be effective in treating depression in the general population but no current evidence exists to determine if BA with or without hearing loss treatment is effective in ameliorating the psychosocial consequences of hearing loss. The proposed project will aim to test if hearing amplification with PSAPs with or without a BA intervention program improves mood, relieves mental distress and social isolation, improves quality of life, and reduces health care costs in older adults with hearing loss. We will utilise a 2x2 factorial design to randomise 240 older adults aged 65 years and older with mild-moderate hearing loss to a 6-month clinical trial of hearing amplification and/or BA compared with an education intervention control group.

Surgical repair of an inguinal hernia is a common procedure in early childhood. The incidence of inguinal hernia’s is inversely related to an infant’s birth weight, gestational age, and is more common in boys. Prematurity (less than 36 weeks gestational age) is identified as a major risk factor for the development of inguinal hernias, with approximately 30% of preterm infants diagnosed with an inguinal hernia. Most preterm infants diagnosed with inguinal hernias in our institution will undergo surgical repair prior to discharge from the neonatal intensive care unit (NICU). It is well documented that preterm infants undergoing general anaesthesia have an increased risk of cardiorespiratory events including apnoea and bradycardia. Respiratory adverse events are common in paediatric anaesthesia and comprise more than three quarters of all critical incidents and half of all unplanned admission to paediatric intensive care unit. While studies have looked at the post-operative apnoeas and the risk associated with apnoea in infants, there are few studies that have explored the respiratory trajectory of these patients undergoing inguinal hernia repairs. In this study, oximetry and apnoeas will be measured both pre- and post-operatively, along with transcutaneous carbon dioxide levels on the night of surgery to investigate the impact of anaesthesia and surgery on these young infants. Particularly, identifying infants at increased risk of respiratory complications through pre-operative continuous pulse oximetry may potentially reduce morbidity and help guide clinicians on the optimal allocation of resources including the length and intensity of post-operative monitoring required, and ultimately the anaesthesia management plan. This is a pilot study to assess the feasibility of investigating the respiratory profile (deviation from baseline SpO2, desaturation events, apnoeas, carbon dioxide levels) in infants (up to 6 months corrected age) undergoing inguinal hernia repair to assess the recovery profile after surgery under general anaesthesia and/ or regional block at Perth Children’s Hospital, a tertiary specialist paediatric centre to inform the planning of a larger trial. The study will also evaluate the rate of participant recruitment and rate of adherence to the protocol.

Pain is extremely prevalent and highly impactful on quality of life. Both acute and chronic pain are routinely treated with paracetamol, non-steroidal anti-inflammatory drugs, monoamine reuptake inhibitors, anticonvulsant agents, and opioids. However, these treatments may have only modest efficacy in the treatment of pain and/or can have significant adverse effects that also interfere with quality of life (e.g., cognitive clouding, sedation, fatigue, weight gain). The high prevalence and high burden of disease associated with pain, combined with ineffectual treatments or treatments with significant adverse effects defines a clear unmet need for new well tolerated and effective therapeutic treatments that are not prone to abuse/misuse. This extends to the management of mild-to-moderate non-palliative pain. Cannabidiol (CBD) represents one such treatment for control of mild-to-moderate non-palliative pain. Three clinical trials and two observational studies demonstrated clear positive effects of chronic CBD dosing regimens on the management of a range of pain indications. This is a first-in-human (FIH) study for the Promethean Health CBD tablet. However, CBD been extensively investigated in human clinical trials at doses ranging from < 10 mg/day to up to 6,000 mg/day. The planned Promethean Health Pty Ltd clinical trial will investigate a total CBD daily dose of 150 mg/day for a period of 30 days. The dose level was selected within the TGA guidance for Schedule 3 registration (16). The 3 times a day dosing schedule was selected based on the half-life of the formulation (approximately 6 hours), with 3 times daily allowing the broadest dosing schedule that can be achieved through waking hours.

Anxiety associated with medical procedures is common with 40-80% of children experiencing perioperative anxiety. Children can experience significant symptoms and postoperative consequences due to perioperative anxiety, including distress and delirium, increased intensity and duration of pain, prolonged hospital stay, behavioural and sleep disturbance and avoidance of medical encounters which often remain into adulthood. The Magic Coat Perioperative Program will be a novel, evidence-based interactive program delivered in an online format and reinforced throughout the hospital journey that aims to promote coping skills and resilience in children. This sequential pre and post intervention prospective cohort clinical trial will examine the impact of an accessible, customisable online resource designed to introduce and build upon skills for communicating and managing anxiety among children in the peri-operative period and improving induction compliance. Primary hypothesis; Children introduced to the Magic Coat Program via the online storybook who have those skills developed and reinforced during their hospital stay will display a significantly smaller increase in anxiety during anaesthetic induction from baseline (Timepoint 1(T1)), compared with conventional techniques for reducing peri-operative anxiety. Secondary hypotheses; Children introduced to the Magic Coat Program via the online storybook who have those skills developed and reinforced during their hospital stay will, compared with conventional methods of managing perioperative anxiety, 1. Display better induction compliance 2. Be less likely to receive a sedative pre-medication 3. Require less postoperative analgesia for comparable interventions (in the 24 hours following surgery) 4. Be less likely to experience postoperative delirium 5. Experience improved parental and child satisfaction with the perioperative experience 6. Less negative behavioural outcomes at 1weeks and 1-month post procedure