ANZCTR search results

A Randomized, Double-Blind, Parallel group, Comparative Phase I study for the assessment of Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of BP16 versus US licensed - Prolia® and EU approved - Prolia® Following a Single dose (60mg/mL) Subcutaneous Administration in Healthy Male Volunteers This is a phase 1 , multi centre randomized double blinded clinical trial in healthy male volunteers Primary objective is to assess the Pharmacokinetic similarity and to establish the Bioequivalence between the BP16 versus US licensed - Prolia® and EU approved - Prolia® Following a Single dose (60mg/mL) Subcutaneous Administration in Healthy Male Volunteers Secondary objective is to assess the Pharmacodynamic similarity , to monitor the safety ,tolerability and to assess the immunogenicity between the BP16 versus US licensed - Prolia® and EU approved - Prolia® Following a Single dose (60mg/mL) Subcutaneous Administration in Healthy Male Volunteers 204 Subjects will be enrolled and randomized in 1:1:1 ratio to receive the single dose subcutaneous injection of BP16/EU Prolia /US Prolia .

This study aims to assess the usefulness of a new cancer imaging technique, [68Ga]-labelled fibroblast activation protein inhibitor (FAPI) positron emission tomography and computed tomography (PET/CT) compared to the current standard [18F] fluorodeoxyglucose (FDG) PET/CT imaging for people with potentially resectable pancreatic cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with early stage pancreatic cancer that is suitable for surgical removal and you have not yet started chemotherapy treatment for your cancer. Study details All participants who choose to enrol in this study will undergo 2 FDG PET/CT scans as part of routine care as well as 2 FAPI PET/CT scans. FAPI PET/CT scans are in addition to the standard of care imaging. Participants will firstly have a standard FDG-PET/CT scan. Participants will then undergo the new FAPI PET/CT scan within one week of the first scan. Both scans will involve injection of a dye prior to the scan, each scan is anticipated to take 1h30mins. Participants will then undergo their scheduled chemotherapy over 8 weeks. After completing their chemotherapy, participants will be asked to complete the final two scans following the same procedures as the first two scans. Should the participant proceed to surgery, the resection specimens will undergo routine histological evaluation as per standard guidelines. After diagnostic requirements have been completed, IHC for FAP expression will be performed. This is the end of the clinical trial and participants will continue care with their regular Medical Oncologist and Hepatobiliary Surgeon. It is hoped this research will demonstrate whether a new imaging procedure is able to better identify tumour tissue borders in people with potentially resectable pancreatic cancer. If the new imaging procedure is successful, it may assist doctors to prescribe more personalised treatment options to pancreatic cancer patients that may increase their treatment success.

Chronic pain in children is a real and significant problem, affecting up to 1/3 of children and adolescents worldwide. The impacts of chronic pain can be profound- negatively affecting children’s physical, emotional and social health, and education. The health, social and economic consequences of children developing chronic pain extend to their family, the health service and wider society. Interventions to prevent or reduce chronic pain are crucial as adolescents with chronic pain are more likely to be depressed or anxious, more likely to feel helplessness and have reduced autonomy compared to healthy children. One area requiring further study is the progression of acute post-surgical pain to chronic pain. One in 20 Australian children undergo surgery every year, with Perth Children’s Hospital alone performing almost 18000 procedures annually. While most children make a full recovery after surgery, some develop chronic postoperative pain. A review of four studies (>600 children) across major surgeries reported 20% had chronic post-surgical pain at 12 months. The PCH complex pain service sees around twenty patients annually with significant dysfunction and pain following surgery. Developing chronic pain post-surgery has a distressing impact on these children and their families and significantly impacts quality of life and development. Biological factors and tissue trauma cannot fully explain chronic pain development. Risk factors associated with the development of postoperative chronic pain include pre-existing anxiety level of the child and the child’s ability to cope with pain. POPSICLE aims to understand how psychological, social and environmental factors may play a role in the development and maintenance of chronic pain in children. Over three years, we will follow children (0-15 yrs) undergoing common paediatric surgeries in a series of longitudinal prospective cohorts involving pre-operative and post-operative surveys of parents and patients. Initially, we will include planned procedures (orchidopexy, circumcision) and urgent procedures (appendicectomies, surgery for testicular torsion), before incorporating other common paediatric surgeries. This newly acquired knowledge will lead to the development of strategies that reduce poor pain outcomes in children. Evidence-based knowledge from this research will inform perioperative practice minimising the risk of a child going on to develop chronic post-surgical pain. This will benefit the child, their family and the healthcare system.

This pilot mixed methods RCT of Peers® Plus aims to test the effectiveness, acceptability and feasibility of a face-to-face group delivered Program for the Education and Enrichment of Relational Skills (PEERS®) adapted for children aged 8–13 years with acquired brain injury (ABI) or cerebral palsy (CP). In this pilot randomised controlled trial, we will recruit 32-36 children with brain injuries and their caregiver across Queensland and randomise them to receive PEERS® Plus immediately or be waitlisted for 6 months. PEERS® Plus will be run for groups of 8 children and their caregiver. Four groups will be run over a two-year period in order to deliver the program to the immediate groups and control groups after the waitlist period. Outcomes will be measured before the intervention, after the PEERS® Plus program, and then 3 months later (6 months post baseline) and 9 months later (12 months post baseline). Focus groups using semi-structured interviews will be conducted separately with children and caregivers at the end of the program to explore experiences of participation in PEERS® Plus.

Haemorrhoidectomy (surgical removal of haemorrhoid) is a common surgical procedure carried out by general and colorectal surgeons worldwide. Pain following haemorrhoidectomy is universal and problematic, causing absenteeism from work and school as well as a hospital readmission for pain relief. This is thought to be related to spasm of the anal sphincter muscles or creation of an anal fissure. Topical medications to aid in pain relief are well studied and accepted due to their ready availability and low side effects. Calcium channel blockers (CCB), such as diltiazem and nifedipine, are available in topical preparation, and are thought to aid in pain relief by decreasing muscle spasm. Whilst there are some studies accessing the role of CCB in post haemorrhoidectomy pain relief, most are focussed on diltiazem. Interestingly, nifedipine has reported better healing rates in anal fissure than diltiazem. This study aims to ascertain the effectiveness of topical nifedipine versus placebo as a post operative adjunct in the hopes of reducing pain experienced and reducing the post-operative short-term disability associated with haemorrhoidectomy.

Responsive feeding practices among parents have been shown to improve child eating behaviours and diet quality. Responsive practices are those that attend to a child’s hunger and fullness cues, such as allowing a child to decide how much they eat, rather than pressuring them. Families who experience economic hardship or food insecurity face challenges in child feeding. Aim: Eat, Learn, Grow will design and evaluate an intervention to support parents with economic hardship to use responsive feeding practices. This research program includes 2 phases: Phase I (ethics approval ref: LNR/21/QCHQ/72314): exploratory data collection and co-design of the intervention with parents; and Phase II (ethics approval ref: HREC/23/QCHQ/94215): evaluation of the co-designed intervention. Outcomes: The primary outcome measure is feeding practice - parental responsiveness. Secondary outcomes are uptake, acceptability, and satisfaction. Mediating variables are sociodemographic factors, household food security and chaos. Design: The intervention is called Eat, Learn, Grow and is a brief, low intensity program that includes a series of digital modules delivered via mobile phone with a supplementary mail out package. A randomised controlled trial design (n=150) will be used to pilot the program. Comparative analysis of the control and intervention groups over 3 time points (baseline, 6 weeks, 6 months) will be used as the basis of the evaluation. An online survey using REDCap will be used to collect sociodemographic information, the primary outcome measure and the mediating factors in the control and intervention groups. Validated tools are used to measure parental feeding practices, household food security, and chaos. The control will be wait listed and offered the intervention at the end of the 6 months.

Children with listening difficulties (LiD) have normal sound detection but disproportionate difficulty processing speech, particularly in noisy environments. LiD may be as a consequence of auditory processing, cognitive or language deficits. Clinically, it is challenging to delineate the possible causes of symptoms in individuals, however attention is one cognitive area known to impact listening ability in a large proportion of these children. Remote microphone technology (RMT) improves signal accessibility by transmitting a speaker's voice (via a microphone worn on a lanyard) directly to ear-level receivers worn by the child. These devices are commonly trialled in children with LiD, but the possible assistive benefits for those exhibiting attention deficits have not thoroughly been explored. The current study will investigate the efficacy of remote microphone technology (Phonak Roger Touchscreen Microphone paired with Phonak Roger Focus II receivers) to improve functional listening and cognitive abilities, classroom behaviour and quality of life in children with attention deficits. Based on previous literature, it is hypothesized that 30 weeks of RMT device use will improve classroom behaviour, quality of life, listening and attention skills in children with attention deficits.

Children with listening difficulties (LiD) have normal sound detection but disproportionate difficulty processing speech, particularly in noisy environments. LiD may be as a consequence of auditory processing, cognitive or language deficits. Clinically, it is challenging to delineate the possible causes of symptoms in individuals, however attention is one cognitive area known to impact listening ability in a large proportion of these children. Remote microphone technology (RMT) improves signal accessibility by transmitting a speaker's voice (via a microphone worn on a lanyard) directly to ear-level receivers worn by the child. These devices are commonly trialled in children with LiD, but the possible assistive benefits for those exhibiting attention deficits have not thoroughly been explored. The current study will investigate the efficacy of remote microphone technology (Phonak Roger Touchscreen Microphone paired with Phonak Roger Focus II receivers) to improve functional listening and cognitive abilities, classroom behaviour and quality of life in children with attention deficits.

Children admitted to intensive care units require arterial cannulation for monitoring and blood sampling. In neonates, arterial access can be achieved through umbilical artery catheterization in the first 3-4 days, whereas in older infants and children it is via peripheral arteries. Even in neonates, umbilical arterial catheterization may not be feasible (e.g., abdominal surgical conditions). The radial, posterior tibial, and brachial arteries are commonly used for cannulation in children and neonates. The radial artery cannulation is also being increasingly used for percutaneous cardiac procedures. These arteries are of small calibre, which makes their localization and cannulation challenging and potentially unsuccessful. The radial artery is the most frequently used site for cannulation as it is superficial and has a relatively larger diameter compared to other peripheral arteries. Repeated attempts can lead to bleeding, spasm and dissection of the peripheral arteries. Ultrasound-guided insertion can increase cannulation success but requires high expertise. A recent paediatric audit found that even with ultrasound, the first attempt success rate was only 31%. Resource-limited settings may be limited by the expense of the ultrasound equipment and maintenance. Therefore, increasing the internal diameter and preventing vasospasm are important for successful peripheral arterial cannulation in neonates. Glyceryl trinitrate (GTN) has the potential to increase cannulation success in children by increasing the diameter of peripheral arteries and preventing vasospasm when used as a local application. We hypothesize that local application of GTN in the form of a transdermal patch will achieve adequate dilatation of the radial artery in neonates. We aim to conduct a randomised controlled trial to establish effectiveness and safety of local GTN in increasing the diameter of the radial artery in neonates.

People with PC are treated according to the extent of their disease at diagnosis. One of the problems that doctors face is adequately distinguishing patients who should receive chemotherapy before surgery versus surgery alone. This study aims to test whether a structured radiology report can improve the accuracy of reporting of CT scans in PC to optimise care. Who is it for? You may be eligible for this study if you are an adult who has suspected pancreatic cancer, you have an abdominal CT scan performed for diagnostic purposes and you are attending one of the participating hospitals for this study. Study details Participants included in this study may either have their CT scan reviewed and reported using standard radiology reporting as per usual practices, or using a more structured radiology reporting tool that is being tested for this study. The radiology reporting that participants receive will depend upon the hospital they are being treated at and the timing of their appointments; as all participating hospitals will be randomly allocated to start using the new radiology reporting tool at different times throughout the study. All participants will receive the best standard of care regardless of whether the hospital they are attending has been allocated to use the new reporting tool or not. It is hoped this research will determine the usefulness and reliability of the new structured radiology reporting tool. If this study finds that using the structured tool leads to more accurate diagnosis of pancreatic cancer types that can then in turn optimise the treatment options available to patients, use of the reporting tool may be expanded to a greater number of hospitals.