ANZCTR search results

The study is a parallel group double-blind Phase 3 randomised control trial comparing a 12-week treatment period of oral Cannabidiol (CBD) (400mg daily, Experimental) to Placebo (Control). The research hypothesis is that CBD, compared to placebo, will achieve significant reductions in cannabis use, as measured by number of self-reported cannabis-free days and urinary THC-COOH levels, among treatment-seeking patients with moderate-severe CUD. Participants will be treatment-seeking clients recruited from study sites under conditions of informed consent. Participants will be randomly allocated to either CBD or placebo (1:1 ratio, double blind conditions), and attend every 3 weeks (weeks 1-12) for (a) clinical review with study doctor, (b) dispensing of medication, (c) collection of urine drug screen and (d) a research interview with an independent researcher. Participants will have up to 4 sessions of Cognitive Behavioural Therapy-based counselling over the 12 weeks. Final research interview will occur at week 24, 12 weeks after the study intervention. Additional qualitative research interviews will be conducted with Aboriginal participants in a sub-study examining their perspectives of treatment. Sample size is 250 participants, with approximately 125 randomised to each condition. It is estimated that approximately 20% of participants (n=50) will be Aboriginal. The study will use an intention to treat between-group analysis.

Interventions used to change behaviour typically rely on providing solely education, however this is usually insufficient for behaviour change. Training of health professionals in effective strategies such as behaviour change techniques can provide positive benefits in both the confidence of health professionals to deliver effective interventions as well as improve primary care. To date, dietitians have received limited training in this area and have expressed a need for professional development on behaviour change. To address this gap, dietitians will be able to participate in two 2-hour workshops in behaviour change. The pre-post trial will allow us to see changes over time over three time points. Outcomes of the study will guide the development of future continuous professional development for health professionals in health-behaviour change to improve client outcomes.

Osteoarthritis is the most common joint disorder in the world and occurs most often in hips and knees, with symptoms including pain, stiffness and limited movement of the affected joint. Diagnosis of OA is the principal indication for total hip arthroplasty which is the treatment for individuals with end stage hip osteoarthritis when conservative therapies to manage symptoms have been exhausted . The aim of this study is to investigate how restoration of the native hip anatomy in total hip arthroplasty (THA) affects biomechanical and functional outcomes. Biomechanics (in this context) refers to gait assessment (joint angles and ground reaction forces) and its integration with musculoskeletal modelling techniques to determine joint contact forces.

Background • Over 2 million people undergo heart surgery every year. • An invasive monitoring device called a ‘pulmonary artery catheter’ can measure how well the heart pumps, and is commonly used in heart surgery patients • Small studies suggest that pulmonary artery catheters may not benefit these patients, and may even lead to harm such as major bleeding and infection • Some experts conclude that pulmonary artery catheters overcomplicate things and lead to unnecessary and risky treatment • There has never been a high quality ‘randomised controlled trial’, so there is still uncertainty amongst doctors Aims • Our ultimate aim is to provide reliable evidence on whether heart surgery patients benefit from pulmonary artery catheters • First, we must test whether a large-scale trial is feasible by starting with a small ‘pilot study’ Methods • 150 patients undergoing low risk heart surgery will be eligible to participate • After providing informed consent and prior to surgery, participants will be allocated at random to receive either a pulmonary artery catheter or a less invasive alternative in a 1-to-1 ratio • We will record how smoothly the pilot study runs by collecting information on the number of patients we recruit, the number of times a person is switched from one strategy to another by their doctor, and how completely we can collect data and follow up patients • We will also assess whether pulmonary artery catheters influence a range of clinical outcomes in the intensive care unit, general ward, and at home after patients are discharged. Impact • If the PUMA Pilot is successful, the research team will conduct a large-scale randomised clinical trial that could change global practice

The main purpose of this study is to better understand how changes in treatment impact muscle wasting (also known as cachexia) in people with head and neck cancer (HNC). In particular, we are interested in understanding the blood marker GDF-15 and swelling/ulceration of the mouth or gut (known as mucositis), and the relationship with cachexia. This study is focused on people diagnosed with head and neck cancer, scheduled to undergo radiotherapy +/- chemotherapy. The study will involve the collection of blood and saliva throughout 7 weeks of radiotherapy, with some additional questionnaires completed by the participant. All assessments will be performed at routine clinic visits to decrease the burden of participating. By understanding the interaction between mucositis and cachexia, we hope to be able to identify people at risk of cachexia and direct them to appropriate care pathways early.

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.