ANZCTR search results

This study is investigating whether an immunotherapy drug (Cemiplimab) is effective as a treatment for cutaneous squamous cell carcinoma (a skin cancer of the head and neck), particularly for patients who have had their cancer spread to large nerves within the head and neck area. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with stage 3-4 cutaneous squamous cell carcinoma (cSCC) and you also have been diagnosed with a spread of this cancer into large peripheral nerves (also known as large-nerve perineural spread). Study details There is only one treatment available as part of this study, all participants who choose to enrol will be offered the same immunotherapy treatment. Cemiplimab will be given to participants via an infusion into a vein, once every 3 weeks for up to 8 treatment cycles (approximately 6 months). Participants will need to attend their local hospital to receive this treatment and to undergo additional CT and MRI scans to review their nerves that may have been impacted by the cancer. Participants will be asked to undergo CT and MR imaging at the time that they enrol in the study, then at 6 weeks, 12 weeks and then at 12-weekly increments for a maximum of 5 years. It is hoped that this study will help us understand whether cemiplimab can shrink the tumour, in which patients this may be more likely to occur, and any side effects that may be experienced during this study. This may help to treat other patients with cSCC of the skin in future and reduce the impact of this type of cancer on the nearby nerves in the head and neck.

Approximately 10% of children under the age of 18 reside with at least one parent who has a substance use disorder. For parents seeking treatment for substance use disorder, this increases to more than 25%. There can be a social stigma associated with using both legal and illegal substances while caring for a child. This does not necessarily mean parents/caregivers who use substances are malicious or unable to care for their child. However, it is often common sense that, for those bearing the task of raising a child, managing their own Alcohol and/or Other Drug (AOD) use and seeking treatment can make parenting/caregiving even more challenging. This project aims to trial and co-develop a group-based pilot parenting program developed for adults seeking treatment for their substance use from AOD services who are also parents/caregivers of one or more children aged 5 to 11. The aim of the plot intervention is to increase the use of effective parenting skills in this population to support parent-child positive interaction and aid in children's positive and healthy developmental outcomes. In this respect, the Alcohol and Drug Assessment Unit (ADAU) at the Princess Alexandra Hospital believes there is a moral imperative to include parents seeking treatment for substance use in the development of parenting programs that are relevant to this population. This is because these parents with substance use disorders often lack a clear voice or perceived legitimacy of their values and concerns in relation to caring for their families. Thus, the outcome here will be a brief group-based parenting support program developed by experts in consultation with parents who seek treatment for their AOD use. This program could, therefore, be offered as front-line treatment for adults in integrated AOD treatment services.

The research project aims to determine the safety of commonly used antibiotics in emergency departments among patient with and without chronic kidney disease, to determine if these antibiotics (gentamicin, tobramycin and amikacin) increase the risk of acute kidney injury in patients with chronic kidney disease.

This study investigates the impact of mechanical vibration on the dental and skeletal effects of different orthopaedic appliance therapies at different skeletal maturities. Orthopaedic appliance therapies are best treated while there is still growth potential at the cartilage but some patients may have missed the ideal treatment period or they are towards the end of growth potential. As a result, these patients may face orthognathic surgery to achieve skeletal correction. The results of this study may shed light on whether these patients who are towards the end of their growth can still be treated orthopaedically which in turns may lead in the avoidance of orthognathic surgery in the future. The hypothesis is that there is no statistically significant difference in the dental and skeletal effects from Class II orthopaedic appliance therapy with mechanical vibration between two different skeletal maturity status.

Vasoplegia is a state of circulatory shock that is a common complication after orthotopic heart transplantation, and increases the risk of prolonged ICU and hospital stay, increases the risk of acute kidney injury, and carries a higher risk of requiring dialysis long-term. It is thought to occur due to an abnormal immune response following the surgery. Currently, there are no licensed therapies to prevent or treat vasoplegia. Cytokine haemadsorption is a form of blood purification therapy, that is believed to reduce the incidence and severity of vasoplegia by removing the immune chemicals contributing to its development. Early evidence has shown improved patient outcomes from using cytokine haemadsorption intraoperatively during heart transplantation, but to date no study has evaluated whether cytokine haemadsorption used post-operatively (in addition to intraoperatively) has benefit. Given the proposed mechanisms of vasoplegia and our institutional experience indicating that it can persist for days after the surgery, we believe that using cytokine haemadsorption intraoperatively and postoperatively may further improve patient outcomes by reducing the incidence and severity of vasoplegia. We therefore propose a randomised trial of cytokine haemadsorption plus standard care vs. standard care alone in adult patients undergoing orthotopic heart transplantation.

This study is evaluating the safety and properties of 177Lu-RAD202, a single-domain antibody joined to a radioactive lutetium isotope targeting HER2-expressing solid tumours. You may be eligible for this study if you are an adult patient with HER2 positive advanced solid tumours that is refractory to or intolerant of standard of care treatment or have no standard of care treatment available that is likely to provide clinical benefit., Participants will undergo a Screening Period of up to 4 weeks, followed by a Phase 0 (Imaging) Period for imaging and receiving a single injection of 177Lu-RAD202. If they are able to tolerate this and show positive uptake in the following 2 week period, they will then proceed to a Phase I (Treatment) Period where they will be assigned a gradual increase of 177Lu-RAD202 dose delivered every 6 weeks for 3 cycles. Blood sampling and imaging studies will be performed to determine how the participant is responding to 177Lu-RAD202. Additional treatment cycles (beyond 3 cycles) will be considered if participant is deemed to receive clinical benefit from 177Lu-RAD202 and approved by study Sponsor. Findings from this study will help determine a recommended dose of 177Lu-RAD202 for future exploration

Resection of the large bowel and creation of a new rectum or reservoir from the small bowel, termed ileoanal pouch, is the surgical treatment of choice for ulcerative colitis (UC) and familial adenomatous polyposis (FAP). Quality of life following pouch creation is generally good. However, a considerable number of patients have persistent pouch-related symptoms of increased frequency, urgency, leakage and incontinence. Additionally, around 40-50% of UC IPAA and 10-20% of FAP IPAA develop inflammation of the pouch, called pouchitis. The cause of pouchitis is not completely understood, but the effectiveness of antibiotics in treating pouchitis suggests that the pouch bacteria play a key role. One possible explanation is that there is an imbalance of key products of bacterial metabolism. On the negative side, hydrogen sulphide (H2S) is a gas (‘rotten egg gas’) produced from bacterial breakdown of undigested protein and processing of sulphates or sulphites that are used as preservatives in many foods. H2S is toxic at high concentrations to cells lining the gut. On the positive side, bacteria make short chain fatty acids (SCFA) as they process (ferment) carbohydrates. One of them, butyrate, is particularly important to maintain the health of the lining of the pouch. Butyrate’s ability to work is also inhibited by high concentrations of H2S. In patients with a pouch, increased H2S and decreased butyrate have been associated with an increase in problems associated with the pouch, particularly pouchitis. What we eat influences the ability of bacteria in the pouch to make H2S and butyrate. A limited number of studies have explored the use of dietary strategies in an attempt to improve pouch symptoms and reduce inflammation. No single strategy has been consistently effective. We recently conducted a pilot study to assess the tolerability and effectiveness of a diet called Monash Pouch diet. The diet strategies included (1) increasing readily fermentable fibre (inulin and oligosaccharides which encompass fructo- and galacto-oligosaccharides), (2) reducing osmotically active carbohydrates such excess fructose and polyols, (3) limiting excessive protein intake (including animal and plant protein) to (less than 100g/d), (4) reducing sulphur-containing protein intake, and (5) restricting intake of preservative. This diet was well tolerated by 80% of participants and was effective in improving pouch-related symptoms in all symptomatic patients along with improved inflammation as shown by a reduction of faecal calprotectin, a non-invasive marker of inflammation. Therefore, we have decided to follow this pilot study with a randomised study to assess its effectiveness in improving symptoms and inflammation as well as influence the pouch bacteria and their function in a beneficial way.

This study is testing the safety, tolerability (if any side effects occur), pharmacokinetics (PK; the amount of investigational drug or any breakdown products in your blood), pharmacodynamics (PD; how the investigational drug affects your body), and Immunogenicity (the ability of cells/tissues to provoke an immune response) of a single dose of an investigational drug called Recombinant Human Thrombopoietin for Injection- (rhTPO). This study drug has been marketed in China and other nine (9) countries since 2005, treating patients with primary immune thrombocytopenia (ITP) and chemotherapy-induced thrombocytopenia (CIT), under the trade name of TPIAO. Participants will undergo screening, admission (baseline), administration and follow-up observation period. Participants will sign an informed consent form before any study procedures are performed. During screening, all participants will be screened for study eligibility within 28 days prior to administration. Eligible participants will be admitted to the clinical study ward no later than one day prior to dosing (D-1). Participants need to fast for at least 10 hours prior to dosing and 4 hours after dosing. Single abdominal subcutaneous injection of the study drug will be given on D1. The administration and follow-up observation period will be 29 days (D1~D29). Participants may be discharged at D7 at the judgment of the investigator. PK blood samples will be collected from D-1 to D14, tolerance and safety will be observed from D1 to D29, and blood samples for PD and ADA will be collected from screening to D29. After completion of relevant assessments on D29, participants will be considered as having completed this study.This is a single-center, single-arm, open-label, single-dose phase I clinical study to evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of Recombinant Human Thrombopoietin for Injection (rhTPO) in healthy Caucasian participants. Approximately 22 healthy Caucasian participants will be enrolled for this study. One dose level is planned in this study, and participants will receive a single abdominal subcutaneous injection at a dose of 300U/kg after entering the study.

This pilot study aims to reveal the profiles of omics profiles in oral biosamples (saliva, GCF and plaque) in periodontal diseases (refers to diseased groups) before and after treatment follow-up (3, 6, 12 and 18 months). Omics profiles from periodontally healthy patients (without follow-ups as no need to follow up) will be used as controls. This project aims to explore diagnosis and prognosis values of salivary omics, plaque microbiome and GCF cytokines in periodontal disease patients. Compare the differences in salivary omics, plaque microbiome and GCF cytokines between periodontally health, periodontitis and periodontitis undergoing treatment over a 1.5-year observation period

This is a study that is aiming to help assess whether a virtual biologic clinic (VBC) used for managing patients on escalated doses of biologic medicines can improve rates of healthcare utilisation and reduce the socio-economic burden of Inflammatory bowel disease whilst maintaining the quality of care delivery and clinical outcomes currently experienced by inflammatory bowel disease patients. In doing so, we hope to evaluate the role that VBC’s can have in the development and implementation of a novel model of care for IBD patients, values-based healthcare. This study will use a combination of clinically reported patient outcomes, objective markers of disease assessment (C-Reactive protein, Faecal Calprotectin and Intestinal Ultrasound), healthcare utilisation costing information as well as patient reported outcomes which aim to determine patients’ quality of life, quality of care provision and patient reported disease activity scores. All of these datasets will allow us to determine whether the virtual clinic model of care delivers the outcomes as stated above and also meets secondary outcomes of improved rates of healthcare utilisation, reduced burden of IBD to society and parity in terms of quality of care delivery to IBD patients.