ANZCTR search results

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.

Osteoarthritis (OA) is a common and debilitating condition affecting millions worldwide, with no known cure. Physical activity is beneficial for managing OA, but most patients fail to meet recommended activity levels. Walking is a safe, low-cost, accessible form of exercise suitable for OA patients. The Walk with Ease program, initially from the US, is a 12-week walking program designed to help OA patients manage pain and symptoms while staying active. It has proven to reduce pain, stiffness, and improve function in people with moderate to severe pain (greater than 4/10), also boosting physical activity levels in individuals with arthritis. This study will test whether Walk with Ease Australia has an effect on physical activity levels in Australians with OA through a two-arm, parallel, randomised controlled trial using a hybrid type 1 effectiveness-implementation design. The primary endpoint is assessed at 12 weeks. After screening and consenting, participants are randomized into either the Walk with Ease Australia plus Fitbit group or the Fitbit-only group. Surveys are completed at baseline (T0), six weeks (T1), 12-weeks (T2), and follow-ups at six and 12 months (T3 and T4). We expect that people assigned to the Walk with Ease Australia will have higher physical activity levels, compared to control at 12 weeks.

Active-Prem is a novel intervention aiming to improve physical activity participation for preschool age children born very preterm. Active-Prem is a 6 part intervention developed through previous research, pilot studies and co-design. It includes goal setting, parent support, coach training, and facilitating the inclusion of children born preterm into physical activities in their local community. The aim of this study is to evaluate the effectiveness of Active-Prem compared with goal setting at improving physical activity participation, as well as evaluating the acceptability, fidelity, feasibility and cost-effectiveness of the Active-Prem intervention.

This study aims to evaluate the safety and functionality of the ProtonPetal Alpha One device, focusing on generating early feasibility data regarding its performance. The device will measure participants' interstitial potassium levels, and these measurements will be retrospectively compared to standard clinical blood potassium measurements, both during baseline conditions and after introducing a potassium challenge.

The purpose of this study is to test a new version of mental health and wellbeing program, the Be Well Plan, in university students. This program aims to build the mental health and wellbeing of participants through 5 weekly, online or in-person, group-based sessions which are designed to assist participants in in developing their own wellbeing plan to better cope with the challenges of university life. In addition, the project aims to understand if the program is beneficial for students with body image or eating concerns and whether any adaptions need to be considered.

This clinical trial will evaluate the effectiveness, safety and cost-effectiveness of NVPs compared to the pharmacotherapy, varenicline, for smoking cessation among people experiencing social disadvantage. The trial is a two-group superiority randomised controlled trial (RCT) that compares smoking rates between two groups of 436 low-socioeconomic status smokers (N = 872), randomly allocated to either: 1) standard varenicline treatment; or 2) NVPs treatment. Both groups will be provided text message behavioural support. This work is of national and international significance as it will provide much-needed data on the effectiveness, safety and cost-effectiveness of latest generation vaping products at achieving smoking cessation amongst a priority population. This will directly address peak health bodies’ calls for high quality large-scale RCT evidence and contribute significantly to existing knowledge in this research area. Furthermore, the outcomes of this study will help guide government and policy decision-making in the future.