ANZCTR search results

The purpose of this study is to investigate the preliminary effectiveness and safety of a topical cannabidiol salve for rheumatoid arthritis. We hypothesise that using the salve for 4 weeks will have a clinically significant effect on functional status. This is an open label trial with all participants receiving the intervention for 4 weeks. Participants will apply the salve to affected joints twice daily for 28 days. The primary outcome is change in functional status. Secondary outcomes include health-related quality of life, pain, swollen and tender joint count, side effects, and change in inflammation.

This study aims to assess the safety, tolerability, tumour uptake, biodistribution and dosimetry of a new tumour imaging agent, [68Ga]Ga-A9-5209, in patients with advanced or metastatic cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above with advanced or metastatic breast cancer, prostate cancer, non-small cell lung cancer, small cell lung cancer or mesothelioma. Study details All participants who choose to consent in this study will undergo a screening visit to assess their eligibility. Participants will receive a single administration of [68Ga]Ga-A9-5209 via intravenous injection on Day 1. Participants will receive up to four PET/CT scans, and four blood draws (one for each scan) on Day 1. Participants will complete a safety follow up visit/end of study visit on Day 2. Patients with advanced or metastatic breast cancer, prostate cancer, NSCLC, SCLC, or mesothelioma can participate in either Part 1 or Part 2 of this study. There will be no differences in the assessments conducted for participants in Parts 1 and 2, the analysis however will differ. Part 1 participants will be evaluated for tumour uptake, biodistribution and dosimetry of [68Ga]Ga-A9-5209. Part 2 participants will be evaluated for tumour uptake. A minimum of 4 participants per indication will be included in the study. Target indications are advanced or metastatic breast cancer, prostate cancer, non small-cell lung cancer (NSCLC), small-cell lung cancer (SCLC), or mesothelioma. If successful, this potential new product could provide more accurate tumour staging and treatment response evaluation.

Medicinal cannabis has recently become available under prescription for the treatment of a range of intractable diseases. The efficacy of medicinal cannabis has not been tested in the general practice setting. We will test the hypothesis that specific formulations of medicinal cannabis will provide partial or complete symptom relief of at least one intractable disease..

The aim of this study is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival (DFS) in patients who do not achieve complete pathological response (pCR) as per local assessment according to the IASLC recommendations Who is it for? You may be eligible for this study if you are male or female over 18 years of age, histologically confirmed stage IIB to IIIB non-small cell lung cancer with an absence of EGFR mutation or ALK translocation, and fit enough to receive at least one of the platinum-based chemotherapy regimens. Study details Participants will receive 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery. Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles (experimental arm) or observation (control arm). Durvalumab is given at a fixed dose of 1500 mg intravenous infusion every 4 weeks (±1 week) until relapse or unacceptable toxicity, for a maximum of 12 cycles after surgery. Disease-free survival, time to treatment, time to recurrence, overall survival and Toxicity will be assess every 12 weeks in year 1, every 6 months in year 2 and 3, until relapse.

This study investigates disease behaviour of PSC-UC and treatment resistant aypical UC presenting similar features to PSC-UC yet without confirmed PSC, before and after therapy with OVT, We compared pre-post OVT clinical presentation and endoscopic findings, and corraleted them to pre-post OVT gut and saliva microbiota composition and function. The gut and saliva microbiota will also be compared to healthy controls. We plan for at least 12 months of follow-up, and will observe crucial time points such as relapses and remissions in more details. In our hypothesis, OVT would induce changes in gut microbiota composition and function, leading to different treatment responses in different patinet, based on these changes.

This is a phase 1, open-label, randomised, multi-centre study to evaluate the safety, immunogenicity, pharmacokinetics, and pharmacodynamics of a single administration of GB-hMG in healthy premenopausal females. Thirty eligible, healthy volunteers will be randomised to one of four single doses and receive one (1) subcutaneous (SC) injection of 150 international units (IU), 225 IU, 300 IU, or 450 IU, to evaluate the pharmacokinetics and dose proportionality of GB-hMG. GB-hMG contains follicle stimulating hormone (FSH), luteinizing hormone (LH) and human chorionic gonadotropin (hCG). FSH, hCG and LH are produced by your body as part of your regular hormonal cycles. It is thought that GB-hMG will be able to stimulate the ovaries to increase fertility and ability to produce healthy ova.

The aim of this study is to validate a previously developed machine-learning algorithm for identifying spinal anatomy on ultrasound scanning in patients with BMI >35. We will assess the success-rate of spinal anaesthesia needle insertion using the ultrasound algorithm. Our hypothesis is that the use of ultrasound and the algorithm will improve the first-time success rate of spinal anaesthesia, by making identification of the important landmarks easier for the anaesthetist. This will also reduce complication rates and improve the safety of spinal anaesthesia.

This study aims to determine whether a medication called tirzepatide is effective for weight loss and improving blood glucose levels and metabolic health in people with type 1 diabetes and obesity. This study will also look at the effects of an exercise program on weight loss and changes in the proportion of muscle and body fat seen with tirzepatide, and how continued participation in this exercise program after stopping tirzepatide treatment affects body weight and body composition. We hypothesise that tirzepatide will lead to significant weight loss benefits in comparison to usual care in adults with type 1 diabetes and obesity.

The purpose of this study is to evaluate the safety and tolerability of JNJ-95597528 after single and optional multiple ascending dose administration in healthy participants.

This pilot study aims to reveal the profiles of extracellular vesicles (EVs) in periodontal, peri-implant diseases (refers to diseased groups) before and after treatment follow-up (3, 6 and 12 months). EVs from periodontally healthy and peri-implant health patients (without follow-ups as no need to follow up) will be used as controls. Whole oral samples (saliva, GCF/PICF and plaque) will be used as controls. There are three general aims for this project: Aim 1: Diagnosis and prognosis values of EVs in periodontal disease groups Compare the differences in host and microbial derived EVs and their EV content expressions between periodontally health, periodontitis and periodontitis undergoing treatment over a 1-year observation period Aim 2: Diagnosis and prognosis values of EVs in peri-implant disease groups Compare the differences in host and microbial EVs and their EV content expressions between peri-implant health, peri-implant mucositis and peri-implantitis and peri-implant disease patients undergoing treatment over a 1-year observation period Aim 3: EV profiles after in vitro biofilm culture Examine the microbial EV microbiome and proteome profiles in samples from both healthy and diseased groups following in vitro biofilm culturing It is hypothesised that host and microbial EVs and EV content are differentially expressed in diseased patients compared with healthy or peri-implant health patients, and correlates with the severity of periodontitis or peri-implant disease. Furthermore, it is hypothesised that EVs will be positively correlated with improvements in clinical parameters after periodontal or peri-implant treatment.