ANZCTR search results

This is a double-blind, placebo-controlled, First-In-Human Study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZE74-0282 in Healthy Volunteers. Who is it for? You may be eligible for this study if you are aged between 18 to 55 years old and are in good general health without a clinically signifcant medical history. Study details The study will be conducted as a single ascending dose (SAD) study, which will enrol groups of 8 healthy participants at a time to receive a single dose of the study drug. Participants will be divided in up to 5 groups, with each subsequent group receiving a higher dose than the previous one. The study drug is either ZE74-0282 or matching placebo which will be administered only once under fasting or fed conditions with a cup of water. The dose will be increased as we move from Cohort 1 to Cohort 5. Participants will be enrolled in the next dose cohort only after ensuring the previous dose level was safe and well tolerated. The total maximum study duration for participants is 37 days, inclusive of screening and visit windows. It is hoped this research will determine the maximum dose of ZE74-0282 that can be administered safely without causing severe reactions. Once the dose of ZE74-0282 has been determined in healthy volunteers, a trial investigating the efficacy of ZE74-0282 as a treatment for patients with Myeloproliferative neoplasms (MPNs) may proceed.

The aim of this study is to determine whether the provision of sunscreen pump packs with personalised prescription labels, toothpaste tubes, and personally labelled containers to store toothpaste and sunscreen together, in combination with written, illustrated information about facial sun protection, will improve adherence with daily sunscreen application for patients with a high risk of developing skin cancers over 3 months. Who is it for? You may be eligible for this study if you are an adult patient who has had a history of at least histologically confirmed 2 skin cancers (melanoma, basal cell carcinoma, squamous cell carcinoma, squamous cell carcinoma in situ) within the past 5 years. Study details Participants will be randomly allocated to either a control or intervention arm. Participants in the intervention arm will receive sunscreen and a personalised prescription label attached. Participants in the intervention arm will also receive toothpaste and a personalised prescription-labelled plastic container to hold the sunscreen and toothpaste together. The intervention group will also receive verbal and colour-illustrated written information advising daily use of facial sunscreen each morning after toothbrushing. Participants in the control group will receive identical sunscreen only (without a prescription label) and verbal information to apply sunscreen to their face every morning after toothbrushing. It is hoped that the findings from this study will show that linking sunscreen application on the face with an established morning habit (brushing teeth),and emphasising the medical need for facial sunscreen in this high risk group, will enhance adherence and facilitate habit formation within three months.

The purpose of this study is to evaluate the efficacy, safety, and PK of atumelnant in participants with ADCS. This study will consist of 3 parts: Part A, Part B (not described in this registration), and Part C (not described in this registration). Part A has 4 groups: -Part A Arm 1: Open-label part: All participants will receive atumelnant by mouth for up to 12 weeks with oral GC therapy as needed. - Part A Arms 2, 3 and 4: Double-blind, randomized, placebo-controlled part: Participants receive study drug (atumelnant or placebo) by mouth in a 1:1:1 ratio. Whether a participant receives atumelnant or placebo will be determined by chance (like drawing straws). A placebo looks like medication but contains no active ingredient. All participants also receive steroid medication or steroid placebo. After participation in Part A of the study, participants might be able to stay in the study in Part C (open-label extension where all participants will receive atumelnant and steroid replacement therapy) if, in the Investigator’s opinion, they would benefit from it.

Coronary artery disease (CAD) accounts for 50% of all heart disease cases and 9.2% of all deaths in Australia. Supplementation with omega-3 fatty acids from fish oil shows promise for reducing adverse cardiovascular events. However, current guidelines for omega-3 supplementation vary in their recommended doses, and the optimal dose for better cardiovascular outcomes remains unclear in the literature. In this study, participants will undergo a 12-week period of individualised dose of supplementation with either a placebo or omega-3 fatty acids (fish oil) to determine whether this strategy improves vascular health. Outcome measures will be assessed at baseline, mid-intervention and after completion of the interventions.

Rationale: Coronary angiography is the gold standard test for identifying the presence of significant coronary artery disease, however the procedure is invasive and has risks which drive anxiety, pain and discomfort for patients. Many operators routinely use conscious sedation during invasive procedures including coronary angiography and device insertions, to help mitigate these symptoms. Important risks associated with these pharmacological agents, including respiratory depression, nausea and vomiting, hypotension, paradoxical agitation and post- procedural delirium. In light of these, options for non- pharmacological methods of anxiolysis are increasingly being considered as an adjunct to current practice. Music in the catheter laboratory can be used to create a more relaxed clinical environment, which in turn can help to put the patient at ease. This study aims to investigate whether playing music in the catheter laboratory can reduce patient anxiety and improve the overall patient experience The objective of this study is to determine whether and how the use of music in the catheter laboratory influences the patient experience. The study design is a prospective randomised controlled trial. The study population consists of participants undergoing best practice coronary angiography, percutaneous intervention or device insertion at Gosford Hospital, John Hunter Hospital, Coff’s Harbour Hospital, Port Macquarie Base Hospital, Tamworth Hospital and Dubbo Base Hospital who consent to become enrolled in the trial. The main study endpoints include the primary outcome of self-reported anxiety levels, as measured by the STAIS-5 (Short-Form State-Trait Anxiety Inventory). Secondary outcomes include patient reported pain, adverse outcomes (MACE: Major Adverse Cardiac Events), dosages of sedative medications required, radial artery spasm, haemodynamic data, operator anxiety, complications.

This pilot study aims to leverage the novel imaging capabilities available at the Australian National Total Body PET Facility to identify peripheral nerve amyloidosis in populations with amyloidosis due to either AL or ATTR with the typical length dependent neuropathy, proximal nerve involvement, small and autonomic neuropathy alone and in populations of ATTRwt with neuropathy not explained by alternate causes. We will evaluate for differences in uptake which could differentiate patients with AL versus ATTR amyloidosis and assess for direct nerve infiltration in ATTRwt. We will evaluate Florbetaben uptake in organs and compare this to routine organ screening investigations, and will aim to quantify previously difficult to identify muscle and tenosynovial uptake. Finally, we will explore the feasibility of generating a global amyloid burden score to provide a quantitative measure of whole-body amyloid load, which would have potential to be used in future clinical trials of amyloid depleters.

The primary purpose of this study is to evaluate the safety, pharmacokinetics, and anti-tumour activity of TLN-372 in combination with cobicistat, in patients with advanced KRAS mutant solid tumours. Who is it for? You may be eligible for this study if you are male or female, at least 18 years of age, have measurable locally advanced or metastatic KRAS mutant solid tumours at study entry, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate organ function. Study details All eligible participants will receive TLN-372 in combination with cobicistat. Patients will be monitored with clinical visits, blood tests, and radiology images. It is hoped that the result of this study will show if TLN-372 is safe when taken with a helper medication, cobicistat, show if cobicistat interacts with TLN-372 and understand the effects of this interaction on the body, understand how the body absorbs, distributes, breaks down, and gets rid of TLN-372 when given with cobicistat, and show if TLN-372 has the possibility of helping treat patients with advanced solid tumours with a KRAS mutation. This research will hopefully help further the development of TLN-372 to improve the treatment for patients with KRAS mutant cancers.

A phase 1, single centre, Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of Orally Administered BT-409 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of BT-409 in Adults with Parkinson’s disease. Study population: Male and female adults with diagnosis of Parkinson’s disease aged 50 to 80 years of age (inclusive) at the time of screening. Study design: This is a double-blind, randomised, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics (PK) of BT-409. The study will be conducted in 3 parts with 1 part on Adult's with Parkinson's Disease: • Part C: a single cohort with 1 dose level in adults diagnosed with Parkinson's Disease

This study will test whether a supervised high-intensity strength training program is safe, practical, and acceptable for people living with mild-to-moderate Parkinson’s disease. Participants will complete a structured gym-based strength training program over approximately 8 weeks, with testing before and after the program. The study will monitor safety (including any adverse events), recruitment and attendance, and changes in physical function, mobility, balance, strength, brain health and quality of life. Some participants and trainers will also be interviewed about their experience. We hypothesise that high-intensity strength training will be safe and feasible to deliver in this population, and may lead to improvements in strength and physical function.

The project consists of a randomised controlled pilot trial to assess whether identification and treatment of obstructive sleep apnea (OSA) in patients with nocturnal hypertension using a previously-validated, general practice-based OSA care model, is: (1) feasible, acceptable and sustainable to patients and general practice staff; (2) clinically effective in improving patient outcomes, including nocturnal hypertension (primary outcome), OSA symptoms, mood and quality of life; and (3) associated with significant reductions in healthcare costs.