ANZCTR search results

This study will examine how small blood vessels in the skin and larger arteries in the arm, leg, and neck function in healthy younger and older adults. Using non-invasive imaging techniques (ultrasound and optical coherence tomography [OCT]), we will measure how these blood vessels dilate and increase blood flow during simple procedures, including blood pressure cuff inflation, gentle skin heating, inhalation of low concentrations of carbon dioxide, and administration of a standard cardiac medication, glyceryl trinitrate, sublingually. We aim to determine how the responses of small and large blood vessels are related and whether age, sex, and fitness level influence these responses. We hypothesise that simple assessments of skin microvascular function may reflect the health of deeper arteries that are more difficult to evaluate directly. This information may help inform the development of simpler methods to detect early vascular dysfunction and future cardiovascular disease risk before clinical symptoms arise.

Spinal cord injuries result in impaired function of the respiratory system, swallowing and trunk control. For people with a spinal cord injury restoration of breathing and coughing ranks highest of all functional recovery targets, closely followed by improved trunk control. Respiratory muscles may be the link between these three functional impairments. Exercise training is the main treatment for improving function after the acute period of a spinal cord injury. Thus, the aim of this study is to explore the efficacy and acceptability of different combinations of respiratory muscle exercise training for people with a chronic spinal cord injury. The study will be a community-based adaptive Bayesian Optimal Phase (BOP) II trial design. A BOP trial design allows for early analysis, identifying and ceasing trial arms that prove to be futile to continue. We hypothesise participants with a SCI will improve in their swallow, seated balance and breathing outcome measures, to reach the pre-determined signal of benefit, to identify a viable treatment option.

Syphilis is a sexually transmitted infection that can be present without causing any symptoms and can pass from a pregnant woman to her baby and make the baby very unwell. The number of syphilis cases in women of childbearing age and who are pregnant is increasing in Australia and the key to stopping its spread is to diagnose and treat it as quickly as possible. This study will look at whether using a rapid test for syphilis in an emergency department, that can be done from a few drops of blood at the bedside, can improve testing and treating for women who are pregnant or who are of childbearing age. The study will also try to understand the opinions of the participants as well as the doctors and nurses as to how they found the process of using the point of care tests.

This is a first in human, single center, randomised, double blind, single and multiple ascending dose study to assess the safety and tolerability of TL-003 and how this drugs acts in the body in healthy volunteers. TL-003 may be indicated for use in patients with Ulcerative Colitis, but a trial of the drug in healthy volunteers is needed before trials in patients with Ulcerative Colitis can proceed. Who is this study for? You may be eligible for this study if you are aged 18 to 55 years and are in good general health without clinically significant medical history. Study details: All healthy volunteer participants who choose to enroll in this study will be assigned by chance to receive either a single or multiple ascending doses of TL-003 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc) and will provide blood and urine samples for testing.

---Why are we doing this research?--- This study aims to find out whether a digital physical activity program can help reduce fatigue and improve wellbeing in colorectcal cancer (CRC) survivors. The program (I-FIT) delivers personalised activity prompts on a smartphone, and uses a wrist-worn activity monitor to support day-to-day exercise. ---Who is it for?--- You may be eligible if you are 18 years or older, have a history of colorectal cancer and have completed treatment, and are able to take part in light-to-moderate physical activity. People with medical reasons that make exercise unsafe will not be able to join. ---Study details--- Participants will be randomly allocated by chance (similar to flipping a coin) to one of two groups. One group will receive usual care. The other group will use the I-FIT digital program for 12 weeks, which includes short smartphone prompts to help build regular physical activity, and guidance and wearing a wrist activity monitor to track daily movement. All participants will complete online questionnaires and brief functional assessments at baseline, week 6, week 12 (end of program), and 4-week follow-up (week 16). Questionnaires ask about fatigue, quality of life, physical activity and sedentary time. The activity monitor will record movement and sleep patterns to help us understand daily activity. We will also ask participants in the I-FIT group about their experience using the app and device (e.g., ease of use and acceptability). It is hoped that this research will provide new information about the feasibility, acceptability and early effectiveness of a digital physical activity program to help manage and improve fatigue in colorectal cancer survivors.

Flow-mediated dilation is a non-invasive procedure that can determine whether blood vessels have dysfunction. Normally, this technique involves preventing/occluding blood flow from the lower arm to the hand for a period of 5 minutes, then using ultrasound to determine how well the brachial (arm) artery relaxes after blood flow resumes. However, this method was established in non-pregnant participants and has been translated in pregnancy without confirming how long the occlusion period needs to be. Therefore, participants will have flow-mediated dilation performed on their brachial artery two times; once after a 3 minute occlusion and once after a 5 minute occlusion. Additionally, an ophthalmic artery Doppler will also be performed. This will occur over a ~2 hour period on the same day.

This multi-site Phase I/Ib open-label study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ACS2015, a non-viral gene-modified CAR-T cell therapy, in adults with advanced solid tumors expressing EPHB4. Who is it for? You may be eligible to join this study if you are aged 18 to 70 years and have a histologically confirmed advanced solid tumor (such as colorectal cancer, hepatocellular carcinoma, or bone/soft tissue sarcoma) where at least 1% of tumor cells are positive for EPHB4. Additional eligibility criteria include good performance status (ECOG 0–1), suitable venous access, and measurable disease. Study details: The study will be conducted in two parts: • Phase I (Dose Escalation): Up to 36 participants (12 per tumor type) will receive ACS2015 at increasing dose levels using a staggered 3+3 design to determine the maximum tolerated dose (MTD). • Phase Ib (Dose Expansion): Up to 12 additional participants (4 per tumor type) will receive ACS2015 at the highest safe dose identified. Participants will first undergo pre-screening to confirm EPHB4 expression using tumor tissue. If eligible, they will proceed to screening and apheresis to collect peripheral blood mononuclear cells (PBMCs), which will be used to manufacture ACS2015. After lymphodepletion over 3 days, ACS2015 will be administered as a single infusion on Day It is hoped that this research will provide a new treatment option for patients with advanced solid tumors who have limited therapeutic alternatives, by targeting EPHB4 with a novel CAR-T cell therapy designed to reduce immune exhaustion and improve durability compared to conventional approaches.

This single-arm pilot feasibility study will evaluate the OA Champions Peer Mentorship Program for people with knee osteoarthritis. The program offers up to six one-to-one sessions between a trained Mentor and matched Mentee, delivered over a 12-week period. The overarching aim is to assess feasibility, acceptability and satisfaction, participant feedback, and preliminary clinical outcomes, as reported by both Mentors and Mentees.

A recent trial (ACTRN12622000113752) with 89 participants demonstrated the efficacy and safety of an online group-based therapy for people with chronic pain, Pain and Emotion Therapy plus TAU (PaET plus TAU). Results showed significant improvements in emotion dysregulation and provided preliminary evidence for a significant reduction in pain severity, depression, anxiety, stress, sleep problems and improved wellbeing (Norman-Nott et al., 2025). The aim of the current randomised controlled trial is to evaluate the efficacy of Pain and Emotion Therapy+ plus TAU, with an additional module on pain and movement education added to the program to reduce pain severity. Secondary aims include evaluating the effects on pain disability, emotion dysregulation, depressive symptoms, anxiety symptoms, sleep quality, level of physical activity, resilience, post-traumatic stress disorder symptoms, suicide cognitions and quality of life.

This project explores new, more accessible ways for people in rural areas to complete a standard heart health check. The feasibility of two new modes of delivery will be evaluated. The at home mode of delivery enables participants to self-administer a heart health check using a returnable kit. The local pharmacy mode of delivery enables participants to receive a hearth health check at their local pharmacy facilitated by the pharmacist using the same kit. Heart Health Check assessments are communicated to participants by post, and optionally by phone. The assessment advice received recommends participants who are evaluated as intermediate and high risk follow up with a GP and bring the assessment letter to their visit. The two new modes of Heart Health Check Delivery are referred to as models of care in the study protocol below. Participants who are not selected onto the Heart Health Check Study Population will be put on to a Heart Health Check Waitlist.