ANZCTR search results

This study is investigating ways to improve treatment of ventricular tachycardia, a potentially malignant heart rhythm disorder, in patients with structural heart disease. Radiofrequency catheter ablation is a recommended approach to treating patients with ventricular tachycardia and structural heart disease, wherein specially engineered wires are passed into the heart where therapeutic lesions can be delivered with heating electrical current. Irrigation fluids, typically 0.9% NaCl saline solution, keeps the catheter cools and reduces risks of blood clots or charring, but also absorbs some of the electrical current that can reduce the the amount of heart tissue treated. An alternative is 0.45% NaCl "half-normal" saline solution, which has been shown to absorb less current, and deliver larger therapeutic lesions. This is a double-blinded, randomised trial to investigate whether using half-normal saline results in better outcomes for patients suffering from ventricular tachycardia.

This is a prospective study with an Umbrella Protocol, where each sub-Protocol investigates a particular condition(s) and challenges to various Vancomycin biosensors and electrode properties. The study will enrol up to 50 healthy participants in the community. The Sub-Protocol described in this registration form is Sub-Protocol #3: Characterization of the Limit of Blank (LoB) for Vancomycin Biosensors on the Nutromics Sensor Device: Optimizing Microneedle Lengths.

RB201 is being developed by Rarefied Biosciences for the treatment of autoimmune diseases. We hypothesize that this new drug, which is being tested for the first time in healthy volunteers, may adjust the body’s immune system in a way that could help reduce the inflammation of autoimmune diseases. This study (RB201-001) is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of escalating single and multiple doses of RB201 in healthy volunteers. This study will be conducted in 2 parts: Single ascending dose and Multiple ascending doses. Up to 88 healthy volunteer subjects total will be entered into the study. RB201 or matching placebo will be administered orally in an observed, inpatient setting to help us learn how the drug behaves in the body, how safe it is, and whether it has any side effects.

In Australia, high-volume private refractive clinics are presented with OHT and OAG patients suitable for iStent technologies; however, most implantation cases occur in glaucoma specialist settings. A published study from a reputable refractive surgical centre in Sydney that demonstrates iStent inject combined with cataract surgery led to improved visual acuity along with intraocular pressure (IOP) or topical IOP-lowering medication reductions in open-angle glaucoma (OAG) eyes with a cataract comorbidity. A similar or improved result with iStent infinite may help drive adoption from other similar clinics in the country. Furthermore, the potential for reducing glaucoma medication burden in patients may also alleviate dry eye disease, thus further improving patients’ quality of life and minimizing out-of-pocket expenses.

Following a heart or lung transplant, medications required to prevent rejection increase the risk of developing post-transplant diabetes mellitus. In many individuals, insulin treatment is required to maintain normal glucose levels and prevent diabetes related complications. Insulin treatment is complex and requires self-monitoring of blood glucose levels using fingerprick testing to avoid prolonged periods of high or low glucose levels. This study aims to determine if continuous glucose monitoring increases the amount of time blood glucose levels are maintained within the normal range compared to standard fingerprick glucose testing.

The ACT for ICE project uses an Acceptance and Commitment Therapy based intervention called the Recovery and Support Program (RaSP) to support women with a diagnosis of methamphetamine use disorder. The purpose of this study is to look at how well the RaSP program works in alcohol and drug treatment. This will include looking at how many people participate, their scores on some questionnaires, what they liked and did not like about the program, whether they can think more flexibly after completing the program and whether they are using less methamphetamine.

ACTIVE KNEECAPs! aims to identify effective and cost-effective interventions for adolescents with kneecap pain. This multicentre randomised controlled trial will investigate whether foot orthoses (shoe inserts) or a targeted physiotherapy program, when combined with advice, are more effective at reducing kneecap pain at 6 weeks, 3 months, 6 months and 9 months than advice alone. We hypothesise that foot orthoses or targeted physiotherapy, combined with advice, will result in greater improvement in kneecap pain than advice alone. Secondary aims are to investigate whether foot orthoses or targeted physiotherapy are more effective at improving function, quality of life, physical activity and pain medication use at 6 weeks, 3 months, 6 months and 9 months, and determine which intervention is more cost-effective.

As the population ages, aortic stenosis (AS, a heart valve disease involving degeneration and obstruction of the aortic valve) is becoming an increasing problem. This condition is often unrecognized until patients present in a crisis. The goal of the ASSURE-ECHO study is to identify the feasibility and value of AI-guided and-interpreted echocardiography for screening for aortic stenosis in the community. The aims of the project are to confirm the feasibility of AI-guided echo acquisition and interpretation in rural and remote communities, and to show greater recognition of AS than through usual care.

Operation Glucose is a clinical trial exploring whether continuous glucose monitors (CGMs) can improve diabetes management in hospitalised patients with insulin-requiring type 2 diabetes who are undergoing surgery. People with diabetes face a higher risk of complications during the surgical period, often due to fluctuations in blood glucose levels. This study aims to assess whether CGMs can help reduce these fluctuations (known as glycaemic variability), to support better blood glucose control and improved clinical outcomes. Participants will be randomly assigned to one of two groups. One group will wear a CGM device (Libre 2 Plus) that displays real-time glucose data to both the patient and the clinical team. This data, alongside regular finger-prick testing, will be used to guide treatment. The other group will wear a blinded CGM device (Libre ProIQ) which does not display glucose data. This group will rely on standard finger-prick testing alone for treatment decisions. The primary outcome will be the percentage of time that a patient's blood glucose levels remain within the healthy target range (4.0 - 10.0 mmol/L).

This is a Phase 1, four-part clinical trial in healthy adult participants to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SPT-320, an investigational oral prodrug of agomelatine. Part B evaluates single ascending doses of SPT-320 compared with placebo. Part D studies multiple ascending doses of SPT-320 given once daily for 7 days, compared with placebo.