ANZCTR search results

This study aims to determine the safety, tolerability, pharmacokinetics, preliminary efficacy, and maximum tolerated dose (MTD) of intralesional FLD-103 when administered to subjects with Basal Cell Carcinoma. Who is it for? You may be eligible to join this study if you are a male or female aged 18 to 85 years old and have at least a single histologically confirmed nBCC suitable for treatment. A nBCC previously biopsied outside the study as part of standard clinical practice may be re-biopsied within the study, provided that approximately less than 25 percent of the area of the nodular lesion is removed as a result of the second biopsy. Study details All participants who meet the eligibility criteria in this study will receive either a single dose of FLD-103 or multiple doses of FLD-103 once weekly for four (4) weeks. FLD-103 is comprised of two (2) components, FSD147L and PMO-Gli1 formulated as an intralesional injection. During and after completion of the treatment participants will be assessed for safety and tolerability of FLD-103, plasma PK and tumor response. It is hoped the research in the Dose Escalation Phase (Part 1) will determine the maximum dose of FLD-103 that can be administered safely without causing severe reactions. Once Part 1 is completed, Part 2 will then evaluate one or more dose level(s) deemed to be safe and well tolerated, based on the data from the Part 1 of the study. A sentinel subject will be required in each Single Ascending Dose Cohort. . Once all subjects of a Cohort have been dosed, all available safety and tolerability data, from evaluable subjects will be reviewed. Updated due to protocol amendment. Update made after enrollment of 13 participants

In this project, we will be exploring the safety, tolerability and Pharmacokinetics of Tizanidine, comparing the oral capsule with a transdermal patch. Oral Tizanidine is currently approved for use for the management of spasticity in the United States, it is not approved for use in Australia by the Australian TGA. Oral Tizanidine is a short-acting muscle relaxant and is rapidly metabolised by the liver requiring daily dosing. The sponsor company has developed a transdermal patch to deliver Tizanidine in an attempt to improve patient compliance and reduce side effects of the medication. Who is it for? You may be eligible for this study if you are aged 18 to 55 years and are in good general health without a clinically significant medical history. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive 2 of the 3 treatments in a fixed sequence (reference regimen for 2 days in Period 1 then 1 of 2 test regimens for 3 days in Period 2). All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. It is hoped this research will determine that doses of MRX-4TZT can be administered continuously and consistently via a transdermal patch safely without causing severe reactions.

Researchers at the Australian Stuttering Research Centre have developed an online anxiety treatment program—iBroadway—for adolescents who stutter. The purpose of this research is to assess the effectiveness and safety of the iBroadway Program as well as evaluate compliance rates. The iBroadway Program has the potential to overcome problems of access to treatment for many adolescents who stutter.

The research project is testing a new imaging device for use during breast conserving surgery, involving the use of a medical device called ORM-P3-D System. The purpose of this study is to find out the diagnostic accuracy and safety of the ORM-P3-D System during breast conserving surgery for patients with breast cancer. Who is it for? You may be eligible for this study if you are a woman aged 22 years or older, you have been diagnosed with invasive or in situ breast cancer and you are eligible to undergo breast conserving surgery as part of your cancer treatment. Study details All participants who choose to enrol in this study will be asked to attend 3-4 study visits scheduled over a 6 month period. The first visit will be a screening visit to determine whether you are eligible to enrol in the study. Those participants who are eligible to enrol will continue with their standard cancer care and will be scheduled for a breast conserving surgery. The surgery will be undertaken per standard protocols, with the addition of the ORM-P3-D medical device. During the surgery, the surgeon will use the device to scan the breast tissue and take additional tissue if indicated by the device. After the surgery, participants will be asked to attend a final study visit where a surgical review and adverse event assessment will be undertaken.

The effects of an acute curcumin supplementation on team sport athletes performance and recovery. The study involves team sport athletes, aged 18-35. This is a randiomised, double-blinded, cross-over study where participants will consume either a curcumin supplement or a placebo at a time, without knowing which one they were given. They will be tested on their athletic performance and recovery over five sessions, with a break between the supplements to ensure any effects of the supplements have worn off. The study will measure performance through a battery of field tests and recovery through blood sample collection and questionnaires. The hypothesis of this study an acute dose of curcumin supplementation will reduce the detriment in exercise performance post-fatiguing exercise. Additionally, muscle damage markers and inflammation will be reduced, and the participants’ perceived recovery will be improved.

The aims of this study are: 1. To determine the feasibility (acceptability and fidelity) of implementing the physiotherapy guideline in patients with pneumonia, incorporating a set dosage of ventilator hyperinflation (VHI) treatment, with target volume determined for each patient according to their estimated inspiratory reserve volume, based on height as per Jacob et al (2021). 2. To explore pneumonia phenotypes which demonstrate treatable traits that are amenable to respiratory physiotherapy intervention commenced during the acute period of invasive mechanical ventilation. 3. To determine the effect of a course of VHI treatment method], at a set dosage and frequency of three times daily for the duration of the period that patients are on the mechanical ventilator on symptomatology and patient-centred outcomes. 4. To determine the cost-effectiveness of physiotherapy guideline care incorporating a course of new VHI treatment for pneumonia requiring invasive ventilation in ICU. It is hypothesised that best practice physiotherapy guideline care, with incorporation of protocolised VHI treatment is safe, feasible and effective in improving patient-important outcomes for critically ill adults requiring invasive mechanical ventilation for pneumonia.

BHV-1300 is being developed by Biohaven Therapeutics Limited for the potential treatment of immune-mediated diseases. This is a single center, Phase 1, randomized, open-label, placebo controlled, single and multiple dose study in healthy adults. This study will include single and multiple dose cohorts to evaluate the safety and tolerability of BHV-1300 and to characterize the pharmacokinetic profile of BHV-1300.

The purpose of this study was to understand how accurately surgical ward round patient case notes are. This was achieved by comparing audio-visual recordings of the ward round, to patient case notes. The hypothesis of this study is that ward round case notes are accurate and capture what is discussed in the ward round.

The study is designed to identify patients from different hospital departments who have been admitted to the Transplant unit, the ICU and/or Outpatients Department, suspected of having a Blood Stream Infection (BSI) and/or an invasive fungal infection. Clinical assessment of patients eligible to be enrolled in this study will be conducted by the department physicians. Study subjects will have blood samples collected for blood culture (standard of care/SOC), as well as an additional blood EDTA tube, and/or bronchiolar lavage and/or sputum samples collected at the same time. These samples will be processed using the Microbio InfectID assay in an experienced diagnostic laboratory. Diagnostic accuracy will be calculated with respect to the SOC blood culture and other culture-based test results.

We are conducting a pilot study to see how well a cardiac rehabilitation program helps patients recover after open heart surgery. We will use the Duke Activity Status Index (DASI) tool to measure how much the program improves your ability to perform daily activities. This study aims to gather early information to understand how cardiac rehabilitation might help patients get better after their surgery. We are also interested in learning about the recovery of patients who choose not to participate in a cardiac rehabilitation program. This will help us compare the outcomes of those who do and do not participate in the rehabilitation program.