ANZCTR search results

Study Overview This study aims to evaluate the safety of a 90-minute Obinutuzumab infusion in patients with Chronic Lymphocytic Leukemia (CLL) or Follicular Lymphoma (FL). Eligibility You may qualify for this study if you are 18 years or older, have Chronic Lymphocytic Leukaemia (CLL) or Follicular Lymphoma (FL) and are receiving treatment with Obinutuzumab at Cairns Hospital. Study Details After the first cycle, participants will receive a 90-minute Obinutuzumab infusion on Day 1 of each 21, 28, or 56-day cycle of treatment, continuing until disease progression or unacceptable adverse events occur. Alternatively, patients may choose to continue with the standard 6-hour infusion which is the current standard of care. As part of the study, patients will be closely monitored for infusion reactions will be assessed at each session. Benefits? This study hopes to improve patient's experience getting treatment with Obinutuzumab by reducing the time burden in chair to receive essential treatment.

A study to investigate Small Mobile Stem Cells (SMS) via nebuliser in participants aged 39 to 69 years with chronic obstructive pulmonary disease. The overall goal of studying these cells in humans is to see if they can be used as a drug therapy to cure the lung damage of at least some sufferers of COPD.

The purpose of this study is to test the effectiveness of a new online patient decision-support intervention for adults with hearing difficulties: HearChoice. HearChoice is a tool designed to help people understand what they can do to manage hearing difficulties and choose what option is best for them. HearChoice will help users understand what hearing loss is, why it's important to get help, what options are available to manage it, and how to get help. The goal of HearChoice is to help more people get the best help available for their hearing difficulties.

This study aims to determine the safety, tolerability and pharmacokinetics 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 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.

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 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 18 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 5 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. The device will provide images on the tissue's optical and mechanical properties on a micro-scale. After the surgery, participants will be asked to attend a final study visit where a surgical review and adverse event assessment will be undertaken. It is hoped this research will determine whether use of the ORM-P3-D System is effective at identification of residual cancerous tissue within the breast-conserving surgery (BCS) cavity.

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.