ANZCTR search results

The gut and tumour microbiome are known to metabolize drugs through various mechanisms resulting in degradation or modification of the drug's chemical structure which can lead to decreased drug bioavailability and effectiveness. Conversely, certain gut microbiome-derived molecules can enhance the absorption and efficacy of drugs. Ibrutinib is an example of an orally administered cancer drug (typically used to treat breast cancer) with variable pharmacokinetics which contributes to both lack of efficacy and increased toxicity. This study aims to assess how the gut microbiome can influence the pharmacokinetics of Ibrutinib in healthy adult volunteers. Who is it for? You may be eligible for this study if you are a male or female adult aged 18 to 65 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Study details Participants who choose to enrol in this study will firstly undergo a series of physical assessments, including blood tests, to ensure that they are suitable to be included in the study. Participants who are found to be suitable will be asked to stay at the research unit for up to 3 days. Participants will be asked to provide a stool sample prior to being given a single oral dose of Ibrutinib. After receiving the Ibrutinib, participants will then be asked to provide a series of blood samples over the next 2 days, and will also be asked to provide a second stool sample for analysis. At the end of the third day, participants will be allowed to return home but will be asked to contact the study team if they experience any side effects. It is hoped this research will determine any impact that different biological features such as the gut microbiome have on the ability to absorb Ibrutinib (chemotherapy) treatment. These results may then inform the usefulness of Ibrutinib as a treatment for patients with breast cancer.

The gut and tumour microbiome are known to metabolize drugs through various mechanisms resulting in degradation or modification of the drug's chemical structure which can lead to decreased drug bioavailability and effectiveness. Conversely, certain gut microbiome-derived molecules can enhance the absorption and efficacy of drugs. Palbociclib is an example of an orally administered cancer drug (typically used to treat breast cancer) with variable pharmacokinetics which contributes to both lack of efficacy and increased toxicity. This study aims to assess how the gut microbiome can influence the pharmacokinetics of palbociclib in healthy adult volunteers. Who is it for? You may be eligible for this study if you are a female adult aged 18 to 65 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Study details Participants who choose to enrol in this study will firstly undergo a series of physical assessments, including blood tests, to ensure that they are suitable to be included in the study. Participants who are found to be suitable will be asked to stay at the research unit for up to 3 days. Participants will be asked to provide a stool sample prior to being given a single oral dose of palbociclib. After receiving the palbociclib, participants will then be asked to provide a series of blood samples over the next 2 days, and will also be asked to provide a second stool sample for analysis. At the end of the third day, participants will be allowed to return home but will be asked to contact the study team if they experience any side effects. It is hoped this research will determine any impact that different biological features such as the gut microbiome have on the ability to absorb palbociclib (chemotherapy) treatment. These results may then inform the usefulness of palbociclib as a treatment for patients with breast cancer.

This research study aims to investigate and establish the feasibility, clinical accuracy of remotely-performed, robot-assisted abdominal ultrasound examination performed by general sonographers.

This pilot study is assessing the acceptability, appropriateness, and feasibility of a group therapy program for people with stage III melanoma at Melanoma Institute Australia. Who is it for? You may be eligible for this trial if you are aged over 18 years and have a diagnosis of stage III melanoma. Study details: Group therapy has been helpful to people diagnosed with cancer as it can reduce feelings of isolation that are often experienced following a diagnosis of cancer by increasing social connection to people with similar experiences, while also providing people with tools and strategies to help address difficult emotions or thoughts. Thus, Melanoma Institute Australia have created a new group therapy program for people diagnosed with stage III melanoma, and the aim of this study to ensure it is acceptable and appropriate to participants. There will be a total of 8 sessions that occur every two weeks (fortnightly) either in-person at Melanoma Institute Australia or online via a videoconferencing platform (Zoom). Sessions will be two hours in length and will be focused on discussing skills and strategies that may be helpful in coping with difficult situations/emotions associated with a diagnosis of stage III melanoma. Groups will consist of approximately 8 people recently diagnosed with stage III melanoma. Information from this study will be used to design a larger study to test how helpful it is with the aim or implementing MELGROUP therapy into routine clinical practice in the future.

Over 1.2 million Australian patients are at risk of experiencing perioperative hypothermia (heat loss to below 36°C) annually, with a cost of over $1.2 billion to the Australian health care system. Perioperative hypothermia is associated with numerous adverse outcomes including increased wound infection, increased blood loss, longer hospital stays, patient discomfort and poor surgical experience. Prevention involves consistent temperature monitoring and appropriate use of warming strategies throughout surgery. However, in Australia, temperature monitoring during surgery occurs in around 20% of procedures and rates of perioperative hypothermia remain high at approximately 27% of patients. Our trial will evaluate practice recommendations and an implementation strategy for sustainable improvement in perioperative hypothermia prevention in Australian hospitals.

This study aims to investigate the feasibility and effect of administering fibrinogen concentrate in the setting of severe traumatic bleeding in the prehospital setting, This is being done to evaluate the possibility of conducting a prehospital arm of the forthcoming FEISTY II study.

The goal of the study is to compare the antigen rapid test results to the corresponding PCR data for overall sensitivity and specificity. Specimens are collected from patients who have COVID-19 like symptoms. Participants are recruited across all genders and eligible age groups. Study staff records participants' information such as symptoms and time since symptom onset. For each study participant, the specimen for RT-PCR is collected first, then for the antigen rapid test. The same group of participants will be included in three arms of the study, one arm is for obtaining data on the Hough COVID-19 antigen rapid home test kit, another arm is for obtaining data on the Coronavirus (COVID-19) antigen rapid test kits, the comparator arm is to obtain data from the RT-PCR specimens. The sensitivity and specificity of the test kits will be determined in relation to the results of the reference PCR test and the day post onset of symptoms. The peak period for detection of COVID-19 infection will be determined. The SARS-CoV-2 variants in the positive samples will be confirmed by the variant-specific RUO assay and sequencing.

This research project aims to: a) To examine the risks of subsequent health complications (determined by ICD-10AM code) in the 12 months following COVID-19, influenza or RSV infection, compared with a control group (no recent evidence of COVID-19 or influenza infection). b) inform Queensland Health about the potential scale of post-viral impacts arising from COVID-19 or influenza, and any system-wide response that may be required. The Project Team is part of the Office of the Chief health Officer in Queensland Health, which accesses the Notifiable Conditions System. The system houses information on COVID-19, influenza and RSV-positive PCRs.

This study aims to evaluate the safety and tolerability of a single ascending dose of CTX310 in patients with refractory dyslipidemias and to determine the recommended Phase 2 dose.

The purpose of the proposed trial is to test an immersive, virtual reality haptic walking (VRHapticWalk) in combination with spinal transcutaneous electrical stimulation (tES) intervention in an effort to restore touch perception among people with discomplete spinal cord injury (SCI). While recognition of surviving pathways in some individuals with a discomplete SCI has tremendous rehabilitative opportunities, currently no effective interventions exist to promote or restore touch perception among these discomplete SCI. The proposed study offers new, exciting diagnostic and therapeutic avenues in complete SCI practice by capitalizing on identification of cases that are discomplete SCI and initiating for the first time sensory/touch rehabilitation. We hopothesise that after 20 sessions of the VRHapticWalk + spinal transcutenous electrical stimulation touch sensation will be restored. For instance, individuals with a discomplete spinal cord injury will experience sensation when someone touches them.