ANZCTR search results

This is A double-blind, placebo-controlled, First-in-Human Study study to assess the safety ofZE50-0134, and how this drug acts in the body in healthy volunteers. ZE50-0134 may be indicated for use in patients with chronic lymphocytic leukaemia (CLL), but a trial of the drug in healthy volunteers is needed before trials in cancer patients can proceed. 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. People who have been diagnosed with cancer will not be eligible for this study. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single dose of ZE50-0134 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. If the drug appears safe, additional participants will be assigned by chance to receive a larger single dose of ZE50-0134 or placebo, followed by blood and urine testing. This will continue until a maximum safe dose is determined. It is hoped this research will determine the maximum dose of ZE50-0134 that can be administered safely without causing severe reactions. Once the dose of ZE50-0134 has been determined in healthy volunteers, a trial investigating the efficacy of ZE50-0134 as a treatment for patients with CLL may proceed.

Respiratory disease is the most common reason for admission to a NICU. Unfortunately, our understanding of how many respiratory therapies used in the NICU help babies lungs is poor. Broadly, we will create a large registry of lung function data during common NICU respiratory events and diseases. By doing so we will be able to address some of the uncertainties in clinical care for babies born with respiratory failure, specifically how best to determine optimal levels of respiratory support and how to guide common respiratory interventions such as extubation and surfactant therapy. We hypothesise that by generating a greater understanding of the relationship between a baby's lung disease and NICU respiratory care we will provide the tools to allow clinicians to improve respiratory care.

This is a substudy of the PRECISION-ITS trial. This study involves developing and evaluating a pharmacogenomics education/implementation program for pharmacists in Australia, The program will be developed by a multidisciplinary working group consisting of healthcare professionals, consumers and patients/carers with lived experience. Surveys assessing the knowledge, attitudes, perceptions and acceptability of pharmacogenomics amongst consumers and healthcare professionals in the adult and paediatric oncology setting will be used to inform the program's design. Who is it for? .You may be eligible to complete the survey(s) if you have received or cared for an adult or child who received treatment for cancer in Australia and are aged 15 years or above; or are a healthcare professional working in adult or paediatric oncology within Australia. Study details The program will be delivered to pharmacists at sites participating in the primary PRECISION-ITS trial. You may be eligible to participate in the program if you are a pharmacist at a regional Victorian hospital that is participating in the primary PRECISION-ITS trial. The program will focus on pharmacogenomics in adults receiving systemic anticancer therapies and implementing a pharmacogenomics service at participating sites in regional Victoria. The program will be evaluated by implementation science frameworks and participant end-user surveys. It is hoped that this research project will: address pharmacists' education needs in pharmacogenomics and establish a framework for wider implementation to other healthcare professionals and craft groups. It is hoped that this program will also facilitate pharmacogenomics knowledge translation into clinical practice, providing opportunities for rapid pharmacogenomics workforce capacity building, scalability and community acceptance beyond the trial.

This is a pre-market, prospective, single-site, open-label, within-subject, non-randomised interventional study of acceptance of the CP1175 and CP1110 Sound Processors through use with adult cochlear implant recipients in real world scenarios. The investigational medical devices include an off-the-ear sound processor, a behind-the-ear sound processor, used in conjunction with investigational versions of fitting software, the Nucleus Smart App and a software measuring postoperative implant function. The objectives of the investigation are to collect device and procedure-related deficiencies to optimise clinical care for recipients of the investigational CI1000 Series cochlear implants.

The aim of the present study is to investigate the effects of Brain and Body protein powder on sleep quality and other health-related outcomes—including cognition, mood, brain activity and biochemical parameters— in ageing adults 55-to-75 years of age. The Brain and Body protein powder may have the potential to affect benefits in the outcomes noted. This will be an 8-day randomised, double-blind placebo-controlled trial where 40 participants will be recruited. The trial will consist of two arms: 1) Dairy-based protein powder (Brain & Body Protein Powder) and 2) Rice starch placebo control.

This is a first-in-human, single-centre, randomised, double blind, ascending single dose study to assess the safety and tolerability of AP13 and how this drug acts in the body in healthy volunteers. AP13 may be indicated for use in patients with pulmonary hypertension, but a trial of the drug in healthy volunteers is needed before trials in patients with pulmonary hypertension can proceed. 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 either a single dose of AP13 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. The data generated in this study will inform the design of future clinical studies and to select the dose(s) for future studies in patients with pulmonary hypertension.

This study aims to assess the safety and tolerability of a new tumour imaging agent in patients with locally advanced or metastatic melanoma. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older and have been diagnosed with locally advanced or metastatic melanoma. All potential participants will be reviewed by the study investigators to ensure that they meet additional health criteria before enrolment. Study details All participants who choose to consent in this study will undergo a screening visit to assess their eligibility. An 18F-FDG-PET and CT scans will be required for assessing participant eligibility, however if these scans were performed as part of standard of care prior to the date of consent but are within 28 days of the Day 1, they may not need to be repeated. Each participant's circumstances will be assessed by a study investigator and participants will be advised if scans need to be repeated. If eligible, participants will receive a single dose of 68Ga-A9T-3202 via intravenous injection, and then undergo 4 whole body PET-CT scans at set timepoints on the day of administration. Participants will then complete an End of Observation visit (one day post IP administration) to check participant safety and tolerability of 68Ga-A9T-3202. It is hoped this research will demonstrate that 68Ga-A9T-3202 is safe and well tolerated by patients with metastatic melanoma, and provide more accurate staging and treatment response evaluation when compared to the current standard of care PET/CT imaging.

The aim of this study is to examine whether intensive telehealth dietetic counselling, education, proactive medication management of nutrition impact symptoms, oral nutrition support +/- supplemental ('top-up') tube feeding into the small bowel will enhance quality of life for people with borderline resectable and inoperable pancreatic cancer having palliative chemotherapy, compared with usual care. Who is it for? Participants may be eligible to join this study if they are aged 18 years or above and have a new primary diagnosis of borderline resectable or inoperable pancreatic cancer. Participants will be randomised (allocated by chance) to one of two groups: usual care or intensive dietetics intervention (counselling, education, symptom management, oral nutrition support, +/- jejunal tube feeding if participant chooses) delivered via telehealth. For those randomised to intervention group, participants will receive the active intervention for 6-months, commencing as soon as possible after diagnosis. Personalised nutrition support/advice will be provided. Outcomes will be measured at baseline and at follow up at 3 and 6 months. It is hypothesised that this study will demonstrate effectiveness of early and frequent dietetic intervention and supplemental jejunal feeding (when required), in enhancing quality of life.

This is a combined drug treatment arm within the ALLG AMLM26 INTERCEPT trial platform, which is registered on ANZCTR with ID ACTRN12621000439842. The combination of gilteritinib and venetoclax will be evaluated for its activity in a population of participants with progressive acute myeloid leukemia (AML). Who is it for? You may be eligible for to receive this treatment if you are a part of the AMLM26 Intercept trial which is registered on ANZCTR with ID ACTRN12621000439842 (ie if you are aged 18 or older, you have been diagnosed with progressive acute myeloid leukemia, and are currently in your first or second morphologic remission with a known and trackable minimal residual disease (MRD) marker.). If you are on the AMLM26 Intercept trial you may be eligible for this treatment option if your disease is worsening. The trial management committee will review your disease characteristics and determine your best treatment option(s) available on the trial. Study details: The trial will commence with a safety run to determine the optimal dosing. Gilteritinib is given orally with or without food. Venetoclax is given orally after food. Venetoclax dose ramp-up is required only for patients commencing therapy with bone marrow blasts of greater than or equal to 5%. Each cycle will be 28-days in length Participants will undergo a disease assessment at screening after cycle 1, cycle 2, cycle 3, cycle 6 and then 2 monthly until progression. This will require blood tests and bone marrow biopsies. Safety and tolerability of treatment will be assessed throughout the trial whilst you are receiving treatment. Health related quality of life during treatment will be assessed on the first treatment day of 3 consecutive cycles. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that Gilteritinib and Venetoclax will be well tolerated and may improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

The headset has in-built sensors that are able to track the movements of surgeons. There are specific patterns of movement that are associated with increased expertise. It is based on these specific patterns of movement that we aim to utilise to objectively assess surgeons. The project will involve surgical registrars and consultants performing operations as they normally would whilst wearing the motion-tracking headset. A transition to the operating theatre will allow us to further identify whether this headset can be used in a clinical environment and continue to provide objective assessment data. We aim to video tape the procedures to allow for further post-hoc analysis of the footage. We hope to use a headset that can tell us how efficiently a surgeon performs an operation to allow us to improve how we assess surgeons. We aim to use this technology to improve the surgical educational landscape by creating an objective method of assessing surgeons.