ANZCTR search results

The aim of this trial is to assess the effectiveness of tailored, multicomponent educational interventions on improving evidence-based, guideline-concordant secondary stroke prevention care provided by Australian general practitioners. We hypothesise that participation in tailored, multicomponent education on secondary stroke prevention will lead to improved guideline-concordant care provided to patients with stroke and/or TIA in general practice compared with control.

This study looks at two proteins in the blood — GFAP and UCH-L1 — that are released when the brain is injured. We will measure these proteins in trauma patients admitted to intensive care, using two blood samples (one on admission and one 24 hours after injury), and compare the levels between patients with and without a traumatic brain injury. We will then see how well these blood markers predict patients' recovery six months later and compare our results against international standards to check whether the tests are reliable enough for everyday hospital use. We hypothesise that higher blood levels of GFAP and UCH-L1 are associated with the presence of traumatic brain injury and with poorer recovery at six months.

Hypertension remains a major risk factor for heart disease which is amendable to lifestyle medicine through optimisation of nutrition, exercise, sleep, stress, social connection and minimising harmful substances. Digital health programs are growing in popularity as useful tools to facilitate healthy behavioural changes, but formal evaluations of their therapeutic benefits are scarce. This pilot study aims to assess how this digital health anti-hypertension program (Lyfy) facilitates healthy diet and physical activity in patients with high blood pressure in Australian general practice settings. Our hypothesis is that implementing this digital health program is both feasible and acceptable; It will also improve the blood pressure and healthy behavioural changes of the participants.

Brief description of the study purpose This study aims to evaluate the effectiveness and cost effectiveness of acupuncture in managing symptom clusters among breast cancer survivors, compared to usual care. Who is it for? You may be eligible for this study if you are a female aged 18 and older, diagnosed with breast cancer (excluding DCIS) who are experiencing multiple moderate symptoms (score >=4/10 for at least two symptoms such as hot flushes, pain, or memory concerns) and have completed active cancer treatment (with no additional active cancer treatment planned for the next 3 months). Study details Participants who are eligible will be randomly assigned to receive either acupuncture or usual care. The acupuncture group will receive eight 40 minute sessions over 8 weeks, delivered face to face by registered practitioners using single-use needles, followed by 4 weeks of follow-up. The control group will receive usual care for 12 weeks and will then be provided with a guided acupressure protocol. Participants may undergo assessments such as symptom scoring using numeric rating scales to monitor changes over time. It is hoped that the result from this study will provide evidence on whether acupuncture is an effective and cost-efficient intervention, supporting improved symptom management and access to supportive care for breast cancer survivors.

This study aims to explore the safety of BYT-1007 and BYT-1007/venetoclax combination and their potential to treat certain blood cancers. Who is it for? You may be eligible for this study if you are male or female, aged 18 to 74. To be eligible for Part A you must be diagnosed with specific hematologic malignancies such as acute lymphoblastic leukaemia (ALL), acute myeloid leukaemia (AML), and high-risk myelodysplastic syndromes (HR-MDS), either in relapsed/refractory status or, in some cases, treatment-naive but unfit for intensive chemotherapy. To be eligible for Part B you must only be diagnosed with acute myeloid leukaemia (AML). Participants must also be unsuitable for standard intensive treatment and have adequate organ function, including kidney function (creatinine clearance of at least 30 mL/min), liver function within the study-specified limits, and a white blood cell count below 25 billion cells/L (supportive treatment may be used to achieve this threshold). Study details Part A will evaluate increasing dose levels of BYT-1007 given alone. Participants will be enrolled sequentially into dose-escalation cohorts and receive five doses of BYT-1007 during a 28-day treatment period. Information collected from Part A will help determine the most appropriate dose for further evaluation. Part B will evaluate BYT-1007 given together with venetoclax. Participants will receive BYT-1007 at dose levels determined based on the results from Part A, in combination with venetoclax during a 28-day treatment period. Participants will attend regular study visits and undergo blood tests, bone marrow assessments, physical examinations, and other safety evaluations to monitor their health and response to treatment. It is hoped that the results of this study will help determine whether BYT-1007, alone or in combination with venetoclax, may be further developed as a potential treatment option for patients with blood cancers, particularly AML.

Brief description of the study purpose This study aims to assess the feasibility and accuracy of using core biopsies to diagnose uterine masses at two hospital centres. Who is it for? You are eligible for this study if you are aged 18 years or over, are not pregnant and have a uterine mass at least 5cm or greater with either rapid growth on sequential assessment, suspicious features on MRI or have known or suspected cancer predisposition syndromes including pathogenic mutations in BRCA1 or BRCA2 and mismatch repair genes (Lynch syndrome). Study details All those who are eligible will undergo a one-off percutaneous uterine needle biopsy (PUB) which will be performed by the treating gynecology oncologist at the hospital site where you are being treated. A comparison will be made with the findings from your resected specimen as part of the planned surgery. If surgery is not performed then the comparator will be the clinical course of the uterine mass at 6 and 12 month clinical follow up visits. If you are not eligible for PUB prior to surgery then you may still have the option to participate by consenting to a biopsy of your removed uterine mass. The cases contributed via this alternate pathway will help to improve the determination of the accuracy and reliability of core biopsies. It is hoped that the results from this study will help explore the possibility of using core biopsies for diagnosis of uterine masses, particularly for women who wish to preserve their fertility.

This study will evaluate LipReader, a smartphone-based artificial intelligence communication tool designed to support voiceless intensive care unit and step-down patients. LipReader uses the device camera to analyse silently mouthed phrases and convert them into text and speech output. Participants will complete a single supervised study session using both LipReader and standard bedside communication tools such as alphabet charts and pen-and-paper. The study will assess time to successful message understanding, message success rate, usability and perceived impact on nursing workflow. Findings will inform future refinement of the technology and the design of larger clinical trials.

The primary purpose of this study is to test a new experimental recombinant Poliomyelitis vaccine (rPV) in comparison to the commercially available inactivated poliovirus vaccine. The design of the study is double-blinded, randomised and active controlled. The active controlled product is considered the commercially available vaccine (IPOL).

This study is testing a new experimental antibody treatment called MQ005 for adults with sepsis, a serious infection that can cause organ failure. The main goal is to evaluate whether MQ005 is safe and well-tolerated when given in single ascending doses. Researchers will also explore how the drug affects the immune system and sepsis outcomes. The study aims to determine the best dose for future research while monitoring participants closely for side effects.

The single group assignment, open label, clinical trial will enroll up to 30 participants with the goal of at least 20 participants completing the yearlong study implant duration. Enrolled Participants will have the CBGM system implanted via a 20–30-minute procedure. Post procedure, after the initial 14-day post implant assessment, Participants will undergo In-Clinic visits every few months during their yearlong implant duration that include both safety and performance assessments of the CBGM System. Outside of the clinic, Participants will complete a minimum of 3 fingerpicks per day (with a study provided commercially approved BG meter and supplies, carry a study phone to collect investigational sensor data (data is blinded to the participant) and complete a study diary. Removal of the CBGM System will be similar to the implant procedure. A final 14-Day post removal visit will occur to follow-up with the participant to assess the wound. If there are not outstanding safety events or items for follow-up, this will be considered the participants final visit and they can safely exit the study.