ANZCTR search results

Lower respiratory tract (chest) infections are a common complication in patients placed onto mechanical ventilation (life support) in the intensive care unit (ICU). Patients with brain injuries who require invasive mechanical ventilation may be particularly susceptible to chest infections – the consequence of which may be worsening of their neurological injury. A recent multi-centre randomised clinical trial showed a significant reduction in ventilator associated pneumonia in mechanically ventilated patients after out of hospital cardiac arrest who received prophylactic (preventative) antibiotics starting within 6 hours of cardiac arrest. It is possible that patients with acute brain injuries would also benefit from this strategy as indicated by small pilot studies but it is not known whether this will lead to patient important outcomes such as increased survival with a favourable neurological outcome. This study aims to answer the question, do prophylactic antibiotics reduce the occurrence of lower respiratory tract infections in adults with acute neurological injuries requiring mechanical ventilation. This will then inform the design of a phase 3 trial testing the hypothesis that this treatment regime will increase survival with a favourable outcome at day 180 in these patients.

This study will be conducted in two parts to assess the safety of AT-0174, how the treatment interacts within the body and to determine the maximum safe dose that may be administered to patients with advanced solid cancers. Who is it for? You may be eligible for this study if you are aged 18 years or older and you have been diagnosed with a solid cancer, including but not limited to: non-small cell lung carcinoma, small cell lung carcinoma, triple-negative breast carcinoma, malignant melanoma, gastric carcinoma/gastroesophageal junction carcinoma/oesophageal cancer, colorectal carcinoma, pancreatic ductal adenocarcinoma, epithelial ovarian carcinoma (fallopian, ovarian, primary peritoneal carcinoma), endometrial carcinoma, thyroid carcinoma (non- medullary) or moderate-high grade astrocytoma (brain cancer). Study details This study will be conducted across two parts. In the first sub-study (Part 1), participants who choose to enrol in this study will be allocated to the next available dosing cohort. The first cohort will be asked to take a daily oral capsule of AT-0174 for 7 days, followed by 3 weeks of no treatment. The second cohort will be asked to take a daily oral capsule of AT-0174 for 14 days, followed of 2 weeks of no treatment. The third cohort will be asked to take a daily oral capsule of AT-0174 for 28 days with no breaks. In the second sub-study (Part 2), participants who choose to enrol in this study will be allocated to the next available dosing cohort. This sub-study will ask all participants to take a daily oral capsule of AT-0174 for 28 days with no breaks. The dose of AT-0174 may increase in amount or frequency (e.g., twice per day) with each successive cohort in Part 2, based on a careful assessment of the safety and tolerability of each dose. All participants will have their vital signs (heart rate, blood pressure, temperature, etc) checked and will provide blood and urine samples for testing. In addition, participants will have their cancer assessed using CT, MRI or CT/PET scans during the study. Participants may continue taking AT-0174 for as long as they and their doctor agree. It is hoped this research will determine the maximum dose of AT-0174 that can be administered safely without causing severe reactions. Once the safest maximum dose of AT-0174 has been determined, a larger trial investigating the efficacy of AT-0174 as a treatment for a greater number of cancer patients may proceed.

Currently we are not meeting glycaemic targets using standard care models. This provides the opportunity to review models of care to maximise outcomes. The use of continuous glucose monitor (CGM) data to detect changes in glycaemic control provides an opportunity to adapt our model of care to deliver more personalised and targeted care for young people with diabetes. This trial will test a new model of care, aiming to use CGM data to detect early adverse changes in glycaemic control and provide targeted and tailored intervention to those individuals needing more intensive support. Aim: This study aims to investigate if using fortnightly review CGM for early identification of adverse markers in glycaemic control, with implementation of targeted intervention improves glycaemic outcomes and patient reported outcomes in children living with diabetes compared to those receiving care using the current standard model of care. Objectives: 1) To investigate if targeted intervention based on adverse glycaemic control on CGM metrics improves glycaemic control compared to standard models of care 2) To investigate if patient and family reported satisfaction and outcomes are improved with targeted intervention based on CGM metrics 3) To conduct cost-benefit analysis of targeted intervention compared to standard models of care 4) To conduct post study consultation with consumers and health care professionals for feedback on the study and relevant comments on next stages of digital dashboard development Hypothesis: 1. Using fortnightly review of digital CGM upload for early identification of adverse changes in glycaemic control with targeted personalised clinical intervention can improve overall glycaemic control and patient and family satisfaction compared to 3-monthly review at multidisciplinary appointments.

Individuals with Cerebral Palsy who are reliant on wheelchairs for mobility have significantly reduced options for participating in physical activity and movement. For those with significant disabilities encompassing not only the musculoskeletal system but also cognition, behaviour and communication face a unique set of challenges requiring new and novel treatment options. In addition to the barriers of access and transport consideration also needs to be given to the timing of medications and feeds. The MOTOmed is a motorised movement (cycling) device, accessed from a person’s wheelchair that provides an option to move for non-ambulant adults with CP. The passive rhythmical cycling motion provides movement at the hip, knee and ankle joints that is otherwise not possible for those with a lack of independent and functional active movement. This movement opportunity may be beneficial given that adults with CP are otherwise in static postures for the majority of their day and night. The primary study aim is to investigate the effects of physical activity on cardiometabolic biomarkers in non-ambulant adults with CP. Commonly used measures of increased physical activity such as strength, walking speed and distance are not able to be used in this group of adults. Blood markers offer a way to measure the effects of physical activity with change possible within 1 to 3 months of moderate intensity exercise training in able-bodied individuals. Changes are anticipated to occur in the proposed population as participants are beginning from an extreme low or non-existent level of activity. The secondary study aim is to explore the experience of MMT including any perceived benefits and burdens.

The primary aim of this project is to evaluate the efficacy of shoe inserts in the treatment of pain associated with osteoarthritis of the midfoot. This study is a parallel group, participant- and assessor- blinded, randomised controlled trial with a 12 week follow-up. One-hundred and forty participants will be randomised to receive one of two types of shoe inserts. All participants will receive clinical guideline-based information and support. Primary and secondary outcome measures will be collected at baseline and at 4, 8 and 12 weeks. The primary outcome measure will be the severity of average pain in the midfoot whilst walking in the last 7 days, scored using an 11-point numerical rating scale (NRS). Secondary outcome measures will include function, self-reported global rate of change, level of physical activity, general health-related quality of life, use of co-interventions and adverse events.

Assessing whether applying a different technology to access the inside of the oocyte is beneficial for patients with previous poor fertilisation or high number of degenerate oocytes after using conventional ICSI. Use of piezo-ICSI will be determined by the IVF specialist after consultation with the patient. Monitoring of fertilization rates, utilisation rates and pregnancy / birth rates will be assessed.

The study aims to understand how pregnancy affects women with Multiple Sclerosis (MS) or Neuromyelitis Optica Spectrum Disorder (NMOSD). In the past, pregnancy was thought to worsen MS, but a 1990s study contradicted this, revealing reduced relapses during pregnancy followed by increased postpartum relapses, especially in severe cases. Recent research, including CI Jokubaitis’ work, suggests that pregnancy might delay MS onset and diminish long-term disability, as symptoms often diminish or entirely disappear during pregnancy. This study delves into the biological changes during pregnancy in women with MS and NMOSD. A central hypothesis is that epigenetic factors, like altered DNA methylation, underlie enhanced disability outcomes in MS. Additionally, the study explores the role of natural killer (NK) cells in mediating these improvements. The study has several key goals: revealing cellular and molecular changes, which involves comparing immune cells and genomic and proteomic markers in pregnant women with MS and a non-MS population; identifying relapse biomarkers by investigating whether ratios of immune cells and hormone levels (estrogen, progesterone) correlate with clinical and MRI outcomes during pregnancy and postpartum. Understanding improved disability outcomes by analysing molecular shifts during pregnancy in women with MS and NMOSD with improved disability outcomes versus those without. The study enrols participants into four groups: non-MS controls, healthy pregnant women, nulligravida MS (or NMOSD) patients, and pregnant MS (or NMOSD) patients. By comparing these groups, researchers aim to unravel the complex connections between pregnancy, immune changes, and the progression of MS/NMOSD. MS and NMOSD women will be analysed separately. This study holds the promise of shedding light on the potential benefits of pregnancy for women with MS/NMOSD and providing fresh insights into new therapeutic approaches.

This study aims to determine whether the use of warmed, humidified CO2 to protect the internal membranes within the lower abdomen in patients with peritoneal metastases from colorectal cancer, who are undergoing surgery and internally delivered focussed chemotherapy can reduce the recurrence of abdominal metastases and impact 5 year survival rates. Who is it for? You may be eligible for this study if you are an adult aged between 18 and 70 years of age, you have been diagnosed with colorectal cancer that has spread (metastastised) to other areas within your abdomen and you are eligible to undergo a combined surgical removal and internally delivered chemotherapy procedure called cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. Study details Participants who choose to enrol in this study will be randomly assigned by chance (similar to flipping a coin) to one of two treatment groups. Both groups will undergo the surgical procedure and internally delivered chemotherapy, but one group will also have warmed humidified CO2 gas applied to their internal membranes during the surgery. It is not anticipated that use of the CO2 will extend the duration of the surgery. Participants in both groups will also have tissue samples taken during the surgery for further analysis and will be asked to consent to their health information being accessed by the study team for up to 5 years after the surgery. Participants in both groups will also be asked to attend regular colonoscopies, CT scans and blood tests at regular intervals after the surgery, as per standard care for patients with this type of cancer. It is hoped this research will determine whether use of warmed humidified CO2 during cancer removal surgery has an impact on the future spread of cancer within the abdomen and whether this technique has any impact on 5 year survival rates for patients with metastatic colorectal cancer.

ECHOES-AF Pilot is a Phase II preparatory to Phase III, Patient Reported Outcomes Burdens and Experiences (PROBE) clinical trial to assess the safety of the trial medications (oral anticoagulants (OAC)) with a lower dose use in patients with cardioembolic stroke, non-valvular atrial fibrillation (AF) and cerebral micro bleed (CMB) taking routine post-stroke secondary prevention medications. We aim to recruit 200 participants with a 1:1 randomization ratio. They will either receive adjusted (lower dose) OAC treatment or follow regular guideline-recommended OAC treatment dosage. Participants will be followed for 12 months after group allocation. The primary outcome will be all-cause death. This study will be conducted in multiple hospitals and clinic-based centres across Australia. The study is funded by NSW Health and The George Institute for Global Health, with Dr. Zien Zhou as Chief Investigator. Findings from this trial will help ascertain whether a very large clinical trial to identify optimal anticoagulation strategies for stroke patients with AF and CMBs will be possible.

This project is evaluating the safety, tolerability (if any side effects occur), and immunogenicity (the ability of a molecule or substance to provoke an immune response) of two vaccinations with the study drug TVAX-006, a vaccine which is being developed with the aim to help prevent shingles. To evaluate the study drug, it will be tested in different groups who will receive different comparators. Grand Theravac Life Sciences (Nanjing) Co., Ltd is developing the study vaccine, a recombinant zoster vaccine, as a potential new way to prevent shingles for adults aged between 30-70 years. These long-term complications are the primary reason why vaccination is needed. Vaccination protects individuals from herpes zoster and postherpetic neuralgia and reduces associated medical and psychosocial outcomes and costs for the patient. The current treatments available once someone has herpes zoster and postherpetic neuralgia have limited success, so it is much better to prevent it from occurring at all. This makes vaccination a particularly important strategy for Australians to prevent this debilitating disease, especially in the elderly.