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This study aims to assess a new cancer drug, GRWD5769, in patients with advanced cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or older, have a cytologically or histologically confirmed locally advanced or metastatic solid malignancy not considered for further treatment, and have progressive disease after treatment with other agents. Study details All participants will receive treatment with GRWD5769 and cemiplimab-rwlc 350 mg. After an initial single dose, GRWD5769 will be administered as an oral capsule throughout the study twice a day. cemiplimab-rwlc will be administered by intravenous infusion of 350mg over 30 minutes once every 3 weeks. Treatment will continue until participants withdraw from the study or their disease progresses. During the treatment period, participants will undergo study visit for screening and an initial confinement period commencing up to 2 days prior to the first dose until Day 2 of Cycle 1 (minimum of 2 nights). Further confinement periods are required for assessments on Day 14 & 15 of Cycle 1. Participants will also undergo imaging every 56 days for the duration of the study to assess for their response to treatment. It is hoped that this study will show that GRWD5769 is safe, tolerable, and effective for the treatment of advanced solid cancers. This study will also help to define the dose of GRWD5769 that may be used for treatment of similar individuals in future.

Automated insulin delivery (artificial pancreas systems) can help to improve management of glucose levels in people living with type 1 diabetes while at the same time reducing the heavy intellectual and psychological burden of care. However, the success of closed-loop/artificial pancreas devices moving forward relies upon their ease of use and ability to reduce and relieve the burden of living with type 1 diabetes. Current commercially available automated insulin delivery devices represent hybrid closed loop (HCL) systems requiring the user to initiate boluses of insulin to address meal-time insulin requirements. Eliminating a requirement for the user to bolus for meals, without compromising glucose control, would substantially reduce the burden of care on people living with type 1 diabetes. The Medtronic MinimedTM NMX-AID system is a new-generation closed loop system (artificial pancreas) similar to an existing, commercially available Medtronic insulin pump, the MiniMedTM 780G Pump, and has the capability to operate in Manual Mode (also referred to as open loop) or with the SmartGuard feature active (also referred to as closed loop). However, the NMX-AID system differs from the Minimed 780G Pump as it contains modifications to the closed loop algorithm, including the addition of a Pump Start feature that enables the user to skip the 48-hour warm-up to enter SmartGuard and also allows automatic delivery of meal boluses without user input or acknowledgement. These new advances have significant potential to improve the experience of using closed-loop technology. The aim of this study is to demonstrate feasibility of the device, and to generate initial data to evaluate safety, user acceptance and system efficacy of the Medtronic Minimed NMX-AID system in adults with type 1 diabetes. We believe that the Medtronic Minimed NMX-AID system will be feasible and safely improve user satisfaction in people with type 1 diabetes without sacrifices in glucose control compared with insulin delivery with the MiniMed 780G system.

Our previous research found that an ultra-brief online treatment was effective for managing depression and anxiety symptoms. This research trial is testing how quickly people with a diagnosed depressive or anxiety disorder benefit from an ultra-brief treatment. People will be randomly allocated to receive access immediately or after a 4-month waiting period. Questionnaires will be administered every 2 weeks for 4 months. The primary endpoint is Week 17 and we expect that the treatment will result in larger reductions in depression and anxiety compared to the control.

This trial will evaluate a highly accessible and ultra-brief online psychological treatment for women with perinatal depression or anxiety. The treatment involves online materials and optional support from a psychologist. We will evaluate how helpful the treatment has been 2 weeks and then 4 weeks after baseline. All participants will complete questionnaires at baseline, Week 3, and Week 5. We hypothesise that the treatment will lead to reductions in depression and anxiety.

Recent research suggests that our circadian rhythm plays a very important role in how we develop and how our immune system works. The CIRCA DIEM Study (ACTRN12618000371291) is randomising hospitalised premature infants born before 32 weeks gestation to be standard routine care or to be cycled between an artificial night-time from 8 pm to 6 am (using eye masks to block out light and ear plugs to reduce noise) and then to be exposed to an artificial daytime from 6 am to 8 pm (removal of eye masks and ear plugs and light levels from 300-600 lux (similar to low-level office lighting). The intervention continues until babies are discharged home to a normal day/night environment. As part of the CIRCA DIEM trial, we are inviting participating families to enrol their baby into an Infection and Immunology substudy. The main aim of the CIRCA DIEM Infection and Immunology Sub-Study is to find out whether the timing of the development of a circadian rhythm influences the likelihood of premature babies developing infections that require hospitalisation over the first 2 years of life. Babies enrolled in the CIRCA DIEM main study whose parents agree to their participation in the Infection and Immunology Substudy will be followed-up after discharge home using a mobile app to track infant well-being, presence of symptoms of infection, visits to health care providers and hospitalisations. Some infants will also have some biological samples collected to help us understand the mechanism of any differences that are evident between the intervention and control groups with respect to hospitalisations for infections and other secondary substudy outcomes.

This study aims to assess the effect of combining two different cancer treatments, Lu-PSMA and capecitabine, for the treatment of castration-resistant metastatic prostate cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with castration-resistant metastatic prostate cancer and you meet additional health criteria that will be determined by a blood test. Study details This study will be conducted in two parts. Participants who choose to enrol in the first part - dose escalation - will be allocated into one of four capecitabine dosing groups. Participants will attend their cancer treatment centre and receive twice daily doses of capecitabine for 14 days. On the 10th day, participants will also receive a dose of Lu-PSMA. Treatment will be administered to a maximum of 6 cycles, at an interval of 6 weeks (42 days). Participants will be enrolled firstly into the lowest dose group, if there are no serious side effects noted then enrolment into the higher dosing groups will occur. Once the maximum tolerated dose is determined, the second part will begin enrolling participants. Participants who choose to enrol in the second part - dose expansion - will all receive the maximum tolerated dose of capecitabine twice daily for 14 days. On the 10th day, participants will also receive a dose of Lu-PSMA. Treatment will be administered to a maximum of 6 cycles, at an interval of 6 weeks (42 days). Participants who choose to enrol in either the first or second part will be asked to undergo routine blood tests and CT imaging to determine any impact the combined treatments may be having on their cancer. Overall participation is not expected to exceed 12 months.. It is hoped this research will determine the maximum safest dose of capcitabine that can be administered to prostate cancer patients together with Lu-PSMA. Once a safe dose has been determined, a larger trial enrolling more cancer patients may be undertaken to further assess the efficacy of the combined treatments.

The result of injury in humans is scar formation. In the case of burn injuries, particularly larger surface area and deeper burn injuries, extensive scar formation has a significant physical and psychosocial impact on patients after recovery. Scar formation after injury is driven initially by the inflammatory response but subsequently by matrix producing cells (fibroblasts) that generate excess collagen. This collagen is organized in parallel bundles and the excess collagen as well as organization of collagen underpins the poor appearance and physical properties of scar. A family of 5 lysyl oxidase (LOX, LOXL1-4) enzymes are involved in a process of cross-linking collagen. This cross-linking is increased in scars. This study will test an inhibitor of these enzymes, PXS 5505, in burn patients with moderate burn injuries and that require surgery. The study will test the safety of PXS-5505 when given to burn patients after their surgery and also measure the scarring after their recovery. The study will be a double-blind and randomised controlled trial with 60 patients randomised 2:1 to PXS-5505 or placebo.

The REPAIRS pilot trial aims to investigate the feasibility and acceptability of a randomised controlled trial comparing a ‘standard’ regimen of opioid pain medicines to a ‘reduced’ regimen of opioid pain medicines prescribed upon discharge after total hip or knee replacement. Both groups will also receive the same robust regimen of non-opioid pain medicines. The pilot trial will be open label to prescribers and participants, however the researchers conducting the surveys and statistical analysis will be blinded to treatment allocation. We will recruit ~50 participants to test outcomes such as recruitment per screening rate, adherence to medication regimens, acceptability of surveys. There will also be an inbuilt process evaluation where we will interview all participants, and ~ 10 key staff members to qualitatively investigate the acceptability of the trial interventions and processes. Participants will be followed up for 6 weeks from hospital discharge.

Many trades (e.g. infantry, special operations) within the Australian Army require individuals to perform consecutive days of prolonged (>10 h), physically demanding work in the heat, as part of multi-day training exercises and operations. These conditions can cause dangerous rises in body core temperature, cardiovascular strain and fluid depletion over the course of the day, which can cause carry-over effects that may exacerbate exertional heat illness (EHI) risk on the following day. For example, recent epidemiological data from the US Armed forces indicate that the odds of developing EHI on a given day is exacerbated when training is conducted in hot weather on the preceding day. Further, several field- and laboratory-based studies have demonstrated that this elevated EHI risk may be related to exacerbated increases in body core temperature and cardiovascular strain on the second of consecutive days of work in the heat. While the mechanism(s) explaining these impairments in thermoregulatory and cardiovascular strain remain unclear, there is recent evidence to indicate that these carry-over effects may progressively worsen over two or more days. Despite the potentially deleterious effects of multi-day exercise in the heat on physiological strain, there are major gaps in our understanding of the factors (e.g. aerobic fitness, environment, work intensity) that may exacerbate the magnitude of these effects. For example, recent work has demonstrated that increasing age may worsen the next-day effects of a prolonged workday in the heat on thermoregulatory function. There also exists shortcomings in our knowledge of the impact of multi-day exercises in the heat on cognitive function and fatigue, which may reduce task performance and increase the risk of errors and risk taking behaviour. This makes it difficult to develop interventions to mitigate risk of decrements in performance and improve safety. The overarching aim of this project is to investigate the cumulative physiological effects of consecutive days of physical work in hot conditions.

Depression is a common mental illness, and it is one of the leading causes of disease burden worldwide. Fortunately, there are many effective treatments available for depression, including lifestyle changes, psychological treatments, and medications such as antidepressants. However, not all patients will respond to the first treatment prescribed. Some patients may only experience a 'partial response', where a few treatments help their depression somewhat, but they do not achieve a full recovery. Currently, the reasons why some patients do not respond, or only experience a partial response to an antidepressant, is not fully understood. Recently, researchers have been investigating new medications that may help patients recover from depression. One of these new medications is Esketamine, which is a relatively new molecule derived from a drug called Ketamine - an anaesthetic that has been used medically for decades. Researchers have been investigating the antidepressant properties of Ketamine for a long time. It is thought that Ketamine, and its derivative, Esketamine, help to treat depression for a number of reasons. However, it is not yet known which patients benefit most from Esketamine when used in conjunction with conventional antidepressants. In addition, we do not yet understand how the effect of Esketamine is impacted by other treatments that a patient may be taking for their depression. Finally, it has not yet been investigated how patients with a partial response to an antidepressant will benefit from adding Esketamine to their therapeutic regimen without switching to a new baseline antidepressant. Therefore, there are two principle aims of this study 1) to investigate whether Esketamine is effective when added to ongoing antidepressant treatment and 2) to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice. In patients that improve with the addition of Esketamine to their current antidepressant treatment, we hypothesize that their improvement will be determined by their personal characteristics and/or the type of treatment they are already receiving.