ANZCTR search results

Humans require sufficient sleep to maintain physical and mental health. Reductions in sleep quantity and quality are associated with reduced cognitive function and productivity and increased absenteeism, along with chronic diseases such as hypertension and cardiovascular disease, dementia, depression and anxiety. Laboratory studies have shown that hot temperatures result in worse sleep, with epidemiological data suggesting that hot overnight conditions are independently related to mortality. To date, nearly all solutions for combatting heat stress are pre-occupied with reducing air temperature – usually using air conditioning (AC). Currently, despite no supporting evidence, all major international public health agencies (including WHO) state that fans should be turned OFF above 32-35°C as they accelerate heat/dehydration risk. A series of recent publications from our research group has shown that fans can mitigate heat stress at temperatures as high as 42°C. However, how these findings translate to overnight fan use at these temperatures remains unknown. Thus, the purpose of this trial is to test the use of electric fans to improve sleep quantity and quality in ambient conditions of 35°C and 40% Relative Humidity.

Apart from topical aminosalicylates and steroids, there is limited local treatment available for ulcerative proctitis, a incurable relapsing inflammatory condition of the bowel. This study aims to assess the safety of using locally injected stem cells derived from healthy placentas to treat ulcerative proctitis. Participants will receive a single injection of cells during routine colonoscopy and undergo assessment using routine colonoscopy, blood tests and stool tests. We hypothesise that these placental-derived stem cells will be safe and well-tolerated and that local injection is feasible.

Identify the feasibility of MI-CBT via telehealth in supporting people with knee/hip osteoarthritis to uptake and adhere to a walking program based on rehabilitation. Hypothesis: Telehealth based on MI-CBT is feasible.

This is a double-blind, randomized, placebo-controlled study which is subdivided in 2 parts, Part 1 (SAD) and Part 2 (MAD). Decisions about how and when to move between cohorts will be based on reviews of the available blinded safety data and available pharmacokinetic (PK) data; this data will be reviewed by a prespecified Safety Review Committee (SRC). In Part 1, healthy volunteers will be enrolled to receive single ascending doses of LTSE-2578 or placebo. In Part 2, healthy volunteers will be enrolled to receive once or twice daily doses of LTSE-2578 or placebo for fourteen consecutive days.

Some people over the age of 65 years experience a substantial fall in BP after eating, so-called, postprandial hypotension. Recent, compelling, evidence indicates that the gut hormones, GLP-1 and GIP, modulate BP after a meal. Unlike GLP-1, GIP does not slow stomach emptying and may accelerate it. While the role of endogenous GIP in the regulation of postprandial blood glucose and BP remains uncertain, due to the lack of a specific GIP antagonist, our recent studies strongly support the concept that GIP regulates BP and gut blood flow. Colleagues in Copenhagen have recently developed an effective GIP antagonist in humans. We will use the GIP antagonist to define the roles of GIP, in the blood glucose, BP, gut blood flow flow and stomach emptying responses to a glucose drink in healthy older people..

Asthma is a common disease and significant public health problem in Australia, affecting one in nine adults. Current asthma management approaches treat all patients the same, using a step up- step down approach, which fails to recognise the complexity and heterogeneity that is evident, particularly in those with more severe disease. While this approach significantly improved asthma outcomes, in the early 21st century its limitations have become apparent, as improvements in asthma outcomes have stalled. Indeed, people continue to die from asthma, have an ongoing burden from acute attacks and symptoms, and suffer severe iatrogenic consequences of treatment, in particular from oral corticosteroids (OCS). Alarmingly, in Australia it has been demonstrated that more than 25% of patients using inhaled corticosteroids reach a cumulative OCS dose of >1000mg which is associated with increased risk of serious adverse side effects and irreversible harm. Management approaches that address the heterogeneity of asthma, including risk factors and comorbidities associated with the prevalence and persistence of the disease, and that incorporate advances in knowledge are urgently needed. “Treatable Traits” have been proposed as a useful concept to implement precision medicine. This approach recommends an assessment of traits or disease characteristics that fall within three domains: pulmonary, extra pulmonary and risk factor/behavioural, and the application of targeted individualised interventions based on the identified traits. This project will test the clinical and cost-effectiveness of a Treatable Traits model-of-care as an OCS-sparing strategy for the management of adults with asthma, while gathering information on its potential for implementation in real-world settings.

Ewing Sarcoma is a cancer of bone or soft tissue that occurs in children and adults. Treatment usually includes chemotherapy, surgery and/or radiotherapy. This is an international clinical trial (INTER-EWING-1) that will assess multiple combinations of these treatment types to determine whether different combinations are better able to improve survival for patients with Ewing Sarcoma. Who is it for? You may be eligible for this study if you are aged 2 years or older and you have been diagnosed with Ewing Sarcoma. There will be additional criteria that patients who wish to enrol in this study may need to meet in order to be entered into one of the different treatment arms, these are outlined in detail in the 'Inclusion Criteria' section of this form. Study details Participants who choose to enrol in this trial may enter into one of three different treatment arms, depending upon which inclusion criteria they meet. A researcher will assess eligible participants to determine which treatment arm they are most suitable for, and patients will then be randomly allocated by chance (similar to flipping a coin) into one of two groups for that treatment arm. Treatment group A will receive a new chemotherapy drug over 9 cycles. Treatment group B will receive doses of radiotherapy which may differ depending upon whether they are able to undergo surgical removal of their cancer or not. Participants will be asked to attend a maximum of 36 sessions over 7.2 weeks. Treatment group C will receive either additional doses of a currently used chemotherapy drug, or will be asked to stop their treatment after the standard treatment cycles have been given. If participants are eligible for more than one of these treatment groups they can choose to enrol in a second and then third treatment group once they have completed their first allocated treatment. It is hoped this research will determine whether having standard chemotherapy plus a type of drug designed to target tumour cells, called a multi-tyrosine kinase inhibitor (MTKI) is better for patients. The effects of radiotherapy and additional doses of standard chemotherapy will also be assessed to determine if any of these combined treatments can lead to improved survival for patients with Ewing Sarcoma.

The aim of this project is to assess the psychometric properties of a ‘point of collection’ technology to measure salivary cortisol levels in adults. Objectives are to use the IPRO© ‘point of collection’ saliva analysis method to report: 1) concurrent validity by comparison with reference standard cortisol assay analysis; 2) over-time reliability of cortisol measurements; 3) inter-rater reliability of cortisol measurements.

The purpose of this study is to test out a consumer engagement strategy called Making it Meaningful (MiM). The MiM has been designed for people who use cancer services and may be undergoing a change in their medications. Eligibility criteria: Outpatients who are receiving treatment or care at participating cancer service and aged 18 years or older will be eligible to take part. Patients who attend the service must identify their primary language as English or Mandarin to be eligible to participate Study details Participants who choose to enroll in this study will be randomly allocated to either receive the MiM medication management tool, or to receive standard care provided by the cancer service. Participants who are allocated to the MiM group will attend an appointment with their health practitioner (medical practitioner) who will use the Make it Meaningful Tool (MiM) to facilitate communication at the individual appointment where medications are changed. It is anticipated that this appointment will take no longer than your usual consultation. The health care practitioner will provide a paper copy of the MiM for the patient to take away from the appointment. The health care practitioner will also provide instructions to the patient about how the tool can be used to inform them of who to contact if they have any concerns about medication, treatment or experience side effects, etc.. Participants who are allocated to the standard care group will not receive the MiM tool, they will instead discuss the medication management together with their health care practitioner using the usual care strategy currently provided. All participants will be asked to complete a series of questionnaires over the phone when they first agree to participate in the study, 1 week and then 4 weeks after the medication discussion with their health care practitioner. It is expected that completion of these questionnaires will take 15 minutes. It is hoped this research will determine that use of the MiM tool is practical and acceptable to cancer patients. If this small study shows that the MiM tool is helpful for cancer patients, it may be studied further in a larger trial that may lead to improvements in medication communication for cancer patients in the future

This is a first-in-human, single-ascending and multiple-ascending dose study. Products with the same mode of action are approved in the form of intravenous infusions. The study drug was designed for local release in the colon. The purpose of the study is to assess the safety profile of this new drug in comparison to placebo.