ANZCTR search results

This clinical study is an uncontrolled, non-randomised, open-mask, pilot study aiming to test the feasibility of a single microdose of ayahuasca alkaloids on neurotransmitters and inflammation blood pathology markers. This pilot study will recruit four healthy adult volunteers with strict exclusion criteria. This study will test whether an ayahuasca microdose has any measurable biological effects outside of the subjective mood self-efficacy effects. This study will also measure safety observations such as blood pressure, heart rate, pain and oxygen saturation (SPO2). The study hypotheses is that a single microdose of ayahuasca alkaloids will increase neurotransmitters, decrease or have no effect on inflammation markers, have no effect on safety observations, and may enhance mood.

This is a longitudinal proof-of-concept study of benzalkonium chloride (BAC) wound gel in conjunction with standard of care (SOC), We plan to enroll 20 individuals presenting to the Liverpool Hospital High Risk Foot Service (Sydney, Australia) with a diabetes-related foot ulcer (DRFU) suspected of having a local chronic biofilm infection. "Biofilm" is a term given to microorganisms, typically bacteria, that demonstrate alterations in behaviour, such as slow growth, multi-drug resistance, virulence, pathogenicity and aggregation. They are not visible to the naked eye and hence clinicians cannot see which tissue to target during sharps debridement, therefore debridement alone may not be enough to remove biofilms. This study has been designed to provide proof of concept regarding a wound dressing's ability to impact biofilm and may assist in building an evidence base for their continued use in wounds with chronic biofilm infection. We plan to assess the total microbial microbial load before, during and after therapy. We will use a combination of molecular and microscopy techniques to determine the number of bacteria and to better understand the effects of the wound gel on biofilms in real study participants, living with a DRFU with chronic biofilm infection.

In people with Cystic Fibrosis (CF) those who have higher numbers of lung (pulmonary) exacerbations (increased cough, sputum, shortness of breath) live shorter lives than those who have fewer exacerbations. We think that a delay in managing lung exacerbations can lead to worse results. In the past two years more people with CF have been interested in digital ways of getting CF healthcare. The COVID-19 pandemic meant more people got healthcare at home or in the local community rather than in hospitals. People with CF have said they want this to continue post pandemic. This research study will look at new ways of providing care for people with CF using an online system, which is connected to our hospital medical record, that can pick up lung exacerbations in people with CF by examining symptoms (cough, sputum, breathing) that they enter into the system. If the system identifies a lung exacerbation, it will send out an action plan to the person with CF, explaining what they can do to help them get better from their lung exacerbation. The research study will run for 12 months and will compare the online detection system to normal CF care to understand if the new system is easy to use, liked and supported for ongoing use by people with CF and the CF team compared to the current system.

This study aims to evaluate and develop the topic of conflict management in medical student education. This will be addressed through the following objectives: 1. Explore the experiences of final year medical students with conflict whilst on placement 2. Quantify the extent to which medical students encounter conflict whilst on placement 3. Assess the baseline individual skills and individual characteristics of the student cohort to identify gaps that could be addressed through education 4. Use the experiences of medical students combined with gaps in baseline skills to develop an educational intervention (workshop) on conflict management 5. Assess the effectiveness of this intervention in terms of student self-assessed confidence and competence in managing conflict, amount of conflict experienced, and individual skills.

The purpose of this study is to investigate the safety, tolerability and effectiveness of cannabinoid therapy prescribed to eligible patients for management of recognized chronic conditions using data reported by patients during treatment over a 12 month period.

Crossover Study to Assess the Relative Bioavailability of FP 045 Capsules vs. Reconstituted Drug Substance in Healthy Male Participants

The involvement of the circadian system is becoming an increasingly important topic in respect to the aetiology and treatment of Parkinson’s disease (PD). PD is traditionally described as, a disorder predominantly of motor impairment, mediated by nigro-striatal DA (NSD) function. However, the secondary symptoms that proceed and accompany the disease during its course tell a different story. Insomnia, fatigue, depression and sleep disturbance are four of the most troublesome symptoms of PD that not only herald disease onset but also exacerbate primary symptoms and rob patients of their quality of life. Realigning circadian phase is the mechanism by which we can intervene in circadian function and phototherapy is the most effective method for doing so. Unfortunately, only a few studies have examined the efficacy of phototherapy as it relates to the protracted, ongoing nature of the disease itself. The present study examines the effect of light treatment for as long as ten years during the course of PD by monitoring primary and secondary symptoms at regular intervals. Improvement in circadian based symptoms observed including insomnia, fatigue, sleep architecture and depression may occur, and it is hypothesized that motor function will be subtle and occur incrementally. It is hypothesized that Improvement in both motor and secondary symptoms will occur for the duration of the study as long as patients used the treatment daily. The sequence of symptom recovery from secondary symptoms to motor impairment is expected to be slow suggesting that an incremental process of improvement is in tow, representing an inverse of the degenerative sequelae that continues over decades. Such a process would emulate the slow incremental process that characterizes the reparative process seen with pure disorders of circadian function. Recent findings suggesting that weakened circadian rhythmicity is associated with increased risk of PD thereby corroborating the possibility that “tweaking” the circadian system with a potent Zeitgeber may interfere with internal timing to slow the degenerative process of PD.

The primary purpose of this study is to determine the acceptability of different bowel testing methods including but not limited to faecal tests, blood tests, and colonoscopy. Who is it for? Participants in this study include adults who are undergoing colonoscopy at Flinders Medical Centre, Noarlunga Health Service, Tennyson Centre Day Hospital, or the Queen Elizabeth Hospital in response to gastrointestinal symptoms or for CRC surveillance. It will also include currently registered medical doctors practising in Australia as surgeons, gastroenterologists, and/or general practitioners who are involved in the clinical care of people undergoing colonoscopy. Study details: Eligible participants scheduled to undergo colonoscopy will be sent a letter inviting them to complete a survey 2-4 weeks prior to their colonoscopy. All study invitees who complete this initial survey will be sent a letter one month after their colonoscopy inviting them to complete a follow-up survey. Surveys will contain questions about their testing experiences and knowledge, health beliefs, health literacy, health-related quality of life, and fear of bowel cancer. Clinicians will also be invited into the study through a direct approach or self-selection via advertisements where they will be asked to complete a single survey at their earliest convenience. The clinician survey will contain questions about their familiarity with and previous use of bowel testing methods, perceived effectiveness of bowel testing methods, perceived barriers to bowel screening test use, and preferences for bowel screening test attributes. It is hoped that the outcomes of this research will establish the level of knowledge, trust, and acceptability of colonoscopy consumers and clinicians to different bowel screening strategies. This study will obtain evidence highlighting the benefits and/or perceived barriers towards adopting a simple faecal and/or blood-based test to better determine risk of significant gastrointestinal disease. Adoption of an effective and acceptable biomarker screening test would then lead to better management of colonoscopy resources and reduced costs to the healthcare system through improved colonoscopy triaging and overall reductions in the overall number of colonoscopies performed.

The SWAP IT program is integrated within an app-based communication platform used by schools to communicate with parents and consists of text-messages sent to parents targeting barriers to packing healthier lunchboxes. SWAP IT has proven to be effective in improving child nutrition and weight outcomes, is acceptable to parents and principals, and is cost effective (ACTRN12616001228471; ACTRN12618001731280). Although SWAP IT has the potential to improve child health at a population-level, little evidence exists to guide efforts to encourage school adoption of these programs at scale. This research aims to maximise the impact of the SWAP IT program through a scale-up involving 344 primary schools across 11 NSW local health districts. A randomised trial will be undertaken with schools allocated to receive either a 9-month multi-component scale-up strategy or to a control group. The scale-up strategy is theory-based and was developed in consultation with researchers and stakeholders from health, education and industry. Key outcome measures include: a) SWAP IT program adoption; b) Cost efficiency and affordability of the intervention; and c) mechanisms of action. This research will result in new knowledge to inform how school-based nutrition programs can be successfully scaled-up at a population level.

Converging evidence has shown that treatment choice can enhance the deceptive placebo effect for a range of conditions, such as pain. The current study aims to test whether treatment choice can facilitate the effect of open-label placebo (OLP) on chronic pain in a randomized controlled trial. Participants will be randomized to one of the three conditions: Choice, No Choice and Natural History. Both Choice and No Choice will receive OLP treatment and use their OLP treatment twice every day for two weeks while Natural History will not receive any treatment. Critically, the Choice group will be given the opportunity to choose a treatment between two options and decide when to use their treatment every day, whereas the No Choice group will be assigned a treatment and must use their treatment once in the morning and once in the evening. We hypothesize that (1) OLP will reduce chronic pain relative to Natural History; (2) choice over OLP treatment will enhance the OLP effect relative to No Choice.