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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.

Our nose and sinuses produce mucus which contains protective molecules. These molecules are part of our body’s first line of defence known as the innate immune system. However, sometimes when this system is disrupted, we can get diseases like chronic rhinosinusitis with nasal polyps (CRSwNP). People with CRSwNP have their nose and sinuses irritated for more than 3 months. These patients often use nasal saline irrigation for treatment which is a solution that rinses your nose. Previous work from our group has shown that, in healthy volunteers, using irrigation solutions with a lower salt concentration provides an increase in some of these protective molecules. We now want to see if this happens in people with CRSwNP too. Hence, we will compare effect of two different irrigation solutions (isotonic NaCl and low Na) on levels of protective molecules in nasal secretions of people with CRSwNP.

Spinal cord injury (SCI) is associated with severe rapid bone loss below the level of injury, and subsequently osteoporosis and increased risk of minimal trauma fractures. There is currently no effective treatment for treating SCI-induced osteoporosis. Current methods of prevention, predominantly bisphosphonates, have very limited efficacy. Sclerostin is now known to mediate SCI-induced bone loss. Recently, a sclerostin inhibitor, romosozumab, has become available for the treatment of osteoporosis. Sclerostin inhibition prevents bone loss following SCI in pre-clinical studies. We hypothesis that romosozumab will be highly effective for the prevention of bone loss and osteoporosis in SCI. This study will compare romosozumab followed by the bisphosphonate, zoledronic acid versus zoledronic acid alone, administered early after acute SCI, for prevention of SCI-induced osteoporosis. We will recruit 32 participants (16 in each group) in a randomised controlled study. Participants will either receive romosozumab for 12 months followed by maintenance therapy with zoledronic acid, or zoledronic acid alone. We expect to show that the marked bone loss which occurs following acute SCI can be prevented by the administration of romosozumab.

It is difficult to manage patients with end-stage wrist osteoarthritis. Though fusion of the wrist is effective in reducing pain, there are significant losses in range of motion and potential complications relating to healing or hardware. For these reasons, a more conservative approach for management of chronic wrist pain may be preferable. Partial wrist denervation, instead, is a procedure which targets the small nerves in the wrist to manage chronic pain, whilst still preserving baseline range of motion. This has traditionally been performed surgically, which involves a small incision and resecting the relevant nerves. Patients receive an anaesthetic and parenteral sedation. Recently, a technique using ultrasound and heat ablation through the skin has instead been described. This avoids the risks of surgery and can be done on an outpatient basis without sedation. The limited data thus far show similar benefits to surgery, however it is still an emerging technique without a direct comparison to surgery. In this randomised control trial we look to compare two techniques of partial wrist denervation (surgery, radiofrequency ablation) for improvement of pain in end-stage wrist arthritis. Our hypothesis is that the intervention (radiofrequency ablation) is non inferior to the control (surgery). The primary outcome is to compare pain scores for the two groups using a visual analogue scale. The secondary outcomes include an assessment of function, motion, strength, satisfaction and return to work. We believe this study to have importance in guiding future management decisions for this complex clinical scenario. This study is therefore designed to compare the effectiveness of partial wrist denervation through surgery or through ultrasound ablation.

Objectives: 1 - To evaluate the effectiveness of a media-led intervention that includes evidence-based information on the management of low back pain (LBP), distributed and broadcasted at point-of-care in primary care settings (General Practice clinics), to change patient beliefs about LBP. Effectiveness will be measured in terms of patients’ beliefs and attitudes about LBP. 2 - To evaluate the delivery of care at a practice level to determine if the media-led intervention changes Medical Practitioner practice (i.e., prescriptions for opioid medication, referrals for medical imaging and Specialists). Target sample size: 30 GP practices 3780 participants Study Design: Stepped wedge cluster randomised clinical trial that will randomise 30 GP clinics into 5 clusters to receive the study information video intervention within their waiting rooms. The order by which each cluster receives the intervention will be randomised, and by the end of the study all 30 clinics will broadcast the media intervention. Patients attending GP clinics will be invited to participate in the study to capture their LBP beliefs at a single time-point either during the control period (no informative study video) or during the intervention period (during the delivery of the intervention video). GP key referral and prescriptions for LBP will be collected at 3 time points: pre, mid and post the delivery of the study intervention

This study is performing construct validation of a new virtual reality (VR) training software designed to teach regional anaesthesia needling skills.. Validation will compare novices versus experienced regional anaesthetists when they are using the software. Construct validity is determined if the software can discriminate between novice and experienced participants using generated performance scores; compare the quality of the virtual reality environment using validated questionnaires testing for the "realism" and "immersiveness" of the software; and compare cognitive task loads generated during use of the software against real-life medical procedural procedures.