ANZCTR search results

Maintenance of Remission for Ulcerative Colitis with Faecal Microbiota Transplantation; the MR-UC-FMT trial is prospective clinical trial designed to determine the dosing interval of Faecal Microbiota Transplantation administered by enema with a view to maintain remission following induction with FMT and prednisolone. The study recruits patients with mild to moderate Ulcerative Colitis and enrols them into two phases of the trial. The first phase involves an 8 week course of prednisolone with a Faecal Microbiota Transplantation given via colonosopy at week 5 with a view to induce remission or adequate clinical response. Those patients who respond to treatment will be openly randomised to receive FMT via clinician administered enema every 4 or 8 weeks for a further 40 weeks (total 52 weeks). The study aims to test the hypothesis that: -FMT given more frequently via enema is more likely to result in the patient's microbiome becoming more similar to the FMT than the patient's baseline microbiome. -The therapeutic effect of FMT is that the bacteria in the patient's colon become the same as those in the transplant material. -The therapeutic effect of FMT is to improve the diversity of bacteria in the patient's colon -FMT is more effective if given with prednisolone for induction of remission. -FMT given more frequently improves outcomes including time to flare, weeks in flare and clinical or endoscopic remission at 28 and 52 weeks.

This pilot study aims to compare patient-rated outcomes and range of motion between patients who undergo surgical stiff elbow release, treated with an injection of botulinum toxin (botox) pre-surgery vs placebo. We hypothesized that the injection of botox into the biceps and brachialis immediately before surgery may result in greater range of motion (less stiffness) following surgical release.

Physical activity has the potential to improve the mental health and wellbeing of university students. Given the high prevalence of mental ill health diagnoses in university students when compared to individuals from other age groups, the Fit 4 Study program aims to use physical activity to help first-year undergraduate university students manage their experiences of psychological wellbeing, symptoms of depression, anxiety, somatic symptoms, loneliness, increase their use of physical activity, decrease amount of time spent engaging in sedentary behaviour, improve their academic performance (GPA), and bring benefits to their social group belonging.

Current first-line antibiotic therapies for bacterial vaginosis (BV) provide cure rates of 70-80% 1 month after treatment, but >50% experience BV recurrence within 3-6 months of completing recommended treatment. There is epidemiological and microbiological evidence supporting sexual exchange of vaginal bacteria (both optimal and non-optimal) between sexual partners. BV imposes a heavy burden on the healthcare system, as recurrence results in multiple presentations to clinical services and repeated antibiotic use. In addition, the obstetric and reproductive sequelae associated with BV have significant implications for healthcare expenditure. Effective therapeutic approaches are an urgent health priority. The LGBTQIA+ community have a higher prevalence of BV in many settings. Given the evidence of sexual exchange of bacteria between partners, treatment of only one individual in a partnership may result in re-infection when sex resumes post-treatment. Given the high rate of BV in the LGBTQIA+ community, we hypothesise that treating the regular sexual partner of people diagnosed with BV (the index) will reduce BV recurrence. All couples will have access to treatment which will be anatomically directed. We aim to recruit 74 couples (148 individuals) in Australia, and we are using single-arm design, where if both individuals have a vagina, they will both be offered first-line therapy with oral metronidazole. There is also provision for couples where a partner decides not to receive treatment, or has anatomy requiring combination-therapy. We will collect genital, oral and anal specimens from all participants before and after treatment, and then weekly for up to 9 weeks to see if the index gets their BV back again or not.

This is a randomized, double-blind, placebo-controlled, single ascending dose study. Approximately 48 men and women aged 18 to 70 years who fulfill the inclusion and exclusion criteria will be enrolled at 2 to 3 sites in Australia. Eligible subjects will be admitted to the clinical research unit on Day -1, dosed on Day 1, discharged on Day 2 after completing the 24-hour post-dose follow-up assessments, and return for outpatient visits through Week 24. The single ascending dose study includes 4 cohorts (50mg, 150mg, 300mg and 600mg) of subjects with mild to moderate hypertension (N = 12 per dose cohort).

This is a randomized, double-blind, placebo-controlled, single ascending dose study of BW-00112 when administered subcutaneously to subjects. Approximately 32 male and female subjects with elevated Low-density lipoprotein cholesterol , aged 18 to 65 years who fulfill the inclusion and exclusion criteria will be enrolled at 2 to 3 sites in Australia. Eligible subjects will be admitted to the clinical research unit on Day -1, dosed on Day 1, discharged on Day 2 (24 hours post-dose) after completing the 24-hour post-dose follow-up assessments, and return for outpatient visits through Day 85. There will be 4 separate and sequential dose cohorts. The population in Cohorts 1 to 4 (50mg, 150mg, 300mg and 600mg) will include subjects with fasting Low-density lipoprotein cholesterol levels > = 100 mg/dL and 100 mg/dL < = Triglycerides (fasting) < 500 mg/dL who are not on a lipid-lowering therapy.

Hyperbaric oxygen is the provision of oxygen in a compression chamber.The aim of this trial is to test the hypothesis that hyperbaric oxygen treatment (HBOT) may improve symptoms in people with Long-COVID . We will compare symptoms of those allocated to the HBOT to participants allocated to no HBOT.

QUENDA is part of a broader research program aimed at using mobile devices and digital technology to better assess children’s pain. Digital mobile technology (e.g. mobile phones, tablets) can enable pain assessment tools that are interactive and respond to children’s inputs. The broader program seeks to embrace the potential of digital-enabled interactive tools and create new approaches to the assessment of pain that are better for kids, allow more engagement, and therefore give clinicians better insight into children’s pain, and enable better care. QUENDA is the first step in the program and is designed to better understand how children perceive and communicate their pain.

This study plans to determine if splinting in a neutral (straight) position of more effective than buddy loops in preventing reduced extension (straightening) at the proximal interphalangeal joint (middle joint of the finger). Specific hypotheses will address; splinting the PIPJ in a neutral position produces a) a lower average extension contracture of FFD than splinting in buddy loops; b) lower mean pain scores than buddy loops; c) lower mean oedema measure than buddy loops; and d) splinting the PIPJ in a neutral position results in changed Participants will be randomly assigned to one group and both will commence active exercises within the splint or buddy loop. Both interventions will be worn full-time for 3 weeks and then discharged at 5 weeks. Each participant will be treated and assessed by experienced hand therapists (occupational therapists or physiotherapists) and the assessing therapist will be blinded to the treatment group of there participants. Assessment will be undertaken at their initial presentation, weeks' 3, 5 and 8.

This double-blind randomised controlled trial will investigate the the feasibility, acceptability, and efficacy of digital support to improve pain and well-being of people with chronic pain who are reducing prescription opioids. Participants will be patients with chronic non-cancer pain who are commencing prescription opioid tapering (dose reduction). 74 participants who meet the selection criteria will be randomized to receive either an educational video followed by text messages for 12 weeks (group 1) or an educational video (group 2) in addition to their usual care. The digital support intends to increase the self-efficacy to taper prescription opioids. This includes pain management and opioid tapering information, as well as supportive content. The study will evaluate the efficacy of the intervention in improving pain and well-being as the primary objective.