ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31604 results sorted by trial registration date.
  • Stratified care integrated with eHealth for low back pain: a feasibility randomised controlled trial

    Long waiting times stop many Australians with musculoskeletal pain (eg. back pain) from receiving effective, affordable treatment, particularly the 55% of Australians who do not have private health insurance. Long waiting times can delay recovery and lead to worse symptoms that become difficult to treat and require more intensive, costly clinic-based treatment. In many public hospitals, patients with musculoskeletal pain are seen in the order they join the waiting list, with little consideration for the severity of their condition. We want to develop and test a new treatment system where patients with less severe musculoskeletal pain are managed using less resources (eg. brief virtual appointments, mobile App exercise programs) and patients with more severe symptoms are provided fast access to clinic-based care. The aims of this project are to: i) determine the feasibility of delivering this treatment system (‘Rapid Virtual Care’) to patients in a physiotherapy/rheumatology clinic in a public hospital; and ii) determine the feasibility of conducting a larger research study in multiple public hospital clinics that will determine whether this treatment system (‘Rapid Virtual Care’) reduces waiting times Results from the larger research project will determine whether Rapid Virtual Care can reduce treatment waiting times for people with severe musculoskeletal pain while not compromising outcomes for patients with less severe symptoms who are provide less care.

  • A single-site study of the effectiveness of Dapagliflozin for diabetic patients admitted to the intensive care unit

    Type-2 diabetes (T2DM), a disease of abnormal blood sugar control, is known to contribute to poor immune function, impaired wound healing and increased risk of heart disease, kidney disease and stroke. When patients who have T2DM are admitted to intensive care they receive a range of routine therapies to support their condition. However, the effectiveness of these current therapies is affected by abnormal blood sugar levels and it would be desirable to restore a normal blood state quickly. Over the last few years, evidence has emerged that Dapagliflozin, a blood sugar lowering drug that can be administered as a tablet, may help to return blood sugar levels to normal with minimal or no side effects. This drug has also been shown to slow the progression of heart and kidney related complications of diabetes. This makes treatment with Dapagliflozin potentially desirable in patients with T2DM who are admitted to the intensive care unit. However, the effect of Dapagliflozin in such complex and very sick patients has not yet been studied. For this reason, we are planning to perform a clinical research project, known as a randomised controlled trial. We aim to evaluate whether giving oral Dapagliflozin (10mg daily for up to 28-days while in ICU) compared to placebo (a dummy tablet), normalises blood sugar levels and \ or decreases the need for insulin in 40 patients with T2DM admitted to intensive care. Importantly, should our findings demonstrate safety and potential benefit, it will allow this treatment to be studied in larger groups and, perhaps become a standard of care for the many patients with T2DM who are admitted to the intensive care unit each year in Australia and potentially worldwide.

  • Pain relief following Mirena Intrauterine Device (IUD) insertion: vaginal Diazepam vs placebo

    Levonorgestral-releasing intrauterine devices (LNG-IUS), such as the Mirena (Bayer), are being increasingly prescribed in Australia. Despite their proven efficacy in contraception, heavy menstrual bleeding and pelvic pain, overall population usage remains low. One of the contributing factors to this is thought to be fear around pain with and following IUD insertion. 59% of nulliparous women reported moderate to severe pain in the first 24 hours following LNG- IUD insertion, reducing to 31% from 24-72 hours. Vaginal administration of diazepam has been proposed as a treatment for pelvic floor muscle spasm and is recommended for this indication by the Pelvic Pain Foundation of Australia. Diazepam acts as a muscle relaxant and vaginal route of administration prolongs the half-life while allowing local administration. Oral preparations are currently being evaluated (clinicaltrials.gov), however, to our knowledge, no data exists on the impact of vaginal Diazepam administration following IUD insertion. Our aim is to evaluate the impact of a dose of vaginal diazepam following insertion of the Mirena IUD in an outpatient setting on pelvic pain and cramping. We hypothesise that patients will experience a reduction in post-insertion pain compared to placebo.

  • Investigating the effect of topical testosterone cream on bone loss and sexual function in women with premature ovarian insufficiency and early menopause: a randomized, double blind, placebo-controlled trial..

    The purpose of this research is to determine whether the use of a topical testosterone cream prevents bone loss and improves sexual function in women with premature ovarian insufficiency (POI) and early menopause who are taking a standard dose of estrogen. We hypothesize that 0.5ml of testosterone cream, versus placebo, applied daily for 12 months will result in a clinical improvement in total hip bone mineral density in these women, and other markers of musculoskeletal health, as well as improvements in sexual function and reduced sexually associated personal distress. The purpose of this research is to determine whether the use of transdermal testosterone therapy, in a dose shown restores testosterone levels to those of premenopausal women, prevents bone loss and improves sexual function in women with POI who are taking the standard dose of estrogen.

  • Observing Risk Factors for Heart Disease in Inflammatory Bowel Disease

    Atherosclerosis is a disease that is thought to be primarily inflammatory in origin. It is well established that patients with inflammatory diseases, including inflammatory bowel disease (IBD), are at higher risk of experiencing poor cardiovascular outcomes. Recent studies have shown having active disease seems to be the key driver for these outcomes in IBD patients. We aim to look at whether commencing treatment for IBD in patients who are at high risk of developing these poor cardiovascular outcomes reduces their risk.

  • A study of psilocybin-assisted psychotherapy for treatment-resistant depression (TRD)

    This open-label trial will investigate feasibility and efficacy of psilocybin-assisted psychotherapy for treatment-resistant depression. Individuals will be thoroughly screened to ensure they meet all eligibility criteria before entering the trial. All participants will receive the trial treatment. The treatment consists of two psilocybin dosing sessions (second dose optional), preceded by 3 preparatory psychotherapy sessions and followed by 3 integrative psychotherapy sessions. Participants will be under the care of a specialist team of two psychotherapists throughout the intervention. Participants will undergo multiple assessment sessions throughout the trial and there will be a long-term follow up assessment 20 weeks after the second dose. Where possible, assessments will be conducted via online surveys. Some assessments need to take place at the study site; these will be at baseline, 1 day, 3 weeks, and 20 weeks after dose 2. Assessments include questionnaires, cognitive and social processing tasks, fMRI scans, blood samples, and semi-structured interviews. It is predicted that this treatment will be effective in reducing symptoms of depression in those with treatment resistant depression.

  • Workplace evaluation of online procedures to manage risk of both musculoskeletal and stress-related mental health disorders.

  • A pilot study for delivering self-care strategies for psychological distress in university students using a smartphone app.

    This study is a pilot to inform a larger RCT that will use Artificial Intelligence (AI) and adaptive trial methods to discover the most effective treatments to provide to Australian university students, 25% of whom experience severe psychological distress and, consequently, drop out of study or go on to develop more severe psychiatric disorders in their peak years. Both the pilot study and the planned RCT (to be registered after this pilot study) will compare app-delivered self-care intervention for psychological distress in tertiary students based on mindfulness, physical activity and sleep hygiene, with an active control condition consisting of Ecological Momentary Assessment (daily mood monitoring). The current pilot study aims to test the feasibility of the study infrastructure, including study app, intervention content, and the algorithm.

  • The Youth Pain Course: An Internet-delivered psychological pain management program for adolescents with chronic pain

    The primary objective is to evaluate, through a randomised controlled trial, the clinical efficacy of an Internet-delivered pain self-management program, the Youth Pain Course, for adolescents with chronic pain. Clinical efficacy will be assessed through clinically meaningful (>30%) improvements in primary (physical functioning) and secondary (pain effects, emotional functioning, role functioning) outcomes at post-treatment. We hypothesise that: (a) The Youth Pain Course will result in improvements in physical functioning at the completion of treatment; (b) The Youth Pain Course will result in improvements in pain effects (intensity, frequency, affect and cognitions), emotional functioning (anxiety and depressions symptoms), and role functioning (quality of life, school presenteeism and absenteeism) at the completion of treatment; and (c) Improvements on primary and secondary outcomes will be maintained at 3- and 12-months post-treatment. The secondary objectives of this project are to explore predictors and moderators of treatment response to guide program improvements and research directions. These objectives are exploratory, and no specific hypotheses can be made; however, the results of these analyses will guide the further development, evaluation and eventual deployment of the treatment.

  • Assessment of food-specific IgG4 directed elimination diet in eosinophilic oesophagitis

    Eosinophilic oesophagitis is a chronic allergic, inflammatory disorder that leads to oesophageal dysfunction. The underlying eosinophilic inflammation seen on biopsy manifests itself clinically with symptoms such as dysphagia (difficulty swallowing), food impaction and heartburn. The mainstays of therapy include both pharmacological and dietary modifications. Elimination diets involve patients empirically eliminating all common allergens with gradual re-introduction and reassessment to then identify the offending food antigen(s). Although studies have demonstrated the efficacy of elimination diets in EoE, the high level of dietary restriction, duration of intensive follow-up and requirement for multiple endoscopies limits patient participation. Consequently, finding a process to identify the offending food allergens for a targeted elimination diet would be beneficial. The purpose of this study is to test the effectiveness of using food-specific IgG4 (FS-IgG4) to direct a targeted elimination diet in patients with eosinophilic oesophagitis. The effectiveness will be determined by clinical assessment with a symptom survey, as well as histological improvement (via endoscopy and biopsy).

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