ANZCTR search results

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

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32103 results sorted by trial registration date.
  • Falls Precede Fractures: Examining the Effects of an Online Exercise Program in People with an Osteoporotic Fracture

    This study aims to deliver health care in a novel way by creating an opportunity for people with osteoporosis and osteoporotic fracture to engage in an exercise program within their own home. Participants will be recruited from the Osteoporosis Re-fracture Prevention service at Westmead Hospital and will be randomly allocated to one of two treatment groups: 1) usual care for people with osteoporotic fractures, and 2) usual care for people with osteoporotic fractures, plus participating in a 6-month online exercise program. This study will also have a control group of participants with osteoporosis who have not had an osteoporotic fracture. The findings from this study will help to determine whether an online exercise program can improve the effectiveness of standard bone treatment in reducing the rate of re-fracture and improving other health outcomes for people with osteoporosis and osteoporotic fracture. The study will also provide insight into the safety, adherence and feasibility of an online exercise program for people with osteoporosis.

  • Nocturnal supplemental oxygen for obstructive sleep apnoea in patients with fibrotic interstitial lung disease

    Obstructive sleep apnoea (OSA) affects more than 50% of people with interstitial lung disease (ILD), with inadequate treatment due to poor compliance with current treatments such as CPAP and mouth splints. Supplemental oxygen is a potential treatment for OSA in people with ILD, which is readily available and easy to use, and ovenight oximetry may be helpful for establishing the diagnosis of OSA in people with ILD.

  • The effects of light therapy on daytime sleepiness, fatigue, occupational outcomes and quality of life in individuals following traumatic brain injury

    Excessive daytime sleepiness (EDS) and fatigue are common complaints following traumatic brain injury (TBI). EDS and fatigue interfere with daily activities, including work productivity, and negatively impact quality of life (QoL). Treatment of EDS and fatigue in TBI are therefore paramount. Light therapy has been shown to reduce EDS and fatigue in several clinical populations including TBI, however whether these benefits translate into meaningful outcomes, including enhanced work productivity and quality of life, has not been robustly investigated. The proposed study aims to evaluate the effects of light therapy on EDS, fatigue, work productivity and QoL outcomes in people post-TBI. It is hypothesised that both green-blue light therapy plus sleep hygiene guidelines and sleep hygiene guidelines alone will improve EDS, fatigue, work productivity and QoL outcomes, however green-blue light therapy plus sleep hygiene guidelines will produce an effect greater than that of sleep hygiene guidelines alone.

  • Optimum Diagnostic Testing for Glucocorticoid Induced Hyperglycaemia

    We hypothesise that a random afternoon glucose has superior sensitivity to a fasting blood glucose to diagnose diabetes in patients taking long-term prednisolone. Hyperglycaemia is a known adverse effect of Prednisolone and previous research has demonstrated that the pattern of hyperglycaemia seen in patients taking prednisolone, typically occurs in the afternoon with less of an effect on morning fasting blood glucose levels. In the clinical setting, the diagnosis of diabetes can made via different testing modalities. Taking into account the pattern of hyperglycaemia caused by prednisolone, the sensitivity of each of the diagnostic modalities may vary. As a result, we will compare a random afternoon blood glucose to a morning fasting glucose. These two testing modalities will be compared to the current gold standard test which is an oral glucose tolerance test.

  • 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.

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