ANZCTR search results

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

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31097 results sorted by trial registration date.
  • Testing the effects of a novel psychological program for adults with chronic pain

    Research to date has found variable success in using attentional bias modification training (ABMT) procedures in pain samples. Several factors could contribute to these mixed findings, including boredom and low motivation. Indeed, the training paradigm is repetitive, which can lead to disengagement and high drop-out rates. A potential approach to overcome some of these barriers is to attempt to increase engagement and motivation through gamification (i.e., the use of game elements) of this task. This clinical trial aims to investigate the effects of a gamified web-based ABMT procedure in a sample of adults with chronic pain. One hundred and twenty adults with chronic musculoskeletal pain, recruited from a hospital outpatient waiting list and the wider community, will be included in this randomised, double-blind, placebo-controlled, 3-arm trial. Participants will be randomly assigned to complete six online sessions of dot-probe non-gamified sham control ABMT, non-gamified standard ABMT, or gamified ABMT, across a period of three weeks. Active ABMT conditions will aim at training attention away from pain-relevant words. Participant outcomes will be assessed at pre-training, during training, immediately post-training and at 1-month follow-up. Primary outcomes include pain intensity, pain interference, behavioural and self-reported engagement. Secondary outcomes include attentional bias for pain, anxiety, depression, interpretation bias for pain, and perceived improvement.

  • Analysis of Patient Outcomes following Platelet Rich Plasma Treatment for Joint Osteoarthritis

    Platelet Rich Plasma (PRP) is a preparation of autologous plasma enriched with a platelet concentration above that normally contained in whole blood. PRP can be used to treat orthopaedic conditions including osteoarthritis, bursitis, muscle strain, tendinitis, and tendinosis. The aim of the present study was to compare the response of knees and ankles following platelet rich plasma (PRP) treatment. It was hypothesised that the application of PRP treatment to non-specific ankle pain cases would result in a significant reduction in self-reported pain.

  • The Bushfire, Respiratory protection, Emphysema, bronchitis and Asthma Triggering Health Effects (BREATHE) study – evaluating the effectiveness of mask and respirator usage against respiratory symptoms in Australian adults with asthma or chronic obstructive pulmonary disease during bushfire season

    The aim of this trial is to determine the impact of the use of surgical masks and P2 respirators compared to outdoor air avoidance on adverse respiratory outcomes during bushfire season in Australia. The research questions/hypotheses that this study seeks to address are: During or after smoke exposure does the use of masks or P2 respirators by patients with asthma and/or chronic obstructive pulmonary disease (COPD), compared with outdoor air avoidance, 1. Reduce the incidence of exacerbations? 2. Reduce respiratory symptoms? 3. Improve quality of life? 4. Cause adverse effects? This research will provide the first clinical efficacy data on mask and respirator use for prevention of smoke-induced exacerbations of asthma and COPD in the world, and will be key to informing appropriate use of such devices for Australians affected by increased frequency of exposure to bushfires and hazardous smoke.

  • The effects of an Oroxylum indicum extract (Sabroxy) on cognitive function in adults with mild cognitive impairment

    In this randomised, double-blind, placebo-controlled study, 80 adults with mild cognitive impairment will be randomly assigned to receive capsules containing either an Oroxylum indicum extract (1000 mg a day) or placebo for 12 weeks. A computer-based assessment and several validated clinician-administered and self-report measures (to be completed at various time points throughout the study) will be administered to assess change in cognitive performance and quality of life. We will also examine changes in blood concentrations of brain-derived neurotrophic factor (BDNF).

  • Long-term Impact in Intensive Care Survivors of Coronavirus disease-19 (COVID-19)

    Long-term impact of COVID-19 on neurological, pulmonary, renal, liver function and health-related quality of life is unknown. We theorise that COVID-19 patients admitted to the ICU will have various degrees of organ dysfunctions up to 2 years post ICU discharge, which could result in an impaired quality of life and prolonged recovery. This is a multi-centre international prospective study in survivors of COVID-19, who required admission to the intensive care unit, to assess the health-related quality of life, the dynamics of organs dysfunction and recovery, cognitive outcome and pulmonary function.

  • Evaluation of the Study Without Stress program for reducing academic stress in senior school students.

    Academic stress is common in secondary school students in the final year of school. This stress increases throughout the academic year and is heightened in the lead up to the major examination period. No interventions have been developed or evaluated to specifically reduce academic stress in this period. This project evaluated Study without Stress, a cognitive behavioural therapy program compared to a wait list control in four Sydney based secondary schools in a randomised controlled trial. The effective of the program was examined at post treatment, as well as at a three month follow up in an intent to treat analysis. The results will provide evidence for the effectiveness of the Study without Stress program for reducing academic stress in final year secondary school students.

  • Allied health and nursing student placements and remote and rural workforce location outcomes study

    Flinders University has a long history of delivering education and training to develop the Northern Territory health workforce. In 2016, Flinders University was awarded a national federal government grant (the Rural Health Multidisciplinary Training Expansion Program) to provide Territory-wide support for work integrated learning placement students from nursing and allied health professions. The grant encourages rural/remote placements as a strategy for recruitment of health professions to the rural/remote workforce. In order to evaluate the effectiveness of this program, this study will track the career location decisions of former placement students and explore the impact of their NT placement on their work choices. This research is a tracking study of the work practice locations of all nursing and allied health students annually for five years after completing a Northern Territory work integrated learning placement. The study will also investigate the factors that contribute to the work location decisions of the participants; and to determine if, and how, a Northern Territory placement influenced career decision-making.

  • Arthroplasty Outcomes in Regional Australia (AORA) A clinical quality registry of patients with hip and knee arthritis treated in a regional area

    This is a prospective, observational registry-based study assessing outcomes of total knee and hip joint replacement surgery. The primary objective of this protocol is to determine predictors of patient outcomes collected routinely as part of the standard clinical pathway for lower limb arthroplasty performed by the participating surgeons. Predictors will include demographics, comorbidities, relevant clinical and operative details, and preoperative patient-reported pain and function measures including the Veterans-Rand 12-item quality of life questionnaire (VR-12), the Knee Osteoarthritis Outcome Score (12-item; KOOS-12), the Hip Osteoarthritis Outcome Score (12-item; HOOS-12), and the MODEMs patient expectations scale. Patient outcomes will include postoperative KOOS-12/HOOS-12 scores, self-rated kneeling ability, the postoperative component of the MODEMs expectations scale, patient satisfaction, and revisions or complications arising as a result of treatment. Recruitment will include all patients presenting with lower limb (knee or hip) pathology to the principal and associate investigators at their consulting rooms. Patients will undergo routine standard of care preoperative work-up, including the collection of demographic information, medical history, radiology, pathology, and functional analysis. Patients will in addition be requested to complete patient-reported outcome measures (PROMs) to enable evaluation of important surgical outcomes as part of the post-operative follow up. The outcomes of individual patients will be monitored up to 2 years postoperatively.

  • Prostate Cancer Screening Study of 50-75 year old men using the combination test of Circulating Tumour Cells (CTC) and Prostate-Specific Markers

    Prostate cancer is the most common in men, and the second leading cause of cancer deaths (25%) in Australia. One-in-Seven Australian men will be diagnosed with prostate cancer by aged 85, with more than 3,300 men dying each year. Our recent research has provided evidence that our new screening test using the ISET®-Circulating Tumour Cells (CTC) Test and Prostate-specific Marker Test, can improve the early detection of Prostate Cancer. Our new prostate cancer screening test is markedly more accurate (True Positives: 99%, True Negatives: 97%) compared to the existing Prostate Specific Antigen (PSA) blood test (True Positives: 25%; True Negatives: 15%). This study will determine the accuracy of a new prostate cancer screening blood test as compared to the current standard screening tests which generally involve blood tests, imaging scans and/or biopsy. Who is it for? You may be eligible for this study if you are a male aged between 50-75 years, either with no history of cancer, or if you have been previously diagnosed with prostate cancer. Study details All participants will be required to provide one blood sample at the time of enrolment into the study, which will be processed using the ISET technology to determine the number and types of Circulating Tumour Cells (CTC), as well as the levels of prostate-specific biomarkers. The CTC test report will be available for discussion with the referring doctor 2-4 weeks after the blood draw. Participants who have a positive Prostate Cancer Screening Test result will be advised to undergo further assessment via imaging and/or biopsy of their prostate tissue. The PET imaging scan will involve injection of a radioactive tracing agent into your arm with a 30 minute delay before the scan is performed. It is anticipated that the scan will take approximately 2 hours to complete. If the referring doctor determines that a prostate biopsy is required, a tissue sample will be taken under local anaesthetic by an experienced doctor. The aim of this research is to determine the accuracy of this simple blood test for the diagnosis of prostate cancer that can be used in the future as a cancer screening tool.

  • Outcomes from the implementation of a telepractice delivered Lidcombe Program service for primary school aged children who stutter.

    In this study, speech pathologists will deliver stuttering treatment to up to 30 primary school aged in Victoria, Australia. Participants will receive treatment delivered via telepractice (i.e. videoconferencing) for 9 months. The treatment is the Lidcombe Program which is a behavioural treatment approach in which parents are trained to implement treatment in the child’s natural environment. Parents are taught in weekly clinic sessions to provide verbal contingencies for stutter-free and stuttered speech in both controlled and naturalistic settings. The Lidcombe Program has previously been shown to be effective when delivered using telepractice. To date however there is no published evidence regarding the use of telepractice delivered Lidcombe Program within a primary school setting. It is anticipated that results from this trial will demonstrate that telepractice has the potential to provide effective accessible direct treatment while maximising workload and travel efficiencies for the speech pathologists,

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