ANZCTR search results

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

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31095 results sorted by trial registration date.
  • The TIRED trial - Transdiagnostic Intervention for Remote Ex-military and first-responDers study

    By the nature of their work, veterans and first-responders are vulnerable to developing difficulties with sleep (e.g. insomnia), and these problems can sometimes affect mental health and vice versa. The aim of this clinical trial is to investigate the effectiveness of a new treatment for sleep disorders called the Transdiagnostic Sleep and Circadian Intervention (Trans-C), and its efficacy when delivered using tele-health (via videoconferencing). In this trial, the Trans-C treatment is provided to veterans and first responders who meet the trial eligibility criteria. Eligible participants will be randomly allocated into one of two conditions: 1) an immediate treatment condition or 2) a wait-list delayed treatment condition (individuals who receive treatment after 12 weeks waiting period). Participation also involves completing a number of clinical interviews and self-report questionnaires over the duration of the trial. Additional daily assessments of sleep quality is also collected using a smartphone app, and objective sleep quality data is collected via a provided actigraph (i.e., watch) worn for the duration of treatment. Early studies using TranS-C intervention are showing that sleep can be improved, as well as benefits gained in mental health and overall well being, and this trial is examining whether similar benefits can be seen when treatment is delivered via telehealth, and if improvements can also be seen in high risk exposed populations such as veterans and first responders. We expect that participants who receive the TranS-C intervention, will demonstrate significant improvements in sleep, as well as other mental health symptoms (e.g., PTSD, depression, anxiety). In addition to this, we expect that participants will be satisfied with the TranS-C treatment, as well as the delivery of the treatment via tele-health.

  • Effects of glycogen availability on human skeletal muscle molecular responses to exercise

    The energy status of skeletal muscle is tightly coupled to the activity of proteins and genes within the network of molecular responses to exercise and the resulting health benefits of exercise. This research project will investigate how protein and gene responses to a single session of exercise are changed when skeletal muscle glycogen levels are altered in healthy adults. A total of 10 healthy, recreationally active males, 18-30 yr of age with a body mass index (BMI) of 18.5-27 kg/m2 will be recruited after providing written informed consent. In the fortnight before the experimental two-legged high intensity exercise session, all participants will complete preliminary testing including a 3-day food record, body composition scan (DXA), fitness testing (VO2 peak test), exercise session familiarisation and one-legged glycogen depletion exercise. This study will use a healthy human model whereby glycogen concentration in the right and left legs of the same individual are differentiated (low versus high glycogen) the evening prior to the experimental day. This experimental design allows us to distinguish between possible systemic and local effects because the systemic concentrations of circulating hormones and metabolites are the same for both legs, yet the local (muscle) glycogen availability is markedly different. On the experimental day, a total of 6 muscle biopsies (including 3 from each leg) and a total of 3 blood samples will be obtained from each participant. These samples will be utilised to determine how exercise-induced changes in protein post-translational modifications (i.e. phosphorylation), protein content and gene expression in skeletal muscle are influenced by glycogen availability. We hypothesise that a single session of exercise with low skeletal muscle glycogen availability will result in greater increases in exercise-stimulated muscle protein post-translational modifications (i.e. phosphorylation) and muscle gene expression (i.e. transcription), but comparable changes in muscle protein content, compared to high glycogen availability.

  • The long-term impact of endometriosis on reproductive outcomes.

    This study is one of nine projects being run as part of a program of endometriosis research recently funded by Medical Research Future Fund Infertility is associated with an increased rate of endometriosis. Surgically treating mild endometriosis has been demonstrated to improve fertility outcomes but studies assessing moderate and severe endometriosis are limited. Even the best studies, however, show that pregnancy rates via natural conception are substantially lower than those seen in fertile women. Laparoscopic surgery to remove endometriosis exposes women to surgical risks including infections, adhesion formation and damage to a major organ. Exposing women to this risk can only be justified if there is a real benefit, either in symptom reduction or with improved fertility. This study will explore the impact of surgical treatment of moderate to severe endometriosis on pregnancy and live birth rates from both natural conception and IVF. In addition, it will seek to clarify whether pre-emptive surgical treatment of endometriosis has an impact on future fertility.

  • Evaluation of a patient and clinician education program for falls prevention in hospitals

    This study evaluates a falls education intervention designed to empower patients to reduce falls by increasing their knowledge and risk awareness, and by supporting behaviour change. This study will also educate and train clinicians on how to deliver this intervention in hospital within an inter-professional context. This study also examines the views of the patients and clinicians on this falls education intervention.

  • Oral Ketamine Trial on people aged 16 years and older with Treatment-Resistant Depression

    This study is an open-label, dose-ranging clinical trial aiming to explore the feasibility, tolerability, and safety of low-dose oral ketamine on treatment-resistant depression. In this 8-week trial, participants will undergo 6 weeks of active treatment followed by 2 follow-up assessments. Additionally to any changes in depressive symptomatology, this study will determine whether the intervention improves rates of anxiety, stress, suicidality, and social and occupational functioning. The study will also explore neurobiological effects of oral ketamine, assessing the treatment mechanisms of action and identifying predictors of response.

  • Airway clearance techniques for individuals with an acute exacerbation of bronchiectasis: a randomised controlled trial

    Bronchiectasis is a chronic lung condition characterised by recurrent flare-ups, which are a common reason for hospital admissions and lead to deteriorating lung function, poorer quality of life and a higher mortality rate. Optimising management of flare-ups is imperative to improve outcomes for individuals with bronchiectasis. National and international guidelines support the inclusion of physiotherapy airway clearance techniques (ACTs) as part of patient care during a flare-up, with further investigation of this highlighted as a research priority. The primary aim of this project is to compare the effects of three different but commonly used ACTs on mucous clearance for adults admitted to hospital during a flare-up of bronchiectasis. Secondary aims are to compare the effects of these three approaches on quality of life, health status, flare-up rates and hospital admissions in a six-month period following hospital admission.

  • Telehealth Voice Assessment by Speech Language Pathologists during a global pandemic using principles of a Primary contact Model.

    The aim of this study is to look at how a speech language pathology (SLP) telehealth assessment contributes to diagnosis and if it can be used to prioritise people with vocal symptoms to urgent or routine visualisation of the voice box for diagnosis. A range of clinical tests are used to assess a voice problem including a detailed symptom case history, listening and analysing the voice quality, and looking at the voice box using a camera inserted in the nose or throat (laryngoscopy with stroboscopy). Some of these are typically completed by an Ear Nose and Throat (ENT) specialist and then an SLP, either in a combined clinic (with both professional’s present) or separate clinics (where one professional makes a referral to another after assessment). Laryngoscopy is the only assessment that cannot be performed in a telehealth appointment but is still important to complete diagnosis. Considering the current global pandemic, many face-to-face assessments have transitioned to a telehealth model to help reduce the risk of virus transmission. In addition, laryngoscopy is being prioritised for urgent patients because it requires additional personal protective equipment (PPE), due to a risk of viral transmission from the nose and throat in patients who may have a contagious virus. Past research has shown that an SLPPC face to face assessment can reduce waiting times for patients, and in most cases, enable them to commence treatment with the SLP without needing ENT treatment. In this model, the SLP sees the patient first and an ENT is still involved in confirming the diagnosis and ensuring the most appropriate treatment pathway has been offered. In this study participants we will use a combination of written information about symptoms provided by the patient and voice assessments completed in a telehealth model to predict how quickly patients need to attend hospital for a laryngoscopy and an ENT diagnosis. We will measure what parts of the SLP assessment help to predict the voice diagnosis, the cost-benefit of the alternative pathway and what consumers think about the alternative model of providing care. We hope to demonstrate that telehealth assessment with a SLP can help to prioritise how urgently a laryngoscopy is needed, whilst also providing strategies to manage symptoms while waiting for this assessment and diagnosis. In addition, we hope this research will help us to understand which parts of the SLP voice assessment can be used to contribute to a diagnosis before laryngoscopy.

  • Is laser acupuncture an effective treatment for shoulder and neck pain in office workers?

    Shoulder and neck pain (SNP) are common and burdensome conditions in office workers with a high prevalence. It is a serious public health problem and has a significant detrimental impact on one’s quality of life, physical functioning, economic structure, families, employers and health care system. Lengthened working hours on the computer, prolonged sitting position, and static postures are the most contributing factors, and medication and physiotherapy were the most common intervention strategies that people chose to manage their pain. The low-level laser therapy (LLLT), also known as cold laser, photobiomodulation, applies specific wavelengths and low power density, has been shown to be an additional option in the SNP management to relive pain and re-establish quality of life. LLLT can promotes analgesic and anti-inflammatory effects, improve blood circulation, boosts immunity and speeds up wound healing, with no reported adverse effects and well received by many patients. Low-level laser acupuncture (LLLA), is one of the recent technological developments (e.g., electroacupuncture) in the practice of acupuncture, which integrate the cutting-edge laser technology and thousands of years old TCM modality. Instead of the needle stimulation on the acupuncture points, low intensity non thermal laser irradiation is applied to elicit the cellular level’s physiologic effects with sufficient energy. It is, therefore, non-invasive, painless, non-infectious and safe to use. LLLA has become increasingly attractive for patients with needle phobias, older people and children. Several studies demonstrated that LLLA is a promising modality in pain management. However, there is no consolidated evidence for LLLA in managing shoulders and neck pain, and more studies in this field are required to provide updated evidence. Therefore, this study aims to provide compelling evidence of the feasibility and therapeutic efficacy of LLLA for office workers with SNP. We anticipate, based on past research, the LLLA we will provide may be helpful in reducing levels of SNP. We hope that the results of our research can be used to inform our knowledge about how to better manage SNP that many office workers are suffering.

  • Menstrual cycle phase effects on performance and fatigue of team sport athletes

    A better understanding of how performance and fatigue are affected by the hormonal fluctuations in different menstrual cycle phases will ensure coaches and sport scientists can make informed and evidenced based decisions relating to the training, recovery and monitoring of female field-based, team sport athletes. This study primarily aims to determine whether physical performance (in countermovement jump, concentric hamstring and quadriceps strength, and 1500m treadmill time trial tests) and markers of fatigue status (maximal rate of heart rate increase, 60s heart rate recovery and ratings of perceived exertion, and responses to the Athlete Sleep Screening Questionnaire and Recovery Stress Questionnaire for Athletes) are affected by menstrual cycle phase. Additionally, it aims to determine whether a change in subjective fatigue correlates to a change in objective fatigue, and if either subjective or objective fatigue correlate to a change in performance.

  • MYSS-HYPE: A pilot study of contingency management for smoking cessation in young people with Borderline Personality Disorder features

    The aim of this pilot study is to investigate whether Contingency Management (CM) is acceptable and safe as an intervention for smoking cessation in young people with Borderline Personality Disorder (BPD) features. Existing patients of Orygen's HYPE clinic (N=40) between the ages of 15 and 25 (inclusive) will receive eight weekly sessions of CM in an open-label pilot study, with assessments at baseline, week 8, and follow-up at 16 weeks. The primary hypotheses are that CM will be an acceptable and safe intervention for cigarette smoking in young people with BPD features.

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