ANZCTR search results

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

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31350 results sorted by trial registration date.
  • Evaluating the efficacy of improved diet on the risk of asthma attacks in children (the ImpACt study)

    Asthma is the most common chronic childhood disease, affecting one in seven children. Many children have asthma flare-ups, which often results in several sick days requiring increased use of medications, such as ventolin, and may lead to an emergency room visit or even a hospital admission. We have conducted studies in adults, which indicate that certain dietary changes can reduce the risk of an asthma flare-up. However, we do not know whether this is true in children. This study will examine whether the frequency of asthma flare-ups in children can be reduced, by making specific changes to the diet. We hope to gain insight into how diet may be useful for managing children with asthma.

  • A Phase II exploratory, open-label, single arm study of BYL719 monotherapy, a selective PI3K alpha inhibitor, in adult patients with advanced breast cancer progressing after first line therapy

    The primary purpose of this study is to determine whether BYL719, an oral selective PI3K alpha specific inhibitor, is a safe and effective drug treatment for adult patients with advanced breast cancer who have progressed after first line anti-cancer therapy. Patients who enrol in this study are required to have their breast cancer genetically characterised so we can understand the mutational profiles of their tumor. Who is it for? You may be eligible to join this study if you are over 18 years old, male or female, with advanced metastatic or locally recurring breast cancer which has progressed after first line therapy. It is a requirement of the study that some of your tumor tissue will evaluated in the laboratory for genetic alterations in their DNA. Regular blood tests will also be required to try to understand if we can detect the breast cancer's abnormal DNA in the blood. Study details All participants enrolled in this study will take the study drug, BYL719, which is an oral selective PI3K alpha specific inhibitor. Dose will commence at 350mg orally daily. This will involve taking tablets daily. Even though the study medication is taken daily, cycles are considered every 4 weeks. Visits to the Oncologist will be required every 4 weeks. Study medication will be continued until disease progression, unacceptable toxicity or requirement for new anti-cancer therapy. Participants will attend regular follow-up visits for up to 2 years in order to evaluate objective response rate, clinical benefit rate, progression free survival, safety and tolerability of treatment. Regular CT and/ or bone scans as well as blood tests will be performed. There will be two cohorts of participants involved in this study – those with advanced/ metastatic TNBC and those with advanced/metastatic ER+/HER2- breast cancers with a genetic mutation in the PI3K pathway. We plan to evaluate the efficacy and safety of BYL719 in these patients and associations with genetic features in order to try to identify biomarkers that can indicate those breast cancers more likely to respond to the study medication.

  • A randomized control trial comparing ultrasound visual feedback and ReST (Rapid Syllable Transition Training) to improve speech in childhood apraxia of speech (CAS).

    A pilot Randomized Control Trial providing treatment for children with Childhood Apraxia of Speech using the ReST treatment or Ultrasound Biofeedback. ReST is a newly developed program, based on motor learning principles. It was shown to be effective in treating CAS in a Randomized Controlled Trial and Single Case Design study. Ultrasound Biofeedback treatment trains articulatory patterns using real-time visual displays of the tongue. It has recently been shown to improve productions of consonants and vowels involving the tongue in several Single Case Design studies. This study aims to compare ReST and Ultrasound Biofeedback results when treating CAS in school-age children. Treatment sessions will be delivered by Speech Pathologist or trained Student Speech Pathologist with no home practice required. Participants will have a current diagnosis of dyspraxia or Childhood Apraxia of Speech who will be between the ages of 7;0 and 16;0 years between May 2015 and January 2016. Participants will also have normal or adjusted to normal hearing and vision; no receptive language disorder; speak Australian English and have no other developmental or genetic diagnoses. The research is being conducted by Dr Tricia McCabe and Dr Jonathan Preston. All clinic- based sessions will take place at the Communication Disorders Treatment and Research Clinic on East Street at Lidcombe. All children will receive treatment 2 days per week for 6 weeks for a total of 12 sessions. Each session will be 1 hour in duration. Speech pathologists worldwide repeatedly report feeling unprepared and underskilled in treating children with CAS (Forrest, 2003) The research literature currently contains no high level evidence and only limited high quality experimental single case evidence. Consequently clinicians use ad hoc approaches to intervention with limited success as the research vacuum prevents practice based on evidence from the literature (Pring, Flood, Dodd & Joffe, 2012). The current research will therefore improve service delivery options and reduce uncertainty for SPs in working with children with CAS and their families. We hope to add to our understanding of how motor learning principles should be implemented for children with CAS. We might find that both interventions are equally effective in facilitating improvement in speech production (beyond pretreatment levels) and even this contribution would be useful, as it may indicate that either program can be used. The current study is designed to be a preliminary investigation that could lead to future funding. Pending the results, effect sizes observed here can be used to drive power calculations for future larger-scale studies that may involve variations on the implementation of the procedures for these approaches.

  • Whole body vibration for osteoporosis: Shaking up treatment options.

    For the many individuals with established osteoporosis who will not, or cannot take medication there are currently no recommended therapeutic alternatives. Calcium and vitamin D are vital but insufficient therapies and are similarly limited by poor patient compliance. Recent evidence suggests high intensity exercise is an effective stimulus for bone. Whole body vibration (WBV) can also be anabolic to the musculoskeletal system. Early research has shown that WBV is a simple, passive therapy with greater appeal to the target population than exercise or drugs. This trial will be the first to use rigorous methods to examine the effects of WBV alone, and in combination with high-intensity exercise, in participants on and off bone medications, to improve risk factors for hip fracture (bone density, balance and muscle strength).

  • An investigation of the relationships between pain, physical activity, sleep and mood in people with Parkinson's disease

    The primary purpose of this study is to investigate if people with Parkinson's disease have the usual reduction in pain threshold following exercise (i.e. exercise induced analgesia). We hypothesize that people with Parkinson's disease will have the usual exercise-induced analgesia response to exercise. The secondary purpose is to investigate the relationships between measures of exercise-induced analgesia with pain, physical activity levels, sleep quality and mood in people with Parkinson’s disease and the relationships between physical activity levels, sleep quality, mood and pain in people with Parkinson’s disease. We hypothesize that increased physical activity, better sleep and better mood will be associated with a better exercise-induced analgesia response and with less pain in people with Parkinson's disease.

  • Peri-Operative Evaluation of Sedation Depth in Cardiac Surgery: Validity and Reliability of Ocular Micro-Tremor (OMT)

    The purpose of this study is to assess monitoring of anaesthetised and sedated patients in intensive care using devices that assess different parts of your brain activity which reflects your level of consciousness and sedation. Sedation management is based on a wide range of factors including variable assessments of amnesia and recall, comfort level, risk of self-injury, and nurses’ judgment. At present the standardised sedation scoring systems such as the Richmond Agitation Scoring Scale (RASS) and the Glasgow Coma Score (GCS) are used frequently by doctors and nurses to manage sedative medication to ensure patient comfort. Monitoring device such as the Bispectral Index (BIS), which measures electrical activity of the brain via small external pads attached to the forehead, is used in patients undergoing general anaesthesia fairly routinely. Comparison of these three different sedation monitoring techniques with the different combinations of standardly used anaesthetics and analgesics will hopefully determine more accurate ways of tracking patient’s sedation levels and improve management in both surgery and intensive care settings. Furthermore, as light sedation is highly desirable in intensive care patients, this study will test the feasibility of using OMT in achieving light sedation more effectively than with clinical scales.

  • Randomised control trial of less Invasive Piriformis sparing Hip Approach: 10 year Follow-up

    To assess the long term quality of the tendon, it’s isometric strength and the clinical outcomes of a piriformis sparing approach to total hip arthroplasty as compared to a standard posterior approach. A randomised, controlled cohort of 100 patients previously followed to the 5 year period will be assessed at 10 year follow-up with clinical scores.

  • Does infiltration of local anaesthesia improve recovery after anterior hip replacement?

    Major joint replacement surgery has an important role in improving the quality of life for many people. As Australia’s population grows and ages, joint replacement surgery will be performed more often. In 2014, over 11,000 hip joint replacements were performed in Victoria alone. Improved postoperative and longer-term mobility and comfort provides benefits not just for an individual, but also for the whole community. The anaesthetist’s role as a perioperative physician means that one clinical responsibility is to provide patients with rapid recovery to an appropriate level of function. This can be achieved by providing effective analgesia, which can be administered well, with few side effects. In practice, there is sometimes a trade-off in the balance between these goals. The widely used technique of infiltrating local anaesthetic into the hip joint during surgery is simple, with seemingly few side-effects. It is usually used together with analgesics such as paracetamol, anti-inflammatories and morphine tablets. However, recent studies have questioned its effectiveness at reducing pain in the traditional surgical approach to hip replacement. To date, no study has examined its effectiveness in the setting of less invasive surgery (anterior hip replacement). We aim to determine whether adding intraoperative local anaesthetic infiltration to standard multimodal oral analgesia will improve recovery after anterior hip replacement. 160 participants will be randomly allocated to receive infiltration of local anaesthetic or saline placebo during surgery. Any improvement in general wellbeing and mobility, or reduction in postoperative pain, will have a positive impact on a large surgical population. A negative result will provide evidence that the local anaesthetic infiltration technique should no longer be used for pain relief after anterior hip replacement surgery.

  • Evaluation of decision aids for parents about the benefits and harms of antibiotic use for coughs and colds in children.

    Acute respiratory infections in children are one of the most common reasons for consulting in primary care. An antibiotic is prescribed in the majority of cases, despite high quality evidence that antibiotics provide marginal benefit for many common acute respiratory infections, which may be outweighed by exposure to common harms (such as diarrhoea, vomiting and rash) and development of antibiotic resistance - now a global public health crisis. Shared decision making - which aims to elicit patients’ expectations, clarify misperceptions, and discuss the best available evidence for treatment benefits and harms - may enable clinicians and parents to choose appropriate treatment or management options, including the decision to not use an antibiotic. Decision aids are a tool that have been shown to improve communication between patients and their doctor, and their active participation in decision making. Therefore, the aim of the current study is to develop and evaluate (pilot) decision aids about antibiotic use for common acute respiratory infections (middle ear infection, sore throat and acute cough).

  • The Australian Capital Territory It's Your Move: a systems based community intervention to prevent obesity among adolescents

    The Australian Capital Territory It's Your Move is a community-based obesity prevention intervention for secondary school students, aiming to promote and support healthy nutrition and physical activity systems. It is expected that students experiencing healthier nutrition and physical activity systems will prevent an increase in the number of adolescents classified as overweight or obesity.

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