ANZCTR search results

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

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31194 results sorted by trial registration date.
  • Mirena for treatment of polyps

    Objective – To test the hypothesis that the LNG-IUD can have a role in the treatment of endometrial polyps confirmed at outpatient hysteroscopy in premenopausal women. Design - We designed a case control study, in which premenopausal women who had a polyp diagnosed at outpatient hysteroscopy and had a LNG-IUD inserted were booked for GA hysteroscopy and polypectomy through the standard booking process. A contemporaneous control was taken sequentially from the outpatient hysteroscopy database to match the case. Results - A total of 39 patients were included in the study, with 19 in the exposed group and 20 in the control group. The mean age was 43.6 (SD = 5.6) and 43.2 (SD = 8.1) in the two groups, respectively. No difference was found in time interval between the two procedures in the intervention and control groups (mean 92 vs 84 days, p=0.73). However, the proportion of polyps present at second procedure was significantly higher in the control group (80% vs 37%; relative risk (RR) 2.17; 95% CI [1.16, 4.07]; p=0.0062). Conclusion – Our case control study found that the LNG-IUD can have a role in the treatment of polyps for women who have heavy menstrual bleeding. This is the first study to show regression of endometrial polyps post treatment with LNG-IUD by direct visualisation at hysteroscopy.

  • A Participant Rotation Magnetic Resonance Imaging Study

    Background: Current radiation therapy requires a radiation beam to be rotated around a patient. An alternative approach is to rotate a patient while the radiation beam remains stationary. Such a system may greatly reduce the costs of radiation therapy and would simplify the incorporation of radiation therapy with Magnetic Resonance Imaging (MRI), which would allow therapists to deliver treatment with greater precision. Since this approach has never been utilised for either radiation therapy or in combination with MRI, the acceptance of the rotation to cancer patients is not known. It is also unclear how this rotation will impact the position and shape of the body’s internal organs and subsequently on the radiation therapy. The rotation will have no impact on the organ functions. This study aims to bring patient rotation in MRI closer to reality, which would reduce the costs and complexity of radiation therapy. The participant rotation device used for this study is not a medically approved device. All other devices used in the study, including the MRI, are medically approved. Who is this for? You may be eligible for this study if you have a current or previous diagnosis of cancer. Study Details: The study will be discussed with you at the time of your clinic appointment or prior to the MRI imaging session. You will have the opportunity to discuss the study with a qualified physician. Written informed consent will be obtained prior to registration on the study and before any assessments are performed. Prior to the MRI imaging, you will be asked to complete a questionnaire, where you will be required to rate your current levels of anxiety, claustrophobia and motion sickness. The questionnaire will take approximately 5 minutes to complete. During the imaging session, you will be asked to lie down on the couch on your back, supported by cushions under your back, head and knees. You will then be fastened with belts around the legs, across the chest and across the forehead and will be made as secure as possible without causing discomfort. Once you are comfortable, three inflatable air-cushions will be placed around you, the air cushions will then be inflated to support the weight of your body and restrict movement during the rotation. You will then be inserted into the MRI by the clinical investigators. They will then manually rotate the device to 45 degrees, and reposition you back in the MRI bore for each scan. The device will not rotate during the imaging.The whole imaging session should last approximately 40 minutes. You will be monitored constantly during the study in addition to holding a distress buzzer. Following the imaging, you will again be asked to complete the questionnaire to assess any change in your levels of anxiety and motion sickness. At the end of the session you will be asked a series of open ended questions relating to your experience. The full session will take 2 hours.

  • INB03 for patients with metastatic cancer with increased inflammatory biomarkers in peripheral blood

    The purpose of this study is to determine the safety and tolerability of INB03 in patients with metastatic cancer. Who is it for? You may be eligible for this study if you have epithelial cancer of the lung, breast, upper or lower gastrointestinal tract, kidney, or skin (melanoma only). Study details. All participants will receive INB03 subcutaneously once a week for up to 9 months. There will be three groups who each receive a different dose. As a part of the clinical research study patients will have regular blood tests, physical examinations, will have to complete short questionnaires on their depression, sleep and fatigue. This is first in the human clinical research study and its results will help to determine if INB03 is safe and is tolerated well. Dose of INB03 selected in this study will be used in future study intended for patients with metastatic cancer.

  • Airway collapsibility as an indicator of perioperative adverse event risk and obstructive sleep apnoea

    This project is an observational study assessing upper airway collapsibility and peri- and post-operative adverse events in patients undergoing surgery not related to the head, neck, airways or chest. Demographic and anthropometric (height, weight, neck circumference, Mallampati) information will be recorded and a STOP-Bang assessment performed prior to surgery in all consenting patients. Following surgery, prior to transfer to the recovery room, assessment of airway collapsibility will be performed using the Pclose technique. In addition, all adverse events including respiratory adverse events (respiratory depression (rate & depth), desaturation events, requirement for re-intubation or other medical intervention including unplanned initiation of positive airway pressure therapy) will be documented as well as length of stay in hospital and planned and unplanned intensive care unit or high dependency unit admissions. Within 3 weeks of surgery, sleep apnoea severity will be ascertained in a subgroup of consenting participants with a reliable home monitoring device (ApneaLink). The expected outcome of this research is to demonstrate that Pclose is a suitable method for quickly identifying the presence of abnormal airway collapsibility in surgical patients and that airway collapsibility, as measured by Pclose, is greater in those people who experience post-operative adverse events. This will then potentially enable high-risk patients to be stratified to the appropriate level of care and improve post-operative patient safety. It is hypothesised that more adverse respiratory events will occur in those patients with the greatest airway collapsibility. In addition, a measure of airway collapsibility in the early post-operative period may provide a useful tool for identifying patients at high risk of OSA beyond the perioperative period. In those patients, it is hypothesised that airway collapsibility will be greatest in those with the most severe OSA and lowest in those patients without OSA.

  • The MASTER Coaching Program: Creating positive sporting experiences for players through coach education

    The primary aim of this study is the evaluate the impact of a coach development program for improving coaching practices and player outcomes with a cohort of community level netball coaches (using a randomised controlled trial) Based on previous findings with football coaches (pilot study), it is anticipated that coaches participating in the program will demonstrate significant improvements in: 1. The coaching environment (with reference to the MASTER framework) 2. The quality of their training sessions (use of playing-form activities within training sessions and learning opportunities) 3. The quality of coach feedback during training sessions

  • Cardiac Magnetic Resonance Imaging in Heart Transplant Rejection Detection

    Comparing safety outcomes of patients treated based on Cardiac MR/ imaging screening of acute rejection compared to endomyocardial biopsy guided screening. The imaging technniques used will be a combination of tissue characterisation, strain and ventricular function on CMR and TTE. Objectives: Primary Safety Outcomes Endpoints 1) Frequency and severity of cardiac rejection 2) Frequency and severity of serious infections 3) Cardiovascular morbidity 4) Cardiovascular hospitilisation 5) All cause for hospitilization 6) Death 7) Biopsy - related complications 8) Frequency and severity of cardiac allograft vasculopathy as determined by CTCA or Invasive angiography at 1 year 9) Total immunosuppression required 10) Measures of tissue characterisation and myocardial performance by CMR and TTE utilising in addition CMR strain and TTE global longitudinal strain

  • The effect of lens diameter on orthokeratology lens centration

    Orthokeratology (OK) lenses are specialised rigid contact lenses that are worn overnight during sleep in order to reshape the front surface of the eye to temporarily correct short-sightedness or myopia. The traditional approach to improve centration of conventional rigid contact lenses on the eye involves increasing total lens diameter. Similarly, it has been proposed that increasing the diameter of an OK lens will improve lens centration. However, this has not yet been comprehensively investigated. Therefore this research study aims to explore the influence of OK lens diameter on lens centration. This study is significant, as it will provide insight into methods to improve the fitting and efficacy of orthokeratology lenses for myopia correction.

  • A Feasibility Study of An Online Mindful Well-being Course.

    The current study aims to conduct a primary investigation of the feasibility and effectiveness of an online-based ‘Compassion based mindfulness course’ that is self-directed (low interaction) compared to a highly interactive (collaboratively based) online course on psychological well-being outcomes. The present study aims to address prior methodological issues by evaluating the impact of the online course using an adequately powered parallel randomised controlled trial design to increase well-being in a student sample. Whilst monitoring levels of engagement to determine the effectiveness of the delivery and use of the online space. In addition, assessing the levels of engagement against course completions.

  • Validating a new system for measuring pressure beneath feet lacking sensation

    Foot ulcers are a frequent complication of diabetes. These wounds can be serious, and may result in amputation or even death, if left untreated. A frequent cause of these wounds is high pressure under the foot. Prevention of such wounds is of great importance. This is especially the case in people who cannot feel touch or pressure on their foot, which is called peripheral neuropathy, or an insensate foot. Reduced foot sensation can prevent people from noticing when high pressure develops and this places them at high risk of developing foot ulceration. Clinical guidelines recommend the provision of protective footwear and pressure relieving insoles in the prevention of ulceration in the insensate foot. This needs to be guided by measuring pressure under the foot and subsequent modification of footwear or orthoses to provide optimal conditions for the prevention of ulceration. Many systems exist to measure pressure beneath the foot to determine how effective pressure relieving strategies are. Current validated systems consist of high numbers of sensors but are expensive, which limits implementation into routine clinical practice, and can be difficult to use for untrained clinicians. In this study, we will test how well an affordable portable multi-point pressure sensor module measures pressure at key sites during normal, overground, walking and whilst changing from sitting to standing and back. We will compare this to a validated gold-standard reference pressure measurement system. Clients of the Metro North Hospital and Health Services (MNHHS) community-based High-Risk Foot Clinic (HRFC) with peripheral neuropathy and no current foot ulcers will have pressure measurements taken prior to routine follow-up care. The results obtained from portable multi-point pressure sensor module will be compared to results from a laboratory insole testing system, which is considered to be “gold standard” for the measurements. Fifteen participants with diabetes mellitus type 1 or 2 and peripheral neuropathy will be included in the study. People with severe peripheral artery disease, a foot wound, severe foot deformities or unsteadiness in normal walking will be excluded from the study. When the study is finished, we will know if the portable multi-point pressure sensor module gives similar results as “gold standard” measurement system.

  • Personalised advice and instructions for pain relief following discharge from ED (PAIN study)

    This research project is called "Personalised advice and instructions for pain relief following discharge from ED". This research project is aiming to study the ways doctors and nurses to give pain relief instructions to patients who are being discharged from the emergency department. We are particularly interested in whether personalising the pain relief instructions and making them print outs and accessible on mobile phone is useful for patients. We aim to use the information from this research to improve the ways we provide pain relief instructions to patients leaving the emergency department.

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