ANZCTR search results

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

You can narrow down the results using the filters

31247 results sorted by trial registration date.
  • A descriptive study on prediction of myopic progression in Australian population

    BACKGROUND Myopia is defined as a refractive anomaly of the eye where parallel rays of light from an object at optical infinity are focused in front of the retina when accommodation is at rest. In recent years, the prevalence of myopia has increased dramatically especially in the East Asian population. In the year 2000, the prevalence of myopia was estimated to be 21% in 7 year olds, 61% in 12 year olds and a disturbingly high 81% in 15-year-old Taiwanese school children. While evaluating the causes of visual impairment and blindness in a group of adult Chinese in urban and rural region, it was found that 32.7% was contributed by degenerative myopia. However, the rapid and disturbing increase in the prevalence rates of high myopia over the years’ warrants amending our current knowledge on myopia. The distribution of peripheral refraction profile across different meridians and whether the pattern of distribution of the peripheral refraction can predict the progression of myopia needs to be investigated. The current study is planned to investigate up on a number of optic disc parameters to determine if there is an association between features such as tilt, torsion, RNFL thickness and choroidal thickness and progression of myopia. Analyzing this relationship will help in predicting myopia at an early stage. PURPOSE OF THE STUDY Correlating the peripheral refraction profile and structural variations in the optic disc in different meridians will guide us in identifying potential predictive factors responsible for the progression of myopia. The aim of this study is to determine if risk of progression of myopia can be identified using peripheral refractive error profile, optic disc features and retinal and choroidal thicknesses. STUDY DESIGN A cross sectional and interventional pilot study will be conducted as a first step to derive the required sample size and refine the experimental methods. The sample population aimed for this study is an age group between 18 to 39 years. The study sample will include a minimum of 20 participants to up to 50 participants in individual subgroups of emmetropia, hyperopia and myopia is planned for this pilot study. STUDY METHODS Preliminary examinations will be carried out in order to screen the individuals who fit into the eligibility criteria. The initial examinations included a routine ocular examination comprising detailed history taking, measurement of objective and subjective refraction values, anterior and posterior segment examination and measurement of intra ocular pressures. Participants who meet the inclusion criteria will undergo Shin Nippon auto-refractor and BHVI Eye-Mapper assessments for peripheral refraction profile at different field angles. The order of testing with these 2 instruments will be randomized using http://www.graphpad.com/quickcalcs/index.cfm online software. 3 repeat measurements will be obtained from both the instruments during the assessment by same examiner.

  • Accuracy of electrocardiogram to insert peripherally inserted central catheters (PICCs) in adult hospitalised patients

    Peripherally Inserted Central Catheters (PICCs) are tubes inserted into the veins of patients to infuse medications, fluids and blood products. The ends of these tubes need to sit near the heart to reduce side effects. Commonly live xray (fluoroscopy) is used to make sure the PICC is at the right place. But this is expensive and difficult to coordinate. ECG tracing represents different parts of the heart working and when the PICC is placed near the heart, this tracing will change. Thus, we can see when the end of the PICC is in the correct place. But, there is limited evidence that this system is accurate compared to fluoroscopy and the cost implications are unknown. This research aims to compare the accuracy of an ECG tip verification system (Nautilus Delta) with fluoroscopy and determine the economic implications of a change in practice. Patients already undergoing PICC insertion will be recruited at Fiona Stanley Hospital. The PICC will be inserted the usual way and when the Nautilus Delta ECG system indicates it’s in the correct area, fluoroscopy will be used to verify where the tip is. Hospital and enterprise bargaining information will be used to determine the costs associated with the different systems. Hypothesis: the Nautilus Delta ECG system will be accurate when compared to fluoroscopy and more cost effective

  • Telehealth delivery of memory rehabilitation following stroke.

    About half of all stroke survivors experience memory difficulties, which affects their ability to work, carry out daily activities independently, and enjoy a rich quality of life. Memory rehabilitation programs significantly improve everyday memory function. However, barriers to accessing rehabilitation include geographic location, mobility restrictions, and cost. Telehealth service provision could overcome these barriers, however we lack evidence that this mode of delivery results in the same positive outcomes. This project will compare outcomes of a one-on-one telehealth memory skills program with face-to-face one-on-one and group-based programs as well as waitlist control. This innovative study will be the first to establish whether telehealth approaches to memory rehabilitation are feasible, effective, and cost-efficient. If so, this could improve access to effective rehabilitation and represent a significant cost saving to health services, patients and the community.

  • Oral tranexamic acid to reduce blood loss in patients undergoing total knee replacements

    Background and Significance Evidence supporting the use of tranexamic acid (TXA) in large joint replacements to reduce blood loss and the need for transfusion has been available for many years. To date evidence supports the use of topical or intravenous (IV) TXA, with a recent meta-analysis concluding that the two produced similar effects in the reduction of blood loss due to surgery. Very few studies have investigated the possibility of the use of oral TXA in place of topical/IV. The use of oral TXA has the potential to provide significant financial savings to healthcare facilities, with equivalent quantities of IV TXA ampoules being almost 40-fold more expensive than oral tablets. Aim and method This study aims to identify the non-inferiority of oral TXA in the reduction of peri-operative blood loss when compared to a topical/IV regimen in patients undergoing total knee replacements (TKR). In addition, the effect of pre-operative TXA on surgical blood-loss or total blood loss will be examined, in comparison to post-operative. The study will also investigate safety by incidence of deep vein thrombosis (DVT). The study will comprise of two arms, a study arm which will be treated with and oral TXA regimen and a control arm that will be treated with a currently used topical/IV TXA regimens. The TXA treatment regimens will be as follows: Study: 1g oral TXA 2hr prior to surgery, 1g oral TXA two hours post-surgery and a final 1g oral dose six hours post-surgery. Control: 3g topical TXA perioperatively, 1g IV four hours post-surgery and a final 1g oral dose eight hours post-surgery. Both groups will receive 2.5mg of oral apixaban twice daily for 15 days, commencing 8 hours post-surgery as prophylactic antithrombotic therapy. All procedures will be conducted by the same orthopaedic surgeon and the anaesthetist for the study arm will remain constant throughout. The primary outcome will be blood loss due to surgery. This data will be determined by the amount of blood loss in theatre and the volume collected from the joint drain at ten hours post-surgery. Safety will be measured by the incidence of adverse events attributed to TXA, in particular the incidence of DVT. This will be determined by means of Doppler ultrasound at six weeks post-surgery. Duration and participants The study will be ongoing with an aim of gathering approximately 50 participants in total, i.e. 25 participants per arm. All data will be collected from patients undergoing TKRs at John Flynn Private Hospital, all of which will be conducted by the same orthopaedic surgeon. Patients will be excluded if they require adjustments in the TXA regimen or changes to prophylactic antithrombotic therapy. Patient’s will also be excluded if they are undergoing a TKR revision.

  • Effect of enzalutamide dose reduction on fatigue, cognition, and drug trough levels in patients with prostate cancer

    The primary purpose of this trial is to determine effect of enzalutamide dose reduction on fatigue, cognition, and drug trough levels in patients with prostate cancer Who is it for? You may be eligible to join this study if you are a male aged 18 years or above, have prostate cancer who have commenced enzalutamide within 3 months. Study details All patients will be receiving standard dose enzalutamide (160mg daily). If patients experiences a Grade 3 toxicity or an intolerable side effect, enzalutamide will be withheld for one week or until symptoms improve to at least Grade 2, then resume at the same or a reduced dose (120 mg or 80 mg). Dose reduction will be undertaken in 40mg increments, depending on level of cognition and fatigue impairment. Total duration of the intervention period is at the discretion of the investigator. Fatigue and cognition levels will be assessed weekly and blood samples will be collected every four weeks. We hope that this study will improve the individualisation of the enzalutamide treatment by tailoring the doses to each person's needs

  • Evaluation of intensive risk factor modification in patients referred to a public clinic with chest pain.

    Patients referred to hospital chest pain clinics are often found to have non-cardiac (non threatening) symptoms, but have been found to have a high prevalence of risk factors (eg high cholesterol, smoking) for subsequent cardiovascular events (eg heart attack, stroke). These risk factors are not often formally addressed within a traditional chest pain clinic or cardiology clinic. The chest pain clinic provides an opportunity to identify patients at higher risk of subsequent cardiovascular events. We hypothesize that initiating strategies to modify individual risk factors during this initial visit will assist patients to develop a more favourable cardiovascular risk profile.

  • Ultrasound or landmark for identification of the cricothyroid membrane.

    A small number of patients who are brought to the emergency department need a general anaesthetic. This lets us help them by keeping their airway open and breathing for them, and allows us to perform tests and provide further treatment. In very rare cases, the breathing tube cannot be passed through the mouth. This is a life threatening emergency, and an emergency procedure called a cricothyroidotomy then has to be performed. This involves making a cut in the front of the neck, directly into the windpipe, so that the breathing tube can be put directly into the airway. This is similar to a tracheostomy. The area of the neck where the cut is made is called the cricothyroid membrane, and it is usually identified by feeling the front of the neck with a finger. Recently, it has become clear that ultrasound scans can be used to locate the membrane, but it is not clear if this is more or less accurate than locating it by feel, and whether using an ultrasound takes more or less time. The study aims to compare two groups of patients. One group will have their cricothyroid membrane identified by touch, and the other group will have it identified by ultrasound. The participants in the study, will be randomly assigned (like tossing a coin) into one of these two groups. Immediately before having a CT scan, a doctor will try and locate the patients’ cricothyroid membrane using either touch or ultrasound (depending on the group they are randomised to), and then place a marker (a small metal cross) on the neck, which will be held in place with adhesive tape. After the CT scan, an x-ray specialist will then be able to see whether or not the marker has been placed accurately. We will then compare whether one method is more accurate than the other, as well as how long it took to place the marker. With the exception of (1) the attempt of cricothyroid membrane localisation, via ultrasound or landmark palpation and (2) placing a marker on their neck, the rest of the participants’ care will be carried out as normal.

  • Examining the effects of probiotics on the immune system.

    This study aims to examine the effects of probiotics on immune system function. 120 healthy adults will take part and we will investigate the immune effects of six commercially available probiotics (20 participants in each probiotic group). Participants will take a probiotic for 2 weeks and provide a blood sample on Day 1, Day 8 and Day 15 (the day after their last probiotic dose). We will examine immune system function using the three blood samples provided. This study will provide important information on whether taking probiotics improves the function of the immune system.

  • The Baby-Directed Umbilical Cord Clamping Feasibility Study: The Baby-DUCC Feasibility Study

    Using the PICO format (participants, intervention, comparison, outcome): P: In babies greater than or equal to 28 weeks gestational age at birth I: can umbilical cord clamping be delayed for 60 seconds after newborn end-tidal carbon dioxide levels exceed >15 mmHg (baby-directed umbilical cord clamping)? C: no comparator O: The primary outcome is adherence to study protocol and evaluation of protocol safety. The purpose of this non-randomized feasibility study is to gain experience providing baby-directed umbilical cord clamping (BABY-DUCC) in newborn infants born at 28 weeks or later immediately after birth. BABY-DUCC is delaying umbilical cord clamping after birth to maintain placental circulation and gas exchange and provide respiratory support (if indicated) until lung aeration and pulmonary gas exchange has begun indicating successful neonatal adaption after delivery. This will be a single centre non-randomized feasibility study in babies born at a gestational age of 28 weeks or later at the Royal Women’s Hospital. We plan to provide respiratory support to the newborn infant with the umbilical cord intact. The umbilical cord will then be clamped after physiologic changes indicating a successful neonatal adaption has begun, based on end tidal carbon dioxide monitoring. Specifically, umbilical cord clamping will be delayed for 60 seconds after the newborn’s end-tidal carbon dioxide is measured at >15 mmHg. The clinical team in charge of the care for the baby will use a portable BABY-DUCC warming mattress allowing the evaluation and initiation of respiratory support to occur next to the mother. Specifically, the portable BABY-DUCC warming mattress will be equipped to provide heat to the newborn (chemical heating packs or electric warming mattress) and a dedicated study “respiratory support pole” with the ability to provide blended oxygen, CPAP, positive pressure ventilation, heated and humidified gas, and suction. We will monitor and record end tidal carbon dioxide, tidal volume, pulse, and saturation of peripheral oxygenation using the NM3 Respiratory Monitor, heart rate via electrocardiographic electrodes or portable ultrasound machine, and a high definition audio/video recording of the events. All physiologic information will be converted from analog to digital signal and recorded at 100 Hz using a custom built software program called the BABY-DUCC Data Acquisition System which presents the data in graphical and table form for analysis. In addition to the standard medical staff attending the deliveries, two dedicated members of the research team will be present at each delivery to review the study protocol with all the clinical staff in the delivery room (including staff looking after the mother), confirm with the clinical teams that there are no increased risks to the mother’s or baby’s health that would preclude attempting the BABY-DUCC protocol, set up the study materials, and carry out the study protocol.

  • Normal saline instillation and lung recruitment with paediatric endotracheal suction

    In the presence of a critical illness a child may require mechanical ventilation to support their breathing. In the intensive care unit this is achieved through the insertion of an endotracheal tube. This tube serves as the child’s airway and is cared for by a nurse. The nurse removes mucous from the tube by performing an endotracheal suction (ETS). Saline is often used with ETS. Saline use is thought to help loosen dried mucous and prevent it from blocking the tube. Researchers have shown suction is important to prevent complications which arise from retained airway mucous, however, there is no quality research regarding saline use with suction to help guide nurses ETS practice. ETS is associated with a number of complications including pulmonary derecruitment. Collapsed alveolar negatively impair gas exchange and may be colonised by bacteria leading to nosocomial infection and ventilator associated pneumonia. The use of lung recruitment following ETS may help to restore pulmonary volumes and prevent harmful, accumulative atelectasis. We will compare ETS in mechanically ventilated children with i) normal saline instillation (NSI) and no NSI and ii) lung recruitment (LR) and no LR. The primary outcome is trial feasibility as determined by a composite analysis of recruitment, retention, protocol adherance and missing data. Secondary outcomes include measures of gas exchange, respiratory mechanics and ventilator associated pneumonia. Research examining ETS best nursing practice is lacking. Leaving nurses to make ETS related decisions in a vacuum of evidence. These decisions can influence the outcomes of critically ill children. Conducting research in paediatric populations is challenging and piloting trial protocols prior to committing the resources needed for a definitive trial helps maximise the efficiency of the trial and processes.

Tags:
  • Finding clinical trials