ANZCTR search results

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

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31604 results sorted by trial registration date.
  • Dose Adjustment with Food Insulin Index: the DAFII study, comparing carbohydrate counting versus DAFII algorithm for estimating insulin dosage on measures of glycemic control in adults with type 1 diabetes consuming two different breakfast meals

    In this within-subject crossover study in individuals with type 1 diabetes, we will compare two methods of adjusting the dose of insulin to match the nutrients in a meal. One method, known as carbohydrate counting, uses an algorithm (= formula) that matches the dose of insulin to the carbohydrate content of the meal. The second method uses a novel algorithm based on the food’s normal insulin response in healthy subjects (the Food Insulin Index or FII). Participants who are experienced users of insulin pumps will consume three breakfast meals and apply different insulin to food algorithms on 3 consecutive test days. Their blood glucose levels will be monitored using a continuous glucose monitoring system (CGMS) and finger-prick blood testings with a blood monitor over the next 3 hours. We hypothesize that using the novel FII to adjust mealtime insulin dose will improve blood glucose readings (ie reduce hyperglycaemia) without increasing the risk of hypoglycaemia, compared with carbohydrate counting.

  • Health care communication in general and specialist practice

    The aim of this study is to evaluate the effect of consumers asking targeted questions to prompt evidence-based, shared decision making on the frequency and nature of evidence-based, shared decision making behaviours. Asking these three questions improved information given by family physicians and increased physician facilitation of patient involvement. Practice implications. These questions can drive evidence-based practice, strengthen patient–physician communication, and improve safety and quality. Heather L. Shepherd, Alexandra Barratt, Lyndal J. Trevena et al. Three questions that patients can ask to improve the quality of information physicians give about treatment options: A cross-over trial Patient Education and Counseling, 2011 84(3) 379-385

  • Online cognitive behaviour therapy for the prevention of postnatal depression in at-risk mothers: a randomised controlled trial

    The current project is a randomised controlled trial of online cognitive behaviour therapy (MoodGYM) to prevent postnatal depression in at-risk women. To date, there have not been broad scale, cost-effective prevention programs for postnatal depression that have been effective. While the MoodGYM is effective in the wider community, it has never been used in a postnatal population. Although women will need an internet connection to access MoodGYM, major barriers, such as childcare, lack of time, stigma and low clinician availability are all overcome with this intervention. The prevention of postnatal depression in a way that is acceptable to mothers could have the potential to reduce the burden of the most common complication of the perinatal period. Prevention of this illness will result in better outcomes, not just for mothers, but for their infants and families as well.

  • A prospective, observational case series to assess the clinical utility of improved methods of functional hip navigation for total hip replacement

  • The effect of chitosan spray on bleeding and wound healing following tear duct surgery.

    This study is been carried out to investigate the effect of a new drug (Chitosan) on bleeding and wound healing following tear duct surgery that is performed through the nose (endoscopic dacryocystorhinostomy-endoDCR). If this new drug reduces scarring, it may have an effect on the successful outcome of the tear duct surgery (endoDCR). You have presented to the clinic because you have been troubled by a watering eye. The doctor has diagnosed that you have a blockage of your tear duct, which is the passage that links the eyelids to the inside of the nose and allows your tears to drain. The doctor will examine the inside of your nose and providing that there is adequate space, may offer to perform the surgery through the nose. This surgery is called an endonasal dacryocystorhinostomy (endoDCR). If there is not adequate space in the nose, then an external dacryocystorhinostomy (extDCR) may be offered to you. The dacryocystorhinostomy (DCR) operation attempts to create a new route for the drainage of tears between the tear sac and the lining of the nose. The operation can be performed either externally by cutting into the skin on the side of the nose or through the nose as in endonasal DCR. Failure in DCR surgery often results when scarring occurs at the new junction between the tear sac and the nose lining, which can then close over. There have been different steps taken during the operation to reduce this scarring, but it still occurs. A major bleed following this type of surgery can occur in about 2% of patients and is similar to both approaches. This study is looking at the effect of a drug called Chitosan on bleeding and wound healing. This drug is made of 2 components called dextran and chitosan. We will randomly assign patients to receiving either Chitosan or nothing at the end of their endonasal DCR surgery. The Chitosan comes in the form of a spray, which is squirted once over the site of the operation inside the nose. This does not need to be repeated. At each visit you will be examined as part of the routine post-operative care. The inside of the nose will be examined using a nasal endoscope and assessed for evidence of scarring. The clinic visits will be at 1 week, 4 weeks and 3 months following the surgery. There are no additional clinic dates for you as a result of this study.

  • A comparison of fentanyl with pethidine for pain relief during childbirth.

    Pethidine is currently the most widely used narcotic administered systemically for the relief of labour pain, but has been shown to have numerous side effects on both mother and neonate. An alternative narcotic, fentanyl when administered intravenously (IV) has been shown to have fewer side effects and a shorter duration of action than does pethidine. There is a lack of research relating to the use of fentanyl administered during labour via alternative routes. Alternative routes have the benefit of being less invasive, requires fewer resources and provides more autonomy to the midwife providing care. This has particular benefits for rural and remote birthing communities. This study will examine the safety and efficacy of fentanyl administered by intranasal (IN) or subcutaneous (s.c) routes for pain relief during childbirth for both mother and neonate. It also will investigate possible maternal and neonatal side effects. Outcomes will be compared with intramuscular (IM) pethidine.

  • The effect of iodine supplementation on cognition in school-aged children

    The study aims to examine the effect of iodine supplementation on cognition in mildly iodine-deficient school-aged children The research hypothesis is that the cognitive test scores of children taking a daily iodine supplement will improve relative to baseline performance and compared to children taking a daily placebo over the 28-week trial period

  • The sub-chronic effects of coffee on cognitive function in a healthy older population

    This study is being conducted to see the sub-chronic effects of various coffee beverages on cognition, cardiovascular function and mood in healthy older adults. The study will compare the effect of different types of instant coffee beverages. Participants will consume one of four types of coffee beverages daily for 3 months. We will measure performance on different cognitive tasks, mood and cardiovascular measures before the consumption of the coffee beverage (baseline), 1-month after consumption of the coffee beverage and 3-months after consumption of the coffee beverage.

  • A Group-based Cognitive-Behavioural intervention to treat sleep disorders that negatively impact mood, daily functioning and externalising behaviour in adolescents.

    Sleep problems are common during adolescence and have a significant impact on the daily functioning and future potential of young people. This project evaluates the effectiveness of Cognitive-Behavioural Treatment (CBT) for sleep disorders in high-school aged young persons. Young people will take part in a randomised controlled trial in which they will be randomly allocated to complete a 7-week group-based Cognitive-Behavioural program for sleep or a 7-week waitlist control condition. Participants allocated to the waitlist condition will be asked to wait 7 weeks and be assessed again prior to beginning treatment. The effect of treatment will be measured on young persons’ sleep, mood, daily functioning, externalising behaviour and quality of life immediately after completing treatment and 3 months later. Hypotheses: We expect that compared with the no-treatment waitlist group, young people that complete CBT will show: 1) Improved sleep/wake behaviour, including less time to fall asleep, longer total sleep duration, fewer night-time awakenings, and more consolidated sleep. 2) Improved daytime functioning including less reported daytime sleepiness and fatigue. 3) Improved anxiety and depression symptomatology. 4) Improved quality of life. 5) Reduced externalising difficulties on questionnaire measures of disruptive, aggressive and delinquent behaviours. It is expected that treatment gains will be maintained at 3 month follow up.

  • A prospective randomized control trial comparing a non adherent dry dressing with a silver foam dressing in the management of Kirscher wire (K-wire) pin sites in the closed fractures of the hand.

    This study looks at two types of surgical wound dressing used after fixing fractures of the hand with a pin called a K-wire and whether there is a difference in infection rates and the ease of , and pain associated with, application and removal. When a person fractures a bone they may have a closed fracture or an open or compound fracture. A closed fracture is when the broken bone does not penetrate the skin. In this study, we are only looking at patients with closed fractures. In addition, for inclusion in this study, the fracture must be of the hand higher (distal) than the wrist crease. The Kirscher Wire Pin (commonly known as a K-wire) is a sharpened, sterilised metal pin that is used to hold the fractured bone fragments together. After insertion of the K-wire, the wound is dressed and then assessed on a weekly basis for infection. Infection is common (about 10% of cases) because the insertion of the wire through the skin into the bone creates a passage for bacteria. The area around the wire may become red and swollen and there may be a discharge. Antibiotics may have to be prescribed and sometimes the pin needs to be removed prematurely. Current practice involves dressing the wound in Melolin – a dry non-adherent sterile dressing and Mefix – a surgical tape. In this study we would like to compare this dressing with a new anti-microbial barrier dressing which contain nanocrystalline silver. This type of silver has long been known for its antimicrobial properties. The patients would be consented prior to surgery and then randomly allocated one of the two wound dressings. For both arms of the study, the patients will be followed up and assessed in exactly the same manner. If a patient does not wish to participate in the trial the wound will be dressed in the dry dressing as is current practice.

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