ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Planning, timing and quit success: A randomised controlled trial.

    It is currently unclear whether there is a benefit for smokers to act immediately on impulses to quit smoking, and if so, whether delay is detrimental in its own right, or only if the time is not used productively for appropriate planning. It is also unclear whether planning can effectively be carried out after quitting, allowing smokers to quit spontaneously yet still effectively plan for the maintenance of their attempt. The study is designed to untangle these issues, specifically exploring the benefit of structured support and the possible positive effects of recommending immediate implementation, apart from any delay required by the help to be used (e.g., medications that need to be used for a period before quitting). We hypothesize that among smokers who seek help, 6-month sustained abstinence assessed on an intention-to-treat basis will be greater among: 1. Those encouraged to quit immediately as compared with those encouraged to quit to their own timetable; 2. Those who are provided with a structured planning program based around the development of implementation intentions (if-then statements designed to increase the likelihood that a goal is attained), as compared with those only provided motivational messages and general encouragement to plan; 3. And that these two effects will be independent. We will also explore the outcomes as a function of compliance with the recommended strategies, and whether the trial outcomes differ for different outcome measures (e.g. point-prevalence cessation, different imputation strategies for dealing with missing cases).

  • What is the optimal insulin amplitude for a square wave bolus in people with type 1 diabetes

    BACKGROUND: In patients with type 1 diabetes insulin is required to control the rise in blood sugar levels that occurs after eating. Insulin boluses may be given in 3 main ways - a standard bolus (rapid bolus of insulin usually given just prior to a meal), a square wave bolus (a fixed dose of insulin given over a set period of time) or a dual wave bolus (a combination of the previous 2 boluses). AIM: To determine the amplitude (dose) required for a square wave insulin bolus of two hours duration to maintain blood glucose levels (glycaemic control) when a standard carbohydrate (60g) meal is eaten. METHOD: 40 participants between the ages of 7 and 35 years with Type 1 Diabetes on insulin pump therapy will be recruited. The inclusion criteria are HbA1C </= 8%, Body Mass Index (BMI) <91st percentile, no complications of their diabetes and no other medical conditions. During a 1 week lead up to the study blood glucose control will be closely monitored. Participants will be contacted daily-2nd daily by a member of the research team. Adjustments may be made to the participant's insulin pump settings in conjunction with their treating endocrinologist. A continuous glucose monitoring system (CGMS) will be inserted on the first morning of the study. On this morning the participant will need to come to the hospital prior to breakfast. They will check their BGL 1 and 2 hours after insertion of CGMS for machine calibration. Participants will be provided with standard breakfast containing 60g of carbohydrate for each of the 6 days of the study. Insulin for the breakfast will be delivered as a square wave bolus over two hours starting just before the person starts eating. The bolus rate will be based on the participant's insulin: carbohydrate ratio and randomised each day to deliver a different percentage of this ratio (1:1 i.e 100% of the participant's insulin:carbohydrate dose for 2 hours, 1:2 i.e 50% of the participant's insulin:carbohydrate dose for 2 hours, 1:3, 1:4 and 1:6). The 6th bolus will be the participant’s standard bolus dose delivered as per usual practice. After the bolus is completed participants will return the pump to their usual basal rate. Participants should not eat until 4 hours after the test meal. Participants will self-monitor their blood glucose levels (BGLs) according to usual practice. If BGL is >18mmol/L at any time from >/= 4 hours after breakfast a correction bolus will be used. If the BGL goes below 3.5mmol/L or the participant has symptoms of hypoglycaemia at any time then they will eat 15 grams of carbohydrate. OUTCOMES: Primary outcome is the blood glucose excursion at 1 hour. Secondary outcomes include maximal blood glucose increase, maximal blood glucose excursion, time to maximal blood glucose excursion, time in target blood glucose range, area under the curve and hypoglycaemic events.

  • Safer anaesthesia for children with asthma (SAFA trial): Can exhaled nitric oxide (NO) levels predict children at risk for respiratory complications? – a pilot study

    Australia has one of the highest rates of asthma and allergy in the world. Both are strong risk factors for perioperative respiratory adverse events (PRAE), which are the leading cause of critical incidents in paediatric anaesthesia It is already well established that the severity of current asthma, as well as the effect of therapeutic asthma drugs, can be assessed by monitoring exhaled nitric oxide levels. In addition, exhaled nitric oxide levels can be easily measured in children using a simple non-invasive device. The aim of this study is to assess whether the measurement of exhaled nitric oxide levels may be used to identify children at a particularly high risk for respiratory complications. By identifying this at risk group, the anaesthetist will be able to make a more informed decision regarding the optimal time for surgery, as well as institute the appropriate medical management prior to surgery for each individual child. Optimising the anaesthesia management for this high-risk group would be expected to lead to a reduction in perioperative respiratory complications. Since respiratory complications are one of the leading causes for morbidity and mortality in paediatric anaesthesia, such a reduction would lead to a major improvement in outcomes for high-risk children undergoing anaesthesia. In addition to an anticipated reduction in the occurrence of respiratory complications, this study has the potential to reduce the health costs associated with the occurrence of these complications (e.g. unplanned hospital admissions, prolonged hospital stay, additional treatment). We also anticipate that our findings will lead to an improvement in waiting list times, aid the scheduling of surgery, assist in the preoperative identification of children at a higher risk of PRAE and aid the planning of appropriate preventive strategies, thereby reducing the cancellation of surgery. Cancellations have associated adverse economic impacts for the health care system, cause enormous emotional and financial burdens for the child and his/her family as well as engender lack of confidence in the public health care system. To conclude, we anticipate that this study will improve the safety of children undergoing anaesthesia by providing early detection of high-risk patients which will aid the optimal timing of surgery, enhance the anaesthesia management of our patients, help reduce the costs of prolonged hospital stay associated with peroperative complications and optimise waitlist times. Further benefits may include a reduced requirement for critical care facilities, a decrease in unexpected intensive care admissions and enhanced child/parent satisfaction rates.

  • Acupuncture to reduce symptoms of lymphoedema in women recovering from breast cancer

    This study aims to determine whether acupuncture can reduce symptoms of lymphoedema (chronic swelling) in women recovering from breast cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have had chronic swelling (lymphoedema) on one arm present for at least 6 months following treatment for breast cancer. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will receive 12 acupuncture treatments over a period of 8 weeks in a schedule of twice weekly for four weeks then once weekly for four weeks. Participants in the other group will continue to receive their usual care and will not undergo any acupuncture treatment. Participants will be assessed at regular intervals to determine how lymphoedema is affected by acupuncture over a course of treatment. This study will also determine the feasibility and safety of acupuncture.

  • School-based eating disorder prevention: A pilot effectiveness trial of teacher-delivered Media Smart

    This study aims to pilot how well a previously successful school-based eating disorder prevention program works when delivered by teachers rather than health professionals.

  • Appraisal of the LIFT and BioLIFT procedure: initial experience and short-term outcomes of patients with complex anal fistula.

    The surgical management of anal fistulas remains in an evolutionary phase. A new sphinctersaving technique known as the LIFT (ligation of intersphincteric tract) procedure has gained growing interest. Early results together with reports from other authors have been promising with 57-94% success and minimal complications. The use of a bioprosthetic device has been suggested to augment the LIFT procedure (BioLIFT). The purpose of this study is to evaluate and compare outcomes of patients where repair of transphincteric anal fistula was performed using LIFT and BioLIFT techniques. Patients who have undergone LIFT or BioLIFT procedure from 2011-current, by a single surgeon will be retrospectively reviewed. Case notes will be retrieved and data entry performed. Statistical analysis of outcomes will be assessed. Outcomes measures of complications, recurrence, physiology studies performed pre and post operative, will be evaluated.

  • A 12 month randomised controlled trial to determine biomarkers from the gut microbiota as management tools for overweight and obesity

    Microbes influence how much energy we extract from our diet, how we regulate the storage of this as fat, and also on glucose regulation. There are both good and bad microbes. We have found that in overweight or obese persons undergoing weight loss diets not everyone is successful and significantly those who fail to lose weight are also those who fail to change their microbial community composition. In this study we aim to identify microbial signals in stool samples that will allow clinicians to predict which diets will give successful weight loss outcomes (thus avoiding the frustration of diet failures) and also to test how to improve and change a person’s microbiota to a healthy composition.

  • A study to determine the effects of nutrient-containing pellets on the release of gut hormones, and blood glucose and appetite control, in patients with type 2 diabetes

    The purpose of the study is to determine the effects of enterically coated, nutrient-containing (CTM#3) pellets on glycaemic control, the release of gastrointestinal peptides, and sensations of appetite in patients with type 2 diabetes

  • The effect of fructose and high fat feeding on the regulation of hunger and satiety.

    The aim of this project is to determine the effects of fructose feeding on fat-induced weight gain in humans. The hypothesis is that the satiety effect will be greater in those consuming a high fat meal with fructose as oppose to water or non-sugary drink.

  • The effect of the drug resiniferatoxin on the bladder as a treatment for cases of incontinence previously unresponsive to treatment.

    This project involves administering a solution into the bladder to treat incontinence, which ahs already been used in eight countries overseas. Urge incontinence (detrusor overactivity (DO)) is treated with anticholinergic drugs which are generally palliative, not curative. Bladder instillation of vanilloids i.e. capsaicin and resiniferatoxin (RTX) for DO has shown symptomatic improvement for up to 3 months. We wish to offer this therapy for urge incontinent women who have not responded to two anticholinergic drugs. RTX will be instilled into the bladder via a urinary catheter. Women will be assessed at 1 and 3 months by routine measures. This novel project will study which types of DO respond best to the treatment

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