ANZCTR search results

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

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31373 results sorted by trial registration date.
  • Can cervical auscultation improve the diagnosis of aspiration in children?

    Background: Oropharyngeal aspiration (OPA) can lead to recurrent respiratory illnesses and chronic lung disease in children. Current clinical feeding evaluations (CFE) performed by speech pathologists have poor reliability in detecting OPA when compared to radiological procedures such as the modified barium swallow (MBS). Improved ability to diagnose OPA accurately via clinical feeding evaluation potentially reduces reliance on expensive, less readily available, radiological procedures. Our study investigates the utility of adding cervical auscultation (CA), a technique of listening to swallowing sounds, in improving the diagnostic accuracy of a clinical feeding evaluation for the detection of OPA. Aims of the study Our study investigates the utility of cervical auscultation (CA) in the assessment and diagnosis of OPA in children. The primary aim is to determine whether the clinical feeding evaluation (CFE) combined with CA increases the detection of OPA determined by MBS, compared to the clinical feeding evaluation (CFE) only. We hypothesize that the use of CA (compared to not using CA) as an adjunctive clinical tool to assess oropharyngeal dysphagia, improves the detection of OPA in children as assessed with the current gold standard, MBS.

  • B-AWAKE - The effect of muscle relaxants on the performance of the Bispectral Index depth-of-anaesthesia monitoring device.

    The Bispectral Index system (BIS) is an electronic device used during anaesthesia to determine whether or not a patient is "awake". A previous study reported that when fully awake subjects were given the muscle relaxant suxamethonium, the BIS system incorrectly reported that they were anaesthetised. Our study will investigate the effect of the two muscle relaxant drugs suxamethonium, and rocuronium, in awake volunteers, to confirm whether or not the BIS system behaves in this manner.

  • Do people with severe traumatic brain injury benefit from making errors? A randomized control trial of the efficacy of error-based and errorless learning training

    Poor skills generalization poses a major barrier to successful outcomes of rehabilitation after traumatic brain injury (TBI). Error-based learning (EBL) is a relatively new intervention approach that aims to promote skills generalization by teaching people internal self-regulation skills, or how to anticipate, monitor and correct their own errors. This study aims to compare the efficacy of EBL and errorless learning (ELL) for improving awareness of deficits, skills generalization and long-term social outcomes after TBI.

  • The impact of exercise and exercise-related reductions in insulin pump basal delivery on blood insulin levels in type 1 diabetes

  • The Maternal Pertussis Randomised Control Trial: best practice for the communication of pertussis booster vaccine recommendations to new mothers.

    The cocooning strategy, which was implemented in Australia in 2009, can have a strong protective effect (indirect) against pertussis in infants. To achieve high maternal coverage, understanding maternal attitudes and other potentially influential factors is important. In this study, we examined the influence of baseline attitudes, modifiable factors and health message framing on pertussis booster vaccine uptake among postpartum women in the hospital setting.

  • Fish oil in recent onset rheumatoid arthritis: High versus low dose fish oil on a background of dose-responsive combination disease-modifying anti-rheumatic drugs.

    The omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) can suppress synthesis of the omega-6 pro-inflammatory eicosanoids, prostaglandin E2 and leukotriene B4. Meta-analysis of 10 randomised controlled trials (RCTs) in 1995 reported that fish oil supplementation reduced tender joint count and duration of morning stiffness. Meta-analysis in 2007 of 17 RCTs of fish oil in inflammatory joint pain included 14 RA studies and reported a benefit of fish oil for patient assessed pain, morning stiffness, number of painful and/or tender joints and NSAID consumption. Collectively, these studies determined that symptomatic benefits were seen above doses of 2.7g EPA+DHA per day after a delay of 2 to 3 months. There were at least two features common to these RCTs that are problematic for demonstrating the potential for use of fish oil in RA. Firstly, participants had established disease with the average disease duration being 10.2 +/- 5.2 years across all studies. Secondly, DMARD use was not ‘real life’. DMARDs were held constant with the need for change being a withdrawal criterion, or if drug variation was allowed, it was not according to pre-defined rules. This is an investigator-initiated, double-blind RCT with fish oil in recent onset RA with disease duration < 12 months, using a study design which addresses some of the shortcomings of previous RCTs of fish oil in RA. A treatment algorithm for DMARD use that is responsive to disease activity and tolerability / toxicity, according to pre-defined rules, allows the extent of DMARD to be used as an outcome measure.

  • The effects of communication styles on the pain and anxiety experienced by patients during subsequent painful procedures.

    We intend to assess the effects of negative suggestion / communication styles on the patient's perception of pain and anxiety during subsequent multiple painful procedures (Local anaesthetic injection, IV cannulation and combined spinal epidural insertion). We will compare these outcomes with the effects that positive suggestion / communication styles has on perception of pain and anxiety during subsequent multiple painful procedures (local anaesthetic injection, IV cannulation and epidural insertion). Null hypothesis = negative or positive styles of communication before painful procedures will have no effect on patient's perception of pain and anxiety during subsequent multiple painful procedures.

  • Impact of nasogastric tubes on swallowing physiology in older healthy volunteers: A randomised controlled trial

    A nasogastric tube (NGT) may be inserted into the nostril and passed down through the pharynx (throat) to the stomach to feed patients who are unable to swallow or are unable to eat and drink adequate amounts. If a patient starts or continues eating with a NGT in place, clinical experience suggests the presence of a NGT within the pharynx may in fact interfere with swallowing and hinder a patient’s return to oral intake. Changes in swallowing due to NGT presence have been shown in young volunteers, but not investigated in older individuals. With increasing age we get changes to the normal swallow. As a large proportion of patients requiring NGT feeding are elderly it is important to understand what impact, if any, a NGT might have on an ageing swallow. The aims for this study were to determine what effects, if any, fine-bore and/or wide-bore NGTs have on: (1) airway penetration-aspiration, (2) pharyngeal residue, and (3) duration of pharyngeal transit in older healthy adults.

  • Breaking up prolonged sitting with walking and brief simple resistance activities for the management of Type 2 Diabetes: The REWARD Study.

    Sedentary behaviours have become a predominant feature of most adults waking hours. Specifically, prolonged sitting time is now understood to have adverse effects on glycaemic control and other health parameters, adversely impacting on those with Type 2 Diabetes (T2D). Physical activity, including structured resistance exercise, is recommended for the treatment and management of T2D. Resistance activities utilise the larger muscle groups, potentially providing a greater stimulus for glucose uptake; however, many people with T2D may be unable or insufficiently motivated to meet these recommendations. Encouraging recent evidence shows that walking breaks throughout the day are an effective strategy to offset the deleterious effects of prolonged uninterrupted sitting in older, overweight adults. However, these experimental findings are yet to be verified in those with T2D – who could derive the greatest benefit. This study will examine the acute effects of a single bout of prolonged sitting on postprandial blood glucose, insulin and lipids with and without intermittent bouts of light-intensity walking or simple resistance activities in adults with T2D. Twenty four inactive and injury free participants aged between 35-75 years with diagnosed T2D (longer than 3 months) who are either diet or Metformin controlled will be recruited. Participants will visit the lab on 5 separate occasions. First, they will attend a 120 minute screening and medical exam, then a 60 minute familiarisation session one week prior to the commencement of the experimental trial. During screening, participants will complete a standard Glycated Haemoglobin (HbA1c) test to verify diabetes status (>=6.5%, but <=9%) and will be assessed on their suitability and safety to participate in the study. Familiarisation will ensure they are comfortable with the equipment and exercises, and suitable technique and movement consistency are achieved. The energy expenditure of the two activity breaks will also be measured a this visit. Participants will then complete three experimental conditions in a random order (each 8 hours duration with an initial 1 hour steady-state period) separated by a minimum 6 day washout period. The experimental conditions are: (A) Uninterrupted sitting (control condition): Participants will sit quietly in a lounge chair for 8 hours, with breakfast and lunch provided during this period; (B) Sitting + light-intensity walking breaks: Following baseline measurements and after sitting quietly for 1 hour (steady state) and allowing for consumption of the breakfast meal (20 minutes), participants will complete a 3 min bout of light-intensity walking on the treadmill (level, firm surface, slow pace – 3.2 km.hr-1). They will then return to the seated position. This procedure will be repeated on a further 11 occasions every 30 min (except where a lunch meal is consumed) for a total of 36 min of light-intensity activity; (C) Sitting + simple resistance activities: Identical procedure to condition B, however, participants will complete a 3 min bout of simple resistance activities. The activities will be allocated into nine 20 second segments, alternating between body weight half-squats, calf raises and brief gluteal contractions in-between single leg knee raises. This interchange between movements will provide rest for the corresponding muscle groups between each activity segment. To ensure appropriate standardisation, participants will complete each activity in a controlled manner within their range of motion (knee/hip 45 to 90° for half-squats/knee raises). Exercise tempo and correct ‘form’ will be achieved by participants mimicking a pre-prepared video recording, with which they have been previously familiarised. Fasting and postprandial blood samples (glucose/lipids, insulin/C-peptide, incretins, catecholamines and full blood examination) will be measured half-hourly throughout each trial, while blood pressure will be collected at each hour time point. Perceived fatigue will be assessed every 2 hours. With high volumes of sitting becoming a growing concern, there are potentially important and practical benefits of breaking up sitting time with brief bouts of light intensity activities. This research will provide insights into whether breaking up sitting time with light intensity walking and simple resistance activities has the potential for health benefits in those with T2D. The results of this study have potential to provide more detailed, practical and potentially prescriptive information to help shape clinical and public health approaches in T2D.

  • Pilot study of low- vs. high-dose Rosuvastatin in minor heart attack patients and healthy controls: assessment of skin microvascular blood flow.

    The cardiovascular system is made up of the heart, blood vessels and blood, and is responsible for the delivery of nutrients and removal of waste from the body. Blood flow is primarily regulated by the very small blood vessels. Examination of the skin blood vessels using laser Doppler flowmetry is an easy method that provides an index of global microvasculature function. Statins are a class of drug that reduce cardiovascular events and mortality. In addition to lowering cholesterol levels, statins demonstrate a number of other effects that protect the heart. After a heart attack, statins improve patient outcomes by improving the function of the large and small blood vessels. Rosuvastatin is more potent and effective than other statins. However, no studies have investigated the effect of Rosuvastatin on the very small skin blood vessels in patients who have had a minor heart attack. This pilot study aims to evaluate the effect of 1-week low- vs. high-dose Rosuvastatin therapy on very small blood vessel function in patients who present with a minor heart attack compared to a healthy population. We hypothesise that 1-week high-dose Rosuvastatin in minor heart attack patients and healthy controls does not improve the function of the very small blood vessels when compared to 1-week low-dose Rosuvastatin.

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