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.
  • Does a High Protein Enriched Drink and Vitamin D Enhance the Health Benefits of Progressive Resistance Training Program in Older Adults with Type 2 Diabetes?

    Lifestyle factors such as exercise and diet remains the cornerstone in the management of type 2 diabetes. Progressive resistance training is one mode of exercise that can improve glycaemic control and other metabolic risk factors that contribute to the development of diabetes complications. Whether diet and exercise combined can have added benefits remains unknown. In non-diabetic adults, high protein diets can enhance the benefits of resistance training on muscle mass and strength. There is also evidence that vitamin D deficiency is associated with glucose intolerance and insulin resistance, which can be improved with treatment. This study builds upon our current community-based resistance training program, titled ‘Lift for Life (L4L)’, to examine whether post-exercise ingestion of a protein enriched drink and vitamin D can enhance the benefits of resistance training on glycaemic control, body composition and cardiometabolic health in adults with type 2 diabetes. This study is important as the findings will underpin more precise exercise and nutrition guidelines for the management of glycaemic control and cardiometabolic risk factors in people with type 2 diabetes, along with the ongoing refinement of community-based initiatives for the management of this condition.

  • An evaluation of individually delivered Secret Agent Society: A multi-component social skills intervention for children with Asperger syndrome

    The current study will trial the effectiveness of the Secret Agent Society (SAS) program delivered individually to children with Asperger syndrome. Originally designed as a group-based intervention, SAS has been found to result in a variety of benefits for children including improvements in their social skills, ability to regulate their emotions and knowledge in dealing with bullying and teasing. As such, it is anticipated that the individually delivered SAS protocol adopted in this study will result in similar improvements. Results from the study is expected to increase practitioners’ and parent’s confidence in delivering SAS individually to children and potentially increase the intervention’s reach.

  • To explore safety and feasibility of mobile teledermoscopy for Queensland residents 50-64 year of age at high risk for melanoma.

    This study will test consumer use of mobile teledermoscopy in the home in combination with the Asymmetry and Colour (AC) lesion identification rule, which together may be a powerful tool for melanoma early detection in the future. Who is it for? You may be eligible to join this study if you are aged 50 – 64 years, living in Queensland, have had a previous diagnosis of melanoma or skin cancer, and have fair skin or a high number of moles. Trial details Participants in this study will be randomly (by chance) divided into one of two groups. Participants in both groups will receive a Handyscope dermatoscope which they will keep for one month, instructions on dermatoscope functionality and how to email lesions for assessment, and an information booklet describing how to assess lesions using the Asymmetry and Colour Rule for detecting melanoma to allow selection of concerning lesions for submission to the teledermatologist. In addition, participants in one group will also receive detailed skin self-examination (SSE) instructions on how to conduct a thorough whole body SSE. The detailed SSE instructions will guide participants towards hard to see areas such as the back or back of the neck, and the use of two mirrors or utilising the assistance of a partner to visualise these areas. Participants in the other group will receive a set of instructions that will ask participants to look for and photograph suspicious skin lesions without specifying body areas to self-examine. Participants in both groups will be expected to complete one SSE during the month they have the Handyscope dermatoscope, and email their selected lesions of most concern to the dermatologist for evaluation.

  • 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.

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