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.
  • Randomised Controlled Trial of Cognitive Behavior Therapy and Supportive Counselling for Reduction in Posttraumatic Stress Disorder (PTSD) Symptoms in Refugees

    This study will randomly allocate patients with PTSD to either (a)cognitive behaviour therapy, or (b) supportive counselling.

  • Does Peritoneal Lavage Influence the Rate of Complications in Paediatric Laparoscopic Appendicectomy? A Prospective Randomised Clinical Trial.

    Appendicitis is the most common abdominal pathology in children. Laparoscopic appendicectomy is the standard treatment in most developed countries. Infection remains the most common post operative complication; with reported rates between 2.5–36% Currently at Monash Medical Centre we perform approximately 330 laparoscopic appendicectomies per 12 month period. Of these approximately one third will be perforated appendicitis with significant peritoneal pus. Our overall infection rate is 5%. The abscess formation rate for the perforated appendicitis group is higher, 11.3%. Compared to the best reported results in the literature, there is room for improvement. Peritoneal lavage is an intraoperative manoeuvre performed whereby following removal of contamination the peritoneal cavity is lavaged with saline and then suction applied to remove the saline solution. At appendicectomy not all surgeons will perform peritoneal lavage. Peritoneal irrigation has been advocated as a method to reduce post operative complications. The evidence for peritoneal lavage is largely historical and based on adult practice . It is proposed that lavage reduces intraperitoneal bacterial load, and furthermore that laparoscopy facilitates improved peritoneal lavage in peritonitis. However, the evidence is divided with some indicating that it may in fact increase the risk of post operative infections. Advocates of this argument proposed that lavage may spread contamination throughout the peritoneal cavity with an increased risk of abscess formation. Studies assessing lavage with antibiotic solutions have shown no difference in outcomes Currently throughout the world there is no consensus and both techniques are commonplace and accepted modes of practice. Within our department of Paediatric Surgery in Monash Medical Centre there are surgeons who advocate generous lavage and other surgeons who advocate no lavage. Currently our patients will receive lavage or not depending on which consultant is in charge of their care. To date there have been no prospective randomized clinical studies in children assessing the difference in outcome in laparoscopic appendicectomy following peritoneal lavage or no peritoneal lavage. Therefore, the aim of this study is to assess whether intraoperative peritoneal lavage in laparoscopic appendicectomy in children reduces post operative complications, with the eventual goal of minimizing post-operative infection rate. Our proposal is to carry out a prospective randomised clinical trial.

  • The effect of an oral health education program for mothers and fluoride treatment on oral health in Indigenous Maori children

    Early Childhood Caries (ECC) causes profound suffering, frequently requiring expensive treatment under a general anaesthetic. It is the strongest predictor of poor oral health in adulthood. Despite ECC being entirely preventable, marked ECC disparities exist between Maori and non-Maori children in New Zealand. If the burden of ECC and associated oral health inequalities experienced by Maori children is to be reduced, more needs to be done to ensure that appropriate preventive measures, together with support for maintaining optimal oral health, are provided to carers of such children in the early life stages. This will be an interventional study, with all the participants receiving the intervention benefits. Pregnant Maori women and their families will be included. The intervention will be implemented from birth and continue for the first three years of a participating child’s life. It will involve four components: dental care provided to the mother, application of a topical fluoride to the teeth of children, anticipatory guidance and motivational interviewing. Following a kaupapa Maori research framework and methodology, the intervention will be tailored at the individual- or whanau-level, with each carer or whanau progressing to the next level only when they are ready. Developing a culturally-appropriate ECC intervention that aims to improve child oral health, in full partnership with the Maori communities involved, will provide much needed evidence for policy makers to address the challenge of improved oral health and related outcomes for Maori children. The goal of this study is to determine whether implementation of a culturally-appropriate Early Childhood Caries (ECC) intervention utilising a kaupapa Maori methodology reduces dental disease burden and oral health inequalities among young Maori children living wthin the Waikato-Tainui tribal area. More specifically, the aim is: Aim: To determine whether implementation of a culturally-appropriate ECC intervention, that employs a tailored approach and draws on a range of kaupapa Maori relevant contexts including oral health knowledge, oral self-care, dental service utilisation, and oral health-related self-efficacy, reduces dental disease burden and oral health inequalities among young Maori children living within the Waikato-Tainui tribal area. Hypothesis: Exposure to a culturally-appropriate (kaupapa Maori) ECC intervention will reduce dental disease burden and oral health inequalities among young Maori children who reside within the Waikato-Tainui tribal area. It is anticipated that implementation of a culturally-appropriate ECC intervention that aims to improve levels of oral health among tamariki Maori will, in turn, lead to improved general health outcomes. This is through (1) Maramatanga – increased understanding of the processes that lead to dental diseases and in turn, other health conditions; (2) Te Taha Tinana – a greater appreciation of the role of prevention in reducing ECC; the dietary component of which may, in turn, have benefits for other preventable, dietary-related conditions such as obesity and diabetes; (3) Te Taha Whanau – improved knowledge of lifestyle habits that are not conducive to optimim oral health; (4) Te Ara Tika – increased understanding of how to access oral health care for the whanau.

  • Establishment of a Routine Glycemic Index testing capability using healthy volunteers.

    The Glycemic Index is a system of ranking carbohydrate-containing foods according to their immediate effect on blood sugar levels. A pool of up to 20 participants will initially need to be formed and maintained (ie have up-to-date glycemic response data for the reference food) for this purpose. If required due to demand for testing, the pool of participants will be increased further. The test protocol itself is standardised, straightforward and well-defined. Briefly, a set number of participants (minimum of 10) consume the test or reference food (containing 50 g of available carbohydrate). Immediately before, and at designated intervals after food consumption, capillary blood (a few microlitres) is collected by fingerprick and its glucose content measured. Integrated areas under the glycemic response curves are then derived. To calculate the Glycemic Index of the test food, its Integrated Area Under Curve is indexed against that of the average Integrated Area Under Curve for the reference food (mean of three separate tests).

  • TICTOC 1 - Transcutaneous interferrential current to overcome constipation- 1 phyiostherapist clinic based

    Slow transit constipation (STC) is marked by small soft stools and soiling and is refractory to medical management. Following a pilot study applying transcutaneous electrical stimulation using interferential current (IFC) to STC children, we undertook a randomized controlled trial to determine whether IFC improved colonic function in pediatric STC. Forty-six children (8 -18 years) with confirmed STC were randomly assigned to receive twelve sessions (20 min/session) of active or sham stimulation with IFC over 4 weeks. Two electrodes were placed paraspinally and 2 over the abdomen. Active stimulation was applied by physiotherapists at a comfortable intensity (<40mA, carrier frequency 4kHz, varying beat frequency 80-150Hz). Daily diaries recorded defecation (primary endpoint), soiling, pain and laxative use for 1-month before, during and 2-months after treatment. Quality of life (QOL), colonic transit and 24-hr colonic manometry were compared before and after treatment. Transcutaneous IFC 3-times/week for 1 month increased colonic activity, sped up colonic transit, and improved fecal soiling, abdominal pain, and QOL, in STC children. More frequent stimulation may be required to improve defecation frequency.

  • Mindfulness-based Cognitive Therapy for Bipolar Disorder

    Treatments that target the risk factors for relapse in bipolar disorder are vital if a better prognosis for this disorder is to be achieved. This study will investigate a novel approach to preventing relapse (mindfulness-based cognitive therapy). A randomised controlled trial will be conducted comparing two groups; Mindfulness based Cognitive Therapy and Treatment as Usual (which will include the addition of bipolar education material).

  • An evaluation of the irritation and sensitization of an opioid analgesic gel applied to the skin in healthy volunteers.

    The purpose of this study is to determine if tocopheryl phosphate mix, in combination with oxycodone (TPM/O) in the form of a patch, will cause irritation when applied daily for a long period of time (9 consecutive days).

  • Pregnancy Iodine and Neurodevelopment in Kids (PINK)

    Severe iodine deficiency during pregnancy is a known cause of cretinism and mental retardation. There is now growing recognition that milder iodine deficiency may also be related to cognitive deficits. Mild iodine deficiency has been consistently found in all studies of pregnant women living in Australia and New Zealand. The Australian and New Zealand governments have recently mandated the use of iodised salt in breads as a strategy to combat iodine deficiency in the general population. However, this strategy may not sufficiently increase iodine intakes to meet the requirements of pregnant women, and Food Standard Australia and New Zealand has recommended that these women take a daily dietary supplement containing 150 ug/day of iodine. However, no studies have examined the effect of iodine supplementation in pregnancy on clinical outcomes of mothers or babies in regions with mild iodine deficiency. The aims of this study are to assess the effect of maternal iodine supplementation during pregnancy at levels designed to meet the recommended dietary intake on neurodevelopment of children at 2 years of age (primary outcome), and pregnancy outcomes and general health and wellbeing of mothers. Eligible pregnant women will be randomly assigned to take either a iodine supplement (150ug/d) or placebo dairly from enrolement to the end of pregnancy. Neurodevelopment of children will be assessed using Bayley Scale of Infant and Toddler Development and maternal general health and mental function will be assessed using validated questionnaires.

  • Acute and chronic effects of glucocorticoids on carbohydrate metabolism in subjects with inflammatory rheumatologic disease.

    The study aims to assess: * How low dose steroids affect insulin secretion and sensitivity * Whether low dose steroids increase the risk of heart disease We hope that this information will increase understanding of the risk of diabetes conferred by low dose steroids and how best to treat it. We will be studying participants with inflammatory joint disease. One group of participants will usually take prednisolone (a steroid tablet) for their joint disease. They will be studied once. The other group of participants will not usually be treated with prednisolone for their joint disease. This group of participants will be studied, and then they will be asked to take low dose prednisolone for 7-10 days before being studied again. On the first study day we will assess how sensitive the body is to insulin with an insulin clamp study. On the second day we will assess the risk of heart disease, how much insulin the body is making and body composition.

  • Pilot trial of the e-couch Anxiety and Worry program in an adolescent school-based population.

    The aim of the current project is to test the effectiveness of the e-couch Anxiety and Worry program (www.ecouch.anu.edu.au) in preventing and reducing adolescents’ levels of generalised anxiety. The e-couch GAD module is an Internet-based program that provides evidence-based information and strategies for anxiety. The trial will delimit the likely range of the benefit of using this intervention as a universal, active school-based prevention program. Secondary aims of the pilot trial are to evaluate the program’s effect on participants’ depressive symptoms, mental health literacy, anxiety stigma, and help-seeking behaviour, attitudes and intentions.

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