ANZCTR search results

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

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31402 results sorted by trial registration date.
  • Efficacy of Triple Antibiotic Therapy in Symptomatic Blastocystis patients

    We intend to evaluate the efficacy of 14 days of the triple antibiotics listed above in eradicating Blastocystis infection in symptomatic patients.

  • Multicentre randomised controlled trial of minimally-invasive surfactant therapy in preterm infants 29-32 weeks gestation on continuous positive airway pressure

    Research question: Does administration of exogenous surfactant using a minimally-invasive technique improve outcome in preterm infants 29-32 weeks gestation treated with continuous positive airway pressure (CPAP)? A multicentre, randomised, masked, controlled trial will be conducted in preterm infants 29-32 weeks gestation, aged less than 12 hours, requiring CPAP because of respiratory distress, with an FiO2 of >=0.32 (CPAP pressure 5-6) or >=0.28 (CPAP pressure 7-8). Infants randomised to surfactant treatment will receive 100 mg/kg of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter, followed by reinstitution of CPAP. Controls will continue on CPAP. The intervention will be masked from the clinical team. Care thereafter will be as per usual in both groups, other than the requirement to adhere to intubation criteria. The primary outcome will be duration of respiratory support (all hours of intubation, CPAP and high flow nasal cannula). Secondary outcomes will include Need for intubation and surfactant therapy; durations of intubation, CPAP, intubation and CPAP, HFNC, oxygen therapy, intensive care stay and hospitalisation; hospitalisation cost; incidence of death, major neonatal morbidities, pneumothorax and patent ductus arteriosus; and applicability and safety of the MIST procedure. The sample size will be 227/group, allowing detection of a 25% reduction in duration of respiratory support with 90% power. The trial will commence at Royal Hobart Hospital and Royal Women's Hospital during 2011, and will ultimately be conducted over 5 years in multiple centres nationally and overseas.

  • Multicentre randomised controlled trial of minimally-invasive surfactant therapy in preterm infants 25-28 weeks gestation on continuous positive airway pressure

    Does administration of exogenous surfactant using a minimally-invasive technique improve outcome in preterm infants 25-28 weeks gestation treated with continuous positive airway pressure (CPAP)? A multicentre, randomised, masked, controlled trial will be conducted in inborn preterm infants 25-28 weeks gestation, aged less than 6 hours, requiring CPAP because of respiratory distress, with an FiO2 of >=0.3 and CPAP pressure 5-8. Infants randomised to surfactant treatment will receive 200 mg/kg of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter, followed by reinstitution of CPAP. Controls will continue on CPAP. The intervention will be masked from the clinical team. Care thereafter will be as per usual in both groups, other than the requirement to adhere to intubation criteria. The primary outcome will be incidence of death or BPD. Secondary outcomes will include incidence of death, major neonatal morbidities (BPD, intraventricular haemorrhage, periventricular leukomalacia, retinopathy of prematurity, necrotising enterocolitis), pneumothorax and patent ductus arteriosus; need for intubation and surfactant therapy; durations of mechanical respiratory support, intubation, CPAP, intubation and CPAP, high flow nasal cannula (HFNC), oxygen therapy, intensive care stay and hospitalisation; hospitalisation cost; applicability and safety of the MIST procedure; and outcome at 2 years. The sample size will be 303/group, allowing detection of a 33% difference in the primary outcome with 90% power. The trial commenced at Royal Hobart Hospital December 2011 and Royal Women's Hospital during 2012, and will ultimately be conducted over 7 years in multiple centres nationally and overseas. Followup: at 2 years corrected age, parents of each infant will complete a brief health assessment and a validated child development assessment (PARCA-R, Dev Med Child Neurol 2004;46:389–97) administered as a web-based questionnaire located on a secure server. No identifying details will be revealed in the completion of the questionnaire. Health information to be collected will include duration of oxygen therapy at home, details of hospitalisations in the first 2 years (age, duration and classification of illness [respiratory/non-respiratory]), whether immunized against respiratory syncytial virus and influenza, family history of asthma, details of respiratory symptoms (respiratory distress and wheezing) and medications, details of feeding, vision and hearing capabilities, and presence and severity of motor problems. The PARCA-R questionnaire will seek information on the child’s development and speech.

  • The effect of routine reversal of neuromuscular blockade on surgical conditions for thyroid surgery

    Participants will receive a standard anaesthetic with- propofol induction, remifentanil induction, 2x ED 95 (intubating conditions) atracurium 0.4mg/km, sevoflurane, dexamethasone and cefazolin. At 30 mins post induction patients will either get neostigmine/glycopyrrolate injection or saline injection prepared by an independent person, given by anaesthetist. Then the surgeon will determine, using the NIM stimulator whether the reversal of neuromuscular blockade is adequate.

  • The Impact Pain, Anxiety and Stress Levels Have on Acute Burn Wound Healing in Children

    To determine whether the use of the Ditto(TM) device (a virtual reality based portable console, involving procedural preparation and distraction), used during acute burn wound care procedures with children 4-12 years, will result in reduced pain levels, stress levels and anxiety. In addition, determine whether its use will improve the wound healing of children with acute burns compared to standard practice.

  • The use of dedicated interpreter services for post-operative care following total knee replacement: A pilot randomised controlled trial.

    The aim of this study is to investigate whether providing dedicated Greek interpreter services to patients for post-operative care improves health status and self management outcomes compared to usual care for patients who undergo total knee replacement.

  • The efficacy of mangosteen pericarp fruit extract as an adjunct to second generation antipsychotic medication for the treatment of Schizophrenia.

    Mangosteen pericarp has potential to act as a tolerable and adjunct treatment option for schizophrenia, however a clinical trial is required to establish efficacy.

  • A study of factors affecting the concentrations of metformin in type 2 diabetic patients

    This study investigates the use of metformin in patients with type 2 diabetes with an aim to develop a population pharmacokinetic model to describe the pharmacokinetics. It involves obtaining a medical history of the patient and asking patients about their metformin formulation, dose, dosing times and their compliance to the medication.

  • Administration of granulocyte colony-stimulating factor (G-CSF) to an unresponsive endometrium in an IVF cycle

    There is some preliminary evidence that the endometrial administration of granulocyte colony-stimulating factor (G-CSF) several days prior to embryo replacement leads to a substantial and rapid improvement in endometrial thickness . The rationale for its use is that it is has successfully been used in the treatement of recurrent miscarriages. Granulocyte colony-stimulating factor (G-CSF) is a cytokine which stimulates neutrophilic granulocyte proliferation and differentiation. It is expressed and produced by the decidual cells, and its receptor, c-fms, is expressed by the trophoblastic cells. In addition, in an animal model, G-CSF showed a marked anti-abortion activity. G-CSF is safely used in the treatment of neutropenia during cancer chemotherapy, and no embryotoxic effects of this substance have been reported and its safety profile is reassuring. Since experimental findings showed a positive effect on the trophoblast and particularly thickening of the endometrium in previously very resistant patients we would like to prospectively observe the influence of G-CSF on endometrial development in patients with poor endometrial development. It has a very short half life and is administered to the endometrial cavity 5 days prior to embryo replacment so it is not present in the endometrial cavity when the embryo is placed in the uterus.

  • Development of a screening and treatment program using oral ivermectin to manage pediculosis capitis (head lice) in primary schools

    The principal aim of this study is to obtain information that will enable the development of an effective sustainable head lice education, screening and treatment program suitable for implementation in all primary schools. The proposed study builds on the results of a pilot study we conducted in 2008 where we tested the feasibility and acceptability of whole-school head lice screening and the use of oral ivermectin as a treatment for head lice among those found to be infested. As screening hundreds of students is time consuming and therefore expensive and the provision of oral ivermectin free of charge to the consumer is also expensive the proposed study is designed to identify a more efficient approach. The specific objectives of the proposed study are to determine if (1) parents/guardians (hereafter parent(s)) are as efficient at identifying head lice as trained screeners, (2) if oral ivermectin is an acceptable treatment for head lice in primary school children and their household members and (3) the most acceptable way to provide oral ivermectin treatment for head lice. An instrument to enable parents to screen their children for head lice has been developed and will be tested and validated; the acceptability of oral ivermectin, provided in three ways (free of charge to all infested students and their infested household members, through user pays prescription to all infested students and their infested household members and free of charge only to hyper-infested students and their infested household members (infested with more than 12 lice), will be ascertained using questionnaires, uptake of ivermectin and telephone contact (acceptability) and rescreening of infested and treated students (effectiveness)

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