ANZCTR search results

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

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31380 results sorted by trial registration date.
  • Evaluation of a meditation based stress reduction program during acquired brain injury rehabilitation in an inpatient setting: a pilot study

    This study will investigate whether individuals who are receiving inpatient rehabilitation following an acquired brain injury (ABI) are able to participate safely in a meditation based stress reduction program. In addition we will try to determine whether participants’ level of “mindfulness”, cognitive performance, level of anxiety, levels of vitality and overall perceived quality of life improves in response to their participation in the program compared to a control group.

  • Is internet-delivered treatment specifically for symptoms of generalised anxiety disorder as effective as internet-delivered treatment for symptoms of both anxiety and depression, and are self-guided versions of these as effective as therapist-guided versions?

    This project is part of a research program funded by the NHMRC (No. 630560) to develop and evaluate Internet based transdiagnostic education and treatment programs for people with anxiety and depression. This project examines the relative efficacy of a disorder-specific internet-delivered treatment for generalised anxiety disorder vs. trans-diagnostic internet-delivered treatment for both anxiety and depression. Both interventions will be tested in guided and self-guided formats. We expect that the guided interventions will result in superior outcomes to the unguided interventions. We do not expect differences between the two guided interventions at post-treatment, but expect that the trans-diagnostic treatment will result in superior outcomes at follow-ups.

  • The effect of saline instillation during physiotherapy (SIP) in the intensive care unit - a randomized crossover trial

    Insertion of an artificial airway for respiratory failure, either endotracheal, nasotracheal or tracheostomy, inhibits normal mucociliary clearance, thus increasing the risk of secretion retention and pneumonia. Suctioning of the artifical airway is one of the most common procedures in the intensive care unit and high dependency wards: the aim is to remove respiratory tract secretions, thus maintaining airway patency, and prevent complications of secretion retention. Normal saline instillation is defined as delivery of 2 to 10 cc of normal saline solution (0.9%) into an artificial airway prior to suctioning. This technique is utilised by many health practitioners and is believed to increase sputum yield by diluting and loosening secretions, stimulating a cough and lubricating the suction catheter. However, there are conflicting views about the safety and efficacy of this procedure. To date studies have investigated saline instillation as a stand alone technique and not as part of a respiratory physiotherapy regimen. The aim of this trial is to examine the effects of normal saline instillation on sputum clearance, haemodynamic parameters, oxygenation and respiratory mechanics during physiotherapy in patients with an artificial airway. Design Prospective, single blinded, randomised, cross-over design where patients act as their own controls. Patients will be randomised using a computer generated sequence. Those allocated to group A will have saline instillation prior to suction during physiotherapy on day one, day two no saline will be used. The reverse will happen for those patients allocated to group B. Investigator collecting outcome measures will be blinded to group allocation. Participants Adults >18 years, expected to be mechanically ventilated for >48 hours. Outcome measures The primary outcome measure is sputum weight. Sputum will be collected during physiotherapy.Secondary outcome measures include airway resistance, oxygenation, blood pressure and heart rate which will be calculated at various times pre and post procedure. Significance This study would add to the body of knowledge regarding the efficacy and safety of saline instillation during physiotherapy in the intensive care unit.

  • Is internet-delivered treatment specifically for symptoms of panic disorder as effective as internet-delivered treatment for symptoms of both anxiety and depression, and are self-guided versions of these as effective as therapist-guided versions?

    This project is part of a research program funded by the NHMRC (No. 630560) to develop and evaluate Internet based transdiagnostic education and treatment programs for people with anxiety and depression. This project examines the relative efficacy of a disorder-specific internet-delivered treatment for panic disorder vs. trans-diagnostic internet-delivered treatment for both anxiety and depression. Both interventions will be tested in guided and self-guided formats. We expect that the guided interventions will result in superior outcomes to the unguided interventions. We do not expect differences between the two guided interventions at post-treatment, but expect that the trans-diagnostic treatment will result in superior outcomes at follow-ups.

  • Is internet-delivered treatment specifically for symptoms of social phobia as effective as internet-delivered treatment for symptoms of both anxiety and depression, and are self-guided versions of these as effective as therapist-guided versions?

    This project is part of a research program funded by the NHMRC (No. 630560) to develop and evaluate Internet based transdiagnostic education and treatment programs for people with anxiety and depression. This project examines the relative efficacy of a disorder-specific internet-delivered treatment for social phobia vs. trans-diagnostic internet-delivered treatment for both anxiety and depression. Both interventions will be tested in guided and self-guided formats. We expect that the guided interventions will result in superior outcomes to the unguided interventions. We do not expect differences between the two guided interventions at post-treatment, but expect that the trans-diagnostic treatment will result in superior outcomes at follow-ups.

  • A randomised controlled trial of Strain-Counterstrain treatment for people with neck pain selected using a treatment based classification system

    Question: Is Strain-Counterstrain treatment (manual therapy treatment using passive positioning) more effective than sham Strain-Counterstrain intervention in reducing levels of pain and disability in people with neck pain selected using a treatment-based classification system? Design: Randomised trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Participants: 85 participants (male and female) between 18 and 60 years experiencing non-specific neck pain for less than 30 days. Intervention: Participants are to attend two treatments in a week. The experimental group is to receive Strain-Counterstrain treatment and the control group sham Strain-Counterstrain intervention. Following the initial intervention period, participants are to receive standard Physiotherapy treatment for neck pain for up to 6 weeks. Outcome measures: The primary outcome is to be the Neck disability questionnaire, measured at 1 week (ie, end of initial intervention), 6 weeks, and 28 weeks. Secondary outcome measures are to include the Fear avoidance beliefs questionnaire, SF-36, visual analogue scale pain ratings and a 7-point global rating of change.

  • Randomised Controlled Trial of Melatonin for Delayed Sleep Phase Disorder

    The primary aim of the study is to test the usefulness of melatonin treatment in delayed sleep phase patients who present with delayed melatonin rhythms.

  • Sodium excretion and dietary intake in people with coeliac disease, an observational study.

    High sodium intake, as measured by urinary sodium excretion, is associated with increased bone loss (Divine, 1995). In Australia, the national target for salt intake was achieved by only 6% of men and 36% of women (Beard, 1997). A positive relationship exists between urinary sodium and urinary calcium excretion, with repeated studies showing that a high level of salt in the diet increases calcium excretion (Ilich, 2000). Other studies have recognised that people following a gluten-free diet have a lower bone mineral density, likely related to calcium malabsorption (Scott, 2000). It is not clear from the research how much sodium is ingested by those following a gluten free diet.

  • Effects of Rapid Administration of Iron Polymaltose in Patients with Anaemia, Under General Anaesthesia for Routine Surgery. “The RAPID Trial”

    Aim We aim to show that giving intravenous iron polymaltose over 10 minutes to patients who are under general anaesthesia is convenient, safe and not associated with a significant incidence of low blood pressure or other adverse effects. Background - Anaemia and iron deficiency are very common in surgical patients. A recent audit at KEMH, the tertiary womens hospital in WA, showed that 18% of women were anaemic prior to their gynaecological surgery. In patients undergoing surgery anaemia has been linked with an increased risk of needing a blood transfusion, slower recovery from surgery and an increase in postoperative complications. Patients often suffer from decreased energy, fatigue and poor ability to concentrate, all of which will affect their quality of life. - Iron polymaltose is an intravenous iron medication commonly used to correct anaemia and iron deficiency. It has been used in Australia for over 40 years, has a very good safety record and about 4-500 women a year receive iron polymaltose at KEMH currently. It is usually administered as a slow infusion over 2 - 3 hours in a general ward setting. Common adverse effects can include headache, nausea, flushing, low blood pressure and muscle cramps all of which are not as relevant to patients whilst they are under general anaesthesia. Serious adverse events such as anaphylaxis are extremely rare and are not related to the speed at which iron polymaltose is given. - Oral iron tablets are not effective in many patients for a number of reasons. It would labour intensive, expensive and inconvenient to bring all these patients back to a ward for a 1-2 hour infusion of iron polymaltose after surgery. Other intravenous iron preparations, with similar pharmacological properties, have been shown to be safe when given over similar short periods of time and we believe this will be the case with iron polymaltose too. Some anaesthetists (in Australia and NZ) have already administered iron polymaltose in this manner with no anecdotal reports of any problems, however we believe it warrants formal evaluation. Study Design and Methods We aim to recruit 100 patients with iron deficiency anaemia or iron deficiency who are scheduled to undergo general anaesthesia for an elective surgical procedure. Routine care will be unaffected and they will receive general anaesthesia as they would if they were not involved in this trial. Following commencement of surgery and during a period of haemodynamic stability (as assessed by the responsible anaesthetist), they will receive an iron polymaltose infusion over a 10 min period and we will collect data on any adverse effects and change in blood pressure over this time. In order to assess the haemodynamic impact of the infusion, any changes in blood pressure will be compared to the decrease in blood pressure seen at the start of the anaesthetic. Outcomes Primary outcome will be the incidence of significant low blood pressure following the administration of iron polymaltose (definition = systolic BP less than 80mmHg or blood pressure treatment required). Secondary outcomes, will be the incidence of all adverse effects as ascertained by questionnaire 2 hours after surgery and changes in blood markers of iron deficiency. Potential Benefits / Ethical Issues The current drug manufacturers product information sheet, recommends a slow infusion of iron polymaltose over approximately 4.5 hours, however most WA hospitals already administer iron polymaltose over a shorter periods of time, with no serious problems. We believe that if we demonstrate this technique of administration is safe it may lead to more effective & widespread treatment of iron deficiency and anaemia in surgical patients

  • A randomised study of IVF patients to assess whether freezing all of the embryos and transferring them in a later natural, unstimulated cycle results in a higher pregnancy rate than transferring an embryo 5 days after egg collection

    At Genea frozen embryo transfer pregnancy success rates have improved to a level close to fresh embryo transfer success rates. The embryos used in the frozen cycles are the second and third best embryos - as graded for development rate and morphology- compared to the embryos transferred in the fresh cycles when the best quality embryo is selected for transfer to the uterus. The hormone stimulation undertaken prior to oocyte collection may affect the endometrium (uterine lining) - advancing it to a stage whereby the embryo implantation prospect could be impaired and therefore reducing the chance of an ongoing pregnancy. The hypothesis is that freezing of all embryos may help to overcome any reduction in implantation potential by allowing improved synchronisation between the embryo and the endometrium, leading to both higher implantation and pregnancy rates. There are a number of causes of pregnancy failure following IVF treatment including genetically abnormal embryos, poor quality embryos and potentially a non-receptive uterine environment. The transfer of genetically and morphologically normal embryos into a non-receptive uterine environment will likely not achieve a pregnancy. Generally the suitability of the uterine environment is measured by ultrasound. However such measurement is not able to provide full information on how the uterus has developed under the influence of hormone stimulation drugs used routinely in an IVF treatment cycle. Genea has extensive experience with vitrification technology having been the first clinic to introduce the procedure into routine clinical practise in Australia, January 2006. Subsequently the technology has been performed routinely in all Genea laboratories following IVF, ICSI and PGD treatment cycles. More than 1000 babies have now been born after vitrification at Genea. The vitrification procedure used in this study will be applied to embryos cultured at the Genea Kent Street laboratory for 5 days (blastocyst stage). By vitrifying and NOT TRANSFERRING embryos in “routine” IVF cycle fresh, we wish to see if this will: increase the chance of fetal heart pregnancy and increase the chance of a live born baby

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