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.
  • Comparison of the effectiveness of three oral analgesic combinations in adults presenting to the Emergency Department with moderate pain from acute limb injury.

    Very little information exists on the effectiveness of oral pain-relieving medication administered acutely to adult patients presenting to the Emergency Department (ED) with moderate pain. As a result, the most effective combination of pain-relievers for acute pain is unknown. Studies in children in the emergency setting have suggested that a number of pain reliever combinations may be equally as effective for the treatment of moderate pain. Similar studies have not been replicated in adults. Southern Health (SH) Emergency Medicine has an established guideline for the management of patients presenting to the Emergency Department with pain. The triage Nurse may administer one of a number of combinations of pain relieving medications provided certain clinical requirements are met. However, the guideline for pain relief when a patient has moderate pain (pain score >3 and <8), is not clear, suggesting the administration of a number of pain relief alternatives. These include; paracetamol with oxycodone and Ibuprofen, or alternatively Panadeine Forte-Registered Trademark (R) (paracetamol & codeine phosphate) with or without ibuprofen. It is not clear from past research whether or not one combination is superior. Additionally, the ease of nursing accessibility varies with oxycodone and Panadeine Forte(R) due to the different drug schedule of each pain reliever. Oxycodone is an S8 drug, requiring a higher degree of security and accountability to dispense. This has implications for nursing time to retrieve and give the drug to patients. Anecdotally, there is a perception by some emergency nursing staff that it may be easier or quicker to administer Panadeine Forte(R) compared to oxycodone. Some studies done in other settings suggest that oxycodone with paracetamol may be a more effective pain reliever for acute pain than Panadeine Forte(R), but data is conflicting and despite numerous systematic reviews of both pain relievers the differences may be small in patients with moderate pain. In the initial management of moderate pain at triage, the small benefit oxycodone+paracetamol confers over Panadeine Forte (R) may be offset by the added time it takes to deliver the former agent to the patient and the subsequent time of onset of pain relief. Our study intends to compare three widely accepted combinations of analgesics for treatment of moderate pain in adults who present to the ED following acute limb injury. Firstly, paracetamol 1g with ibuprofen 400mg will be compared to 2) Codeine Phosphate 60 mg with paracetamol 1g and ibuprofen 400mg and, 3) Oxycodone (Endone (R)) 10 mg with paracetamol 1g and ibuprofen 400mg. All of these drugs are currently included in some combination in the current Southern Health Emergency Medicine nurse-initiated pain guideline for management of moderate pain. The study will be carried out in all three Southern Health EDs. Subjects will be given one of three randomly assigned and unknown combinations of the drugs. Their pain scores will be determined at regular intervals for 90 minutes. There will be regular monitoring for side effects and for the need for additional painkillers. We aim to recruit 216 subjects. Equal relief of pain with all the regimens may improve delivery of pain relief in the ED by reducing the need to access S8 medications in moderate pain, thus reducing time to delivery of effective analgesia. If the oxycodone arm is found to provide superior analgesia the current guideline could be amended to simplify the currently recommended treatment options. Alternatively if it is found the arm without opioid analgesia is equivalent the routine use of codeine and oxycodone for moderate pain will be reviewed.

  • Treatment for public speaking fears

    D-cycloserine (DCS) is an antibiotic that has been used for the treatment of Tuberculosis over the last 40 years. Research indicates that DCS affects receptors in the brain known as N-methyl-D-aspartate (NMDA) receptors which are located in a region of the brain called the Amygdala. When the NMDA receptors become active (as occurs during extinction) this leads to a reduction in fear levels. Research suggests that DCS enhances the activity of these receptors, and as a result, enhances therapy techniques such as exposure (Guastella, Lovibond, Dadds, Mitchell & Richardson, 2007). To date, few studies have investigated the effects of DCS as an adjunct to exposure therapy using human participants, and of these none have done so using imaginal exposure therapy. The research thus far has focused primarily on the effects of DCS with in-vivo exposure on individuals. Yet, the same underlying processes appear to contribute to the success of both imaginal and in-vivo exposure therapy, i.e. the activation of anxiety and the formation of new associations in the brain through confrontation of the feared stimulus or situation. If DCS works by strengthening the formation or accessibility of new, non-threat associations (Guastella, Richardson, Lovibond, Rapee, Gaston, Mitchell & Dadds 2008), then it should also enhance the effects of imaginal exposure. Therefore there is good theoretical reason to see whether DCS has the same exposure enhancing properties when used as an adjunct to imaginal exposure therapy. In terms of its application in clinical settings, imaginal exposure therapy has several advantages compared to in-vivo exposure techniques, offering greater practicality and flexibility, particularly with regards to situations that are not readily accessible. Research also suggests that individuals experience less aversion when exposed to fearful images than when they are in direct contact with the feared object or situation (Hunt, Bylsma, Brock, Fenton, Goldberg, Miller, Tran & Urgelles, 2006). This relatively novel area of research has the potential to revolutionise the practice of psychotherapy and possibly offer new treatment options to individuals with public speaking anxiety and possibly other anxiety disorders. Aims of the study - 1. To replicate previous research which shows that DCS enhances in-vivo exposure therapy for individuals with public speaking anxiety 2. To extend previous research by showing that DCS enhances imaginal exposure therapy for individuals with public speaking anxiety 3. To determine whether the ability to conjure up a vivid image and become absorbed in that image increases anxiety levels as measured by self-report and physiological changes, and in turn, leads to positive treatment outcome 4. To determine whether competency in public speaking improves as treatment progresses

  • Moving forward in anorexia nervosa treatment.

    The purpose is to investigate an enhanced psychotherapy for anorexia nervosa. Anorexia nervosa is a serious psychological illness that is associated with much distress and many difficulties for people living with the illness. Many people do not get better with current therapies. Dr Meyer and her colleagues in Loughborough (England) have developed an enhanced form of cognitive behaviour therapy (CBT), which is a psychotherapy or talking therapy for anorexia nervosa. CBT in anorexia nervosa treatment focuses on how people think about eating, weight and shape and what they do about them (e.g. diet to lose weight). The therapy we are testing in this study has been enhanced by focussing more on some features of anorexia nervosa that have been found to be prevent people getting better from anorexia nervosa.

  • Randomised Control Trial of the Effectiveness of Exercise Augmentation in Patients with Post Traumatic Stress Disorder

    This study will investigate the effects of a 12 week individualised exercise program on PTSD symptoms, physical parameters such as blood pressure, sleep patterns and medication useage. It is hypothesized that by adding this structured exercise program to usual care, patient outcomes will improve.

  • Evaluation of the Behaviour Skill Builder: An Online Parenting Intervention for Difficult Child Behaviour

    The aim of this study is to determine the extent to which the Behaviour Skill Builder (BSB) is an acceptable, useable and effective tool for parents of young children with a developmental disability who are exhibiting difficult behaviour.

  • Australian Adolescent Type 1 Diabetes Intervention Trial (Aussie AdDIT) - to assess the prevalence and progression of microvascular and macrovascular disease in adolescents with Type-1 diabetes.

    The prognosis for childhood onset type 1 diabetes (T1D) remains generally poor with the number of life years lost is 17 years for a child diagnosed aged 10 years. Whilst in the second decade from diagnosis diabetic nephropathy (DN)accounts for around 60% of deaths, by the third decade cardiovascular disease (CVD) accounts for two thirds of all deaths. Although complications are rarely seen during childhood, there is evidence that their pathogenesis begins soon after diagnosis and accelerates during puberty. Adolescence may be a critical period for lifetime risk of complications in childhood onset diabetes. During puberty, the first signs of complications become evident. Microalbuminuria, an early risk marker for DN and CVD may be found in 12 to 16% of adolescents and this has been associated with renal pathology indicative of early nephropathy. This study is investigating the changes in retinopathy, aortic intima media thickness (aIMT) and heart rate variability which are indicators of macrovascular disease and autonomic neuropathy respectively. Diabetic retinopathy is the most common cause of blindness in young adults less than 40 years in the developed world. Factors affecting the genesis of autonomic neuropathy include glycaemic control, lipids and blood pressure. Studies have shown that atherosclerosis develops first in the abdominal aorta and precedes that seen in the carotid arteries. A study has reported that both high blood pressure and lipids increase neuropathy risk and it is likely therefore that intervention with ACE inhibitors and / or statin impact on neuropathy progression. Specific aims: a. To assess retinopathy (by retinal photography), atherosclerosis ( by aortic intima media thickness and carotid intima media thickness) and neuropathy (by heart rate variability) in an identified sample of adolescents with T1DM at high risk of microalbuminuria as compared to adolescents with T1DM at low risk of microalbuminuria. b. To determine whether ACE inhibition/statin therapy during puberty will reduce retinopathy, atherosclerosis and autonomic neuropathy progression in adolescents with T1DM at high risk of Microalbuminuria compared to adolescents with T1DM at low risk of Microalbuminuria.

  • Assessment of a dietary intervention designed to optimise nutritional status in women of child-bearing age

    Studies have shown that adequate maternal docosahexanoic acid (DHA) intake during pregnancy is an important factor for optimal development of the foetus. Fish is a good source of DHA, however, its intake in Australian women is generally low and well below recommendation. This 8-week study aims to determine if a diet higher in fish (providing an average of at least 200mg of DHA/day) obtained from consuming Australian fish 4 times a week can improve health-related bio-makers and outcomes (e.g. erythrocytes membrane n-3 concentrations, lipids, inflammatory markers, depression score) without compromising iron nutriture when compared to a typical Australian diet that is generally low in fish and higher in meat. This study will also predict the blood level of mercury if the higher fish dietary pattern was to be maintained long term.

  • A Phase I-II Clinical Study of Nimotuzumab (TheraCIM h-R3) in Combination with External Radiotherapy in Stage IIB, III and IV Non-Small Cell Lung Cancer (NSCLC)

    This study looks at the effectiveness of nimotuzumab (TheraCIM h-R3) in combination with external radiotherapy in treating non-small cell lung cancer (NSCLC) at stage IIB, III and IV. Who is it for? You can join this study if you have non-small cell lung cancer which is suitable for palliative radiation therapy, and is at stage IIB, III or IV. Trial details Participants will be divided into two groups. One group will receive 200 mg nimotuzumab in addition to 2 weeks' standard radiation. The second group will receive a non-active compound (placebo) plus standard radiation. Despite aggressive surgical and chemotherapeutic interventions, non-small cell lung cancer is the leading cause of cancer-related death in men and women, with overall cure rates of less than 15%. Nimotuzumab is a novel therapy which may offer new hope.

  • The Brighten Your Mood Program: A randomized controlled trial of internet based treatment of depression for Chinese Australians

    The current study aims to reduce the practical and cultural barriers to mental health treatment for Chinese Australians by developing an Internet-based cognitive behavior therapy (ICBT) program for depression, based on the Sadness Program developed by Perini, Titov & Andrews (2009; www.virtualclinic.org.au) that is culturally sensitive and appropriate. A randomized controlled trial will compare the enhanced Chinese ICBT program for depression (the Brighten Your Mood Program) with telephone support to a waitlist control group. The project will examine the efficacy of the Internet Program in reducing symptoms of depression and disability in Chinese Australians, as well as its acceptability.

  • The effects of timing of buffet-meal presentation on energy intake following a nutrient preload in humans: relationships with gastrointestinal functions.

    This study has been designed to investigate how energy intake at a buffet meal will be affected when the meal is presented at different times following a nutrient preload, and and how it is related to antral area, gut hormones and appetite sensations. Volunteers are required to visit the department on 4 occasions approximately 1 week apart. They will be required to ingest either a water or liquid nutrient preload, and 2D Ultrasound scans, blood samples and VAS will be taken at various timepoints depending on the treatment. A buffet meal will be presented 30, 90 or 180 min after the preload, and will be consumed over 30 min until the volunteer is comfortable full.

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