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Ascending multiple doses of a novel Interluken(IL-1) agonist administered to healthy subjects
HMPL-011, the Hutchison MediPharma study drug, is an experimental compound being investigated for its potential to control how the body responds to certain inflammatory processes found in a number of autoimmune diseases such as rheumatoid arthritis. It is hoped that this information will lead to an improved anti-inflammatory drug which could reduce the inflammation responsible for the damage to the body’s organs caused by these diseases (such as the joint destruction seen in rheumatoid arthritis).
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A study to evaluate whether increased codeine levels are seen when both codeine and ketamine are given in small doses to well volunteers.
Pain from damaged nerves is a common problem particularly in the aged and those with medical problems including diabetes, vascular disease and cancer.A medication called ketamine which is used for anaesthetics is, at much lower doses, also used to help try and control severe chronic nerve pain. In an experiment that has been carried out at Flinders University in the laboratory, it appears that ketamine may increase the effective blood levels of opioid pain killers such as codeine or morphine that are often given in conjunction with ketamine. This study will evaluate whether increased codeine levels are seen when both codeine and ketamine are administered in small doses to well volunteers.Ketamine is already being evaluated in a clinical study by a team led by Flinders University at eight sites across Australia for severe nerve-based pain. This study will be a definitive study on the place of ketamine in the control of chronic, complex pain and should be finished in mid-2010.This study will have huge importance if ketamine is shown to be of clinical benefit. To date, it may well be that the perceived clinical benefit is only because of its effect on increasing the blood levels of strong pain killers.
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Enhancing the effects of the Positive Thinking Program: a longitudinal evaluation in 8-9 year old children
The current project is a new efficacy trial to evaluate the enhanced version of the Aussie Optimism- Positive Thinking Skills Program (AOP-PTS). This research project builds on recent information about emotional competence and cognitive skills in the middle childhood period to promote and enhance mental health benefits for 8-9 year olds. The projected outcomes are: Children who received the enhanced version of AOP-PTS program in Year 4 and 5 will report lower levels of internalising symptomatology (anxiety and depressive symptoms) and negative attributional style at the post test, 6 and 18 months follow-up compared to the children in control condition.
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The efficacy and safety of zoledronate in children and adolescents with chronic neurological conditions and osteoporosis: a crossover trial with long term follow up.
Children and teenagers with chronic neurological disease are at risk of having thin bones (osteoporosis). Throughout your life, new bone cells grow and old bone cells break down to make room for the new, stronger bone. Osteoporosis is characterised by the old bone breaking down faster than the new bone can replace it, resulting in the bones losing minerals (such as calcium). This makes bones weaker and more likely to break even after a minor injury. All the bones in your body are weaker if you have osteoporosis but not everyone who has osteoporosis gets a broken bone. Bone pain and fracture are common complications of osteoporosis. Bisphosphonates are a class of drug that slows down the thinning of bone, and are the standard treatment for osteoporosis in adults. Bisphophonates come in oral and intravenous forms. Gastrointestinal problems and compliance issues associated with oral bisphosphonates can be avoided by the use of intravenous bisphosphonates. Pamidronate, an intravenous bisphosphonate, is given every 6-8 weeks and has been shown to be effective in children. Zoledronate, a new potent intravenous bisphosphonate, is given yearly. Since intravenous bisphosphonates have to be given during a 3 day stay in hospital, zoledronate requires far fewer hospital admissions than does pamidronate.
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The NACIAM Study – Assessing the benefit of N-Acetylcysteine (NAC) in acute heart attacks.
N-Acetylcysteine (NAC) is an anti-oxidant which also potentiates the action of nitroglycerine. When used with nitrates in the context of acute myocardial infarction, it may reduce infarct size by minimising reperfusion injury as well as potentiating nitroglycerine's vasodilating and anti-platelet effects. The NACIAM trial is a randomised, double-blind, placebo-controlled study assessing the impact of early NAC therapy in reducing infarct size (as assessed by cardiac MRI) in patients with acute ST elevation myocardial infarction receiving intravenous nitrate therapy and undergoing primary percutaneous coronary intervention.
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Efficacy of Botulinum toxin and Repetitive Transcranial Magnetic Stimulation in treating Cervical Dystonia: A Double-blind Placebo Controlled Trial
Cervical dystonia is the term used to describe a certain pattern of involuntary neck muscle movements. The most effective current treatment for cervical dystonia is injecting overactive muscles with botulinum toxin type A, inducing paralysis of the overactive muscles. Botulinum toxin type A is approved in Australia to treat cervical dystonia. Disadvantages of this therapy are the discomfort associated with the treatment, its temporary effect and lack of response in some cases. There is emerging evidence for efficacy of low frequency repetitive transcranial magnetic stimulation (rTMS), for relief of symptoms in focal forms of dystonia, including cervical dystonia. rTMS is a technique for stimulating a part of the brain in a non-invasive way. In this case, magnetic pulses are delivered through the scalp and stimulate the brain cells. The procedure is largely pain free and has no significant adverse effects. This technique has been used for research as well as treatment of several neurological disorders. rTMS can lead to changes in the brain area stimulated, that persist after the stimulus. There is some evidence that these changes can be used in the treatment of cervical dystonia. However, it is still an experimental treatment. This means that it is not an approved treatment for treatment of dystonia in Australia or other parts of the world. This study aims to investigate if treatment of cervical dystonia with Botulinum toxin injection, when combined with rTMS, produces an additive effect. If the latter treatment is found to have a significant additive effect, it may offer a rationale to directly compare rTMS with botulinum toxin. If rTMS is effective as a treatment on its own, it may offer a less painful and perhaps longer lasting alternative to botulinum toxin injections.
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The SHADE (Self-Help for Alcohol/other drug use and DEpression) project: Computerised treatment for depression and alcohol/other drug use comorbidity in rural and urban New South Wales, Australia.
The SHADE study commenced in 2004 with the overall aim to evaluate the effectiveness of integrated, computer-delivered Cognitive Behaviour Therapy (CBT) for alcohol and other drug (AOD) problems among people with coexisting depression. Specifically, the project aimed to: * Trial CBT among people experiencing coexisting depression and AOD use problems employing either a psychologist or computer program to deliver the treatment; * Conduct the trial in both a rural and urban setting; * Assess the efficacy of the interventions relative to a non-specific treatment control group on measures of AOD use, service utilisation, symptomatology and functioning.
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PIANO: Pharmacokinetics of Ibuprofen and Acetaminophen in Normal and Overweight adults
Whilst paracetamol and ibuprofen are relatively safe and effective medications, high doses have been associated with potentially fatal liver damage or gastrointestinal problems whilst administration of low doses can result in inadequate treatment of pain and/or fever. This study is being conducted to investigate how increased body size impacts on how the body handles these medications. It is proposed that the results of this study will be used to guide dosing strategies for patients who are overweight or obese.
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Study Evaluating the Prevalence of Undiagnosed Psoriatic Arthritis in Patients With Plaque Psoriasis
The purpose of this study is to evaluate how common psoriatic arthritis is in patients with plaque psoriasis. The study will also explore whether psoriasis severity affects a patient's daily activities and quality of life. This information is important to assess if there is unmet medical need in Australian patients with psoriasis.
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Lenalidomide and 5azacitidine treatment versus 5azacitidine alone in patients with the blood cancers myelodysplastic syndrome or acute myeloid leukaemia
Lenalidomide and Azacitidine each have clear evidence of efficacy in MDS, and have shown activity in AML. However, not all patients respond so better regimens, including combinations, are required. MDS and AML are heterogeneous diseases, and lenalidomide and azacitidine may target different cellular populations and induce differing clinical responses. Combinations of immunomodulatory drugs and azacitidine have been explored and shown to be feasible. This is an open label, multi-centre, randomised Phase II study exploring the toxicity and efficacy of the combination of lenalidomide and 5azacitidine compared to 5azacitidine alone. After an initial 2 cycles with 5azacitidine (75mg/m2/day x7days over 9days of a 28 day cycle; 5-2-2 regimen), patients will be randomised 1:1 to either combination 5azacitidine and lenalidomide (5azacitidine 75mg/m2/day x5days of a 28 day cycle + lenalidomide commencing cycle 3 10mg/dayx21days of a 28 day cycle) or 5azacitidine alone (75mg/m2/day x7days over 9days of a 28 day cycle; 5-2-2 regimen) for 12 months to primary endpoint, then all patients may continue 5azacitidine alone until progression or toxicity. Response will be determined by peripheral blood counts, transfusions, bone marrow morphology and cytogenetics, according to IWG criteria. The study also incorporates a correlative laboratory component designed to determine the mechanism of action of 5azacitidine +/- lenalidomide and to determine a baseline profile which may predict those most responsive. These studies will incorporate gene methylation and expression, and enumeration of lymphocyte subsets, natural killer cell function and cytokine profiles.