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.
  • A Double-blind, Randomised, Placebo-controlled, Flexible-dose of 50 mg/day to 400 mg/day, Phase IIIb Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel XR) as an Add-on Therapy in Patients with Chronic Somatoform Pain Disorder

    The main rationale for this study is to evaluate the analgesic effect of Quetiapine XR in conjunction with non-opioid analgesic/s and/or nonsteroidal anti-inflammatory drugs (NSAIDs), with or without an antidepressant in treating patients with Chronic Somatoform Pain Disorder (CSPD), who have not responded adequately to their existing pain management therapy alone.

  • A randomised, double-blind, placebo-controlled study to determine the effects of enterically coated, nutrient-containing (CTM#3) pellets on the release of gastrointestinal peptides, glycaemic control, gastric emptying and sensations of appetite in patients with type 2 diabetes, when given concurrently with sitagliptin.

    The purpose of the study is to determine the effects of enterically coated, nutrient-containing (CTM#3) pellets on glycaemic control, the release of gastrointestinal peptides, gastric emptying and sensations of appetite in patients with type 2 diabetes, when given concurrently with the dipeptidyl dipeptidase IV inhibitor, sitagliptin.

  • Gait and postural control to change the knee loading in patients with knee osteoarthritis (OA).

    The primary hypothesis is that participants randomised to the 1 month gait training program will reduce KAM and improve symptoms of OA compared to the control group. Osteoarthritis is the most common musculoskeletal disorder affecting Australians and is the leading cause of pain and disability. OA is caused by rapid degeneration of articular cartilage. Knee osteoarthritis reduces physical activity level due to the associated pain, impaired gait and balance and lower-extremity muscle weakness. Osteoarthritis treatment is typically driven by a pharmacologic approach to provide analgesia and reduce inflammation, rather than employment of disease-modifying agents, or risk factor reduction, with knee replacement surgery the only option in advanced cases. Gait retraining and postural control is theoretically far more targeted to the impairments in knee OA. The primary hypothesis that participants randomised in the 1 month gait program will have a significant reduction in the KAM compared to the control group, and have a significant improvement in symptoms of OA such as pain.

  • Sleep Disturbances in Moderate to Severe Chronic Obstructive Pulmonary Disease

    Patients with chronic obstructive pulmonary disease (COPD) have previously been shown to complain of poor sleep, daytime fatigue and sleepiness. This has been seen in large studies based on questionnaires, however a US study of over 2,000 participants with mild COPD found little sleep disturbance. This study will measure sleep quality and symptoms of sleep disturbance in a group of participants with moderate to severe COPD and correlate perceived with actual sleep disturbance. Thirty participants with moderate to severe COPD (defined as at least 1 standard deviation below the lower limit of their predicted function) will complete questionnaires measuring quality of life, symptoms of respiratory and sleep disturbance and daytime sleepiness. They will be required to have a stable regimen of treatment for their lung disease and no significant medical or psychological conditions which could prevent them completing the study. Standard clinical spirometry will be performed and an in-laboratory sleep study carried out. This sleep study will monitor sleep, airflow, oxygen and carbon dioxide (CO2) levels during the night, as accumulation of CO2 during the night in these patients may contribute to sleep disruption and fragmentation. Participants will be asked to describe the quality of their sleep and this will be compared to the measured sleep, as sleep perception is thought to be poor in these patients. The outcomes of the study will be a description of sleep architecture, including the number of changes in sleep stage. It is thought that sleep stage transitions are important for daytime sleepiness. The degree of sleep fragmentation will be correlated with the sleep questionnaire outcomes and also with the severity and other measures of the respiratory function.

  • Physical activity levels of patients with cystic fibrosis admitted to hospital with an acute pulmonary exacerbation

    To determine objectively how inactive cystic fibrosis patients are during and after a hospital admission for an acute pulmonary exacerbation by assessing them using a highly accurate physical activity level monitor. The study also seeks to determine whether exercise tolerance and skeletal muscle strength are reduced during periods of hospitalisation for an acute exacerbation.

  • Fish oil as adjunct therapy for periodontitis.

    Periodontitis is a chronic inflammatory condition affecting 1 in 5 Australian adults. Current treatment involves intensive cleaning although treatment does not completely resolve the associated inflammation. The long chain omega-3 polyunsaturated fatty acids (omega-3) from fish oil help reduce inflammation in several chronic conditions. Regular consumption of food rich in omega-3 may benefit periodontal health. Studies suggest that omega-3 metabolites may serve as “stop signals” for preventing neutrophil-mediated tissue damage, a key component of periodontal disease. Studies in rodents show a positive, modulating effect of omega-3 on gingival inflammation, which can be mediated through reduced expression of pro-inflammatory cytokines. Other reports that are less positive have used limited treatment periods which may have been insufficient to induce substantial incorporation of omega-3 into cell membranes. The aim of this study is to see whether supplementation with different types of fish oil improves the efficacy of standard periodontal treatment (scaling and debridement) in patients with newly diagnosed, but not aggressive periodontitis. We will also investigate the involvement of anti-inflammatory mechanisms.

  • Study of orBec (Registered Trademark (R)) With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)

    Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.

  • Earlier diagnosis and management of Chronic Obstructive Pulmonary Disease (COPD) in general practice

    COPD is a common problem for current or ex smokers but is often undiagnosed or diagnosed late when the condition has deteriorated significantly. Effective treatment is available so early diagnosis is very important. In this study practice nurses will identify patients who are at risk of COPD and undertake case finding. Patients newly diagnosed with COPD who attend the “intervention practices” will be offered a management involving the GP and practice nurse working in partnership. The patients who attend the “control practices” will receive usual care from their GPs. We will then primarily examine the impact of the “intervention” or the “usual care” on patients' quality of life, health status and lung function and draw a comparison between the two groups in order to asses the effectiveness of the intervention.

  • The effects of preoperative warming and/or warmed irrigation fluids on elective arthroscopic shoulder surgery patients' temperature, thermal comfort, and total recovery time: A randomised controlled trial.

    In this study we aim to investigate the effects of preoperative warming and/or warmed irrigation fluid on temperature control, thermal comfort, and post-anaesthetic recovery time in patients undergoing elective arthroscopic shoulder surgery.

  • A single arm, open label pilot study of low dose regular opioids with low dose regular benzodiazepines for the relief of refractory breathlessness.

    Breathlessness at rest or on minimal exertion (speaking, bathing, dressing) continues to be a major clinical problem for many people with advanced progressive illnesses such as cancer, end-stage cardiac failure or chronic obstructive pulmonary disease even when they are receiving the best treatment for that underlying disease. Although there are some interventions that may offer benefit (oxygen therapy (when oxygen levels in the blood are low), sustained release low dose morphine) for this refractory breathlessness, other therapeutic options need to be explored. Benzodiazepines are widely used as sedatives to help with sleep, to reduce anxiety and to decrease the risk of seizures in people who have, or are at risk of epilepsy. These medications are also widely used around the world to treat breathlessness, however there have been no adequately powered studies that have explored net symptomatic benefit (symptom relief, side effects, maintenance of any benefit) for refractory breathlessness. Each benzodiazepine has slightly different properties in the level of sedation, ability to reduce anxiety and duration of effect. Two key questions need to be answered in order to establish the place of benzodiazepines in the management of refractory background dyspnoea: is there a net symptomatic benefit from benzodiazepines and, if so, is that benefit maintained over time? The latter question is important given the rapid tolerance to benzodiazepines when used as sedatives. Given the ability to dose once daily, the well defined pharmacokinetic and pharmacodynamics (including in children) and the range of formulations/routes of administration available, clonazepam has been chosen for this study. The proposed dose is unlikely to cause significant sedation and is at the lower end of the dosing range for its major long term clinical use in epilepsy. Aim: The primary aim of this pilot study is to refine protocol design including recruitment and retention to the study, establish levels of symptomatic response and variance in that response for power calculations for a definitive trial, and establish whether that benefit is maintained at two weeks.

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