Search results for " trial"
showing 10 items of 3715 documents
Compliance and arthralgias in clinical therapy (COMPACT): Assessment of the incidence of arthralgia, therapy costs, and compliance in the first year …
2012
e11040^ Background: Aromatase Inhibitors (AI) are well established as adjuvant endocrine treatment for postmenopausal women with HR+ early breast cancer (EBC). However, clinical trial data show higher frequently of arthralgia with AI than tamoxifen. As arthralgia may be greatly influencing compliance to adjuvant therapy, we designed a prospective trial to collect real world data on the effects of AI-associated arthralgia on patient compliance, patient outcomes and treatment costs of arthralgia. Methods: COMPACT is an open, prospective non-interventional study (NCT00857012) assessing the incidence of arthralgia, therapy costs, and compliance within the first year of adjuvant anastrozole (AN…
Infliximab, azathioprine or combination therapy in the treatment of active Crohn's disease.
2010
The treatment of moderate-to-severe steroid-dependent Crohn's disease has been a challenging issue for the gastroenterologist. Until to 10 years ago, immunosuppressors, mainly azathioprine or 6-mercaptopurine, were the best possible treatments available, and remission rates ranged from 30 to 60% according to the results of open studies and controlled trials. Recently, infliximab has been shown to be effective in steroid-dependent patients and, combined with azathioprine, it has been shown to increase 1-year remission rates. A recent large randomized controlled trial comparing infliximab, azathioprine and infliximab plus azathioprine demonstrated that the combination of infliximab plus azath…
Assessing Single Joints in Arthritis Clinical Trials
2009
The need to develop validated outcome measures to assess response to therapies in single joints has been recognized. In 2004, a task force was established to assess established and novel outcome measures in accordance with the OMERACT filter (truth, discrimination, and feasibility) for single joint assessment. This report describes the proceedings of the single joint assessment special interest group (SIG) at OMERACT 9, including an updated literature review of imaging of the knee joints, with a focus on the extent to which these modalities fulfill the OMERACT filter. A series of studies are reported that examine patient reported, clinical examination, and imaging outcomes in therapeutic st…
COX-2 expression in chondrosarcoma: A role for celecoxib treatment?
2010
Chondrosarcomas are resistant to conventional chemo- and radiotherapy. A subset of chondrosarcomas arises secondarily in the benign tumour syndromes enchondromatosis (EC) and multiple osteochondromas (MO), and prevention of tumour development would greatly improve prognosis. We therefore investigated the effect of selective COX-2 inhibition on chondrosarcoma growth. COX-2 expression was studied in central- and peripheral cartilaginous tumours. The effect of COX-2 inhibition was assessed in four high-grade chondrosarcoma cell lines using celecoxib and NS-398 treatment. COX-2 activity (prostaglandin E-2 (PGE(2)) ELISA) and cell viability were measured. The (prophylactic) effect of celecoxib o…
High frequency of lumbar fusion in patients denied surgical treatment of the sacroiliac joint.
2019
Purpose: Effective treatment of medical conditions relies on proper diagnosis. Clinical trials show the safety and effectiveness of sacroiliac joint (SIJ) fusion in patients with chronic SI joint dysfunction. To what extent is the condition under recognised? Objective: To determine whether under recognition of SIJ pain affects healthcare trajectories in Spanish patients with low back pain. Methods: Retrospective study of characteristics and consequences of 189 patients with persistent SIJ pain seen in an outpatient neurosurgery clinic. Results: Patients with SIJ pain who were denied surgical treatment had a longer pain duration, higher likelihood of prior lumbar fusion, and a high rate (63%…
A controlled trial of intra-articular corticosteroids with or without methotrexate in oligoarticular juvenile idiopathic arthritis
2014
In contrast with the numerous controlled trials conducted in polyarticular or systemic juvenile idiopathic arthritis (JIA), little evidence-based information is available for oligoarticular JIA. As a result, the management of children with this subtype, which is the most prevalent in Western countries, is largely empiric. Intra-articular corticosteroid (IAC) injection is the therapy of first choice for oligoarthritis in many pediatric rheumatology centers. However, although IAC injections are usually highly efficacious, relapses of synovitis are common and sometimes occur only a few months after the procedure. It is still unclear whether concomitant administration of methotrexate (MTX) may …
Improving the cementation of the tibial component in knee arthroplasty : a study of four techniques in the cadaver.
2021
Aims The main objective of this study is to analyze the penetration of bone cement in four different full cementation techniques of the tibial tray. Methods In order to determine the best tibial tray cementation technique, we applied cement to 40 cryopreserved donor tibiae by four different techniques: 1) double-layer cementation of the tibial component and tibial bone with bone restrictor; 2) metallic cementation of the tibial component without bone restrictor; 3) bone cementation of the tibia with bone restrictor; and 4) superficial bone cementation of the tibia and metallic keel cementation of the tibial component without bone restrictor. We performed CT exams of all 40 subjects, and mea…
Intra-articular corticosteroids versus intra-articular corticosteroids plus methotrexate in oligoarticular juvenile idiopathic arthritis: a multicent…
2017
Summary Background Little evidence-based information is available to guide the treatment of oligoarticular juvenile idiopathic arthritis. We aimed to investigate whether oral methotrexate increases the efficacy of intra-articular corticosteroid therapy. Methods We did this prospective, open-label, randomised trial at ten hospitals in Italy. Using a concealed computer-generated list, children younger than 18 years with oligoarticular-onset disease were randomly assigned (1:1) to intra-articular corticosteroids alone or in combination with oral methotrexate (15 mg/m 2 ; maximum 20 mg). Corticosteroids used were triamcinolone hexacetonide (shoulder, elbow, wrist, knee, and tibiotalar joints) o…
Is time to joint replacement a valid outcome measure in clinical trials of drugs for osteoarthritis?
2003
The rate of radiographic joint space narrowing is commonly used today as a structural outcome measure in clinical trials evaluating potential disease-modifying drugs in patients with hip osteoarthritis, but this results in a continuous variable. Among the methods proposed to circumvent this problem, it has been suggested that the incidence of total hip arthoplasty (THA) provides a hard outcome measure. It is a dichotomized variable, easy to measure and sensitive to change, with acceptable intrinsic validity. However, because this measure is limited by the variability of factors underlying the decision to perform surgery and the length of waiting lists, it has been suggested that time to ful…
MINIMIZING INFLIXIMAB TOXICITY IN THE TREATMENT OF INFLAMMATORY BOWEL DISEASE
2008
Abstract Background Infliximab is a widely used biological agent for the treatment of inflammatory bowel disease, and has a favorable risk/benefit ratio. Aim It is useful to know that patients treated with infliximab are exposed to developing adverse events that could be reduced with a prudent and a rational clinical approach and by optimizing the treatment protocol. Methods PubMed (including Epub) was searched in October 2006 and again in March 2007. Results The high immunogenic potential of infliximab determines the antibodies that inhibit the effect of infliximab and the appearance of subsequent acute and delayed infusion reactions. Infliximab has an immunomodulatory effect, thus increas…