Articles: treatment.
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Arthritis Res. Ther. · Aug 2015
Randomized Controlled Trial Multicenter StudyA randomized, double-blind, placebo-controlled phase III trial of duloxetine in Japanese fibromyalgia patients.
Fibromyalgia is characterized by widespread pain and is often accompanied by accessory symptoms. There are limited treatment options for this condition in Japan. Therefore, we conducted a phase III study to assess the efficacy and safety of duloxetine in Japanese patients with fibromyalgia. ⋯ Although the MMRM analysis did not demonstrate superiority of duloxetine over placebo, duloxetine treatment was associated with improved outcomes in secondary and post hoc analyses of the mean change in the BPI average pain score and most of the secondary outcomes, including analgesia and QoL. Duloxetine treatment was safe and well tolerated. These results suggest that duloxetine treatment could be associated with improvements in pain relief and QoL in Japanese patients with fibromyalgia.
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Randomized Controlled Trial Multicenter Study
Pioglitazone in early Parkinson's disease: a phase 2, multicentre, double-blind, randomised trial.
A systematic assessment of potential disease-modifying compounds for Parkinson's disease concluded that pioglitazone could hold promise for the treatment of patients with this disease. We assessed the effect of pioglitazone on the progression of Parkinson's disease in a multicentre, double-blind, placebo-controlled, futility clinical trial. ⋯ National Institute of Neurological Disorders and Stroke.
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Randomized Controlled Trial Multicenter Study
Thrombectomy in patients ineligible for iv tPA (THRILL).
A relevant proportion of patients with acute ischemic stroke are ineligible for intravenous thrombolysis with recombinant tissue plasminogen activator. Mechanical thrombectomy offers a treatment alternative for these patients; however, only few data are available on its safety and efficacy. ⋯ Whether mechanical thrombectomy in patients with acute ischemic stroke who are not eligible for intravenous thrombolysis with recombinant tissue plasminogen activator improves clinical outcomes is unclear. 'Thrombectomy in patients ineligible for iv tPA' may change clinical practice by providing evidence of an effective and safe treatment for such patients.
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Randomized Controlled Trial Multicenter Study
Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension.
The safety and efficacy of adding bosentan to sildenafil in pulmonary arterial hypertension (PAH) patients was investigated. In this prospective, double-blind, event-driven trial, symptomatic PAH patients receiving stable sildenafil (≥20 mg three times daily) for ≥3 months were randomised (1:1) to placebo or bosentan (125 mg twice daily). The composite primary end-point was the time to the first morbidity/mortality event, defined as all-cause death, hospitalisation for PAH worsening or intravenous prostanoid initiation, atrial septostomy, lung transplant, or PAH worsening. ⋯ Except for NT-proBNP, no difference was observed for any other end-point. The safety profile of bosentan added to sildenafil was consistent with the known bosentan safety profile. In COMPASS-2, adding bosentan to stable sildenafil therapy was not superior to sildenafil monotherapy in delaying the time to the first morbidity/mortality event.
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Multicenter Study Comparative Study
Clinical Health Service Research on the Surgical Therapy of Acute Appendicitis: Comparison of Outcomes Based on 3 German Multicenter Quality Assurance Studies Over 21 Years.
The treatment of acute appendicitis has seen changes in diagnosis and therapy in Germany. The objective of this analysis was to assess changes in therapy and outcome after open appendectomy (OA) and laparoscopic appendectomy (LA) over the last 21 years. ⋯ Changes in patient data reflected demographic changes. Preoperative selection leads to 2 clearly defined groups. LA is the most dominant method of current operative therapy. The negative selection in OA group has influenced the worse outcome of that group.