Articles: treatment.
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Randomized Controlled Trial Multicenter Study
Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial.
The calcitonin gene-related peptide (CGRP) pathway is important in migraine pathophysiology. We assessed the efficacy and safety of erenumab, a fully human monoclonal antibody against the CGRP receptor, in patients with chronic migraine. ⋯ Amgen.
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Randomized Controlled Trial Multicenter Study
Statistical analysis plan for the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial.
The Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial, a 3800-patient, multicentre, randomised controlled trial, will be the largest study to date of corticosteroid therapy in patients with septic shock. ⋯ We have developed an SAP for the ADRENAL trial. This plan accords with high-quality standards of internal validity to minimise analysis bias.
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Randomized Controlled Trial Multicenter Study Comparative Study
Critical care management of aneurysmal subarachnoid haemorrhage in Australia and New Zealand: what are we doing, and where to from here?
Patients with an aneurysmal subarachnoid haemorrhage (SAH) frequently require admission to the intensive care unit. There, a variety of therapeutic strategies are initiated, in addition to definitive procedures aimed at securing the aneurysm. Despite a substantial investment in caring for these patients, outcomes for this group remain poor. ⋯ Delayed cerebral ischaemia is a significant cause of longterm morbidity and mortality after SAH. There are limited data supporting much of the critical care provided to patients with SAH in the ICU, leading to substantial institutional and practitioner variation in treatment. Whether this influences patient outcomes is unknown, although it represents a major knowledge gap in neurocritical practice in Australia and New Zealand.
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Critical care medicine · Jun 2017
Randomized Controlled Trial Multicenter StudyThe Septic Shock 3.0 Definition and Trials: A Vasopressin and Septic Shock Trial Experience.
The Septic Shock 3.0 definition could alter treatment comparisons in randomized controlled trials in septic shock. Our first hypothesis was that the vasopressin versus norepinephrine comparison and 28-day mortality of patients with Septic Shock 3.0 definition (lactate > 2 mmol/L) differ from vasopressin versus norepinephrine and mortality in Vasopressin and Septic Shock Trial. Our second hypothesis was that there are differences in plasma cytokine levels in Vasopressin and Septic Shock Trial for lactate less than or equal to 2 versus greater than 2 mmol/L. ⋯ The Septic Shock 3.0 definition decreased sample size by half and increased 28-day mortality rates by about 10%. Vasopressin lowered mortality versus norepinephrine if lactate was less than or equal to 2 mmol/L. Patients had higher plasma cytokines in lactate greater than 2 versus less than or equal to 2 mmol/L, a brisker cytokine response to infection. The Septic Shock 3.0 definition and our findings have important implications for trial design in septic shock.
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Osteoarthr. Cartil. · Jun 2017
Randomized Controlled Trial Multicenter StudyEfficacy and safety of duloxetine in Chinese patients with chronic pain due to osteoarthritis: a randomized, double-blind, placebo-controlled study.
We assessed the efficacy and safety of duloxetine (60 mg, once daily), compared with placebo, during a 13-week treatment period in Chinese patients with chronic pain due to osteoarthritis (OA). ⋯ This study demonstrated the efficacy of duloxetine in Chinese patients with chronic pain due to OA. The safety profile of duloxetine observed in this study was consistent with that in previous duloxetine trials. This trial is registered with ClinicalTrials.gov (NCT01931475).