Efficacy and safety of fasinumab in patients with chronic low back pain: a phase II/III randomised clinical trial.

Objectives: To study the efficacy and safety of fasinumab in moderate-to-severe, chronic low back pain (CLBP).

Methods: In this phase II/III, double-blind, placebo-controlled study, patients with CLBP aged ≥35 years with inadequate pain relief/intolerance to acetaminophen, non-steroidal anti-inflammatory drugs and opioids were randomised to fasinumab 6 or 9 mg subcutaneous every 4 weeks (Q4W), 9 mg intravenous every 8 weeks (Q8W) or placebo. Primary endpoint was change from baseline to week 16 in average daily low back pain intensity (LBPI) numeric rating score.

Multicenter Phase II Study of Whole-Body and Intracranial Activity With Ceritinib in Patients With ALK-Rearranged Non-Small-Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib: Results From ASCEND-2.

Purpose: Phase I data (ASCEND-1) showed ceritinib efficacy in patients with ALK-rearranged non-small-cell lung cancer (NSCLC), regardless of brain metastases status and with or without prior therapy with an inhibitor of the ALK protein. Data are presented from a phase II trial (ASCEND-2) in which ceritinib efficacy and safety were evaluated in patients who had ALK-rearranged NSCLC previously treated with at least one platinum-based chemotherapy and who had experienced progression during crizotinib treatment as their last prior therapy.

Patients And Methods: Patients with advanced ALK-rearranged NSCLC, including those with asymptomatic or neurologically stable baseline brain metastases, received oral ceritinib 750 mg/d.

Racial/ethnic disparities in contraceptive use: variation by age and women's reproductive experiences.

Objective: Disparities in unintended pregnancy in the United States are related, in part, to black and Hispanic women being overall less likely to use effective contraceptive methods. However, the fact that these same groups are more likely to use female sterilization, a highly effective method, suggests there may be variability in disparities in contraceptive use across a woman's life course. We sought to assess the relationship between race/ethnicity and contraceptive use in a nationally representative sample and to approximate a life course perspective by examining effect modification on these disparities by women's age, parity, and history of unintended pregnancy.

Prospective evaluation of a clinical pathway for suspected appendicitis.

Objective: To evaluate the diagnostic accuracy of a clinical pathway for suspected appendicitis combining the Samuel's pediatric appendicitis score (PAS) and selective use of ultrasonography (US) as the primary imaging modality.

Methods: Prospective, observational cohort study conducted at an urban, academic pediatric emergency department. After initial evaluation, patients were determined to be at low (PAS 1-3), intermediate (PAS 4-7), or high (PAS 8-10) risk for appendicitis.

Depressive symptomatology, quality of life and disease control among individuals with well-characterized severe asthma.

Objectives: A thorough examination of the relationship of asthma severity and control with symptoms of depression is needed to identify groups of asthmatics at high risk for poor disease control outcomes. This study examines the relationship of symptoms of depression with severity and control in a well-characterized cohort of asthmatics and healthy controls.

Methods: Depressive symptoms and quality of life were assessed using the Beck Depression Inventory.

Does a history of unintended pregnancy lessen the likelihood of desire for sterilization reversal?

Background: Unintended pregnancy has been significantly associated with subsequent female sterilization. Whether women who are sterilized after experiencing an unintended pregnancy are less likely to express desire for sterilization reversal is unknown.

Methods: This study used national, cross-sectional data collected by the 2006-2010 National Survey of Family Growth.

A comparison of the E-BEHAVE-AD, NBRS, and NPI in quantifying clinical improvement in the treatment of agitation and psychosis associated with dementia.

Objectives: The aim of this study is to compare the Empirical Behavioral Rating Scale (E-BEHAVE-AD), Neurobehavioral Rating Scale (NBRS), and Neuropsychiatric Interview (NPI) in detecting behavioral disturbance and psychotic symptoms in dementia and characterizing changes in response to treatment.

Design: Eighty-seven subjects in the randomized controlled trial "Continuation Pharmacotherapy for Agitation of Dementia" were included in this analysis. We compared the detection in, and changes of, both agitation and psychosis, using these three instruments.

Acupuncture for the treatment of major depressive disorder: a randomized controlled trial.

Background: Over 50% of patients with major depressive disorder (MDD) either do not tolerate or do not respond to antidepressant medications. Several preliminary studies have shown the benefits of acupuncture in the treatment of depression. We sought to determine whether a 2-point electroacupuncture protocol (verum acupuncture) would be beneficial for MDD, in comparison to needling at nonchannel scalp points with sham electrostimulation (control acupuncture).

Impact of prior pharmacotherapy on remission of psychotic depression in a randomized controlled trial.

Having failed to respond to an adequate antidepressant treatment course predicts poorer treatment outcomes in patients with major depression. However, little is known about the impact of prior treatment on the outcome of major depression with psychotic features (MDpsy). We examined the effect of prior treatment history on the outcome of pharmacotherapy of MDpsy in patients who participated in the STOPD-PD study, a randomized, double-blind, clinical trial comparing a combination of olanzapine plus sertraline vs.