Final Results of a Randomized, Phase III Study of Rituximab With or Without Idelalisib Followed by Open-Label Idelalisib in Patients With Relapsed Chronic Lymphocytic Leukemia.

Purpose: A randomized, double-blind, phase III study of idelalisib (IDELA) plus rituximab versus placebo plus rituximab in patients with relapsed chronic lymphocytic leukemia (CLL) was terminated early because of superior efficacy of the IDELA-plus-rituximab (IDELA/R) arm. Patients in either arm could then enroll in an extension study to receive IDELA monotherapy. Here, we report the long-term efficacy and safety data for IDELA-treated patients across the primary and extension studies.

Elastin-Specific Autoimmunity in Smokers With Thoracic Aortic Aneurysm and Dissection is Independent of Chronic Obstructive Pulmonary Disease.

Background Thoracic aortic aneurysm ( TAA ) and dissection ( TAD ) are characterized by progressive disorganization of the aortic wall matrix, including elastin, a highly immunogenic molecule. Whether acquired autoimmune responses can be detected in TAA / TAD patients who are smokers is unknown. The objectives of this study were to determine whether TAA / TAD smokers have increased T-cell responses to human elastin fragments, and to determine whether autoimmune responses in TAA / TAD smokers are dependent on chronic obstructive pulmonary disease.

A Randomized Controlled, Treat-to-Target Study Evaluating the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) Administered Using Either Device-Supported or Routine Titration in People With Type 2 Diabetes.

Background: The efficacy/safety of device-supported versus routine titration with Gla-300 in type 2 diabetes (T2DM) was evaluated.

Method: AUTOMATIX was a 16-week, randomized, open-label, parallel-group, multicenter, noninferiority trial in insulin-treated or insulin-naïve people with T2DM. The fasting self-monitored plasma glucose (FSMPG) target was 90-130 mg/dL (5.

Organ Donor Management: Part 1. Toward a Consensus to Guide Anesthesia Services During Donation After Brain Death.

Worldwide 715 482 patients have received a lifesaving organ transplant since 1988. During this time, there have been advances in donor management and in the perioperative care of the organ transplant recipient, resulting in marked improvements in long-term survival. Although the number of organs recovered has increased year after year, a greater demand has produced a critical organ shortage.

Six-Month Morbidity and Mortality among Intensive Care Unit Patients Receiving Life-Sustaining Therapy. A Prospective Cohort Study.

Rationale: Understanding long-term outcomes of critically ill patients may inform shared decision-making in the intensive care unit (ICU).

Objectives: To quantify 6-month functional outcomes of general ICU patients, and develop a multivariable model comprising factors present during the first ICU day to predict which patients will return to their baseline function 6 months later.

Methods: We conducted a prospective cohort study in three medical ICUs and two surgical ICUs in three hospitals.

How Substance Users With ADHD Perceive the Relationship Between Substance Use and Emotional Functioning.

Objective: Although substance use (SU) is elevated in ADHD and both are associated with disrupted emotional functioning, little is known about how emotions and SU interact in ADHD. We used a mixed qualitative-quantitative approach to explore this relationship.

Method: Narrative comments were coded for 67 persistent (50 ADHD, 17 local normative comparison group [LNCG]) and 25 desistent (20 ADHD, 5 LNCG) substance users from the Multimodal Treatment Study of Children with ADHD (MTA) adult follow-up (21.

Design and Rationale of the Reevaluation of Systemic Early Neuromuscular Blockade Trial for Acute Respiratory Distress Syndrome.

The Reevaluation of Systemic Early Neuromuscular Blockade (ROSE) trial is a multicenter, randomized trial designed to assess the efficacy and safety of early neuromuscular blockade in patients with moderate to severe acute respiratory distress syndrome. This document provides background for interpretation of the trial results, and highlights unique design approaches that may inform future trials of acute illness. We describe the process by which ROSE was chosen as the inaugural trial of the multidisciplinary Prevention and Early Treatment of Acute Lung Injury Network, provide the trial methodology using the Consolidated Standards of Reporting Trials framework, and discuss key design challenges and their resolution.

Research Priorities for Endometriosis.

The 3rd International Consensus Workshop on Research Priorities in Endometriosis was held in São Paulo on May 4, 2014, following the 12th World Congress on Endometriosis. The workshop was attended by 60 participants from 19 countries and was divided into 5 main sessions covering pathogenesis/pathophysiology, symptoms, diagnosis/classification/prognosis, disease/symptom management, and research policy. This research priorities consensus statement builds on earlier efforts to develop research directions for endometriosis.

Attitudes, Knowledge, and Correlates of Self-Efficacy for the Provision of Safer Conception Counseling Among Ugandan HIV Providers.

High rates of childbearing desires (59%) and serodiscordant partnerships (50%) among people living with HIV (PHLA) in Uganda highlight the need for safer conception counseling (SCC). Provider attitudes about counseling PLHA on the use of safer conception methods (SCM) have been explored in qualitative studies, but published quantitative investigations are scarce. Data from 57 Ugandan providers were collected to examine providers' attitudes about childbearing among PLHA and engagement in discussions about childbearing, as well as their knowledge, interest, self-efficacy, and intentions to provide SCC.

The Investigation of ADAMTS16 in Insulin-Induced Human Chondrosarcoma Cells.

Objectives: A disintegrin-like metalloproteinase with thrombospondin motifs (ADAMTS) is a group of proteins that have enzymatic activity secreted by cells to the outside extracellular matrix. Insulin induces proteoglycan biosynthesis in chondrosarcoma chondrocytes. The purpose of the present in vitro study is to assess the time course effects of insulin on ADAMTS16 expression in OUMS-27 (human chondrosarcoma) cell line to examine whether insulin regulates ADAMTS16 expression as well as proteoglycan biosynthesis with multifaceted properties or not.

Multicenter evaluation of the safety and efficacy of radioembolization in patients with unresectable colorectal liver metastases selected as candidates for (90)Y resin microspheres.

Background: Metastatic colorectal cancer liver metastases Outcomes after RadioEmbolization (MORE) was an investigator-initiated case-control study to assess the experience of 11 US centers who treated liver-dominant metastases from colorectal cancer (mCRC) using radioembolization [selective internal radiation therapy (SIRT)] with yttrium-90-((90)Y)-labeled resin microspheres.

Methods: Data from 606 consecutive patients who received radioembolization between July 2002 and December 2011 were collected by an independent research organization. Adverse events (AEs) and survival were compared across lines of treatment using Fisher's exact test and Kaplan-Meier estimates, respectively.