Combined immunotherapy with controlled interleukin-12 gene therapy and immune checkpoint blockade in recurrent glioblastoma: An open-label, multi-institutional phase I trial.

Background: Veledimex (VDX)-regulatable interleukin-12 (IL-12) gene therapy in recurrent glioblastoma (rGBM) was reported to show tumor infiltration of CD8+ T cells, encouraging survival, but also up-regulation of immune checkpoint signaling, providing the rationale for a combination trial with immune checkpoint inhibition.

Methods: An open-label, multi-institutional, dose-escalation phase I trial in rGBM subjects (NCT03636477) accrued 21 subjects in 3 dose-escalating cohorts: (1) neoadjuvant then ongoing nivolumab (1mg/kg) and VDX (10 mg) (n = 3); (2) neoadjuvant then ongoing nivolumab (3 mg/kg) and VDX (10 mg) (n = 3); and (3) neoadjuvant then ongoing nivolumab (3 mg/kg) and VDX (20 mg) (n = 15). Nivolumab was administered 7 (±3) days before resection of the rGBM followed by peritumoral injection of IL-12 gene therapy.

A Structured Approach Using the Systematic Review Data Repository (SRDR): Building the Evidence for Oral Health Interventions in the Population With Intellectual and Developmental Disability.

Background: This review describes the methods used for a systematic review of oral health intervention literature in a target population (people with intellectual and developmental disability (I/DD)), which spans a broad range of interventions and study types, conducted with specialized software.

Objective: The aim of this article is to demonstrate the review strategy, using the free, online systematic review data repository (SRDR) tool, for oral health interventions aimed at reducing disparities between people with I/DD and the general population.

Research Design: Researchers used online title/abstract review (Abstrackr) and data extraction (SRDR) tools to structure the literature review and data extraction.

Innovations in data collection, management, and archiving for systematic reviews.

Data abstraction is a key step in conducting systematic reviews because data collected from study reports form the basis of appropriate conclusions. Recent methodological standards and expectations highlight several principles for data collection. To support implementation of these standards, this article provides a step-by-step tutorial for selecting data collection tools; constructing data collection forms; and abstracting, managing, and archiving data for systematic reviews.

Asymptomatic carotid artery stenosis treated with medical therapy alone: temporal trends and implications for risk assessment and the design of future studies.

Background: The rate of adverse clinical outcomes among patients with asymptomatic carotid stenosis receiving medical therapy alone can be used to guide clinical decision-making and to inform future research. We aimed to investigate temporal changes in the incidence rate of clinical outcomes among patients with asymptomatic carotid stenosis receiving medical therapy alone and to explore the implications of these changes for the design of future comparative studies.

Summary: We searched MEDLINE, the Cochrane Central Register of Controlled Trials, US Food and Drug Administration documents, and reference lists of included studies (last search: December 31, 2012).

A community consultation survey to evaluate support for and success of the IMMEDIATE trial.

Background: The IMMEDIATE (Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care) Trial, a randomized controlled double-blind clinical effectiveness trial of glucose-insulin-potassium (GIK) administered in ambulances in the out-of-hospital setting, used the Exception from Informed Consent Requirements (EFIC) for Emergency Research under Title 21 of the Code of Federal Regulations. EFIC requirements include community consultation that typically involves using a variety of communication methods and venues to inform the public of the research and to receive their feedback. Although not the primary purpose of the community consultation process, a common concern to research sponsors, staff, and institutional review boards (IRBs) is whether there will be a sufficient number of participants to justify mounting a study in their community.

The lack of evidence for PET or PET/CT surveillance of patients with treated lymphoma, colorectal cancer, and head and neck cancer: a systematic review.

Unlabelled: PET and PET/CT are widely used for surveillance of patients after cancer treatments. We conducted a systematic review to assess the diagnostic accuracy and clinical impact of PET and PET/CT used for surveillance in several cancers.

Methods: We searched MEDLINE and Cochrane Library databases from 1996 to March 2012 for English-language studies of PET or PET/CT used for surveillance of patients with lymphoma, colorectal cancer, or head and neck cancer.

Management strategies for asymptomatic carotid stenosis: a systematic review and meta-analysis.

Background: Adults with asymptomatic carotid artery stenosis are at increased risk for ipsilateral carotid territory ischemic stroke.

Purpose: To examine comparative evidence on management strategies for asymptomatic carotid stenosis and the incidence of ipsilateral stroke with medical therapy alone.

Data Sources: MEDLINE, Cochrane Central Register of Controlled Trials, U.

A Web-based archive of systematic review data.

Systematic reviews have become increasingly critical to informing healthcare policy; however, they remain a time-consuming and labor-intensive activity. The extraction of data from constituent studies comprises a significant portion of this effort, an activity which is often needlessly duplicated, such as when attempting to update a previously conducted review or in reviews of overlapping topics.In order to address these inefficiencies, and to improve the speed and quality of healthcare policy- and decision-making, we have initiated the development of the Systematic Review Data Repository, an open collaborative Web-based repository of systematic review data.

Emerging magnetic resonance imaging technologies for musculoskeletal imaging under loading stress: scope of the literature.

Imaging under loading stress is hypothesized to improve the diagnostic value of magnetic resonancel imaging (MRI) for musculoskeletal conditions. This article reviews 57 studies about MRI under physiologic loading stress performed in an upright or sitting position or under axial loading by using a compression device. The most commonly imaged regions were the spine (33 studies) and knee (13 studies).

Symptom clusters and physical function for patients receiving chemotherapy.

Objectives: To examine the literature on symptom clusters and the impact of co-occurring symptoms on the physical function of patients with cancer during treatment.

Data Sources: Research and review articles.

Conclusion: Unmanaged symptoms occur in what are often called symptom clusters.