Tumor lysate particle only vaccine (TLPO) vs. Tumor lysate particle-loaded, dendritic cell vaccine (TLPLDC) to prevent recurrence in resected stage III/IV melanoma patients: Results of a phase I/IIa trial.

Background: The autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine is produced from dendritic cells (DC) loaded ex vivo with autologous tumor lysate (TL). TLPLDC has been shown to decrease recurrence in resected Stage III/IV melanoma patients in a Phase IIb trial. The TL particle only (TLPO) vaccine is produced by loading of yeast cell wall particles with autologous TL and direct injection allowing for in vivo DC loading.

A systematic review and meta-analysis of retrograde type A aortic dissection after thoracic endovascular aortic repair in patients with type B aortic dissection.

Background: Retrograde type A dissection (RTAD) is a devastating complication of thoracic endovascular repair (TEVAR) with low incidence but high mortality. The objective of this study is to report the incidence, mortality, potential risk factors, clinical manifestation and diagnostic modalities, and medical and surgical treatments.

Methods: A systematic review and single-arm and two-arm meta-analyses evaluated all published reports of RTAD post-TEVAR through January 2021.

Preoperative Risk Prediction for Pancreatectomy: A Comparative Analysis of Three Scoring Systems.

Introduction: Pancreatectomy is associated with high morbidity and mortality. Therefore, patient selection and risk prediction is paramount. In this study, three validated perioperative risk scoring systems were compared among patients undergoing pancreatectomy to identify the most clinically useful model.

Downstaging of Pancreatic Adenocarcinoma With Either Neoadjuvant Chemotherapy or Chemoradiotherapy Improves Survival.

Background: Neoadjuvant chemotherapy (NAC) or chemoradiation (NAC+XRT) is incorporated into the treatment of localized pancreatic adenocarcinoma (PDAC), often with the goal of downstaging before resection. However, the effect of downstaging on overall survival, particularly the differential effects of NAC and NAC+XRT, remains undefined. This study examined the impact of downstaging from NAC and NAC+XRT on overall survival.

Contemporary Assessment of Need for Palliative Bypass After Aborted Pancreatoduodenectomy Following Neoadjuvant Therapy.

Background: Planned pancreatoduodenectomy (PD) for pancreatic adenocarcinoma (PDAC) can be aborted due to intraoperative findings. There is little guidance regarding the need for prophylactic bypass following an aborted PD to prevent symptomatic biliary obstruction or gastric outlet obstruction (GOO) postoperatively. The aim of this study was to characterize postoperative interventions and postsurgical survival in patients following aborted PD.

Frozen Elephant Trunk Completion: Endovascular Extension in The Distal Thoracic Aorta.

Introduction: Complex pathologies involving the aortic arch can be treated using the frozen elephant trunk (FET) technique, which is versatile and continues to be improved with different innovations to further reduce, for example, circulatory arrest time and the need for hypothermia. FET may or may not be a definitive repair, however. Distal extension or completion-especially endovascular-is common but not well described in the literature.

Implementation of a Traumatic Brain Injury Guideline at A Department of Defense Level 1 Trauma Center.

Background: Traumatic brain injury (TBI) is one of the most prevalent diagnoses among trauma populations and places significant strain on valuable rural hospital resources. Limited studies show safety and efficacy of implementation of a Brain Injury Guideline (BIG) protocol at a Department of Defense (DoD) Level 1 trauma center.

Materials And Methods: Data from patients diagnosed with traumatic brain injury during the study period were collected from our institutional trauma database.

Impact of Hepatic Metastasectomy in the Multimodal Treatment of Metastatic Breast Cancer.

Background: Surgical management of hepatic metastases in patients with stage IV breast cancer remains controversial. The purpose of this study was to examine the impact of hepatic metastasectomy on long-term outcomes.

Methods: The 2004-2015 National Cancer Database was queried for all patients diagnosed with stage IV breast cancer with metastases isolated to the liver.

A Phase IIb Randomized Controlled Trial of the TLPLDC Vaccine as Adjuvant Therapy After Surgical Resection of Stage III/IV Melanoma: A Primary Analysis.

Background: Melanoma therapy has changed dramatically over the last decade with improvements in immunotherapy, yet many patients do not respond to current therapies. This novel vaccine strategy may prime a patient's immune system against their tumor and work synergistically with immunotherapy against advanced-stage melanoma.

Methods: This was a prospective, randomized, double-blind, placebo-controlled, phase IIb trial of the tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine administered to prevent recurrence in patients with resected stage III/IV melanoma.

Rectal Injury After Foreign Body Insertion: Secondary Analysis From the AAST Contemporary Management of Rectal Injuries Study Group.

Background: Retained rectal foreign bodies are a common but incompletely studied problem. This study defined the epidemiology, injury severity, and outcomes after rectal injuries following foreign body insertion.

Methods: Twenty-two level I trauma centers retrospectively identified all patients sustaining a rectal injury in this AAST multi-institutional trial (2005-2014).

Research methodology and practical issues relating to the conduct of a medical device registry.

Background: The postmarket research goal is to assess "generalizability" or "external validity" to see if the early results of clinical trials with investigational devices are reproducible in everyday practice in the real world and the longer term. Registries have an important but ambivalent role in achieving this goal.

Methods: Although registries are common, in practice they follow the regulatory processes that appear designed primarily for pharmaceutical clinical trials and confirmatory studies.

Traumatic rectal injuries: Is the combination of computed tomography and rigid proctoscopy sufficient?

Background: There are no clear guidelines for the best test or combination of tests to identify traumatic rectal injuries. We hypothesize that computed tomography (CT) and rigid proctoscopy (RP) will identify all injuries.

Methods: American Association for the Surgery of Trauma multi-institutional retrospective study (2004-2015) of patients who sustained a traumatic rectal injury.

The Respiratory Rate: A Neglected Triage Tool for Pre-hospital Identification of Trauma Patients.

Background: Under-triaged trauma patients have worse clinical outcomes. We evaluated the capability of four pre-hospital variables to identify this population at the lowest level trauma activation (level 3).

Methods: A retrospective review of adult trauma activations from 2004 to 2014 was completed.

Contemporary management of rectal injuries at Level I trauma centers: The results of an American Association for the Surgery of Trauma multi-institutional study.

Introduction: Rectal injuries have been historically treated with a combination of modalities including direct repair, resection, proximal diversion, presacral drainage, and distal rectal washout. We hypothesized that intraperitoneal rectal injuries may be selectively managed without diversion and the addition of distal rectal washout and presacral drainage in the management of extraperitoneal injuries are not beneficial.

Methods: This is an American Association for the Surgery of Trauma multi-institutional retrospective study from 2004 to 2015 of all patients who sustained a traumatic rectal injury and were admitted to one of the 22 participating centers.

Well-Defined Chiral Gold(III) Complex Catalyzed Direct Enantioconvergent Kinetic Resolution of 1,5-Enynes.

The development of a gold(III) catalyzed direct enantioconvergent 1,5-enyne cycloisomerization and kinetic resolution reaction is described. The transformation results in highly enantioenriched bicyclo[3.1.

Optimizing physician skill development for medical students: The four-part assessment.

Background: Medical student performance has been poorly correlated with residency performance and warrants further investigation. We propose a novel surgical assessment tool to determine correlations with clinical aptitude.

Methods: Retrospective review of medical student assessments from 2013 to 2015.

Phase II randomized study of PM01183 versus topotecan in patients with platinum-resistant/refractory advanced ovarian cancer.

Background: PM01183 is a new compound that blocks active transcription, produces DNA breaks and apoptosis, and affects the inflammatory microenvironment. PM01183 showed strong antitumor activity in preclinical models of cisplatin-resistant epithelial ovarian cancer.

Patients And Methods: Patients with platinum-resistant/refractory ovarian cancer were included in a two-stage, controlled, randomized (in a second stage), multicenter, phase II study.

Phase I clinical and pharmacokinetic study of PM01183 (a tetrahydroisoquinoline, Lurbinectedin) in combination with gemcitabine in patients with advanced solid tumors.

Background To determine the recommended dose (RD) of a combination of PM01183 and gemcitabine in patients with advanced solid tumors. Methods Forty-five patients received escalating doses of PM01183/gemcitabine on Days 1 and 8 every 3 weeks (d1,8 q3wk) following a standard 3 + 3 design. Results PM01183 3.

Phase Ib/II study of elisidepsin in metastatic or advanced gastroesophageal cancer (IMAGE trial).

Purpose: To determine the recommended dose and antitumor activity of single-agent elisidepsin as a 24-h intravenous (i.v.) infusion fortnightly [biweekly, d1 and 15 every 4 weeks (q4wk); Arm A, dose-intensity strategy] or as a 3-h i.

Palladium-catalyzed, ring-forming aromatic C-H alkylations with unactivated alkyl halides.

A catalytic C-H alkylation using unactivated alkyl halides and a variety of arenes and heteroarenes is described. This ring-forming process is successful with a variety of unactivated primary and secondary alkyl halides, including those with β-hydrogens. In contrast to standard polar or radical cyclizations of aromatic systems, electronic activation of the substrate is not required.

Use of a systems-based approach to an environmental health assessment for a waterborne disease outbreak investigation at a snowmobile lodge in Wyoming.

Investigations into disease outbreaks generally incorporate an epidemiologic investigation, laboratory analysis, and an environmental health assessment. This last component is designed to discover connections between factors in the environment and the outbreak, but is often limited, either by time and resources, or the expertise of the personnel included in outbreak investigation teams. A waterborne Norovirus outbreak investigation in Sheridan County, Wyoming, in 2001 provides an excellent example of the importance of including an in-depth, systems-based environmental health assessment in outbreak investigations.