Pharmacokinetics and Pharmacodynamics of Rusfertide, a Hepcidin Mimetic, Following Subcutaneous Administration of a Lyophilized Powder Formulation in Healthy Volunteers.

Background And Objective: Hepcidin, an endogenous peptide hormone, binds to ferroportin and is the master regulator of iron trafficking. Rusfertide, a synthetic peptide, is a potent hepcidin mimetic. Clinical studies suggest rusfertide may be effective in the treatment of polycythemia vera.

CAPER: patient preferences to inform nonsurgical treatment of chronic low back pain: a discrete-choice experiment.

Objective: We developed and used a discrete-choice measure to study patient preferences with regard to the risks and benefits of nonsurgical treatments when they are making treatment selections for chronic low back pain.

Methods: "CAPER TREATMENT" (Leslie Wilson) was developed with standard choice-based conjoint procedures (discrete-choice methodology that mimics an individual's decision-making process). After expert input and pilot testing, our final measure had 7 attributes (chance of pain relief, duration of relief, physical activity changes, treatment method, treatment type, treatment time burden, and risks of treatment) with 3-4 levels each.

Real-world treatments and thrombotic events in polycythemia vera patients in the USA.

Polycythemia vera (PV) is a myeloproliferative neoplasm associated with increased risk of thrombotic events (TE) and death. Therapeutic interventions, phlebotomy and cytoreductive medications, are targeted to maintain hematocrit levels < 45% to prevent adverse outcomes. This retrospective observational study examined medical and pharmacy claims of 28,306 PV patients initiating treatment for PV in a data period inclusive of 2011 to 2019.

Local Application of Vancomycin in Spine Surgery Does Not Result in Increased Vancomycin-Resistant Bacteria-10-Year Data.

Study Design: Case-control study.

Objectives: To analyze the microbial flora in surgical spine infections and their antibiotic resistance patterns across time and determine the correlation between vancomycin application in the wound and vancomycin-resistant microbes.

Summary Of Background Data: Prior studies show a reduction in surgical site infections with intrawound vancomycin placement.

Phase 2 studies of oral hypoxia-inducible factor prolyl hydroxylase inhibitor FG-4592 for treatment of anemia in China.

Background: FG-4592 (roxadustat) is an oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (HIF-PHI) promoting coordinated erythropoiesis through the transcription factor HIF. Two Phase 2 studies were conducted in China to explore the safety and efficacy of FG-4592 (USAN name: roxadustat, CDAN name: ), a HIF-PHI, in patients with anemia of chronic kidney disease (CKD), both patients who were dialysis-dependent (DD) and patients who were not dialysis-dependent (NDD).

Methods: In the NDD study, 91 participants were randomized to low (1.

Outcomes and effectiveness of posterior occipitocervical fusion for suboccipital spinal metastases.

OBJECTIVE The incidence of suboccipital spinal metastases is rare but has increased given cancer patients' longer life expectancies. Operative treatment in this region is often challenging because of limited fixation points due to tumor lysis, as well as adjacent neural and vascular anatomy. Few studies have reported on this population of cancer patients.

Outcomes following Laminoplasty or Laminectomy and Fusion in Patients with Myelopathy Caused by Ossification of the Posterior Longitudinal Ligament: A Systematic Review.

 Systematic review.  To compare laminoplasty versus laminectomy and fusion in patients with cervical myelopathy caused by OPLL.  A systematic review was conducted using PubMed/Medline, Cochrane database, and Google scholar of articles.

Lateral interbody fusion combined with open posterior surgery for adult spinal deformity.

OBJECTIVE Lateral interbody fusion (LIF) with percutaneous screw fixation can treat adult spinal deformity (ASD) in the coronal plane, but sagittal correction is limited. The authors combined LIF with open posterior (OP) surgery using facet osteotomies and a rod-cantilever technique to enhance lumbar lordosis (LL). It is unclear how this hybrid strategy compares to OP surgery alone.

FG-3019 anti-connective tissue growth factor monoclonal antibody: results of an open-label clinical trial in idiopathic pulmonary fibrosis.

FG-3019 is a fully human monoclonal antibody that interferes with the action of connective tissue growth factor, a central mediator in the pathogenesis of fibrosis.This open-label phase 2 trial evaluated the safety and efficacy of two doses of FG-3019 administered by intravenous infusion every 3 weeks for 45 weeks in patients with idiopathic pulmonary fibrosis (IPF). Subjects had a diagnosis of IPF within the prior 5 years defined by either usual interstitial pneumonia (UIP) pattern on a recent high-resolution computed tomography (HRCT) scan, or a possible UIP pattern on HRCT scan and a recent surgical lung biopsy showing UIP pattern.

Efficacy of transcranial motor evoked potentials, mechanically elicited electromyography, and evoked electromyography to assess nerve root function during sustained compression in a porcine model.

Study Design: This is an animal experiment using transcranial motor evoked potentials (TcMEPs), mechanically elicited electromyographic (EMG) responses, and evoked EMG responses during nerve root compression in a pig model.

Objective: To compare these 3 electrophysiological measures for compression applied to a lumbar nerve root.

Summary Of Background Data: Lumbar nerve root injury may result in motor weakness in up to 30% of spinal deformity cases.

Hip arthroscopy: from the beginning to the future--an innovator's perspective.

Hip arthroscopy is one of the fastest-growing areas of orthopaedic surgery. There are many reasons for this, including a better understanding of the pathophysiology of damage to the hip joint, improvements in imaging and technology advancements in arthroscopic instrumentation. This manuscript documents the historical development of hip arthroscopy, in general, as well as advances and ideas that have led to common techniques with regard to portal placement, traction and instrumentation.

Current trends in rotator cuff repair: surgical technique, setting, and cost.

Purpose: The purpose of this study was to evaluate national trends in the surgical setting and hospital costs of shoulder arthroscopy and rotator cuff repair (RCR) using the Florida State surgical database and national inpatient database.

Methods: In part I we analyzed population-adjusted shifts in RCR technique (arthroscopic v open) in the Florida surgical database from 2000-2007 and quantified the procedural codes associated with arthroscopic and open RCR. In part II we analyzed the Nationwide Inpatient Sample database from 2001-2009 for the total number of inpatient RCRs, the inpatient hospital type (rural, urban non-teaching, or urban teaching), and the cost.

Trends in hip arthroscopy utilization in the United States.

Introduction: The purpose of this study was to evaluate the changing incidence of hip arthroscopy procedures among newly trained surgeons in the United States, the indications for hip arthroscopy, and the reported rate of post-operative complications.

Methods: The ABOS database was used to evaluate the annual incidence of hip arthroscopy procedures between 2006-2010. Procedures were categorized by indication and type of procedure.

Stereotactic lesions for the treatment of psychiatric disorders.

Object: The use of deep brain stimulation (DBS) has recently been expanded to the investigational treatment of specific psychiatric disorders. Much like movement disorders, the targets selected for DBS are based on past experience with stereotactic lesions. A literature review of past studies incorporating stereotactic lesions for psychiatric disorders was performed to provide historical context and possible guidance for current and future attempts at treating psychiatric disorders with DBS.

Induction therapy for poor-prognosis anal canal carcinoma: a phase II study of the cancer and Leukemia Group B (CALGB 9281).

Purpose: Although most patients with anal canal cancer are cured with sphincter-preserving, nonsurgical, combined-modality therapy, those with large tumors and lymph node involvement have a poor prognosis. To establish the safety and efficacy of induction chemotherapy with infusional fluorouracil (FU) plus cisplatin followed by FU plus mitomycin C with concurrent radiation in patients with poor-prognosis squamous cell cancers of the anal canal.

Methods: Patients with previously untreated anal canal cancers with T3 or T4 tumors and/or extensive nodal involvement (bulky N2 or N3) received two 28-day cycles of induction treatment with infusional FU plus cisplatin followed by two 28-day cycles of FU plus mitomycin C with concurrent split-course radiation.

Phase 2 trial of a DNA vaccine encoding myelin basic protein for multiple sclerosis.

Objective: To evaluate the efficacy and safety of BHT-3009 in relapsing-remitting multiple sclerosis (MS) and to confirm that BHT-3009 causes immune tolerance.

Methods: BHT-3009 is a tolerizing DNA vaccine for MS, encoding full-length human myelin basic protein. Relapsing-remitting MS patients were randomized 1:1:1 into three groups: placebo, 0.

Induction of antigen-specific tolerance in multiple sclerosis after immunization with DNA encoding myelin basic protein in a randomized, placebo-controlled phase 1/2 trial.

Objective: To assess safety and immune modulation by BHT-3009, a tolerizing DNA vaccine encoding full-length human myelin basic protein, in patients with multiple sclerosis (MS).

Design: The study was a randomized, double-blind, placebo-controlled trial. Subjects receiving placebo were crossed over into an active arm after treatment unblinding.

Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer.

Purpose: Sipuleucel-T (APC8015) is an investigational immunotherapy product designed to stimulate T-cell immunity against prostatic acid phosphatase. A phase III study was undertaken to evaluate the safety and efficacy of sipuleucel-T in a placebo-controlled study.

Patients And Methods: A total of 127 patients with asymptomatic metastatic hormone refractory prostate cancer (HRPC) were randomly assigned in a 2:1 ratio to receive three infusions of sipuleucel-T (n = 82) or placebo (n = 45) every 2 weeks.

Phase III trial of 5-fluorouracil and leucovorin plus either 3H1 anti-idiotype monoclonal antibody or placebo in patients with advanced colorectal cancer.

Background: The monoclonal antibody 3H1 mimics the external structure of the carcinoembryonic antigen (CEA). It therefore has the potential, via the anti-idiotypic network, to stimulate immune responses to CEA that may benefit colorectal cancer patients.

Patients And Methods: A total of 630 patients with previously untreated metastatic colorectal cancer were randomised in a 2:1 fashion to receive bolus 5-fluorouracil (5-FU) and leucovorin (LV) plus either 3H1 (n = 422) or placebo (n = 208).

Phase II trial of the histone deacetylase inhibitor pivaloyloxymethyl butyrate (Pivanex, AN-9) in advanced non-small cell lung cancer.

This multicenter phase II trial evaluated the therapeutic activity and safety profile of pivaloyloxymethyl butyrate (Pivanex, AN-9) as a single agent in refractory non-small cell lung cancer (NSCLC). Pivanex (2.34 g/m2 per day) was administered as a 6-h continuous intravenous infusion, daily for 3 days, and repeated every 21 days until disease progression.