bluuebunny/crossref_metadata_2025_split huggingface dataset:
LONG-TERM PHYSICAL STABILITY, STERILITY, AND ANTI-VEGF BIOACTIVITY OF REPACKAGED BEVACIZUMAB IN 2-ML GLASS VIALS
Authors: Peterson Jan S. , Rockwell Kenneth , Scott Ingrid U. , Ip Michael S. , VanVeldhuisen Paul C. , Blodi Barbara A. ,   for the SCORE2 Investigator Group
Published: May 2018

Purpose:
Repackaged bevacizumab in single-dose, prefilled syringes for intravitreal injection is available, but with shelf life limited from 60 days to 90 days. For the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2), 2-mL sterile glass vials were used rather than prefilled syringes to provide a longer shelf life for study supplies.

Methods:
Repackaged bevacizumab in glass vials was tested at release and, for 1 lot, after 1, 3, 6, and 12 months for physical stability, including concentration, purity and appearance, and for sterility and endotoxins. Vials from 2 lots were tested at release and after 20 months and 21 months, respectively. One lot was tested at 21 months for anti-VEGF bioactivity compared with a fresh supply of commercial bevacizumab.

Results:
Repackaged bevacizumab in 2-mL glass vials continued to meet all quality release specifications and remain sterile for up to 21 months. In addition, no degradation in anti-VEGF bioactivity was observed at 21 months compared with a fresh bevacizumab control.

Conclusion:
Bevacizumab can be repackaged into small, single-dose glass vials for intravitreal injection and the qualities of the commercial product maintained, including anti-VEGF bioactivity, for up to 21 months in refrigerated storage. Consideration should be given to repackaging bevacizumab for ophthalmic use in small glass vials as opposed to plastic syringes.
Donor Cornea Harvest Techniques: Comparison Between Globe Enucleation and In Situ Corneoscleral Disc Excision
Authors: Filev Filip , Bigdon Eileen , Steinhorst Nils Alexander , Kammal A. , Schröder Carolin , Wulff Birgit , Linke Stephan , Feuerstacke Jana , Hellwinkel Olaf 
Published: May 2018

Purpose:
To compare whole eye enucleation and corneoscleral disc (CD) excision as donor cornea harvesting techniques for possible effects on corneal cultivation and the clinical outcome of the corneal grafts after transplantation in 2929 cases.

Methods:
A retrospective analysis was performed on the Hamburg Eye Bank database using comparative statistics. The standard method for donor cornea recovery at the Hamburg Eye Bank changed from enucleation of the whole eye to CD in situ excision in 2008. Corneas recovered between 2003 and 2013 were included in this study. We compared the contamination rate, the endothelial density after retrieval, endothelial cell loss during cultivation, and the clinical outcome (visual acuity, astigmatism, and refraction) of transplanted corneas.

Results:
Once the retrieval method was changed from whole globe enucleation to in situ CD excision, the donation numbers increased (after several years of constant decrease). Furthermore, we observed slightly lower endothelial cell density after retrieval in corneas obtained by in situ CD excision compared with those from enucleated eyes, whereas endothelial cell loss during cultivation was similar. After changing the recovery procedure to in situ excision, initially a higher rate of contamination was observed, but but it eventually decreased. Finally, the corneas of both groups had a similar clinical outcome.

Conclusions:
After a transient technical learning period, in situ CD excision proved to be a method of donor cornea recovery with similar cultivation performance and clinical results compared with whole eye enucleation. It also may have led to higher willingness to donate, possibly because of better acceptance by the relatives of the deceased.
Safety and Feasibility of Out-of-Bed Mobilization for Patients With External Ventricular Drains in a Neurosurgical Intensive Care Unit
Authors: Gaspari Clara H. , Lafayette Sabrina , Jaccoud Anna Carolina , Kurtz Pedro , Lavradas Luiz A. , Cavalcanti Daniel D. 
Published: May 2018

Introduction:
Prolonged bed rest is a frequent problem for patients with critical illness that may negatively impact survival, quality of life, and medical care cost. Patients with critical neurologic problems are often kept on bed rest or only cleared to perform bed-based activities because of the inherent risk of displacing or damaging intracranial monitoring devices such as the external ventricular drains (EVDs) during activity. Specific recommendations for out-of-bed (OOB) mobilization of such patients are lacking.

Purpose:
To review the occurrence of adverse events related to OOB mobilization in patients with EVDs.

Methods:
This was a retrospective study. Data from all adult patients with an EVD and medical clearance for OOB physical therapy (PT) from October 2014 to November 2016 were analyzed.

Results:
Eighteen patients with EVDs received 108 interventions of OOB PT sessions during this period. No catheter-related mechanical complications occurred during or immediately following the sessions. No serious adverse events were recorded. Minor adverse events included transient dizziness, headache, episodes of hypertension, and hypotension. Vital signs showed no clinically relevant variations before and after the sessions.

Conclusions:
OOB mobilization was feasible and safe in this group of patients. The effect on morbidity and survival should be further investigated in a larger prospective study.
A Comparison of Gait Parameters Using Varying Orthotic Designs in a Child With Spastic Diplegic Cerebral Palsy After Selective Dorsal Rhizotomy Surgery: A Case Report
Authors: Barkocy Marybeth , Zhang Zhenxiong , Dexter James , Doty Deane 
Published: May 2018

Introduction
Cerebral palsy (CP) is the most common developmental disorder in children. Selective dorsal rhizotomy (SDR) is an effective neurosurgical treatment to reduce lower-limb spasticity in children with spastic diplegic CP. An intensive period of rehabilitation, including gait training, is required for most children after this surgery. Orthoses have been widely used in children with CP. However, there is a lack of research showing which orthosis type is the most appropriate for children with spastic diplegic CP after SDR.

Materials and Methods
In this retrospective case report, we compared spatial and temporal gait parameters using three commonly used orthoses: foot orthosis (FO), supramalleolar orthosis (SMO), and ankle-foot orthosis/footwear combination (AFO/FC), before and after 3-month accommodation of combination use in a 5-year-old male patient with spastic diplegic CP after SDR.

Results
The results showed that although all orthoses improved gait function, the AFO/FCs appeared to initially provide the most stable support; however, after acclimatization, spatial and temporal gait parameters generally demonstrated greater improvement in FO and SMO conditions compared with AFO/FC.

Discussion
This report suggests stance phase stability may be enhanced with AFO/FCs, but swing phase may improve with FO and SMO conditions in children with weakness after SDR. Further studies analyzing gait, balance, and motor function using varying orthoses in children with CP after SDR are warranted.
High-Intensity Bowel Protocol for Trauma Patients
Authors: Smith Anita , Stimson Christopher , Stevens Penelope 
Published: May 2018

Background:
Internal performance improvement data showed extended length of stay (LOS) in addition to an increased number of patients with constipation. This study was designed to evaluate the number of hospital days a trauma patient with opioid use had a bowel movement (BM) utilizing a high-intensity bowel protocol compared with the standard hospital bowel protocol.

Methods:
This was a retrospective analysis of the trauma registry at a Level I trauma center from 2 different time periods to assess the number of hospital days that patients had a BM. These patients had a traumatic mechanism of injury that required admission to the hospital with a LOS equivalent to 3 or more days. Other data analyzed included age, gender, injury severity score (ISS), morphine equivalents (ME), and hospital days with a BM.

Results:
A total of 282 patients were included in the final analysis. Group 1 represented the standard hospital bowel protocol (n = 166), and Group 2 represented the high-intensity bowel protocol (n = 116). No significant difference was calculated between age, gender, ISS, or ME per day. A significant difference was observed with the number of hospital days with a BM between these 2 groups. The group with the high-intensity bowel protocol exhibited more days with a BM than the standard bowel protocol group (p < .05).

Conclusion:
The high-intensity bowel protocol averaged 1 BM every 2 days, whereas the standard hospital bowel protocol averaged 1 BM every 3 days. There was no significant change in LOS.
Delta Alert: Expanding Gerotrauma Criteria to Improve Patient Outcomes: A 2-Year Study
Authors: Wiles Lynn L. , Day Mark D. 
Published: May 2018

Background/Significance:
Because of their decreased physical reserve and increased risk of complications, the geriatric trauma patient (GTP) population warrants heightened awareness by clinical staff.

Purpose:
The purpose of this study is to determine whether the institution of a third-tier trauma protocol results in a change in GTP outcomes, complications, and mortality rates.

Methods:
Researchers conducted a retrospective review of 2 years of data from the trauma registry, hospital quality improvement audits, and patient charts to examine what, if any, patient outcomes were impacted by the institution of the expanded GTP protocol.

Results:
Sample homogeneity was determined. Emergency department (ED) length of stay and time to the operating room decreased in the protocol cohort. The rate of complications decreased from 16.4% preprotocol to 1.6% postprotocol. Discharge to home rates in the GTP population improved from 31% preprotocol to nearly 77% postimplementation of the protocol.

Discussion:
The expanded GTP protocol front loads evaluation and resuscitation to be consistent with ED trauma protocols already in place. By fast-tracking radiology and laboratory testing, patients injuries are identified and the appropriate consultations are initiated. Appropriate inpatient nursing unit placement is identified or treatment and discharge from the ED are expedited.

Conclusion:
The expanded GTP protocol provided early and comprehensive evaluation and interventions for GTPs who fall outside of traditional trauma alert criteria. Patients spend less time in the ED and the hospital. Patients had decreased length of stay in the ED, less complications, and return to home rates showed significant improvement after the protocol was implemented.
LDL and foam cell formation as the basis of atherogenesis
Authors: Orekhov Alexander N. 
Published: May 2018

Purpose of review
Lipoprotein-induced intracellular lipid accumulation (foam cell formation) is a trigger of atherogenesis at the subendothelial arterial cell level. The purpose of this review is to describe the recent data related to the possible mechanisms of LDL-induced formation of lipid-laden foam cells and their role in the onset and development of atherosclerotic lesion.

Recent findings
The most interesting current studies are related to the factors affecting foam cell formation.

Summary
The phenomenon of lipid accumulation in cultured cells became the basis for creating a cellular test system that has already been successfully applied for development of drugs possessing direct antiatherosclerotic activity, and then the efficacy of these drugs was demonstrated in clinical studies. Moreover, this test system could be used for diagnostic assessing lipoproteins atherogenicity.
Screening Endoscopy Contributes to Relevant Modifications of Therapeutic Regimen in Children With Intestinal Failure
Authors: Busch Andreas , Sturm Ekkehard 
Published: May 2018

ABSTRACTObjective:The role of endoscopy in the diagnostic workup of children with intestinal failure (IF) is not well defined. It is unclear whether endoscopies should be performed as a screening procedure or only upon manifestation of symptoms. The aim of this study is to evaluate, whether performing screening endoscopy contributes to clinical management in children with IF.Methods:Comparative retrospective case series study in children with IF (mean age 70.4 months ± 58.4 months) presenting for diagnostic workup in a single intestinal rehabilitation center. Endoscopies were performed either as a screening procedure (Group 1, n = 45) or as indicated by symptoms of gastrointestinal dysfunction (Group 2, n = 11).Results:A total of 92 endoscopies (56 esophagogastroduodenoscopies; 12 enteroscopies; 24 colonoscopies) were performed in 56 children. IF etiology included short bowel syndrome (n = 37), motility disorder (n = 16), and mucosal enteropathy (n = 3). Comparing Group 1 with Group 2 abnormal endoscopic findings were detected in 66.7% versus 81.8%. Findings led to adaptation of therapeutic regimes in 64.7% versus 85.7%. We detected a higher rate of erosive and ulcerative gastritis and duodenitis, enteritis, and colitis in Group 1 compared to Group 2.Conclusions:Endoscopy in children with IF frequently reveals abnormal findings, leading to recommendations for treatment adaptation in the majority of cases, irrespective of whether endoscopy has been performed as a screening procedure or as indicated by symptoms. Using endoscopy as a screening tool may improve both, the detection of gastrointestinal pathology and the clinical management of children with IF.
Cancer Risk Among Children Undergoing Renal Replacement Therapy: Results From the Israel National Renal Replacement Therapy Registry, 1990-2012
Authors: Nuss Naama , Libruder Carmit , Dichtiar Rita , Weinstein Talia , Keinan-Boker Lital , Shohat Tamy , Golan Eliezer 
Published: May 2018

Background:
Patients with end-stage renal disease who undergo chronic renal replacement therapy (RRT) have a higher incidence of cancer. A limited number of studies addressed the risk for cancer in children exposed to RRT. The purpose of the present study was to examine whether children undergoing RRT in Israel are at increased risk for all-site and specific cancers.

Subjects and Methods:
The study population comprised 674 children 0 to 19 years of age who were registered between January 1990 and December 2012 in the Israel National Renal Replacement Therapy Registry. The Registry database was linked with the Israel National Cancer Registry to trace cancer incidence. Variables associated with malignancy were estimated by univariate analysis. Standardized incidence ratios for cancer were calculated using the general Israel population 0 to 15 years of age, for the corresponding years 1990-2012, as a reference.

Results:
Seventeen children developed cancer during the follow-up period. Younger age at RRT initiation was the only variable associated with malignancy in the univariate analysis (hazard ratio, 0.91; 95% confidence interval, 0.84-0.99; P=0.03). Cancer incidence was 6.7-fold higher among children undergoing RRT than the general population.

Conclusions:
Children treated by chronic RRT have a higher incidence of cancer than their peers, and therefore should be followed closely.
Ingrown Toenails During Chemotherapy and Stem Cell Transplantation in Children With Hematologic Malignancies and Solid Tumors
Authors: Hori Daiki , Kobayashi Ryoji , Suzuki Daisuke , Sano Hirozumi , Kobayashi Kunihiko 
Published: May 2018

Background:
At our institution, we noted that children with hematologic malignancies and solid tumors often suffered from ingrown toenails (IGTNs) during hospitalization for chemotherapy and stem cell transplantation. However, only few reports have dealt with IGTNs in the above setting.

Procedure:
Between August 2007 and July 2017, 180 children who received treatment for hematologic malignancies and solid tumors at our institute were enrolled in this study. Twelve patients with insufficient data and 7 patients with past histories of IGTNs were excluded. A total of 161 patients were analyzed. Median age at admission was 7.9 years (range, 1.0 to 25.4 y), with 92 males and 69 females. Diagnoses were hematologic diseases in 128 patients, including acute lymphoblastic leukemia (ALL) in 75 patients, and solid tumors in 33 patients.

Results:
A total of 22 patients (13.7%) suffered from IGTNs (or toe paronychia) during hospitalization. Multivariable analysis disclosed a strong correlation between the occurrence of IGTNs and older age (over 9.0 y) and ALL.

Conclusions:
Patient-related factors, such as age over 9 years and ALL were associated with IGTNs. This is the first report of a survey on IGTNs in patients with hematologic malignancies and solid tumors hospitalized for chemotherapy and stem cell transplantation.
Genetic Analysis of 13 Iranian Families With Leukocyte Adhesion Deficiency Type 1
Authors: Teimourian Shahram , De Boer Martin , Roos Dirk , Isaian Anna , Bemanian Mohammad Hassan , Lashkary Sharhzad , Nabavi Mohammad , Arshi Saba , Nateghian Alireza , Sayyahfar Shirin , Sazgara Faezeh , Taheripak Gholamreza , Alipour fayez Elham 
Published: May 2018

Background and Aim:
Leukocyte adhesion deficiency type 1 is a rare, autosomal recessive disorder that results from mutations in the ITGB2 gene. This gene encodes the CD18 subunit of β2 integrin leukocyte adhesion cell molecules. Leukocyte adhesion deficiency type 1 is characterized by recurrent bacterial infections, impaired wound healing, inadequate pus formation, and delayed separation of the umbilical cord.

Materials and Methods:
Blood samples were taken from 13 patients after written consent had been obtained. Genomic DNA was extracted, and ITGB2 exons and exon-intron boundaries were amplified by polymerase chain reaction. The products were examined by Sanger sequencing.

Results:
In this study, 8 different previously reported mutations (intron7+1G>A, c.715G>A, c.1777 C>T, c.843del C, c.1768T>C, c.1821C>A, Intron7+1G>A, c.1885G>A) and 2 novel mutations (c.1821C>A; p.Tyr607Ter and c.1822C>T; p.Gln608Ter) were found.

Conclusions:
c.1821C>A (p.Tyr607Ter) and c.1822C>T (p.Gln608Ter) mutations should be included in the panel of carrier detection and prenatal diagnosis.
The Effect of Uncertainty Management Program on Quality of Life Among Vietnamese Women at 3 Weeks Postmastectomy
Authors: Ha Xuan Thi Nhu , Thanasilp Sureeporn , Thato Ratsiri 
Published: May 2018

Background
In Vietnam, breast cancer is a top contributor to cancer-related deaths in women. Evidence shows that, after mastectomy, women in Vietnam have a lower quality of life than women in other countries. In addition, high uncertainty is a predictor of low quality of life postmastectomy. Therefore, if nurses can manage uncertainty, the quality of life postmastectomy can improve.

Objective
This study examined the effect of the Uncertainty Management Program (UMP) on quality of life at 3 weeks postmastectomy in Vietnamese women.

Methods
This research was a quasi-experimental study using a “posttest only with control group” design. There were 115 subjects assigned to either the experimental group (n = 57), who participated in the UMP and routine care, or the control group (n = 58), who received only routine care. Participants were assessed 2 times postmastectomy using the modified Quality of Life Index Scale–Vietnamese version.

Results
The experimental group exhibited low uncertainty before discharge and significantly higher quality of life than the control group at 1 and 3 weeks postmastectomy, respectively (P < .05). Women’s physical well-being, psychological well-being, body image concerns, and social concerns were significantly increased with UMP.

Conclusion
The UMP was considered as a promising program that might benefit the QoL of women with breast cancer 3 weeks postmastectomy.

Implications for Practice
The UMP appears feasible to apply for women with breast cancer to improve their QoL postmastectomy in various settings. Nurses can flexibility instruct women in their holistic care attention both in the hospital and at home.
The Association Between Nurse Shift Patterns and Nurse-Nurse and Nurse-Physician Collaboration in Acute Care Hospital Units
Authors: Ma Chenjuan , Stimpfel Amy Witkoski 
Published: May 2018

OBJECTIVE
The aim of this study was to examine the impact of nurse shift patterns on nurses' collaboration with nurses and physicians in US acute care hospital units.

BACKGROUND
Collaboration between nurses and other healthcare providers is critical for ensuring quality patient care. Nurses perform collaboration during their shift work; thus, nurse shift patterns may influence collaboration. However, there is a dearth of empirical evidence of the relationship between nurse shift patterns and collaboration of nurses with other healthcare providers.

METHODS
This is a cross-sectional study using data from 957 units in 168 acute care hospitals. Measures of collaboration include nurse-nurse collaboration and nurse-physician collaboration. Measures of shift patterns included shift length and overtime. Multilevel linear regressions were conducted at the unit level, controlling unit and hospital characteristics.

RESULTS
Overtime (more nurses working overtime or longer overtime hours) was associated with lower collaboration at the unit level; however, shift length was not.

CONCLUSIONS
Working overtime may negatively influence nurses' collaboration with other healthcare providers.
Concordance Between FISH Analysis of Her-2/Neu Gene in Breast Duct Carcinoma and Corresponding Axillary Nodal Metastases: Egyptian National Cancer Institute Experience
Authors: Badawy Omnia M. , Hassan Hannan , ELBakey Heba A. , Mosaad Maha 
Published: May 2018

Background:
Breast cancer is a major health problem in Egypt. Her-2/Neu gene is routinely assessed for all breast cancer patients primarily by immunohistochemistry. At National Cancer Institute (NCI), Cairo University, Flourescence In Situ hybridization (FISH) analysis of Her-2/Neu gene is carried out for Her-2/Neu score 2 and for some cases of score 3 (particularly those assessed outside NCI). The test is performed essentially on the primary tumor. However, some situations require testing on corresponding lymph node metastases. There is a debate about the concordance between Her-2/Neu status in the primary tumor and synchronous lymph node metastases in various studies.

Aim of the Study:
The aim of this study was to test for the concordance between Her-2/Neu status in the primary breast tumor and corresponding axillary nodal metastases.

Materials and Methods:
This is a retrospective study in which FISH analysis of Her-2/Neu was carried out simultaneously on archived material of 50 cases previously diagnosed as invasive duct carcinoma and the corresponding nodal metastases from the Pathology Department, NCI.

Results:
There was complete concordance between Her-2 status in the primary tumor and the corresponding axillary lymph node metastatic deposits in which Her-2 was amplified in 44% of the studied cohort of Egyptian patients.

Conclusions:

Her-2/Neu gene assessed by FISH analysis on synchronous lymph node metastases is strongly correlated with the primary tumor. Hence, it is justified to carry out the Her-2/Neu test on synchronous lymph nodes to decide on whether to carry out anti-Her-2/Neu target therapy. Further studies on other metastatic sites is recommended.