bluuebunny/crossref_metadata_2025_split huggingface dataset:
Human Otopathologic Findings in Cases of Folded Cochlear Implant Electrodes
Authors: Trakimas Danielle R. , Kozin Elliott D. , Ghanad Iman , Nadol Joseph B. , Remenschneider Aaron K. 
Published: July 2018

Hypothesis:
We hypothesize that human cases of cochlear implantation (CI) with folding of the electrode array will demonstrate greater degrees of intracochlear ossification, lower spiral ganglion neuron (SGN) counts, and poorer audiometric outcomes.

Background:
CI electrode array folding, such folding of the proximal array, is a relatively common surgical complication that can occur with forceful electrode insertion and may be an important and avoidable factor affecting implant outcomes. However, otopathologic findings and audiologic outcomes of human cases where folding of the implant electrode array is observed remain undefined.

Methods:
Specimens from a human temporal bone repository having undergone CI during life were evaluated. Specimens with folding of the electrode array on histological analysis constituted study cases. Electrode-matched specimens without array folding constituted controls. All specimens were examined by light microscopy and histopathologically described. Intracochlear fibrosis and osseous tissue, and SGN counts were measured. Pre- and postoperative word recognition scores were also compared.

Results:
Cases with folded electrodes showed greater volumes of intracochlear osseous tissue than controls, which was most prominent in areas adjacent to array folding. Both cases and controls demonstrated similar amounts of fibrous tissue. Folded cases showed decreased SGNs when compared with the contralateral ear, whereas controls showed stable SGN populations between ears. In this small cohort, postoperative hearing outcomes were similar between groups.

Conclusion:
Atypical fibro-osseous changes and lower SGN counts are observed in cases of CI electrode folding. Future studies are necessary to determine if recognition and correction of folding can prevent long-term intracochlear changes.
Evolution and current status of United States Food and Drug Administration and European Medicines Agency regulatory guidance for studies of nosocomial pneumonia
Authors: Talbot George H. 
Published: July 2018

Purpose of review
Regulatory guidance for design, conduct and analysis of studies of nosocomial pneumonia, including ventilator-associated pneumonia, has undergone substantial evolution over the past three decades. This review summarizes this evolutionary process and the current status of guidance.

Recent findings
The US Food and Drug Administration and the European Medicines Agency have taken different approaches to defining endpoints for studies of nosocomial pneumonia, especially with regard to the primary endpoint. Both agencies accept a noninferiority design. Independent efforts to develop new endpoints and bridge existing discordances have been fruitful.

Summary
Transatlantic differences in the approach to study of nosocomial pneumonia complicate study design and analysis, but they will hopefully be resolved in future iterations of regulatory agency guidance.
Risk factors for anastomotic recurrence after primary ileocaecal resection in Crohn’s disease
Authors: Aaltonen Gisele , Keränen Ilona , Carpelan-Holmström Monika , Lepistö Anna 
Published: July 2018

Objective
Ileocaecal resection is the most common operation performed in Crohn’s disease. Our study aimed to identify the risk factors for anastomotic recurrence following primary ileocaecal resection.

Patients and methods
We retrospectively analysed data from all Crohn’s disease surgical patients in a single colorectal unit between 2006 and 2016, including all patients who underwent primary ileocaecal resection. We defined anastomotic recurrence as the postoperative need for endoscopic dilatation of the ileocolic anastomosis or neoterminal ileal resection, and used Cox regression to determine the risk factors for such recurrence.

Results
In total, 101 patients underwent primary ileocaecal resection during the study period. Nine (8.9%) patients were excluded because of follow-up less than 1 year and 12 (13.0%) patients had anastomotic recurrence. The median follow-up was 4.7 (1.3–10.8) years. At 3 years, 93.1% of patients required no neoterminal ileal resection or dilatation of the ileocolic anastomosis. Urgent primary ileocaecal resection [hazard ratio (HR)=4.98, 95% confidence interval (CI)=1.45–17.11, P=0.011], stapled anastomosis (HR=20.34, 95% CI=5.06–81.77, P<0.001) and need for postoperative corticosteroid treatment after the primary ileocaecal resection (HR=3.58, 95% CI=1.03–12.40, P=0.044) emerged as significant risk factors for anastomotic recurrence.

Conclusion
Urgent surgery and postoperative corticosteroid need represented risk factors for anastomotic recurrence. Hand-sewn anastomosis with an opening of the bowel’s antimesenteric border seems to be a safe choice for ileocaecal resection.
Insulin resistance does not impair response of chronic hepatitis C virus to direct-acting antivirals, and improves with the treatment
Authors: Elhelbawy Mostafa , Abdel-Razek Wael , Alsebaey Ayman , Hashim Mohamed , Elshenawy Hassan , Waked Imam 
Published: July 2018

Background
Insulin resistance (IR) is a common complication in chronic hepatitis C virus (HCV) patients. The impact of IR on outcome of therapy with direct antivirals has not been studied.

Aim
The aim was to assess the impact of direct-acting antiviral (DAA) therapy on IR status in chronic HCV patients.

Patients and methods
A total of 511 patients [mean age: 50.7±10.4 years, 29.7% pegylated interferon and ribavirin (RBV) experienced] were enrolled. Patients with uncontrolled diabetes, decompensated liver disease, or previous nonresponse to DAAs were excluded. Homeostatic model assessment (HOMA) was calculated before and 12 weeks after treatment, and IR was defined as HOMA greater than 1.9. Patients were treated according to the treating physician’s choice, and received 12 weeks of either ombitasvir/ritonavir/paritaprevir/RBV (n=28); sofosbuvir (SOF)/simeprevir (n=36); SOF/ravidasvir (n=101); SOF/pegylated interferon/RBV (n=192); or 24 weeks of SOF/RBV (n=154).

Results
Most patients received IR pretreatment (80.6%); 51.3% had fibrosis stage F4 and 24.7% had diabetes. A sustained virological response (SVR) at 12 weeks after treatment (SVR12) was achieved in 465 (91%) patients. SVR12 was achieved in 90.5% of patients with IR and in 92.9% of patients without IR (P=0.560), and pretreatment HOMA was not different in responders and nonresponders (P=0.098). The number of patients with IR decreased significantly in patients who achieved an SVR much more than in nonresponders (P<0.0001) and HOMA improved significantly more in patients with SVR than in nonresponders (P=0.001). All treatment protocols were associated with a comparable improvement in HOMA (P=0.101). Predictors of SVR12 included age, platelets, and liver stiffness, but not pretreatment IR.

Conclusion
IR does not impair the response of patients with HCV treated with DAAs, and improves significantly in patients who achieve an SVR.
Apoptotic cell-based therapies for promoting transplantation tolerance
Authors: Dangi Anil , Yu Shuangjin , Luo Xunrong 
Published: July 2018

Purpose of review
This article is aimed to provide readers with an updated review on the applicability, efficacy, and challenges of employing donor apoptotic cell-based therapies to promote transplantation tolerance in various experimental and clinical settings.

Recent findings
Recently, donor apoptotic cell-based therapies have been employed in various models of cell (including pancreatic islets and bone marrow hematopoietic stem cells) and solid organ (heart and kidney) transplantation to promote donor-specific tolerance. Published data, thus far, have revealed a high potential of this approach in inducing robust transplantation tolerance. Recent clinical trials have also underscored the safety and potential efficacy of this approach in alleviating graft-versus-host disease (GVHD) in bone marrow transplantation (BMT). Host factors including prior allo-sensitization and opportunistic infections pose major obstacles in establishing transplantation tolerance employing this strategy. However, emerging data provide strategies for overcoming such obstacles in these clinically relevant settings.

Summary
Donor apoptotic cell therapy is an emerging strategy in promoting transplantation tolerance, with recent data emphasizing its efficacy and applicability for transplantation tolerance in the clinic.
Safety and Feasibility of Integrating Yttrium-90 Radioembolization With Capecitabine-Temozolomide for Grade 2 Liver-Dominant Metastatic Neuroendocrine Tumors
Authors: Soulen Michael C. , van Houten Diana , Teitelbaum Ursina R. , Damjanov Nevena , Cengel Keith A. , Metz David C. 
Published: July 2018

Objectives
An integrated protocol combining capecitibine-temozolomide with yttrium-90 radioembolization (CapTemY90) for liver-dominant grade 2 neuroendocrine tumors (NETs) was designed in the hope of achieving synergistic improvement in liver disease control with no more than additive toxicities. This report describes the feasibility and safety of this regimen.

Methods
Twenty-one patients with unresectable grade 2 NET liver-dominant metastases without contraindications to radioembolization or to CapTem initiated therapy with capecitabine 600 mg/m2 twice daily for 14 days and temozolomide 150 to 200 mg/m2 in 2 divided doses on days 10 to 14, with 14 days between cycles. During the first cycle, simulation angiography was performed. The dominant lobe was radioembolized on day 7 of the second cycle. In patients with bilobar disease, the other lobe was treated on day 7 of the third or fourth cycle.

Results
Nineteen of 21 patients completed the protocol. Adverse events were as expected. Objective response rate was 74% in the liver and 55% for extrahepatic tumor. Median progression-free survival was not reached. Progression-free survival at 3 years was 67%, with 74% progression-free in the liver.

Conclusions
CapTemY90 is feasible and safe for grade 2 NETs. Toxicities were additive. Oncologic outcomes suggest synergy.
Utility of Endoscopic Ultrasound-Guided Biopsy for Next-Generation Sequencing of Pancreatic Exocrine Malignancies
Authors: Larson Brent K. , Tuli Richard , Jamil Laith H. , Lo Simon K. , Deng Nan , Hendifar Andrew E. 
Published: July 2018

Objectives
Endoscopic ultrasound-guided fine-needle biopsy and aspiration (EUS FNB/A) are the standard diagnostic tests for pancreatic malignancies. Oncologists increasingly use tumor genomic analysis for management. Adequacy of FNB/A tissue for next-generation sequencing (NGS) has not been evaluated. This study examined FNB/A and other biopsy types for features that might predict adequacy for NGS.

Methods
Seventy-six pancreatic exocrine malignancy biopsies submitted for NGS were assessed for adequacy, which was compared with other tumor/biopsy features.

Results
Twenty-two (29%) of 76 samples were inadequate, including 16 (30%) of 54 FNBs and 4 (57%) of 7 FNAs. Larger-gauge needles were associated with adequacy in all samples (P = 0.0047) and in FNBs (P = 0.05). Metastatic samples were more likely to be adequate for NGS compared with pancreatic samples (P = 0.0357). Percutaneous biopsies were more likely to be adequate than EUS-guided FNB/As, although this trend was not significant (P = 0.0558). Other tumor/biopsy characteristics were not associated with adequacy.

Conclusions
Endoscopic US FNA and FNB provided similar NGS adequacy rates. Metastatic lesions accessible by percutaneous biopsy may be preferable to EUS FNB/A of primary lesions for obtaining tissue for NGS. All biopsies, including EUS FNB, were more likely to be successful using larger-gauge needles.
Sustained Viral Response in Genotype 4 Chronic Hepatitis C Virus–infected Children and Adolescents Treated With Sofosbuvir/Ledipasvir
Authors: El‐Karaksy Hanaa , Mogahed Engy Adel , Abdullatif Hala , Ghobrial Carolyne , El‐Raziky Mona S. , El‐Koofy Nehal , El‐Shabrawi Mortada , Ghita Haytham , Baroudy Sherif , Okasha Sawsan 
Published: July 2018

ABSTRACTObjectives:Recently, direct acting antivirals (DAAs), sofosbuvir (SOF) combined with ledipasvir (LED), were approved for treatment of hepatitis C virus (HCV)–infected children 12 years of age and older or weighting at least 35 kg for all HCV genotypes. The aim of this study was to assess the safety and efficacy of SOF/LED in genotype 4 HCV‐infected Egyptian children and adolescents.Methods:This observational study included 40 consecutive HCV‐infected children of age 12 to <18 years old or weighing >35 kg, both treatment‐naive and treatment‐experienced. All of the children were hepatitis B virus–negative and had normal renal functions and heart rate. Patients received oral, fixed‐dose combination tablet of SOF/LED (400 mg SOF, 90 mg LED [Harvoni]) once daily for 12 weeks. Potential side effects were recorded at weeks 4, 8, and 12 weeks of treatment. The study primary outcome was sustained virological response 12 weeks (SVR12) after end‐of‐treatment.Results:The study included 40 children and adolescents, 24 were boys (60%); their age ranged between 11.5 and 17.5 years (mean 13.9 ± 1.5). Baseline viral load ranged between 9630 and 24,600,000 IU/mL. HCV RNA became negative in 39 patients (97.5%) at 4 weeks and in all patients (100%) at weeks 8, 12, and SVR12. Asthenia was the commonest side effect, reported in 52.5% followed by headache in 47.5%.Conclusions:Treatment with all‐oral DAAs (SOF/LED) for 12 weeks was well tolerated in Egyptian children and adolescents infected with genotype 4 HCV, with 100% SVR12 and negligible side effects.
Serum Immunoglobulin A Levels Do Not Correlate With Liver Disease Severity in Pediatric Nonalcoholic Fatty Liver Disease
Authors: Mouzaki Marialena , Bramlage Kristin , Arce‐Clachar Ana Catalina , Xanthakos Stavra A. 
Published: July 2018

ABSTRACTSerum immunoglobulin A (IgA) is a biomarker of liver disease severity in adult nonalcoholic fatty liver disease (NAFLD). The objective of this study was to assess whether this is true in pediatric NAFLD. This was a retrospective study of children followed in the Steatohepatitis Center of a tertiary care center (2010–2017). Serum IgA levels, histology and biochemical markers of hepatocellular injury and metabolic dysregulation were collected. Of the 600 children with available serum IgA levels (mean age 14 ± 3 years, 62% boys, 80% non‐Hispanic), IgA was elevated in 4%. The group with elevated IgA levels was younger and had a greater representation of Hispanic ethnicity compared with those with normal or low IgA. Body mass index and aminotransferases were not different between the groups. Histology was available for 170 children and was not different in those with elevated, normal and low IgA. In contrast to adults, serum IgA is not a biomarker of liver disease severity in pediatric NAFLD.
Meaning-Centered Interventions for Patients With Advanced or Terminal Cancer
Authors: Kang Kyung-Ah , Han Suk-Jung , Lim Young-Sook , Kim Shin-Jeong 
Published: July 2018

Background
For patients with advanced or terminal cancer undergoing hospice or palliative care, spiritual care based on meaning-centered intervention (MCI) has become an essential form of support.

Objective
The aim of this study was to characterize MCI systematically and the effectiveness of hospice and palliative care for patients with advanced or terminal cancer.

Methods
MEDLINE via PubMed, Cochrane Library CENTRAL, EMBASE, CINAHL, and several Korean electronic databases were searched from inception to May 2017. The RevMan 5.3 program of the Cochrane Library was used for data analysis.

Results
A meta-analysis was conducted of 10 controlled trials (6 randomized and 4 nonrandomized) featuring 623 patients with cancer. Meaning-centered interventions were compared with usual care control groups or other psychosocial interventions. The weighted average effect sizes across studies were −0.96 (P < .001, I
2 = 7%) for meaning in life, −0.37 (P = .002, I
2 = 0%) for spiritual well-being, −0.48 (P < .001, I
2 = 0%) for quality of life, −0.28 (P = .02, I
2 = 0%) for anxiety, and −0.31 (P = .02, I
2 = 17%) for physical symptoms.

Conclusion
Spiritual care based on MCI may help to improve the physical, psychosocial, and spiritual well-being of patients with advanced or terminal cancer.

Implication for Practice
Meaning-centered interventions could be a valuable way to enhance quality of life at the end stage for patients with advanced or terminal cancer.
Trying to Feel Normal Again: Early Survivorship for Adolescent Cancer Survivors
Authors: Walker Amy J. , Lewis Frances M. , Lin Yuting , Zahlis Ellen , Rosenberg Abby R. 
Published: July 2018

Background
Despite knowing the potential medical consequences of cancer treatment, little is known about how adolescents cognitively and emotionally frame, process, and manage in the early survivorship period.

Objective
The specific aims were to describe the worries, perceived challenges, and ways of dealing with these issues for adolescent cancer survivors in the early period of survivorship.

Methods
Twenty-nine adolescent survivors (12–18 years) completed a semistructured interview. Inductive coding methods adapted from grounded theory were used to analyze the data.

Results
Seven domains and 18 categories organized the adolescent's experience with early posttreatment survivorship. The domains included getting back to school; relationships with parents, siblings, friends; feeling changed by the experience; and concerns about relapse.

Conclusions
This study contributes to our understanding of survivors' relationships with parents, siblings, and friends and survivors' models of the illness. Future studies are needed to understand how parents can help adolescents assume greater responsibility for their care, to understand what it is like for friends to have a peer with cancer and what behaviors by healthcare providers contribute to feelings of abandonment later in survivorship, and to better understand adolescent survivors' models of the illness and survivorship.

Implications for Practice
Study results suggest that nurses are in an ideal position to begin and to continue discussions with adolescent survivors about the adolescent's view of medical follow- up, its purpose and importance, and ways in which the adolescent can begin, early on, to engage in planning their own health during survivorship.
An Initial Study of Alexithymia and Its Relationship With Cognitive Abilities Among Mild Cognitive Impairment, Mild Alzheimer's Disease, and Healthy Volunteers
Authors: Smirni Daniela , Beadle Janelle N. , Paradiso Sergio 
Published: July 2018

Abstract
The present study examined the degree to which alexithymia is greater in mild Alzheimer's disease (AD) and mild cognitive impairment (MCI) relative to healthy volunteers (healthy comparison [HC]), and investigated relationships between alexithymia and cognition. Eighty-five participants (MCI = 30, AD = 21, HC = 34) underwent a comprehensive neuropsychological examination and completed the 20-item Toronto Alexithymia Scale (TAS-20). Relative to HC, MCI and AD reported greater alexithymia total scores and higher scores on the TAS factor difficulty in identifying feelings (DIF). The remaining two factors, difficulty in describing feelings (DDF) and externally oriented thinking showed no significant group differences. In MCI, TAS-20 and DIF were negatively correlated with working and long-term verbal memory. In AD, TAS-20 was negatively correlated with general cognition, attention, memory, and visual spatial constructive and executive abilities. Also in AD, DIF was negatively correlated with general cognition, memory, and executive abilities. The correlation between DIF and long-term verbal memory in both MCI and AD suggests a potential common mechanism for alexithymia in these neurocognitive disorders. Declines in verbal memory may hinder a patient's ability to recall an association between a given sensation and the episodic experience of that sensation, thus leading to difficulty identifying feelings, as measured by the DIF factor of the TAS-20.
Social Anxiety and Benign and Toxic Online Self-Disclosures
Authors: Molavi Parviz , Mikaeili Niloofar , Ghaseminejad Mohammad Ali , Kazemi Zhila , Pourdonya Misagh 
Published: July 2018

Abstract
This work aimed to explore the relationship between social anxiety with benign and toxic online self-disclosures with the mediating role of rejection sensitivity, self-regulation, and Internet addiction. In this study, 358 students who were active members of social networks at the Mohaghegh Ardabili University, Iran were evaluated in the form of a structural equation model. The results substantiated that social anxiety could explain 47% of the variance in benign online self-disclosure and 27% of toxic online self-disclosure with the mediating role of rejection sensitivity, self-regulation, and Internet addiction. It was found that people with high social anxiety had higher rejection sensitivity and lower self-regulation. Also, people with higher social anxiety had directly higher benign and toxic online self-disclosures. The results indicated that self-regulation did not have a direct impact on benign online self-disclosure; however, it had a direct negative impact on toxic online self-disclosure.
Emergency Department Documentation of Alleged Police Use of Excessive Force in Cases Where Formal Complaints Are Ultimately Filed
Authors: Strote Jared , Hickman Matthew J. 
Published: July 2018

Background
Emergency physicians encounter patient concerns of police use of excessive force (UOEF). However, unlike other forms of potential assault, there are no guidelines for documentation of these encounters. Our objective was to examine the adequacy of emergency department documentation of injuries from police encounters where formal complaints of UOEF were later filed with the law enforcement agency.

Methods
A retrospective cohort design was used, identifying all citizen complaints of UOEF to a single police department in a 3-year period. Emergency department records associated with these encounters were then accessed and evaluated using standards for other forms of abuse and assault.

Results
Of 235 complaints, 33 (14.0%) presented to the emergency department within 7 days of the incident and were able to provide a history. For these subjects, 13 charts (39.4%) contained 3 or more of the 4 components thought to be necessary in cases of potential assault, and 11 (33.3%) contained documentation that should not be present: the guilt of the patient, subjective terminology by the provider, and/or documentation of law enforcement's description of the events as the only factual history. Of the total, 14 charts (42.4%) documented the patient's concern for UOEF.

Conclusions
In this limited study, documentation of encounters where patients later filed a formal complaint of UOEF by law enforcement did not meet the standards for other forms of assault and abuse, having the potential to impact both the citizens and officers involved. Further study is necessary to identify the best practice guidelines for emergency physicians when they encounter patients injured in police encounters.