bluuebunny/crossref_metadata_2025_split huggingface dataset:
Temporal Trends of Urogynecologic Mesh Reports to the U.S. Food and Drug Administration
Authors: Sassani Jessica C. , Artsen Amanda M. , Moalli Pamela A. , Bradley Megan S. 
Published: April 2020

OBJECTIVE:
To compare temporal trends of urogynecologic mesh medical device reports with sentinel U.S. Food and Drug Administration (FDA) notices and to examine all linked reports of patient death.

METHODS:
The Reed Tech Navigator is an online tool used to extract and analyze data in the Manufacturer and User Facility Device Experience database. We used FDA product codes to search for reports of synthetic mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Reports with “death” listed as a patient event were queried further.

RESULTS:
There were 43,970 medical device reports involving urogynecologic mesh reported to the FDA between August 2000 and January 2019, with most occurring after the 2011 FDA communication (n=43,018, 97.8%). Of these medical device reports, 64.6% (n=28,422) were for SUI products, 27.0% (n=11,876) were for transvaginal POP products, and 8.4% (n=3,672) were for transabdominal POP products. Peak reporting occurred in 2013, which corresponded with the first major plaintiff verdicts and class action vaginal mesh settlement. There were 645 (1.5%) medical device reports of death, with 49.3% (n=318) having no cause of death identified. Only four (0.6%) could be directly attributed to the initial surgery.

CONCLUSION:
Since 2011, urogynecologic mesh has been the focus of thousands of medical device reports annually, although the data submitted are often incomplete. Few reported deaths are directly attributable to mesh products, and the majority lack sufficient information to draw causal conclusions. A high-quality registry is necessary to improve our understanding of the patient effect from urogynecologic mesh products.
Final Program Data and Factors Associated With Long-Acting Reversible Contraception Removal
Authors: Lathrop Eva , Hurst Stacey , Mendoza Zipatly , Zapata Lauren B. , Cordero Pierina , Powell Rachel , Green Caitlin , Moreno Nilda , Jamieson Denise J. , Romero Lisa 
Published: April 2020

OBJECTIVE:
To describe characteristics of the full population of women who participated in the Zika Contraception Access Network program in Puerto Rico during the virus outbreak and to examine factors associated with removal of a long-acting reversible contraception (LARC) method by a Zika Contraception Access Network provider during the program's duration (May 2016–September 2017).

METHODS:
We conducted an observational cohort study. The Zika Contraception Access Network program was designed to increase access to contraception services in Puerto Rico for women who chose to prevent pregnancy during the Zika virus outbreak as a primary strategy to reduce adverse Zika virus–related pregnancy and birth outcomes. Among program participants, an observational cohort of women served by the Zika Contraception Access Network Program, we describe their demographic and program-specific characteristics, including contraceptive method mix before and after the program. We also report on LARC removals by Zika Contraception Access Network providers during the program. We examined factors associated with LARC removal using multivariable logistic regression.

RESULTS:
A total of 29,221 women received an initial Zika Contraception Access Network visit during the program. Ninety-six percent (27,985) of women received same-day provision of a contraceptive method and 70% (20,381) chose a LARC method. While the program was active, 719 (4%) women who chose a LARC at the initial visit had it removed. Women with a college degree or higher were more likely to have their LARC removed (adjusted prevalence ratio [aPR] 1.24); breastfeeding women (aPR 0.67) and those using a LARC method before Zika Contraception Access Network (aPR 0.55) were less likely to have their LARC removed.

CONCLUSION:
The Zika Contraception Access Network program was designed as a short-term response for rapid implementation of contraceptive services in a complex emergency setting in Puerto Rico and served more than 29,000 women. The Zika Contraception Access Network program had high LARC uptake and a low proportion of removals by a Zika Contraception Access Network provider during the program. A removal-inclusive design, with access to removals well beyond the program period, maximizes women's reproductive autonomy to access LARC removal when desired. This model could be replicated in other settings where the goal is to increase contraception access.
EPIDEMIOLOGY OF VITREOMACULAR INTERFACE ABNORMALITIES USING MACULAR SPECTRAL-DOMAIN OPTICAL COHERENCE TOMOGRAPHY IN AN ELDERLY POPULATION (THE MONTRACHET STUDY)
Authors: Ben Ghezala Inès , Seydou Alassane , Gabrielle Pierre-Henry , Bouche-Pillon Jacques , Binquet Christine , Delcourt Cécile , Daien Vincent , Bron Alain M. , Creuzot-Garcher Catherine 
Published: April 2020

Purpose:
The aim of this study was to investigate the prevalence of vitreomacular interface abnormalities (VMIAs) and to identify associated factors in an elderly population in Europe.

Methods:
The MONTRACHET (Maculopathy Optic Nerve nuTRition neurovAsCular and HEarT diseases) Study is a population-based study, conducted in subjects older than 75 years. Vitreomacular adhesions, vitreomacular tractions, macular holes, epiretinal membranes, and macular cysts were assessed on spectral-domain optical coherence tomography examinations. The prevalence of VMIAs was estimated. We studied the association of demographic and clinical factors with VMIAs.

Results:
The mean age of the participants was 82.3 (SD, 3.8) years, and 37.3% were men. The prevalence rates of VMIAs were vitreomacular adhesions (17.7%), vitreomacular tractions (1.4%), lamellar macular holes (1.0%), full-thickness macular holes (0.2%), macular pseudoholes (0.4%), epiretinal membranes (38.9%), and macular cysts (5.8%). In multivariate analysis, vitreomacular adhesions were positively associated with male sex (P < 0.001) and negatively associated with older age (P < 0.001) and cataract extraction (P < 0.001). Epiretinal membranes were positively associated with older age (P < 0.001) and cataract extraction (P < 0.001).

Conclusion:
The prevalence of VMIAs based on spectral-domain optical coherence tomography analysis was high in subjects older than 75 years.
Endothelial Cell Density Changes in the Corneal Center Versus Paracentral Areas After Descemet Membrane Endothelial Keratoplasty
Authors: Musayeva Aytan , Livny Eitan , Dragnea Diana C. , Ham Lisanne , Vasiliauskaitė Indrė , Ní Dhubhghaill Sorcha , van Dijk Korine , Oellerich Silke , Melles Gerrit R. J. 
Published: April 2020

Purpose:To analyze whether endothelial cell density (ECD) differs between central and paracentral areas after Descemet membrane endothelial keratoplasty (DMEK) and to identify the locations of the highest and lowest ECD.Methods:In this retrospective cohort study, central and paracentral ECDs of 30 eyes of 30 patients who underwent DMEK for Fuchs endothelial corneal dystrophy were evaluated. Central, superonasal, superotemporal, and inferior specular microscopic images were analyzed at 1, 3, 6, 9, and 12 months after DMEK. Changes in ECD by location and over time and changes in location for the highest and lowest ECD were evaluated.Results:When compared with the preoperative donor ECD, the central ECD decreased by 32 (±11)% at 12 months postoperatively. ECD decline between 1 and 12 months postoperatively in the central, inferior, superonasal, and superotemporal location were 7%, 12%, 16%, and 13%, respectively (P< 0.0001 for all locations). Mean ECD was the highest in the center between the 3- to 12-month follow-up, whereas mean ECD was the lowest in the paracentral superonasal area at all time points (P< 0.001). Mean ECD of the highest and lowest density locations differed at all follow-up time points (P< 0.003).Conclusions:Postoperative ECD was not found to be uniform across the graft. Contrary to the density distribution in the normal endothelium, paracentral area ECDs were found to be consistently lower than in the central area. These differences were most prominent in the superonasal area and persisted 12 months postoperatively. Central ECD after DMEK might, thus, not represent an accurate proxy for cell density of the entire graft.
Malignant Mixed Tumor (Carcinoma Ex Pleomorphic Adenoma) of the Lacrimal Gland
Authors: Tom Ashley , Bell Diana , Ford Joshua R. , Debnam J. Matthew , Guo Yunxia , Frank Steven J. , Esmaeli Bita 
Published: April 2020

Purpose:
To review the clinical presentation, treatment, and prognosis of patients with malignant mixed tumor (carcinoma ex pleomorphic adenoma) of the lacrimal gland.

Methods:
Clinical records and radiographic images were reviewed for patients with malignant mixed tumor of the lacrimal gland treated at the center during 2008–2019.

Results:
The study included 9 patients (6 men, 3 women) aged 17–66 years (median age, 56 years). Six had primary malignant mixed tumor with no history of orbital lesions, and 3 had previously been diagnosed with pleomorphic adenoma. Tumor, Node, Metastasis classification per the eighth edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual were T1aN0M0 in 2 patients, T2aN0M0 in 3 patients, T4bN0M0 in 2 patients, and T4cN0M0 in 2 patients. Two patients underwent orbital exenteration, 6 patients underwent eye-sparing surgery, and 1 patient had an unresectable tumor because of cavernous sinus extension. All patients received radiotherapy (intensity-modulated radiotherapy in 3 and proton therapy in 6). All patients received chemotherapy, 8 concurrently with radiotherapy and 1 after radiotherapy. The median follow-up time was 70 months. At last contact, 6 patients were alive without evidence of disease; 2 had died of disease, 1 of distant metastasis, and the other of cavernous sinus invasion.

Conclusions:
The findings suggest that de novo malignant mixed tumor of the lacrimal gland is more common than disease that results from transformation after incomplete resection of lacrimal gland pleomorphic adenoma. Most cases can be treated with eye-sparing surgery and radiation unless skull base extension is present.
Mast cell activation syndrome
Authors: Vacheron Nathalie , McClinton Tracy , Lynch-Smith Donna J. , Umberger Reba 
Published: April 2020

ABSTRACT
Mast cell activation syndrome (MCAS) is a systemic autoinflammatory disease in which mast cells behave erratically. It is unknown whether MCAS recently evolved or if it has been an unrecognized entity for years. Clinically, the patient may present in a constant to near-constant state of allergic reaction. However, the patient may also present with a variety of nonallergic symptoms. There is currently no curative treatment, and providers must prepare to be persistent in seeking symptom-management strategies. This case study describes the vast array of symptoms a typical MCAS patient may exhibit. There is a need for provider education and awareness of this disease that could affect up to 17% of the population on a spectrum from very mild to debilitating symptoms. MCAS is often either misdiagnosed or the diagnosis is greatly delayed due to a lack of provider awareness. Patients may approach primary care providers as their first line of treatment for their aberrant, mysterious symptoms, and therefore it is imperative that nurse practitioners are aware of the disease. Nurse practitioners can play a vital role in the management of MCAS using their attention to detail to recognize patterns, validate patients' experiences, and have a voice in diagnostic criteria consensus.
Condom use philosophy and behaviors among young men who have sex with men: Variations among HIV pre-exposure prophylaxis users and nonusers
Authors: Fontenot Holly B. , Krakower Douglas , White Bradley Patrick , Marquez Samantha M. , Dormitzer Julian , Psaros Christina , O'Cleirigh Conall , Mayer Kenneth H. 
Published: April 2020

ABSTRACT

Background:
In the United States, sexually transmitted infections, particularly HIV, occur at disproportionally high rates among young men who have sex with men (YMSM). Oral pre-exposure prophylaxis (PrEP) is a highly effective in reducing HIV acquisition. Reduction of condom use has been noted among adult populations of MSM using PrEP. However, less is known about PrEP and condom use among YMSM.

Purpose:
Our objective was to understand condom attitudes/beliefs and behaviors among YMSM in the context of PrEP use and nonuse.

Methodological orientation:
We conducted qualitative interviews between May and November, 2017 in Boston, MA. All YMSM were HIV-negative by self-report. We purposively sampled youth who used PrEP and those who did not use PrEP. Data were analyzed using content analysis.

Sample:
The sample consisted of 31 YMSM aged 17–24 years (mean = 21.5 years).

Conclusions:
Young men who have sex with men provided rich descriptions of their condom-use philosophies and behaviors. Three themes emerged: 1) Different condom philosophies between youth who used PrEP and youth who do not, 2) Inconsistent or absent condom use by PrEP users, and 3) Similar condom behaviors regardless of PrEP use with certain partner types, if low self-efficacy was reported, and when sex occurred during periods of substance use and/or intoxication.

Implications for practice:
This study provides understanding of YMSM condom decision-making process in the context of PrEP use or nonuse. Findings are useful to inform development and testing of individually tailored interventions for YMSM based on their personal condom-use philosophies and behaviors to improve risk reduction decision making, use of condoms, and PrEP.
Comparison between teriparatide and bisphosphonates for improving bone mineral density in postmenopausal osteoporosis patients
Authors: Fan Guiyong , Zhao Qun , Lu Pei , Chen Hao , Tan Wei , Guo Weixiao , Liu Chaoqun , Liu Jinlian 
Published: April 2020

Abstract

Background:
We performed a systematic review and meta-analysis of the efficacy and safety of teriparatide and bisphosphonates in managing postmenopausal osteoporosis.

Methods:
PubMed, EMBASE, Web of Science, and China National Knowledge Infrastructure were searched for relevant randomized controlled trials that were published before April 2018 and compared teriparatide and bisphosphonates in treating postmenopausal osteoporosis. Stata 12.0 was used for the meta-analysis. The pooled risk ratio (RR) or weighted mean difference and 95% confidence interval (CI) were calculated using a fixed effects or random effects meta-analysis.

Results:
A total of 14 randomized controlled trials were included in this meta-analysis. The teriparatide group was associated with a lower total occurrence of vertebral fractures (RR = 0.55, 95% CI: 0.40–0.77; P = .001) and nonvertebral fractures (RR = 0.65, 95% CI: 0.46–0.90; P = .009) than the bisphosphonate group. Moreover, compared with the bisphosphonate group, the teriparatide group had improved bone mineral density at the lumbar spine and femoral neck at the final follow-up (P < .05). There was no significant difference between the teriparatide and bisphosphonate groups in terms of complications (RR = 1.05, 95% CI: 0.90, 1.22, P = .516).

Conclusions:
Teriparatide significantly reduced the occurrence of vertebral and nonvertebral fractures in osteoporosis patients. More studies should focus on the quality of life of patients using these 2 drugs.
Association of finasteride with prostate cancer
Authors: Wang Lei , Lei Yonghua , Gao Yanyao , Cui Dong , Tang Qisheng , Li Ruixiao , Wang Dong , Chen Yu , Zhang Bo , Wang He 
Published: April 2020

Abstract

Background:
The Prostate Cancer Prevention Trial has shown a protective effect of finasteride on prostate cancer, but it also showed that finasteride can increase the risk of high-grade prostate cancer. Several studies have investigated the relationship between finasteride and prostate cancer, but these studies have shown inconsistent results.

Ethics:
The protocol was approved by the institutional review board of each study center. Written informed consent will be obtained from all patients before registration, in accordance with the Declaration of Helsinki.

Methods:
We performed a systematic literature review and meta-analysis to assess the association between finasteride and prostate cancer. Systematic literature searches were conducted using PubMed, EMBASE, Science Direct/Elsevier, MEDLINE, CNKI, and the Cochrane Library up to October 2018 to identify studies that involved the relationship between finasteride and prostate cancer. Meta-analysis was performed using Review Manager and Stata software. Combined ORs were identified with 95% confidence intervals (95% CI) in a random or fixed effects model.

Results:
Eight studies were identified, including 54,335 cases of patients that used finasteride and 9197 patients who served as placebo controls. Our results illustrate that there is a significant correlation between finasteride use and prostate cancer with combined ORs of 0.70 [0.51, 0.96]. A significant correlation between finasteride use and high-grade prostate cancer was also observed with combined ORs of 2.10 [1.85, 2.38].

Conclusions:
This study confirms that finasteride significantly reduced the risk of prostate cancer; however, the malignant degree of prostate cancer was increased. Studies with larger sample sizes are needed to better clarify the correlation between finasteride use and prostate cancer.
Cytokine Removal in Critically Ill Patients Requiring Surgical Therapy for Infective Endocarditis (RECReATE)
Authors: Gisler Fabian , Spinetti Thibaud , Erdoes Gabor , Luedi Markus M. , Pfortmueller Carmen A. , Messmer Anna S. , Jenni Hansjörg , Englberger Lars , Schefold Joerg C. 
Published: April 2020

Abstract

Introduction:
Infective endocarditis (IE) and other severe infections induce significant changes in the immune response in a considerable number of affected patients. Numerous IE patients develop a persistent functional immunological phenotype that can best be characterized by a profound anti-inflammation and/ or functional “anergy.” This is pronounced in patients with unresolved infectious foci and was previously referred to as “injury-associated immunosuppression” (IAI). IAI can be assessed by measurement of the monocytic human leukocyte antigen-DR (mHLA-DR) expression, a global functional marker of immune competence. Persistence of IAI is associated with prolonged intensive care unit length of stay, increased secondary infection rates, and death. Immunomodulation to reverse IAI was shown beneficial in early immunostimulatory (randomized controlled) clinical trials.

Methods:
Prospective 1:1 randomized controlled clinical study to compare the course of mHLA-DR in patients scheduled for cardiac surgery for IE. Patients will receive either best standard of care plus cytokine adsorption during surgery while on cardiopulmonary bypass (protocol A) versus best standard of care alone, that is, surgery without cytokine adsorption (protocol B). A total of 54 patients will be recruited and randomized. The primary endpoint is a change in quantitative expression of mHLA-DR (antibodies per cell on CD14+ monocytes/ macrophages, assessed using a quantitative standardized assay) from baseline (preoperation [pre-OP], visit 1) to day 1 post-OP (visit 4).

Discussion:
This randomized controlled clinical trial (RECReATE) will compare 2 clinical treatment protocols and will investigate whether cytokine adsorption restores monocytic immune competence (reflected by increased mHLA-DR expression) in patients with IE undergoing cardiac surgery.

Trial registration:
This protocol was registered in ClinicalTrials.gov, under number NCT03892174, first listed on March 27, 2019.
Importance and safety of autologous sperm cryopreservation for fertility preservation in young male patients with cancer
Authors: Li Yinfeng , Zhang Jian , Zhang Hanfeng , Liu Bo , Wang Guorong , Cao Maoqiu , Fu Bencui , Li Hui , Jiang Qinghua , Yu Lin , Xian Yang , Su Bizhen , Jiang Xiaohui 
Published: April 2020

AbstractWith development of tumor treatment, survival time of patients with cancer is significantly prolonged. Therefore, the current emphasis is not only the survival, but also the quality of life, especially, it is crucial for young male cancer patients who are unmarried and maintaining fertility. However, the awareness of fertility preservation for these patients is currently insufficient.To give physician and cancer patients more clear understanding of the importance and safety of sperm cryopreservation, so that achieve patient fertility benefits.First, the knowledge level and attitudes about fertility preservation were investigated by surveying 332 cancer patients and 103 medical staff with questionnaires. Second, 30 male cancer patients (experimental group) and 30 normal donors (control group) were selected and their sperm samples were cryopreserved. The sperm quality was compared between cancer patients and normal donors, before and after antitumor treatment in the cancer patients, and before and after sperm cryopreservation in both groups.In the questionnaire survey, we found that there were 70% to 80% of medical staffs and cancer patients lacked knowledge of fertility preservation, and 27.7% of patients worried that tumor and sperm cryopreservation might affect their offspring. In the sperm preservative experiment, we found that sperm quality in cancer patients was further damaged after radiotherapy/chemotherapy in addition to tumor itself had a negative effect. However, sperm deoxyribonucleic acid fragments were not affected by sperm cryopreservation although there were significant differences in sperm quality before and after sperm preservation in both groups.Radiotherapy/chemotherapy would further damage sperm quality of young male cancer patients. Medical staff should be aware of importance of sperm cryopreservation for fertility preservation for these patients. It is also necessary that medical staff should inform the patient about the safety of sperm freezing and guide the patient to participate in sperm cryopreservation.