bluuebunny/crossref_metadata_2025_split huggingface dataset:
Major Abdominal and Perianal Surgery in Crohn’s Disease: Long-term Follow-up of Australian Patients With Crohn’s Disease
Authors: Toh James W.T. , Wang Nelson , Young Christopher J. , Rickard Matthew J.F.X. , Keshava Anil , Stewart Peter , Kariyawasam Viraj , Leong Rupert 
Published: December 2017

BACKGROUND:
Most patients with Crohn’s disease still require surgery despite significant advances in medical therapy, surveillance, and management strategies.

OBJECTIVE:
The purpose of this study was to assess surgical strategies and outcomes in Crohn’s disease, including surgical recurrence and emergency surgery.

DESIGN:
This was a multicenter, retrospective review of a prospectively collected database.

SETTINGS:
A specialist-referred cohort of patients with Crohn’s disease between 1970 and 2009 was studied.

PATIENTS:
Included were 972 patients with Crohn’s disease who were referred to the Sydney Inflammatory Bowel Disease cohort database.

MAIN OUTCOME MEASURES:
Main outcomes of interest were the rates of major abdominal and perianal surgery between decades (1970–1979, 1980–1989, 1990-1999, and 2000-2009), indications for surgery, types of procedure performed, rate of elective and emergency surgery, risk of surgical recurrence, and predictive factors for surgery.

RESULTS:
Between 1970 and 2009, the overall risks of surgery within 5, 10, and 15 years of diagnosis were 31.7%, 43.3%, and 48.4%. The median time to first surgery from time of diagnosis was 2 years (range, 0–31 years). A total of 6.7% of patients required emergency surgery within 5 years of diagnosis. In total, 8.8% of patients required emergency surgery within 15 years. The overall risk of surgical recurrence was 35.9%. The risk of major abdominal surgery significantly decreased between 2000 and 2009 when compared with the 1970 to 1979 period (OR = 0.49 (95% CI, 0.34–0.70). However, the rate of perianal surgery significantly increased (OR = 5.76 (95% CI, 2.54–13.06)). The main indications for surgery were enteric stricture or obstruction, perianal disease, and intra-abdominal fistulas/abscess. Of the 972 patients over 4 decades, only 11 patients (1.1%) were diagnosed with colorectal cancer.

LIMITATIONS:
This was a specialist-referred cohort, not a population-based study.

CONCLUSIONS:
The rate of major abdominal surgery has decreased, with surgery reserved for more severe and complicated disease. The natural history of patients with more complicated Crohn’s disease and severe phenotypes puts them at higher risk of surgical recurrence and emergency surgery. There has been no reduction in emergency surgery rates and there has been an increase in surgical recurrence despite the reduction in surgical rate morbidity. See Video Abstract at http://links.lww.com/DCR/A483.
Prophylactic Ureteral Catheters for Colectomy: A National Surgical Quality Improvement Program-Based Analysis
Authors: Coakley Kathleen M. , Kasten Kevin R. , Sims Stephanie M. , Prasad Tanushree , Heniford B. Todd , Davis Bradley R. 
Published: December 2017

BACKGROUND:
Despite improvement in technique and technology, using prophylactic ureteral catheters to avoid iatrogenic ureteral injury during colectomy remains controversial.

OBJECTIVE:
The aim of this study was to evaluate outcomes and costs attributable to prophylactic ureteral catheters with colectomy.

DESIGN:
This was a retrospective study.

SETTINGS:
The study was conducted at a single tertiary care center.

PATIENTS:
The colectomy-targeted American College of Surgeons National Surgical Quality Improvement Program database from 2012 to 2014 was queried.

MAIN OUTCOME MEASURES:
The primary end point was the rate of 30-day ureteral injury after colectomy. Univariate and multivariate analyses determined factors associated with ureteral injury and urinary tract infection in patients undergoing colectomy.

RESULTS:
A total of 51,125 patients were identified with a mean age of 60.9 ± 14.9 years and a BMI of 28.4 ± 6.7 k/m2; 4.90% (n = 2486) of colectomies were performed with prophylactic catheters, and 333 ureteral injuries (0.65%) were identified. Prophylactic ureteral catheters were most commonly used for diverticular disease (42.2%; n = 1048), with injury occurring most often during colectomy for diverticular disease (36.0%; n = 120). Univariate analysis of outcomes demonstrated higher rates of ileus, wound infection, urinary tract infection, urinary tract infection as reason for readmission, superficial site infection, and 30-day readmission in patients with prophylactic ureteral catheter placement. On multivariate analysis, prophylactic ureteral catheter placement was associated with a lower rate of ureteral injury (OR = 0.45 (95% CI, 0.25–0.81)).

LIMITATIONS:
This was a retrospective study using a clinical data set.

CONCLUSIONS:
Here, prophylactic ureteral catheters were used in 4.9% of colectomies and most commonly for diverticulitis. On multivariate analysis, prophylactic catheter placement was associated with a lower rate of ureteral injury. Additional research is needed to delineate patient populations most likely to benefit from prophylactic ureteral stent placement. See Video Abstract at http://links.lww.com/DCR/A482.
Concentration range of serum sex steroids in normal postmenopausal women and those with diagnosis of vulvovaginal atrophy
Authors: Ke Yuyong , Bélanger Alain , Simard Jean-Nicolas , Gonthier Renaud , Martel Céline , Vaillancourt Mario , Labrie Fernand 
Published: December 2017

Abstract

Objective:
The aim of the study was to determine the range of serum sex-related steroids in normal postmenopausal women and in women of the same age with a diagnosis of vulvovaginal atrophy (VVA).

Methods:
Validated mass spectrometry-based assays coupled to gas or liquid chromatography were used over a 10-year period for steroid measurements. Serum samples were obtained in up to 1,512 women aged 55 to 65 years.

Results:
Serum estrone sulfate (E1S) and androsterone glucuronide (ADT-G), the main metabolites of estrogens and androgens, respectively, were 16.9% (P = 0.005) and 16.1% (P = 0.001) higher in women not diagnosed with moderate/severe VVA than those diagnosed with VVA. Serum estrone (E1) was 14.5% (P < 0.0001) higher in women with no diagnosis of VVA, whereas the other steroids did not show meaningful differences. The limited biological significance of serum estradiol (E2) and testosterone is supported by the lack of statistical significance in the serum concentrations of these two steroids between the two groups. Most importantly, for the women without a diagnosis of VVA, the normal upper limit (95th centile) of serum E2 was 9.15 pg/mL (n = 364) and 10.7 pg/mL (n = 67) for a weighted average of 9.99 pg E2/mL. A limit of 10 pg E2/mL has recently been found by two other laboratories. When comparing 50- to 59-year-old and 70- to 79-year-old women, serum E2, E1S, ADT-G, and DHEA were, respectively, 24.4%, 22.6%, 27.0%, and 85.9% higher in the younger group.

Conclusions:
Somewhat higher values, namely, 16.9% and 16.1%, are observed in the serum concentrations of the estrogen (E1S) and androgen (ADT-G) metabolites in normal compared with women with a diagnosis of VVA. Such data indicating a lower estrogenic and androgenic global exposure in women diagnosed with VVA offers an opportunity for the local intravaginal administration of DHEA to replace the deficiency in endogenous DHEA.
Associations between improvement in genitourinary symptoms of menopause and changes in the vaginal ecosystem
Authors: Mitchell Caroline M. , Srinivasan Sujatha , Plantinga Anna , Wu Michael C. , Reed Susan D. , Guthrie Katherine A. , LaCroix Andrea Z. , Fiedler Tina , Munch Matthew , Liu Congzhou , Hoffman Noah G. , Blair Ian A. , Newton Katherine , Freeman Ellen W. , Joffe Hadine , Cohen Lee , Fredricks David N. 
Published: December 2017

Abstract

Objective:
The aim of the study was to identify associations between improvement in genitourinary symptoms of menopause (GSM) and vaginal microbiota, vaginal glycogen, and serum estrogen.

Methods:
Thirty postmenopausal women enrolled in a hot flash treatment trial (oral estradiol vs venlafaxine vs placebo) who reported GSM and provided vaginal swabs at 0, 4, and 8 weeks were studied. Bacterial communities were characterized using deep sequencing targeting the 16S rRNA gene V3-V4 region. Participants selected a most bothersome genitourinary symptom (dryness, discharge, pain, itch/burn, or inability to have sex) and rated severity on a 10-point scale at baseline and 8 weeks. Vaginal glycogen and serum estradiol and estrone were measured at enrollment and 8 weeks. Comparisons according to improvement in most bothersome symptom (MBS) were made using χ2, Wilcoxon signed-rank test, or Hotelling's t test.

Results:
Of 30 participants, 21 (70%) had improvement in MBS over the 8-week study and 9 (30%) had no improvement or worsening of MBS. A higher proportion of women receiving estradiol or venlafaxine reported improvement in MBS (88%, 78%) compared with placebo (54%; P = 0.28). MBS improvement was associated with Lactobacillus-dominant vaginal microbiota at enrollment (57% vs 22%, P = 0.08). Vaginal glycogen, serum estradiol, and estrone significantly increased in women whose MBS improved.

Conclusions:
A larger proportion of women whose MBS improved had a Lactobacillus dominant microbiota at enrollment than those who had no improvement during the trial, though this difference was not statistically significant. Larger trials are needed to determine whether vaginal microbiota modify or mediate treatment responses in women with GSM.
THE OASIS MP-1 SUBSTUDY
Authors: Sadda SriniVas R. , Dugel Pravin U. , Gonzalez Victor H. , Meunier Esmeralda , Kozma Petra 
Published: December 2017

Purpose:
To evaluate the effects of ocriplasmin and symptomatic vitreomacular adhesion resolution on visual fixation and macular sensitivity using microperimetry.

Methods:
MP-1 parameters were analyzed from 3 OASIS sites after the use of standardized instruments and testing procedures over 24 months.

Results:
A total of 27 patients (19 ocriplasmin, 8 sham) were evaluated. Mean distance of the preferred fixation locus to the anatomical center was farther in the sham group at baseline and farther in the sham versus ocriplasmin group throughout the study. Retinal sensitivity values were consistently higher in the ocriplasmin versus sham group after Month 3. Fewer patients in the ocriplasmin group had predominantly eccentric fixation at study end compared with the sham group, which also had an increased number of patients with unstable fixation. Patients with vitreomacular adhesion resolution had lower bivariate contour area, fewer relative scotomas, and higher retinal sensitivity parameters at baseline than those with unresolved vitreomacular adhesion.

Conclusion:
Substudy results suggest that fixation and sensitivity parameters tended to be better in the ocriplasmin group than in the sham group over time. The substudy identified parameters that were distinct between patients with and without vitreomacular adhesion resolution, suggesting that microperimetry warrants further study as a relevant biomarker for visual function.
EARLY MICROVASCULAR AND NEURAL CHANGES IN PATIENTS WITH TYPE 1 AND TYPE 2 DIABETES MELLITUS WITHOUT CLINICAL SIGNS OF DIABETIC RETINOPATHY
Authors: Vujosevic Stela , Muraca Andrea , Alkabes Micol , Villani Edoardo , Cavarzeran Fabiano , Rossetti Luca , De Cilla' Stefano 
Published: December 2017

Purpose:
To assess and compare early modifications in inner retinal layer thickness and optical coherence tomography angiography parameters in patients with diabetes mellitus (DM) Types 1 and 2 without clinical signs of diabetic retinopathy.

Methods:
Ninety eyes of 90 subjects (24 Type 1 DM, 36 Type 2 DM, and 30 healthy controls) were prospectively evaluated with spectral domain OCT, swept-source OCT angiography, and color fundus photography (on the same day). Retinal nerve fiber layer, ganglion cell layer (GCL+), and nerve fiber layer + GCL+ (GCL++) thickness were automatically determined by the instrument in the 1, 3, and 6 central mm. On OCT angiography, the following parameters were evaluated: area of foveal avascular zone, number of focally dilated endings of the capillaries (detected only on OCT angiography), presence of regular/irregular foveal avascular zone, capillary loss, and capillary network irregularities in the superficial capillary plexus (SCP) and deep capillary plexus (DCP).

Results:
Ganglion cell layer+ (P = 0.0099) and GCL++ (P = 0.0367) were significantly thicker in DM Type 1 versus DM Type 2 in 1 central mm, after adjustment for age and DM duration. The area of foveal avascular zone was significantly larger in DM Type 1 versus controls in both SCP and DCP and in DM Type 1 versus Type 2 only in DCP (P < 0.05 for all); the number of focally dilated endings of the capillaries was higher in DM Type 1 versus controls in both SCP and DCP (P < 0.01 for all); and in DM Type 2 versus controls only in DCP (P = 0.007). Perifoveal capillary loss in SCP and inner retinal layer thickness had the highest correlation in both DM types.

Conclusion:
There are specific neural and microvascular modifications even before clinical signs of diabetic retinopathy in DM Types 1 and 2. Perifoveal capillary loss in the SCP is highly correlated with inner retinal layer. These data may help in characterization of patients at the preclinical stage of diabetic retinopathy.
MULTIMODAL IMAGING OF CHOROIDAL LESIONS IN DISSEMINATED MYCOBACTERIUM CHIMAERA INFECTION AFTER CARDIOTHORACIC SURGERY
Authors: Böni Christian , Al-Sheikh Mayss , Hasse Barbara , Eberhard Roman , Kohler Philipp , Hasler Pascal , Erb Stefan , Hoffmann Matthias , Barthelmes Daniel , Zweifel Sandrine A. 
Published: December 2017

Purpose:
To explore morphologic characteristics of choroidal lesions in patients with disseminated Mycobacterium chimaera infection subsequent to open-heart surgery.

Methods:
Nine patients (18 eyes) with systemic M. chimaera infection were reviewed. Activity of choroidal lesions were evaluated using biomicroscopy, fundus autofluorescence, enhanced depth imaging optical coherence tomography, fluorescein angiography/indocyanine green angiography, and optical coherence tomography angiography. Relationships of choroidal findings to systemic disease activity were sought.

Results:
All 9 male patients, aged between 49 and 66 years, were diagnosed with endocarditis and/or aortic graft infection. Mean follow-up was 17.6 months. Four patients had only inactive lesions (mild disease). In all five patients (10 eyes) with progressive ocular disease, indocyanine green angiography was superior to other tests for revealing new lesions and active lesions correlated with hyporeflective choroidal areas on enhanced depth imaging optical coherence tomography. One eye with a large choroidal granuloma developed choroidal neovascularization. Optical coherence tomography angiography showed areas with reduced perfusion at the inner choroid. All 5 patients with progressive ocular disease had evidence of systemic disease activity within ±6 weeks' duration.

Conclusion:
Choroidal manifestation of disseminated M. chimaera infection indicates systemic disease activity. Multimodal imaging is suitable to recognize progressive ocular disease. We propose ophthalmologic screening examinations for patients with M. chimaera infection.
Pharmacokinetics and Pharmacodynamics of Atazanavir in HIV-1-Infected Children Treated With Atazanavir Powder and Ritonavir
Authors: Sevinsky Heather , Zaru Luna , Wang Reena , Xu Xiaohui , Pikora Cheryl , Correll Todd A. , Eley Timothy 
Published: December 2017

Background:
Two clinical studies (PRINCE-1 and -2) in HIV-1-infected children assessed the safety, efficacy and pharmacokinetics of dual nucleos(t)ide reverse transcriptase inhibitor background therapy plus once-daily atazanavir (ATV) powder formulation boosted with ritonavir (ATV + RTV). Here, we present a combined analysis of ATV pharmacokinetics and pharmacodynamics across these studies.

Methods:
Intensive 24-hour pharmacokinetic profiles at steady state compared ATV exposures (area under the concentration–time curve in one dosing interval) in 5 ATV + RTV baseline weight-band dosing categories, with historic data in adults receiving ATV + RTV 300/100 mg capsules. Repeated ATV C
trough measurements over 48 weeks explored relationships between ATV composite C
trough quartiles (CCQs) with virologic efficacy and key safety parameters.

Results:
Of 146 children included in this combined analysis, 49.3% were male, 56.8% were Black/African American and 62.3% were antiretroviral experienced. Proportions with HIV-1 RNA <50 copies/mL at week 48 were 13/32, 24/32, 19/32 and 13/28 in the lowest through highest ATV CCQs, respectively. Mean changes from baseline in total bilirubin at week 48 were +0.3, +0.5, +0.6 and +1.0 mg/dL in the lowest through highest ATV CCQs, respectively. Corresponding proportions with adverse events of hyperbilirubinemia by week 48 were 1/36, 4/36, 5/36 and 13/35, respectively. Changes from baseline in total amylase or electrocardiogram parameters and adverse events of diarrhea did not vary by ATV CCQs.

Conclusions:
Weight-band dosing of ATV + RTV plus optimized dual nucleos(t)ide reverse transcriptase inhibitors in young HIV-1-infected children achieved similar ATV exposure to that in adults; no unexpected safety findings occurred, and with the exception of lower virologic suppression in the lowest ATV CCQ, there was no apparent trend in virologic suppression across ATV CCQs.
Ceftazidime–Avibactam Antimicrobial Activity and Spectrum When Tested Against Gram-negative Organisms From Pediatric Patients
Authors: Sader Helio S. , Huband Michael D. , Duncan Leonard R. , Flamm Robert K. 
Published: December 2017

Background:
Ceftazidime–avibactam was approved by the US Food and Drug Administration in 2015 to treat complicated intra-abdominal and urinary tract infections in adults and is under clinical development for treating pediatric patients.

Methods:
Among 53,381 Gram-negative organisms (1 per patient) collected in 2011–2015, 8461 (15.9%) were from pediatric (≤17 years old) patients. The isolates were collected from 82 US medical centers and susceptibility tested against ceftazidime–avibactam (avibactam at fixed 4 μg/mL) and comparators by reference broth microdilution methods. Susceptibility results were stratified by patient age: ≤1 (3671 isolates); 2–5 (1900); 6–12 (1644) and 13–17 years old (1246). Enterobacteriaceae with an extended-spectrum β-lactamase (ESBL) screening-positive phenotype were evaluated by microarray-based assay for genes encoding ESBLs, KPC, NDM and transferable AmpC enzymes.

Results:
Ceftazidime–avibactam inhibited >99.9% of all Enterobacteriaceae at the ≤8 μg/mL susceptible break point and was highly active against ESBL screening–positive phenotype Escherichia coli and Klebsiella pneumoniae. Overall, 83.6% of ESBL screening–positive phenotype K. pneumoniae were susceptible to meropenem. Only 1 of 4724 Enterobacteriaceae (0.02%) isolates was nonsusceptible to ceftazidime–avibactam, an Enterobacter aerogenes with a ceftazidime–avibactam minimum inhibitory concentration (MIC) value of 16 μg/mL and negative results for all β-lactamase tested. Ceftazidime–avibactam was very active against Pseudomonas aeruginosa (MIC50/90, 1/4 μg/mL; 99.1% susceptible), including isolates nonsusceptible to meropenem (94.0% susceptible to ceftazidime–avibactam) or piperacillin–tazobactam (91.7% susceptible) or ceftazidime (89.6% susceptible). Ceftazidime–avibactam activity against P. aeruginosa did not vary substantially among age groups (98.8%–99.3% susceptible) or year of isolation (98.5%–100.0% susceptible).

Conclusions:
Ceftazidime–avibactam was very active against a large collection of Gram-negative bacilli isolated from pediatric patients, including P. aeruginosa and Enterobacteriaceae with an ESBL screening–positive phenotype and resistant to carbapenems.
Abdominal Ultrasound Does Not Reveal Significant Alterations in Patients With Nonceliac Wheat Sensitivity
Authors: Soresi Maurizio , Mansueto Pasquale , Terranova Antonino , D’Alcamo Alberto , La Blasca Francesco , Cavataio Francesca , Iacobucci Rosario , Carroccio Antonio 
Published: December 2017

Goals:
The goal of this study was (A) to evaluate abdominal ultrasound signs in nonceliac wheat sensitivity (NCWS) patients for features useful in diagnosis and (B) to compare these aspects with those of celiac patients to assess whether ultrasound can be useful in the differential diagnosis between NCWS and celiac disease (CD).

Background:
NCWS diagnosis is difficult as no biomarkers of this condition have as yet been identified. In CD ultrasound aspects have been identified that have a good diagnostic accuracy.

Study:
We prospectively recruited 45 NCWS patients (11 males, 34 females; mean age 35.7 y). Three control groups were included: (A) 99 age-matched CD patients; (B) 18 patients with seronegative CD; (C) 50 patients with irritable bowel syndrome (IBS) who did not improve on a wheat-free diet. NCWS diagnosis was confirmed on the basis of an elimination diet and double-blind placebo-controlled (DBPC) challenge. Ultrasound sign investigation included: dilatation of the small bowel loops, thickening of the small bowel wall, hyperperistalsis, enlarged mesenteric lymph nodes, ascites, hyposplenism, altered diameter of the portal vein.

Results:
NCWS patients showed a low frequency of pathologic ultrasound findings. Dilated or thickened loops appeared more often in CD patients than in NCWS patients (88.8% vs. 20%; P<0.0001). These US signs were significantly more frequent in seronegative CD than in NCWS patients (both P<0.0001), whereas no difference was found between NCWS patients and IBS controls.

Conclusions:
In NCWS patients’ ultrasound does not show a characteristic pattern which could be helpful for diagnosis. However, US can be useful to differentiate between NCWS and CD patients and especially those with seronegative CD. (ClinicalTrials.gov NCT03017274).
Family planning in inflammatory bowel disease: childlessness and disease-related concerns among female patients
Authors: Walldorf Jens , Brunne Susanne , Gittinger Fleur S. , Michl Patrick 
Published: December 2017

Objective
Inflammatory bowel disease (IBD) frequently affects women when family planning and pregnancy (FPP) are important issues. This survey aimed to identify patients with an increased need for medical counselling.

Patients and methods
An internet-based questionnaire was offered to women with IBD. Characteristics in terms of FPP were analysed with respect to sociodemographic and disease-related factors.

Results
Childlessness was frequently reported (64.8% of 443 participants). In women older than 35 years with IBD, childlessness was significantly more prevalent than that in the general population (36.7 vs. 22.9%, odds ratio=1.9, P<0.001). Overall, 44.2% of the women were satisfied with counselling in general, and only 27.3% with the specific advice on FPP. Women younger than 25 years were rarely satisfied with the advice in terms of FPP (18.2%) and demanded an intensified counselling (44.6%). Frequent concerns were the heritability of IBD (all women, 59.2%; mothers, 51.5%; childless, 62.5%, P<0.01), medication during FPP (44.7, 26.1, 52.4%, P<0.01) and miscarriage (38.9, 16.8, 48.7%, P<0.01).

Conclusion
The prevalence of childlessness in women with IBD compared with the general population increases with age. FPP-related worries, especially in terms of heredity, medication and miscarriage, are associated with an increased risk for childlessness. The results underline the importance of qualified counselling as early as possible during the course of the disase.