bluuebunny/crossref_metadata_2025_split huggingface dataset:
Ulipristal acetate vs gonadotropin‐releasing hormone agonists prior to laparoscopic myomectomy (MYOMEX trial): Short‐term results of a double‐blind randomized controlled trial
Authors: de Milliano Inge , Huirne Judith A. F. , Thurkow Andreas L. , Radder Celine , Bongers Marlies Y. , van Vliet Huib , van de Lande Jonas , van de Ven Peter M. , Hehenkamp Wouter J. K. 
Published: August 2019

AbstractIntroductionLaparoscopic myomectomy can be difficult when fibroids are large and numerous. This may result in extensive intraoperative bleeding and the need for a conversion to a laparotomy. Medical pretreatment prior to surgery might reduce these risks by decreasing fibroid size and vascularization of the fibroid. We compared pretreatment with ulipristal acetate (UPA) vs gonadotropin‐releasing hormone agonists (GnRHa) prior to laparoscopic myomectomy on several intra‐ and postoperative outcomes.Material and methodsWe performed a non‐inferiority double‐blind randomized controlled trial in nine hospitals in the Netherlands. Women were randomized between daily oral UPA for 12 weeks and single placebo injection or single intramuscular injection with leuprolide acetate and daily placebo tablets for 12 weeks. The primary outcome was intraoperative blood loss. Secondary outcomes were reduction of fibroid volume, suturing time, total surgery time and surgical ease.ResultsThirty women received UPA and 25 women leuprolide acetate. Non‐inferiority of UPA regarding intraoperative blood loss was not demonstrated. When pretreated with UPA, median intraoperative blood loss was statistically significantly higher (525 mL [348‐1025] vs 280 mL[100‐500]; P = 0.011) and suturing time of the first fibroid was statistically significantly longer (40 minutes [28‐48] vs 22 minutes [14‐33]; P = 0.003) compared with GnRHa. Pretreatment with UPA showed smaller reduction in fibroid volume preoperatively compared with GnRHa (−7.2% [−35.5 to 54.1] vs −38.4% [−71.5 to −19.3]; P = 0.001). Laparoscopic myomectomies in women pretreated with UPA were subjectively judged more difficult than in women pretreated with GnRHa.ConclusionsNon‐inferiority of UPA in terms of intraoperative blood loss could not be established, possibly due to the preliminary termination of the study. Pretreatment with GnRHa was more favorable than UPA in terms of fibroid volume reduction, intraoperative blood loss, hemoglobin drop directly postoperatively, suturing time of the first fibroid and several subjective surgical ease parameters.
Colour vision testing in young children with reduced visual acuity
Authors: Pfäffli Oliver Andreas , Tamási Bálint , Hanson James V. M. , Gerth‐Kahlert Christina 
Published: August 2019

AbstractPurposeTo investigate feasibility, reliability and discriminative validity of pseudoisochromatic (PIC) colour vision tests, the Mollon–Reffin minimalist (MRM) test and the Cambridge Colour Test (CCT) among children (3–10 years) with reduced visual acuity.MethodsThirty‐three patients with reduced visual acuity and 38 healthy control subjects with age‐related normal visual acuity were recruited for this prospective study. Visual acuity in patients was reduced due to amblyopia, binocular maculopathy, or optic neuropathy. Tests were performed in a single 1‐hr session.ResultsAll but two children successfully completed the PIC and MRM tests. Success rate for the CCT was lower, 87%, CI [72%, 96%] for control subjects and 79%, CI [61%, 91%] for patients, with a strong positive effect of age on the odds of successful completion (OR 5.63, p = 0.007). Reliability was high in PIC and MRM tests but comparably lower in CCT. The rate of correct answers in PIC tests was between 88% and 100%. One proband was diagnosed with deuteranomaly with an average Ishihara score of 21%. All children (with the exception of one daltonian) scored at least two points in the MRM test. Sensitivity thresholds in CCT decreased with age with a strong effect size in control subjects and weak to moderate effect size in patients.ConclusionsPseudoisochromatic and MRM tests show sufficient feasibility in young children with reduced visual acuity. For CCT feasibility in 3–5‐year olds is reduced, most probably due to the longer test duration. Consistent with earlier findings, colour discrimination thresholds decrease with age independent on visual acuity status.
Analysis of the location of retinal lesions in central retinographies of patients with Type 2 diabetes
Authors: Munuera‐Gifre Eduardo , Saez Marc , Juvinyà‐Canals Dolors , Rodríguez‐Poncelas Antonio , Barrot‐de‐la–Puente Joan‐Francesc , Franch‐Nadal Josep , Romero‐Aroca Pere , Barceló Maria Antonia , Coll‐de‐Tuero Gabriel 
Published: August 2019

AbstractPurposeTo describe the distribution of Type 2 DM retinal lesions and determine whether it is symmetrical between the two eyes, is random or follows a certain pattern.MethodsCross‐sectional study of Type 2 DM patients who had been referred for an outpatients’ ophthalmology visit for diabetic retinopathy screening in primary health care. Retinal photographic images were taken using central projection non‐mydriatic retinography. The lesions under study were microaneurysms/haemorrhages, and hard and soft exudates. The lesions were placed numerically along the x‐ and y‐axes obtained, with the fovea as the origin.ResultsFrom among the 94 patients included in the study, 4770 lesions were identified. The retinal lesions were not distributed randomly, but rather followed a determined pattern. The left eye exhibited more microaneurysms/haemorrhages and hard exudates of a greater density in the central retina than was found in the right eye. Furthermore, more cells containing lesions were found in the upper temporal quadrants, (especially in the left eye), and tended to be more central in the left eye than in the right, while the hard exudates were more central than the microaneurysms/haemorrhages.ConclusionThe distribution of DR lesions is neither homogeneous nor random but rather follows a determined pattern for both microaneurysms/haemorrhages and hard exudates. This distribution means that the areas of the retina most vulnerable to metabolic alteration can be identified. The results may be useful for automated DR detection algorithms and for determining the underlying vascular and non‐vascular physiopathological mechanisms that can explain these differences.
Optimal indications for an intercostal port for the superior segments in laparoscopic partial liver resection
Authors: Araki Kenichiro , Harimoto Norifumi , Ishii Norihiro , Tsukagoshi Mariko , Igarashi Takamichi , Watanabe Akira , Kubo Norio , Shirabe Ken 
Published: August 2019

AbstractIntroductionIntercostal port is useful for the superior segments in laparoscopic liver resection, but optimal indications for its use remain unclear. This study analyzed the surgical outcomes in patients undergoing laparoscopic partial liver resection for superior segments to determine the optimal indications.MethodsA total of 30 cases of laparoscopic partial liver resection for superior segments were retrospectively reviewed. First, comparison of cases according to use of the intercostal port was performed. Second, cases were classified into two groups according to the branch of the hepatic vein in the superior segments: superior‐ventral group (S4a/S8vent: Svent group, n = 18) and superior‐dorsal group (S7/S8dor: Sdor group: n = 12). The surgical outcomes were then compared to assess the performance of intercostal ports.ResultsNo differences in surgical outcomes were observed between patients with or without intercostal port. In this series, no complication due to the intercostal port, and no major complication were observed. In the comparison between Svent and Sdor, similar values of the operation time (Svent: 275 minutes vs Sdor: 316 minutes, P = .161) and blood loss (Svent: 30 mL vs Sdor: 17 mL, P = .718) were observed in both groups. The tumor size tended to be smaller in Sdor (Svent: 20 mm vs Sdor: 17 mm, P = .018), but use of the intercostal port was significantly more frequent in Sdor (58%) compared to Svent (33%) (P < .001).ConclusionThe lesion located at Sdor or that close to this location was considered as optimal indication for placement of intercostal port in patients undergoing laparoscopic partial liver resection.
A phase II study of addition of pracinostat to a hypomethylating agent in patients with myelodysplastic syndromes who have not responded to previous hypomethylating agent therapy
Authors: Yalniz Fevzi F. , Berdeja Jesus G. , Maris Michael B. , Lyons Roger M. , Reeves James A. , Essell James H. , Patel Prapti , Sekeres Mikkael , Hughes Amanda , Mappa Silvia , Garcia‐Manero Guillermo 
Published: August 2019

SummaryHypomethylating agents (HMAs) are standard of care for higher‐risk myelodysplastic syndromes (MDS). However, less than half of patients achieve objective responses and most eventually lose their response. Pracinostat is a pan‐histone deacetylase inhibitor with demonstrated activity in advanced myeloid malignancies. This phase II study explored the benefit of adding pracinostat to HMAs in MDS patients who did not respond to single‐agent HMA treatment. The goal was to estimate the clinical improvement rate [complete remission (CR), marrow CR, partial response (PR) and haematological improvement]. Group 1 included patients with primary/secondary HMA failures; Group 2 included those who did not achieve response but had stable disease (SD) after single‐agent HMAs. Forty‐five patients (39 Group 1, 6 Group 2) received a median of 3 cycles. Among all patients, 1 (2%) had CR, 7 (16%) had marrow CR and 18 (40%) had SD; disease progression occurred in 3 (7%). Median overall survival was 5·7/5·6 months for Group 1/2. Grade ≥3 adverse events occurred in 38 patients (84%) leading to treatment discontinuation in 12 (33%). Adding pracinostat to HMAs did not improve outcomes in patients previously treated with HMAs. Frequent dose modifications/early discontinuation resulted in suboptimal drug exposure. A reduced pracinostat dose may improve tolerability and efficacy.
Food protein‐induced enterocolitis syndrome
Authors: Caubet Jean‐Christoph , Cianferoni Antonella , Groetch Marion , Nowak‐Wegrzyn Anna 
Published: August 2019

AbstractFood protein‐induced enterocolitis syndrome (FPIES) is a non‐IgE‐mediated gastrointestinal food allergic disorder that has gained a major interest the past decade. FPIES prevalence, which still needs to be accurately determine in different populations, appears to be higher than previously thought (ie up to 0.7% in infants in the 1st year of life). FPIES to seafood in adults is also increasingly reported; limited data suggest that adult FPIES is most commonly triggered by shellfish, tends to affect females more than men, is characterized by a significant delay in diagnosis and a prolonged course. The first international consensus guidelines on diagnosis and management of FPIES have been published in 2017, proposing new diagnostic criteria as well as new criteria for a positive oral food challenge. However, there is a need to develop new biomarkers to improve the diagnosis and management of FPIES patients, and this requires a better understanding of the pathophysiology. Recently, the role of T cells has been questioned and a major role of innate immune cells has been suggested in acute FPIES. Regarding the treatment of acute FPIES reaction, ondansetron has emerged as an adjunct to intravenous rehydration in moderate‐severe reactions and as a first‐line treatment in mild reactions. Important information regarding the nutritional management of FPIES patients that might be complex has also been provided in the international guidelines. In this review, we discuss recent advances regarding all those different aspects.
Oral administration of recombinant Bacillus subtilis spores expressing Helicobacter pylori neutrophil‐activating protein suppresses peanut allergy via up‐regulation of Tregs
Authors: Mai Jialiang , Liang Bingshao , Xiong Zhile , Ai Xiaolan , Gao Fei , Long Yan , Yao Shuwen , Liu Yunfeng , Gong Sitang , Zhou Zhenwen 
Published: August 2019

AbstractBackgroundHelicobacter pylori neutrophil‐activating protein (NAP) is an immune modulator with anti‐Th2 inflammation activity that can be used to prevent IgE‐mediated allergic reactions. Cholera toxin B (CTB) is a mucosal adjuvant that can induce antigen tolerance. Bacillus subtilis spores are an ideal vehicle for the oral delivery of heterologous antigens.ObjectiveWe investigated the therapeutic effect of recombinant NAP B subtilis spores on peanut allergies in a mouse model.MethodsFemale C3H/HeJ mice were sensitized and challenged with peanut extract by oral administration. Before challenge, recombinant NAP and CTB‐NAP (CNAP) spores were orally administered to sensitized mice for 4 weeks. Faecal peanut‐specific IgA and serum‐specific IgE, IgG1, and IgG2a levels were measured, and the intestinal microbiota was analysed. Mice were intraperitoneally injected with anti‐CD25 antibodies for regulatory T cell (Treg) depletion to evaluate the efficacy of Tregs in preventing peanut allergy. After challenge, anaphylactic reactions, plasma histamine, Tregs, and splenocyte interleukin (IL)‐10, IL‐4, IL‐5 and interferon‐γ (IFN‐γ) levels were evaluated.ResultsAfter 4 weeks of recombinant spore treatment, faecal IgA levels and serum IgG2a levels were increased, while serum IgG1 and IgE levels were reduced. Intestinal microbiota analysis revealed that CNAP spores increased the taxonomic abundance of Firmicutes at the phylum level and Clostridia at the class level. After challenge, the administration of NAP or CNAP spores to mice was found to ameliorate anaphylactic reactions and decrease plasma histamine levels. Administration of NAP or CNAP spores also enhanced IL‐10 and IFN‐γ secretion, and suppressed IL‐4 and IL‐5 secretion. The protective effect of CNAP spores was more pronounced than that of NAP spores; this therapeutic effect was lost after Treg depletion.Conclusions and Clinical RelevanceRecombinant NAP spores successfully suppressed Th2 inflammation via the up‐regulation of Tregs; this may serve as a novel therapeutic approach for treating food allergies.
Functional parameter measurements in children with ataxia telangiectasia
Authors: Shenhod Efrat , Benzeev Bruria , Sarouk Ifat , Heimer Gali , Nissenkorn Andreea 
Published: August 2019

AimTo collect preliminary functional data on ataxia telangiectasia and create a disease specific scale: the Ataxia Telangiectasia Functional Scale (ATFS).MethodRetrospective information on patients with ataxia telangiectasia referred to the Assistive Technology Unit was included. Functional mobility scales (the Gross Motor Function Classification System [GMFCS] and the Functional Mobility Scale [FMS]‐5, FMS‐50, FMS‐500) and activities of daily living [ADL] parameters were recorded. We created a 51‐point ATFS, that consisted of three ambulation items adapted for ataxia telangiectasia in the frame of FMS (home, school, outdoors), five ADL items, and one schooling item.ResultsTwenty‐seven participants (17 males, 10 females; mean age 10y 8mo [SD 5y 1mo], range 1y 9mo–25y 6mo), were enrolled; 168 measurements were recorded. Patients walked at a mean age of 1 year 4 months (SD 5y 4mo) and lost ambulatory capacity at 8 years 8 months (SD 2y 1mo). GMFCS level and FMS‐5, FMS‐50, FMS‐500 assessments correlated with age (Spearman's correlations r=0.555, −0.617, −0.639, −0.662 respectively, p<0.01 for all), but plateaued after 12 years of age. ATFS mean score was 37.46 (SD 7.88) and increased with age (Spearman's correlation r=0.585, p<0.01). The scale showed three stages of disease progression.InterpretationIn this pilot study we show longitudinal functional data of ambulation and ADL skills in ataxia telangiectasia, and created a framework for a functional scale. This functional scale closely approximated disease course, but further validation is required.What this paper adds

The Gross Motor Function Classification System and the Functional Mobility Scale are ill‐suited for ataxia telangiectasia assessments.

Three functional mobility scales (home, school, outdoors) suited to ataxia telangiectasia were created.

The Ataxia Telangiectasia Functional Scale (ATFS) combines mobility and items of activities of daily living.

The ATFS closely approximates the three‐stage progression of the disorder.
Rituximab in children with myelin oligodendrocyte glycoprotein antibody and relapsing neuroinflammatory disease
Authors: Albassam Fahad , Longoni Giulia , Yea Carmen , Wilbur Colin , Grover Stephanie A , Yeh E Ann 
Published: August 2019

The aim of this study was to evaluate tolerability of and response to rituximab in children with myelin oligodendrocyte glycoprotein (MOG) antibody‐positive relapsing neuroinflammatory disease. This was an observational study of prospectively collected data on 12 consecutive children (eight females, four males; median age at onset 10y 6mo [interquartile range {IQR} 7y 2mo–12y 5mo], median follow‐up 2y 1mo [IQR 1y 7mo–2y 6mo]) with central nervous system inflammation and persistent serum MOG immunoglobulin G positivity more than 12 weeks after clinical presentation. Patients received a standardized rituximab treatment protocol. MOG antibody testing was performed following standardized cell‐based methods. Median clinical follow‐up after rituximab induction was 2 years (IQR 1y 7mo–2y 10mo). The relapse rate in the first 12 months posttreatment was 0 (IQR 0–0). After rituximab, two patients relapsed during B‐cell suppression and four showed clinical or radiological disease recurrences at B‐cell reconstitution. Mild‐to‐moderate infusion related adverse events occurred in two patients. Leukopenia developed in seven patients and serum immunoglobulin suppression in five patients with no significant age effect on the risk of their development. None developed severe life‐threatening events. Rituximab‐induced B‐cell suppression was associated with absence of relapses in 10 patients who were MOG‐positive with recurrent disease. Rituximab was well tolerated. The most frequent adverse effects were hypogammaglobulinemia and leukopenia. We recommend monitoring of complete blood counts and immunoglobulins in this population.What this paper adds

Rituximab appears to control disease in most anti‐myelin oligodendrocyte glycoprotein‐positive patients with relapsing neuroinflammatory disease.

Rituximab was associated with transitory, mild‐to‐moderate infusion‐related effects.

Half of patients treated with rituximab developed leukopenia or hypogammaglobulinemia.

No opportunistic infections were observed.
Health care service for families with children at early risk of developmental delay: an All Our Families cohort study
Authors: Russell Matthew J , Premji Shainur , Mcdonald Sheila , Zwicker Jennifer D , Tough Suzanne 
Published: August 2019

AimThis study examined children’s health care service use, mothers’ workforce participation, and mothers’ community engagement based on children’s risk of developmental delay.MethodWe used data from the All Our Families study, a prospective pregnancy cohort. Ages and Stages Questionnaire (ASQ) scores at year 2 indicated risk of developmental delay. To investigate the impact of risk of developmental delay when children were not diagnosed, a sensitivity analysis excluded reports of neurodevelopmental disorder (NDD) diagnosis at year 3. Outcomes were maternal reports of children’s health and allied health visits (and estimated costs), and maternal workforce participation and community engagement from year 2 to 3.ResultsAmong 1314 mother–child dyads, 209 (16%) children were classified as being at risk of developmental delay by the ASQ, and 42 (3%) had a reported diagnosis of NDD. Risk of developmental delay was related to increased use of allied health care services (incidence risk ratio 5.04 [year 3]; 95% confidence interval 2.49–10.2) and health visits (incidence risk ratio 1.33 [year 3]; 95% confidence interval 1.14–1.54). The average expected allied health costs were greater for children at risk versus not at risk of developmental delay. However, when excluding children with reported diagnoses of an NDD from this analysis, increased service use and costs in the remaining at‐risk population were not observed. Community engagement and workplace participation among families did not differ on the basis of risk of developmental delay.InterpretationThese results suggest increased health care service use by families of children at risk of developmental delay is driven by those receiving a diagnosis of an NDD in the subsequent year.What this paper adds

Early developmental delay risk was related to health care service use and costs.

Diagnosis of neurodevelopmental disorder drove increased health care service use and costs.

Early developmental delay risk did not relate to parental workforce participation.

Early developmental delay risk did not relate to community engagement participation.
Factors associated with glycaemic control in adults with Type 1 diabetes: a registry‐based analysis including 7601 individuals from 34 centres in Norway
Authors: Cooper J. G. , Bakke Å. , Dalen I. , Carlsen S. , Skeie S. , Løvaas K. F. , Sandberg S. , Thue G. 
Published: August 2019

AbstractAimsTo use data from the Norwegian Diabetes Registry for Adults and Statistics Norway to assess factors associated with glycaemic control in type 1 diabetes.MethodsThe analyses included all individuals aged ≥18 years who had a type 1 diabetes duration of >2 years and a recorded value in the registry between 2013 and 2015 (n=7601). Predicted mean HbA1c levels for subgroups of participants were assessed using linear regression analysis.ResultsYoung age (18–25 years), low education levels, smoking, living alone, exercising infrequently, monitoring glucose infrequently, high insulin requirements, low frequency of symptomatic hypoglycaemia, history of ketoacidosis and a BMI <18.5 kg/m2 were associated with a 2–12‐mmol/mol (0.2–1.1%) higher HbA1c level. Those with 10–15 years of diabetes duration had 5‐mmol/mol (0.5%) higher HbA1c level than those who had a diabetes duration of 2–5 years. Sex, participation (ever) in a diabetes education course, or ever experiencing serious hypoglycaemia were not associated with glycaemic control.ConclusionsWe present representative national data on factors that were associated with glycaemic control. A better understanding and awareness of these factors, together with technological advances in diabetes management, could lead to more personalized management strategies, better glycaemic control and a lower risk of diabetes complications.