bluuebunny/crossref_metadata_2025_split huggingface dataset:
P039 CLINICAL HYPNOSIS IN PEDIATRIC CROHN’S DISEASE: A RANDOMIZED CONTROLLED TRIAL
Authors: Lee Amanda , Moulton Dedrick , Acra Sari , Walker Lynn , Mckernan Lindsey , Russell Alexa 
Published: January 2020

Abstract

Background
Crohn’s disease (CD) is a chronic, immune-mediated condition associated with abdominal pain, psychological comorbidities, and reduced quality of life (QoL), even in remission. Clinical hypnosis, involving focused relaxation and therapeutic suggestion, is helpful for irritable bowel syndrome, pain, and anxiety, and may have anti-inflammatory effects. Study Aims: To implement hypnosis as an adjunctive therapy for adolescents with CD. To assess the impact on QoL, abdominal pain, psychosocial measures, and disease activity compared to standard care.

Methods
Forty 12–18 year-olds with CD diagnosed &gt;3 months prior randomized to hypnosis intervention (HI) or waitlist control (WC). HI receive one in-person hypnosis session focused on enhancing comfort, calm, and energy; education on self-hypnosis; audio recordings for 8 weeks home practice. Assessments at 8 and 16 weeks. Primary outcome: disease-specific health-related (HR) QoL Impact III, single-item QoL modified Cantril Scale, parent-proxy HRQoL PedsQL 4.0. Secondary outcomes: Anxiety, Depressive Symptoms, Sleep Disturbance (PROMIS pediatric short forms); abdominal pain frequency and intensity; Pain Beliefs Questionnaire short form (PBQ-SF); school absences; healthcare utilization; Physician’s Global Assessment (PGA); Pediatric Crohn’s Disease Activity Index. With n=40, 80% power to detect 13-point difference in Impact III. Two-sided Wilcoxon test used to compare differences from baseline to follow up and between groups.

Results
Demographics: 40 participants enrolled February-May 2019. 50% female. 15.8 y ± 2. PGA: 28 quiescent, 6 mild, 3 moderate, 3 not documented. 18, 8, and 13 of 40 with moderate-severe depressive symptoms, anxiety, and sleep disturbance, respectively. 25 of 40 with abdominal pain in the past week. WC with poorer systemic symptom-related QoL by Impact III (p=0.01) and greater depressive symptoms (p=0.03) compared to HI. Post-Intervention (8 Weeks): In HI and not in WC, significant improvement was noted in parent-reported QoL (p=0.006; Figure 1), maximum abdominal pain intensity (p=0.01, Figure 2), PBQ-SF subdomain emotion-focused coping efficacy (p=0.04), and school absences (p=0.03). 50% of HI participants used self-hypnosis at least 3–4 times per week and tended to have greater QoL improvement than those who practiced less. Participants described improvement in stress, anxiety, and sleep, though corresponding measures were unchanged. 16-week outcomes and disease activity pending.

Conclusions
Adolescents with CD have pain, reduced QoL, and psychological impairment despite inactive disease. Hypnosis is an acceptable, feasible, and promising complementary therapy in CD and may improve QoL, abdominal pain, coping efficacy, and school attendance. Additional RCTs with longer follow up, objective disease activity assessment, and measures to improve compliance are warranted.
P051 USING A HUMAN-CENTERED QUALITATIVE RESEARCH APPROACH FOR DEVELOPING IBD EDUCATIONAL VIDEOS DELIVERED THROUGH SOCIAL MEDIA
Authors: Khalil Carine , van Deen Welmoed , Dupuy Taylor , Bonthala Nirupama , Almario Christopher , Spiegel Brennan 
Published: January 2020

Abstract

Background
Patients with inflammatory bowel disease (IBD) can have knowledge gaps regarding their disease and its management, which may lead to anxiety and reduced quality of life. They often use social media as a tool to seek information and manage their chronic disease. The goal of this study was to develop a series of educational videos optimized for social media that are informed by patient insights and address their experiences, concerns, and unmet educational needs.

Methods
We used a human-centered design approach to guide our qualitative data collection and analysis. We performed two focus groups and 6 semi-structured interviews with patients with IBD to gain insights into their educational needs and expectations regarding these videos. In total, 19 patients with diverse demographic profiles and varying health and digital literacy levels were included in our purposive sample. The collected data was transcribed and analyzed using a thematic analysis. We visualized patients’ thoughts, feelings, and needs in an empathy map. The mapping process helped us create a shared understanding of patient-users, and generate ideas on the topic and the script of each video. Subsequently, 5 video prototypes were built and tested by 22 patients with IBD. The collected feedback was used to refine the prototypes and develop the final videos.

Results
We noted conflicting thoughts and feelings towards online information; on one hand, IBD-related online information was perceived as overwhelming and unreliable, but on the other it was empowering and helpful. Five major themes for the video topics also emerged from the analyses (Figure 1). First, patients noted a major need to learn about the risks and benefits associated with available treatment options. Participants expressed concerns regarding starting biologics, biologics side-effects and long-term effectiveness. Second, they accentuated the need to know how to be self-advocates in order to navigate their insurance and to obtain the information they need from their providers. Third, they mentioned the importance of learning ways to stay healthy beyond just medical therapy. Fourth, they wanted information on how to cope with their IBD diagnosis and live with their condition. Fifth, participants expressed desire for a video that educates their families, friends and colleagues about IBD, so that they can better understand IBD patients’ psychological and physical experiences.

Conclusion
We used a human centered qualitative approach to get an in-depth understanding of IBD patients’ educational needs, thoughts and feelings. A series of focus groups and interviews were performed with patients, which informed the development of 5 educational videos that are tailored to suit their needs. In the next phases of this study, the videos will be formally tested and widely disseminated through social media.
P086 EFFECTIVENESS OF VEDOLIZUMAB IN PATIENTS WITH REFRACTORY IMMUNOTHERAPY-RELATED COLITIS: A CASE SERIES
Authors: Harris Jessica , Faleck David 
Published: January 2020

Abstract

Intro
Immune checkpoint inhibitors (ICIs) have become a new standard of care in several cancers but often lead to undesirable immune-related adverse effects, including GI toxicity in up to 1/3 of patients. ICI-related colitis (irColitis) is generally treated with immunosuppressive medications such as steroids, but may be refractory in up to 50% of cases and require further treatments such as infliximab. The role of vedolizumab (VDZ), a newer gut-selective agent approved for inflammatory bowel disease (IBD), remains unclear.

Methods
We describe a retrospective study of all patients treated with VDZ for irColitis at a tertiary care cancer center in New York City between 2018–2019. Clinical response was defined as initial improvement in diarrhea to CTCAE Grade ≤1. Sustained remission was defined as resolution of diarrhea with no further flares within 30 days.

Results
Eleven patients were treated with VDZ during this time period. Patients were followed for a median of 11.6 months from the time of ICI initiation. Two patients with pre-existing IBD (ulcerative colitis n=1, lymphocytic colitis n=1) with prior severe irColitis were started on VDZ as a steroid-sparing agent (n=1) and prophylaxis during ICI re-challenge (n=1). Both patients’ colitis remained in remission without further flares.
Nine patients were treated with VDZ for steroid-refractory irColitis, seven (78%) of whom had already failed at least one TNF inhibitor. VDZ was started a median of 76 (IQR 72–124) days after onset of colitis and patients were treated with a median of 2 (IQR 2–5) doses. The median time to initial clinical response after starting VDZ was 7 (IQR 5–14) days. Six (67%) achieved sustained remission with VDZ after a median of 15 (IQR 5–43) days. Two (22%) of patients were refractory to both infliximab and VDZ therapy and required further salvage with fecal microbiota transplantation and/or surgery. Median total steroid duration was 80 (IQR 52–108) days, and median duration from onset until final resolution of colitis was 126 (IQR 51–133) days.

Conclusion
In this series of patients with refractory irColitis, VDZ treatment led to successful resolution of colitis in the majority of patients, with sustained remission achieved generally after 1–2 doses. Prospective studies are needed to further elucidate the role of VDZ in the treatment of irColitis.
Patient Demographics
Immune-Related Colitis Treatment
P087 REAL-WORLD EFFECTIVENESS OF USTEKINUMAB IN ULCERATIVE COLITIS
Authors: Hong Simon , Zullow Samantha , Axelrad Jordan , Chang Shannon , Hudesman David 
Published: January 2020

Abstract

Introduction
Ulcerative colitis (UC) is a chronic inflammatory condition of the colon. Ustekinumab is a monoclonal antibody to the p40 subunit of interleukin-12 and interleukin-23 FDA approved for use in Crohn’s disease. A recent randomized control trial UNIFI [Sands et al, NEJM 2019] demonstrated the efficacy of ustekinumab in patients with moderate-to-severe UC. The goal of this study was to describe the real-world effectiveness of ustekinumab in patients with UC.

Methods
A retrospective, single-center, chart review was performed of all patients with UC who received ustekinumab between January 2017 and October 2019. As ustekinumab is not yet FDA approved for UC, for patients who have exhausted other treatment options its use is considered “off-label”. Patient demographics, disease characteristics and prior treatment history were recorded. The primary outcome was clinical remission at 12 months after initiation of ustekinumab. Secondary outcomes were clinical response and remission at 3 months, and endoscopic response, corticosteroid-free remission, and deep remission (combined clinical and endoscopic remission) at 12 months (all outcomes defined in Figure 1).

Results
19 pts received ustekinumab for moderate-to-severe UC. They were 47.4% male with a mean age of 42.7 ±17.0 years. Mean total Mayo score was 7.6 ± 1.5 and 47.4% of pts had disease limited to the left colon. 18/19 pts received a weight-based IV induction dose (520 mg, 390 mg or 260 mg for &gt; 85 kg, &gt;55 to 85 kg or ≤55 kg respectively) and 1/19 received 90mg subcutaneous injection as induction. All pts received 90mg subcutaneous injections every 8 weeks initially for maintenance, and 9/19 eventually needed dose escalation to every 4 weeks. All pts had prior exposure to a TNF antagonist, 26.3% had exposure to two or more TNF antagonists, 89.5% had prior failure of vedolizumab and 10.5% had prior failure of tofacitinib (Table 1). At 12 months, 38.5% had a clinical response, 30.8% were in clinical remission, 38.5% had an endoscopic response, and 30.8% were in deep remission (Figure 1). Two infectious adverse events (shigellosis, Escherichia coli enterocolitis) were reported in follow-up.

Conclusions
Ustekinumab is effective in patients with UC. The efficacy of ustekinumab in the UNIFI trial translated to our real-world population, despite higher rates of prior biologic failure with TNF antagonists and vedolizumab in our cohort. Further studies of large, real-world cohorts are needed to assess the long-term effectiveness and safety of ustekinumab in UC.
P090 SAFETY AND EFFICACY OF COMBINING BIOLOGICALS IN CHILDREN WITH INFLAMMATORY BOWEL DISEASE
Authors: Goyal Alka , Bass Julie 
Published: January 2020

Abstract

Background and Aims
Inflammatory bowel disease (IBD) is a chronic inflammatory condition requiring treatment with lifelong immunosuppressive treatment. Up to 30% of the patients do not respond to standard medical therapy. There is limited data on the use of combining two biological agents in medically refractory patients. Our aims were to review patients who received two biological agents concurrently for at least 4 weeks or longer to assess for safety and efficacy of this approach.

Methods
We performed a retrospective study on patients (1–22 years old) being treated at Children’s Mercy Kansas City for IBD who were placed on a combination of two biological agents concurrently for medically refractory disease. Charts of eligible patients were reviewed to abstract demographics, Paris classification, extraintestinal manifestations, concomitant morbidities, drug therapy, surgeries, disease activity scores, outcomes and adverse events related to therapy.

Results
Nine patients with a median age of 16 (8–19 years) were found to be eligible. Eight were Caucasians and one was of African American origin. Eight patients were diagnosed with Crohn’s disease (CD), and one was thought to have ulcerative colitis (UC) but later found to have CD. Two had celiac disease, 2/9 had growth failure, one each had arthritis and sacroiliitis. Two had ileo-anal pouch and one patient had recurrent macrophage activating syndrome. Indications included partially responsive luminal disease(7), pouchitis (2), perianal fistulizing disease (2), sacroiliitis (1). Five patients were also on an immunomodulator at the time of combination therapy. Only one patient received Anakinra with infliximab whereas rest were on combination of either infliximab or adalimumab with vedolizumab. Four patients achieved remission, two were unresponsive, one had improvement in growth only and two had partial response. One patient developed staphylococcal skin infection but there was no other therapy related adverse events.

Conclusions
Combination of two biological agents is safe. Further studies are needed to determine the utility of this approach.
Antipsychotic Treatment Effectiveness in First Episode of Psychosis: PAFIP 3-Year Follow-Up Randomized Clinical Trials Comparing Haloperidol, Olanzapine, Risperidone, Aripiprazole, Quetiapine, and Ziprasidone
Authors: Gómez-Revuelta Marcos , Pelayo-Terán José María , Juncal-Ruiz María , Vázquez-Bourgon Javier , Suárez-Pinilla Paula , Romero-Jiménez Rodrigo , Setién Suero Esther , Ayesa-Arriola Rosa , Crespo-Facorro Benedicto 
Published: January 2020

Abstract

Background
Different effectiveness profiles among antipsychotics may be a key point to optimize treatment in patients suffering a first episode of psychosis to impact on long-term outcome. The aim of this study is to compare the clinical effectiveness of olanzapine, risperidone, haloperidol, aripiprazole, ziprasidone, and quetiapine in the treatment of first episode of psychosis at 3-year follow-up.

Method
From February 2001 to January 2011, 2 phases of a prospective, randomized, open-label study were undertaken. A total of 376 first-episode drug-naïve patients were randomly assigned to olanzapine (n = 55), risperidone (n = 63), haloperidol (n = 56), aripiprazole (n = 78), ziprasidone (n = 62), or quetiapine (n = 62) and followed up for 3 years. The primary effectiveness measure was all cause of treatment discontinuation. In addition, an analysis based on intention-to-treat principle was conducted in the analysis for clinical efficacy.

Results
The overall dropout rate at 3 years reached 20.75%. Treatment discontinuation rates were significantly different among treatment groups (olanzapine = 69.09, risperidone = 71.43, aripiprazole = 73.08%, ziprasidone = 79.03%, haloperidol = 89.28%, and quetiapine = 95.53%) (χ2 = 79.86; P = .000). Statistically significant differences in terms of lack of efficacy, adherence, and tolerability were observed among treatment groups along the 3-year follow-up, determining significant differences in time to all-cause discontinuation (log-rank = 92.240; P = .000). Significant differences between treatments were found in the categories of sleepiness/sedation, increased sleep duration, akinesia, weight gain, ejaculatory dysfunction, extrapyramidal-symptoms, and amenorrhea.

Conclusions
Olanzapine, risperidone, and aripiprazole presented advantages for the first-line treatment of first episode of psychosis in terms of effectiveness. Identifying different discontinuation patterns may contribute to optimize treatment selection after first episode of psychosis.
ClinicalTrials.gov Identifier: NCT02526030 https://clinicaltrials.gov/show/NCT02526030
Tigecycline efflux in Acinetobacter baumannii is mediated by TetA in synergy with RND-type efflux transporters
Authors: Foong Wuen Ee , Wilhelm Jochen , Tam Heng-Keat , Pos Klaas M 
Published: January 2020

Abstract

Objectives
To investigate the role of Major Facilitator Superfamily (MFS)-type transporters from Acinetobacter baumannii AYE in tigecycline efflux.

Methods
Two putative tetracycline transporter genes of A. baumannii AYE (tetA and tetG) were heterologously expressed in Escherichia coli and drug susceptibility assays were conducted with tigecycline and three other tetracycline derivatives. The importance of TetA in tigecycline transport in A. baumannii was determined by complementation of tetA in WT and Resistance Nodulation cell Division (RND) gene knockout strains of A. baumannii ATCC 19606. Gene expression of the MFS-type tetA gene and RND efflux pump genes adeB, adeG and adeJ in A. baumannii AYE in the presence of tigecycline was analysed by quantitative real-time RT–PCR.

Results
Overproduction of TetA or TetG conferred resistance to doxycycline, minocycline and tetracycline in E. coli. Cells expressing tetA, but not those expressing tetG, conferred resistance to tigecycline, implying that TetA is a determinant for tigecycline transport. A. baumannii WT and RND-knockout strains complemented with plasmid-encoded tetA are significantly less susceptible to tigecycline compared with non-complemented strains. Efflux pump genes tetA and adeG are up-regulated in A. baumannii AYE in the presence of subinhibitory tigecycline concentrations.

Conclusions
TetA plays an important role in tigecycline efflux of A. baumannii by removing the drug from cytoplasm to periplasm and, subsequently, the RND-type transporters AdeABC and AdeIJK extrude tigecycline across the outer membrane. When challenged with tigecycline, tetA is up-regulated in A. baumannii AYE. Synergy between TetA and the RND-type transporters AdeABC and/or AdeIJK appears necessary for A. baumannii to confer higher tigecycline resistance via drug efflux.
Pharmacokinetic Study of Multiple Components of Gelsemium elegans in Goats by Ultra-Performance Liquid Chromatography Coupled to Tandem Mass Spectrometry
Authors: Cao Jun-Jie , Yang Kun , Huang Chong-Yin , Li Yu-Juan , Yu Hui , Wu Yong , Sun Zhi-Liang , Liu Zhao-Ying 
Published: January 2020

Abstract
Gelsemium elegans (G. elegans) has been used in traditional Chinese medicine. This plant is highly toxic to humans, but can promote the growth of pigs and goats in the veterinary clinic. It is a very complex mixture containing tens or hundreds of different components. Therefore, multiple-component pharmacokinetic studies of G. elegans are a major challenge due to the lack of authentic standards of the components. The purpose of this study was to investigate the plasma pharmacokinetics of multiple components after a single oral dose of G. elegans in goat using a sensitive ultra-performance liquid chromatography coupled to tandem mass spectrometry method for the simultaneous semiquantification of multiple alkaloids without standards. The method was validated in terms of the specificity, LOD, LOQ, linearity, accuracy, precision and matrix effects. To validate the global pharmacokinetic characteristics, the results obtained from the semiquantitative analysis of three authentic compounds (gelsemine, koumine and humantenmine) were compared with the absolute quantification from our recently published method. The results showed that the two methods had similar analytical results, and the obtained values of Tmax, T1/2 and MRT0−t of the three alkaloids were similar between the two methods. In addition, the values of Cmax and AUC0−t of the three alkaloids after normalization were close to the real values, which indicated that this semiquantitative method could be used in the pharmacokinetic study of multiplecomponents. Then the pharmacokinetic parameters of 23 other G. elegans alkaloids in goats were obtained. The results suggested that the gelsedine-type alkaloids were the major active ingredients that predict and explain the efficacy and toxicity of G. elegans.
Litter size and cub age influence weight gain and development in American black bears (Ursus americanus)
Authors: Mesa-Cruz J Bernardo , Olfenbuttel Colleen , Vaughan Michael R , Sajecki Jaime L , Kelly Marcella J 
Published: January 2020

AbstractWe assessed the effects of cub age, litter size, and sex, on body mass (BM), absolute and relative growth rates (AGR, RGR), opening of ears and eyes, and deciduous teeth eruption from 129 cubs of American black bears (Ursus americanus) born at Virginia Tech’s Black Bear Research Center. Specific ages, related to maternal food consumption, and litter size, best described BM, AGR, RGR, and ear and eye development. Overall, newborns weighed ~0.44 kg at birth and increased ~9-fold by ~14 weeks. Twins were greater in BM than single cubs and triplets. Single and triplet cubs had higher AGR and RGR than twins after mothers resumed food consumption post-hibernation. Newborns displayed RGR &gt; 3.5% that decreased until den emergence (RGR &lt; 3.5% after emergence). RGR differed among litter sizes, particularly after den emergence. Ear and eye opening occurred concurrently at ~44 days of age, while teeth erupted ~10 days later. Single cubs experienced delayed development of these organs compared to other litter sizes. Postnatal developmental differences between black bears and other carnivores likely stem from strategies allowing black bears to minimize energy expenditure during the gestational period when hibernating.
Hoshi: A Japanese morphological adorner for TEI XML
Authors: Bonnell Jerry , Ogihara Mitsunori 
Published: January 2020

Abstract
Morphological adornment of text in Text Encoding Initiative (TEI) XML can be useful for studies in textual analysis. MorphAdorner is a principal tool for providing such functionality in English texts. However, its practical use is limited when the input XML contains branching text, e.g. when &lt;choice&gt; appears, as it modifies the input document. In such cases, preprocessing is required to obtain the desired results. This article introduces a new tool Hoshi with the purpose of determining how this issue can be best handled with minimal input modification and preprocessing needed. It also investigates whether parsing software available online can be used to supply morphological information that can be encoded in an output format like MorphAdorner, and whether such a tool can be developed to adorn text in other languages. Challenges include those posed by the target language, the current software available for providing morphological analysis in it, and the schema needed for encoding the results. Moreover, technical hurdles presented by segmented and branching text can complicate the alignment process, especially when the intent is to guarantee input document integrity. Our approach for handling these is presented, and the article ends by outlining future applications of Hoshi that can help to enhance TEI scholarship that prioritizes the use of morphological word metadata.