Journal articles: '347.122:007 (043.2)'

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Undas, Anetta, Kathleen Brummel, Jacek Musial, Kenneth G. Mann, and Andrew Szczeklik. "Blood coagulation at the site of microvascular injury: effects of low-dose aspirin." Blood 98, no. 8 (October 15, 2001): 2423–31. http://dx.doi.org/10.1182/blood.v98.8.2423.

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Abstract The sequence of coagulant reactions in vivo following vascular injury is poorly characterized. Using quantitative immunoassays, the time courses were evaluated for activation of prothrombin, factor (F)V, FXIII, fibrinogen (Fbg) cleavage, and FVa inactivation in bleeding-time blood collected at 30-second intervals from 12 healthy subjects both before and after aspirin ingestion. Prothrombin decreased at a maximum rate of 14.2 ± 0.6 nM per second to 10% of initial values at the end of bleeding. Significant amounts of α-thrombin B chain appeared rapidly at 90 seconds of bleeding and increased at a maximum rate of 0.224 ± 0.03 nM per second to a peak value of 38 nM. Kinetics of prethrombin 2 generation was almost identical. Prothrombinase concentration reached a peak value of 22 pM at 150 seconds and then decreased to 9 pM at the end of bleeding. Prothrombin fragment 1.2 (F1.2) was produced explosively (0.673 ± 0.05 nM per second), whereas thrombin-antithrombin III (TAT) complexes were generated at a much slower rate (0.11 ± 0.008 nM per second;P = .002). FVa light chain was detectable 30 seconds later than the heavy chain (150 seconds) and was produced at a slightly slower rate (0.027 ± 0.001 nM per second) when compared with the heavy chain (0.032 ± 0.002 nM per second; P = .041). The 30 000 fragment (residues 307-506) of FVa heavy chain produced by activated protein C appeared as early as at 90 seconds and increased with time. Fbg was removed from the blood shed with a high rate of 0.047 ± 0.02 μM/s and became undetectable at approximately 180 seconds of bleeding. The velocity of FXIII activation correlated with thrombin B-chain formation. A 7-day aspirin administration (75 mg/d) resulted in significant reductions in maximum rates of (1) prothrombin removal (by 29%; P = .008); generation of α-thrombin B-chain (by 27.2%; P = .022), and prethrombin 2 (by 26%; P = .014); formation of F1.2 (by 31.4%;P = .009) and TAT (by 30.3%; P = 0.013); (2) release of FVa heavy chain (by 25%; P = .003) and FVa light chain (by 29.6%; P = .007); (3) Fbg depletion from solution (by 30.5%; P = .002); and (4) FXIII activation (by 28.6%; P = .003). Total amounts of the proteins studied, collected at every interval, also significantly decreased following aspirin ingestion. These results indicate that low-dose aspirin impairs thrombin generation and reactions catalyzed by this enzyme at the site of the injury.

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Rimer, Ernest G., Linda R. Peterson, Andrew R. Coggan, and James C. Martin. "Increase in Maximal Cycling Power With Acute Dietary Nitrate Supplementation." International Journal of Sports Physiology and Performance 11, no. 6 (September 2016): 715–20. http://dx.doi.org/10.1123/ijspp.2015-0533.

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Muscle-shortening velocity and hence power have been shown to increase in the presence of nitric oxide (NO). NO availability increases after consuming nitrate (NO3-). Ingestion of NO3-rich beetroot juice (BRJ) has increased muscle power in untrained adults.Purpose:This study determined whether NO3- supplementation could acutely enhance maximal power in trained athletes.Methods:In this double-blind, crossover study, 13 trained athletes performed maximal inertial-load cycling trials (3–4 s) immediately before (PRE) and after (POST) consuming either NO3-rich (NO3) or NO3-depleted (PLA) BRJ to assess acute changes (ie, within the same day) in maximal power (PMAX) and optimal pedaling rate (RPMopt). Participants also performed maximal isokinetic cycling (30 s) to assess performance differences after supplementation.Results:2 x 2 repeated-measures ANOVA indicated a greater increase in PMAX from PRE to POST NO3 (PRE 1160 ± 301 W to POST 1229 ± 317 W) than with PLA (PRE 1191 ± 298 W to POST 1213 ± 300 W) (P = .009; ηp2 = 0.45). A paired t-test verified a greater relative change in PMAX after NO3 (6.0% ± 2.6%) than with PLA (2.0% ± 3.8%) (P = .014; d = 1.21). RPMopt remained unchanged from PRE (123 ± 14 rpm) to POST PLA (122 ± 14 rpm) but increased from PRE (120 ± 14 rpm) to POST NO3 (127 ± 13 rpm) (P = .043; ηp2 = 0.30). There was no relative change in RPMopt after PLA (–0.3% ± 4.1%), but there was an increase after NO3 (6.5% ± 11.4%) (P = .049; d = 0.79). No differences were observed between the 30-s isokinetic trials.Conclusions:Acute NO3- supplementation can enhance maximal muscle power in trained athletes. These findings may particularly benefit power-sport athletes who perform brief explosive actions.

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Forconi, Francesco, Emanuele Cencini, Francesco Zaja, Tamara Intermesoli, Francesca Fiore, Benedetta Puccini, Caterina Stelitano, et al. "Analysis of Parameters Predicting Treatment Efficacy and Outcome In Patients with Hairy Cell Leukemia (HCL) Receiving Subcutaneous Cladribine In the ICGHCL2004 Protocol (by the Italian Cooperative Group on HCL)." Blood 116, no. 21 (November 19, 2010): 1369. http://dx.doi.org/10.1182/blood.v116.21.1369.1369.

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Abstract Abstract 1369 Introduction: Single-agent cladribine (2CdA) given intravenously or subcutaneously (sc) is highly effective in Hairy cell leukemia (HCL). However, HCL patients are projected to progress in their life-span or, in a minority, are refractory and may benefit from other treatment strategies. Parameters predicting efficacy of (sc)2CdA in HCL are scarcely known. Aims: In a national multicentre clinical trial (EudraCT code: ICGHCL2004) we prospectively sought parameters able to predict efficacy of sc2CdA in classic HCL requiring first treatment (1987 Consensus Criteria). Methods: Clinical data and samples were collected centrally for diagnostic revision according to the WHO criteria and for molecular analyses prior to treatment. Tumor IGH and TP53 analyses or Genome-wide DNA profiling was performed in the cases with >10% or >50% hairy cells (HC) in the test sample, respectively (Forconi, Blood 2009). Patients entering the study received 0.5–0.7 mg/kg sc2CdA as a single course. Efficacy endpoints were response to sc2CdA, treatment free interval (TFI), relapse free survival (RFS), and overall survival (OS). Responses were assessed on month 2 and 6 after treatment and defined according to the 1987 Consensus criteria. Complete Remissions (CR) and Partial Remissions (PR) were rated as beneficial responses (CR/PR), while minor Responses (mR) and No Responses (NR) were rated as failures (mR/NR). TFI was measured in all patients from sc2CdA initiation to time of new treatment requirement. RFS was measured in patients with CR/PR from sc2CdA initiation to relapse. OS was measured from sc2CdA initiation to death. Results: Of 148 patients, 116 were males (78,4%). Median values were: age 52 years (range 30–83), splenomegaly below costal margin 2 cm (0-16), hemoglobin 11,8 (5-17 g/dL), PLT 77×10e9/L (14-255), WBC 2,7×10e9/L (0,7-48), HC 0,2×10e9/L (0-38). Serum B2microglobulin was twice above upper limit (B2M>2X) in 9/122 patients (7,4%), IGH unmutated (UM) in 7/62 (11,3%) and TP53 mutated (mutTP53) in 2/62 (3,2%). Onehundred-forty patients (94,6%) had a CR/PR (101 CR, 68,2%; 39 PR, 26,4%) and 8 (5,4%) a mR/NR (5 mR, 3,4%; 3 NR, 2%). Risk factors of sc2CdA failure were splenomegaly (p=.001, best-cutoff> 3 cm bcm by ROC and Youden's Test), WBC (p<.001, best cut-off >10×10e9/L), HC counts (p<.001, best cut-off >5×10e9/L), and B2M>2X (p=.013). In 62 patients investigated for molecular features, UM-IGH and TP53 were confirmed as risk factors for mR/NR (p<.001 and p=.011). Conversely, age, performance status, 2CdA schedule, lymphadenopathy, neutrophil, haemoglobin and platelet counts, prior transfusions, time from diagnosis to treatment, Jansen score, LDH, marrow infiltration and hairy cell index failed to predict response. After a median follow-up of 37,5 months (range 12–67), 5 year TFI, RFS and OS were 67%, 71% and 94%, respectively. Causes of death were one infection in progressive refractory disease, 2 cardiac events and 3 second tumors. By Kaplan-Maier estimates, risk factors of shorter TFI at diagnosis were splenomegaly (p=.007), WBC>10×10e9/L (p<.001) or HC>5×10e9/L (p<.001), UM-IGH (p<.001), and TP53 disfunction (p=.002). By Cox multivariate analysis (covariates: HC>5×10e9/L, spleen>3cm, UM-IGH and mutTP53), UM-IGH (HR=8.1, 95%CI 1.7–38.1, p=.008, median TFI=8.5 months), high HC (HR=6.9, 95%CI 1.5–31.6, p=.012, TFI=27,4 months) and splenomegaly (HR=3.7, 95%CI 1.1–12.8, p=.039, TFI=49,3 months) scored as independent risk factors. Quality of response also predicted risk of short TFI (NR=mR>PR>CR, p<.001). In the patients with beneficial response, univariate analysis of clinical parameters identified WBC>5×10e9 (p=.016) and PR (p=.001)as risk factors of short RFS. Cox multivariate analysis revealed PR as the sole independent risk factor of relapse after a median of 46 months (HR=4.5, 95%CI 1,7-12,3, p=.003). 2CdA dose schedule was among other factors that did not associate with TFI or RFS. Conclusion: This data confirm that sc2CdA has potent activity in HCL. Tumor UM-IGH status, splenomegaly, high HC count (or leukocytosis) are confirmed as independent risk factors of treatment failure and rapid progression. RFS analysis identify PR as the sole independent factor of relapse risk in the patients initially responsive to sc2CdA. This analysis may have important implications for the selection of HCL patients that will require treatments alternative to single-agent 2CdA. Disclosures: No relevant conflicts of interest to declare.

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Hasrouni, Edy, Valeria Visconte, Ali Tabarroki, Heesun J. Rogers, Fabiola Traina, Anna Jankowska, Yang Liu, et al. "Pathway Analysis of Molecular Mutations Can Modify Morphologic, Cytogenetic and Prognostic Risk Stratification Schemes in Myelodysplastic Syndromes (MDS), Myelodysplastic Syndromes/Myeloproliferative Neoplasms (MDS/MPN), and Secondary Acute Myeloid Leukemia (AML)." Blood 120, no. 21 (November 16, 2012): 3791. http://dx.doi.org/10.1182/blood.v120.21.3791.3791.

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Abstract Abstract 3791 Molecular mutations of genes important in MDS pathogenesis have been identified using next generation sequencing technologies. These mutations have variable effects on prognosis: results from individual studies are conflicting, and the impact of combining mutations based on pathogenetic pathways has not been explored. Furthermore, most studies do not take into account the types of therapies received by patients (pts). We hypothesized that analyses of mutations incorporating pathways would yield more meaningful results, especially if studied in the context of therapies. We studied 340 pts with MDS (N=176), MDS/MPN (N=88) and sAML (N=76). Median age was 69 years (range, 19–92), 118 (35%) were female. Direct sequencing of 14 genes important in MDS pathogenesis originally identified using whole exome sequencing and involved in methylation (TET2/IDH1/2/DNMT3A), histone modification (ASXL1/EZH2/UTX), signaling (CBL/KRAS, NRAS, JAK2), transcription (RUNX1/TP53) and RNA splicing (SRSF2/U2AF1) was performed. Pts were classified by 2008 WHO criteria. Prognosis was assigned by IPSS (low=67, Int-1=85, Int-2=56, high=64). Karyotypes by metaphase cytogenetics (MC) and SNP-A were stratified by IPSS cytogenetic risk group (Low=82, intermediate=87, poor=106). Treatment received included high intensity (cytarabine+ anthracycline, high dose ARA-C,) (N=75), low intensity (N=124) (hypomethylating therapy, IMiDs, low dose ARA-C), and supportive therapy (N=141) (growth factors, hydroxyurea). Categorical variables were analyzed using X2 or Fischer-exact test. Overall survival (OS) and progression-free survival (PFS) were defined using IWG criteria and analyzed by Kaplan-Meier and log-rank statistics. P-values0.05 were considered statistically significant. Univariate and multivariate analyses were performed by Cox Proportional Hazards, covariates included were age, BM blasts, cytopenias, karyotype, jointly with molecular pathway data. A total of 258 mutations were detected in 158 pts. Mutations involving genes key to methylation (41 vs 37%, p=.01), and histone modification (52 vs 25%, p=.008) were more common in MDS/MPN compared to MDS pts. Mutations in methylation (37 vs 23%, p=.05), transcription (38 vs 14%, p=.01) and splicing (38 vs 17%, p=.007) were more common in MDS compared to sAML pts, and mutations of genes involved in methylation (41 vs 23%, p=.02), signaling (60 vs 7%, p=.005), histone modification (52 vs 23%, p=.004), transcription (49 vs 13%, p=.001) and splicing (45 vs 17%, p=.0005) were more frequent in MDS/MPN compared to sAML pts. Worse outcomes were noted in pts with mutations in histone modification (OS: 17 vs 21 mos, p=.04), transcription (PFS: 7 vs 13 mos, p=.02) and splicing (OS: 11 vs 23 mos, p=.01) genes. This was evident in pts with MDS who had transcription factor-related gene mutations (OS: 9 vs 30 mos, p=<.0001), splicing (PFS: 8 vs 21 mos, p=.008) and in MDS/MPN and MDS pts with histone pathway (27 vs 31 mos, p=.04) and splicing mutations (7 vs 21 mos, p=.0001). Of note, this was clearly mentioned in WHO lower-risk MDS pts with histone pathway (OS: 30 vs 39 mos, p=.01; PFS: 21 vs 32 mos, p=.05) and splicing mutations (PFS: 15 vs 28 mos, p=.003). Pts with good-risk karyotype defects had poor survival if they had histone mutations (OS: 17 vs 35 mos, p=.005; PFS: 11 vs 20 mos, p=.002) while those with intermediate-risk karyotype had worse outcomes if they had splicing mutations (OS: 10 vs 35 mos, p=.001; PFS: 7 vs 35 mos, p=.0001). The survival effects were retained even after accounting for presence of new SNP-A lesions. By IPSS, lower-risk pts had worse outcomes if they had mutations in methylation (OS: 36 vs 18 mos, p=.02), histone modification (28 vs 37 mos, p=0.02) or splicing (OS: 7 vs 17 mos, p=.04; PFS: 14 vs 28 mos, p=.04). Therapeutically, LIC treated pts had better OS if they had methylation mutations (23 vs 8 mos, p=.0009) but worse outcomes if they had transcription factor (7 vs 11 mos, p=.02) or splicing (8 vs 13 mos, p=.05) mutations. Mutations in transcription factors (OS: HR=2.9 CI: 1.58–5.13, p=.0007; PFS: HR=3.3 CI: 1.87–5.63, p=<.0001) and splicing (OS: HR=2.1, CI=1.22–3.76, p=.008; PFS: HR=2.1, CI=1.27–3.71, p=.005) remained independent predictors of poor outcomes in MDS by multivariate analysis. In conclusion, the presence of molecular pathway mutations can modify morphologic, cytogenetic and prognostic scoring schemes in MDS, MPN, AML and other hematological cancers. Disclosures: No relevant conflicts of interest to declare.

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Крюков, В. А. "Выявить, донести, реализовать. Институту исследования Сибири – 100 лет." Журнал «ЭКО» 49, no. 2 (January 31, 2019): 4. http://dx.doi.org/10.30680/eco0131-7652-2019-2-4-7.

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Экономическая наука, как и любая другая область познания окружающего мира, развивается от постижения отдельных фактов и явлений к формированию более общей и связной картины изучаемой действительности, а затем если и рассматривает частности, то уже на новом уровне осмысления. Это касается как науки в целом, так и отдельных ее предметов и областей, что прекрасно иллюстрирует этот номер журнала.Российская экономическая мысль на своем непростом пути познания все дальше отходит от эйфории по поводу рынка, рыночных сил и присущих им процедур координации экономических агентов и возвращается к пересмотру роли и места государства в экономических процессах. Именно с этим связано обсуждение на страницах настоящего номера таких проблем, как структурная политика и ее направленность, подходы и инструменты реализации промышленной политики, скрытые искажения экономической структуры и их последствия. Злободневность данных вопросов лишь усиливает значение отмеченного выше общенаучного подхода продвижения от частного к общему и затем движения в обратном направлении.Не менее важно, кто и как осуществляет этот, циклический по своей сути, процесс познания и воплощения выявленного и задуманного в жизнь. По крайней мере, в том, что касается экономики, силы и возможности отдельного, пусть даже гениального, исследователя более чем скромны и ограничены, как и возможности отдельных групп подвижников. Причиной тому – колоссальность и изменчивость самого объекта исследования – экономической действительности.В какой-то мере решить эту непростую проблему помогают два обстоятельства:• системный подход к изучению, обобщению и формированию предложений по развитию экономики (от отдельного домохозяйства, фирмы до региона, страны и далее);• формирование и развитие научно-исследовательских организаций и учреждений, которые в тесном взаимодействии осуществляют обмен накопленными знаниями, подходами и умениями.Каждое из данных обстоятельств более чем необходимо. Лишний повод подчеркнуть значимость второго из них нам дает отмечаемое в январе 2019 г. 100-летие одного из знаменательнейших событий в истории изучения Сибири (в более широких границах – Азиатской России) – съезда по организации Института исследования Сибири<a class="_idFootnoteLink _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-008">1</a>,<a class="_idFootnoteLink _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-007">2</a>. В «Кратком отчете исполнительного бюро по учреждению Института исследования Сибири» было отмечено, что «… Для успеха дела надо в корне изменить характер работ, надо, чтобы Сибирь изучалась не учреждениями, находящимися вне ея, надо, чтобы сама Сибирь взяла в свои руки один из существенных вопросов ея будущаго существования, вопрос о всестороннем и планомерном ея изучении. Только такое исследование даст прочный фундамент для многих дальнейших государственных мероприятий Сибири»<a class="_idFootnoteLink _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-006">3</a>. Председатель съезда профессор Б.П. Вейнберг подчеркивал, что «Институт исследования Сибири рисуется проектом Бюро не в виде безответственного объединения представителей различных учреждений, сходящихся на почве необязательных соглашений, не в виде сростка насильственно вырванных с мясом и кровью из различных ведомств частей их, которыя вели до тех пор дело исследования Сибири, и не в виде величественной, но не лишенной опасности застыть в отвлеченной от практики формы Сибирской Академии Наук, а в виде гибкаго, но тесного объединения ведомственности и общественности, практической жизни и науки, причем последняя должна быть не в названии Института, а в применяемых им методах исследования»<a class="_idFootnoteLink _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-005">4</a>.Подход к организации работы института отличали такие важнейшие особенности, как междисциплинарность (в течение пяти дней 18-22 января 1919 г. (!!!) в г. Томске «был сделан всего 71 доклад 56 авторов»<a class="_idFootnoteLink _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-004">5</a>) и стремление к поиску приемлемых форм интеграции усилий «науки», «бизнеса» и «власти».Ряд выводов и обобщений, представленных в те дни, поражают своей проницательностью. Так, в докладе инженера Н.А. Сборовского (при обсуждении направлений деятельности «Института практической экономической политики (в Томске))» было отмечено, что «…длительная невозможность для нашей промышленности успешного конкурирования с иноземною… может привести к устарелости фабрично-заводских установок, и паралич нашей европейско-российской обрабатывающей промышленности перейдет в смерть ея… Капиталы, с большим уроном освободившиеся из нея, перейдут в область добывающей промышленности<a class="_idFootnoteLink _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-003">6</a>».Идеи и подходы, сформулированные на съезде, опередили свое время – многие из них были реализованы позднее, другие (такие как междисциплинарность и системность) остаются актуальными и поныне.Несмотря на быструю ликвидацию Института исследования Сибири, уже очень скоро, во второй половине 1920-х годов, были созданы научно-исследовательские институты и организации, занимающиеся той же проблематикой. Так, например, в Новосибирске появился «НИИ экономики при ЗапСибкрайплане»<a class="_idFootnoteLink _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-002">7</a>. Следующим логически необходимым шагом стало формирование, говоря современным языком, «сетевой структуры» – институтов, обеспечивающих и переток знаний, и формирование целенаправленного понимания осуществляемых процессов – общесибирских научных съездов и конференций. Так, уже в 1927 г. в Новосибирске состоялся Первый Сибирский краевой научно-исследовательский съезд<a class="_idFootnoteLink _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-001">8</a>. В дальнейшем с определенной регулярностью стали проводиться конференции по развитию производительных сил как Сибири в целом (последняя подобная конференция под эгидой СО АН СССР состоялась в 1985 г.), так и отдельных краев и областей макрорегиона<a class="_idFootnoteLink _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-000">9</a>.На протяжении длительного времени усилиями многих выдающихся исследователей, промышленников, деловых людей (от горнозаводчиков, инженеров и директоров советских предприятий, до предпринимателей – наших современников) складывалась и совершенствовалась система выявления актуальных проблем и поиска эффективных путей их решения, а также продвижения их в «общественное сознание».Статьи настоящего номера, к сожалению, говорят о том, что многие из ранее апробированных и хорошо зарекомендовавших себя подходов и практик, в лучшем случае, «переоткрываются» заново. Связь и преемственность поколений или утрачена, или значительно ослаблена.Именно поэтому, например, в Ростовской области использование инновационного потенциала региона сдерживается наличием «проблемных зон», таких как «низкая инновационная активность региональных предприятий… а также имитация заимствованных инноваций» (статья О.С. Белокрыловой). Непоследовательность научно-технической и отсутствие целенаправленной промышленной политики ведут к тому, что изменения и направления развития институциональной среды «…слишком часто носят имитационный характер, в них не генерируются мотивационные механизмы, созидающие новые экономические отношения, связи, порядки» (статья М.А. Гасанова, С.А. Жиронкина, В.В. Гузырь, А.В. Жаворонок).Преодоление возникающих проблем требует не только интеграции усилий и институционализации процесса выявления проблем (таких, например, как набирающий силу «процесс развития структурных деформаций в динамично развивающейся инновационной экономике» (статья Л.А. Щербаковой)), но и формирования адекватных рамок и форм убеждения и продвижения эффективных решений на практике. По сути, таких, которые пытались предвидеть и развивать участники съезда по организации Института исследования Сибири.Наши уважаемые старшие коллеги и учителя «сказали свое слово» ١٠٠ лет назад, теперь очередь за нами. Чем мы ответим? Думается, что разработка и продвижение реалистичной современной промышленной политики, учитывающей исторические и пространственные особенности нашей страны, являются существенным, но далеко не достаточным шагом в данном направлении.____________________________________________________________________<div id="footnote-008" class="_idFootnote"><a class="_idFootnoteAnchor _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-008-backlink">1</a> Труды съезда по организации Института исследования Сибири (изданы под наблюдением председателя съезда проф. Б.П. Вейнберга). Томск: Типографии: Томск губернская, Сибирской железной дороги, Т-ва печатного дела и Дома трудолюбия. 1919. I часть - 121 с., II часть - 129 с., III часть - 123 с., IV часть - 42 с., V часть - 32 с.</div><div id="footnote-007" class="_idFootnote"><a class="_idFootnoteAnchor _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-007-backlink">2</a> «Институт исследования Сибири возник по инициативе томских ученых во главе с проф. Б.П. Вейнбергом, В.В. Сапожниковым, А.П. Поспеловым, М.А. Усовым и др. в январе 1919… Институт… ставил своей целью научно-практическое исследование природы, жизни и населения Сибири в целях наиболее рационального использования естественных богатств края и его культурно-экономического развития… С приходом советской власти деятельность Института замерла. Постановлением Сибревкома летом 1920 года Институт был закрыт». (Статья «Институт исследования Сибири»//Сибирская Советская Энциклопедия, том II. Новосибирск: ОГИЗ. 1931. С. 280-281).«Для Института исследования Сибири характерна попытка сочетания государственных и общественных форм управления наукой… из-за отсутствия необходимых финансовых средств деятельность Института… была свернута». (Статья «Институт исследования Сибири» // Историческая энциклопедия Сибири, том I. Новосибирск: Институт Истории СО РАН, Издательский Дом «Историческое наследие Сибири». 2009. С. 628).</div><div id="footnote-006" class="_idFootnote"><a class="_idFootnoteAnchor _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-006-backlink">3</a> Труды съезда.., Ч. I. С. 17.</div><div id="footnote-005" class="_idFootnote"><a class="_idFootnoteAnchor _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-005-backlink">4</a> Труды съезда.., Ч. I. С. 39.</div><div id="footnote-004" class="_idFootnote"><a class="_idFootnoteAnchor _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-004-backlink">5</a> Труды съезда.., Ч. V. С. 28.</div><div id="footnote-003" class="_idFootnote"><a class="_idFootnoteAnchor _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-003-backlink">6</a> Труды съезда.., Ч. III. С. 112.</div><div id="footnote-002" class="_idFootnote"><a class="_idFootnoteAnchor _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-002-backlink">7</a> См., например, «Проблемы освоения Севера Западной Сибири» / Под общ. ред. С.Я. Эдельман. Новосибирск: Зап.-Сиб. краевое издательство. 1935. 260 с.</div><div id="footnote-001" class="_idFootnote"><a class="_idFootnoteAnchor _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-001-backlink">8</a> Первый Сибирский краевой научно-исследовательский съезд. Том I. Протоколы и резолюции. Новосибирск: Общество изучения Сибири и ее производительных сил. 1927. 272 с.</div><div id="footnote-000" class="_idFootnote"><a class="_idFootnoteAnchor _idGenColorInherit" href="file:///Y:/2019_02/HTML/Column_2.html#footnote-000-backlink">9</a> См., например, «Конференция по развитию производительных сил Иркутской области. Тезисы докладов». Москва-Ленинград: Издательство АН СССР. 1947. 344 с.</div>

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Duman, Hakan, Göksel Çinier, Eftal Murat Bakırcı, Handan Duman, Ziya Şimşek, Hikmet Hamur, Hüsnü Değirmenci, and Nadir Emlek. "Relationship Between C-Reactive Protein to Albumin Ratio and Thrombus Burden in Patients With Acute Coronary Syndrome." Clinical and Applied Thrombosis/Hemostasis 25 (January 1, 2019): 107602961882441. http://dx.doi.org/10.1177/1076029618824418.

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Increased coronary thrombus burden is known to be a strong predictor of adverse cardiovascular (CV) outcomes. C-reactive protein to albumin ratio (CAR) can be used as a surrogate marker of pro-inflammation which is closely related to prothrombotic state. We aimed to evaluate the association between CAR and coronary thrombus burden in patients who presented with acute coronary syndrome (ACS). Patients who presented with ACS and treated with primary percutaneous coronary intervention were included in the study. Patients were divided into 2 groups as high thrombus burden and low thrombus burden. The study population included 347 patients with non-ST-segment elevation myocardial infarction (169 [48.7%]) and ST-segment elevation myocardial infarction (178 [51.3%]). The CAR was significantly higher in patients with higher thrombus burden (24.4 [1.2-30.2] vs 31.9 [2.2-31.3], P < .001). Independent predictors for increased thrombus burden were higher CRP level (odds ratio [OR]: 0.047; 95% confidence interval [CI]: 0.004-0.486; P = .010), lower serum albumin level (OR: 0.057; 95% CI: 0.033-0.990; P = .049), higher CAR (OR: 1.13; 95% CI: 1.03-1.23; P = .008), higher neutrophil–lymphocyte ratio (OR: 1.18; 95% CI: 1.05-1.31; P = .004), and baseline troponin I level (OR: 1.06; 95% CI: 1.01-1.13; P = .017). Novel CAR can be used as a reliable marker for increased coronary thrombus burden that is associated with adverse CV outcomes.

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Davies, M. A., A. Y. Bedikian, S. McIntyre, T. Smith, K. Kim, W. Hwu, N. Papadopoulos, and P. Hwu. "Natural history of metastatic melanoma patients with CNS metastases." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 8054. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.8054.

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8054 Background: Melanoma has a high rate of CNS metastasis (mets). The objective of this study was to evaluate the characteristics and outcomes of melanoma patients (pts) who develop CNS mets. Methods: 333 pts with a diagnosis of CNS mets were identified from databases of 743 chemotherapy naïve metastatic melanoma (MM) pts enrolled on clinical trials between 1986 and 2004. Their clinical and pathological characteristics were reviewed. Results: The site of primary melanoma was head or neck (60/333; 18%), trunk/abdomen (144/333; 43%), limbs (66/333; 20%), ocular (2/333; 1%), or unknown (61/333; 18%). Median Breslow thickness (BT) = 2.2 mm; BT < 1 mm = 39/217 (18%); and BT < 2 mm = 95/217 (44%). Median Clark level (CL)= IV; CL I = 0/180 (0%); CL II = 14/180 (8%); CL III = 70/180 (39%); and CL IV = 96/180 (53%) . The median interval from diagnosis of primary melanoma to CNS mets = 29.6 (range 0.3–393) months (mos). Median survival (MS) from CNS diagnosis = 4.6 (range 0–120) mos. MS was highest for pts with brain mets (n=307; 4.8 mos) compared to pts with brain mets plus leptomeningeal disease (LMD) (14; 2.0 mos) or pts with LMD alone (11; 1.2 mos) (p=.0048 for pts with LMD vs. without). MS varied for pts with 1 (6.6 mos), 2 (4.2 mos), 3 (5.9 mos) or >3 (3.5 mos) brain lesions at diagnosis of CNS mets. Among pts diagnosed with CNS mets at or prior to systemic therapy, MS was longer for pts with CNS mets only (n=20; 14.3 mos) compared to pts with CNS mets concurrent with extracranial mets (63; 7 mos) (p=.003). Patients who developed CNS mets after starting chemotherapy for extracranial mets (n=250; 3.7 mos) had a shorter MS than those diagnosed at or before systemic therapy (83; 7.9 mos, p<.001). Among pts diagnosed after starting systemic therapy, CNS mets were detected ≤ 12 months from the start of chemotherapy in 30% of pts (MS = 3 mos), 12–24 mos in 37% of pts (MS = 4.6 mos), and > 36 mos in 32% of pts (MS = 11.1 mos, p=.044 vs. other groups). Conclusions: This study represents one of the largest cohorts of pts with melanoma CNS mets. The presence of LMD, or development of CNS mets after starting systemic therapy, is associated with a worse prognosis. Among pts diagnosed with CNS mets at or before starting systemic therapy, the presence of concurrent non-CNS mets also portends for a worse outcome. Supported in part by Carol Courtney Memorial fund and Chiron Corporation. No significant financial relationships to disclose.

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Zhang, Lingyun, Xiujuan Qu, Yuee Teng, Jing Shi, Ping Yu, Tao Sun, Jingyan Wang, et al. "Efficacy of Thalidomide in Preventing Delayed Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Trial (CLOG1302 study)." Journal of Clinical Oncology 35, no. 31 (November 1, 2017): 3558–65. http://dx.doi.org/10.1200/jco.2017.72.2538.

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Purpose We examined the efficacy and safety of thalidomide (THD) for the prevention of delayed nausea and vomiting in patients who received highly emetogenic chemotherapy (HEC). Patients and Methods In a randomized, double-blind, active-controlled, phase III trial, chemotherapy-naive patients with cancer who were scheduled to receive HEC that contained cisplatin or cyclophosphamide-doxorubicin/epirubincin ≥ 50 mg/m2 regimens were randomly assigned to a THD group (100 mg twice daily on days 1 to 5) or placebo group, both with palonosetron (0.25 mg on day 1) and dexamethasone (12 mg on day 1; 8 mg on days 2 to 4). Primary end point was complete response to vomiting—no emesis or use of rescue medication—in the delayed phase (25 to 120 h). Nausea and anorexia on days 1 to 5 were evaluated by the 4-point Likert scale (0, no symptoms; 3, severe). Quality of life was assessed by the European Organization for Research and Treatment of Cancer QLQ-C30 version 3 questionnaire on days −1 and 6. Results Of 656 patients, 638 were evaluable: 317 in the THD group and 321 in the control group. Compared with placebo, delayed and overall (0 to 120 h) complete response rates to vomiting were significantly higher with THD: 76.9% versus 61.7% ( P < .001) and 66.1% versus 53.3% ( P = .001), respectively. Rates of no nausea were also higher in the THD group (delayed: 47.3% v 33.3%; P < .001; overall: 41% v 29.6%; P = .003), and mean scores of anorexia were lower overall (0.44 ± 0.717 v 0.64 ± 0.844; P = .003). Adverse effects were mild to moderate. The THD group had increased sedation, dizziness, constipation, and dry mouth, but experienced better quality of life after chemotherapy. Conclusion Thalidomide combined with palonosetron and dexamethasone significantly improved HEC-induced delayed nausea and vomiting prevention in chemotherapy-naive patients.

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VERMA, A. S., SHEETAL SHARMA, and V. K. JINDAL. "INHERENT PROPERTIES OF TERNARY $(A^{N}B^{2+N}C_{2}^{7-N})$ TETRAHEDRAL SEMICONDUCTORS." International Journal of Modern Physics B 26, no. 15 (June 5, 2012): 1250079. http://dx.doi.org/10.1142/s0217979212500798.

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In this paper we have evaluated inherent properties (i.e., heat of formation and cohesive energy) for chalcopyrite structured solids. We have presented two expressions relating the heat of formation and cohesive energy for [Formula: see text] and [Formula: see text] semiconductors with the product of ionic charge (ZAZBZC) and nearest neighbor distance (d in Å). The heat of formation and cohesive energy of these solids exhibit a linear relationship when plotted on a log–log scale against the nearest neighbor distance, but fall on different straight lines according to the product of ionic charge of the compounds. We have applied the modified relations on these solids and found a better agreement with experimental data as compared to the values evaluated by previous researchers so far. The results for heat of formation differ from experimental values by the following amounts: ZnSiP 2 — 4.8%, ZnSnP 2 — 0.4%, ZnSiAs 2 — 0.7%, ZnGeAs 2 — 2.6%, ZnSnAs 2 — 1.2%, CdGeP 2 — 3.8%, CuGaSe 2 — 0.3% and AgInSe 2 — 5% and the results for cohesive energy differ from experimental values by the following amounts: ZnSiP 2 — 0.3%, ZnSnAs 2 — 1.5%, CuGaSe 2 — 3.7%, CuGaTe 2 — 2%, CuInTe 2 — 2.7%, AgGaTe 2 — 0.7%, AgInSe 2 — 3%, AgInTe 2 — 3%.

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Reyes, E. A., D. R. Bergfelt, V. F. Ratto, X. P. Valderrama, E. Arcelay, and M. H. Ratto. "122 OVARIAN FOLLICULAR DYNAMICS IN CROSS-BRED EWES DURING THE RAINY SEASON UNDER TROPICAL CONDITIONS." Reproduction, Fertility and Development 29, no. 1 (2017): 169. http://dx.doi.org/10.1071/rdv29n1ab122.

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Small ruminants are an important livestock species on many island nations of the Eastern Caribbean region and serve as a vital source of food and income. This study was designed to characterise follicular development during the inter-ovulatory interval (interval between 2 consecutive ovulations) under tropical conditions. Non-lactating, 2- to 4-year-old crossbred Barbados-Black Belly × White Virgin Island ewes weighing a mean 30.4 kg with mean body condition score 2.9 (score 1–5) were used during September–November for the study. Ewes were maintained in a paddock of 100 m2 at the research farm in St. Kitts and Nevis (17.3°N, 62.7°W). Animals were fed daily with 100 g of concentrate (17% crude protein) and had free access to elephant grass (Pennisetum purpureum), mineral salt, water, and shade. Ovaries of 19 females were examined daily for 46 days by transrectal B-mode ultrasonography using a 7.5-MHz lineal array transducer (Honda HS-2200UV, MA, USA) to detect ovulations and growth and regression of antral follicles. Data were analysed using chi-square, Student t-test, or one-way ANOVA. Proportion of females with 2, 3, and 4 follicular waves was 2/19 (10.5%), 10/19 (52.6%), and 7/19 (36.8%), respectively. Mean (± SEM) length of the inter-ovulatory intervals did not differ (P = 0.9) among females with 2 (16.5 ± 0.5 days), 3 (16.3 ± 0.4 days), and 4 (16.6 ± 0.2 days) follicular waves, respectively. Mean diameter of ovulatory follicles was 4.4 ± 0.1 mm, proportion of multiple ovulations was 11/19 (57.9%), and mean number of follicular waves was 3.3 ± 0.1. Wave emergence was normalized to the first ovulation of the inter-ovulatory interval (ovulation = Day 0). Mean days of wave emergence for 2 follicular waves were Days 1.0 ± 0 and 10.0 ± 0.0; for 3 follicular waves were Days 0.7 ± 0.1, 5.6 ± 0.5, and 10.4 ± 0.3; and 4 follicular waves were Days 0.8 ± 0.3, 4.7 ± 0.6, 8.4 ± 0.5, and 11.7 ± 0.3, respectively. The inter-wave intervals were 9.0 ± 0.0 days for 2 waves; 5.1 ± 0.5 and 4.8 ± 0.3 days for 3 waves; and 3.8 ± 0.5, 3.7 ± 0.3, and 3.3 ± 0.4 days for 4 waves. Growth rate (mm/day) of the largest follicle/wave did not differ (P = 07) among animals with 2 follicular waves (1.2 ± 0.7 v. 1.1 ± 0.0) or 3 follicular waves (0.9 ± 0.1 v. 0.9 ± 0.1 v. 1.2 ± 0.2). However, in animals with 4 follicular waves, the largest follicle grew faster (P < 0.05) for wave 1 (1.3 ± 0.2) than that of waves 2 (0.5 ± 0.2), 3 (0.6 ± 0.1), and 4 (0.6 ± 0.1). In conclusion, length of inter-ovulatory intervals, emergence of antral follicles, growth, and regression follicles in a wave-like pattern, inter-wave intervals, and diameter of ovulatory follicles in cross-bred ewes under tropical conditions are comparable to that described in sheep from temperate climates.

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Gough, Lewis A., Steven Rimmer, Callum J. Osler, and Matthew F. Higgins. "Ingestion of Sodium Bicarbonate (NaHCO3) Following a Fatiguing Bout of Exercise Accelerates Postexercise Acid-Base Balance Recovery and Improves Subsequent High-Intensity Cycling Time to Exhaustion." International Journal of Sport Nutrition and Exercise Metabolism 27, no. 5 (October 2017): 429–38. http://dx.doi.org/10.1123/ijsnem.2017-0065.

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This study evaluated the ingestion of sodium bicarbonate (NaHCO3) on postexercise acid-base balance recovery kinetics and subsequent high-intensity cycling time to exhaustion. In a counterbalanced, crossover design, nine healthy and active males (age: 23 ± 2 years, height: 179 ± 5 cm, body mass: 74 ± 9 kg, peak mean minute power (Wpeak) 256 ± 45 W, peak oxygen uptake (V̇O2peak) 46 ± 8 ml.kg-1.min-1) performed a graded incremental exercise test, two familiarization and two experimental trials. Experimental trials consisted of cycling to volitional exhaustion (TLIM1) at 100% WPEAK on two occasions (TLIM1 and TLIM2) interspersed by a 90 min passive recovery period. Using a double-blind approach, 30 min into a 90 min recovery period participants ingested either 0.3 g.kg-1 body mass sodium bicarbonate (NaHCO3) or a placebo (PLA) containing 0.1 g.kg-1 body mass sodium chloride (NaCl) mixed with 4 ml.kg-1 tap water and 1 ml.kg-1 orange squash. The mean differences between TLIM2 and TLIM1 was larger for PLA compared with NaHCO3 (-53 ± 53 vs. -20 ± 48 s; p = .008, d = 0.7, CI =-0.3, 1.6), indicating superior subsequent exercise time to exhaustion following NaHCO3. Blood lactate [Bla-] was similar between treatments post TLIM1, but greater for NaHCO3 post TLIM2 and 5 min post TLIM2. Ingestion of NaHCO3 induced marked increases (p < .01) in both blood pH (+0.07 ± 0.02, d = 2.6, CI = 1.2, 3.7) and bicarbonate ion concentration [HCO3-] (+6.8 ± 1.6 mmo.l-1, d = 3.4, CI = 1.8, 4.7) compared with the PLA treatment, before TLIM2. It is likely both the acceleration of recovery, and the marked increases of acid-base after TLIM1 contributed to greater TLIM2 performance compared with the PLA condition.

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Stilgenbauer, Stephan, Raymonde Busch, Andrea Schnaiter, Peter Paschka, Marianna Rossi, Konstanze Döhner, Thorsten Zenz, et al. "Gene Mutations and Treatment Outcome in Chronic Lymphocytic Leukemia: Results From the CLL8 Trial." Blood 120, no. 21 (November 16, 2012): 433. http://dx.doi.org/10.1182/blood.v120.21.433.433.

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Abstract Abstract 433 Novel gene mutations have been found in CLL by next generation sequencing including mutations of NOTCH1 and SF3B1 in 5–20% of cases. In initial studies, both have been associated with advanced disease and poor outcome. We assessed the incidence and impact of gene mutations in the CLL8 trial (1st line FC vs. FCR, n=817). TP53 (exons 2–11) was analyzed by a re-sequencing chip (Amplichip, Roche Molecular Systems) with confirmatory Sanger sequencing. NOTCH1 was analyzed by Sanger sequencing exon 34, chr9:139,390,619–139,391,290 (PEST domain). SF3B1 (exons 13–16) was analyzed by DHPLC (WAVE® 3500HT, Transgenomic Inc.) with subsequent Sanger sequencing. Baseline samples were available for analysis of genetic markers in 619 (75.8%) to 645 (78.9%) patients. All markers were available for 573 (70.1%) patients and this cohort was representative of the full trial population. Mutations (mut) were found in TP53, NOTCH1, and SF3B1 in 11.5%, 10.0%, and 18.4%, respectively. At least one mutation was identified in 35.2% patients, while 30.6% had one, 4.4% had two and 0.2% had three mutations. Concurrent NOTCH1mut and SF3B1mut were found in only 0.5% patients. TP53mut was observed in 16.7% of NOTCH1mut cases (p=.528) and in 14.5% of SF3B1mut patients (p=.472). Regarding baseline characteristics, there were significant associations of TP53mut with CIRS>1, unmutated IGHV and 17p-; of NOTCH1mut with Binet A/B, no B-symptoms, unmutated IGHV, and 17p-; and of SF3B1mut with TK>10, and no +12. Regarding response to therapy, TP53mut was significantly associated with refractory disease in both arms (FCR: 25.0% vs. 1.8%, p<.001, FC: 48.4% vs. 7.8%, p<.001,); while NOTCH1mut showed only a trend in the FCR arm (FCR: 10.9% vs. 3.4%, p=.109, FC: 11.9% vs. 12.9%, p=.775); and SF3B1mut did not impact response to therapy (FCR: 3.6% vs. 3.7%, p=1.00, FC: 12.3% vs. 10.9%, p=1.00). At extended follow-up (median 69.97 months), FCR resulted into significantly improved PFS (HR 0.586, p<.001) and OS (HR 0.678, p=.001). TP53mut was associated in both treatment arms with significantly decreased PFS (FC: HR 4.295, p<.001; FCR: HR 3.173 p<.001) and OS (FC: HR 4.642 p<.001; FCR: HR 4.447, p<.001). In contrast, NOTCH1mut was only in the FCR arm associated with significantly decreased PFS (FC: HR 0.931, p=.741; FCR: HR 1.718, p=.013) and a trend to inferior OS (FC: HR 0.854, p=.605; FCR: HR 1.610, p=.112). SF3B1mut was associated in both treatment arms with significantly decreased PFS (FC: HR 1.520, p=.009; FCR: HR 1.463, p=.033) and a trend to inferior OS (FC: HR 1.338, p=.178; FCR: HR 1.305, p=.301). To evaluate the independent prognostic impact, we performed multivariable analyses by Cox regression for PFS and OS including the following variables: treatment, age, sex, stage, ECOG status, B-symptoms, WBC, TK, β2-MG, 11q-, +12, 13q-, 17p-, IGHV, TP53, NOTCH1 and SF3B1. Regarding PFS, the following independent prognostic factors were identified: FCR (HR 0.510, p<.001), TK>10 (HR 1.367, p=.019), IGHV<98% (HR 1.727, p<.001), 11q- (HR 1.536, p<.001), 17p- (HR 2.949 p<.001), TP53mut (HR 2.113 p<.001), and SF3B1mut (HR 1.348, p=.024). Regarding OS, the following independent prognostic factors were identified: FCR (HR 0.701, p=.049), ECOG>0 (HR 2.202, p<.001), TK>10 (HR 2.707, p<.001), IGHV<98% (HR 1.547, p=.055), 17p- (HR 3.546 p<.001) and TP53mut (HR 3.032 p<.001). To identify a predictive impact of gene mutations for a specific treatment effect by the addition of rituximab, we performed multivariable analyses including the treatment arms, the gene mutations and the interaction of both. Regarding PFS, FCR (HR 0.544, p<.001), TP53mut (HR 3.607, p<.001), SF3B1mut (HR 1.355, p=.012) and NOTCH1mut interaction with FCR (HR 1.652, p=.022) were identified as independent factors. Regarding OS, FCR (HR 0.654, p=.002) and TP53mut (HR 4.470, p<.001) were identified as independent factors while NOTCH1mut interaction with FCR (HR 1.331, p=.344) showed a trend. The interaction between NOTCH1mut and FCR treatment is illustrated in univariate PFS analysis, in which the addition of rituximab led to a benefit only among patients without NOTCH1mut (Figure). In conclusion, gene mutations show independent prognostic value for PFS (TP53, SF3B1) and OS (TP53) in patients receiving 1st line FC and FCR treatment. Of note, NOTCH1mut appears to identify a subset of CLL patients that does not benefit from the addition of rituximab to FC. Disclosures: Stilgenbauer: Roche: Consultancy, Honoraria, Research Funding. Patten:Roche: Employment. Wenger:Roche: Employment. Mendila:Roche: Employment. Hallek:Roche: Consultancy, Honoraria, Research Funding.

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Walz, Lars, Gian M. Salzmann, Thomas Fabbro, Stefan Eichhorn, and Andreas B. Imhoff. "The Anatomic Reconstruction of Acromioclavicular Joint Dislocations Using 2 TightRope Devices." American Journal of Sports Medicine 36, no. 12 (September 2, 2008): 2398–406. http://dx.doi.org/10.1177/0363546508322524.

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Background For the reconstruction of acromioclavicular (AC) joint separation, several operative procedures have been described; however, the anatomic reconstruction of both coracoclavicular ligaments has rarely been reported. Purpose The aim of this biomechanical study is to describe a new procedure for anatomic reconstruction of the AC joint. Study Design Controlled laboratory study. Materials and Methods Forty fresh-frozen cadaveric shoulders were tested. Cyclic loading and a load-to-failure protocol was performed in vertical (native, n = 10; reconstructed, n = 10) and anterior directions (native, n = 10; reconstructed, n = 10) on 20 AC joints and repeated after anatomic reconstruction. Reconstruction of conoid and trapezoid ligaments was achieved by 2 TightRope devices (Arthrex, Naples, Florida). Dynamic, cyclic, and static loading until failure in vertical (n = 5) and horizontal (n = 5) directions were tested in native as well as reconstructed joints in a standardized setting. Results The native coracoclavicular ligaments in static load for vertical force measured 598 N (range, 409–687), elongation 10 mm (range, 6–14), and stiffness 99 N/mm (range, 67–130); static load for anterior force was 338 N (range, 186–561), elongation 4 mm (range, 3–7), and stiffness 140 N/mm (range, 70–210). The mean maximum static load until failure in reconstruction for vertical force was 982 N (range, 584–1330) ( P = .001), elongation 4 mm (range, 3–6) ( P < .001), and stiffness 80 N/mm (range, 66.6–105) ( P = .091); and for anterior static force 627 N (range, 364–973) ( P < .001), elongation 6.5 mm (range, 4–10) ( P = .023), and stiffness 78 N/mm (range, 46–120) ( P = .009). During dynamic testing of the native coracoclavicular ligaments, the mean amount of repetitions (100 repetitions per stage, stage 0–100 N, 100–200 N, 200–300 N, etc, and a frequency of 1.5 Hz) in native vertical direction was 593 repetitions (range, 426–683) and an average of 552 N (range, 452–683) load until failure. In vertical reconstructed testing, there were 742 repetitions (range, 488–893) ( P = .222; with a load until failure of 768 N (range, 486–900) ( P = .095). In the anterior direction load, the native ligament failed after an average of 365 repetitions (range, 330–475) and an average load of 360 N (range, 307–411), while reconstructed joints ended in 549 repetitions (range, 498–566) (P = .008J with a load until failure of 547 N (range, 490–585) ( P = .008). In all testing procedures, a preload of 5 N was performed. Conclusion The anatomic reconstruction of the AC joint using TightRope is a stable and functional anatomic reconstruction procedure. The reconstruction technique led to favorable in vitro results with equal or even higher forces than native ligaments. Clinical Relevance Through anatomic repair, stable function of the AC joint can be achieved in an anatomic manner.

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Rumalla, Kavelin, Chester K. Yarbrough, Andrew J. Pugely, and Ian G. Dorward. "Spinal Fusion for Pediatric Spondylolisthesis: National Trends, Complications, and Short-Term Outcomes." Neurosurgery 82, no. 5 (July 7, 2017): 701–9. http://dx.doi.org/10.1093/neuros/nyx295.

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AbstractBACKGROUNDCurrent surgical management guidelines for pediatric spondylolisthesis (PS) are reliant on data from single-center cohorts.OBJECTIVETo analyze national trends and predictors of short-term outcomes in spinal fusion surgery for PS by performing a retrospective cross-sectional analysis of the Kids’ Inpatient Database (KID).METHODSThe KID (sampled every 3 yr) was queried from 2003 to 2012 to identify all cases (age 5-17) of spinal fusion for PS (n = 2646). We analyzed trends in patient characteristics, surgical management, and short-term outcomes. Both univariate and multivariable analyses were utilized.RESULTSThe 2646 spinal fusions for PS included posterior-only fusions (86.8%, PSF), anterior lumbar interbody fusions (4.8%, ALIF), and combined anterior and posterior fusions (8.4%, APLF) procedures. The utilization of APLF decreased over time (9.9%-6.4%, P = .023), whereas the number of total spinal fusions and the proportion of PSF and ALIF procedures have not changed significantly. Uptrends in Medicaid insured individuals (1.2%-18.9%), recombinant human bone morphogenetic protein-2 insertion (8.8%-16.6%), decompression (34.7%-42.8%), and mean inflation-adjusted hospital costs ($21 855-$32 085) were identified (all P < .001). In multivariable analysis, Medicaid status (odds ratio [OR] = 1.93, P = .004), teaching hospitals (OR = 1.94, P = .01), decompression (OR = 1.78, P = .004), and the APLF procedure (OR = 2.47, P = .001) increased the likelihood of complication occurrence (all P < .001).CONCLUSIONThe addition of decompression during fusion and the APLF procedure were associated with more in-hospital complications, though this may have been indicative of greater surgical complexity. The utilization of the APLF procedure has decreased significantly, while costs associated with the treatment of PS have increased over time.

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Arivoli, Subramanian, Miriam Vassou, Samuel Tennyson, Athikesavan Ramanan, Selvaraj Divya, and Pac Kamatchi. "Analysis of Soil and Water Quality in Selected Villages of Ranipet District, Tamil Nadu, India." Current World Environment 16, no. 2 (August 30, 2021): 477–91. http://dx.doi.org/10.12944/cwe.16.2.14.

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Quality of soil and water are determined by measuring the concentration of their parameters and comparing them with standards. In the present study, soil samples (top, sub and inner) from three zones, zone 1 (industrial area), zone 2 (10km from industrial area) and zone 3 (agricultural land/fields) of Puliyanthangal village, and the bore well, well and pond water samples of Kathiyavadi village were analysed from January 2019 to December 2019. Soil texture was sandy loam in all the zones. The pooled values for pH, electrical conductivity (dS/m), organic carbon (%), available nitrogen, phosphorous, potassium, iron, manganese, zinc and copper (mg/Kg) tested in zone 1, 2 and 3 were 7.9, 6.8 and 6.8; 0.3, 0.3 and 0.1; 0.09, 0.5 and 0.5; 11.7, 96.0 and 137.8; 4.5, 4.5 and 4.2; 88.3, 111.3 and 206.7; 3.6, 3.4 and 3.7; 2.1, 1.7 and 2.3; 0.4, 0.3 and 0.2; and 0.7, 0.5 and 0.7, respectively. The bore well and well water samples were clear and colourless without odour, whereas the pond water was slightly yellowish in appearance and colour, and without odour in all the three zones. The physicochemical parameters viz., water temperature, electrical conductivity, turbidity, total dissolved solids, pH, total alkalinity and total hardness for bore well, well and pond water were 27.9, 22.8 and 33.0°C; 975, 1532 and 737μS/cm; 0, 1 and 11NTU; 683, 1072 and 516mg/L; 7.4, 7.8 and 7.3; 276, 344 and 248mg/L; and 190, 732 and 272mg/L, respectively. Calcium, magnesium, free ammonia, nitrate, nitrite, chloride, fluoride, sulphate and phosphate represented the nutrient parameters and their respective values (mg/L) were 41, 174 and 58; 21, 71 and 30; 0, 0 and 1.1; 24, 29 and 22; 0, 0 and 0.8; 100, 184 and 60; 0.4, 0.4 and 0.4; 77, 120 and 49; 0, 0 and 0.8. The values of metal parameters reported nil except for iron (0.2mg/L) in pond water. The study inferred that the waning nature of soil and water might be due to location of industrial units.

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Martin, I. K., K. M. Weber, R. C. Boston, F. P. Alford, and J. D. Best. "Effects of epinephrine infusion on determinants of intravenous glucose tolerance in dogs." American Journal of Physiology-Endocrinology and Metabolism 255, no. 5 (November 1, 1988): E668—E673. http://dx.doi.org/10.1152/ajpendo.1988.255.5.e668.

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Effects of four- to fivefold elevations of epinephrine (EPI) on glucose (Glc) metabolism were assessed in eight dogs before and after an intravenous Glc tolerance test, performed 30 min (short EPI) and 72 h (long EPI) after start of EPI infusion. Short EPI increased plasma nonesterified fatty acids (NEFA; 0.46 +/- 0.08 to 0.78 +/- 0.12 mmol/l, P less than 0.05), but Glc and insulin were unchanged. After long EPI, NEFA returned to control but Glc increased from 5.1 +/- 0.1 to 5.7 +/- 0.2 mmol/l (P less than 0.05). EPI reduced overall Glc tolerance (KG) from 3.5 +/- 0.7 to 2.5 +/- 0.2 (short EPI, P less than 0.05) and 2.3 +/- 0.3%/min (long EPI, P less than 0.02). Minimal model analysis showed that short EPI decreased insulin sensitivity (SI) from 7.9 +/- 1.1 to 4.2 +/- 1.2 min-1 per mU/l X 10(-4) (P less than 0.005) and increased pancreatic responsiveness (phi 1 from 3.7 +/- 0.3 to 7.4 +/- 2.9 mU/l.min-1 per mg/dl, P less than 0.025; phi 2 from 2.6 +/- 0.7 to 4.9 +/- 1.2 mU/l.min-2 per mg/dl). After long EPI SI, phi 1, and phi 2 returned to control. In contrast, Glc-mediated Glc disposal (SG) was decreased from 3.5 +/- 0.5 X 10(-2) to 2.8 +/- 0.6 X 10(-2) (short EPI) and 1.3 +/- 0.6 X 10(-2) min-1 (long EPI, P less than 0.02). We conclude that prolonged infusion of EPI leads to adaptation to its acute effects on NEFA, SI, phi 1, and phi 2.(ABSTRACT TRUNCATED AT 250 WORDS)

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Işık, Emregül, Belma Haliloglu, Jaap van Doorn, Hüseyin Demirbilek, Sitha A. Scheltinga, Monique Losekoot, and Jan M. Wit. "Clinical and biochemical characteristics and bone mineral density of homozygous, compound heterozygous and heterozygous carriers of three novel IGFALS mutations." European Journal of Endocrinology 176, no. 6 (June 2017): 657–67. http://dx.doi.org/10.1530/eje-16-0999.

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Objective Acid-labile subunit (ALS) deficiency (ACLSD), caused by homozygous or compound heterozygous IGFALS mutations, is associated with moderate short stature, delayed puberty, low serum IGF-I and ALS and extremely low serum IGFBP-3. Its effect on birth weight, head circumference, bone mineral density (BMD), serum IGF-II and IGFBP-2 is uncertain, as well as the phenotype of heterozygous carriers of IGFALS mutations (partial ACLSD). Design From all available members of five Turkish families, carrying three mutations in exon 2 of IGFALS (c.1462G > A, p.Asp488Asn (families A, B, E); c.251A > G, p.Asn84Ser (families C and E) and c.1477del, p.Arg493fs (family D)), clinical, laboratory and BMD data were collected. Methods Auxological and biochemical findings were expressed as SDS for age and gender. Ternary complex formation in serum was investigated by size-exclusion chromatography. BMD using DXA bone densitometry was adjusted for height and age (Ha-BMD z-score). Results In ACLSD (n = 24), mean ± s.d. height SDS (−2.7 ± 1.2), head circumference SDS (−2.3 ± 0.5) and body mass index (BMI) (−0.6 ± 1.0 SDS) were lower than those in partial ACLSD (n = 26, P ≤ 0.01) and birth weight SDS (n = 7) tended to be lower (−2.2 ± 1.1 vs −0.6 ± 0.3 in partial ACLSD (P = 0.07)). Serum IGF-I was −3.7 ± 1.4 vs −1.0 ± 1.0, IGF-II: −5.6 ± 0.7 vs −1.3 ± 0.7, ALS: <−4.4 ± 1.2 vs −2.1 ± 0.9 and IGFBP-3: −9.0 ± 1.9 vs −1.6 ± 0.8 SDS respectively (P < 0.001). Ha-BMD z-score was similar and normal in both groups. Conclusions To the known phenotype of ACLSD (i.e. short stature, reduced serum levels of IGF-I and ALS, extremely low serum IGFBP-3 and disturbed ternary complex formation), we add reduced birth weight, head circumference and serum IGF-II.

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Claviez, Alexander, Markus Tiemann, Heike Lueders, Reza Parwaresch, Guenther Schellong, and Wolfgang Doerffel. "The Impact of Latent Epstein-Barr Virus Infection on Outcome in Children and Adolescents with Hodgkin’s Lymphoma." Blood 104, no. 11 (November 16, 2004): 3121. http://dx.doi.org/10.1182/blood.v104.11.3121.3121.

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Abstract The prognostic significance of latent Epstein-Barr virus (EBV) infection in Hodgkin’s lymphoma (HL) is debated controversially. Especially in the pediatric age group, no conclusive data are available due to small series. 842 children and adolescents (55% male) with a median age of 13.7 years (range, 2–20) from consecutive pediatric DAL/GPOH multicenter treatment studies HD-90 and HD-95 were studied for the presence of latent EBV infection in Hodgkin and Reed-Sternberg cells by immunostaining against latent membrane protein 1 (LMP-1). Histology subtypes were as follows: nodular sclerosis (NSHL) 549, mixed cellularity (MCHL) 190, lymphocyte predominance (NLPHL) 90, lymphocyte depletion (LDHL) 6, lymphocyte-rich classical HL (LRCHL) 5, not specified 2. 88 patients had stage I, 470 had stage II, 172 had stage III and 112 had stage IV. B symptoms were present in 274 patients (33%). LMP status was compared with clinical parameters and established risk factors. A total of 263 patients (32%) were LMP positive. EBV infection correlated with gender (male 39% vs. female 23%; p<.001), histological subtype (MCHL 69% vs. NSHL 22% vs. NLPHL 6%; p<.001) and age (<10 years 67% vs ≥10 years 28%, p<.001. With a median follow-up of 4.9 years (0.3–12) 820 patients (97%) are alive. Probability of overall survival at 10 years (±SD) for EBV negative and positive patients was 98±1% and 95±1%, respectively (p=.017 by log-rank test). Probability of failure-free survival (FFS) in LMP positive and negative patients was 89±2% and 84±4%, respectively (p=.86). With respect to LMP status, a negative effect of latent EBV infection on overall survival became evident only for patients treated for advanced stages (p=.003), those with nodular sclerosis subtype Bennett II (p=.02) and B symptoms (p=.05). In a multivariate regression analysis, allocation to treatment group (RR=3.7) and LMP positivity (RR=3.01) were independent factors for overall survival and presence of B symptoms (RR=2.4) for FFS. Under current highly effective polychemotherapy with or without involved field radiotherapy in pediatric HL, latent EBV infection has no influence on FFS in univariate and multivariate analysis. LMP positivity, however, seems to be associated with an inferior overall survival in some subgroups.

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Tucker, Larry A., Amy J. Cook, Neil R. Nokes, and Troy B. Adams. "Telephone-Based Diet and Exercise Coaching and a Weight-Loss Supplement Result in Weight and Fat Loss in 120 Men and Women." American Journal of Health Promotion 23, no. 2 (November 2008): 121–29. http://dx.doi.org/10.4278/ajhp.07051646.

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Purpose. Determine the effects of telephone-based coaching and a weight-loss supplement on the weight and body fat (BF) of overweight adults. Design. Randomized, placebo-controlled experiment with assessments at baseline, 2 months, and 4 months. Setting. Community. Subjects. Sixty overweight or obese men and 60 overweight or obese women, 25 to 60 years old. Intervention. Eleven 30-minute telephone coaching sessions were spaced throughout the study; the initial conversation lasted 60 to 90 minutes. Supplement or placebo capsules were taken daily over the 17 weeks. Measures. Weight was measured using an electronic scale, and BF was assessed using dual energy x-ray absorptiometry. Results. Subjects taking the placebo lost 1.8 + 3.3 kg of weight and 0.7 + 2.2 kg of BF, whereas supplement users lost more: 3.1 + 3.7 kg of weight (F = 4.1, P = .045) and 1.7 + 2.6 kg of BF (F = 4.4, p = .039). Participants receiving no coaching lost 1.8 + 3.3 kg of weight and 0.7 + 2.2 kg of BF, whereas adults receiving coaching lost more: 3.2 + 3.6 kg of weight (F = 4.8, p = .032) and 1.6 + 2.5 kg of BF (F = 4.2, p = .044). Adults receiving both the supplement and coaching had the greatest losses of weight and BF, suggesting an additive effect (F = 3.2, p = .026; F = 2.9, p = .039, respectively). Conclusions. Both treatments, coaching and the supplement, viewed separately and in combination, worked to help subjects lose weight and BF. Adults can be educated and motivated via telephone to change behaviors leading to weight loss, and a weight-loss supplement can be included to increase success.

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Mallari, Regin Jay, Jai Deep Thakur, John H. Rhee, Amalia Eisenberg, Howard Krauss, Chester Griffiths, Walavan Sivakumar, Garni Barkhoudarian, and Daniel F. Kelly. "Endoscopic Endonasal and Supraorbital Removal of Tuberculum Sellae Meningiomas: Anatomic Guides and Operative Nuances for Keyhole Approach Selection." Operative Neurosurgery 21, no. 2 (June 10, 2021): E71—E81. http://dx.doi.org/10.1093/ons/opab138.

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Abstract BACKGROUND With growing worldwide endoscopy experience, endonasal and supraorbital removal of tuberculum sellae meningiomas (TSM) has increased. OBJECTIVE To describe anatomic factors for guiding approach selection and outcomes. METHODS Retrospective analysis of patients undergoing endonasal or supraorbital TSM resection: approach criteria, clinical outcomes, acute magnetic resonance imaging (MRI) fluid-attenuated inversion-recovery (FLAIR)/T2 changes. RESULTS From 2008 to 2020, 33 patients (mean age 55 ± 11 yr) were identified: 20 (61%) had endonasal and 13 (39%) supraorbital removal. Comparing endonasal and supraorbital approaches, mean tumor volume (3.7 ± 3.5 cm3 vs 7.7 ± 8.5 cm3, P = .07); percent tumor above planum (42% vs 65%, P = .02), and lateral tumor beyond supraclinoid internal carotid arteries (1.4 ± 2.0 mm vs 4.0 ± 3.2 mm, P = .006) were greater for supraorbital route. Sellar depth was greater for endonasal route tumors (12.2 ± 2.6 mm vs 9.3 ± 2.4 mm, P = .003). Endoscopy, used in 10/13(77%) supraorbital cases, was helpful in additional tumor removal in 4/10(40%). Gross total removal and mean volumetric tumor resection were 16/20(80%) and 97.5% by endonasal, and 5/13(39%) and 96% by supraorbital route. Vision improved in 12/17 (71%) endonasal, 6/8 (75%) supraorbital operations, and worsened in 1 (3%) supraorbital case. Endonasal approach with optic canal decompression increased over study period: 15/20 (75%) endonasal patients vs 1/13(8%) supraorbital (P < .001). Postoperative FLAIR/T2 MRI changes occurred in 2/12 supraorbital and 0/20 endonasal cases. CONCLUSION In our experience, both endonasal and supraorbital routes are safe and effective for TSM removal. Greater tumor extension below planum and medial optic canal invasion favor endonasal route, while larger size and lateral extension favor supraorbital route. Given high frequency of TSM growth into optic canals and better access for medial optic canal tumor removal, endonasal route may be preferred for most TSMs.

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Rivera Teran, V., D. Alpizar-Rodriguez, S. Sicsik, F. Irazoque-Palazuelos, D. Miranda, D. Vega-Morales, J. C. Casasola, et al. "FRI0546 GENDER DIFFERENCES OF RHEUMATIC DISEASES IN MEXICAN POPULATION: DATA FROM THE MEXICAN BIOLOGICS REGISTRY." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 874–75. http://dx.doi.org/10.1136/annrheumdis-2020-eular.6091.

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Background:Most autoimmune diseases are more prevalent in women. Symptom severity, disease progression, response to therapy and overall survival differ between males and females with rheumatic diseases.Objectives:To identify the characteristics of autoimmune diseases presentation and treatment between male and female population using information from the Mexican Adverse Events Registry (BIOBADAMEX).Methods:BIOBADAMEX is a Mexican ongoing cohort that collects the information of patients using biologic and biosimilar drugs since 2016. For this study we included all patients enrolled in the registry and compared baseline clinical and disease characteristics, treatment and presence of adverse events between genders. We used logistic regression to analyze univariable associations.Results:A total of 655 participants were analysed, of which 82% were female (Table 1). We found women were older with a median of 53 years compared to 46 years in men (OR 1.02, CI 1.0-1.1). Smoking was higher in men (16%) compared to women (5%), (OR 0.3, CI 0.2-0.6). Women had longer disease duration, 9 years compared to 7 years in men (OR 1, CI 1.0-1.1). Rheumatoid arthritis (RA) was more prevalent in women (OR 2.7, CI 1-6.9), while ankylosing spondylitis (AS) and psoriatic arthritis (PsA) were more prevalent in men (OR 0.2, CI 0.1-0.4, and OR 0.3, CI 0.1-0.9 respectively). Women had more comorbidities than men (OR 1.8, CI 1.1-2.8) and used steroids more frequently (OR 1.7, CI 1.1-2.7). Differences in disease activity were not found, however we noticed high activity scores among participants.Table 1.Baseline characteristics in the cohort by sexWomenn=532 (82%)Menn=123 (18%)UnivariableaOR(95%CI)Age, median (IQR)53 (44-60)47 (34-55)1.02 (1.0-1.1)*Body Mass Index, median (IQR)27 (23-31)26 (23-30)1.0 (0.9-1.1)Smoking, n(%)28 (5)18 (16)0.3 (0.2- 0.6)*Disease duration, median (IQR)9 (4-16)7 (2-13)1.0 (1.0-1.1)*Diagnosis, n(%): RA414 (78)37 (30)2.4 (1.0-5.7)* AIJ12 (2)5 (4)0.5 (0.1-1.9) AS37 (7)56 (46)0.1 (0.1-0.4)* PsA19 (4)15 (12)0.3 (0.1-0.8)* SLE17 (3)3 (2)1.2 (0.3-5.2) Others33 (6)7 (6)1Disease Activity indexes, median (IQR) DAS28a4.9 (3.6-5.9)4.9 (3.0-5.9)1.1 (0.9-1.3) BASDAIb4.8 (2.9-8)5.3 (2.8-7.5)0.9 (0.8- 1.1) ASDASc3.2 (1.9-4.5)3.9 (2.5-4.7)0.8 (0.6-1.2) SLEDAId14.5 (5.0-19.5)25 (25.0-31.0)0.6 (0.4-1.1)High blood pressure, n(%)77 (15)14 (12)1.3 (0.7-2.4)Diabetes mellitus, n(%)46 (9)7 (6)1.5 (0.7-3.5)High cholesterol, n(%)41 (8)8 (7)1.2 (0.4-2.6)Other comorbidities, n(%):173 (33)26 (21)1.8 (1.1 -2.8)*Use of previous biologic, n(%):216 (40)44 (36)1.2 (0.8- 1.8)Use of steroids, n(%):215 (42)34 (29)1.7 (1.1 -2.7)*Use of DMARD, n(%):418 (79)89 (72)1.4 (0.9-2.2)Adverse eventsb, n(%):69 (13)14 (11)1.2 (0.7-2.1) Severeb, n(%):12 (17)3 (21)0.8 (0.2-3.1)Univariable logistic regression analysis. *p<0.05.an=469,bn=99,cn=71,dn=19,Table 1.Analysis of association between change (Δ) in FMD and relevant parameters by univariate and multivariate linear regression analysis.UnivariateRho (p)MultivariateBeta (p)Δ FMD (%)(r2=0.30)ChangeADMA (µmol/l)-0.63 (<0.001)-0.25 (0.01)MDA (nmol/ml)-0.58 (<0.001)-0.18 (0.02)SOD (U/ml)0.48 (<0.001)NSGSH (U/ml)0.02 (0.75)NSHOMA-0.21 (0.001)NSeGFR (ml/min/ 1.73 m2)-0.03 (0.62)NShsCRP (mg/l)-0.45 (<0.001)NSPTX3 (ng/ml)-0.49 (<0.001)-0.21 (0.01)SBP (mmHg)-0.26 (<0.001)NSDBP (mmHg)-0.11 (0.12)NSHemoglobin (g/dl)0.07 (0.32)NSTotal Cholesterol (mg/dl)-0.05 (0.49)NSTriglyceride (mg/dl)-0.11 (0.12)NSLDL (mg/dl)-0.12 (0.07)NSHDL (mg/dl)0.02 (0.82)NSHbA1c (%)-0.26 (<0.001)NSFigure 1.Scatter-plot graphs between FMD and ADMA, MDA, CuZn-SOD, PTX-3.Conclusion:In our study we found sex differences regarding age and disease duration, being higher in women. As expected, the prevalence of RA was higher in women and AS and PsA in men. Overall, women used more steroids than men. An interesting finding was that patients had high disease activity. Future longitudinal analyses will allow us to analyse sex differences in disease progression and treatment response.References:[1] Ortona E et al. Ann Ist Super Sanita 2016;52(2):205-12[2] Ngo ST et al. Front Neuroendocrinol 2014;3(3):347-69Disclosure of Interests:Vijaya Rivera Teran: None declared, Deshire Alpizar-Rodriguez: None declared, Sandra Sicsik: None declared, Fedra Irazoque-Palazuelos Consultant of: Bristol-Myers Squibb, Janssen, Pfizer Inc, Roche and UCB, Dafhne Miranda: None declared, David Vega-Morales: None declared, Julio Cesar Casasola: None declared, Sandra Carrilo: None declared, angel castillo: None declared, Sergio Duran Barragan: None declared, Omar Muñoz: None declared, Aleni Paz: None declared, Angélica Peña: None declared, Alfonso Torres: None declared, Daniel Xavier Xibille Friedmann Consultant of: Lilly, Abbvie, Speakers bureau: Lilly, Abbvie, Azucena Ramos: None declared, José Francisco Moctezuma: None declared, Francisco Aceves: None declared, Estefania Torres: None declared, Natalia Santana: None declared, Miguel Vazquez: None declared, Erick Zamora: None declared, Francisco Guerrero: None declared, Claudia Zepeda: None declared, Melanea Rivera: None declared, Kitzia Alvarado: None declared, Cesar Francisco Pacheco Tena: None declared

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Sesin, C., G. Gallo, A. Gellett, A. Kronbergs, A. T. Sprabery, W. Xu, H. Patel, A. Deodhar, B. Combe, and G. R. Burmester. "POS1033 SAFETY OF IXEKIZUMAB IN PATIENTS WITH PSORIATIC ARTHRITIS: AN INTEGRATED ANALYSIS OF 4 CLINICAL TRIALS." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 789.1–789. http://dx.doi.org/10.1136/annrheumdis-2021-eular.567.

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Background:Patients with psoriatic arthritis (PsA) require long-term treatment, which may lead to adverse events (AEs). Ixekizumab, an interleukin-17A antagonist, is approved for the treatment of adults with active PsA.Objectives:We report a summary of safety outcomes for patients enrolled in 4 PsA studies with up to 3 years of exposure to ixekizumab.Methods:This integrated safety analysis included all patients with PsA who received at least 1 dose of ixekizumab (80 mg every 2 or 4 weeks) in 4 clinical trials (NCT01695239, NCT02349295, NCT02584855, NCT03151551). Safety outcomes included treatment-emergent adverse events (TEAEs), serious AEs (SAEs), discontinuations due to AEs, deaths, and AEs of special interest.Results:A total of 1401 patients were included in this safety analysis (51.5% female; mean age 49 years), with 2247.6 patient-years of exposure (Table 1). In all, 1131 patients (80.7%) reported ≥1 TEAE (exposure-adjusted incidence rate per 100 patient-years [IR] 50.3, 95% CI 47.5–53.3), mostly mild (32.9%) or moderate (39.7%) in severity. The most common TEAEs were nasopharyngitis (n=202, IR 9.0), upper respiratory infections (n=186, IR 8.3), and injection site reaction (n=156, IR 6.9). SAEs were reported by 134 patients (IR 6.0, 95% CI 5.0–7.1). 115 (8.2%) patients discontinued due to AEs (IR 5.1, 95% CI 4.3–6.1). Six deaths were reported (IR 0.3, 95% CI 0.1–0.6). Allergic reactions/hypersensitivity were reported in 102 patients (IR 4.5, 95% CI 3.7–5.5). Three cases were adjudicated as de novo inflammatory bowel disease (IR 0.13, 95% CI 0.04–0.41); 1 was ulcerative colitis (IR 0.04, 95% CI 0.01–0.32), 2 were Crohn’s disease (IR 0.09, 95% CI 0.02–0.36). Major adverse cardiac events occurred in 12 patients (IR 0.5) and malignancies in 15 (IR 0.7), 9 of which were non-melanoma skin cancer. Opportunistic infections occurred in 40 (2.9%) patients (IR 1.8, 95% CI 1.3–2.4). Candidiasis occurred in 24 patients (oral: IR 0.7, 95% CI 0.4–1.2; oral fungal infection: IR 0.3, 95% CI 0.1–0.6; esophageal infection: IR 0.1, 95% CI 0.0–0.4). No active or reactive cases of tuberculosis were reported. Other opportunistic infections included hepatitis B (IR 0.0, 95% CI 0.0–0.3), herpes simplex (IR 1.8, 95% CI 1.3–2.5), and herpes zoster (IR 0.7, 95% CI 0.4–1.2).Conclusion:The safety profile of ixekizumab across 4 clinical trials and up to 3 years of continuous treatment in patients with active PsA was consistent with the known safety profile reported in previous studies for psoriasis and PsA. No new safety events were found in this analysis.Pooled Ixekizumab(N=1401; Total Patient-Years=2247.6)n (IR)95% CIYear 0–1(n=1401)n (IR)95% CIYear 1–2(n=946)n (IR)95% CIYear 2–3(n=510)n (IR)95% CIYear ≥3(n=89)n (IR)95% CITotal Patient-Years2247.71207.3689.8347.72.9Patients with ≥1 TEAE1131 (50.3)1050 (87.0)496 (71.9)234 (67.3)6 (206.2)47.5–53.381.9–92.465.9–78.559.2–76.592.6–458.9SAEs134 (6.0)72 (6.0)53 (7.7)19 (5.5)1 (34.4)5.0–7.14.7–7.55.9–10.13.5–8.64.8–243.9Discontinuations due to AEs115 (5.1)61 (5.1)37 (5.4)17 (4.9)0 (0)4.3–6.13.9–6.53.9–7.43.0–7.90.0–274.7Hepatic reactions112 (5.0)80 (6.6)32 (4.6)14 (4.0)0 (0)4.1–6.05.3–8.33.3–6.62.4–6.80.0–274.7Allergic reaction/hypersensitivity102 (4.5)83 (6.9)23 (3.3)5 (1.4)0 (0)3.7–5.55.5–8.52.2–5.00.6–3.50.0–274.7Serious infection28 (1.2)18 (1.5)9 (1.3)3 (0.9)0 (0)0.9–1.80.9–2.40.7–2.50.3–2.70.0–274.7Malignancies15 (0.7)4 (0.3)8 (1.2)4 (1.2)0 (0)0.4–1.10.1–0.90.6–2.30.4–3.10.0–274.7Major adverse cardiac events12 (0.5)3 (0.2)8 (1.2)1 (0.3)0 (0)0.3–0.90.1–0.80.6–2.30.0–2.00.0–274.7Inflammatory bowel disease3 (0.1)3 (0.2)1 (0.1)0 (0.0)0 (0.0)0.0–0.40.1–0.80.0–1.00.0–2.30.0–274.7 Ulcerative colitis1 (0.0)1 (0.1)1 (0.1)0 (0.0)0 (0.0)0.0–0.30.0–0.60.0–1.00.0–2.30.0–274.7 Crohn’s disease2 (0.1)2 (0.2)0 (0.0)0 (0.0)0 (0.0)0.0–0.40.0–0.70.0–1.20.0–2.30.0–274.7AE, adverse event; CI, confidence interval; IR, exposure-adjusted incidence rate per 100 patient-years; SAE, serious adverse event; TEAE, treatment-emergent adverse event.Disclosure of Interests:Carlos Sesin Speakers bureau: Amgen, AbbVie, Sanofi, Radius, Pfizer, Eli Lilly and Company, Novartis, Gaia Gallo Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Amanda Gellett Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Andris Kronbergs Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Aubrey Trevelin Sprabery Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Wen Xu Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Himanshu Patel Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Atul Deodhar Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Galapagos, Glaxo Smith & Kline, Janssen, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Eli Lilly and Company, Glaxo Smith & Kline, Novartis, Pfizer, UCB, Bernard Combe Speakers bureau: AbbVie, BMS, Gilead-Galapagos, Eli Lilly and Company, MSD, Pfizer, Roche Chugai, Consultant of: AbbVie, Bayer, Gilead-Galapagos, Janssen, Eli Lilly and Company, Novartis, Roche Chugai, Grant/research support from: AbbVie, Eli Lilly and Company, Pfizer, Roche Chugai, Gerd Rüdiger Burmester Speakers bureau: AbbVie, Janssen, Novartis, Eli Lilly and Company, MSD, Pfizer, Consultant of: AbbVie, Janssen, Novartis, Eli Lilly and Company, MSD, Pfizer.

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McIsaac, Mark, Gordon Kaban, Adam Clay, Warren Berry, and Bhanu Prasad. "Long-Term Impact of Bariatric Surgery on Renal Outcomes at a Community-Based Publicly Funded Bariatric Program: The Regina Bariatric Study." Canadian Journal of Kidney Health and Disease 6 (January 2019): 205435811988490. http://dx.doi.org/10.1177/2054358119884903.

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Background: Obesity is recognized as an independent risk factor for chronic kidney disease through multiple direct and indirect biological pathways. Bariatric surgery is a proven, effective method for sustained weight loss. However, there is a relative paucity of data on the impact of bariatric surgery on renal outcomes. Objective: The primary objective was to evaluate the change in urine albumin/creatinine ratio (ACR) in patients undergoing bariatric surgery, at 12 months after the procedure. Secondary objectives were to determine the changes in ACR at (6 and 24 months), estimated glomerular filtration rate (eGFR; 6, 12, and 24 months), and hemoglobin A1c (HbA1c); 12 and 24 months) after the procedure. Design: This observational retrospective cohort study included consecutive obese patients who underwent bariatric surgery. Setting: Provincial Bariatric Surgery Clinic at the Regina General Hospital, Saskatchewan. Patients: This study includes 471 consecutive obese adult patients who underwent bariatric surgery between 2008 and 2015. Measurements: We studied the impact of bariatric surgery on body mass index (BMI), renal outcomes (urine ACR and eGFR) and metabolic outcomes (fasting glucose, total cholesterol, low-density lipoprotein, triglycerides, and HbA1c) in 471 patients. Methods: Patients were followed for 2 years postsurgery in the bariatric clinic. Mixed linear models that accounted for the repeated nature of the data were used to access changes in outcomes over time. Results: Patients were predominantly female (81%) with a mean age (±SD) of 46 ± 10 years. Most patients (87%) had a BMI > 40 kg/m2 and 81% of the patients underwent Roux-en-Y gastric bypass. The mean BMI decreased from 47.7 ± 7.8 kg/m2 at baseline to 37.1 ± 7.9 kg/m2 at 6 months and 34.8 ± 8.8 kg/m2 at 12 months. In a subcohort of patients with microalbuminuria, ACR showed an improvement from a median [interquartile] value of 5.1 [3.7-7.5] mg/mmol at baseline to 2.3 [1.2-3.6] mg/mmol at 6 months ( P = .007), to 1.4 [0.9-3.7] mg/mmol at 2-year follow-up ( P < .001). Similarly, eGFR increased in patients with microalbuminuria from 109 ± 10 mL/min/1.73 m2 at baseline to 120 ± 36 mL/min/1.73 m2 at 2-year follow-up ( P = .013). There were statistically significant reductions in triglycerides, fasting glucose, and HbA1c. Limitations: This was a retrospective chart review, with the lack of a control group. Patients with eGFR less than 60 mL/min/1.73 m2 were not considered for surgery, and we had to measure renal outcomes predominantly on the presence of proteinuria. Conclusions: Our results suggest bariatric surgery significantly decreased weight and consequently improved renal and metabolic outcomes (eGFR, ACR, fasting glucose, cholesterol, and triglycerides) in patients with elevated BMI.

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Teshima, Takanori, K. Matsuo, K. Matsue, F. Kawano, S. Taniguchi, K. Hatanaka, S. Nakao, et al. "Impact of HLA Mismatch on the Incidence of Acute GVHD and Rejection after Reduced-Intensity Conditioning Hematopoietic Stem Cell Transplantation (RICT)." Blood 104, no. 11 (November 16, 2004): 2758. http://dx.doi.org/10.1182/blood.v104.11.2758.2758.

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Abstract HLA incompatibility between the donor and recipient is the most critical factor governing the incidence of rejection and GVHD after conventional allogeneic stem cell transplantation. But the impact of HLA disparity on GVHD and graft rejection after RICT remains to be elucidated. We retrospectively analyzed the outcomes of 437 patients who underwent bone marrow (n=95) or peripheral blood stem cell RICT (n=342). The numbers of patients who received a graft from a HLA-matched (275 from siblings, 11 from family members, and 54 from unrelated donors), one-locus-mismatched, 2- or 3-loci-mismatched donor were 340, 65, and 32, respectively. The HLA-matched group included significantly higher population of patients who received cyclosporine alone for GVHD prophylaxis. The overall cumulative incidence of grade II-IV acute GVHD was 40% for all subjects. It was 38% (95% CI; 33%–43%) in recipients of HLA-matched donors, 43% (95% CI; 31%–54%) in those of one-locus-mismatched donors, and 54% (95% CI; 37%–68%) in those of 2–3-loci-mismatched donors. A Cox regression model adjusted for potential confounders including GVHD prophylaxis demonstrated that 2-3 loci-mismatch was identified as an independent risk factor of grade II-IV acute GVHD (Table). Use of antithymocyte globulin was identified as an independent better protective factor for GVHD (HR;0.66, p=.003). Cumulative incidence of rejection was significantly higher after one-locus mismatch RICT (Table) and the risk tended to increase in relation to an increase of HLA disparity. Malignant disease was identified as an independent prognostic factor for rejection. In patients with hematologic malignancies, overall survival (OS) of recipients of 2–3-loci-mismatched RICT at 1 year (38%, 95%CI; 21%–54%) was significantly worse than that after HLA-matched RICT (65%, 95%CI; 59%–70%). By contrast, there was no statistical difference in the incidence of grade II-IV acute GVHD and OS between HLA-matched RICT and one-locus-mismatched RICT. Multivariate analysis demonstrated 2–3-loci-mismatch (Table) and high-risk disease (HR; 2.3, p=.001) as independent risk factors for OS. Thus, HLA incompatibility between the donor and recipient is an important risk factor for rejection, acute GVHD and overall survival after RICT. Therefore RICT from a one-locus-mismatched donor may represent an effective alternative approach in patients lacking HLA-matched sibling donors. multivariate analysis n acute GVHD Rejection OS HR (95%CI) p HR (95%CI) p HR (95%CI) p match 340 1.0 1.0 1.0 1-mismatch 65 1.4 (0.9–2.2) 0.20 4.5 (1.1–17.9) 0.03 1.0 (0.6–1.6) 0.88 2–3-mismatch 32 2.2 (1.2–4.1) 0.02 7.0 (0.8–64.8) 0.08 3.3 (1.8–6.2) <0.001

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Dasari, Arvind, James C. Yao, Alberto F. Sobrero, Takayuki Yoshino, William R. Schelman, Shivani Nanda, Caly Chien, et al. "FRESCO-2: A global phase III study of the efficacy and safety of fruquintinib in patients (pts) with metastatic colorectal cancer (mCRC)." Journal of Clinical Oncology 39, no. 3_suppl (January 20, 2021): TPS154. http://dx.doi.org/10.1200/jco.2021.39.3_suppl.tps154.

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TPS154 Background: Pts with mCRC have limited treatment options following progression on standard therapies. Current standard of care (SOC) after pts progress on trifluridine/tipiracil (TAS-102) or regorafenib is re-challenge with previous systemic treatments, enrollment in a clinical trial, or best supportive care (BSC). Fruquintinib (Elunate) is a novel, highly selective, vascular endothelial growth factor (VEGF) receptor (VEGFR)-1, -2, and -3 tyrosine kinase inhibitor (TKI) ( Cancer Biol Ther 2014;15:1635-1645). Fruquintinib is approved in China to treat pts with mCRC who received or are intolerant to fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, if RAS wild type, anti-epidermal growth factor receptor (EGFR) therapy. Approval was based on results of the phase 3 FRESCO study (2013-013-00CH1; NCT02314819; JAMA 2018;319:2486-2496), in which fruquintinib 5 mg daily (QD), 3 weeks on, 1 week off (3 on/1 off), significantly improved overall survival (OS) in pts with mCRC in the 3rd-line+ setting when compared to placebo (median OS 9.3 months [mo] versus 6.6 mo; hazard ratio [HR] 0.65; p < .001). Progression-free survival (PFS) was also superior (median PFS 3.7 mo versus 1.8 mo; HR 0.26; p < .001). The toxicities of fruquintinib were consistent with those of other VEGF TKIs and were manageable. At the time FRESCO was conducted in China, SOC for pts with mCRC differed from that in the US, EU, and Japan. We describe here a global phase 3 study (FRESCO-2; 2019-013-GLOB1; NCT04322539) being conducted to investigate fruquintinib’s efficacy and safety in pts with refractory mCRC and a treatment profile representative of the global SOC. Methods: FRESCO-2 is a randomized, double-blind, placebo-controlled study to compare fruquintinib + BSC to placebo + BSC. Key inclusion criteria are progression on or intolerance to treatment with TAS-102 and/or regorafenib; previous treatment with standard approved therapies including chemotherapy, anti-VEGF therapy, and, if RAS wild type, anti-EGFR therapy. Prior therapy with immune checkpoint or BRAF inhibitors is required for pts with corresponding tumor alterations. Pts (~522) will be randomized 2:1 to receive either fruquintinib 5 mg orally (PO) QD + BSC or placebo 5 mg PO QD + BSC, with a 3 on/1 off schedule. Randomization will be stratified by prior therapy, RAS status, and duration of metastatic disease. The primary endpoint is OS; secondary endpoints include PFS, disease control rate, objective response rate, duration of response, and safety. Final OS analyses will be performed when 364 OS events are observed; futility analysis will be conducted with 1/3 (121) OS events. If enrichment of post-regorafenib pts occurs, enrollment to that strata will be capped at approximately 262. FRESCO-2 will be activated in the US, EU, and Japan; global enrollment is anticipated over 13 mo. Clinical trial information: NCT04322539.

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Sierra-Díaz, Diana Carolina, Adrien Morel, Dora Janeth Fonseca, Nora Contreras, Mariana Angulo-Aguado, Valentina Balaguera, Kevin Llinás-Caballero, et al. "Abstract P3-07-05: Genetic profile of germline mutations in unselected women with breast cancer in a Colombian population." Cancer Research 82, no. 4_Supplement (February 15, 2022): P3–07–05—P3–07–05. http://dx.doi.org/10.1158/1538-7445.sabcs21-p3-07-05.

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Abstract Introduction In Colombia Breast cancer (BC), is the most frequent and has the highest mortality rate among all types of cancer. There are few studies of the genomic profile in unselected affected population by BC in Colombia. Some of these studies have only tested the presence of variants reported as founders named “Colombian Profile”.We conducted a large-scale genomic analysis using Whole Exome Sequencing (WES) to evaluate germline mutations in unselected BC patients. Methods This trial included 299 unselected BC female patients aged over 18 years old, without personal and family history of germline BC risk mutations.The protocol was approved by the IRC and EC of Fundación Cardioinfantil (FCI). All patients signed informed consent before recruitment.Genomic DNA was extracted from peripheral blood samples and was used to WES (Novogene Inc. Beijing, China). The variants were filtered using VarSeq v2.1.1 software, following the criteria: missense, non-sense, frameshift, and intronic variants, we additionally considered a MAF ≤0.01 for ATM, CHEK2, and PALB2 genes.Clinical significance of each variant was annotated according to the ACMG/AMP and ENIGMA guidelines.MLPA was assessed using the commercial kit SALSA MLPA Probemix P002-D1 for BRCA1 and P090-C1 for BRCA2 (MRC-Holland, Amsterdam).This study was financially supported by an unrestricted grant from Pfizer. Results This abstract is the first report from 299 patients. To determine the presence of germline variants in the patients a WES was performed. Here we describe the pathogenic and probably pathogenic mutations in BRCA1, BRCA2, ATM, CHEK2, PALB2. We found BRCA1/2 alterations were found in 3.7% of the patients (11 patients, IC 95% 1.7-5.6%), 5 patients in BRCA1 and 6 patients in BRCA2 (1.7% IC 95% 0.7-4%, and 2% IC 95% 0.9-4.4% respectively). We found 29 patients had mutations unrelated to BRCA1/2 (9.5% IC 95% 5.8-11.7%). The most frequently affected gene was ATM (17 patients, 5.7% IC95% 3.6-9%). Discussion and conclusion We found that 12.2% of the population of the study were carriers of a pathogenic/likely pathogenic variant in the evaluated genes, and interestingly 9.5% of them corresponded to non-BRCA1/2 genes. ATM variants have a prevalence of 5.7% in the whole population and represent 42% of all the variants. Other mutations in genes like BRCA2, ATM and CHEK2 were exclusive in non-TNBC. Meanwhile, BRCA1 and PALB2 mutations had higher frequencies in TNBC. We identified five novel mutations.We demonstrate that LGRs are not an important molecular cause in non-hereditary cases of BC.27% of the carriers of mutations in BRCA1/2 did not fulfilled NCCN criteria and 82% of the mutations are not described in “Colombian Profile”. These findings demonstrate the particular genetic profile in an unselected population with breast cancer, and this highlights the importance of WES as a molecular diagnostic tool. We think that universal germline testing in cancer should be considered. Baseline demographic and clinical characteristics Demographic and clinical characteristics of patients with pathogenic and likely pathogenic mutationsVariableBRCA1 n (%, IC 95%)BRCA2 n (%, IC 95%)ATM n (%, IC 95%)PALB2 n (%, IC 95%)CHEK2 n (%, IC 95%)Median age37.4 (22.4 – 54.3)45.5 (36.2 – 54.7)53.1 (45.4 – 60.7)55.8 (27.9 – 83.5)NA*Age≤ 50 years4 (80, 11.1 – 99.2%)4 (66.7, 14.8 – 95.8%)8 (47.1, 23.5 – 80%)2 (50, 24.7 – 97.5)NA*> 50 years1 (20, 0.7 – 88.9%)2 (33.3, 4 – 85%)9 (52.9, 28 – 76.5%)2 (50, 24.7 – 97.5)OverweightYes4 (80, 11 – 99-2%)(33.3, 4 – 85%)9 (52.9, 28 – 76.5%) 3 (75, 0.4 – 99.5%)NA*No1 (20, 0.8 – 88.9%)(66.7, 14.9 – 94.8%)8 (47, 23.5 – 80%)1 (25, 0.4 – 95.9%)Estrogen receptor(+)2 (0.9%, 0.2 – 3.5%)5 (2.2%, 0.9 – 5.3%)16 (7.1%, 4.4 – 11.3%)3 (1.3%, 0.4 – 4.1%)3 (1.3%, 0.4 – 4.1%)(-)3 (4.3%, 1.4 – 12.6%)1 (1.4%, 0.2 – 9.6%)1 (1.4%, 0,2 – 9.6%)1 (1.4%, 0.2 – 9.6%)1 (1.4%, 0.2 – 9.6%)Progesterone receptor(+)2 (0.9%, 0.2 – 3.5%)5 (2.2%, 0.9 – 5.3%)13 (6%, 3.7 – 10.5%)3 (1.3%, 0.4 – 4.1%)4 (1.9%, 0.7 – 5%)(-)3 (4.3%, 1.4 – 12.6%)1 (1.4%, 0,2 – 9.6%)4 (4%, 1.7 – 11.7%)1 (1.4%, 0.2 – 9.6%)0HER-2 3+Yes1 (1.3%, 0.2 – 8.5%)1 (1.3%, 0.2 – 8.5%)4 (5%, 1.9 – 12.7%)1 (1.3%, 0.2 – 8.5%)2 (2.5%, 0.6 – 9.6%)No4 (1.9%, 0.7 – 4.9%)5 (2.3, 0.1 – 5.5%)13 (6%, 3.5- 10.2%)3 (1.4%, 0.4 – 4.3%)2 (0.9%, 0.2 – 3.7%)ER/Pgr y HER-2 negativeYes2 (5.1, 1.3 – 18.7%)001 (2.5%, 0-3 – 16.5%)0No3 (1.2%, 0.4 – 3.6%)6 (2.3%, 1 – 5.1%)17 (6.6%, 4-2 – 10.4%)3 (1.2%, 0.4 – 3.6%)4 (1.6%, 0.6 – 4.1%)Ki67<20%0 1 (16.7, 0.9 – 81%) 5 (29.4, 11.5 – 57.1)0NA*≥20%5 (100%)5 (83.3, 18.6 – 99%)12 (70.6, 42.8 – 88.5%)4 (100%)Median tumoral size mm (min-max)24 (19.6 – 47.8)21 (12.5 – 29.5)24.9 (19.6 – 30.3)27.6 (0 – 59)NA* Lymph nodes involvementYes1 (0.7%, 0.1 – 4.6%)2 (1.3%, 0.3 – 5.2%)10 (6.7%, 3.6 – 12.1%)3 (2%, 0.6 – 6.1%)4 (2.7%, 1 – 7%)1No4 (2.7%, 1 – 7%)4 (2.7%, 1 – 7%)7 (4.7%, 2.2 – 9.5%)1 (0.7%, 0.1 – 4.6%)0MetastasisYes00001 (9%, 1.1 – 46.6%)2No5 (1.9%, 0.8 – 4.5%)6 (2.3%, 1 – 5%)17 (5.7%, 3.5 – 9.3%)4 (1.5 – 0.5 – 4%)3 (1.1%, 0.4 – 3.5%)Clinical stage (AJCC)I2 (40, 3.7 – 91.9%)1 (16.7, 0.9 – 81.3%)4 (23.5, 81 – 51.8%)0NA*II2(40 3.7 – 91.9%)4 (66.7, 14.8 – 95.8%)7 (41.2, 19.3 – 67.3%)4 (100%)III1 (20, 0.7 – 88.9%)1 (16.7, 0.9 – 81.3%)6 (23-3, 15.2 – 62.3%)0IV0000Family history for cancerYes4 (80, 11.1 – 99.2%)5 (83.3, 9 – 81.4%)13 (76.5 – 48.2 – 91.9%)2 (50, 2- 97.5%)NA*No1 (20, 0.7 – 88-9)1 (16.7, 0.9 – 81.4%)4 (23, 8 – 51.8%)2 (50, 2- 97.5%)NCCN criteriaYes4 (2.4%, 0.9 – 6.3%)4 (2.4%, 0.9 – 6.3%)NA*NA*NA*No1 (0.8%, 0.1 – 5.9%)2 (1.7%, 0.4 – 6.6%)Colombian profileYes1 (50%, 19 – 98%)31(50%, 19 – 98%)3NA*NA*NA*No4 (13.5%, 5 – 35.5%)5 (17%, 7 – 40%) Citation Format: Diana Carolina Sierra-Díaz, Adrien Morel, Dora Janeth Fonseca, Nora Contreras, Mariana Angulo-Aguado, Valentina Balaguera, Kevin Llinás-Caballero, Isabel Munevar, Mariana Borras, Mauricio Lema, Henry Idrobo, Daniela Trujillo, Norma Serrano, Ana Isabel Orduz, Diego Lopera, Jaime Gonzalez, Gustavo Rojas, Paula Londoño, Ray Manneh, Catalina Quintero, Paul Laissue, Rodrigo Cabrera, Carlos M Restrepo, William Mantilla. Genetic profile of germline mutations in unselected women with breast cancer in a Colombian population [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-07-05.

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Hackney, Madeleine E., Eeshani Singh, Ella Leeth, Allison Bay, and Liang Ni. "MEN WITH PARKINSON'S MAY HAVE GREATER DISEASE BURDEN IN ASPECTS OF COGNITIVE AND PSYCHOSOCIAL FUNCTION THAN WOMEN." Innovation in Aging 3, Supplement_1 (November 2019): S948—S949. http://dx.doi.org/10.1093/geroni/igz038.3445.

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Abstract Early in PD, women may experience a more benign disease course than man. Limited research has examined differences between men and women with moderate, treated PD with a mean duration >5 y. Retrospective analyses were performed on data collected from studies, conducted 2011–2019, that assessed motor, cognitive and psychosocial function in 199 people with PD (women=72). We compared performance using univariate analyses, adjusting for age, housing type and education. Men and women patients were not different in PD stage (Stage Mdn= 2, IQR=.5), age (mean±SD; 69.1± 8.9 y), education (16.4 ± 2.3 y), number of medications (5.9±4.1), comorbidities (3.4±1.8), physical function, nor time with PD (6.6±4.6 y). Women were more likely to live in assisted living or senior residences (p=.005). Men gave more correct answers in subtraction, (8.8 ± 4.0 vs. 6.4±3.7; p<.001) but sexes did not differ in percent correct. On the MDS-UPDRS, Men exhibited more burden in subjectively rated non-motor (13.4 ± 7.6 vs. 10.7±7.3; p=.013), and motor experiences of daily living (16.9±8.9 vs. 10.6±7.1; p<.001) and motor symptoms (34.1 ± 12.1 vs. 31.8±12.2; p=.014). Men performed worse at inhibition (6.4±4.6 vs. 7.8 ± 5.0; p=.014) but made fewer errors on inhibition/switching (7.0±3.9 vs.7.8±4.4; p=.05). Men had higher depression scores: 12.5±8.9 vs. 9.4±7.8; p=.016. No differences in performance on spatial cognition were noted. Men with moderate PD were more depressed, had worse motor and cognitive function, non-motor and motor experiences of daily living and motor symptoms than women. Sex-tailored therapies may reduce differences in performance between sexes.

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Fairushina, I., D. Abdulganieva, E. Kirillova, and E. Mukhametshina. "AB1091 FREQUENCY OF ULTRASOUND ENTHESITIS AND SYNOVITIS IN DIFFERENT ANATOMICAL SITES OF UPPER AND LOWER EXTREMITIES IN PATIENTS WITH PSORIATIC ARTHRITIS: CROSS-SECTIONAL STUDY." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1834.2–1835. http://dx.doi.org/10.1136/annrheumdis-2020-eular.5900.

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Background:Psoriatic arthritis (PsA) is characterized by asymptomatic enthesitis and synovitis1. The location of pathological lesions is not clear. Furthermore, ultrasound (US) enthesitis indices assess limited number of entheses.Objectives:To detect the most frequent sites of US enthesitis and synovitis in PsA.Methods:57 PsA patients were enrolled to the study. US examination included bilateral large 14 joints; entheses of tendons and ligaments in the projection of examined joints (total number - 54). Totally, 798 joints, 3078 entheses were examined. The study was conducted by US rheumatologist. Data collection: demographical, clinical, US (total synovitis count by grey scale, enthesitis counted as the sum of structural and acute components (US entheseal findings assessed by the definition and scoring for enthesitis in PsA (OMERACT US)2. Chi-square test used to calculate difference of articular and entheseal frequency between upper and lower extremities.Results:In all 57 patients: male - 25 (43.9%), mean age 43.4±10.3(SD) years (y), PsA duration was 7 (3;10) y, Disease Activity in PsA score 18.1 (10.2;26.1).Table.Frequency of articular and entheseal involvement of different anatomical sites in PsAUpper extremities / Joints / EnthesesFrequencyLower extremities / Joints / EnthesesFrequencyAcromioclavicular29/456 (6.4%)Hip19/342 (5.6%)Shoulder3/456 (0.7%)Knee28/342 (8.2%)Elbow10/456 (2.2%)Ankle23/342 (6.7%)Wrist27/456 (5.9%)Trochanter major:-gluteus minimum-gluteus medium31/2166 (1.4%)36/2166 (1.7%)Short head of the biceps brachii11/912 (1.2%)Spina iliaca anterior-superior-inferior13/2166 (0.6%)8/2166 (0.4%)Coracoacromial ligament5/912 (0.5%)Ischiadicus tuberositas36/2166 (1.7%)Infrascapularis19/912 (2.1%)Medial collateral ligament-Proximal-Distal44/2166 (2%)25/2280 (1.2%)Supraspinatus18/912 (1.9%)Lateral collateral ligament-Proximal-Distal23/2166 (1.1%)9/2166 (0.4%)Infraspinatus5/912 (0.5%)Patellar ligament-Proximal-Distal19/2166 (0.9%)25/2166 (1.2%)Triceps brachii21/912 (2.3%)-Pes anserinus37/2166 (1.7%)Medial epicondyle21/912 (2.3%)Biceps femoris7/2280 (0.3%)Lateral epicondyle34/912 (3.7%)Semimembranosus35/2166 (1.6%)Quadriceps femoris52/2166 (2.4%)Tibialis anterior9/2166 (0.4%)Tibialis posterior13/2166 (0.6%)Achille46/2166 (2.1%)Plantar fascia30/2166 (1.4%)There was difference between US synovitis detection of upper (57,1%) and lower (42,9%) extremities (p=0.04). Total count of US enthesitis of lower extremities (70,4%) was significantly higher than of the upper (29,6%;p<0.01).Conclusion:US synovitis of upper extremities was slightly higher than in lower. US enthesitis of lower extremities is significantly higher. US imaging can be used to diagnose enthesitis and synovitis, especially in patients in whom symptoms may be difficult to discern, and data on location of pathological lesions will be useful.References:[1]Perrotta FM, Astorri D, Zappia M, Reginelli A, Brunese L, Lubrano E. An ultrasonographic study of enthesis in early psoriatic arthritis patients naive to traditional and biologic DMARDs treatment. RheumatolInt 2016;36:1579-83.[2]Balint PV, Terslev L, Aegerter P et al. Reliability of a consensus-based ultrasound definition and scoring for enthesitis in spondyloarthritis and psoriatic arthritis: an OMERACT US initiative. Ann Rheum Dis.;2018;77(12):1730-1735.Disclosure of Interests:None declared

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Yu, Hongfan, Qingsong Yu, Yuxian Nie, Wei Xu, Yang Pu, Wei Dai, Xing Wei, and Qiuling Shi. "Data Quality of Longitudinally Collected Patient-Reported Outcomes After Thoracic Surgery: Comparison of Paper- and Web-Based Assessments." Journal of Medical Internet Research 23, no. 11 (November 9, 2021): e28915. http://dx.doi.org/10.2196/28915.

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Background High-frequency patient-reported outcome (PRO) assessments are used to measure patients' symptoms after surgery for surgical research; however, the quality of those longitudinal PRO data has seldom been discussed. Objective The aim of this study was to determine data quality-influencing factors and to profile error trajectories of data longitudinally collected via paper-and-pencil (P&P) or web-based assessment (electronic PRO [ePRO]) after thoracic surgery. Methods We extracted longitudinal PRO data with 678 patients scheduled for lung surgery from an observational study (n=512) and a randomized clinical trial (n=166) on the evaluation of different perioperative care strategies. PROs were assessed by the MD Anderson Symptom Inventory Lung Cancer Module and single-item Quality of Life Scale before surgery and then daily after surgery until discharge or up to 14 days of hospitalization. Patient compliance and data error were identified and compared between P&P and ePRO. Generalized estimating equations model and 2-piecewise model were used to describe trajectories of error incidence over time and to identify the risk factors. Results Among 678 patients, 629 with at least 2 PRO assessments, 440 completed 3347 P&P assessments and 189 completed 1291 ePRO assessments. In total, 49.4% of patients had at least one error, including (1) missing items (64.69%, 1070/1654), (2) modifications without signatures (27.99%, 463/1654), (3) selection of multiple options (3.02%, 50/1654), (4) missing patient signatures (2.54%, 42/1654), (5) missing researcher signatures (1.45%, 24/1654), and (6) missing completion dates (0.30%, 5/1654). Patients who completed ePRO had fewer errors than those who completed P&P assessments (ePRO: 30.2% [57/189] vs. P&P: 57.7% [254/440]; P<.001). Compared with ePRO patients, those using P&P were older, less educated, and sicker. Common risk factors of having errors were a lower education level (P&P: odds ratio [OR] 1.39, 95% CI 1.20-1.62; P<.001; ePRO: OR 1.82, 95% CI 1.22-2.72; P=.003), treated in a provincial hospital (P&P: OR 3.34, 95% CI 2.10-5.33; P<.001; ePRO: OR 4.73, 95% CI 2.18-10.25; P<.001), and with severe disease (P&P: OR 1.63, 95% CI 1.33-1.99; P<.001; ePRO: OR 2.70, 95% CI 1.53-4.75; P<.001). Errors peaked on postoperative day (POD) 1 for P&P, and on POD 2 for ePRO. Conclusions It is possible to improve data quality of longitudinally collected PRO through ePRO, compared with P&P. However, ePRO-related sampling bias needs to be considered when designing clinical research using longitudinal PROs as major outcomes.

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Viñoles, C., B. L. Paganoni, K. P. McNatty, D. A. Heath, A. N. Thompson, K. M. M. Glover, J. T. B. Milton, and G. B. Martin. "Follicle development, endocrine profiles and ovulation rate in adult Merino ewes: effects of early nutrition (pre- and post-natal) and supplementation with lupin grain." REPRODUCTION 147, no. 1 (January 2014): 101–10. http://dx.doi.org/10.1530/rep-13-0104.

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In adult ewes, we tested whether ovarian function, including the response to short-term supplementation, was affected by the nutrition of their mothers during the pre-/post-natal period. A 2×2 factorial design was used with nutrition in early life (low or high) and a 6-day supplement (with or without) as factors. All ewes received three prostaglandin (PG) injections 7 days apart, and the supplement (lupin grain) was fed for 6 days from 2 days after the second until the third PG injection. We measured reproductive and metabolic hormones, studied follicle dynamics (ultrasonography), and evaluated granulosa cell numbers, aromatase activity and oestradiol (E2) concentrations in follicular fluid in healthy follicles at days 3 and 7 of supplementation. Ovulation rate was increased by 25% by exposure to high pre-/post-natal nutrition (1.5 vs 1.2; P<0.05), in association with a small decrease in FSH concentrations (P=0.06) and a small increase in insulin concentrations (P=0.07). The number of healthy antral follicles was not affected. Acute supplementation increased the number of granulosa cells (3.7±0.2 vs 3.0±0.2 million; P<0.05) in the largest follicle, and the circulating concentrations of E2 (4.6±0.3 vs 3.9±0.3 pmol/l; P<0.05) and glucose (3.4±0.03 vs 3.3±0.03 mmol/l; P<0.01). Both early life nutrition and acute supplementation appear to affect ovulation rate through changes in glucose–insulin homoeostasis that alter follicular responsiveness to FSH and therefore E2–FSH balance.

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Pinte, Larisa, Simona Caraiola, Daniel Vasile Balaban, Camelia Badea, Diana Mazilu, Georgeta Daniela Ionescu, Maria-Ilinca Iosub, et al. "COVID-19 Impact and Vaccination Willingness among Romanian Patients with Autoimmune/Immune-Mediated Diseases." Healthcare 9, no. 12 (December 8, 2021): 1707. http://dx.doi.org/10.3390/healthcare9121707.

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Background: During the COVID-19 pandemic, patients with immune diseases are a vulnerable population. We aimed to evaluate their access to medical care, as well as their awareness and willingness to obtain the vaccine after a year of the SARS-CoV-2 pandemic. Methods: A cross-sectional, multicenter study was conducted on a questionnaire basis, handled both online as well as in person. Results: 651 patients with autoimmune or immune mediated diseases were enrolled. More than half (339/641 [53%]) reported difficulties in obtaining medical care throughout the pandemic and 135/651 ([21%]) of them were confirmed with COVID-19; 442/651, ([68%]) expressed their willingness to be vaccinated against SARS-CoV-2. The factors associated with an increased probability of vaccination were the male gender (OR = 2.01, CI95% 1.2–3.7, p = 0.001), the patient’s opinion that she/he was well informed (OR = 3.2, CI 95% 2.1–6.01, p < 0.001), physician’s advice (OR = 2.1, CI 95% 1.3–3.5, p < 0.001), and flu vaccination in the past (OR = 1.5, CI 95% 1.1–2.3, p < 0.001), while those associated with a decreased probability of vaccination were COVID-19 disease in the past medical history (OR = 0.7, CI 95% 0.3-0.95, p = 0.02), and the opinion that patients with autoimmune diseases are at increased risk for adverse reactions (OR = 0.7, CI95% 0.53–0.89, p = 0.001). Conclusions: Given the fact that considering themselves informed regarding vaccination is the most important factor in order to be immunized against SARS-CoV-2, effective information campaigns would substantially increase willingness.

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Gossec, L., D. D. Gladman, E. Mcdearmon-Blondell, P. Sewerin, C. T. Ritchlin, D. Feng, A. Lertratanakul, et al. "AB0550 EFFICACY OF UPADACITINIB IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS AND A LOW OR HIGH SWOLLEN JOINT COUNT: A SUBGROUP ANALYSIS OF 2 PHASE 3 STUDIES (SELECT-PsA 1 AND SELECT-PsA 2)." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 1308.2–1309. http://dx.doi.org/10.1136/annrheumdis-2021-eular.2127.

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Background:Although most patients with psoriatic arthritis (PsA) enrolled in clinical trials have polyarticular arthritis, patients in clinical practice may present with oligoarthritis. Data on the efficacy of Janus kinase inhibitors in patients with PsA with low joint counts are limited.Objectives:To evaluate the efficacy of upadacitinib (UPA) in subgroups of patients with PsA with a low (baseline swollen joint count [SJC] <5) or high (SJC ≥5) SJC (LSJ or HSJ).Methods:Data were pooled across the SELECT-PsA 11 (non-biologic disease-modifying antirheumatic drug [non-bDMARD] inadequate response [IR] or intolerance) and SELECT-PsA 22 (bDMARD IR or intolerance) trials, which both enrolled patients with ≥3 involved joints (SJC ≥3 and tender joint count [TJC] ≥3). Subgroup analysis was performed for patients with LSJ or HSJ treated with UPA 15 mg once daily (QD) or placebo (PBO). Efficacy endpoints included minimal disease activity (MDA), very low disease activity (VLDA), Psoriatic Arthritis Disease Activity Score (PASDAS) low disease activity (LDA; ≤3.2), PASDAS remission (≤1.9), and 20/50/70% improvement in American College of Rheumatology (ACR) criteria (ACR20/50/70), all at Week 24, and Psoriasis Area Severity Index (PASI) 75 and static Investigator Global Assessment of Psoriasis (sIGA) 0/1 at Week 16.Results:At baseline, patients with HSJ (n=1060) had similar demographic characteristics but tended to have higher overall disease activity than patients with LSJ across multiple disease domains (n=215; Table 1). UPA efficacy appeared comparable in patients with LSJ and HSJ, with similar proportions of patients achieving composite (MDA, VLDA, PASDAS LDA, and PASDAS remission) measures at Week 24, and skin endpoints (PASI 75 and sIGA 0/1) at Week 16 (Figure 1). At Week 24, 60.0/36.8/22.1% of patients with LSJ receiving UPA 15 mg achieved ACR20/50/70 vs 40.0/17.5/5.8% in the PBO group; rates were 70.3/49.7/26.2% (UPA 15 mg) and 36.1/15.3/3.3% (PBO) in those with HSJ.Table 1.Baseline characteristicsPBOUPA 15 mg QDTotalLSJn=120HSJn=515LSJn=95HSJn=545LSJn=215HSJn=1060Female, n (%)65 (54.2)266 (51.7)49 (51.6)302 (55.4)114 (53.0)568 (53.6)Age (years), mean (SD)52.2 (12.7)51.5 (12.0)52.0 (10.6)52.0 (12.4)52.1 (11.8)51.8 (12.2)Duration since PsA symptoms (years), mean (SD)10.5 (9.2)11.1 (10.2)9.8 (8.2)10.3 (8.9)10.2 (8.7)10.7 (9.6)BMI, mean (SD)29.7 (6.3)31.1 (7.2)29.8 (6.2)30.7 (6.9)29.7 (6.2)30.9 (7.0)Prior failed bDMARDs, n (%)03 (2.5)15 (2.9)1 (1.1)15 (2.8)4 (1.9)30 (2.8)122 (18.3)113 (21.9)22 (23.2)104 (19.1)44 (20.5)217 (20.5)24 (3.3)31 (6.0)7 (7.4)28 (5.1)11 (5.1)59 (5.6)≥34 (3.3)20 (3.9)7 (7.4)27 (5.0)11 (5.1)47 (4.4)Use of ≥1 non-bDMARD atbaseline, n (%)87 (72.5)360 (69.9)63 (66.3)388 (71.2)150 (69.8)748 (70.6)Dactylitis (LDI >0), n (%)21 (17.5)169 (32.8)15 (15.8)176 (32.3)36 (16.7)345 (32.5)Enthesitis (LEI >0), n (%)60 (50.0)325 (63.1)60 (63.2)343 (62.9)120 (55.8)668 (63.0)TJC68, mean (SD)12.5 (11.3)23.9 (15.8)14.6 (13.5)23.1 (15.8)13.4 (12.3)23.5 (15.8)SJC66, mean (SD)3.5 (0.5)13.2 (8.3)3.6 (0.5)12.9 (9.0)3.6 (0.5)13.0 (8.7)HAQ-DI, mean (SD)1.0 (0.6)1.2 (0.7)0.9 (0.6)1.2 (0.6)0.9 (0.6)1.2 (0.7)hs-CRP > ULN (mg/L), n (%)82 (68.3)363 (70.5)62 (65.3)388 (71.2)144 (67.0)751 (70.8)BSA-Ps, median (range)3.0 (0.1–70.0)4.0 (0.1–95.0)2.0 (0.1–80.0)3.0 (0.1–97.0)3.0 (0.1–80.0)3.0 (0.1–97.0)BSA-Ps ≥ 3%, n (%)57 (47.5)285 (55.3)44 (46.3)300 (55.0)101 (47.0)585 (55.2)PASI (baseline BSA-Ps ≥ 3%), mean (SD)7.7 (7.5)12.1 (11.9)8.2 (7.0)10.2 (10.0)7.9 (7.2)11.1 (11.0)PASI (baseline BSA-Ps ≥ 3%), median (range)5.3 (0.1–39.4)7.9 (0.3–64.8)6.5 (0.2–35.4)6.8 (0.1–70.8)6.0 (0.1–39.4)7.3 (0.1–70.8)Conclusion:UPA efficacy was generally similar in patients with PsA with LSJ or HSJ, with both patient groups showing improvements in composite clinical endpoints and skin responses vs PBO.References:[1]McInnes I, et al. Ann Rheum Dis 2020;79(Suppl. 1):16–17;[2]Mease PJ, et al. Ann Rheum Dis 2020; Epub ahead of print.Acknowledgements:AbbVie funded this study; contributed to its design; participated in data collection, analysis, and interpretation of the data; and participated in the writing, review, and approval of the abstract. No honoraria or payments were made for authorship. Medical writing support was provided by Grant Kirkpatrick, MSc of 2 the Nth (Cheshire, UK), and was funded by AbbVie.Disclosure of Interests:Laure Gossec Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, and UCB, Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, and UCB, Dafna D Gladman Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Novartis, Pfizer, and UCB, Erin McDearmon-Blondell Shareholder of: May own stock or options in AbbVie, Employee of: AbbVie, Philipp Sewerin Consultant of: AbbVie, Amgen, Axiom Health, Biogen, Bristol-Myers Squibb, Celgene, Chugai, Deutscher Psoriasis Bund, Eli Lilly, Fresenius Kabi, Gilead, Hexal, Janssen, Johnson & Johnson, Medi-login, Mediri, Novartis, Onkowissen, Pfizer, Roche, Rheumazentrum Rhein-Ruhr, Sanofi, Swedish Orphan Biovitrum, and UCB, Grant/research support from: AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Bundesministerium fuer Bildung und Forschung, Deutsche Forschungsgesellschaft, Deutscher Psoriasis Bund, Eli Lilly, Fresenius Kabi, Gilead, Hexal, Janssen, Novartis, Pfizer, Rheumazentrum Rhein-Ruhr, Roche, Sanofi, and UCB, Christopher T. Ritchlin Consultant of: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Sun, and UCB, Grant/research support from: AbbVie, Amgen, and UCB, Dai Feng Shareholder of: May own stock or options in AbbVie, Employee of: AbbVie, Apinya Lertratanakul Shareholder of: May own stock or options in AbbVie, Employee of: AbbVie, R Ranza Consultant of: AbbVie, Eli Lilly, Janssen, Novartis, and Pfizer, Grant/research support from: AbbVie, Janssen, Novartis, and Pfizer, Lai-Shan Tam Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly, Janssen, Pfizer, and Sanofi, Grant/research support from: Amgen, Boehringer Ingelheim, GSK, Janssen, Novartis, and Pfizer, Antonio Marchesoni Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, and UCB, Laura C Coates: None declared., Peter Nash Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, and UCB, Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, and UCB.

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Tamba, Rony, Magdalena Sidhartani, and Musrichan Musrichan. "Faktor Risiko Infeksi Respiratorik Akut Bawah pada Anak." Sari Pediatri 11, no. 5 (November 23, 2016): 330. http://dx.doi.org/10.14238/sp11.5.2010.330-4.

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Latar belakang. Infeksi respiratorik akut (IRA) bawah merupakan penyebab terpenting morbiditas danmortalitas pada anak. Beberapa faktor risiko yang berpengaruh tehadap IRA bawah pada anak, antara lainstatus ekonomi rendah, berat badan lahir rendah, ASI tidak eksklusif, malnutrisi, hunian padat, dan polusiudara.Tujuan. Menentukan faktor risiko yang berpengaruh terhadap terjadinya IRA bawah pada anak yang dirawatdi bangsal Anak RSUP dr Kariadi.Metode. Penelitian dengan rancangan kasus kontrol. Subjek penelitian adalah 78 pasien IRA bawah usia1 bulan sampai 14 tahun yang dirawat di bangsal bagian Anak RS dr Kariadi Semarang dan 78 anak sehatsebagai kontrol. Diagnosis ditegakkan berdasarkan anamnesis, pemeriksaan fisik, dan pemeriksaan penunjangseperti hematologi, mikrobiologi, dan foto toraks. Faktor risiko didapat dari kuesioner melalui wawancaradengan orang tua. Analisis statistik dilakukan dengan uji 􀁃2 pada analisis bivariat, dan analisis multivariatdilakukan dengan uji regresi logistik untuk menghitung OR.Hasil. Didapatkan status ekonomi rendah (OR: 3,7; 95% CI: 1,6-8,4; p=0,002), dan hunian padat (OR:2,5; 95% CI: 1,2-5,5; p=0,02) secara bermakna merupakan faktor risiko IRA bawah. Sedangkan berat badanlahir rendah (OR: 2,7; 95% CI: 0,9-7,6, p=0,06), malnutrisi (OR: 0,9; 95% CI: 0,3-2,9, p=0,7), polusiudara (OR: 0,7; 95% CI: 0,2-2,0, p=0,5) dan ASI tidak eksklusif (OR: 0,5; 95% CI: 0,2-1,1, p=0,08)bukan merupakan faktor risiko.Kesimpulan. Status ekonomi rendah dan hunian padat merupakan faktor risiko kejadian IRA bawah padaanak.

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Yanchenko, S. V., A. V. Malyshev, and S. N. Sakhnov. "The Choice of Dry Eye Therapy Depending on Ocular Surface Condition." Ophthalmology in Russia 18, no. 2 (July 5, 2021): 346–54. http://dx.doi.org/10.18008/1816-5095-2021-2-346-354.

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Purpose: to develop approaches to differentiated substitution therapy in patients with dry eye (DE) of mild and moderate severity.Patients and methods. We examined 86 DE patients (22–45 years old; 38 men, 48 women). Group-1 included 54 patients (54 eyes) with mild DE under conditions of combined lipid-mucose-deficiency, group-2 32 patients (32 eyes) with moderate DE against the background of combined lipid-aqua-mucose-deficiency. Conducted: DE symptoms registration (OSDI scale); Norn and Shirmer-1 tests; OCT meniscometry; assessment of the Bijsterveld xerosis index and ‘lid-vipers’ symptom identification; Norn’s compression test. To assessment the therapy effectiveness, patients in both groups were divided into subgroups. Patients of subgroup 1.1 (18 eyes) carried out ‘fat-water’ type emulsion instillations, subgroup 1.2 (18 eyes) — 0.15 % sodium hyaluronate instillation (Hylabak®), subgroup 1.3 (18 eyes) — 3.0 % trehalose (Thealoz®) — 1–2 drops, 4 times a day. All persons included in group-1 were additionally recommended to apply 5.0 % dexpanthenol gel at night. Patients of subgroup 2.1 (16 eyes) received 0.15 % sodium hyaluronate instillation (Hylabak®), patients of subgroup 2.2 (16 eyes) 0.15 % sodium hyaluronate (Hylabak®) and 3.0 % trehalose (Thealoz®) instillation — 4 times a day. All patients included in group-2 were additionally recommended to apply ointment with vitamin A at night. The main criterion for the therapy effectiveness was the tear film brake up time (TBUT, s) two months after the start treatment. Statistical processing included: calculation the mean and its standard deviation (M ± s); assessment of the significance of differences (Wilcoxon’s t-test, KruskalWallis test, Mann-Whitney U-test).Results. In group-1 patients the following TBUT dynamics was recorded: in subgroup 1.1 — from 5.4 ± 0.5 to 6.2 ± 0.6 s (p < 0.05); in subgroup 1.2 — from 5.2 ± 0.4 to 6.6 ± 0.6 s (p < 0.05); in subgroup 1.3 — from 5.3 ± 0.5 to 7.1 ± 0.7 s (p < 0.05). The most pronounced TBUT increase was noted in subgroup 1.3 (trehalose instillation). In group-2, the increase in TBUT was: in subgroup 2.1 — from 3.5 ± 0.3 to 4.7 ± 0.3 s (p < 0.05); in subgroup 2.2 — from 3.4 ± 0.2 to 5.2 ± 0.4 s (p < 0.05). A significantly more pronounced TBUT increase was noted in subgroup 2.2 (sodium hyaluronate and trehalose instillation).Conclusion. In our opinion, differentiated approaches to DE replacement therapy may be included: for mild DE in conditions of lipid-mucose-deficiency — instillation of bioprotector based on 3.0 % trehalose (Thealose®); in case of moderate DE against the background of lipid-aqua-mucose-deficiency — 0.15 % sodium hyaluronate (Hylabak®) instillation in combination with a bioprotector based on 3.0 % trehalose (Thealoz®).

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Sasaki, Koji, Nina Shah, Qaiser Bashir, Chitra M. Hosing, Uday R. Popat, Yago Nieto, Simrit Parmar, et al. "Outcome of Patients with Light Chain Multiple Myeloma Compared to IgG/IgA Myeloma after Autologous Stem Cell Transplant." Blood 126, no. 23 (December 3, 2015): 3194. http://dx.doi.org/10.1182/blood.v126.23.3194.3194.

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Abstract Introduction: High-dose chemotherapy followed by autologous hematopoietic stem cell transplantation (auto-HCT) is the standard of care for younger patients with newly diagnosed multiple myeloma (MM). In approximately 15% of MM patients the monoclonal (M) spike consists of k or l light chains only as opposed to heavy + light chains. It remains unclear whether light chain (LC) MM has a different prognosis compared to other monoclonal protein subtypes after an auto-HCT. Methods: We retrospectively analyzed 1067 patients with MM who underwent auto-HCT between January 1, 2004 and January 1, 2011 at our institution. We evaluated the outcome of newly diagnosed patients with LCMM and compared it to patients with IgG or IgA MM, who underwent an auto-HCT after induction therapy. Primary endpoints were complete remission (CR), progression-free survival (PFS) and overall survival (OS) from the date of auto-HCT. Kaplan-Meier analysis with the log-rank test was performed for univariate comparison of survival. Cox proportional hazards regression method was used for univariate and multivariate analyses. Results: Of 1067 patients who underwent auto-SCT during the period, 223 underwent auto-SCT after relapse, and were excluded. From the remaining 844 who underwent auto-SCT in first remission, we excluded 102 patients (AL amyloidosis 60, POEMS and other plasma cell disorders 10, non-secretory MM 15, IgD 10, IgM 6 and IgE 1) from the analysis. The remaining 742 patients were divided as follows: IgA, 162 patients (22%); IgG, 444 (60%) and LC, 136 (18%). Baseline patient characteristics are described in Table 1. Patients with LCMM were younger and had a higher CR rate to induction. Median follow-up for the entire cohort after auto-HCT was 38 months (range, 0.2-87.0). Post auto-HCT, 28% with IgG/IgA MM and 38% with LCMM achieved a CR (p=0.015). Median PFS was 26.0 months and 27.7 months in IgG/IgA MM and LCMM groups, respectively (p= 0.742). Median OS was not reached and 71.1 months in IgG/IgA MM and LCMM groups, respectively (p= 0.18, Figure 1). Multivariate Cox regression analysis for PFS identified <PR after auto-SCT, non-diploid karyotype, and induction chemotherapy without thalidomide or bortezomib as adverse prognostic factors. Multivariate Cox regression analysis for OS identified presence of hypodiploidy or monosomy 13/del13, higher lactate dehydrogenase pre-transplant, lower hemoglobin pre-transplant, and <PR after auto-HCT as adverse prognostic factors. M protein subtype did not affect PFS (hazard ratio [HR], 1.040; 95% confidence interval [CI], 0.825-1.311; p=0.742) or OS (HR, 1.313; 95% CI, 0.874-1.971; p=0.190). Conclusions: Patients with LCMM have a higher CR rate after auto-HCT, but their PFS and OS were similar to patients with IgG/IgA MM. Table 1. Patient Characteristics Variables, No. (%)/median (range) IgG/IgA myelomaN= 606 Light chain myelomaN= 136 P Median age at transplant, (y) 59 (31-80) 56 (32-78) .004 Age >65 years 138 (23) 23 (17) .134 Male 357 (59) 74 (54) .337 Ethnicity .731 Caucasian 399 (66) 94 (69) African American 99 (16) 22 (16) Mixed 87 (14) 18 (13) Asian 16 (3) 2 (2) Cytogenetic abnormalities at diagnosis by conventional cytogenetics Diploid 180 (30) 36 (27) .159 Hyperdiploid 93 (15) 9 (7) .008 Hypodiploid 27 (5) 11 (8) .082 t(11;14) 4 (1) 3 (2) .092 Monosomy 13 / del 13 44 (7) 9 (7) .789 Other high-risk abnormalities 2 (0) 1 (1) .456 Induction chemotherapy Bortezomib or IMiD-based 507 (84) 123 (90) .046 Pre-transplant evaluation Bone marrow plasma cell, (%) 2 (0-71) 2 (0-50) .136 Bone marrow plasma cell >10% 90 (15) 18 (13) .735 Hemoglobin, (g/dL) 11.3 (4.4-16.0) 10.8 (6.8-15.3) .025 Lactate dehydrogenase, (IL/L) 526 (221-5062) 526 (239-2748) .522 Calcium, (mg/dL) 9.0 (7.6-10.4) 9.0 (7.5-11.0) .055 Creatinine, (mg/dL) 0.9 (0.4-12.5) 0.9 (0.5-9.8) .017 Beta-2 microglobulin (mg/dL) 2.4 (1.1-40.0) 2.8 (1.2-33.8) .001 Time from diagnosis to auto-HCT (month) 8.0 (1.9-174.4) 6.8 (2.4-44.6) .001 Pre-transplant disease status .004 ≥ CR 24 (4) 15 (11) VGPR/PR 545 (90) 109 (80) SD/PD 37 (6) 12 (9) Conditioning regimen .008 Melphalan alone 508 (84) 126 (93) Melphalan-based regimen 98 (16) 10 (7) Final response after transplant .080 ≥ CR 168 (28) 52 (38) VGPR/PR 353 (58) 70 (52) SD/PD 81 (13) 14 (10) Figure 1. a) Progression-free survival, b) Overall survival in patients with light chain myeloma compared to those with IgG/IgA myeloma Figure 1. a) Progression-free survival, b) Overall survival in patients with light chain myeloma compared to those with IgG/IgA myeloma Disclosures Shah: Celgene: Consultancy, Research Funding. Thomas:Novartis, Celgene, Acerta Pharmaceuticals, Idera Pharmaceuticals: Research Funding.

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Iqbal, Sehar, Norbert Klammer, and Cem Ekmekcioglu. "The Effect of Electrolytes on Blood Pressure: A Brief Summary of Meta-Analyses." Nutrients 11, no. 6 (June 17, 2019): 1362. http://dx.doi.org/10.3390/nu11061362.

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Nutrition is known to exert an undeniable impact on blood pressure with especially salt (sodium chloride), but also potassium, playing a prominent role. The aim of this review was to summarize meta-analyses studying the effect of different electrolytes on blood pressure or risk for hypertension, respectively. Overall, 32 meta-analyses evaluating the effect of sodium, potassium, calcium and magnesium on human blood pressure or hypertension risk were included after literature search. Most of the meta-analyses showed beneficial blood pressure lowering effects with the extent of systolic blood pressure reduction ranging between −0.7 (95% confidence interval: −2.6 to 1.2) to −8.9 (−14.1 to −3.7) mmHg for sodium/salt reduction, −3.5 (−5.2 to −1.8) to −9.5 (−10.8 to −8.1) mmHg for potassium, and −0.2 (−0.4 to −0.03) to −18.7 (−22.5 to −15.0) mmHg for magnesium. The range for diastolic blood pressure reduction was 0.03 (−0.4 to 0.4) to −5.9 (−9.7 to −2.1) mmHg for sodium/salt reduction, −2 (−3.1 to −0.9) to −6.4 (−7.3 to −5.6) mmHg for potassium, and −0.3 (−0.5 to −0.03) to −10.9 (−13.1 to −8.7) mmHg for magnesium. Moreover, sufficient calcium intake was found to reduce the risk of gestational hypertension.

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Vaganov, Yu E., E. A. Khomyakov, A. B. Serebry, and E. U. Abdulzhalieva. "Endoscopic mucosal resection and conventional polypectomy in colon adenomas." Koloproktologia 20, no. 2 (June 19, 2021): 29–34. http://dx.doi.org/10.33878/2073-7556-2021-20-2-29-34.

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Aim: to compare the early and long-term results of endoscopic mucosal resection (EMR) and conventional polypectomy for benign epithelial colon neoplasmsPatients and methods: the retrospective study included 344 patients with histologically verified adenomas of the size of up to 40 mm in the colon, who underwent EMR or conventional polypectomy. Mucosectomy (EMR) was performed in 207 patients, while conventional polypectomy was performed in 137.Results: there were no significant differences in the postoperative morbidity rates between the methods (OR = 1.8; 95% CI = 0.7–4.8, p = 0.3). Fragmentation significantly more often occurred in the group of conventional polypectomy (OR = 3.5; 95% CI = 2.3–5.5, p = 0.001, especially when the size of the neoplasm was over 1 cm (OR = 3.1; 95% CI = 1.1–8.9 = 0.037). Recurrence occurred in 19/173 (10.9%) in 12 (8.3%) patients of the EMR group. In the polypectomy group, recurrence developed in 22 (23.1%) patients, in 24/108 (22.2%) cases at the site of the postoperative scar. It was found that the adenoma recurrence in the area of endoscopic excision occurs significantly more often after conventional polypectomy (OR = 2.3; 95% CI = 1.2–4.4; p = 0.016).Conclusion: EMR and conventional polypectomy both are the safe methods with low morbidity rates. However, the EMR is the preferred method of endoscopic excision for adenomas larger than 1 cm due to the fact that it allows for deeper and more complete resection of the tissue than conventional polypectomy.

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Rescigno, Giuseppe, Sandeep Hothi, Christopher Bond, Mauin Uddin, Veena Bhatti, and John Stephen Billing. "CorMatrix Anterior Leaflet Augmentation of the Tricuspid Valve: Midterm Results." Heart Surgery Forum 24, no. 2 (March 8, 2021): E261—E266. http://dx.doi.org/10.1532/hsf.3599.

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Background: Tricuspid annuloplasty is the most common surgical approach to correct tricuspid regurgitation (TR). In some patients, however, anterior leaflet patch augmentation may be necessary to optimize tricuspid competence. We reviewed our center cohort over the midterm and long term. Methods: From January 2013 to August 2018, 424 tricuspid valve procedures were performed, of which 420 were repairs and 4 were replacements. Indications were either isolated severe TR or moderate or greater TR, concomitant with other surgery. In the repair cohort, we identified those that had a patch augmentation, and the database was interrogated for preoperative characteristics. The resulting patients had outpatient assessment (clinical and echocardiography) at 6 weeks and at a later interval. Additionally, a comparison was made between those who had good and poor results (moderate or greater TR or cardiac death). Results: In the repair cohort, 19 patients underwent complex tricuspid valve repair with CorMatrix anterior leaflet augmentation. Preoperative characteristics were as follows: age, 65.5 ± 13.5 years; New York Heart Association (NYHA) class, 3.5 ± 0.5; left ventricular ejection fraction, 48.3% ± 5.9%; tricuspid annular plane systolic excursion, 17.1 ± 3.7 mm; right ventricle (good, mild, moderate, poor), 10, 5, 4, 0; annulus size, 40.9 ± 6.9 mm; mean tethering distance, 1.00 ± 0.3 cm; and mean tethering area, 1.53 ± 1.16 cm2. Mean follow-up was 2.1 ± 1.9 years, and survival at 2 years was 73.8%. There were 2 in-hospital deaths. Mean NYHA class was 1.0 ± 0.5 (6 weeks) and 1.5 ± 0.6 (later follow-up); mean residual TR grade was 0.5 ± 0.6 (6 weeks) and 1.3 ± 1.4 (follow-up). Ten of 13 survivors had a good result at last follow-up (TR 0 to 1). We compared the preoperative and operative data of this group versus those with poor results (TR >1 or cardiac mortality). Significant univariate predictors of poor results were larger preoperative tethering area (1.18 ± 0.43 versus 2.4 ± 1.5 cm2; P = .02), longer tethering distance (0.87 ± 0.21 versus 1.2 ± 0.19 cm; P = .007), or the presence of mild or greater TR at 6 weeks (0.2 ± 0.4 vs 1.25 ± 0.5; P = .03). Conclusions: CorMatrix anterior leaflet augmentation produces successful, stable repair in the majority of this complex population. The presence of even mild TR at 6 weeks’ follow-up predicts a poor result. When the tethering area or the tethering distance is significantly high, replacement is probably a better option.

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Suttorp, Meinolf, Ralf Knoefler, Hélène Deutsch, Franziska Paul, Oliver Tiebel, Markus Metzler, and Frederic Millot. "High Platelet Counts, Thrombosis, Bleeding Signs, and Acquired Von Willebrand Syndrome at Diagnosis of Pediatric Chronic Myeloid Leukemia." Blood 134, Supplement_1 (November 13, 2019): 4152. http://dx.doi.org/10.1182/blood-2019-123343.

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Background: At diagnosis of chronic myeloid leukemia (CML) patients (pats) may present with elevated platelets (PLT) counts. Generally, high PLT counts may result in thrombosis and/or bleeding complications, the latter being due to binding of von Willebrand factor (VWF) multimers to platelets. Pediatric CML is very rare (Hijiya N, Suttorp M 2019; Blood 33:2374-2384) and no systematic investigation on clinical complications of elevated PLT counts has so far been reported. Methods: Data on PLT counts and associated thrombo-hemorrhagic complications were retrospectively analyzed in newly diagnosed pediatric pats (0 - 18 yrs old) with CML in chronic phase. Data were pooled from a German pediatric trial (CML-paed II, N= 146 pats; registered as NCT00445822, [Suttorp M, et al. 2018; Leukemia 32:1657-1669], data collection closed Dec 2016) and the International registry for CML in children and adolescents (I-CML- Ped Study, N= 475 pats, registered as NCT01281735, [Millot F, et al. 2017; Haematologica 102:1704-1708], data collection closed June 2019). Results: A total of 621 pediatric pats with CML in chronic phase could be analyzed. At diagnosis 343/621 (55.2%) pats (median age 13.2 yrs, range 1.3 - 18 yrs) presented with thrombocytosis (>500 000 PLT/µl). PLT ranged from 500 000 - 1 000 000 PLT/µl in 239/621 (38.5%) pats while extremely high PLT counts (>1 000 000 PLT /µl) were present in 94/621 (11.2%) pats. Thrombosis was observed in 2/621 (0.3%) pats including priapism occurring at 655 000 PLT/µl and lower leg venous thrombosis at 1 820 000 PLT/µl. Bleeding signs (bruises, mucosal hemorrhage) being of mild nature (grade 1, grade 2, National Cancer Institute Common Terminology Criteria v3.0) only were described in 38/343 (11.1%) pats with thrombocytosis (>500 000 PLT/µl). Bleeding occurred without correlation to elevated PLT counts but was associated in selected cases investigated with a reduced plasma concentration of large VWF multimers pointing to the diagnosis of acquired von Willebrand syndrome (AVWS). AVWS resolved after initiation of CML treatment with imatinib. Discussion: In newly diagnosed pediatric pats with CML, pathologically high PLT counts (>500 000 PLT/µL) were detected in >50% of the cohort and extremely high platelet counts in >10%. However, associated thrombo-hemorrhagic complications were rare events affecting less than 10% (40/621= 6.4%) of the pats. Especially thrombosis was a rare (0.3%) complication whereas mild bleeding symptoms formed the majority of hemostaseological complications observed. Compared to recently published findings in adults (Sora F, et al. 2018; Br J Haematol 181:267-270, N= 1591 pats; Sandal R, et al. 2019; J Clin Oncol (Suppl) abstract #e18546, N= 2350 pats; Liu Z, et al. 2017; Onco Target Ther 10:3515-3520, N= 87 pats) the proportions of adult pats with extremely high platelet counts (Sora F: 5,5%, Sandal R: not listed; Liu Z: 25.3%) is in the same range (5% - 25%) as in pediatric patients (11.2%). Surprisingly, thrombo-hemorrhagic complications were observed more frequently in children (40/621= 6.4%) than in adults (Sora F: 9/1591= 0.5%, Liu Z: 1/85= 0.1%; Sandal R: 66/2350= 2.8%). As a word of caution this comparative analysis is weakened by its retrospective nature and a non-standardized reporting of bleeding signs. Mild bleeding signs in pats with high PLT counts can be caused by an acquired low plasma concentration of large VWF multimers as could be demonstrated in selected pediatric pats from this cohort. Systematic investigations on AVWS in children with CML have not been published so far and AVWS may be underdiagnosed in pediatric CML. Disclosures No relevant conflicts of interest to declare.

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Wohlres-Viana, S., E. K. N. Arashiro, J. G. V. Grazia, L. S. A. Camargo, M. A. Machado, and J. H. M. Viana. "347 COULD THE DIFFERENTIAL EXPRESSION OF LUTEINIZING HORMONE RECEPTOR ISOFORMS EXPLAIN THE VARIABILITY IN SUPEROVULATORY RESPONSES IN CATTLE?" Reproduction, Fertility and Development 27, no. 1 (2015): 261. http://dx.doi.org/10.1071/rdv27n1ab347.

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Embryo production in vivo is highly variable among donors. The Gir breed (Bos indicus) is well known to show a low embryo production after superovulation (2.5 to 3.5 viable embryos per flush), and a high variance in superovulatory responses, which makes this breed an interesting model to study this trait. The aim of this study was to evaluate the expression pattern of LHR isoforms in Gir heifers previously characterised as good (10.3 ± 1.2 embryos/flush, N = 5) or poor (1.1 ± 0.3 embryos/flush, N = 5) responders to superovulation protocols. In both groups, an adapted ultrasound-guided follicular aspiration system (Arashiro et al. 2012 Reprod. Fertil. Dev. 24, 175) was used to collect granulosa cells (GC) from 8-mm follicles growing in either a synchronized but not stimulated follicular wave (FW) or in the fourth day of superovulation (SOV), induced with 200 UI of FSHp (Pluset, Serono). The recovered follicular fluid was centrifuged and the cells were washed with NaCl 0.9% saline and kept in RNA Later (Ambion, Austin, TX, USA). Total RNA extraction was performed using the commercial RNeasy Micro Kit (Qiagen, Valencia, CA, USA). The RNA samples were quantified and reverse transcribed using the commercial Superscript III kit (Invitrogen, Carlsbad, CA, USA). Complementary DNA samples were amplified through real-time PCR, using a LH receptor primer – not selective for LHR isoforms (total LHR) – and 4 sets of isoform selective primers (S1, S10, S10+11, and S11). All samples were previously tested for theca cell contamination through detection of CYP17A1 gene, and those showing contamination were excluded. The β-actin gene was used as endogenous control. Analyses were performed using the REST software and the expression values are shown as mean ± s.e.m. For comparisons between good and poor responders, the first was set as 1.00. For comparisons between FW and SOV, FW was set as 1.00. In the good responder group, there was no difference (P > 0.05) in total LHR expression among GC samples from FW and SOV. However, the S10+11 isoform was down-regulated (0.4 ± 0.1; P < 0.01) after SOV. In the poor responders group, total LHR expression was down-regulated (0.2 ± 0.1; P < 0.01) after SOV, but there was no difference in the expression of isoforms (P > 0.05). Contrasting the response groups (good and poor), total LHR (15.1 ± 7.6; P < 0.001), and the isoforms S10 (5.7 ± 2.7; P < 0.01), S10+11 (1.9 ± 0.6; P < 0.01), and S11 (5.1 ± 2.5; P < 0.01) were up-regulated in FW of poor responders, but there was no difference (P > 0.05) in any LHR form during SOV. We concluded that 1) LHR expression is different between heifers characterised as good or poor responders to superovulation; 2) superovulation modulates the LHR expression and reduces the original differences observed in unstimulated cycles; 3) diminished expression of total LHR, but not in the isoforms, in poor responders heifers could suggest a reduction in the expression of full-length LHR, with possible consequences to ovulatory capability after superovulation.Financial support was provided by CNPq Project 477701 and Fapemig PPM 0067/11.

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van Lierde, Marie-Anne, Eric Strobbe, Larissa De Rop, Filipo Serra, MacDonald MacDonald, Stefaan Vancayzeele, Sabina De Geest, Laurie Letvak, Tara Albrecht, and Ivo Abraham. "Promoting Patient (pt) Adherence (PA) with Imatinib Treatment (IMRx) in Chronic Myeloid Leukemia (CML): Physicians (MD) Perceptions of Utility (Effectiveness [FX], Feasibility [FB], Cost [CO]) and Rankings of Clinical Applicability (CAPL) of 13 Adherence-Enhancing Strategies (AESs) - Results from the ADAGIO Study." Blood 110, no. 11 (November 16, 2007): 5165. http://dx.doi.org/10.1182/blood.v110.11.5165.5165.

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Abstract BACKGROUND. Patterns, prevalence, and associated pt variables of CML pts’ nonadherence (PNA) with ImRx are being better understood. Reducing ImRx PNA may impact on treatment outcomes. Various AESs have been proposed but their perceived value and clinical applicability to treating MDs are unknown. OBJECTIVES. 1. Describe the perceptions of ImRx prescribing MDs of the utility (in terms of FX, FB, CO) of 13 AESs. 2. Describe MD rankings of the applicability in daily practice of each AES. DESIGN AND SUBJECTS. MD data subset from prospective, 90d observational, open-label, multicenter study [1]. 51 evaluable MDs: age 45.6±11.2 years (ys); ys of practice 17.7±8.1; 74% hematologists, 26% oncologists; 65.3% practicing in university(-affiliated) hospital, 34.7% in other hospitals. MEASUREMENTS. Utility rated 0=none to 3=high. For applicability to daily practice, MDs were asked to give top 5 AESs (5=most applicable); nonranked AESs were given zero value. RESULTS. See Table 1. CONCLUSIONS. MDs tended to rate the utility and applicability of AESs higher if an AES involved active MD participation or decision-making. AESs requiring significant patient involvement, behaviorally or through assistive devices, were perceived as less helpful and applicable in clinical practice. Importantly, the critical role of patient education was recognized, thus challenging clinicians to accept greater responsibility for this AES. Nurses in particular may prove pivotal in patient education. These findings provide significant direction for interdisciplinary healthcare education, especially in terms of chronic illness management. Further research is needed to elucidate the physician-centric approach to adherence enhancement in CML pts on ImRx. Table 1 - Physician Utility Ratings and Applicability Rankings of Adherence-Enhancing Strategies Utility (0–3) Applicability FX FB CO in Practice (0–5) M±SD M±SD M±SD M±SD Rx selection per pt characteristics 1.9±1.1 1.6±1.1 1.3±1.0 1.0±1.5 Pt education 2.6±0.6 2.1±0.8 1.4±0.8 3.1±1.9 Improved pt-MD communication 2.7±0.5 2.3±0.8 1.3±0.8 2.8±1.7 Simplifying Rx regimen 2.5±0.7 2.3±0.7 1.6±0.9 2.3±1.9 Pt self-monitoring 1.7±0.8 1.5±0.8 1.1±0.9 0.4±1.1 Pt health status diary 1.7±0.8 1.5±0.8 1.0±0.8 0.5±1.3 Memory aids 1.7±0.8 1.9±0.8 1.0±0.8 0.6±1.3 Spouse/family involved 2.2±0.9 2.0±0.9 0.6±0.8 1.3±1.4 Regular MD contact 2.4±0.5 2.2±0.7 1.7±0.8 2.2±1.8 MD monitoring of PA 2.2±0.7 1.8±0.9 1.4±0.8 0.7±1.1 Electronic reminders 1.5±0.9 1.2±0.8 2.3±0.9 0.3±1.1 Electronic Rx monitoring 1.6±0.9 1.3±0.7 2.3±0.9 0.3±1.1 Rewards for good PA 1.4±1.0 1.3±0.8 1.8±0.9 0.5±1.4

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Schlack, Katrin, Andres Jan Schrader, Laura-Maria Krabbe, Karoline Kannen, Axel Semjonow, and Martin Boegemann. "Prediction of outcome in bone metastatic, castration-resistant prostate-cancer-patients under enzalutamide by combining biomarkers." Journal of Clinical Oncology 36, no. 6_suppl (February 20, 2018): 334. http://dx.doi.org/10.1200/jco.2018.36.6_suppl.334.

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334 Background: Under early Enzalutamide (Enza) treatment of bone mCRPC (bmCRPC), prostate-specific antigen (PSA) might be misleading, since a PSA-flare may occur. Bouncing of alkaline phosphatase (APB) was shown as a promising surrogate for survival outcome. Low lactate dehydrogenase (LDH) usually predicts better outcome. The purpose of this study was to evaluate the prognostic ability of APB, LDH, PSA and information of the pooled markers after initiation of Enza. Methods: 89 bmCRPC-patients were analyzed. PSA, LDH and AP were monitored at 2, 4, 8, 12 and 20 weeks. APB was defined as an increase of AP after initiation of Enza with a subsequent, significant decline below baseline during the first 8 weeks of therapy. APB vs. no Bounce as well as LDH and PSA increase vs. decline were analyzed using Kaplan-Meier analyses (KMA) and uni- and multivariate (UV/MV) cox-regression models. Results: In KMA declining PSA and LDH as well as APB were associated with longer median PFS with 7 (95% confidence interval: 4.2-9.8) vs. 3 months (2.3-3.7) for PSA, 6 (4.1-8) vs. 2 (1.2-2.8) for LDH and 8 (0-16.3) vs. 3 (1.9-4.1) for APB. Analysis of OS showed similar results with 17 (11.7-22.3) vs. 12 months (7.0-17.1) for PSA, 17 (13.2-20.8) vs. 7 (5,8-8.2) for LDH and 19 (7.9-30.1) vs. 12 (7.7-16.3) for APB. In UV APB (Hazard Ratio (HR): 0.52 (0.3-1.0); p = 0.02), PSA-decline ≥50% (HR: 0.49 (0.3-0.7); p < 0.01) and LDH-normalization (LDHnorm) (HR: 0.39 (0.2-0.6); p < 0.01) were significantly associated with longer PFS. Considering OS LDHnorm was a significant prognosticator for longer survival (HR: 0.39 (0.2-0.6); p < 0.01). In MV only LDHnorm showed a trend towards better OS (HR: 0.49 (0.2.-1.1); p = 0.09). Combining those markers and separating a group with APB, LDHnorm and PSA-decline and a group with PSA-decline alone KMA showed better PFS (11 (0.2-21.8) vs. 4 (0-8.6)) and OS (20 (17.7-22.3) vs. 8 (0.3-15.7)) in favor of the group with 3 beneficial markers. In UV the presence of all 3 markers was significantly associated with longer PFS (HR: 0.23 (0.1-0.7); p < 0.01) and OS (HR: 0.26 (0.1-0.8); p = 0.02). Conclusions: APB and LDHnorm may add to identifying bmCRPC-patients with favorable prognosis during early Enza-therapy.

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Albero, G., V. Longobardi, G. Zullo, E. De Carlo, A. Martucciello, A. Salzano, G. Bifulco, and B. Gasparrini. "144 INFLUENCE OF REPEATED OVUM PICKUP ON BUFFALO WELFARE." Reproduction, Fertility and Development 26, no. 1 (2014): 185. http://dx.doi.org/10.1071/rdv26n1ab144.

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The aim of this work was to evaluate the effect of repeated ovum pickup (OPU) on buffalo welfare. The OPU was carried out as previously described (Neglia et al. 2003 Theriogenology 59, 1123–1130) twice per week on 11 buffalo cows at 121 ± 15 days in milk for 2 months (end of October–end of December). Blood samples were collected before the beginning of the trial (time 0), after 1 month (time 1), and after 2 months (time 2) in animals that had undergone OPU and in control animals (n = 10) of the same herd. The following parameters of clinical immunology were evaluated on sera: haemolytic complement (Arya et al. 1992 Vet. Immunol. Immunopathol. 30, 411–418), lysozyme, bactericidal capacity (Amadori et al. 1997 J. Vet. Med. 44, 321–327), and haptoglobin (Phase Haptoglobin Colourimetric Assay kit, Tridelta Development Ltd., Maynooth, County Kildare, Ireland). Data, here reported as means ± s.e.m., were analysed by ANOVA taking into account treatment, time, and the interaction. The number of aspirated follicles and collected oocytes per buffalo per session was 6.6 ± 0.2 and 3.6 ± 0.2, respectively. Interestingly, the OPU treatment did not affect haptoglobin (a reliable marker of acute stress), lysozyme, complement, and bactericidal capacity, whereas the time influenced (P < 0.05) only the complement. In animals that had undergone OPU, no differences among times 0, 1, and 2 in lysozyme (3.9 ± 0.3, 4.0 ± 0.6, and 3.6 ± 0.4 μg mL–1, respectively), bactericidal capacity (92.8 ± 0.8, 92.1 ± 0.8, and 92.2 ± 0.9%, respectively), and haptoglobin (1.8 ± 0.4, 1.4 ± 0.2, and 1.9 ± 0.6 mg mL–1, respectively) were found. Likewise, similar values were recorded at times 0, 1, and 2 in the control group in lysozyme (3.2 ± 0.3, 2.9 ± 0.3, and 3.1 ± 0.8 μg mL–1, respectively), bactericidal capacity (94.2 ± 0.6, 93.0 ± 1.1, and 89.2 ± 3.2%, respectively), and haptoglobin (0.7 ± 0.5, 1.3 ± 0.5, and 1.4 ± 0.4 mg mL–1, respectively). A significant decrease (P < 0.05) of complement (UE/150 mL) in OPU-treated animals was recorded at times 1 (33.6 ± 1.4) and 2 (35.9 ± 2.9) compared to time 0 (67.3 ± 3.3). However, the same pattern was observed in the control (62.8 ± 4.0, 31.3 ± 0.3, and 31.0 ± 0.8, respectively at times 0, 1, and 2; P < 0.05). Therefore, it is not possible to rule out that the decrease was due to other factors, such as the cold winter temperatures incoming, as previously reported. Furthermore, the values recorded at times 1 and 2 fall in the physiological ranges of the species (De Carlo et al. 2011 Joint Annual Meeting, Riccione, Italy). During the whole period of the experiment (and few weeks after), there were neither signs of behavioural modifications nor clinical signs of any disease. Furthermore, there were no differences in average daily milk production between treated and control buffaloes both at the start (9.1 ± 0.8 v. 9.4 ± 0.8) and at the end of the trial (7.6 ± 0.6 v. 6.5 ± 0.7), and all the animals that had undergone OPU conceived within 113.0 ± 25.4 days from the last OPU session. These preliminary results indicate that a regimen of OPU carried out twice per week for 2 months do not affect the welfare of buffaloes.

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Domínguez-Coello, Santiago, Lourdes Carrillo-Fernández, Jesús Gobierno-Hernández, Manuel Méndez-Abad, Carlos Borges-Álamo, José Antonio García-Dopico, Armando Aguirre-Jaime, and Antonio Cabrera-de León. "Decreased Consumption of Added Fructose Reduces Waist Circumference and Blood Glucose Concentration in Patients with Overweight and Obesity. The DISFRUTE Study: A Randomised Trial in Primary Care." Nutrients 12, no. 4 (April 19, 2020): 1149. http://dx.doi.org/10.3390/nu12041149.

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The relationship between fructose intake and insulin resistance remains controversial. Our purpose was to determine whether a reduction in dietary fructose is effective in decreasing insulin resistance (HOMA2-IR). This field trial was conducted on 438 adults with overweight and obese status, without diabetes. A total of 121 patients in a low fructose diet (LFD) group and 118 in a standard diet (SD) group completed the 24-week study. Both diets were prescribed with 30–40% of energy intake restriction. There were no between-group differences in HOMA2-IR. However, larger decreases were seen in the LFD group in waist circumference (−7.0 vs. −4.8 = −2.2 cms, 95% CI: −3.7, −0.7) and fasting blood glucose −0.25 vs. −0.11 = −0.14 mmol/L, 95% CI: −0.028, −0.02). The percentage of reduction in calorie intake was similar. Only were differences observed in the % energy intake for some nutrients: total fructose (−2 vs. −0.6 = −1.4, 95% CI: −2.6, −0.3), MUFA (−1.7 vs. −0.4 = −1.3, 95% CI: −2.4, −0.2), protein (5.1 vs. 3.6 = 1.4, 95% CI: 0.1, 2.7). The decrease in fructose consumption originated mainly from the reduction in added fructose (−2.8 vs. −1.9 = −0.9, 95% CI: −1.6, −0.03). These results were corroborated after multivariate adjustments. The low fructose diet did not reduce insulin resistance. However, it reduced waist circumference and fasting blood glucose concentration, which suggests a decrease in hepatic insulin resistance.

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Wasserman, D. H., J. L. Bupp, J. L. Johnson, D. Bracy, and D. B. Lacy. "Glucoregulation during rest and exercise in depancreatized dogs: role of the acute presence of insulin." American Journal of Physiology-Endocrinology and Metabolism 262, no. 5 (May 1, 1992): E574—E582. http://dx.doi.org/10.1152/ajpendo.1992.262.5.e574.

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To determine the effects of the presence of insulin in poorly controlled diabetes, depancreatized (PX) dogs (n = 5) were studied during rest and 150 min of exercise in paired experiments in which saline alone was infused (IDEF) and in which insulin was replaced intraportally (200 microU.kg-1.min-1) with glucose clamped at the levels in IDEF (IR+G). PX dogs (n = 4) were also studied with insulin, but glucose was allowed to fall (IR). Insulin was not detectable, 6 +/- 1 and 6 +/- 2 microU/ml in IDEF, IR+G, and IR. Plasma glucose was 470 +/- 47, 480 +/- 48, and 372 +/- 35 mg/dl at rest in IDEF, IR+G, and IR, respectively. Levels were unchanged with exercise in IDEF and IR+G, but fell by 139 +/- 13 mg/dl in IR. Basal glucose rate of appearance (Ra) was 7.0 +/- 0.9, 1.3 +/- 1.1, and 6.0 +/- 0.7 mg.kg-1.min-1 in IDEF, IR+G, and IR, respectively. Exercise elicited a rise in Ra in only IDEF. The rises in Rd and metabolic clearance rate in IDEF were reduced (delta 2.6 +/- 0.7 and delta 0.8 +/- 0.3 ml.kg-1.min-1 at 150 min) compared with IR+G (delta 5.3 +/- 1.9 and delta 1.7 +/- 0.2 ml.kg-1.min-1 at 150 min) and IR (delta 3.7 +/- 1.2 and delta 2.4 +/- 0.8 ml.kg-1.min-1). The insulin sensitivity of glucose utilization (Rd) was elevated by approximately 75% at 150 min. Basal glycerol was similar in IDEF and IR but was reduced by approximately 70% in IR+G. Glycerol rose similarly with exercise in IDEF and IR.(ABSTRACT TRUNCATED AT 250 WORDS)

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Kartas, Anastasios, Athanasios Samaras, Dimitra Vasdeki, George Dividis, George Fotos, Eleni Paschou, Evropi Forozidou, et al. "Flaws in Anticoagulation Strategies in Patients With Atrial Fibrillation at Hospital Discharge." Journal of Cardiovascular Pharmacology and Therapeutics 24, no. 3 (January 1, 2019): 225–32. http://dx.doi.org/10.1177/1074248418821712.

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Background: Proper anticoagulation is a crucial therapeutic regimen in atrial fibrillation (AF). Objectives: To evaluate the real-life anticoagulation prescriptions of AF patients upon hospital discharge. Methods: We studied 768 patients with comorbid AF who were discharged from the cardiology ward of a tertiary hospital. We assessed the appropriateness of oral anticoagulation (OAC) regimens at discharge based on stroke risk (CHA2DS2-Vasc score), SAMe-TT2R2 (sex, age, medical history, treatment, tobacco, race) score for vitamin K antagonists (VKA), and European labeling for nonvitamin K oral anticoagulant (NOAC) dosing. Logistic regression identified factors associated with suboptimal OAC use. Results: Of 734 patients at significant (moderate or high) stroke risk, 107 (14.6%) were not prescribed OAC, which was administered to 23 (67.6%) of 34 patients at low risk. Nonprescribing of OAC to high-risk patients was associated with paroxysmal AF (adjusted odds ratio [OR]: 2.42, 95% confidence interval [CI]: 1.47-3.99, P < .001), history of major bleeding (adjusted OR: 1.89, 95% CI: 1.03-3.47, P = .039), and concomitant antiplatelet use (adjusted OR: 5.78, 95% CI: 3.51-9.51, P < .001). Anticoagulation control was inadequate (SAMe-TT2R2 score > 2) in 102 (50.2%) VKA-treated patients. Off-label dosing was evident in 118 (28.9%) NOAC-treated patients and was associated with a prior stroke/transient ischemic attack (adjusted OR: 2.06, 95% CI: 1.10-3.85, P = .023). Both outcomes were independently associated with low creatinine clearance. Conclusions: One of 6 patients with AF newly discharged from the hospital was treated discordantly for the corresponding risk of stroke. Suboptimal OAC use was evident in half of VKA regimens, twice as common compared to NOACs, and could be predicted by several clinical parameters.

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Torres Júnior, J. R. S., M. F. A. Pires, W. F. Sá, A. M. Ferreira, J. H. M. Viana, L. S. A. Camargo, A. A. Ramos, et al. "318 EFFECT OF MATERNAL HEAT STRESS ON OOCYTE QUALITY AND IN VITRO COMPETENCE IN BOS INDICUS CATTLE." Reproduction, Fertility and Development 19, no. 1 (2007): 274. http://dx.doi.org/10.1071/rdv19n1ab318.

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High temperatures can be harmful to the competence of cumulus–oocyte complexes and to embryo development (Al-Katanani et al. 2002 J. Dairy Sci. 85, 390–396). The aim of this study was to evaluate the effect of maternal heat stress on in vitro embryo yield. Ten multiparous nonlactating Gir (Bos indicus) cows were kept in tie stalls for an adaptive period of 28 days [pre-heat-stress period (PRE-HS)/Days -28 to -1]. Cows were subjected to 2 OPU (ovum pickup) sessions (Days -14 and -7). In the heat-stress period (HS; Days 0 to 28), cows were divided into control (C: n = 5) and heat-stressed (HS: n = 5) groups. During this period, OPU sessions were performed once a week from Days 0 to 28. The C group remained in a thermo-neutral environment, and the HS group was kept in a climatic chamber with controlled temperature and humidity (38�C and 80% during the day and 30�C and 80% during the night). In the post-heat-stress period (POST-HS; Days 28 to 147), all cows returned to thermo-neutral conditions. Then 17 OPU sessions were performed once a week from Days 35 to 147. In all periods, blood samples were collected weekly for progesterone (P4) analysis, and ovarian follicles were counted, measured, and aspirated. The COCs were evaluated and selected for the IVF procedure. Data were analyzed by ANOVA (PROC MIXED of SAS) and a chi-squared test. The luteal phase was defined as the period between 2 samples with P4 below 1.0 ng mL-1. A handling accident caused the exclusion of an HS cow after the sixth session. The C and HS groups were subjected to 125 and 107 OPU sessions, respectively. Means � SEM for the C vs. HS groups, in the PRE-HS, HS, and POST-HS periods, respectively, were visualized follicles: 25.5 � 2.5 vs. 28.5 � 2.8, 24.2 � 1.1 vs. 24.0 � 1.9, and 15.3 � 0.6 vs. 15.8 � 0.8; largest follicle diameter: 12.1 � 1.5 vs. 11.1 � 1.7, 13.3 � 0.8 vs. 13.0 � 0.6, and 11.4 � 0.4b vs. 14.0 � 0.4a; P < 0.05; 2nd largest follicle diameter: 6.2 � 1.3 vs. 6.0 � 1.2, 5.9 � 0.6 vs. 7.1 � 0.8, and 6.3 � 0.3b vs. 8.7 � 0.5a; recovered COCs: 11.2 � 2.8 vs. 14.3 � 2.5, 9.6 � 1.0 vs. 11.0 � 1.3, and 8.6 � 0.7 vs. 7.9 � 0.6; COCs selected for IVF: 69/112 (61.6%)b vs. 108/143 (75.5%)a, 164/241 (68%) vs. 172/265 (64.9%), and 426/712 (59.8%) vs. 305/535 (75.0%); cleavage: 44/59 (74.5%) vs. 87/105 (82.9%), 72/101 (71.3%) vs. 74/121 (61.2%), and 226/317 (71.3%) vs. 159/230 (69.1%); embryos per cow/OPU: 2.1 � 1.1y vs. 4.1 � 1.0x, 0.4 � 0.3 vs. 0.5 � 0.3, and 0.9 � 0.2x vs. 0.4 � 0.1y; P < 0.1; and blastocyst yield: 16/59 (27.1%) vs. 33/105 (31.5%), 11/31 (35.5%) vs. 13/52 (25.0%), and 76/279 (27.2%)a vs. 25/188 (13.3%)b. In conclusion, maternal heat stress increased the percentage of short estrous cycles, decreased the P4 concentrations, and decreased the number of embryos produced by Bos indicus cows, mainly from 28 to 147 days post-heat-stress, showing long-term deleterious effects on blastocyst development.

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Parker, Pablo M., Ryotaro Nakamura, Vinod Pullarket, Joseph Rosenthal, Eileen P. Smith, David S. Snyder, Jasmine M. Zain, et al. "Analysis of Predictive Power of Prednisone Dose at 3 Months of Treatment on CGVHD Prognosis." Blood 110, no. 11 (November 16, 2007): 1975. http://dx.doi.org/10.1182/blood.v110.11.1975.1975.

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Abstract Current CGVHD prognostic and staging systems are still undergoing development and have identified plt count; CGVHD types progressive(P), quiescent(Q), de novo(DN); KPS, and GI involvement as significant risk factors affecting outcome. A simple reproducible staging system such as used for AGVHD to apply in clinical trials is still lacking. We evaluated whether the PSE dose required to control CGVHD at 3 months from diagnosis would have a prognostic effect on survival and in and of itself serve as a criteria for secondary intervention or investigational therapy. We hypothesized that by 3 months from start of treatment patients would be on the lowest dose dictated by medical necessity rather than by physician driven dose preference. A retrospective analysis of charts from 109 patients diagnosed with CGVHD between 6/2000 and 6/2003 was done. Data collected included age, donor type(mud/sib), plt count, CGVHD type(P/Q/DN), KPS, GI involvement. Outcome analysis included survival and cause of death. PSE dose was calculated in mg/kg at 3 months from first diagnosis of CGVHD. With a median follow up of 47.2 months(range 6.6–67.2) relapse censored survival of patients on a 3 month PSE dose of more than .3 mg/kg was 53% compared to all lower doses 86%(P.03). In a univariate analysis only PSE dose (P .05) and KPS (P <.01) were significant with plt count approaching significance (P .11). In a multivariate analysis again only PSE dose and KPS were significant (Table 1). Table Univariate Multivariate Variable Value N # of deaths Hazard Rate Ratio (95% CI) p value Hazard Rate Ratio (95% CI) p value Prednisone at 3 month 0 20 1 Baseline 0.05 Baseline 0.1–0.14 18 2 3.0 (0.3–32.7) 3.7 (0.3–43.4) 0.33 0.15–0.29 22 3 2.9 (0.3–28.2) 3.4 (0.3–34.5) 0.32 0.3–0.59 16 7 9.8 (1.2–79.4) 9.3 (1.1–76.0) 0.04 0.6–0.99 0 0 n/a n/a n/a ≥1.0 0 0 n/a n/a n/a cGVHD class Denovo 29 5 Baseline 0.54 Progressive 23 7 1.9 (0.6–6.0) Quiescent 57 13 1.3 (0.5–3.8) Donor type Sibling 48 9 Baseline 0.40 Unrelated 61 16 1.4 (0.6–3.2) Platelet count at 3 month <100 28 9 Baseline 0.11 Baseline ≥100 81 16 0.5 (0.2–1.1) 0.7 (0.2–2.3) 0.59 KPS at 3 month <80 14 7 Baseline <0.01 Baseline ≥80 95 18 0.2 (0.1–0.5) 0.3 (0.0–1.3) 0.03 Lower GI at 3 month No 98 22 Baseline 0.78 Yes 9 2 1.2 (0.3–5.2) Overall survival by Prednisone dose Overall survival by Prednisone dose The analysis of this data to date suggests the PSE dose at 3 months may be an important independent clinical marker for subsequent CGVHD prognosis which could be used to decide which patients to include in 2nd line and experimental therapy trials.

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Sawalha, Yazeed, John McMichael, Lisa Rybicki, Tamara A. Sussman, Alex V. Mejia Garcia, Robert M. Dean, Brad Pohlman, Brian T. Hill, and Deepa Jagadeesh. "Risk of Post-Transplant Lymphoproliferative Disorders (PTLD) in Solid Organ Transplantation Patients with EBV Viremia." Blood 132, Supplement 1 (November 29, 2018): 4202. http://dx.doi.org/10.1182/blood-2018-99-114686.

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Abstract Introduction Post-transplant lymphoproliferative disorders (PTLD) are mostly Epstein-Barr virus (EBV) positive lymphoid proliferations resulting from immunosuppression following allogeneic stem cell or solid organ transplantation (SOT). Despite this strong association, there is a lack of data evaluating the risk of PTLD in SOT patients (pts) with (w/) EBV viremia. The significance of EBV detection remains unclear and can lead to unwarranted preemptive treatments in SOT pts. The aim of this study is to assess the association between peripheral blood EBV viral load and risk of PTLD post SOT. Methods We identified 6468 adult and pediatric pts from the Cleveland Clinic SOT database who underwent SOT from 2002-2016. We included pts who had ≥1 EBV viral load test by PCR, and excluded pts w/ first EBV test at or after PTLD diagnosis. EBV viral load was quantified by polymerase chain reaction (PCR) of whole blood samples and expressed as log copies/mL. Lower detection limits varied from 2.00 to 2.70 log copies/mL. EBV monitoring post SOT was done at the physician's discretion. Potential risk factors for PTLD were assessed using Fine and Gray competing risk regression. Stepwise analysis was used to identify multivariable risk factors. Landmark analyses at 2 and 6 months post SOT (LM-2 and LM-6) were performed based on pts' peak pre-landmark EBV levels. Pts were excluded if they died, lost follow-up (f/u) or developed PTLD prior to the landmark. Two multivariable models were assessed at each landmark using EBV level cutoffs of 3.00 and 4.00 log. Results Of 6324 pts w/ available f/u data, 3348 (52%) had ≥1 quantitative EBV PCR test and were included in this analysis w/ a total of 91,067 tests performed. Median age at SOT was 54 years (range 0.3-79) and 63% were male. The most common SOT was kidney (38%) followed by lung (37%), liver (18%), heart (7%), pancreas (6%) and intestine (2%), w/ 7% receiving >1 organ type (Table 1). Of 3348 pts included, 1503 (45%) developed EBV viremia and 68 (2%) developed PTLD; 45/1503 (3.0%) and 23/1845 (1.2%) of pts w/ and without (w/o) EBV viremia, respectively. EBV was detected in 44% of pts w/o PTLD and 66% of pts w/ PTLD. Median age at PTLD diagnosis was 58 years (range 1-75), with a median time from SOT to PTLD of 33 months (range 2-146). PTLD morphology was DLBCL (n=39), polymorphic (n=9) Burkitt (n=5), other (n=10) and unknown (n=5). EBV-encoded RNA (EBER) testing in tumor was positive in 47%, negative in 44% and unknown in 9% of cases. In pts w/ and w/o PTLD, tacrolimus was the most common immunosuppressant used at 1 month (99% and 89%), 1 year (94% and 88%) and 2 years (81% and 74%) post SOT, respectively. First EBV was checked at a median of 54 days (range 0-5090) in pts w/o PTLD and 28 days (range 0-4308) in pts w/ PTLD. The median number of EBV tests/pt before PTLD or last f/u was 4 (range 1-214) in pts w/o PTLD and 6 (range 1-123) in pts w/ PTLD. Peak EBV levels ≥3.00 and ≥4.00 log were detected in 36% and 13% of pts w/o PTLD, and 60% and 40% of pts w/ PTLD, respectively. Median f/u in both cohorts for pts who were alive was 6.1 years. In multivariable analysis (MVA) for non-EBV risk factors for PTLD, liver (HR 2.19, 95% CI 1.31 - 3.66, p=.003) and intestine SOT (HR 4.62, 95% CI 1.84 - 11.6, p=.001) were the only factors associated w/ higher PTLD risk; age, years since SOT, gender, race, other types of SOT and >1 SOT were not significant. 1685 pts were eligible for LM-2 (43 w/ PTLD) and 2093 for LM-6 (36 w/ PTLD). In univariable analysis at LM-2 and LM-6, peak EBV levels ≥4.00 log (LM-2: HR 2.72, p=.016; LM-6: HR 7.08, p<.001) and ≥5.00 log (LM-2: HR 8.64, p=.006; LM-6: HR 7.06, p=.002) were associated w/ increased risk for PTLD (Table 2 and Figure). Additionally, at LM-6, peak EBV level ≥3 was predictive for PTLD development (HR 2.18, p=.018). MVA at LM-2 was significant using cutoff ≥4 log (HR 2.90, p=.011), and at LM-6 using ≥3 (HR 2.21, p=.02) and ≥4 log (HR 6.91, p<.001). The cumulative incidence rate (CIR) for PTLD was 2.4% at 6 months and 4.9% at 1 and 2 years post SOT in pts w/ EBV ≥4 log by LM-2. By LM-6, EBV value of ≥4 log resulted in a CIR of 3.7% and 5.7% at 1 and 2 years, respectively. Conclusion In this large cohort of SOT pts, <50% had EBV viremia post SOT with only 3% of pts with EBV viremia developing PTLD. EBV viral load of ≥4 log copies/mL at 2 and 6 months was associated with increased risk of PTLD. EBV monitoring post-transplant may benefit a subset of pts, and prospective studies are warranted to evaluate if preemptive treatment can reduce PTLD risk in high-risk pts. Figure. Figure. Disclosures Hill: Pharmacyclics: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Genentech: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Abbvie: Honoraria, Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Research Funding; Pharmacyclics: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees.

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Campbell, Ciara, Declan Millett, Niamh Kelly, Marie Cooke, and Michael Cronin. "Frankel 2 appliance versus the Modified Twin Block appliance for Phase 1 treatment of Class II division 1 malocclusion in children and adolescents: A randomized clinical trial." Angle Orthodontist 90, no. 2 (October 15, 2019): 202–8. http://dx.doi.org/10.2319/042419-290.1.

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ABSTRACT Objective: To compare Phase 1 treatment, using the Frankel 2 (FR2) or the modified Twin Block (MTB), for Class II division 1 malocclusion in children and adolescents with respect to: treatment duration, number of appliance breakages, occlusal outcome, and patient and parent perspectives. Materials and Methods: Sixty participants with a Class II division 1 malocclusion were randomly assigned to either the FR2 or MTB appliance in a two-armed parallel randomized clinical trial with an allocation ratio of 1 to 1. Time to achieve a Class I incisor relationship was the primary outcome. The number of appliance breakages was recorded. The Peer Assessment Rating (PAR) index was used to evaluate pre- and post-treatment occlusal outcome on study models. Participants completed the child OHRQoL (oral health-related quality of life), Piers-Harris, Standard Continuum of Aesthetic Need (SCAN), and Oral Aesthetic Subjective Impact Score (OASIS) questionnaires pre- and post-treatment; parents completed a SCAN questionnaire. Results: Forty-two participants completed treatment (FR2: 20; MTB: 22). Multiple imputation was used to impute missing data for noncompleters. Mean treatment duration was similar for the two appliances (FR2: 376 days [SD 101]; MTB: 340 days [SD 102]; P = .41). There were no significant differences in mean number of appliance breakages (FR2: 0.3 SD 0.7; MTB: 0.4 SD 0.8; P = .67 or mean PAR score P = .48). Patient and parent perspectives did not differ between appliances (P > .05). Conclusions: Phase 1 treatment duration, number of appliance breakages, occlusal outcome, and patient and parent perspectives were similar in 11–14 year olds with Class II division 1 malocclusion treated using the FR2 or MTB appliance.

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