bluuebunny/crossref_metadata_2025_split huggingface dataset:
S1-induced vasospastic angina—diagnostic utility of Holter ECG: a report of a case
Authors: Kanda Tatsuo , Wakai Atsuhiro , Chida Tadasu , Nakamura Yuichi 
Published: August 2020

Abstract
Background
Vasospastic angina is a rare but potentially life-threatening adverse event (AE) of S1, an oral fluoropyrimidine anticancer agent. However, this AE is not well known owing to its low incidence. We report herein a case of a patient who suffered from vasospastic angina associated with S1 chemotherapy for unresectable gastric adenocarcinoma, along with a review of the literature.

Case presentation
A 68-year-old woman was endoscopically diagnosed with gastric adenocarcinoma of the diffuse type. Abdominal pelvic contrast-enhanced computed tomography (CT) revealed small nodules in the omentum and ascites in the pouch of Douglas. The patient was clinically diagnosed with unresectable gastric adenocarcinoma with peritoneal metastasis, and primary chemotherapy with S1 plus cisplatin was selected. Around midnight of day 1, the patient complained of sudden oppressive chest pain. The pain disappeared spontaneously after 3–5 min, but similar events happened every midnight thereafter. No significant change was found on bedside electrocardiograms (ECGs) recorded immediately after the pain attacks. The patient was suspected to have unstable angina and underwent Holter ECG on day 4 of treatment. Holter ECG revealed ST segment elevations and short-run ventricular tachycardia during a pain attack. S1 chemotherapy was discontinued, and no attack was observed thereafter. Coronary CT angiography showed no significant stenosis of coronary arteries.

Conclusions
Clinicians should be aware of vasospastic angina as a serious AE in the chemotherapy with S1. Holter ECG is useful for the early diagnosis of this rare and clinically important AE.
Parent-child communication about sex and romantic feelings: does having older siblings make a difference?
Authors: Pasqualini Marta , De Rose Alessandra 
Published: August 2020

AbstractParental involvement in sex education and the quality of parent-child communication about romantic feelings appear to have a protective effect on adolescent sexual behaviours. However, little research has been conducted on the role played by birth order in the level of parental involvement in sex education. This is the first study seeking to address if the quality of parent-child communication about sex and romantic sentiments differs according to whether respondents have—or do not have—older siblings in Italy. Hypotheses concerning the role of sib-ship gender composition have been tested in order to explain potential intervening mechanisms. Data were drawn from the Sexual and Emotional Life of Youths survey (SELFY), a cross-sectional survey conducted in 2000 and in 2017 on Italian university students (N = 12,265). Our findings identify later-born children as the least likely to confide in parents. Although boys are generally less likely to talk to parents than girls, respondent gender does not moderate the effect of birth order. Instead, sib-ship gender composition plays a role: having grown up with at least one same-gender sibling is associated with a lower communication with parents about intimate matters. This study suggests that growing up with siblings, namely with same-gender siblings, make a difference in parent-child communication and this should be considered while evaluating the role of parental involvement in adolescent sexual education.
What is an estimand & how does it relate to quantifying the effect of treatment on patient-reported quality of life outcomes in clinical trials?
Authors: Lawrance Rachael , Degtyarev Evgeny , Griffiths Philip , Trask Peter , Lau Helen , D’Alessio Denise , Griebsch Ingolf , Wallenstein Gudrun , Cocks Kim , Rufibach Kaspar 
Published: August 2020

AbstractBackgroundPublished in 2019, a new addendum to the ICH E9 guideline presents the estimand framework as a systematic approach to ensure alignment among clinical trial objectives, trial execution/conduct, statistical analyses, and interpretation of results. The use of the estimand framework for describing clinical trial objectives has yet to be extensively considered in the context of patient-reported outcomes (PROs). We discuss the application of the estimand framework to PRO objectives when designing clinical trials in the future, with a focus on PRO outcomes in oncology trial settings as our example.MainWe describe the components of an estimand and take a naïve PRO trial objective to illustrate how to apply attributes described in the estimand framework to inform construction of a detailed clinical trial objective and its related estimand. We discuss identifying potential post-randomization events that alter the interpretation of the endpoint or render its observation impossible (also defined as intercurrent events) in the context of PRO endpoints, and the implications of how to handle intercurrent events in the construction of the PRO objective. Using a simple objective statement,“What is the effect of treatment X on patient’s quality of life?”,we build up an example estimand statement and also use a previously published phase III oncology clinical trial to illustrate how an estimand for a PRO objective could have been written to align to the estimate framework.ConclusionThe use of the estimand framework, as described in the new ICH E9 (R1) addendum guideline will become a key common framework for developing clinical trial objectives for evaluating effects of treatment. In the context of considering PROs, the framework provides an opportunity to more precisely specify and build the rationale for patient-focused objectives. This will help to ensure that clinical trials used for registration are designed and analysed appropriately, enabling all stakeholders to accurately interpret conclusions about the treatment effects for patient-focused outcomes.
Active human herpesvirus infections in adults with systemic lupus erythematosus and correlation with the SLEDAI score
Authors: Reis Alex Domingos , Mudinutti Cristiane , de Freitas Peigo Murilo , Leon Lucas Lopes , Costallat Lilian Tereza Lavras , Rossi Claudio Lucio , Costa Sandra Cecília Botelho , Bonon Sandra Helena Alves 
Published: August 2020

Abstract
Background
Human herpesviruses (HHVs) are responsible for a significant number of clinical manifestations in systemic lupus erythematous (SLE) patients. The aim of this study was to determine the frequency of active HHV infections in SLE patients and correlating them with disease activity.

Methods
Serum samples were collected from 71 SLE patients and their DNAs were extracted and analyzed to detect HHV-DNA viruses using the nucleic acid amplification technique.

Results
Fifteen out of the 71 (21.1%) patients tested positive for the HHV-DNA virus. Of them, 11/15 HHV-DNA-positive patients (73.3%) had SLE activity index (SLEDAI – Systemic Lupus Erythematosus Disease Activity Index) ≥8 (p = 0.0001). Active HCMV infection was the mostly frequently observed infection, occurring in 6/15 patients (40%). The frequencies of other active viral infections were 22% for HSV-1, 16.7% for HHV-7, and 5.5% for HSV-2. Viral coinfection (two or more viruses detected in the same sample) occurred in three patients (16.7%). Active HHV infections in SLE patients are more frequent in those with active SLE (≥8), who is at high risk of HHV reactivation and HCMV disease.

Conclusion
Viral surveillance is important to identify active HHV infections that can cause clinical symptoms and other complication in SLE patients.
Viral hepatitis and interstitial lung diseases: can HRCT assess their relation and characterize its pattern?
Authors: Samir Ahmed , El-Beheiry Ahmed Adel , Gharraf Heba Said , Khalifa Mohamed Hossameldin 
Published: August 2020

AbstractBackgroundClinical and pathological studies suggested the presence of a relation between active viral hepatitis and interstitial lung diseases (ILD) ranging from mild to moderate relation. Most studies attribute this relation to viral geno-physiological characteristics. The purpose of the study is first to assess the role of high-resolution computed tomography (HRCT) in evaluating the relation between viral hepatitis and ILDs, then to characterize the predominant pattern of ILD that affects patient management and prognosis.ResultsThis prospective study was conducted on 300 patients with viral hepatitis. They were divided into three groups of patients according to blood viremia assessed by polymerase chain reaction (PCR) as well as the diffusing capacity of carbon monoxide (DlCO) in examined pulmonary function tests (PFT).Group [A]included 100 patients with low or moderate viremia and showing normal or low to moderate DlCOdecline (> 50%).Group [B]included 100 patients with high viremia and showing normal or low to moderate DlCOdecline (> 50%).Group [C]included 100 patients with high viremia and showing a restrictive DlCOdecline pattern (< 50%). The study included 182 males and 118 females with a ratio of 3:2, while the age ranged between 40 and 70 years (mean age of 55 years).No ILDwas found among the group [A] patient. Meanwhile, 27% of patients in the group [B] showeda non-fibrotic pattern of ILDand 50% of patients in the group [C] showeda fibrotic pattern of ILD. Among patients in group [B] and group [C] together, 77 patients showed ILD accounting for 38.5%.ConclusionIn concordance with the results of the previous clinicopathological and geno-physiological studies, our HRCT results further established a mild to moderate relation between active hepatitis and ILD regardless of the pulmonary functions. The fibrotic pattern of ILD with poor response to therapy and poor prognosis was found in those patients with concomitant restrictive PFT and rapidly progressive symptoms.
Antioxidant activities of some edaphic algae in Egypt
Authors: El-Tablawy Neamat H. , Mansour Hoda A. , Shaaban Abd El-Salam M. 
Published: August 2020

AbstractBackgroundAlgae in general characterized by their rich content of biological compounds. However, few studies were conducted on the soil-inhabiting algae and their antioxidant characteristics.ResultsThe present study was designed to evaluate the antioxidant activity of four edaphic algae including one on-soil alga (Vaucheria geminata) and three axenic isolated in-soil algae (Pleurochloris pyrenoidosa,Botrydiopsis eriensis, andScenedesmus obliquus). Total antioxidant activity by Phosphomolybdenum assay ranged from 6.66 to 36.33 mg of Asc/g dwt; meanwhile, the percentage inhibition of DPPH radical was up to 97.37%. Antioxidant activity of each alga was assessed also by measuring their contents of total phenols, flavonoids, and pigments (chlorophyllaand carotenoids).B. eriensisandS. obliquusrecorded the highest levels of phenols, flavonoids, and chlorophyllafollowed byP. pyrenoidosaandV. geminata, whileB. eriensisshowed the highest carotenoids content. Moreover, about seven types of each phenol and flavonoid compound were identified by HPLC chromatography in the four algae under investigation. The most common detected phenols were gallic, chlorogenic, caffeic, and ferulic, while rutin, quercetin, apigenin, and quercitrin were the most abundant flavonoids among all algae under investigation.ConclusionAll the tested algae were characterized with high antioxidant activities besides the rich contents of compounds with antioxidant properties which recommend their further potential using in nutritional, pharmaceutical, and medicinal implications.
Prevalence and characteristics of neuropsychiatric involvement in an Egyptian cohort of systemic lupus erythematosus patients: a single-center retrospective cohort
Authors: M Medhat Basma , Moghazy Abdelkawy , Eissa Mervat 
Published: August 2020

Abstract
Background
The aim of this study was to retrospectively investigate the prevalence and characteristics of neuropsychiatric (NP) involvement in a cohort of systemic lupus erythematosus (SLE) patients from a single tertiary center.

Results
Of 301 included patients’ medical records, the prevalence of NPSLE, that was defined according to the American College of Rheumatology Nomenclature of 1999, was 33.5% (101/301), of whom 10 (9.9%) were males. The mean age at the last visit of patients with NP involvement was 29.1 ± 8.2 years, whereas the mean age at onset was 21.9 ± 7.3 years, and the mean disease duration was 89.8 ± 59.4 months. The most common NP manifestations were psychosis [34/101 (33.7%)], followed by seizures [22/101 (21.8%)]. Compared to those without NPSLE, patients with NP involvement were characterized by having a younger age of onset (p < 0.001) had a longer disease duration (p = 0.02). Of the cumulative characteristics recorded, NPSLE patients showed a higher prevalence of cutaneous vasculitis (p = 0.002), discoid rash (p = 0.03), pleurisy and pleural effusion (p = 0.004, p = 0.03, respectively), pericarditis (p = 0.007), thrombocytopenia (p = 0.04), and secondary antiphospholipid (APS) (p = 0.04); however, there was no difference in any of the included serologic features between the two groups. Patients with NPSLE had a higher median disease activity score [Systemic Lupus Erythematosus Disease Activity Index-2 K (SLEDAI-2 K)] at the disease onset (p = 0.008), yet it was comparable to those without NP involvement at the last visit (p = 0.3). NPSLE patients demonstrated a higher median damage score (p < 0.001) that was assessed according to the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score. NPSLE patients with secondary APS showed a higher prevalence of cerebrovascular accidents (CVA) (p < 0.001), while those without APS developed psychosis more frequently (p = 0.03).

Conclusion
Neuropsychiatric SLE patients (33.5%) demonstrated a younger age of onset, higher prevalence of secondary APS and distinct clinical characteristics, and had higher disease damage. APS-positive NPSLE patients had a higher prevalence of CVA, while APS-negative patients showed a higher prevalence of psychosis.
Efficacy of BSI-201, a poly (ADP-ribose) polymerase-1 (PARP1) inhibitor, in combination with gemcitabine/carboplatin (G/C) in patients with metastatic triple-negative breast cancer (TNBC): Results of a randomized phase II trial
Authors: O'Shaughnessy J. , Osborne C. , Pippen J. , Yoffe M. , Patt D. , Monaghan G. , Rocha C. , Ossovskaya V. , Sherman B. , Bradley C. 
Published: August 2020

3 The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology. [Table: see text]
Risk of breast cancer recurrence in women initiating tamoxifen with CYP2D6 inhibitors
Authors: Aubert R. E. , Stanek E. J. , Yao J. , Teagarden J. R. , Subar M. , Epstein R. S. , Skaar T. C. , Desta Z. , Flockhart D. A. 
Published: August 2020

CRA508 The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology. [Table: see text]
Concomitant CYP2D6 inhibitor use and tamoxifen adherence in early-stage breast cancer: A pharmacoepidemiological study
Authors: Dezentje V. , Van Blijderveen N. J. , Gelderblom H. , Putter H. , Van Herk-Sukel M. P. , Casparie M. K. , Egberts A. C. , Nortier J. W. , Guchelaar H. J. 
Published: August 2020

CRA509 The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology. No significant financial relationships to disclose.
Long-term follow-up and factors of survival of HER-2 positive breast cancer patients treated either by neoadjuvant trastuzumab docetaxel (TAXHER-S01 study) or by neoadjuvant trastuzumab docetaxel carboplatin (GETN[A]1 study)
Authors: Favier L. , Liegard M. , Guiu S. , van Praagh I. , Largillier R. , Weber B. , Coeffic D. , Vasseur B. , Coudert B. 
Published: August 2020

e11507 Background: Almost 20% of breast cancers over express Her2, which is associated with a more aggressive phenotype and with a decreased survival. Nevertheless, trastuzumab (T) has been a revolutionary step in the adjuvant and in the metastatic treatments of Her2 positive breast cancers. Here, we focus on neoadjuvant T and try to determine the factors correlating with disease free survival and with overall survival in Her2 positive breast cancer treated with T based neoadjuvant chemotherapy. Methods: Data from two published T based neoadjuvant phases II were used: the TAX-HER trial which studied the use of 6 courses of 3 weekly docetaxel with weekly neoadjuvant T (scheme TH) (Coudert et. al. Annals of Oncology 2006) and the GET(N)A-1 trial which studied the use of 6 courses of 3 weekly docetaxel and carboplatin along with weekly neoadjuvant T (scheme TCH) followed by 3 weekly adjuvant T (Coudert et. al. JCO 2007). Moreover, additional patients from our institution and treated by neoadjuvant TH and adjuvant T were included. Survival curves were estimated using Kaplan-Meier methods and compared by log-rank test. Results: Data was available for 128 patients. 62 patients (48.4%) received neoadjuvant TH from whom 39 did not receive adjuvant T. 66 (51.6%) received neoadjuvant TCH and adjuvant T. Tumors characteristics were as followed: 65 (50.7%) SBR 1–2, 54 (42.19%) SBR 3, 49 (38.28%) hormonal receptors (RH) negative and 72 (56.25%) RH positive. The rate of pathological complete response (pCR) (Chevalier 1/2) was 39.6%. Overall survival (OS) for the entire cohort was 74,8 months. Relapse was defined as local, regional, metastatic relapse or death. Survival without relapse (SR) was 74.8 months. No difference was noted in OS and in SR according to the type of chemotherapy, TH or TCH. pCR did significantly influence SR (p = 0. 03) and survival without local recurrence (SLR) (p = 0.04) but neither OS nor survival without metastatic relapse (SMR). Multivariate analysis demonstrated that OS was correlated with node response (as defined by sataloff grade NA or NB) (p=0.0275) and the use of hormonal therapy in RH positive tumors (p=0.0724). [Table: see text]
Predictors of invasive breast cancer or DCIS recurrence in estrogen receptor positive (ER+) and estrogen receptor negative (ER-) ductal carcinoma in situ (DCIS) patients with and without associated invasive carcinoma (IC)
Authors: Picarsic J. , Brufsky A. , Onisko A. , Chivukula M. 
Published: August 2020

e11523 Background: DCIS is a heterogeneous pre-invasive carcinoma with a spectrum of clinical behavior. Patients with ER+ IC have better outcomes compared to ER- patients. FOXA1 and GATA 3 family of transcription factors have been shown to be associated with hormone receptors (ER and PR) and other variables of good prognosis with better overall and relapse-free survival rate. The specific aim of this study is to analyze the expression of these novel biological markers: FOXA1, GATA-3, with recognized markers: MIB-1(Ki-67) and HER2 /neu in DCIS patients with/without associated IC. Methods: Sixty-nine (69) cases of DCIS [(fifty two (52) cases in ER+; seventeen (17) in ER-] were retrieved from our Pathology database. The expressions of the biological markers are analyzed by using a panel of immunohistochemical stains. FOXA1, GATA 3, ER, PR are nuclear stains, a cumulative “H score” is derived based on proportionality (PS) and intensity scores (IS). A proliferation index (PI) is calculated for MIB-1 (Ki67) nuclear stain (low <10%, moderate 11–25%, high 26–50%, very high>50%). Her2/neu is scored as per guidelines for HercepTest (0, or 1+ =negative, 2+ =weakly positive, 3+ =strongly positive). Results: DCIS is categorized into low grade (LG) (nuclear grade 1 and 2), high grade (HG) (grade 3). In the HGDCIS (n=48), four (4) cases had IC after a mean of 7.75 years; three cases of recurrent DCIS after a mean 6 years. No recurrent IC or DCIS is seen in the LGDCIS (n=21) group. The results are shown in the Table . Conclusions: (1) Decreased expression of GATA 3 is observed in HGDCIS ER- group may be a contributor to higher recurrence observed in this group (14%) versus (0%) in ER+ group. (2) A strong expression of FOXA, GATA3, low Ki-67 index, absent Her 2 expression are characteristically seen in our ER+ DCIS group, as previously described in IC. 3. Comparing the response to therapy and outcome in the ER+ and ER- groups is on going. [Table: see text] No significant financial relationships to disclose.
The role of preoperative neoadjuvant cytoreductive dose-dense bevacizumab plus docetaxel followed by bevacizumab-doxorubicin-cyclophosphamide regimen in locally advanced operable breast cancer
Authors: Waintraub S. E. , Tuchman V. 
Published: August 2020

e11524 Background: Neoadjuvant Rx has been shown to downstage locally advanced breast cancer (LABC) to try to achieve a pathological complete response(PCR) and to convert mastectomy to lumpectomy. Bevacizumab (B) was recently approved to treat metastatic breast cancer in combination with paclitaxel (P). NSABP B-27 used preoperative doxorubicin(A) with cyclophosphamide (C) +- docetaxel (Doc) every 3 wks in primary operable breast cancer, yielding a 12.9% PCR with no residual invasive cancer from AC and 26.1% with the addition of Doc. Based on the success of E2100 with P+B over P, and the more recent AVADO trial showing the superiority of B and Doc over Doc, we have treated such Her2neu-neg pts using Doc/B followed by AC/B with a dose dense every (q) 2 week regimen to see if we could achieve a higher PCR rate and to assess the tolerability of this regimen. Methods: Pts with Her2neu-negative locally advanced operable M0 breast cancer were treated initially with B 10mg/kg iv q 2w with Doc 100mg/m2 q 2w four times with pegfilgrastim given 24 hours after chemotherapy, followed by A 60mg/m2 and C 600mg/m2 q 2 weeks four 4 times with pegfilgrastim given 24 hours after chemotherapy with B 10mg/kg iv for the first AC course as the B was discontinued at least 6 weeks prior to definitive breast surgery. All pts were to get radiation therapy after surgery and appropriate anti-estrogen Rx if estrogen receptor was positive. Results: 15 Her-2 neg women aged 35–61 were treated from 9/06-present for locally advanced primary operable breast cancer. All pts had clinically significant tumor reduction. Of the first 12 post-operative evaluable pts that have completed all the pre- operative therapy, the results showed 5 PCR, including one pt with residual sub-cm DCIS, 7 pathological incomplete responses, yielding a 42% PCR. 3 of the 5 PCR pts had lumpectomies. The major toxicity was excessive eye tearing, nail bed changes and lethargy. Conclusions: This novel dose dense q 2 week regimen is safe, tolerable and effective in LABC with acceptable toxicity. The addition of B to dose dense traditional neoadjuvant chemotherapy seems to increase the PCR. Larger prospective trials using B with dose dense therapy are warranted. No significant financial relationships to disclose.