bluuebunny/crossref_metadata_2025_split huggingface dataset:
Clinical features of benign paroxysmal positional vertigo of the posterior semicircular canal
Authors: Ciorba Andrea , Cogliandolo Cristina , Bianchini Chiara , Aimoni Claudia , Pelucchi Stefano , Skarżyński Piotr Henryk , Hatzopoulos Stavros 
Published: January 2019

Objective: The aim of this study was to evaluate the relationship between age, gender and affected ear, in patients presenting benign paroxysmal positional vertigo. Methods: This was a retrospective study. Data from benign paroxysmal positional vertigo clinical reports (January 2009–December 2014) were analysed. A total of 174 patients affected by benign paroxysmal positional vertigo of the posterior semicircular canal have been identified. Pearson chi-square test has been used to evaluate the probability of benign paroxysmal positional vertigo occurrence in relation to gender and side, within the studied groups. The level of significance was set at a p < 0.05. Results: Considering age as a discriminant factor, three groups of patients were identified: group 1: 16 patients with an age <40 years; group 2: 79 patients with an age between 40 and 65 years and group 3: 79 patients with an age >65 years. In each group, the right posterior semicircular canal was involved in the majority of cases (group 1 incidence: 12/16; group 2 incidence: 49/79 and group 3 incidence: 52/79). In all three groups, female patients were significantly more affected (9/16 in group 1, 61/79 in group 2 and 55/79 in group 3). Conclusion: Benign paroxysmal positional vertigo is most prevalent in female subjects having an age>40 years and mainly involves the right posterior semicircular canal.
Statistical Analysis of Dependent Observations in the Orthopaedic Sports Literature
Authors: LeBrun Drake G. , Tran Tram , Wypij David , Kocher Mininder S. 
Published: January 2019

Background: Orthopaedic research may involve multiple observations from the same patient because of bilateral joint involvement, multiple disease sites, or recurrent disease episodes. These situations violate statistical independence and need to be accounted for via appropriate statistical techniques. Failing to account for nonindependence may lead to biased and overly precise effect estimates. Purpose: To determine the degree to which orthopaedic sports medicine studies analyze dependent observations and the proportion of these failing to account for nonindependence. Study Design: Cross-sectional study. Methods: Clinical studies published in The American Journal of Sports Medicine from 2012 to 2017 were reviewed. Studies reporting nonindependent observations because of multiple extremity involvement or multiple disease episodes were identified. Methods to account for nonindependence were recorded. Studies violating the assumption of independence were identified and stratified by study design, level of evidence, body part involved, and inclusion of a statistician coauthor. Univariate logistic regression was used to determine whether these factors were associated with violations of statistical independence. Results: After screening 1016 articles, 886 clinical studies were reviewed. A total of 135 (15%) studies analyzed dependent observations, and 111 (82%) of these failed to account for nonindependence. Relative to the knee, studies of the hip (odds ratio [OR], 0.21; P = .02) and the thigh or leg (OR, 0.03; P = .004) were less likely to violate statistical independence. Study design ( P = .03) was also associated with violations of statistical independence. Among studies that analyzed dependent observations, the median proportion of dependent observations relative to the total number of observations in each study was 0.07 (interquartile range, 0.04-0.12). Conclusion: The analysis of dependent observations is common in the orthopaedic sports literature, but most studies do not adjust for nonindependence in these situations. Investigators should be aware of incorrect inferences arising from nonindependence and how to statistically adjust for dependent data.
Development of shrink resistance cotton using fluorocarbon
Authors: Jain Anil Kumar , Tesema Addisu Ferede , Haile Adane 
Published: January 2019

AbstractAn attempt has been made to develop shrink resistance cotton textile by making it hydrophobic. The cotton fabric was made hydrophobic by treating with fluorocarbon resin emulsion at varying concentrations along with catalyst. The hydrophobicity was measured by carrying out water repellency test and also determining the water contact angle. The air permeability of cotton fabric was also determined and was not adversely affected. The untreated and treated cotton fabric was subjected to repeated domestic laundry condition and shrinkage was measured. In order to determine the impact of fluorocarbon treatment on fabric, the physical properties of treated and untreated cotton fabrics were compared. No adverse impact was observed in colour fastness properties. The tensile and tear strength showed good retention even at higher concentration of water repellent chemicals. This work finds wide use in home textiles and hotel industry. This work is of industrial interest as value added shrink resistance cotton textiles can fetch more export earnings.
Emotional branding speaks to consumers’ heart: the case of fashion brands
Authors: Kim Youn-Kyung , Sullivan Pauline 
Published: January 2019

AbstractIn this highly competitive market, fashion brands struggle to distinguish themselves to increasingly apathetic consumers. To become more competitive, fashion retailers employ emotional branding as a way to engage their customers, addressing the growing trend of consumers’ seeking emotional relationships with a brand. Although brand technicalities such as product attributes, features, and facts may be unmemorable, personal feelings and experiences better shape consumers’ evaluations of brands. This study illustrates why emotional branding is essential, especially to fashion brands, when developing brand strategies in a volatile marketplace. Trends that support a need for these strategies include consumers’ desires for positive experiences, expressing authentic self, achieving warm glow from helping others, and co-creating design or ideas with the brand. We propose a model for emotional branding strategies that focuses on sensory branding, storytelling, cause branding, and empowerment. The case studies we provide for each strategy describe how fashion brands can engage customers through emotional branding.
Randomized, open-label, phase II study comparing five-weekly S-1 plus cisplatin (SP) with tri-weekly capecitabine plus cisplatin (XP) in chemotherapy-naïve patients with HER2 negative advanced gastric cancer (AGC): OGSG 1105 HERBIS-4A trial.
Authors: Takeno Atsushi , Makari Youichi , Endo Shunji , Matsuyama Jin , Kawabata Ryohei , Sugimoto Naotoshi , Taniguchi Hirokazu , Nagai Kenichi , Tamura Shigeyuki , Nishijima Junichi , Ueda Shugo , Kimura Yutaka , Tamura Takao , Kobayashi Kenji , Kawakami HIsato , Fujitani Kazumasa , Sakai Daisuke , Shimokawa Toshio , Kurokawa Yukinori , Satoh Taroh 
Published: January 2019

102 Background: This phase II study aimed to investigate the safety and efficacy of XP compared to SP in the first-line treatment of HER2 negative AGC. Methods: Patients were randomly assigned to receive either SP (S-1 at 40–60 mg twice daily for 21 days plus cisplatin at 60 mg/ m2 on day 8, every 5 weeks) or XP (capecitabine 1,000 mg/m2 twice daily for 14 days plus cisplatin 80 mg/m2 on day 1, every 3 weeks). Primary endpoint was response rate (RR), and secondary endpoints were progression-free survival (PFS), overall survival (OS), time to treatment failure (TTF), and adverse events. Results: 84 eligible patients were randomly assigned to receive SP ( N = 41) or XP ( N = 43). No statistical difference was observed in overall RR between the SP and XP groups [51.2% (95% CI, 35.1% to 67.1%) vs. 53.5% (95% CI, 37.7% to 68.8%), P = 1.000]. Despite not significant, however, SP vs. XP showed a trend toward better PFS [median, 5.9 months vs. 4.1 months; hazard ratio (HR), 0.763; 95% CI, 0.462 to 1.259; P = .284] and OS (median, 13.5 months vs. 10.0 months; HR, 0.776; 95% CI, 0.485 to 1.244; P = .290). This trend in the SP vs. XP comparison was more pronounced in TTF (median, 4.5 months vs. 3.1 months; HR, 0.651; 95% CI, 0.421 to 1.006; P = .052). Common grade 3 to 4 hematological toxicities were neutropenia and anemia (SP group, 23% and 23%; XP group, 35% and 28%). Grade 3-4 anorexia and hyponatremia were more frequently seen in the XP group (31% and 16%) compared to the SP group (13% and 5%). Treatment-related deaths occurred in one patient (2.3%) in the XP group. Conclusions: XP failed to demonstrate the superior efficacy over SP. Higher incidence of severe toxicities by XP suggests SP as the standard 1st line chemotherapy for HER2 negative AGC in Japan. Clinical trial information: UMIN000006755.
Recombinant humanized anti-PD-1 monoclonal antibody (JS001) as salvage treatment for advanced gastric adenocarcinoma: Preliminary results of an open-label, multi-cohort, phase Ib/II clinical study.
Authors: Xu Rui-hua , Wang Fenghua , Xu Nong , Shen Lin , Dai Guanghai , Yuan Xianglin , Shi Jianhua , Yang Shujun , Feng Ji Feng , Hu Xi-Chun , Zhang Qingyuan , Chen Ye , Lin Xiaoyan , Ba Yi , Liu Yunpeng , Jiang Yi , Yongqian Shu , Li Qi , Li Wei , Yao Sheng 
Published: January 2019

108 Background: Patients with gastric adenocarcinoma (GC) or gastroesophageal junction cancer (GEC) often present with advanced or metastatic disease, which has poor prognosis and limited treatment options and represent an important unmet medical need especially in China/Asia. JS001, a humanized recombinant IgG4 antibody against PD-1, selectively blocks the interactions of PD-1 with its ligands PD-L1 and PD-L2, and promotes antigen specific T-cell activation. A phase I study of JS001 in Chinese patients with heavily pretreated solid tumors has demonstrated an acceptable safety profile in doses up to 10 mg/kg Q2W. Here we report the safety and efficacy of JS001 in a phase Ib/II clinical study in Chinese patients with refractory/metastatic GC. (Clinical trial ID: NCT02915432) Methods: Refractory/metastatic GC Patients receive JS001 3 mg/kg Q2W until disease progression or unacceptable toxicity. All patients with measurable disease will be assessed for clinical response every 8 weeks according to the RECIST 1.1 criteria. Tumor PD-L1 expression as well as additional potential predictive biomarkers are monitored for correlation with clinical response. Results: Between Apr 19, 2017 and Sep 11, 2017, 48 GC pts (74.5% received at least 2 Lines of treatment) were enrolled into the study. Treatment related adverse events occurred were mostly grade 1 or 2. As of Sep 11, 2017, 25 GC pts have been evaluated for clinical efficacy. 5 PR (partial response) and 10 SD (stable disease) were observed (ORR 20% and DCR 60%). The PD-L1 expression positivity (defined as positive staining ³1% on Tumor Cell or on Immune Cell by SP142) in EC tumor was 14.3% (7/48). 3/5 (60%) PD-L1+ patients and 2/20 (10%) PD-L1 negative patients achieved partial responses. Conclusions: JS001 showed a promising preliminary clinical activity in heavily pre-treated metastatic GC pts with a manageable safety profile. Of the 25 evaluable GC patients by 9/11/2017, 5 PR and 10 SD were observed (ORR 20% and DCR 60%). Among PD-L1 positive patients (n=5), ORR was 60% and DCR 80%. Pts will be continuously monitored for safety and efficacy upon JS001 treatment. Clinical trial information: NCT02915432.
Patterns of chemotherapy (CT) use in a U.S.-wide cohort of patients (pts) with metastatic gastric cancer (MGC).
Authors: Abrams Thomas Adam , Meyer Gary , Hess Lisa M. , Zhu Yajun , Zhang Sui , Liepa Astra M. , Meyerhardt Jeffrey A. , Schrag Deborah , Enzinger Peter C. , Fuchs Charles S. 
Published: January 2019

112 Background: MGC is associated with poor survival outcomes. Despite multiple therapeutic options, there is no clearly defined standard-of-care (SOC) CT algorithm. Assessing MGC treatment trends of CT utilization is of critical import. Few population studies have examined the frequencies and temporal trends of MGC CT regimens. This study was designed to address this knowledge deficit. Methods: Eligible pts had biopsy-proven MGC diagnoses and received CT between Jan 2005 and Dec 2016 at academic, private or community hospital practices using IntrinsiQ, a US-wide CT order entry system that captures pt, provider and CT data. Temporal trends were analyzed in the context of SOC changes during the study’s observational period. Results: Among 4,333 MGC pts, median age was 64; 74% were male. In 1st-line CT, 26% received fluoropyrimidine [FU] + oxaliplatin (FOLFOX), 15% received epirubicin + platinum + FU [ECF/EOX], 15% received docetaxel (D) + cis/carboplatin (C) + FU [DCF], 13% received C + paclitaxel, 10% received C + FU [CF], 5% received taxane [TAX] monotherapy. FOLFOX use has increased steadily to 41% in 2015 while DCF use dropped from 29% in 2007 to below 10% by 2015. Biologics were used in 11% of all 1st-line starts and 24% of all 2nd-line starts. Trastuzumab represented 72% of 1st line biologic use (with or without CT backbones), overall use increased from 0% in 2008 to 16% of 1st line in 2015 In 2nd line, no single treatment regimen was used in more than 7% of patients in 2005, but the use of newer treatments has increased over time: trastuzumab use increased from 0% in 2008 to a peak of 22% in 2016 and ramucirumab use increased from 0% in 2012 to its peak in 2015 of 26%. Conclusions: This population-based study provides insight into US MGC treatment patterns and recent trends with the availability of novel agents. [Table: see text]
Ramucirumab treatment in patients with gastric cancer/gastroesophageal junction adenocarcinoma: Secondary analysis of efficacy and safety results of 4 dosing regimens in the phase II trial I4T-MC-JVDB.
Authors: Ajani Jaffer A. , Udrea Anghel Adrian , Sarosiek Tomasz , Schenker Michael , Morgan Carys , Pikiel Joanna , Joseph Mano , Salek Tomas , Tournigand Christophe , Ferry David Raymond , Zhang Yawei , Long Amanda , Kuo Wen-Ling , Gao Ling , Russo Francesca , Mansoor Wasat 
Published: January 2019

117 Background: Ramucirumab (RAM) is approved for treatment of advanced gastric cancer or gastroesophageal junction adenocarcinoma with disease progression after prior platinum and/or fluoropyrimidine chemotherapy at 8 mg/kg every 2 weeks (Q2W). Previous phase 3 trials indicated that efficacy of RAM correlated with exposure. While the primary objectives of the open-label RAM monotherapy JVDB study were pharmacokinetics and safety, a secondary analysis was conducted on efficacy and safety of the 3 higher exposure regimens vs. the standard regimen. Methods: Patients ( n = 164) were randomized 1:1:1:1 to 4 treatment arms: 8 mg/kg Q2W (Arm 1), 12 mg/kg Q2W (Arm 2), 6 mg/kg every week (Arm 3), and 8 mg/kg Days 1 and 8 (D1D8) every 3 weeks (Q3W) (Arm 4). Treatment-emergent adverse events (TEAEs) were graded by NCI CTCAE v4.0. Tumor response was assessed by RECIST 1.1. Results: Median (months) progression-free survival (PFS) of the 3 arms and overall survival (OS) of 2 arms was increased compared to the standard regimen (Table). Best overall response was partial response (Arm 2, n = 4; Arm 3, n = 2). The majority of patients experienced ≥1 TEAE (81.4%); 39.1% had ≥1 Grade ≥3 event and 26.7% had ≥1 serious event. The most frequent Grade ≥3 events were fatigue (5.6%), abdominal pain (5.05%), hypertension (5.0%), anemia (4.3%), and vomiting (3.7%). Conclusions: Although the study was not powered for statistical comparisons, some trends toward improved efficacy vs. the standard regimen were observed; the greatest median PFS months and OS improvement was 1 month (Arm 2 vs. Arm 1; PFS = 2.50 vs. 1.45; OS = 6.74 vs. 5.68). Despite higher RAM exposures with the experimental regimens, the safety profile is similar to the standard dose regimen, and no unexpected safety findings were observed. Clinical trial information: NCT02443883. [Table: see text]
A comparison of doublet versus triplet chemotherapy regimens for esophagogastric adenocarcinoma (EGC): Is more always better?
Authors: Felismino Tiago , Alves Ana Caroline , Oliveira Audrey , Costa Wilson Luiz da , Coimbra Felipe José Fernandez , Jesus Victor Hugo Fonseca , Camandaroba Marcos Pedro Guedes , Mello Celso Lopes 
Published: January 2019

124 Background: Recent data showed that a taxane-containing triplet regimen (FLOT) was superior to an anthracycline-containing regimen (ECX/ECF). However, there is no comparison between more costly and toxic triplet (T) regimens versus doublets (D) in the perioperative setting (periCT) of EGC. Methods: A retrospective analysis of patients (pts) with newly diagnosed EGC was carried out at AC Camargo Cancer Center from 2007 to 2015. Pts received either a D with a fluopyrimidine and platin or T with addition of epirubicin or docetaxel. Variables used in the Cox model were age, site, TNM, Lauren subtype and periCT (T versus D). The selection between T and D was at physician's choice. Endpoints were Relapse Free Survival (RFS) and Overall Survival (OS). Results: A total of 128 pts were included. Median age was 59.5y (56.5y for T and 67y for D, respectively). Male/female ratio was 82/46. Sixty-six received T (DCF 26 pts, EOX 28, ECX 8, 4 others) and 62 received D (FOLFOX 47 pts, CF 13, 2 others). Primary site: gastric in 93 pts and 35 EGJ. Main clinical staging cT3 N = 81 (63.3%), cN+ 84 (65.4%). Lauren subtype: intestinal N = 48, diffuse N = 54. Regarding surgery: 114 pts were resected and median lymph nodes removed 30. Pathologic complete response was seen in N = 9 (14.5%) and N = 4 (6.1%) considering D and T regimens, respectively (p = 0.14). In multivariate analysis there was no advantage of T over D regarding RFS (HR = 1.65, 0.87 – 3.11, p = 0.12) or OS (HR = 1.29, 0.65 – 2.57, p = 0.45). The 3y RFS rate was 63.2% for D and 40.6% for T and the 3y OS was 69.4% for D and 56.1% for T. Conclusions: In our analysis outcomes of pts treated with T regimen was not superior to D. Our main T was DCF and D was FOLFOX. We consider that doublet regimens may still have a role in periCT in EGC and could be an option for frail or elderly pts. Future trials are needed to confirm our data.
Extended outcomes of intraperitoneal and systemic chemotherapy for gastric cancer with peritoneal metastases.
Authors: Chan Dexter Yak Seng , Syn Nicholas , Neogh Cui Ting , Phua Niam Sin , . Elya , Ho Jinghsan , Sundar Raghav , Tan Chee Seng , Ngoi Natalie , Chee Cheng Ean , Shabbir Asim , So Jimmy , Yong Wei-Peng 
Published: January 2019

125 Background: Peritoneal metastasis is common in gastric cancer. It is difficult to treat and carries a grave prognosis. Studies have shown increased drug concentration in the peritoneal cavity when chemotherapy is administered intraperitoneally (IP). We had previously published early results on IP paclitaxel plus XELOX for such patients and now present our longer term data. Methods: Patients with unresectable and/or recurrent gastric adenocarcinoma with peritoneal dissemination and/or positive peritoneal washing cytology, not previously-treated or received prior systemic therapy > 180 days ago and ECOG ≤2 are eligible. Patients were treated with 8 cycles of paclitaxel 40 mg/m2 IP on days 1 and 8, oxaliplatin 100 mg/m2 IV on day 1 and capecitabine 1000 mg/m2 b.i.d. PO for 2 weeks followed by 1 week of rest. The primary endpoint is 1-year overall survival rate and the secondary endpoints are safety, response rate and peritoneal cytological response. Patients who subsequently have no distant metastases, with stable or reduced peritoneal disease and 2 consecutive negative peritoneal cytology would be eligible for conversion gastrectomy. Results: 34 patients have been enrolled and received at least one cycle at the time of reporting. Median no. of cycles is 8 (range: 1–8) and median follow-up is 30.2 months. Median OS is 16.4 months (IQR: 10.1–27.2) and 1-year survival rate is 64.9% (95% CI: 45.5%–78.9%). Of 30 evaluable patients, 1 achieved CR (3.3%), 6 (20.0%) achieved PR, 16 (53.3%) achieved SD and 7 (23.3%) experienced PD. Peritoneal cytology turned negative in 17 of 32 (53.1%) patients. Severe (grade ≥ 3) AE were neutropenia ( N= 7), febrile neutropenia ( N= 3), diarrhoea ( N= 3), hand-foot syndrome ( N= 2), bacterial peritonitis ( N= 2) and hypokalaemia ( N= 4) and tumour perforation ( N= 1). One death occurred due to neutropenic sepsis. 8 patients had conversion gastrectomy with no additional morbidity, with a 1-year survival of 87.5% with a median OS of 18.8 months. Conclusions: XELOX + IP paclitaxel appears to be a well-tolerated and active regimen in gastric cancer with peritoneal metastases, and may offer survival benefits. Finally, conversion gastrectomy may be considered in patients with favourable response. Clinical trial information: NCT01739894.
Outcomes for advanced HER2-positive gastroesophageal cancer by anatomical location: Experience from the Princess Margaret Cancer Centre.
Authors: Lim Charles Henry , Yokom Daniel , Jiang Di Maria , Ma Lucy Xiaolu , Sun Peiran , Sim Hao-Wen , Natori Akina , Chan Bryan Anthony , Moignard Stephanie , Knox Jennifer J. , Chen Eric Xueyu , Liu Geoffrey , Swallow Carol Jane , Darling Gail Elizabeth , Brar Savtaj Singh , Hafezi-Bakhtiari Sara , Conner James , Elimova Elena , Jang Raymond Woo-Jun 
Published: January 2019

131 Background: The landmark ToGA trial established trastuzumab (T) based therapy as the standard of care for advanced HER2+ gastric and gastroesophageal junction cancer. However, outcomes for T based therapy for HER2+ esophageal cancer have not been well characterized. Methods: We conducted a retrospective analysis of patients (pts) with HER2+ gastroesophageal cancer receiving T based therapy at our institution from 2011-2016. Distal esophagus ( < 35 cm) and Siewert type I/II tumours were defined as esophageal (E). Siewert type III and stomach tumours were defined as gastric (G). Trained abstractors collected pt demographics and treatment details. Overall survival (OS) and progression-free survival (PFS) were calculated from the date of first T treatment. Chi-square tests, t-tests and Cox proportional hazards models were applied where appropriate. Results: We identified 87 pts with advanced HER2+ disease. 62% (n = 54) had de novo metastatic (M1) disease. 57 patients were treated with T based therapy, with median age 57 years (IQR 48-67), 91% baseline performance status 0-1, 19% female, and 7% Asian. 63% (n = 36) had E and 37% (n = 21) had G primary tumours. 67% (n = 38) presented with M1 disease. 33% (n = 19) underwent surgery with curative intent and received T based therapy at recurrence. Baseline characteristics were balanced between the E and G groups. Survival data were available for 51 patients. The E and G groups did not have significant differences in PFS (median 9.5 vs. 9.1 months, HR 0.89 (95% CI 0.44-1.80), p = 0.74) or in OS (median 15.8 vs. 14.2 months, HR 0.88 (95% CI 0.42-1.82), p = 0.73). 63% (n = 36) were treated with subsequent systemic therapy after progression on T, with 23 receiving one line, 9 receiving two lines and 4 receiving three additional lines of treatment. The number subsequent therapies received was similar between E and G groups. Conclusions: Although patients with distal esophagus tumours were not included in the ToGA trial, our analysis suggests that patients with E and G tumours had similar outcomes. Our contemporary cohort had comparable survival outcomes relative to patients receiving T in the ToGA trial (median PFS = 6.7 months, median OS = 13.8 months).