bluuebunny/crossref_metadata_2025_split huggingface dataset:
The impact of IT governance and data governance on financial and non-financial performance
Authors: Naguib Hend Mohamed , Kassem Hossam Magdy , Naem Abd El-Hamed Mostafa Abou 
Published: January 2024

AbstractThis paper aims to examine the impact of both information technology governance (ITG) and data governance on information technology (IT) performance in the telecommunication industry. A questionnaire of 308 managers was collected from all telecommunication companies that are working in Egypt. Data were analyzed using smart partial least squares (PLS). The results showed that all the hypotheses of the study had been accepted. IT and data governance have a significant impact on both financial and non-financial performance. However, each of them has a different effect on the IT performance dimensions. The financial performance of IT department had been affected by IT governance more than data governance. Also, innovation and flexibility were the most affected by IT governance. On the other hand, data governance affected business processes and ethical compliance more than IT governance. The current study filled the gap on the literature in two ways. First, studying both IT governance and data governance as a critical factors affects financial and non-financial performance. Second, studying IT governance and data governance has become more important, especially in the telecommunication industry as it is a big challenge now to secure the data of the companies.
Role of lactate level in predicting admission need to intensive care unit and short term outcomes in patients with acute gastrointestinal bleeding
Authors: Shawky Hekmat Nashat , Kamel Hala Mostafa , Sayed Zain Elabdeen Ahmed , Abdelwahab Hossam Mahmoud 
Published: January 2024

Abstract
Background
One of the most common emergencies seen in emergency departments is acute gastrointestinal bleeding (GIB). It’s associated with more disease burden and mortality.
Increased venous lactate levels are common in critically ill patients, and it has been used as a possible predictor of patients’ outcomes in many critical cases, but not much is known about its predictive role in patients with acute GIB.
With increasingly limited health care resources, there has been such an interest in coast saving measures and measuring lactic acid through venous blood gases is such a simple bedside test which can be easily done to patients with acute GIB at emergency department.

Objective
This study assessed the predictable value of lactate level on hospital admission on resource use, including length of hospital stay and admission to the intensive care unit (ICU), as well as other patient-oriented outcomes, including the need for blood transfusions and endoscopy.

Patients and methods
A prospective cohort hospital based study that included 300 patients with acute GIB who presented to emergency department (ED) of Assiut University Hospital between September 2019 and June 2022 were subjected to venous blood lactate through venous blood gases.

Results
The current study enrolled 300 patients with acute GIB. Two hundred of those patients had elevated blood lactate and 100 patients had normal blood lactate. It was found that patients with elevated blood lactate had significantly prolonged hospital stay (7.38 days ± 2.05 days vs. 3.96 days ± 1.74 days; (P < 0.001). Also they had higher frequency of blood transfusion (98% vs. 72%), ICU admission (95% vs. 67%) and mortality (9% vs. 3%) in comparison to those with normal lactate level.

Conclusion
It was found that venous lactate level is an effective predictor for patient’s outcomes among patients with acute GIB.
Speech auditory brainstem responses (s-ABRs) as a new approach for the assessment of speech sounds coding
Authors: Elsayed Hagar Ahmed , Nada Ebtessam Hamed , Galhoum Dalia Helal , Elnabtity Nadia Mohamed 
Published: January 2024

Abstract
Background
The evoked auditory brainstem response (EABR) is an objective electrophysiological test used to assess the brainstem’s auditory neural activity. Speech ABR (s-ABR) testing using verbal stimuli gives more important details about how the brainstem processes speech inputs which enables the detection of auditory processing impairments that do not manifest in click-provoked ABR. The use of speech syllables in the s-ABR reveals an important brainstem function that plays a crucial part in reading development and phonologic achievement which is an assessment of speech syllables. The syllable /da/ is often utilized in s-ABR measurement being a global syllable that can be tested in many nations with effective experimental confidence.

Conclusion
The speech ABR is an objective, unbiased, quick test. It can be used to differentiate between many conditions such as auditory processing disorders (APD), specific language impairment (SLI), and children with academic challenges.
Correlation between tympanometric findings and adenoid hypertrophy among children without hearing loss in tertiary care hospital
Authors: Basavaraju K. P. , Ranjani S. K. , Sri Vaibhava V. , Sulhyan Sushmita 
Published: January 2024

AbstractAdenoid hyperplasia is a common cause of nasal obstruction in children. Chronic infection and hypertrophy result in mouth breathing, snoring, sleep apnoea, hyponasality, sinusitis, and otitis media with effusion (OME). Some children with adenoid hypertrophy have OME in spite of having no complaints of hearing loss. Untreated OME may adversely affect the speech and intellectual development of the child.Aim To determine whether there is a correlation between tympanometric findings and various radiological and endoscopic grades of adenoid hypertrophy.To propose a combination of radiological and/or endoscopic assessment of adenoids and tympanometry as a screening program in patients with suspicion of adenoid hypertrophy.Materials and methods One hundred children, presenting with one or more complaints of upper airway obstruction (UAO), suggestive of adenoid hypertrophy, without a history of hearing loss, to the OPD, were chosen for the study. X-ray nasopharynx soft tissue lateral view was done for all patients. Rigid diagnostic nasal endoscopy with 0° endoscope was conducted in only children who were cooperative and with parental consent. Tympanometry was carried out for all patients and plotted on tympanograms.Results In our study, the mean age of children is 9.43 ± 2.430 years with gender distribution being 57% males and 43% females. The majority of children tend to present with nasal obstruction (100%), mouth breathing (83%), and snoring (56%). On both radiological and endoscopic evaluation of adenoids and correlation with tympanogram, a significantly higher number of patients with Grade 1 adenoids have a type A curve, while a significantly higher number of grade 3 adenoids patients have a type B curve and type C is significantly more prevalent in grade 2 and grade 4 adenoids (p < 0.05).Conclusion In our study, adenoid size as measured from both adenoid X-ray and adenoid endoscopy, showed a significant association with the presence of middle ear effusion and also with eustachian tube dysfunction. This helps in early detection, prior to the development of hearing loss, making it easy to plan early intervention, and curbing the possibility of aggravation of the condition and occurrence of complications.
Bulky nodal disease as distinctive prognosticator in anal cancer management.
Authors: Chie Eui Kyu , Chun Seok-Joo , Kim Eunji , Jang Won Il , Kim Mi-Sook , Kang Hyun-Cheol , Kim Byoung Hyuck 
Published: January 2024

1 Background: This study aimed to investigate the prognostic value of bulky nodal involvement in patients with squamous cell carcinoma of anus treated with definitive chemoradiotherapy. Methods: Medical records of patients with anal squamous cell carcinoma receiving definitive chemoradiotherapy at three medical centers from 2004 to 2021 were retrospectively analyzed. Exclusion criteria were (1) distant metastasis including non-regional nodal involvement at diagnosis, (2) 2D radiotherapy, and (3) salvage treatment for local relapse. Bulky nodal disease was defined as node with long-diameter 2cm or greater. Results: A total of 104 patients were accrued, consisting of 51 patients without, 46 patients with non-bulky, and 7 patients with bulky nodal involvement. Median follow-up duration was 54.0 months (range, 6.4-162.2 months). Estimated progression-free survival (PFS), loco-regional recurrence free survival (LRRFS) and overall survival (OS) at 5 years for patients with bulky nodal disease were 42.9%, 42.9%, and 89.4%, respectively. Compared to without or with non-bulky nodal involvement, bulky nodal involvement was significantly related with poor PFS and LR RFS. New staging incorporating bulky nodal disease as N2 stage was devised: T1-2N0-1 as stage I, T3-4N0-1 as stage II, and N2 as stage III. Estimated PFS, LRRFS, and OS at 5 years were as follows: 83.5%, 85.9%, and 91.3%, 60.9%, 67.7% and 93.3%, and 42.9%, 42.9%, and 55.6% for patients with stage I, II, and III disease, respectively (p = 0.0024 for PFS, 0.0015 for LRRFS, and 0.28 for OS, respectively). Conclusions: Patients with bulky nodal disease receiving standard chemoradiotherapy had poor survival outcomes compared to the other patient groups, suggesting the need for further treatment intensification. Moreover, incorporating bulky nodal disease into the staging system improved the prognosis predictability.
Real-world analysis of irinotecan (iri) with or without fluorouracil (5FU) in the second line treatment (2L) of metastatic colorectal cancer (mCRC).
Authors: Lentz Robert William , Hu Junxiao , Robinson Hannah Ruth , Balmaceda Nicole Baranda , Baiyee Ebot Emily Eyoung , Leal Alexis Diane , Kim Sunnie S. , Davis S. Lindsey , Messersmith Wells A. , Lieu Christopher Hanyoung 
Published: January 2024

102 Background: The most used 1st line (1L) chemotherapy backbone for mCRC is fluoropyrimidine (FP) + oxaliplatin. In the 2L, iri alone or with 5FU (FOLFIRI), ± a biologic agent (biologic), are options. It is unclear whether adding 5FU to iri is beneficial following disease progression on prior FP. Methods: This study used the nationwide Flatiron Health electronic health record (EHR)-derived de-identified database to identify patients diagnosed with mCRC from 01-01-2013 to 02-13-2023, who received 1L with FP + oxaliplatin ± biologic, and 2L with irinotecan ± 5FU ± biologic. Baseline patient/tumor characteristics were obtained. The number of major comorbidities was computed using ICD-9-CM/10 codes within 1 year prior to 2L (Quan, 2005). Time to next treatment (TTNT) was defined from the start of 2L to the start of next line treatment (excluding maintenance). For survival outcomes, the median survival time and 95% confidence interval (CI) were estimated using the Kaplan-Meier method. Uni- and multi-variable analyses (UVA and MVA) were performed with the cox proportional hazard model. All covariates were evaluated in UVA, and those significant were included in MVA with adjusted hazard ratio (HR) and 95% CI. Results: 3,215 patients met criteria; most previously received a biologic with 1L (70.5% prior anti-angiogenesis and 5.9% prior anti-EGFR) and had 0 structured major comorbidity diagnoses (82.1%). In the 2L, FOLFIRI was the most used chemotherapy backbone (90.6%, vs iri 9.4%), 79% of patients also received a biologic, and patients who received FOLFIRI were younger (median age 61 vs 65 years) and had better ECOG performance status (87.8% vs 81.8% ECOG 0-1). Overall survival (OS) was longer with FOLFIRI than iri (median 14.4 vs 9.8 months, p<0.001), as was TTNT (median 7.6 vs 5.3 months, p<0.001). In MVA, when controlling for age, comorbidities, CEA, ECOG performance status, and 1L, iri was associated with shorter OS than FOLFIRI (HR 1.38, 95% CI 1.21-1.57, p<0.001). In MVA, the addition of a biologic to FOLFIRI and iri prolonged OS and TTNT in some subgroups (Table). Conclusions: In this retrospective real-world analysis of 3,215 patients with mCRC who received 1L with FP + oxaliplatin ± biologic, 2L FOLFIRI was associated with longer OS compared to iri alone (both ± biologic). [Table: see text]
Peritoneal lavage cytology in patients with curative resection for stage II and III colorectal cancer: A multi-institutional prospective study.
Authors: Kobayashi Hirotoshi , Kotake Kenjiro , Sugihara Kenichi , Ajioka Yoichi 
Published: January 2024

11 Background: Although various prognostic factors in patients with colorectal cancer has been reported, the usefulness of intraoperative lavage cytology in patients with colorectal cancer is controversial. The aim of this study was to clarify the usefulness of intraoperative lavage cytology in patients with curative resection for pSage II-III colorectal cancer in a prospective multicenter study. Methods: The 20 member hospitals of the Japanese Society for the Cancer of the Colon and Rectum prospectively registered the patients diagnosed as stage II or III colorectal cancer preoperatively between 2013 and 2017. Among these patients, pStage II-III patients went through analysis. Lavage cytology was performed twice during surgery. The first procedure was performed right after laparotomy, and the second was performed right after specimen retrieval. The primary endpoint of this study was an effect of lavage cytology on 5-year relapse-free survival (RFS) in patients with pStage II-III colorectal cancer. The secondary endpoint was an effect of lavage cytology on 5-year overall survival (OS) and peritoneal recurrence in patients with pStage II-III colorectal cancer. Results: A total of 1378 patients were eligible and went through analysis. The number of patients with pStage II and III colorectal cancer were 670 and 708, respectively. Among 1378 patients, 54 (3.9%) had positive cytology. The median follow-up period of the entire cohort was 5.3 years. In pStage II patients, the 5-year RFS rate with positive and negative cytology was 61.1% and 81.6%, respectively (P = 0.023). The 5-year OS rate of pStage II patients with positive and negative cytology was 67.1% and 91.7%, respectively (P = 0.0083). However, there was no difference in RFS and OS between patients with positive and negative cytology in pStage III patients. Thirty-three patients had peritoneal recurrence. The peritoneal recurrence rate was 11.8% and 1.5% in pStage II patients with positive and negative lavage cytology, respectively (P = 0.032). That was 10.5% and 2.5% in pStage III patients with positive and negative lavage cytology, respectively (P = 0.022). In total, 11.1% of patients with positive lavage cytology had peritoneal recurrence in this cohort. Conclusions: The pStage II colorectal cancer patients with negative cytology had better RFS and OS compared to those with positive cytology. Peritoneal lavage cytology was useful in predicting peritoneal recurrence after curative resection for pStage II-III colorectal cancer. Clinical trial information: UMIN000026070 .
Real-world evidence of FOLFIRI combined with anti-angiogenesis inhibitors or anti-EGFR antibodies for patients with early recurrence colorectal cancer after adjuvant FOLFOX/CAPOX therapy in Japan: A retrospective observational study using administrative database.
Authors: Sunakawa Yu , Wang Chaochen , Piao Yongzhe , Jin Long , Tanizawa Yoshinori , Cai Zhihong , Kagawa Yoshinori 
Published: January 2024

110 Background: Oxaliplatin-containing regimens (FOLFOX or CAPOX) are the most common adjuvant treatments after curative resection of colorectal cancer (CRC). However, real-world evidence (RWE) of treatment sequence/outcomes for patients with early recurrence CRC after receiving adjuvant chemotherapy are limited. Methods: This retrospective cohort study was based on an administrative database in Japan. The primary objective was to describe the treatment sequence for patients with early recurrence CRC and treated by combination of FOLFIRI and anti-angiogenesis inhibitors (AAIs) or anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs) after adjuvant FOLFOX or CAPOX therapy. The study included patients with CRC who underwent surgical resection, started adjuvant chemotherapy ≤3 months (mo) after the first surgery, had early recurrence of CRC (defined as initiation of FOLFIRI + AAIs/anti-EGFR mAbs second line [2L] regimen) within 1 year after adjuvant chemotherapy ended. Patient characteristics at baseline of 2L (60 days prior to 2L initiation) and treatment sequence were summarized descriptively; time to discontinuation (TTD) for adjuvant and 2L therapy were analyzed using Kaplan-Meier method. Cox proportional hazard model was used to identify risk factors associated with TTD of 2L regimen. Results: The cohort included 832 patients: median (range) age was 67 (24-86) years, 56.4% males, 65.5% with left-sided CRC. Most patients received CAPOX (71.3%) as adjuvant therapy. Median (95% CI) duration of adjuvant therapy was 5.4 mo (5.3-5.5). As 2L therapy, 72.5% and 27.5% of patients received FOLFIRI + AAIs (AAIs group) and FOLFIRI + anti-EGFR mAbs (anti-EGFR group), respectively. Median TTD (95% CI) of the AAIs and anti-EGFR groups in 2L were 6.2 mo (5.8-6.9) and 6.1 mo (5.2-7.4), respectively. Among patients with recurrence within 6 mo (72.6%), the median TTD (95% CI) for AAIs and anti-EGFR groups were 6.1 mo (5.5- 6.5) and 5.8 mo (5.1-7.8), respectively. Among patients with recurrence during 6 to 12 mo (27.4%), the median TTD (95% CI) of AAIs and anti-EGFR groups were 8.1 mo (6.1-9.2) and 6.2 mo (4.6-8.0), respectively. Age ≥70 years was negatively associated with TTD of 2L, HR = 1.19 (95% CI: 1.02-1.39); p=0.03. Conclusions: This is the first RWE based on administrative data on treatment sequence/ outcomes for patients with early recurrence CRC treated by FOLFIRI + AAIs/anti-EGFR mAbs after adjuvant FOLFOX/CAPOX therapy in Japan. The treatment outcomes for patients with early recurrence CRC were similar to previous clinical trials in 2L advanced CRC. The results suggested that these two 2L regimens had similar TTD; however, the timing of relapse may influence the efficacy of AAIs and anti-EGFR mAbs.
Efficacy and safety of trifluridine/tipiracil in combination with bevacizumab in older and younger patients with refractory metastatic colorectal cancer: A subgroup analysis of the phase 3 SUNLIGHT trial.
Authors: Taieb Julien , Prager Gerald W. , Fakih Marwan , Ciardello Fortunato , Van Cutsem Eric , Elez Elena , Cruz Felipe Melo , Wyrwicz Lucjan S. , Stroyakovskiy Daniil , Papai Zsuzsanna , Poureau Pierre-Guillaume , Liposits Gabor , Cremolini Chiara , Bondarenko Igor , Modest Dominik Paul , Roby Lucas , Barboux Valentine , Amellal Nadia , Tabernero Josep 
Published: January 2024

111 Background: SUNLIGHT, an international, open-label, randomized, phase 3 study comparing trifluridine/tipiracil (FTD/TPI) + bevacizumab (FTD/TPI + bev) to FTD/TPI monotherapy in patients with refractory metastatic colorectal cancer (mCRC), demonstrated a 3.3-month increase in overall survival from 7.5 months with FTD/TPI monotherapy to 10.8 months with FTD/TPI + bev (HR, 0.61; 95% CI: 0.49–0.77; P<0.001). This subgroup analysis of SUNLIGHT examined efficacy and safety outcomes by age. Methods: In SUNLIGHT, patients with mCRC with ECOG PS of 0-1 and two prior treatment regimens were randomized to receive FTD/TPI + bev or FTD/TPI. A subgroup analysis was performed to evaluate efficacy and safety outcomes in patients aged <65, 65-74, and ≥75 years. Results: Among 492 randomized patients (n=246 FTD/TPI + bev; n=246 FTD/TPI), 56%, 32%, and 12% were aged <65, 65-74, and ≥75 years, respectively. Concerning overall survival, hazard ratios for FTD/TPI + bev vs FTD/TPI monotherapy were 0.65 (95% CI: 0.48–0.87), 0.64 (95% CI: 0.43–0.94), and 0.49 (95% CI: 0.27–0.90) in patients aged <65, 65-74, and ≥75 years, respectively. Regardless of age, patients receiving FTD/TPI + bev experienced improved progression-free survival and improved time to worsening of ECOG PS to ≥2. Among FTD/TPI + bev treated patients, frequency of any-cause severe adverse events (AEs) was slightly higher in the 65-74 subgroup [69% (<65); 80% (65-74); 67% (≥75 years)]. Frequency of grade 3 and 4 neutropenia was also slightly higher in the 65-74 subgroup [38% (<65); 54% (65-74); 42% (≥75 years)]. AE-related discontinuation rates were similar across age subgroups [11.6% (<65 years), 13.2% (65-74), and 16.7% (≥75 years)]. Conclusions: The results of this subgroup analysis demonstrate the efficacy benefit and tolerability of FTD/TPI + bevacizumab treatment regardless of age in refractory mCRC patients. Clinical trial information: NCT04737187 .
Initial efficacy evaluation of fruquintinib plus capecitabine versus capecitabine as maintenance treatment for metastatic colorectal cancer (mCRC): A randomized, controlled, phase Ib/II study.
Authors: Li Wenhua , Chang Jinjia , Wang Chenchen , Peng Junjie 
Published: January 2024

119 Background: The standard first-line therapy followed by maintenance treatment is an optional approach to balance the efficacy and toxicity for mCRC. Fruquintinib (Fru), a highly specific inhibitor of VEGFR1/2/3, has demonstrated favorable safety and efficacy outcomes in the treatment of mCRC. In this study, we present findings from an investigation into the comparative efficacy and safety of Fru in combination with capecitabine (Cap) versus Cap as a maintenance therapy for patients (pts) with mCRC. Methods: Pts with histologically confirmed mCRC who achieved disease control (including CR/PR and SD) after at least six cycles of first-line standard chemotherapy were included in the study. During phase Ib, pts received Fru (4 mg p.o. qd, 3 weeks on/1 week off, q4w]) plus Cap (850 mg/m2, p.o. bid, d1-7 and d15-21, q4w). In phase II, pts were randomized in a 1:1 ratio to receive either Fru (RP2D, 3mg, 3 weeks on/1 week off) plus Cap or Cap alone. The primary outcome was progression-free survival (PFS). Results: By Sep 10, 2023, a total of 34 pts were enrolled in the study, and 26 pts were considered evaluable for efficacy. During Fru plus Cap (n=14) and Cap (n=12), the median age was 61.5 (39-78) and 57.5 (32-75) years. The main primary tumor side was left (64.3% / 66.7%) and approximately half of the pts harbored a RAS mutation (50.0% / 58.3%). Most pts had previously received bevacizumab therapy (57.1% /58.3%) or cetuximab (35.7% /25.0%), respectively. The mPFS was significantly improved in Fru plus Cap vs Cap (9.1 vs 3.8 months, HR: 0.289, 95% CI 0.083 to 1.01, p=0.039). Consistently, ORR (21.4% vs 0%) and DCR (92.9% vs 66.7%) were improved with Fru plus Cap. Grades 3 and 4 treatment-emergent adverse events (TEAEs) were hypertension (11.1%), oral mucositis (5.6%), voice alteration (5.6%), small intestinal obstruction (5.6%), acrodynia (5.6%) and blood bilirubin increased (5.6%) in Fru plus Cap, and diarrhea (6.3%), oral mucositis (6.3%) and acrodynia (6.3%) in Cap therapy. Conclusions: The findings suggest that Fruquintinib plus Capecitabine can be considered as a first-line maintenance therapy for metastatic colorectal cancer, as it demonstrated a promising improvement in mPFS by 5.3 months while maintaining a controlled level of safety. Clinical trial information: NCT05451719 .