bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase IV noninferiority controlled randomized trial to evaluate the impact on diagnostic thinking and patient management and the test–retest reproducibility of the Gaxilose test for hypolactasia diagnosis
Authors: Monsalve-Hernando Carmen , Crespo Laura , Ferreiro Blanca , Martín Verónica , Aldeguer Xavier , Opio Verónica , Fernández-Gil Pedro Luis , Gaspar María Jesús , Romero Eduardo , Lara Carmen , Santander Cecilio , Torrealba Leyanira , Savescu Theodora , Hermida Carmen 
Published: November 2018

Abstract

Background:
The diagnostic accuracy of the Gaxilose test (GT) for hypolactasia diagnosis has already been proved. The objectives of this clinical trial were to demonstrate the noninferiority of the GT compared to the hydrogen breath test (HBT) on the impact on diagnostic thinking and patient management, to evaluate the GT reproducibility with urine accumulated from 0 to 4 hours and from 0 to 5 hours and to assess test safety.

Methods:
We conducted a randomized, parallel, noninferiority clinical trial. Patients with clinical symptoms suggestive of lactose intolerance were screened for inclusion and randomly assigned to the GT arm or the HBT arm of the study. The impact on diagnostic thinking and patient management was analyzed with pretest and posttest questionnaires in which the investigators indicated their estimated probability of hypolactasia diagnosis and the intended management before and after the GT or the HBT (noninferiority margin: −10%). The primary outcome of the study was the impact on diagnostic thinking, expressed as the mean of the absolute values of the differences between the pretest and posttest probabilities of hypolactasia diagnosis. Patients randomized to the GT arm performed also the retest to evaluate the reproducibility of the GT.

Results:
A total of 147 patients were included in the intend-to-treat (ITT) population. Among them, 74 performed the HBT and 73 performed the GT. The results proved the noninferiority of the GT compared to the HBT on the impact on diagnostic thinking (ImpactGT = 31.74 ± 23.30%; ImpactHBT = 24.28 ± 19.87%; ΔGT−HBT = 7.46%; 95% confidence interval of ΔGT−HBT: 1.55%, infinite) and on patient management. The test–retest reproducibility was better for the GT with urine accumulated from 0 to 5 h: the intraclass correlation coefficient (ICC) was 0.5761, and the Kappa coefficient was 0.7548, indicative of substantial agreement between both tests. No serious adverse events were reported during the study.

Conclusions:
The GT has an impact on diagnostic thinking and patient management noninferior to that of the HBT, is reproducible and well tolerated. These results prove the clinical benefit of its use in the clinical practice (ClinicalTrials.gov identifier: NCT02636413).
Meta-analysis of clinical trials comparing the efficacy and safety of liposomal cisplatin versus conventional nonliposomal cisplatin in nonsmall cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN)
Authors: Xu Bei , Zeng Min , Zeng Jiawei , Feng Jiafu , Yu Lin 
Published: November 2018

Abstract

Background:
While liposomal cisplatin has shown enhanced drug tolerability and higher targeting property as compared with the conventional cisplatin, the doubt remains whether lipoplatin could improve its anticancer efficacy. What's more, there is still no systematic evaluation of the safety profiles of lipoplatin comparing with original cisplatin. Thus, we performed a systematic literature search for randomized clinical trials directly comparing efficacy and safety of liposomal cisplatin versus its conventional nonliposomal cisplatin.

Methods:
The electronic search was conducted in PubMed, Embase, The Cochrane Library, and ClinicalTrials.gov from inception to February 10, 2018. The pooled odds ratio (OR) and 95% confidence intervals (CIs) of progressive disease (PD), partial response (PR), stable disease (SD), and adverse events (AEs) were obtained to assess the efficacy and safety. Heterogeneity was estimated using the I

2
test (I

2
> 50%, significant heterogeneity).

Results:
The search yielded 5 clinical trials that meet inclusion criteria, with a total of 523 patients. We found that the liposome encapsulated cisplatin was more clinical efficacious than cisplatin as assessed by PD rate (OR, 0.46; 95% CI, 0.28–0.74; P = .002), while subgroup analysis of the only nonsmall cell lung cancer (NSCLC) patients showed higher response rates in PR (OR, 0.46; 95% CI, 0.28–0.74; P = .002) and PD (OR, 0.46; 95% CI, 0.28–0.74; P = .002) simultaneously. In addition, the toxicity meta-analysis revealed lipoplatin was much less toxic than the original cisplatin, with respect to grade 3 to 4 neurotoxicity (OR, 0.18; 95% CI, 0.04–0.74; P = .02), grade 3 to 4 leukopenia (OR, 0.47; 95% CI, 0.26–0.85; P = .01), grade 3 to 4 neutropenia (OR, 0.26; 95% CI, 0.09–0.71; P = .009), grade 1 and 2 nausea/vomiting (OR, 0.50; 95% CI, 0.32–0.77; P = .002), and grade 3 and 4 asthenia (OR, 0.11; 95% CI, 0.03–0.42; P = .001).

Conclusions:
This meta-analysis revealed that with both NSCLC and squamous cell carcinoma of the head and neck (SCCHN) patients, liposomal cisplatin-based chemotherapy offers significant advantages regarding the PD and reduced toxicities relative to conventional cisplatin.
Ureteral inflammatory myofibroblastic tumor
Authors: Li Faping , Guo Hui , Qiu Heping , Hou Yuchuan 
Published: November 2018

AbstractRationale:Inflammatory myofibroblastic tumor (IMT) is a rare soft-tissue neoplasm which has been described in a variety of locations. In the urogenital system, IMT predominantly occurs in the bladder and the kidney. IMT arising from the ureter is exceedingly rare and has been sporadically reported before.Patient concerns:We reported an extremely exceptional case of IMT arising from the ureteral submucosa in a 54-year-old man. The patient was hospitalized with the main complaint of intermittent and moderate left abdominal pain for 2 months.Diagnoses and Interventions:Computed tomography scan revealed a nearly circular mass in the left upper ureter. Ureteroscopy showed that the ureteral lumen mucosa was smooth. However, the upper ureter was compressed and narrow. Renal dynamic imaging was performed and the measured glomerular filtration rate was 46.98 mL/min (right renal) and 9.77 mL/min (left renal), respectively. A retroperitoneoscopic radical nephroureterectomy was performed. The histopathologic examination revealed that the soft-tissue neoplasm was mainly composed of myofibroblastic spindle cells proliferation with mixed inflammatory infiltrate, containing lymphocytes, neutrophils, and eosinophils. On immunohistochemical staining, the tumor was positive for smooth muscle actin and Ki-67 (<1%+), indicating a confirmed diagnosis of ureteral IMT.Outcomes:The patient recovered well with no occurrence of complications. At 3-year follow-up, there was no radiologic evidence of tumor recurrence or metastasis and the man was well.Lessons:Ureteral IMT is extremely rare and often asymptomatic, resulting in delayed diagnosis. Radiologic evidences may be suggestive of the diagnosis of IMT. However, it is necessary to make an accurate diagnosis in terms of histopathologic assessment. Complete lesion excision is the best therapeutic approach with rare recurrences and excellent survival.
CT diagnosis for metastasis of clear cell renal cell carcinoma to the pancreas
Authors: Yu Qian , Kan Fanggong , Ma Zhoupeng , Wang Tianke , Lin Guansheng , Chen Bingye , Zhao Wenliang 
Published: November 2018

Abstract

Rationale:
Clear cell renal cell carcinoma (CCRCC) metastasis to pancreas is clinically rare. Misdiagnosis for these cases is frequently due to the low incidence, lack of specific clinical symptoms, and laboratory results.

Patient concerns:
Three female patients aged 47 years, 69 years, and 76 years, respectively, were admitted to hospital for routine examination after resection of clear cell carcinoma of kidney for 69 months, 57 months, and 123 months, respectively. All 3 cases had no specific clinical symptoms. Routine laboratory tests and common tumor markers including CEA, AFP, CA19-9, and CA125 showed no obvious abnormality.

Diagnosis:
All 3 cases were finally diagnosed with CCRCC metastasis to pancreas on the basis of CT and pathological findings. On unenhanced CT, foci of the pancreas showed single or multiple nodules or masses with mildly low or equal density and obscure boundary. On enhanced CT, the enhanced mode of foci was similar to CCRCC and showed “fast in fast out.” The main body was confined in the pancreas. The peripheral structure was clear relatively. Obstruction of common bile duct, main pancreatic duct, and local infringement of foci cannot be seen. Additional metastases of right adrenal gland can be seen in one case.

Interventions:
All 3 cases underwent CT examination and surgical treatment, with complete removal of metastatic tumors.

Outcomes:
All 3 cases underwent surgical treatment successfully, and recovered successfully after operation.

Lessons:
The manifestations of pancreatic metastases from CCRCC on CT show certain characteristics, which may be useful to assess the histological features of pancreatic metastases from CCRCC and facilitate the preoperative diagnosis.
Efficacy of tasquinimod in men with metastatic castration-resistant prostate cancer
Authors: Gong Ping , Liu Hongjian , Liu Xinyu , Zhou Ge , Liu Meitian , Yang Xiaodi , Xiong Wenjing , Wang Qi , Ma Juan , Ren Zheng , He Minfu , Zhang Xiumin 
Published: November 2018

Abstract

Background:
Tasquinimod is an oral quinoline-3-carboxamide derivative for the treatment of metastatic castration-resistant prostate cancer (mCRPC). Tasquinimod has antiangiogenic, immunomodulatory, and antimetastatic properties, but it is also associated with toxicities, including skeletal pain, digestive disorders, fatigue, insomnia, and mental disorders. We aimed to perform a meta-analysis to evaluate the efficacy, safety, and long-term survival for tasquinimod in patients with mCRPC.

Methods:
Searches were carried out in PubMed, Embase, and the Cochrane Library. Eligible articles included randomized clinical trials (RCTs) comparing systemic or combination therapy (excluding primary or secondary androgen deprivation therapy, bone protective agents, or radionuclides) with placebo in men with mCRPC.

Results:
Three RCTs were selected for final evaluation. The pooled results from the 3 studies indicated that tasquinimod was associated with good radiologic progression-free survival (rPFS) in mCRPC. For adverse effects (AEs), the results of meta-analysis indicated that patients with mCRPC who received tasquinimod had obvious anemia (risk ratio (RR) 1.35, 95% confidence interval (CI) 1.06–1.73, P = .02), back pain (RR: 1.57, 95% CI: 1.01–2.47, P = .05), pain in the extremities (RR: 1.90, 95% CI: 1.14–3.17, P = .01), insomnia (RR: 1.50, 95% CI: 1.03–2.17, P = .03), vomiting (RR: 1.52, 95% CI: 1.04–2.21, P = .03), and peripheral edema (RR: 1.52, 95% CI: 1.03–2.23, P = .03).

Conclusions:
Tasquinimod is associated with better rPFS in mCRPC. The toxicity of tasquinimod requires further investigation, it is not recommended for routine clinical use.
Feasibility of a single mediastinal drain through the abdominal wall after esophagectomy
Authors: Zheng Yan , Li Yin , Liu Xianben , Zhang Ruixiang , Wang Zongfei , Sun Haibo 
Published: November 2018

Abstract
This study evaluated the safety and effectiveness of a single mediastinal drainage tube in the thoracic and abdominal cavity after minimally invasive esophagectomy (MIE). This study was undertaken to determine if the procedure could be included in a fast-track surgery program for resectable esophageal carcinoma (EC).
From June 17 to November 30, 2015, clinical data for 78 eligible patients who had undergone a fast-track surgery program and MIE were retrospectively analyzed. Twenty-eight patients had a chest tube and mediastinal drainage tube. Thirty-four patients had only a mediastinal drainage tube through the intercostal space. The remaining 30 patients had a single mediastinal drainage tube in the thoracic and abdominal cavity through the abdominal wall. The complication rates and pain scores for each of the groups were compared. The statistical calculations were performed using SPSS 17.0 for Windows (SPSS Inc., Chicago, IL). The quantitative data among the groups were compared using 1-way analysis of variance (ANOVA). The Chi-square, Mann–Whitney U and Fisher exact tests were used for qualitative data analysis.
There were no significant differences in the anastomotic leak rates, postoperative days and total complication rates (P = .861). The lowest visual analog scale (VAS) scores of the drainage tubes were observed in the group with a single mediastinal drain through the abdominal wall (P <.001).
The results of this study suggested that a single mediastinal drainage tube in the thoracic and abdominal cavity after MIE may be safe and efficient. This clinical practice is a part of our fast-track surgery program.
Effect of prophylactic palonosetron and sugammadex on postoperative nausea and vomiting in patients undergoing microvascular decompression under propofol-maintained anesthesia
Authors: Kang Hee Yong , Park Sung Wook , Lee Sangho , Jeon Jong-Mi , Oh In Duk , Choi Jeong-Hyun 
Published: November 2018

Abstract
Microvascular decompression (MVD) is associated with a particularly high risk of postoperative nausea and vomiting (PONV) among craniotomy patients. However, there is no information regarding the effect of prophylactic palonosetron and sugammadex on PONV in patients undergoing MVD under propofol-maintained anesthesia.
Medical records of 274 adults who had undergone MVD under propofol-maintained anesthesia were reviewed. Patients were classified into 4 groups, based on the reversal agent used (sugammadex/pyridostigmine) and whether or not prophylactic palonosetron was used. The PONV incidence and risk factors were analyzed according to the use of these agents.
The overall incidence of PONV was 30.7% during the first 24 hours postoperatively. The incidence of PONV was lower in the group using combination of prophylactic palonosetron and sugammadex (19.3%) compared with the group not using both agents (37.2%). The combined use of the prophylactic palonosetron and sugammadex was identified as a factor affecting the occurrence of PONV in both univariable (OR = 0.40, 95% CI: 0.21–0.77, P = .006) and multivariable (OR = 0.38, 95% CI: 0.20–0.75, P = .005) logistic regression analyses. In multivariable logistic regression analysis, female sex was also significant independent risk factor in PONV (OR = 2.62, 95% CI: 1.35–5.08, P = .004).
In this retrospective observational study, the combined use of prophylactic palonosetron before anesthetic induction and sugammadex as a reversal of neuromuscular blockade are associated with a reduction in the incidence of PONV in patients undergoing MVD under propofol-maintained anesthesia.
The associations among Helicobacter pylori infection, white blood cell count and nonalcoholic fatty liver disease in a large Chinese population
Authors: Yu Ying-ying , Cai Jian-ting , Song Zhen-ya , Tong Yu-ling , Wang Jing-hua 
Published: November 2018

Abstract
Reported relationships among Helicobacter pylori infection, white blood cell (WBC) count and nonalcoholic fatty liver disease (NAFLD) are inconsistent and controversial. We, therefore, conducted a cross-sectional study to investigate the associations among the presence of NAFLD, WBC count and H pylori infection, as diagnosed using the 13C-urea breath test (UBT).
This study included 20,389 subjects enrolled at the International Health Care Center of the Second Affiliated Hospital of the Zhejiang University School of Medicine from January 2015 to December 2015. All participants underwent a 13C-UBT for the diagnosis of H pylori infection and ultrasonography for NAFLD as well as a blood test to determine WBC count. Multivariate logistic regression was then performed to evaluate the relationship among H pylori infection, WBC count and NAFLD.

H pylori infection was detected in 38.49% (7,848/20,389) of the subjects via the UBT, and NAFLD was present in 37.24% (7,592/20,389) of the subjects. The prevalence of H pylori infection was higher in the NAFLD group than in the control group (41.25% vs 36.85%, P <.001). Significant differences were found between various WBC quartiles and H pylori infection, age, gender, body mass index (BMI), systolic blood pressure (SBP), diastolic blood pressure (DBP), high-sensitivity C-reactive protein (HS-CRP), glycosylated hemoglobin (HbA1c), triglyceride (TG), low-density lipoprotein (LDL-C), fasting blood glucose (FPG), homeostasis model assessment of insulin resistance (HOMA-IR), and smoking. Multivariate logistic regression revealed that the combination of H pylori infection and WBC count (odds ratio [OR] = 1.067, 95% confidence interval [CI]: 1.014, 1.093; P = .007; OR = 1.165, 95% CI: 1.023, 1.488; P <.001; OR = 1.183, 95% CI: 1.085, 1.559; P <.001, respectively) was positively associated with NAFLD.

H pylori infection and WBC count may contribute to the pathogenesis of NAFLD.
Dose-dependent effect of propranolol on the hemodynamic response in cirrhotic patients with gastroesophageal varices
Authors: Zhang Feng , Xu Hui , Chen Min , Zhang Ming , Xiao Jiangqiang , Wang Yi , He Qibin , Zhang Wei , Yin Xiaochun , Zou Xiaoping , Zhuge Yuzheng 
Published: November 2018

Objective
Propranolol is always titrated to the maximum tolerated dose to prevent gastroesophageal variceal bleeding. However, some patients do not achieve a hemodynamic response and experience more intolerance and discontinuation. This study evaluated the dose-dependent effect of propranolol on hemodynamic response and tolerance in cirrhotic patients.

Patients and methods
This retrospective study included 95 consecutive patients recruited from our prospective database. After hepatic venous pressure gradient measurement, patients received propranolol 10 mg, twice daily increased 10 mg daily until to 80 or 120 mg/day. Secondary hepatic venous pressure gradient was also measured. For nonresponders at 80 mg/day, propranolol was titrated to 120 mg/day.

Results
For 58 patients, propranolol was titrated to 80 mg/day, whereas for 37 patients, it was titrated to 120 mg/day. Hemodynamic response was similar in both groups (50 vs. 54.1%, P=0.700). Eighteen of the 29 nonresponders at propranolol 80 mg/day received a dose of 120 mg/day. Two patients achieved a hemodynamic response, but two could not tolerate the dose. Nine (15.5%) patients achieved the target dose of propranolol at 80 mg/day, whereas 16 (43.2%) patients at 120 mg/day achieved this (P=0.003). The difference in patients achieving the target dose between responders and nonresponders was not significant (14 vs. 14, P=0.642). Reduction or discontinuation was required by two (6.9%) patients using 80 mg/day propranolol and six (30%) patients using 120 mg/day propranolol (P=0.032).

Conclusion
There is no dose-dependent effect of 80–120 mg/day of propranolol on the hemodynamic response in cirrhotic patients with gastroesophageal varices. This indicates that low-dose propranolol below the target dose might lead to a considerable hemodynamic response and is much safer and well tolerated.
Impact of Antiretroviral Drugs on Fracture Risk in HIV-Infected Individuals: A Case–Control Study Nested Within the French Hospital Database on HIV (FHDH-ANRS CO4)
Authors: Costagliola Dominique , Potard Valérie , Lang Sylvie , Abgrall Sophie , Duvivier Claudine , Fischer Hugues , Joly Véronique , Lacombe Jean-Marc , Valantin Marc-Antoine , Mary-Krause Murielle , Rozenberg Sylvie ,   on behalf of FHDH ANRS CO4
Published: November 2018

Background:
HIV-infected patients have lower bone mineral density and a higher incidence of fractures than the general population of the same age and sex. To assess the impact of antiretroviral (ARV) drugs exposure on the risk of osteoporotic fractures, we conducted a nested case–control study.

Methods:
Cases were individuals enrolled while ARV-naive, with a first prospectively recorded fracture between 2000 and 2010. Controls were randomly selected after matching for sex, age (±3 years), period of HIV diagnosis (<1997/≥1997), and clinical center. The risk of fracture was analyzed with conditional logistic regression models, using different ways to model ARV exposure. All exposure variables and potential confounders were included in multivariable models.

Results:
Among 861 reviewed cases, 261 fractures were osteoporotic and 254 of cases were matched to at least one control (376 controls). The median year of fracture diagnosis was 2007 (interquartile range 2004–2009): 49% of patients had been exposed to tenofovir disoproxil fumarate (TDF) and 82% to protease inhibitors (PIs). After taking into account the transmission group, AIDS status, geographic origin, body mass index, current smoking status, alcohol consumption, exposure to systemic glucocorticoids, and the period of enrollment, there was no association between the risk of fracture and exposure to TDF [odds ratio for cumulative exposure: 1.04 (0.86–1.27), similar results for ever-exposed subjects], to nucleoside reverse transcriptase inhibitors, or to PIs [odds ratio for cumulative PI exposure: 1.02 (0.92–1.12)].

Conclusions:
We found no evidence of an excess risk of fracture after exposure to TDF or PIs. This has important implications for the debate concerning tenofovir alafenamide versus generic TDF.
Medical Intensive Care Unit Admission Among Patients With and Without HIV, Hepatitis C Virus, and Alcohol-Related Diagnoses in the United States: A National, Retrospective Cohort Study, 1997–2014
Authors: Rentsch Christopher T. , Tate Janet P. , Steel Tessa , Butt Adeel A. , Gibert Cynthia L. , Huang Laurence , Pisani Margaret , Soo Hoo Guy W. , Crystal Stephen , Rodriguez-Barradas Maria C. , Brown Sheldon T. , Freiberg Matthew S. , Graber Christopher J. , Kim Joon W. , Rimland David , Justice Amy C. , Fiellin David A. , Crothers Kristina A. , Akgün Kathleen M. 
Published: November 2018

Background:
HIV, hepatitis C virus (HCV), and alcohol-related diagnoses (ARD) independently contribute increased risk of all-cause hospitalization. We sought to determine annual medical intensive care unit (MICU) admission rates and relative risk of MICU admission between 1997 and 2014 among people with and without HIV, HCV, and ARD, using data from the largest HIV and HCV care provider in the United States.

Setting:
Veterans Health Administration.

Methods:
Annual MICU admission rates were calculated among 155,550 patients in the Veterans Aging Cohort Study by HIV, HCV, and ARD status. Adjusted rate ratios and 95% confidence intervals (CIs) were estimated with Poisson regression. Significance of trends in age-adjusted admission rates were tested with generalized linear regression. Models were stratified by calendar period to identify shifts in MICU admission risk over time.

Results:
Compared to HIV−/HCV−/ARD− patients, relative risk of MICU admission decreased among HIV-mono-infected patients from 61% (95% CI: 1.56 to 1.65) in 1997–2009% to 21% (95% CI: 1.16 to 1.27) in 2010–2014, increased among HCV-mono-infected patients from 22% (95% CI: 1.16 to 1.29) in 1997–2009% to 54% (95% CI: 1.43 to 1.67) in 2010–2014, and remained consistent among patients with ARD only at 46% (95% CI: 1.42 to 1.50). MICU admission rates decreased by 48% among HCV-uninfected patients (P-trend <0.0001) but did not change among HCV+ patients (P-trend = 0.34).

Conclusion:
HCV infection and ARD remain key contributors to MICU admission risk. The impact of each of these conditions could be mitigated with combination of treatment of HIV, HCV, and interventions targeting unhealthy alcohol use.