nils-herrmann/clean_scirepeval huggingface dataset:
Validation of the functional assessment of cancer therapy-gastric module for the Chinese population

Quality of life (QoL) assessment has become an important aspect of the clinical management of gastric cancer (GC), which poses a greater health threat in Chinese populations around the world. Functional Assessment of Cancer Therapy-Gastric Module (FACT-Ga), a questionnaire developed specifically to measure QoL of patients with GC, has never been validated in Chinese subjects. The current study was designed to examine the psychometric properties of FACT-Ga as a GC specific QoL instrument for its future use in Chinese populations.



A sample of 67 Chinese patients with GC in the National University Hospital, Singapore was investigated cross-sectionally. The participants independently completed either English or Chinese versions of the FACT-Ga and the European Quality of Life-5 Dimensions (EQ-5D). Reliability was measured as the Cronbach's α for EQ-5D, and five subscale scores and two total scores of FACT-Ga. The sensitivity to patients' clinical status was evaluated by comparing EQ-5D and FACT-Ga scores between clinical subgroups classified by Clinical Stage and Treatment Intent. The construct validity of FACT-Ga was assessed internally by examining the item-to-scale correlations and externally by contrasting the FACT-Ga subscales with the EQ-5D domains.



For both FACT-Ga and EQ-5D, patients treated with curative intent rated their QoL higher than those treated for palliation, and early stage patients scored higher than those in the late stage. The sensitivity to clinical status of FACT-Ga scores were differential as four of seven FACT-Ga scores were significant for Treatment Intent while only one subscale score was significant for Clinical Stage. Six FACT-Ga scores had Cronbach's α of 0.8 or above indicating excellent reliability. For construct validity, 45 of 46 items converged about their respective subscales. The monotrait-multimethod correlations between QoL constructs of FACT-Ga and EQ-5D were stronger than the multitrait-multimethod correlations as theoretically hypothesized, suggesting good convergent and discriminant validities.



Given the excellent reliability and good construct validity, FACT-Ga scores are able to distinguish patient groups with different clinical characteristics in the expected direction. Therefore FACT-Ga can be used as a discriminative instrument for measuring QoL of Chinese patients with GC.
LIM homeobox protein 5 (Lhx5) is essential for mamillary body development

The mamillary body (MM) is a group of hypothalamic nuclei related to memory and spatial navigation that interconnects hippocampal, thalamic, and tegmental regions. Here we demonstrate that Lhx5, a LIM-HD domain transcription factor expressed early in the developing posterior hypothalamus, is required for the generation of the MM and its derived tracts. The MM markers Foxb1, Sim2, and Lhx1 are absent in Lhx5 knock-out mice from early embryonic stages, suggesting abnormal specification of this region. This was supported by the absence of Nkx2.1 and expansion of Shh in the prospective mamillary area. Interestingly, we also found an ectopic domain expressing Lhx2 and Lhx9 along the anterio-posterior hypothalamic axis. Our results suggest that Lhx5 controls early aspects of hypothalamic development by regulating gene expression and cellular specification in the prospective MM.
A randomized, controlled trial of the renal effects of ultrafiltration as compared to furosemide in patients with acute decompensated heart failure.

This study was designed to evaluate the consequences of ultrafiltration (UF) and standard intravenous diuretic (furosemide) therapy on glomerular filtration rate (GFR) and renal plasma flow in patients with acute decompensated heart failure.



It has been hypothesized that treatment with diuretics may worsen renal function as the result of systemic neurohormonal activation and direct renal vascular effects. UF also removes fluid, but its actions on intrarenal hemodynamics, and therefore renal function, are unknown.



Patients hospitalized for acute decompensated heart failure with an ejection fraction less than 40% and two or more signs of hypervolemia were randomized to receive UF or intravenous diuretics. Urine output, GFR (as measured by iothalamate), and renal plasma flow (as measured by para-aminohippurate) were assessed before fluid removal and after 48 hours.



Nineteen patients (59 +/- 16 years, 68% were male) were randomized to receive UF (n = 9) or intravenous diuretics (n = 10). The change in GFR (-3.4 +/- 7.7 mL/min vs. -3.6 +/- 11.5 mL/min; P = .966), renal plasma flow (26.6 +/- 62.7 mL/min vs. 16.1 +/- 42.0 mL/min; P = .669), and filtration fraction (-6.9 +/- 13.6 mL/min vs. -3.9 +/- 13.6 mL/min; P = .644) after treatment were not significantly different between the UF and furosemide treatment groups, respectively. There was no significant difference in net 48-hour fluid removal between the groups (-3211 +/- 2345 mL for UF and -2725 +/- 2330 mL for furosemide, P = .682). UF removed 3666 +/- 2402 mL. Urine output during 48 hours was significantly greater in the furosemide group (5786 +/- 2587 mL) compared with the UF group (2286 +/- 915 mL, P < .001).



During a 48-hour period, UF did not cause any significant differences in renal hemodynamics compared with the standard treatment of intravenous diuretics.
Linguistic, psychometric validation and diagnostic ability assessment of an Italian version of a 19-item wearing-off questionnaire for wearing-off detection in Parkinson’s disease

A patient self-rated 19-item wearing-off questionnaire (WOQ-19) was shown to be a potent screening tool for wearing-off (WO) in patients with Parkinson’s disease. As part of the early detection of wearing-off in Parkinson’s disease study, we preliminarily performed a linguistic and a psychometric validation of an Italian version of the WOQ-19. Moreover, we assessed the sensitivity and specificity of the WOQ-19 in the office-based settings. The psychometric validation study included assessment of discriminant ability, internal consistency and test–retest reliability. The intraclass correlation coefficient (ICC) and the Cronbach’s Alpha were assessed. The WOQ-19 sensitivity and specificity were calculated in respect to the physician assessment of WO, taken as the gold standard. The Italian version of WOQ-19 was found easy to understand by ≥80% of the patients. The number of WO-related symptoms detected by WOQ-19 was 7.5 ± 3.2 in patients with WO and 1.6 ± 2.6 in patients without WO (p < 0.0001). Cronbach’s alpha was equal to 0.868 for the total number of WO symptoms. The ICC value was equal to 0.858 for WO-related symptoms as a whole. The diagnostic ability study recruited 207 patients: for a WOQ-19 cut-off ≥2, the sensitivity was equal to 0.881 and the specificity was 0.674. This is the first validation of WOQ-19 in Italian, with excellent linguistic validity and psychometric properties. WOQ-19 was confirmed to be reliable in WO detection.
Demographic, tumor and clinical features of clinical trials versus clinical practice patients with HER2-positive early breast cancer: results of a prospective study

Several randomized clinical trials (RCTs) have demonstrated the efficacy of trastuzumab-based adjuvant therapy in HER2-positive breast cancer (BC). However, RCT patients may not invariably be representative of patients routinely seen in clinical practice (CP). To address this issue, we compared the clinical and tumor features of RCT and CP patients with HER2-positive BC. From January to December 2012, 650 consecutive patients with HER2-positive early BC, treated in 36 different types of Italian healthcare facilities, were enrolled in this study. Age, treatment, tumor size (T), nodes (N), grade (G), estrogen receptor (ER) and progesterone receptor (PgR) status were prospectively collected in these CP patients. The same data were extracted from the main adjuvant trastuzumab RCTs and pooled using the random-effects model of DerSimonian and Laird. RCT and CP patients were compared by using the Cochran Q statistics. Versus RCT patients, CP patients were more likely to be older than 50 years (65 vs. 49 %; p < 0.0001) and to have HR (ER and/or PgR)-positive (72 vs. 54 %; p < 0.0001) BC and less likely to have tumor >2 cm (T ≥ 2 cm 39 vs. 59 %; p < 0.0001), positive N (47 vs. 89 %; p < 0.0001) and a high G (61 vs. 67 %; p = 0.0241). CP patients more frequently received adjuvant endocrine therapy (70 vs. 57 %; p < 0.0003) and less frequently adjuvant chemotherapy (97 vs. 99.7 %; p < 0.0001). Most tumor and clinical features differed significantly between CP and RCT patients. These data raise concerns about the applicability of RCT results to CP patients.
Borderline ovarian tumors diagnosed during pregnancy exhibit a high incidence of aggressive features: results of a French multicenter study.

The purpose of the current study was to evaluate the characteristics of borderline ovarian tumors (BOTs) diagnosed during pregnancy.



We conducted a retrospective multicenter study of 40 patients with BOTs diagnosed during pregnancy between 1997 and 2009 at five tertiary universitary departments of Gynecology and Obstetrics and one French cancer center. The medical records were reviewed to determine surgical procedure, histology, restaging surgery and recurrence.



Mean patient age was 30.2 ± 5.4 years. Most BOTs were diagnosed during the first trimester of pregnancy (62%). Salpingo-oophorectomy (N = 24) was more frequently performed than cystectomy (N = 11) during pregnancy (P = 0.01). Only two patients had an initial complete staging. BOTs were mucinous, serous and mixed in 48%, 42% and 10% of patients, respectively. Twenty-one percent of mucinous BOTs exhibited intraepithelial carcinoma or microinvasion. Forty-seven percent of serous BOTs exhibited micropapillary features, noninvasive implants or microinvasion. Restaging surgery performed in 52% patients resulted in upstaging in 24% of cases. Recurrence rate in patients with serous BOT with micropapillary features or peritoneal implants was 7.5%.



BOTs diagnosed during pregnancy exhibit a high incidence of aggressive features and are rarely completely staged initially. Given this setting, up-front salpingo-oophorectomy should be considered and restaging planned.
Comparison of Diagnostic Accuracy of MRI with and Without Contrast in Diagnosis of Traumatic Spinal Cord Injuries

Acute spinal cord injury (SCI) is one of the most common causes of severe disability and mortality after trauma. Magnetic resonance imaging (MRI) can identify different levels of SCI, but sometimes unable to detect the associated soft tissue injuries. The role of MRI with contrast in patients with SCI has not been studied. This is the first study in human to compare the efficacy of MRI with and without contrast in diagnosis and prognosis evaluation of SCIs.In this cross-sectional diagnostic study, MRI with and without contrast was performed on 40 patients with acute spinal injury. In these patients, 3 different types of MRI signal patterns were detected and compared.The most common cases of spinal injuries were accident (72.5%) and the after fall (27.5%). The prevalence of lesions detected includes spine fracture (70%), spinal stenosis (32.5%), soft tissue injuries (30%), and tearing of the spinal cord (2.5%). A classification was developed using 3 patterns of SCIs. Type I, seen in 2 (5.0%) of the patients, demonstrated a decreased signal intensity consistent with acute intraspinal hemorrhage. Type II, seen in 8 (20.0%) of the patients, demonstrated a bright signal intensity consistent with acute cord edema. Type III, seen in 1 (2.5%) of the patients, demonstrated a mixed signal of hypointensity centrally and hyperintensity peripherally consistent with contusion. In the diagnosis of all injuries, MRI with contrast efficacy comparable to noncontrast MRI, except in the diagnosis of soft tissue, which was significantly higher sensitivity (P < 0.05).So given that is not significant differences between noncontrast and contrast-enhanced MRI in the diagnosis of major injuries (hematoma, edema, etc.) and contrast-enhanced MRI just better in soft tissues. We recommend to the MRI with contrast only used in cases of suspected severe soft tissue injury, which have been ignored by detection MRI without contrast.
Circulating Galectin-1 and 90K/Mac-2BP Correlated with the Tumor Stages of Patients with Colorectal Cancer

The simultaneous correlation of serum galectin-1, galectin-3, and 90K/Mac-2BP levels with clinical stages of patients with colorectal cancer has not yet been clarified. We plan to measure the serum levels of galectin-1, galectin-3, and 90K/Mac-2BP of patients at different stages of colorectal cancer and analyze the correlation of these galectins with stages of colorectal cancers.



198 colorectal cancer patients (62 ± 13 (range 31-85) years old, 43.6% female) were recruited for this study. Subjects' blood samples were checked for serum galectin-1, galectin-3, 90K/Mac-2BP, and carcinoembryonic antigen by sandwich enzyme-linked immunosorbent assay. We determined the correlation between plasma concentrations with clinical tumor stages.



Colorectal cancer patients with larger cancer sizes (stages T3, T4 rather than T1, T2) have higher serum 90K/Mac-2BP (P = 0.014) and patients with lymph node metastasis have higher serum galectin-1 (P = 0.002) but there was not a significant correlation between galectin-3 and tumor staging of colon cancer. In colorectal cancer patients even with normal carcinoembryonic antigen, serum galectin-1 could predict more lymph node metastasis.



We found 90K/Mac-2BP correlated with the size of colorectal cancer. Galectin-1 but not galectin-3 was associated with lymph node metastasis. Galectin-1 could predict more lymph node metastasis in colorectal cancer patients with normal serum carcinoembryonic antigen.
Pantoprazole versus ranitidine in the treatment of duodenal ulcer: a multicenter study in Brazil

The aim of this study was to compare the effectiveness and tolerance of pantoprazole versus ranitidine in the treatment of duodenal ulcers in the Brazilian population.A total of 222 patients with active duodenal ulcers (DU) were randomly allocated to a double dummy blind treatment, either with ranitidine (RAN) 300 mg (111, aged from 20–68 yr old, 56 female) or with pantoprazole (PANT) 40 mg (111 patients, 18–70 yr old, 45 female). After a 2-wk course of treatment, each patient was clinically and endoscopically assessed for ulcer healing. Failure to heal required a further 2-wk course of treatment and a new evaluation thereafter.In all, 77 of the 103 patients in the PANT group (74.8%) and 42 of the 94 patients in the RAN group (44.7%) who completed the study had ulcer healing after one 2-wk treatment course, and an additional 23 in the PANT group (22.3%) and 28 in the RAN group (29.8%) after the second 2-wk treatment course, totaling 100 (97.1%) and 70 (74.5%), respectively. Therapeutic gain in favor of pantoprazole was significant both at the end of the first and the second 2-wk treatment course (p < 0.001). At 2 wk, symptoms remission was significantly higher in the PANT group (97.6%) than with the RAN group (77.5%) (p < 0.001). The Intention-to-treat analysis showed results statistically similar to those observed in the per-protocol analysis. Minor adverse events were reported by four patients in the PANT group and three in the RAN group. No relevant laboratory abnormalities were seen. No patient withdrew from the study due to adverse events.Our results show that pantoprazole is more effective than ranitidine in the treatment of duodenal ulcer providing faster ulcer healing in most patients (97.1%), in 4 wk. Adverse events were rare and were similar in both groups, and had no influence on the therapeutic outcome.
Results of a phase III, double-blind, placebo-controlled trial of megestrol acetate modulation of P-glycoprotein-mediated drug resistance in the first-line management of small-cell lung carcinoma.

The objective of this study was to determine if the addition of megestrol acetate (MA), a modulator of P-glycoprotein-mediated drug resistance, to first-line cytotoxic therapy in patients with limited and advanced stage small-cell lung cancer (SCLC) would improve median time to disease progression and median overall survival. Secondary outcomes evaluated were response rates and patient symptom profile. Between 1992 and 1995, 130 eligible patients were randomized in a double-blind fashion to receive standard first-line therapy consisting of alternating courses of cyclophosphamide/doxorubicin/vincristine and etoposide/cisplatin (and thoracic radiotherapy for limited stage patients), along with either placebo or MA 160 mg t.i.d. for 8 days commencing 3 days before initiation of each cycle of chemotherapy. Treatment was continued for a maximum of six cycles. A total of 130 eligible patients were randomized, 65 to each arm. Fifty-two per cent of patients had limited disease and 48% had advanced disease. The median time to disease progression in limited stage disease was 46 weeks in the placebo arm and 43 weeks in the MA arm (P = 0.71) and in advanced stage disease was 28 weeks in the placebo arm and 27 weeks in the MA arm (P = 0.92). The median overall survival in limited stage disease was 75 weeks in the placebo arm and 75 weeks in the MA arm (P = 0.56) and in advanced stage disease was 41 weeks in the placebo arm and 39 weeks in the MA arm (P = 0.96). There was no consistent statistical difference in response rates or patient symptom profiles between the two treatment arms. The addition of MA, in the dose and schedule used, to standard first-line cytotoxic therapy in SCLC did not result in a significant improvement in response rates, symptom profile, median time to disease progression or overall survival.
Conventional Complete Denture in Patients with Ectodermal Dysplasia

Ectodermal dysplasia is described as heritable conditions that involve anomalies of structures derived from the ectoderm, including hypodontia. In the cases of edentulous young patients, who did not finish their craniofacial growth, treatment with conventional complete denture is a suitable alternative. The aim of this study was to report a case of mandibular edentulism treated with conventional complete denture in a thirteen-year-old patient diagnosed with hidrotic ectodermal dysplasia. Typical features, such as frontal bossing, depressed nasal bridge, protuberant lips, scarce hair, and brittle nails, were visualized during the extraoral examination. The intraoral inspection and radiographic analysis revealed oligodontia, dental malformation, and prolonged retention of deciduous teeth at maxilla and total edentulism at mandible. A conventional complete denture was planned and constructed following the same steps of technique as recommended in adults. Although this option is not a definitive treatment, the patient and his parents were satisfied with his improvement in chewing and speech, as well as with the aesthetic benefits.
Effects of Balloon Pulmonary Angioplasty on Oxygenation in Patients With Chronic Thromboembolic Pulmonary Hypertension　- Importance of Intrapulmonary Shunt.

Although balloon pulmonary angioplasty (BPA) improves the hemodynamics and prognosis of patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH), the mechanisms of improvement in oxygenation remain to be elucidated.



From August 2013 to May 2015, we performed a total of 113 BPA procedures in 24 patients with inoperable CTEPH (mean 4.7 procedures per patient). Median age was 70 [60, 74] years and 18 were female (75%). We examined hemodynamics, respiratory functions, and intrapulmonary shunt before and after the BPA procedure. Mean pulmonary arterial pressure (37 [28, 45] to 23[19, 27] mmHg, P<0.01), pulmonary vascular resistance (517 [389, 696] to 268 [239, 345] dyne/s/cm(5)) and 6-min walk distance (390 [286, 484] to 490 [411, 617] m, P<0.01) were significantly improved after BPA therapy. Furthermore, arterial oxygen partial pressure (PaO2, 54.8 [50.0, 60.8] to 65.2 [60.6, 73.2] %, P<0.01) and intrapulmonary shunt (23.4±6.0% to 19.3±5.0%, P<0.01) were also significantly ameliorated. In the multivariate analysis, decrease in intrapulmonary shunt after BPA was significantly correlated with improvement of both PaO2(r(2)=0.26, P<0.01) and SaO2(r(2)=0.49, P<0.01) after BPA.



These results indicated that BPA improved not only pulmonary hemodynamics but also oxygenation with a resultant decrease in intrapulmonary shunt.
QCT Volumetric Bone Mineral Density and Vascular and Valvular Calcification: The Framingham Study.

There is increasing evidence that bone and vascular calcification share common pathogenesis. Little is known about potential links between bone and valvular calcification. The purpose of this study was to determine the association between spine bone mineral density (BMD) and vascular and valvular calcification. Participants included 1317 participants (689 women, 628 men) in the Framingham Offspring Study (mean age 60 years). Integral, trabecular, and cortical volumetric bone density (vBMD) and arterial and valvular calcification were measured from computed tomography (CT) scans and categorized by sex-specific quartiles (Q4 = high vBMD). Calcification of the coronary arteries (CAC), abdominal aorta (AAC), aortic valve (AVC), and mitral valve (MVC) were quantified using the Agatston Score (AS). Prevalence of any calcium (AS >0) was 69% for CAC, 81% for AAC, 39% for AVC, and 20% for MVC. In women, CAC increased with decreasing quartile of trabecular vBMD: adjusted mean CAC = 2.1 (Q4), 2.2 (Q3), 2.5 (Q2), 2.6 (Q1); trend p = 0.04. However, there was no inverse trend between CAC and trabecular vBMD in men: CAC = 4.3 (Q4), 4.3 (Q3), 4.2 (Q2), 4.3 (Q1); trend p = 0.92. AAC increased with decreasing quartile of trabecular vBMD in both women (AAC = 4.5 [Q4], 4.8 [Q3], 5.4 [Q2], 5.1 [Q1]; trend p = 0.01) and men (AAC = 5.5 [Q4], 5.8 [Q3], 5.9 [Q2], 6.2 [Q1]; trend p = 0.01). We observed no association between trabecular vBMD and AVC or MVC in women or men. Finally, cortical vBMD was unrelated to vascular calcification and valvular calcification in women and men. Women and men with low spine vBMD have greater severity of vascular calcification, particularly at the abdominal aorta. The inverse relation between AAC and spine vBMD in women and men may be attributable to shared etiology and may be an important link on which to focus treatment efforts that can target individuals at high risk of both fracture and cardiovascular events.