nils-herrmann/clean_scirepeval huggingface dataset:
Restricted peri-operative fluid administration adjusted by serum lactate level improved outcome after major elective surgery for gastrointestinal malignancy.

Our objective was to compare the effect of a restricted intravenous fluid regimen adjusted by serum lactate level with a standard restricted regimen on complications after major elective surgery for gastrointestinal malignancy.



This is a randomized, observer-blinded, single-center trial conducted across a time span of 13 months. A total of 299 patients were allocated to either a restricted intravenous fluid regimen with supplementary intravenous fluids given based on serum lactate level (group A) or a standard restricted regimen (group R). In group A, the serum lactate level was monitored closely postoperatively to maintain a normal pre-operative serum lactate level. Group R involved patients treated with a restricted fluid regimen in whom additional fluid and electrolytes were administered when deemed necessary based on the usual clinical criteria. The primary outcome measure was complications; the secondary measures were death and adverse effects.



Additional fluid supplementation was needed in some patients in both groups (group A [28%] vs group R [26%]). In group A, the time for additional fluid infusion occurred earlier in the postoperative period than group R. Patients in group A received their first supplementary fluid treatment within the first 12 h more commonly than those in group R (74% vs 37%, respectively; P < .004). The regimen adjusted by serum lactate decreased systemic postoperative complications in group A versus group R (10% vs 22%, respectively; P = .023) but not overall total complications (23% vs 33%, respectively; P = .090). In contrast, in patients who required additional fluid infusion, the difference in complications between the 2 groups was greater (overall complication, 45% vs 85%, respectively; P = .023; major complication, 16% vs 44%, respectively; P = .018; systemic complications, 19% vs 63%, respectively; P = .001). One patient died in group A and 4 died in group R (1% vs 4%, respectively; P = .206).



A fluid-restricted regimen after elective gastrointestinal operations for malignancy may lead to fluid insufficiency and low tissue perfusion in up to 28% of patients. Close monitoring of serum lactate levels with adjustment of intravenous fluid administration intraoperatively and in the early postoperative period may improve the early detection and correction of inadequate tissue perfusion, thereby decreasing the rate of complications.
Effect of preoperative topical diclofenac on intraocular interleukin-12 concentration and macular edema after cataract surgery in patients with diabetic retinopathy: a randomized controlled trial

To determine if preoperative treatment with a topical non-steroidal anti-inflammatory drug (NSAID) lowers the concentration of intraocular interleukin (IL)-12 and the incidence of postoperative macular edema in patients with non-proliferative diabetic retinopathy undergoing cataract surgery.



A total of 55 patients were randomized to diclofenac (n=27) or placebo (n=28). Patients receiving diclofenac started preoperative treatment with 0.1% topical diclofenac four times a day 7 days before cataract surgery and the therapy was discontinued 30 days after surgery. Patients in the control group were administered placebo 7 days preoperatively and a standard postoperative therapy with 0.1% topical dexamethasone four times a day for 30 days after surgery. All patients received postoperative antibiotic prophylaxis with tobramycin eye drops four times daily for 30 days. Seven days before the cataract surgery, on the day of surgery, and 1, 7, 30, and 90 days after surgery, central foveal thickness (CFT) was measured with optical coherence tomography (OCT) and the aqueous humor was sampled at the beginning of cataract surgery for the analysis of IL-12 concentration. Due to loss to follow-up and insufficient aqueous humor samples, the data of 3 patients treated with diclofenac and 8 patients receiving placebo were not analyzed.



The aqueous humor IL-12 concentration was significantly lower in the diclofenac group than in the placebo group (t=-2.85, p=0.007). The diclofenac group had a significantly smaller increase in CFT after phacoemulsification (F=13.57, p<0.001).



Patients preoperatively treated with diclofenac had significantly lower intraocular levels of IL-12 and a lower increase in CFT, which indicates that a combination of preoperative and postoperative treatment with a topical NSAID may lower the incidence of postoperative macular edema in patients with diabetic retinopathy.
A phase II trial of S-1 and cisplatin in patients with metastatic or relapsed biliary tract cancer.

Optimal chemotherapy for advanced biliary tract cancer (BTC) is yet to be defined. We carried out this study to evaluate the efficacy and toxicity of combination chemotherapy with S-1 and cisplatin in metastatic or relapsed BTC.



Patients with pathologically proven BTC were eligible. The chemotherapy regimen consisted of S-1 (40 mg/m(2) p.o. b.i.d. from D1-14) and cisplatin (60 mg/m(2) on D1), repeated every 3 weeks.



Fifty-one BTC patients (metastatic:relapsed = 37:14, Gall-bladder:intrahepatic bile ducts:extrahepatic bile ducts = 16:25:10) were enrolled from January 2005 to December 2006. Median age was 57 years (range, 31-71) and most patients had a good performance status. The overall response rate was 30% [95% confidence interval (CI), 17.3-42.7] and complete response was observed in two patients (4%), partial response in 13 (26%), stable disease in 21 (42%), and progressive disease in 9 (18%). With a median follow-up of 12.4 months, the median time to progression was 4.8 months (95% CI, 3.3-6.3) and median overall survival was 8.7 months (95% CI, 6.0-11.4). Major toxic effects were grade 3/4 neutropenia (8.9% of all cycles) and febrile neutropenia was observed in six cycles (2.7% of all cycles).



Combination chemotherapy with S-1 and cisplatin was a moderately effective outpatient-based regimen in BTC patients. Toxic effects were moderate but manageable.
Anthroposophic vs. conventional therapy for chronic low back pain: a prospective comparative study.

To compare anthroposophic treatment (eurythmy, rhythmical massage or art therapy; counselling, anthroposophic medication) and conventional treatment for low back pain (LBP) under routine conditions.



62 consecutive outpatients from 38 medical practices in Germany, consulting an anthroposophic (A-) or conventional (C-) physician with LBP of >or= 6 weeks duration participated in a prospective non-randomised comparative study. Main outcomes were Hanover Functional Ability Questionnaire (HFAQ), LBP Rating Scale Pain Score (LBPRS), Symptom Score, and SF-36 after 6 and 12 months.



At baseline, LBP duration was > 6 months in 85% (29/34) of A-patients and 54% (15/28) of C-patients (p = 0.004). Unadjusted analysis showed significant improvements in both groups of HFAQ, LBPRS, Symptom Score, SF-36 Physical Component Summary, and three SF-36 scales (Physical Function, Pain, Vitality), and improvements in A-patients of three further SF-36 scales (Role Physical, General Health, Mental Health). After adjustment for age, gender, LBP duration, and education, improvements were still significant in both groups for Symptom Score (p = 0.030), SF-36 Physical Component Summary (p = 0.004), and three SF-36-scales (Physical Function, p = 0.025; Role Physical, p = 0.014; Pain, p = 0.003), and in A-patients for SF-36-Vitality (p = 0.032). Compared to C-patients, A-patients had significantly more pronounced improvements of three SF-36 scales (Mental Health: p = 0.045; General Health: p = 0.006; Vitality: p = 0.005); other improvements did not differ significantly between the two groups.



Compared to conventional therapy, anthroposophic therapy for chronic LBP was associated with at least comparable improvements.
Multi-institution hospital-based cancer incidence data for Nepal: an initial report.

While comprehensive cancer registration data are available for some locations in India and Pakistan, the situation regarding other countries in South Asia is less clear. Only one publication with cancer incidence data is available in the literature for Nepal, for one hospital in the Western provinces. The present study was conducted to assess burden across a greater proportion of country with data from 7 major hospitals where cancer is diagnosed and treated. Data from each were transferred to the BP Koirala Memorial Cancer Hospital in Bharatput, the National Cancer Center of Nepal, for compilation. Overall the most common site in males was the lung, followed by the oral cavity and stomach, while the first three in females were cervix uteri, breast and lung. Shifts in the the main cancers were noted with different ages, with leukemias and lymphomas in young individuals replaced by lung, oral and stomach in middle age and lung, stomach and larynx in the oldest category of males. In females the shift was to breast in young women, then cervix in middle age followed by lung in the very aged. There was also variation between hospitals, but this appeared largely due to the differences in the therapeutic modalities available in different institutions.
Drug use during pregnancy: validating the Drug Abuse Screening Test against physiological measures.

This study examined the ability of the Drug Abuse Screening Test (DAST-10) to identify prenatal drug use using hair and urine samples as criterion variables. In addition, this study was the first to use "best practices," such as anonymity, ACASI technology, and a written screener, to facilitate disclosure in this vulnerable population. 300 low-income, post-partum women (90.3% African-American) were recruited from their hospital rooms after giving birth. Participation involved (a) completing a computerized assessment battery that contained the DAST-10 and (b) providing urine and hair samples. Twenty-four percent of the sample had a positive drug screen. The sensitivity of the DAST-10 was only .47. Nineteen percent of the sample had a positive toxicology screen but denied drug use on the DAST-10. Findings suggest that brief drug use screeners may have limited utility for pregnant women and that efforts to facilitate disclosure via reassurance and anonymity are unlikely to be sufficient in this population.
Hemodynamic and neurohumoral effects of moxonidine in patients with essential hypertension

The hemodynamic and neurohumoral effects of a single oral dose (0.4 mg) of the novel centrally acting antihypertensive agent moxonidine were investigated over 4 hours in ten patients with essential hypertension (WHO I-II). Pulmonary pressure indices and cardiac output were determined both at rest and during ergometric exercise by means of Swan-Ganz catheterization. Blood pressure was measured by sphygmomanometry and in the brachial artery. Moxonidine induced a significant fall in blood pressure over the 4-hour observation period from 176/105 mmHg to 158/95 mmHg (p<0.01), accompanied by a decrease in systemic vascular resistance from 1695 to 1427 dyn.sec/cm5 (p<0.01). Cardiac output remained unchanged, while heart rate increased slightly from 69 to 75 beats/min (p<0.01). No significant changes were recorded for either pulmonary artery pressure or pulmonary vascular resistance. Plasma levels of noradrenaline (337 vs. 224 pg/ml) and renin (2.6 vs 2.0 ng/ml/hr) activity fell significantly after moxonidine (p<0.05), both at rest and during exercise. Although aldosterone plasma levels fell slightly, levels of angiotensin II and ANF remained unchanged. Moxonidine has favorable effects on hemodynamics and the neurohumoral system in patients with essential hypertension and is well tolerated at the dose administered.
Obesity and reduction of the response rate to anti-tumor necrosis factor α in rheumatoid arthritis: an approach to a personalized medicine.

Obesity is a mild, long-lasting inflammatory disease and, as such, could increase the inflammatory burden of rheumatoid arthritis (RA). The study aim was to determine whether obesity represents a risk factor for a poor remission rate in RA patients requiring anti-tumor necrosis factor α (anti-TNFα) therapy for progressive and active disease despite treatment with methotrexate or other disease-modifying antirheumatic drugs.



Patients were identified from 15 outpatient clinics of university hospitals and hospitals in Italy taking part in the Gruppo Italiano di Studio sulle Early Arthritis network. Disease Activity Score in 28 joints (DAS28), body mass index (BMI; categorized as <25, 25-30, and >30 kg/m(2) ), acute-phase reactants, IgM rheumatoid factor, and anti-cyclic citrullinated peptide antibody values were collected. DAS28 remission was defined as a score of <2.6 lasting for at least 3 months.



Six hundred forty-one outpatients with longstanding RA receiving anti-TNFα blockers (adalimumab, n = 260; etanercept, n = 227; infliximab, n = 154), recruited from 2006-2009 and monitored for at least 12 months, were analyzed. The mean ± SD DAS28 at baseline was 5.6 ± 1.4. A BMI of >30 kg/m(2) was recorded in 66 (10.3%) of 641 RA patients. After 12 months of anti-TNFα treatment, a DAS28 of <2.6 was noted in 15.2% of the obese subjects, in 30.4% of the patients with a BMI of 25-30 kg/m(2) , and in 32.9% of the patients with a BMI of <25 kg/m(2) (P = 0.01). The lowest percentage of remission, which was statistically significant versus adalimumab and etanercept (P = 0.003), was observed with infliximab.



Obesity represents a risk factor for a poor remission rate in patients with longstanding RA treated with anti-TNFα agents. A personalized treatment plan might be a possible solution.
Phase IB study of the mTOR inhibitor ridaforolimus with capecitabine.

Synergistic/additive cytotoxicity in tumor models and widespread applicability of fluoropyrimidines in solid tumors prompted the study of the combination of the mammalian target of rapamycin (mTOR) inhibitor, non-prodrug rapamycin analog ridaforolimus, with capecitabine.



Thirty-two adult patients were treated. Intravenous ridaforolimus was given once weekly for 3 weeks and capecitabine was given from days 1 to 14 every 4 weeks. Ridaforolimus was given at 25, 37.5, 50, or 75 mg with capecitabine at 1,650 mg/m(2) or 1,800 mg/m(2) divided into two daily doses. Pharmacokinetics of both drugs were determined during cycles 1 and 2. Pharmacodynamic studies in peripheral blood mononuclear cells (PBMCs) and wound tissue of the skin characterized pathways associated with the metabolism or disposition of fluoropyrimidines and mTOR and ERK signaling.



Two recommended doses (RDs) were defined: 75 mg ridaforolimus/1,650 mg/m(2) capecitabine and 50 mg ridaforolimus/1,800 mg/m(2) capecitabine. Dose-limiting toxicities were stomatitis and skin rash. One patient achieved a partial response lasting 10 months and 10 of 29 evaluable patients had stable disease for ≥ 6 months. The only pharmacokinetic interaction was a ridaforolimus-induced increase in plasma exposure to fluorouracil. PBMC data suggested that prolonged exposure to capecitabine reduced the ridaforolimus inhibition of mTOR. Ridaforolimus influenced the metabolism of fluoropyrimidines and inhibited dihydropyrimidine dehydrogenase, behavior similar to that of rapamycin. Inhibition of the target thymidylate synthase by capecitabine was unaffected. mTOR and ERK signaling was inhibited in proliferating endothelial cells and was more pronounced at the RD with the larger amount of ridaforolimus.



Good tolerability, feasibility of prolonged treatment, antitumor activity, and favorable pharmacologic profile support further investigation of this combination.
Evaluation of the patient generated index as a measure of quality-of-life in people with severe traumatic brain injury.

Quality-of-life (QoL) measures may be useful in quantifying the personal impact of an acquired brain injury and as an indicator of the effectiveness of service provision. This study investigated the validity of the patient generated index (PGI) as a measure of QoL with a sample of adults who had sustained a severe traumatic brain injury.



Fifty-five participants with an acquired brain injury were selected from four regional rehabilitation centres. Each participant completed validated questionnaires measuring subjective satisfaction with life, community integration, emotional distress, socially desirable responding and the patient generated index.



The criterion-related validity of the PGI was demonstrated through a statistically significant positive correlation with life satisfaction. Evidence of construct validity was observed through significant correlations with measures of emotional distress and community integration. Depression had a strong negative association with QoL. Social desirability correlated significantly with both indices of QoL, suggesting that this variable may be treated as a covariate.



The results offer some preliminary evidence for the validity of the PGI as a measure of QoL in people with severe brain injury.
Urinalysis vs urine protein–creatinine ratio to predict significant proteinuria in pregnancy

To compare the urine protein–creatinine ratio with urinalysis to predict significant proteinuria (⩾300 mg per day).Study Design: A total of 116 paired spot urine samples and 24-h urine collections were obtained prospectively from women at risk for preeclampsia. Urine protein–creatinine ratio and urinalysis were compared to the 24-h urine collection. The urine protein–creatinine ratio had better discriminatory power than urinalysis: the receiver operating characteristic curve had a greater area under the curve, 0.89 (95% confidence interval (CI) 0.83 to 0.95) vs 0.71 (95% CI 0.64 to 0.77, P<0.001). When matched for clinically relevant specificity, urine protein–creatinine ratio (cutoff ⩾0.28) is more sensitive than urinalysis (cutoff ⩾1+): 66 vs 41%, P=0.001 (with 95 and 100% specificity, respectively). Furthermore, the urine protein–creatinine ratio predicted the absence or presence of proteinuria in 64% of patients; urinalysis predicted this in only 19%.Conclusion: The urine protein–creatinine ratio is a better screening test. It provides early information for more patients.
SMO Expression in Colorectal Cancer: Associations with Clinical, Pathological, and Molecular Features

Smoothened, frizzled family receptor (SMO) is an important component of the hedgehog signaling pathway, which has been implicated in various human carcinomas. However, clinical, molecular, and prognostic associations of SMO expression in colorectal cancer remain unclear. Using a database of 735 colon and rectal cancers in the Nurse’s Health Study and the Health Professionals Follow-up Study, we examined the relationship of tumor SMO expression (assessed by immunohistochemistry) to prognosis, and to clinical, pathological, and tumor molecular features, including mutations of KRAS, BRAF, and PIK3CA, microsatellite instability, CpG island methylator phenotype (CIMP), LINE-1 methylation, and expression of phosphorylated AKT and CTNNB1. SMO expression was detected in 370 tumors (50 %). In multivariate logistic regression analysis, SMO expression was independently inversely associated with phosphorylated AKT expression [odds ratio (OR) 0.48; 95 % confidence interval (CI) 0.34–0.67] and CTNNB1 nuclear localization (OR 0.48; 95 % CI 0.35–0.67). SMO expression was not significantly associated with colorectal cancer-specific or overall survival. However, in CIMP-high tumors, but not CIMP-low/0 tumors, SMO expression was significantly associated with better colorectal cancer-specific survival (log-rank P = 0.012; multivariate hazard ratio, 0.36; 95 % CI 0.13–0.95; P interaction = 0.035, for SMO and CIMP status). Our data reveal novel potential associations between the hedgehog, the WNT/CTNNB1, and the PI3K (phosphatidylinositol-4,5-bisphosphonate 3-kinase)/AKT pathways, supporting pivotal roles of SMO and hedgehog signaling in pathway networking. SMO expression in colorectal cancer may interact with tumor CIMP status to affect patient prognosis, although confirmation by future studies is needed.
The effect of open-irrigated radiofrequency catheter ablation of atrial fibrillation on left atrial pressure and B-type natriuretic peptide.

Open-irrigated radiofrequency catheter ablation (oiRFA) of atrial fibrillation (AF) imposes a volume load and risk of pulmonary edema. We sought to assess the effect of volume administration during ablation on left atrial (LA) pressure and B-type natriuretic peptide (BNP).



LA pressure was measured via transseptal sheath at the beginning and end of 44 LA ablation procedures in 42 patients. BNP plasma levels were measured before and after 10 procedures.



A median of 3,255 (interquartile range [IQR], 2,014)-mL saline was administered during the procedure. During LA ablation, the median fluid balance was +1,438 (IQR, 1,109) mL and LA pressure increased by median 3.7 (IQR, 5.9) mm Hg (P < 0.001). LA pressure did not change in the 19 procedures with furosemide administration (median ΔP = -0.3 [IQR, 7.1] mm Hg, P = 0.334). The correlation of LA pressure and fluid balance was weak (rs = 0.383, P = 0.021). BNP decreased in all four procedures starting in AF or atrial tachycardia and then converting to sinus rhythm (P = 0.068), and increased in all six procedures starting and finishing in sinus rhythm (P = 0.028). After ablation, symptomatic volume overload responding to diuresis occurred in three patients.



A substantial intravascular volume load during oiRFA can be absorbed with little change in LA pressure, such that LA pressure is not a reliable indicator of the fluid balance. Subsequent redistribution of the volume load imposes a risk after the procedure. Conversion to sinus rhythm may improve ability to acutely accommodate the volume load.
An Online Randomized Controlled Trial Evaluating HIV Prevention Digital Media Interventions for Men Who Have Sex with Men

As HIV infection continues unabated, there is a need for effective interventions targeting at-risk men who have sex with men (MSM). Engaging MSM online where they meet sexual partners is critical for HIV prevention efforts.



A randomized controlled trial (RCT) conducted online among U.S. MSM recruited from several gay sexual networking websites assessed the impact of 2 HIV prevention videos and an HIV prevention webpage compared to a control condition for the study outcomes HIV testing, serostatus disclosure, and unprotected anal intercourse (UAI) at 60-day follow-up. Video conditions were pooled due to reduced power from low retention (53%, n = 1,631). No participant incentives were provided.



Follow-up was completed by 1,631 (53%) of 3,092 eligible men. In the 60 days after the intervention, men in the pooled video condition were significantly more likely than men in the control to report full serostatus disclosure ('asked and told') with their last sexual partner (OR 1.32, 95% CI 1.01-1.74). Comparing baseline to follow-up, HIV-negative men in the pooled video (OR 0.70, 95% CI 0.54-0.91) and webpage condition (OR 0.43, 95% CI 0.25-0.72) significantly reduced UAI at follow-up. HIV-positive men in the pooled video condition significantly reduced UAI (OR 0.38, 95% CI 0.20-0.67) and serodiscordant UAI (OR 0.53, 95% CI 0.28-0.96) at follow-up.



Findings from this online RCT of MSM recruited from sexual networking websites suggest that a low cost, brief digital media intervention designed to engage critical thinking can increase HIV disclosure to sexual partners and decrease sexual risk. Effective, brief HIV prevention interventions featuring digital media that are made widely available may serve as a complementary part of an overall behavioral and biomedical strategy for reducing sexual risk by addressing the specific needs and circumstances of the target population, and by changing individual knowledge, motivations, and community norms.