nils-herrmann/clean_scirepeval huggingface dataset:
Amino acid change in the carbohydrate response element binding protein is associated with lower triglycerides and myocardial infarction incidence depending on level of adherence to the Mediterranean diet in the PREDIMED trial.

A variant (rs3812316, C771G, and Gln241His) in the MLXIPL (Max-like protein X interacting protein-like) gene encoding the carbohydrate response element binding protein has been associated with lower triglycerides. However, its association with cardiovascular diseases and gene-diet interactions modulating these traits are unknown.



We studied 7166 participants in the PREvención with DIeta MEDiterránea trial testing a Mediterranean diet (MedDiet) intervention versus a control diet for cardiovascular prevention, with a median follow-up of 4.8 years. Diet, lipids, MLXIPL polymorphisms, and cardiovascular events were assessed. Data were analyzed at baseline and longitudinally. We used multivariable-adjusted Cox regression to estimate hazard ratios for cardiovascular outcomes. The MLXIPL-rs3812316 was associated with lower baseline triglycerides (P=5.5×10(-5)) and lower hypertriglyceridemia (odds ratio, 0.73; 95% confidence interval [CI], 0.63-0.85; P=1.4×10(-6) in G-carriers versus CC). This association was modulated by baseline adherence to MedDiet. When adherence to MedDiet was high, the protection was stronger (odds ratio, 0.63; 95% CI, 0.51-0.77; P=8.6×10(-6)) than when adherence to MedDiet was low (odds ratio, 0.88; 95% CI, 0.70-1.09; P=0.219). Throughout the follow-up, both the MLXIPL-rs3812316 (P=3.8×10(-6)) and the MedDiet intervention (P=0.030) were significantly associated with decreased triglycerides. Likewise in G-carriers MedDiet intervention was associated with greater total cardiovascular risk reduction and specifically for myocardial infarction. In the MedDiet, but not in the control group, we observed lower myocardial infarction incidence in G-carriers versus CC (hazard ratios, 0.34; 95% CI, 0.12-0.93; P=0.036 and 0.90; 95% CI, 0.35-2.33; P=0.830, respectively).



Our novel results suggest that MedDiet enhances the triglyceride-lowering effect of the MLXIPL-rs3812316 variant and strengthens its protective effect on myocardial infarction incidence.


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Heparin Therapy in Pediatric Patients: A Prospective Cohort Study

Current guidelines for heparin therapy in pediatric patients have been extrapolated from trials in adult patients without rigorous evaluation of efficacy and safety. We prospectively monitored consecutive pediatric patients receiving systemic doses of heparin over 10 mo at one institution using a predetermined nomogram to monitor maintenance therapy. Sixty-five consecutive children; 38 males and 27 females, received systemic doses of heparin. Thirty children had deep venous thrombosis and/or pulmonary embolism; 11 had arterial thrombi, most frequently after diagnostic angiography; and the remaining 24 received heparin prophylactically, for congenital heart disease. Twenty-nine (45%) of the 65 patients were less than 1 y of age and 22 (34%) were 10 y or older. Congenital heart disease was the predominant diagnosis under 1 y and deep venous thrombosis in older children. After a bolus dose of 50 U/kg, 39% of children (n = 30) achieved a minimal level activated partial thromboplastin time (APTT). Sixty-eight percent of children achieved a minimal level APTT by 24 h and 81% by 48 h. For all 65 children, APTT values were within the therapeutic range 43% of the time. APTT values outside the therapeutic range were twice as likely to be low as high. The average amount of heparin required to maintain therapeutic APTT values for children was 22 U/kg/h: 28 U/kg/h for infants <1 y and 20 U/kg/h for the rest. Bleeding was rare (2%) and mild. Documented recurrent thrombotic disease was more common (7%) with associated morbidity. In summary, a commonly used protocol for administration of heparin to children was rigorously evaluated and shown to provide insufficient amounts of heparin in the first days of treatment. Average requirements of heparin per kilogram per hour were determined and will form the bases of future studies.
Olanzapine for cachexia in patients with advanced cancer: an exploratory study of effects on weight and metabolic cytokines

Olanzapine is used for treatment of psychiatric conditions but causes substantial weight gain. This study assessed safety, efficacy, and changes in metabolic cytokines associated with olanzapine administration in patients with cachexia due to advanced cancer. Patients with cancer-related cachexia were treated with olanzapine (doses ranging from 2.5 to 20 mg daily by mouth). Patients also received anti-neoplastic treatments. Serum samples were collected at baseline and after weeks 1, 2, 4, and 8 for analysis of levels of leptin, growth hormone, ghrelin, and interleukin-6 (IL-6). Of the 39 participants, 31 were evaluable for weight change (N = 6 excluded for new ascites; N = 2, incomplete body weight of data). Toxicities related to olanzapine were somnolence (n = 1), pancreatitis (n = 1), extrapyramidal symptoms (n = 1), and nausea/vomiting (n = 1) (all grade 2). The recommended dose of Olanzapine is 20 mg PO daily for cancer patients (same as FDA approved dose for psychiatric conditions). Samples from 29 patients were eligible for analysis of serum cytokine levels. Mean values of leptin, ghrelin, and growth hormone did not change on treatment, though IL-6 levels increased, perhaps due to tumor progression. There was no association between changes in cytokines and weight. The mean change in slope of weight loss before versus after therapy was 0.24 (95 % CI, −0.08, 0.56; p = 0.13) indicating a trend, albeit not reaching statistical significance, toward attenuation of weight loss. Changes in metabolic cytokines and body weight did not correlate. Treatment with olanzapine had only a modest effect in altering the trajectory of weight loss.
Enhanced cosmetic outcome with running horizontal mattress sutures.

Cutaneous sutures should provide good wound eversion, firm closure, and cosmetically elegant results. Simple running sutures are commonly employed in cutaneous surgery but may not always be effective in achieving wound eversion.



We compared the cosmetic results of simple running nonabsorbable sutures with running horizontal mattress sutures in primary closures of facial defects.



Fifty-five patients with facial Mohs surgery defects appropriate for primary multilayer repair were randomized into one of two arms. Either the superior or the inferior half of the wound was closed with a running horizontal mattress suture. The other half of the wound was closed with a traditional simple running suture. At 1 week, 6 weeks, and 6 months, the cosmetically superior half of the wound, if any, was blindly determined by the investigators.



The running horizontal mattress suture was significantly more cosmetically pleasing than the simple running suture. Forty-seven patients completed the study. At the 6-month follow-up, 25 patients did better with the horizontal suture and 5 did worse, and with 17 patients, there was no clinically perceptible difference. The 6-week scores predicted the outcome at 6 months, but the 1-week scores did not.



In primary closures of the face, the running horizontal mattress suture is a cosmetically elegant alternative to a traditional running cutaneous suture. The final scar appears smoother and flatter than those produced by traditional simple running sutures.
Influence of the time of day on physical performance in patients with coronary artery disease

The exercise training workload for cardiac patients is determined from the peak heart rate achieved safely during a stress test. Circadian rhythms may play a key role in changing physiological responses to the stress test. Therefore, the purpose of this study was to evaluate the influence of the time of day on cardiopulmonary and metabolic responses in highly trained men with coronary artery disease. A group of 15 patients with coronary artery disease [53.5 (SD 6) years] performed two sessions of graded tests to exhaustion: one session was performed at 10 a.m. and the second at 5 p.m. in randomized order. Treadmill velocity was kept constant at a speed of 4.8 km · h−1 starting with an elevation of 0% which was increased thereafter by 2.5% every 3 min. At rest the results revealed that only oxygen uptake was significantly lower (P < 0.05) in the morning compared to that observed in the evening [2.9 (SD 0.4) compared to 3.5 (SD 0.5) ml O2 · kg−1 · min−1, respectively]. During exercise, differences due to time of day were found in the variables of maximal oxygen uptake which were significantly higher (P < 0.05) in the evening than in the morning [34.2 (SD 2.6) and 40.8 (SD 2.5) ml O2 · kg−1 · min−1, respectively]. These data indicated that in these well-trained coronary artery disease patients there was a significant time of day effect associated with metabolic responses following stress-testing.
Angiographic detection of carotid plaque ulceration. Comparison with surgical observations in a multicenter study. North American Symptomatic Carotid Endarterectomy Trial.

Carotid plaque ulceration is used as one of the determinants in deciding which patients should be submitted to carotid endarterectomy. Uncertainties about its importance persist. Its detection by angiography is an important consideration.



The detection of ulceration by angiography was compared with observations during endarterectomy in the first 500 patients recruited into the North American Symptomatic Carotid Endarterectomy Trial. This represents the first multicenter compilation of data on this subject and the largest series of patients with both arteriographic and direct surgical observation.



Sensitivity and specificity of detecting ulcerated plaques were 45.9% and 74.1%, respectively. The positive predictive value of identifying an ulcer was 71.8%. These results remained unchanged with differing degrees of carotid stenosis and were confirmed by analyses based on receiver operating characteristic (ROC) methodology. The area under the ROC curve (Az) was estimated to be 0.61 (95% confidence interval, 0.55 to 0.67).



These observations from a multicenter study confirm that little agreement exists between angiography and surgical observation in detecting carotid plaque ulceration.
Assessment of serum free light chain assays for plasma cell disorder screening in a Veterans Affairs population.

This study evaluated serum kappa and lambda free light chain (FLC) concentrations in a Veterans Affairs (VA) population. We hypothesized that our older, mostly male, population should not differ in serum FLC ranges from levels previously established for younger male and female populations and that the assay would improve our screening protocol for plasma cell dyscrasias (PCD). Serum kappa and lambdaFLC were assayed in 312 consecutive serum samples collected during a 16-week period from veterans whose clinical presentation indicated a need for serum protein electrophoresis (SPEP) analysis. We reviewed our laboratory information system (LIS) files to evaluate the patients' diagnoses and treatment status in conjunction with serum FLC levels. All assays and validation studies were conducted using an immunoturbidimetric method with a Roche/Hitachi 911 modular analytical system. The intra-assay variability (CV) was <5%, based on 13 replicate assays of 4 control samples and 1 blank sample. Of the 312 patients, the SPEP results were normal in 235 and abnormal in 77. Of the 235 patients with normal SPEP results, 37 had abnormal FLC values and 20 of these were diagnosed as PCD. Of the 77 patients with abnormal SPEP results, only 9 had diagnoses unrelated to PCD. Using the FLC assay in conjunction with retrospective reviews of medical records, we obtained an 86% detection rate of PCD. This detection rate increased to 100% when both SPEP and FLC results were considered. In conclusion, this study documents an important role for serum FLC assays in diagnosing and monitoring PCD in a VA population. Our results support previously established serum FLC reference ranges that were obtained in younger, male and female populations. Using the serum FLC results in conjunction with SPEP results improves the sensitivity and specificity for managing VA patients whose clinical presentation indicates the need to evaluate PCD.
Intra-rater agreement of the anorectal exam and classification of injury severity in children with spinal cord injury

Intra-rater reliability study, cross-sectional design.To report on the intra-rater agreement of the anorectal examinations and classification of injury severity in children with spinal cord injury (Two, non-profit children's hospitals specializing in pediatric SCI.Methods:180 subjects had at least two trials of the anorectal examinations as defined by the International Standards for Neurological Classification of Spinal Cord Injury. Intraclass correlation coefficients (ICC) and 95% confidence intervals (CI) were used to evaluate the agreement. ICC>0.90=high agreement; ICC between 0.75–0.89=moderate agreement; ICC<0.75=poor agreement.When evaluated for the entire sample, agreement was moderate-high for anal sensation and contraction and injury classification. When evaluated as a function of age at examination and type of injury, agreement for anal sensation was poor for subjects with tetraplegia in the 12–15-year age group (ICC=0.56) and 16–21-year age group (ICC=0.70) and for subjects with paraplegia in the 6–11-year age group (ICC=0.69). Agreement for anal contraction was moderate for subjects with tetraplegia in the 16–21-year age group (ICC=0.81) and subjects with paraplegia in the 12–15-year age group (ICC=0.78) and poor for subjects with paraplegia in the 6–11-year age group (ICC=0.67). Agreement for injury classification was poor for subjects with tetraplegia in the 12–15-year group (ICC=0.56) and 16–21-year group (ICC=0.74) and paraplegia in the 6–11-year group (ICC=0.11) and 12–15-year group (ICC=0.63). Anorectal responses had high agreement in subjects with tetraplegia in the 6–11-year group and moderate to high agreement in subjects with paraplegia in the 16–21-year group.The data do not fully support the use of anorectal examination in children. Further work is warranted to establish the validity of anorectal examination.
MRI diagnosis of bone marrow relapse in children with ALL

Diffuse marrow replacement in acute leukemia is well known, but there are few reports describing the MRI features of pediatric leukemic relapse. Our purpose was to describe the MRI appearance of pediatric leukemic relapse. A total of 53 consecutive children with a history of ALL were referred for musculoskeletal MRI from 1 January 1998 to 28 February 2007 at one center, and from 1 January 2000 to 2 May 2007 at a second center. From this group, 14 children seen at initial diagnosis of leukemia and 2 children who underwent MRI after therapy for relapse were excluded. The remaining 37 children, 8 with relapse and 29 in remission, were studied. Images of patients with relapse and in remission were reviewed for type and configuration of marrow infiltration; coexisting marrow alterations including osteonecrosis or stress reaction were also reviewed. All eight children with relapse demonstrated nodular lesions with well-defined margins. Coexisting osteonecrosis was present in three children (38%) and pathologic fracture in one. Among the 29 children in remission, 9 showed stress reaction/fracture, 14 showed osteonecrosis and 9 showed ill-defined nodules, and in 5 the marrow was completely normal. Well-defined nodules in all patients with leukemic relapse suggest that this appearance is characteristic and distinct from the published findings of diffuse marrow replacement in acute leukemia.
Risk factors for “late-to-test” HIV diagnosis in Riverside County, California

Patients diagnosed late in the course of HIV infection are at an increased risk of negative health outcomes and are more likely to transmit HIV to others. Using the CDC's definition for AIDS, we analyzed case report data from persons diagnosed with AIDS within 12 months of an HIV diagnosis ("late-to-test") in Riverside County, CA, between 2009 and 2014. Of 1385 HIV cases, 422 (30.5%) were late-to-test. Factors associated with late-to-test were: having no insurance (P = 0.005), being Hispanic (P = 0.002) and being between 45 and 64 years of age (P < 0.001). Females (P = 0.013) and those in the eastern region of Riverside County (P = 0.002) were less likely to be late-to-test. In the absence of universal HIV testing, interventions to decrease late testing are needed.
Effects of intracoronary injection of mononuclear bone marrow cells on left ventricular function, arrhythmia risk profile, and restenosis after thrombolytic therapy of acute myocardial infarction.

To assess the efficacy and safety of bone marrow cell (BMC) therapy after thrombolytic therapy of an acute ST-elevation myocardial infarction (STEMI).



Patients with STEMI treated with thrombolysis followed by percutaneous coronary intervention (PCI) 2-6 days after STEMI were randomly assigned to receive intracoronary BMCs (n = 40) or placebo medium (n = 40), collected and prepared 3-6 h prior PCI and injected into the infarct artery immediately after stenting. Efficacy was assessed by the measurement of global left ventricular ejection fraction (LVEF) by left ventricular angiography and 2-D echocardiography, and safety by measuring arrhythmia risk variables and restenosis of the stented vessel by intravascular ultrasound. At 6 months, BMC group had a greater absolute increase of global LVEF than placebo group, measured either by angiography (mean +/- SD increase 7.1 +/- 12.3 vs. 1.2 +/- 11.5%, P = 0.05) or by 2-D echocardiography (mean +/- SD increase 4.0 +/- 11.2 vs. -1.4 +/- 10.2%, P = 0.03). No differences were observed between the groups in the adverse clinical events, arrhythmia risk variables, or the minimal lumen diameter of the stented coronary lesion.



Intracoronary BMC therapy is associated with an improvement of global LVEF and neutral effects on arrhythmia risk profile and restenosis of the stented coronary lesions in patients after thrombolytic therapy of STEMI.
Effect of free plant sterols in low-fat milk on serum lipid profile in hypercholesterolemic subjects

To determine the effect of nonesterified, nonhydrogenated plant sterols solubilized in a partly vegetable oil-filled low-fat milk on serum low-density lipoprotein cholesterol (LDL) in mildly hypercholesterolemic patients. Double-blind, randomized, placebo-controlled three-arm crossover study. Outpatient clinical trial.Subjects: A total of 138 patients were screened, providing 81 patients for randomization; 71 patients completed the study. The study product was a 500 ml milk blend with or without nonesterified, nonhydrogenated sterols. The daily consumption of sterols in the three groups was 0 g/day, control group (C); 1.2 g/day, (Lo); or 1.6 g/day, (Hi), respectively. The patients were randomly assigned to one of three different treatment sequences. Each intervention period was 4 weeks. The total study duration was 12 weeks. The milk product was well tolerated. The placebo-adjusted mean reduction in LDL was 7.13±12.31 and 9.59±12.44% (mean±s.d.) for Lo and Hi groups, respectively (P<0.0001); there was no statistically significant difference in LDL lowering for the Lo and Hi groups. There were no significant changes in serum vitamin E or carotenoid concentrations after standardization with LDL cholesterol during the study period. The present study shows for the first time a substantial reduction in LDL cholesterol with a new, partly vegetable oil-filled 1.2% low-fat milk product, containing nonesterified plant sterols from soybean oil, in a randomized, placebo-controlled trial. This result encourages further development of novel low-fat dairy products containing free plant sterols for future use in cholesterol-lowering initiatives. The study was financed by Nestec Ltd, Switzerland.
A randomized trial of daclatasvir in combination with asunaprevir and beclabuvir in patients with chronic hepatitis C virus genotype 4 infection.

LB-7. Tarek Hassanein1,⇑ Karen D. Sims Michael Bennett Norman Gitlin Eric Lawitz Tuan Nguyen Lynn Webster Zobair Younossi Howard Schwartz Paul J. Thuluvath 11 non-financial support from AbbVie, Achillion, BioCryst, Biotica, Enanta, Gilead Sciences, Idenix, Janssen, Kadmon, Merck, Novartis, Presidio, Santaris, Theravance, and Vertex. L. Webster has received consulting fees from AcelRx, Acura, AstraZeneca, BioDelivery Sciences International, Boehringer Ingelheim, Boston Scientific, and Collegium. Z. Younossi has received consulting fees from Salix, Janssen, Vertex, Gilead Sciences, Enterome, and Coneatus.  Thuluvath has received research grant support from Bristol-Myers Squibb, Gilead Sciences, Vertex, Isai, AbbVie, and Salix, and speaker fees from Gilead Sciences, Onyx, AbbVie, and Bayer. K.D. Sims, B. Rege, N. Zhou, M. Wind-Rotolo, E. Chung, and D.M. Grasela are employees and shareholders of Bristol- F. McPhee, A. Griffies, and D.F. Gardiner are employees of Bristol-Myers Squibb. M. Bennett, N. Gitlin, T. Nguyen, and H. Schwartz have no conflicts of interest to disclose.
Economic Evaluation of the Randomized Aldactone Evaluation Study (RALES): Treatment of Patients with Severe Heart Failure

To use data from the Randomized Aldactone Evaluation Study (RALES) to compare clinical outcomes and costs as part of the assessment of the economic implications of spironolactone treatment of advanced heart failure.  RALES was a randomized, double-blinded, placebo-controlled trial that enrolled participants who had severe heart failure and a left ventricular ejection fraction of no more than 35% and who were receiving standard therapy, including an angiotensin-converting enzyme inhibitor, a loop diuretic, and, in some cases, digoxin. We used a decision analytic model that incorporated data from participants in RALES as well as cost data from five countries that participated in the study. Costs were calculated for nonfatal hospitalizations, ambulatory care, spironolactone therapy, and death. The primary health outcome was quality-adjusted life-years saved (QALYS). Outcomes were evaluated for the first 35 months of observation in RALES.  Spironolactone therapy during the first 35 months of follow-up in RALES increased quality-adjusted survival time (0.13 QALYS, 95% CI, 0.07 to 0.18) without increasing costs ($713 savings, 95% CI, $2123 savings to $783 in costs). Spironolactone therapy either dominated placebo or had a ratio of cost per QALYS that was unlikely to exceed $20,300. These results were robust in both one-way and multiway sensitivity analyses.  Even after implementation of current clinical guidelines, addition of spironolactone therapy provides an opportunity to further reduce the large clinical and economic burden of patients with heart failure.