nils-herrmann/clean_scirepeval huggingface dataset:
Pharmacy refill data can be used to predict virologic failure for patients on antiretroviral therapy in Brazil

Pharmacy adherence measures such as pharmacy dispensing ratios (PDRs) have previously been shown to be predictive of virologic outcomes. We aimed to determine the optimal interval of PDR assessment for predicting virologic failure for HIV-infected patients on antiretroviral therapy (ART).



Using national Brazilian ART pharmacy refill data, we examined PDRs for patients ≥18 years of age with at least one HIV RNA level ≥180 days after ART initiation on or after 1 January 2011. Patients with a documented ART change ≤270 days prior to viral load test date were excluded. Logistic regression models were used to describe associations between virologic failure, defined as an HIV RNA level ≥400 copies/mL and PDRs, defined as the number of days index drug dispensed (non-nucleoside reverse-transcriptase inhibitor or protease inhibitor) per 180- and 90-day, interval preceding viral load testing, adjusting for sex, age, race, time since ART initiation and index drug. Backward elimination of insignificant variables was performed after adjusting for PDR. A predictive probability of virologic failure was calculated using the corresponding odds ratios for the PDR and any other significant variables. The diagnostic performance of the PDR interval was assessed by calculating the area under the receiver operating characteristic curve (AUROC) for the predictive probability with respect to virologic failure.  A total of 1,025 patients were included (68% were male, median age 40 years, median time on ART 3.4 years). The PDR was found to be significantly associated with virologic failure for all of the PDR intervals (p < 0.001). There was an increased risk of virologic failure for all PDRs <0.95. The 90-180 days interval had a AUROC of 0.842, compared to 0.841 and 0.829 for the 0-180 days and 0-90 days intervals, respectively. The PDR performed well as a predictive tool to identify patients in virologic failure with the 90-180-days interval prior to viral load testing being marginally more predictive.



The validation and use of the pharmacy dispensing ratio using public pharmacy refill data could aid in early identification of patients with poor adherence and prevent development of treatment failure and drug resistance in Brazil.
Left ventricular systolic function and the pattern of late-gadolinium-enhancement independently and additively predict adverse cardiac events in muscular dystrophy patients

Cardiac involvement is a frequent finding in patients with Duchenne (DMD) and Becker (BMD) muscular dystrophies. With this study, we aimed at elucidating the relationship between the phenotypic expression of cardiac involvement and the occurrence of adverse cardiac events in DMD/BMD patients.



Eighty-eight male DMD/BMD patients (age 29 ± 14 yrs) were prospectively enrolled. All patients underwent cardiovascular magnetic resonance (CMR) comprising cine- and late-gadolinium-enhancement (LGE)-CMR at study entry and were subsequently followed-up for adverse cardiac events. The primary endpoint was defined as all-cause/cardiac death or cardiac transplantation. Secondary endpoints were (1) hospitalization for heart failure and/or (2) occurrence of non-/sustained ventricular tachycardia (VT).



During a mean follow-up time of 47 ± 18 months, the primary endpoint was observed in three (3%) and the secondary endpoint in 21 (24%) patients. On multivariable analysis, LV-EF (HR, 95% CI: 0.94, 0.89-0.97, p = 0.001) and the presence of "transmural" LGE (HR, 95% CI: 2.89, 1.09-7.68, p = 0.033) were the only independent predictors for secondary endpoints. A cut-off for LV-EF of 45% was associated with the highest hazard ratio (HR, 95% CI: 11.50, 4.49-29.43, p < 0.0001) in a Cox regression survival analysis. In the group of patients with a LV-EF (>45%), those patients already showing "transmural" LGE had a significantly lower event-free-survival (HR, 95% CI: 13.48, 1.89-96.12, p = 0.009) compared to those without.



An impaired LV systolic function (LV-EF ≤45%) and a "transmural" pattern of myocardial fibrosis independently predict the occurrence of adverse cardiac events in DMD/BMD patients. Even in DMD/BMD patients with relatively preserved LV-EF (>45%), the simple and visually assessable parameter "transmural LGE" is of additive prognostic value.
Safety and Tolerability of Transoral Bravo Capsule Placement After Transnasal Manometry Using a Validated Conversion Factor

To prospectively calculate and validate a conversion factor in healthy volunteers that allows accurate nonsedated, transoral (TO) Bravo capsule placement after transnasal (TN) manometry, and to evaluate the ease and safety of nonendoscopic Bravo placement compared with endoscopic placement.Part 1. Twenty-five healthy volunteers underwent sequential TN and TO esophageal manometry to measure the distance to the lower esophageal sphincter (LES). A TN to TO conversion factor was calculated from these measurements. Part 2. Twenty volunteers underwent TN manometry followed by unsedated TO Bravo capsule placement using the conversion factor calculated in part 1. TN endoscopy then measured the location of the Bravo capsule in relationship to the squamocolumnar junction (SCJ). Part 3. During an 18-month period, 370 consecutive patients referred for a Bravo procedure underwent nonendoscopic, unsedated TO placement (308 patients) or standard endoscopically assisted placement (62 patients).RESULTS:Part 1. All 25 volunteers completed TN and TO manometry; a conversion factor of 4 cm was calculated. Part 2. Using the calculated conversion factor of 4 cm, a Bravo capsule was deployed TO 5 cm above the proximal border of the LES. The mean ± standard deviation (SD) TN endoscopic distance to the capsule was 6.0 cm (±0.3 cm) above the SCJ. Part 3. A total of 333 patients completed the entire study (90%). Analysis of 48-h pH measurements did not reveal any significant differences between the two groups.A reliable and valid conversion factor of 4 cm following TN manometry permits accurate TO placement of the Bravo capsule without endoscopy. TO, unsedated Bravo placement is safe, well tolerated, and may minimize costs and potential risks associated with endoscopy.
Validation of the Use of a Point-of-Care Device in Monitoring the International Normalised Ratio in Postoperative Cardiac Patients.

Dear Editor, Warfarin is prescribed for various conditions including mechanical heart valves, atrial fibrillation and venous thromboembolism. Prevention of bleeding and thromboembolic complications require maintenance in a tight therapeutic range. The use of patient self-testing has been well documented in the United Kingdom and Europe in prospective and retrospective studies.1-5 CoaguChek® XS (Roche Diagnostics, Basel, Switzerland) prothrombin coagulation monitoring system6,7 provides point-of-care (POC) monitoring with a measurement range of 0.8 to 8.0 international normalised ratio (INR) and consists of a CoaguChek® XS monitor and test strips. To date, validation studies have been limited to stable outpatient anticoagulation clinic cohorts,7 with studies done in cardiac patients perioperatively.8-10 However, these used arterial or whole blood samples and evaluated patients in the immediate perioperative period. Therefore, there is a void of data in the validity of such devices using capillary blood samples in cardiac patients during the recuperative in-hospital phase. The study aimed to validate the POC testing (POCT) device with capillary samples in an Asian cohort during the postoperative phase. By introducing the concept and validity of POC self-testing in patients, it would help to empower the patient to participate in his or her care, laying ground for developing an outpatient self-testing programme. The authors believe that this period is a window of opportunity for the implementation of self-POCT as patients are under closer supervision and more motivated.
Celiac Disease and Lymphoma Risk: A Multicentric Case–Control Study in Spain

Celiac disease is a highly prevalent condition frequently misdiagnosed because of heterogeneity of the clinical symptoms. It is well recognized that enteropathy-associated T-cell lymphoma is an uncommon lymphoma type linked to celiac disease; it has also been suggested that other types of lymphomas may be associated with celiac disease. Our aim was to estimate the risk of all lymphoma associated with celiac disease. Serological markers and personal interviews were obtained from 298 consecutive lymphoma cases and 251 matched controls recruited in four Spanish hospitals. Celiac disease was detected in two cases (0.67%; n = 298) and in three controls (1.2%; n = 251). Treated celiac disease was observed in one patient with lymphoma and in two control subjects. In our series, there was no evidence that celiac disease was a risk factor for lymphoma (OR=0.62, 95% Cl=0.10–3.79). Serological screening for CD is not recommended in people with lymphoma.
A comparison of knee braces during walking for the treatment of osteoarthritis of the medial compartment of the knee.

In this cross-over study, we evaluated two types of knee brace commonly used in the conservative treatment of osteoarthritis of the medial compartment. Twelve patients confirmed radiologically as having unilateral osteoarthritis of the medial compartment (Larsen grade 2 to grade 4) were studied. Treatment with a simple hinged brace was compared with that using a valgus corrective brace. Knee kinematics, ground reaction forces, pain and function were assessed during walking and the Hospital for Special Surgery scores were also determined. Significant improvements in pain, function, and loading and propulsive forces were seen with the valgus brace. Treatment with a simple brace showed only significant improvements in loading forces. Our findings suggest that although both braces improved confidence and function during gait, the valgus brace showed greater benefit.
Cool-Mem: combining statically speculative memory accessing with selective address translation for energy efficiency

This paper presents Cool-Mem, a family of memory system architectures that integrate conventional memory system mechanisms, energy-aware address translation, and compiler-enabled cache disambiguation techniques, to reduce energy consumption in general purpose architectures. It combines statically speculative cache access modes, a dynamic CAM based Tag-Cache used as backup for statically mispredicted accesses, various conventional multi-level associative cache organizations, embedded protection checking along all cache access mechanisms, as well as architectural organizations to reduce the power consumed by address translation in virtual memory. Because it is based on speculative static information, the approach removes the burden of provable correctness in compiler analysis passes that extract static information. This makes Cool-Mem applicable for large and complex applications, without having any limitations due to complexity issues in the compiler passes or the presence of precompiled static libraries. Based on extensive evaluation, for both SPEC2000 and Mediabench applications, 12% to 20% total energy savings are obtained in the processor, with performance ranging from 1.2% degradation to 8% improvement, for the applications studied.
Effect of anesthesia and cerebral blood flow on neuronal injury in a rat middle cerebral artery occlusion (MCAO) model

Middle cerebral artery occlusion (MCAO) models have become well established as the most suitable way to simulate stroke in experimental studies. The high variability in the size of the resulting infarct due to filament composition, rodent strain and vessel anatomy makes the setup of such models very complex. Beside controllable variables of homeostasis, the choice of anesthetics and the grade of ischemia and reperfusion played a major role for extent of neurological injury. Transient MCAO was induced during either isoflurane or ketamine/xylazine (ket/xyl) anesthesia with simultaneously measurement of cerebral blood flow (CBF) in 60 male Wistar rats (380–420 g). Neurological injury was quantified after 24 h. Isoflurane compared with ket/xyl improved mortality 24 h after MCAO (10 vs. 50 %, p = 0.037) and predominantly led to striatal infarcts (78 vs. 18 %, p = 0.009) without involvement of the neocortex and medial caudoputamen. Independent of anesthesia type, cortical infarcts could be predicted with a sensitivity of 67 % and a specificity of 100 % if CBF did not exceed 35 % of the baseline value during ischemia. In all other cases, cortical infarcts developed if the reperfusion values remained below 50 %. Hyperemia during reperfusion significantly increased infarct and edema volumes. The cause of frequent striatal infarcts after isoflurane anesthesia might be attributed to an improved CBF during ischemia (46 ± 15 % vs. 35 ± 19 %, p = 0.04). S-100β release, edema volume and upregulation of IL-6 and IL-1β expression were impeded by isoflurane. Thus, anesthetic management as well as the grade of ischemia and reperfusion after transient MCAO demonstrated important effects on neurological injury.
Associations of soluble fiber, whole fruits/vegetables, and juice with plasma Beta-carotene concentrations in a free-living population of breast cancer survivors.

Soluble fiber and the physical state of fruits/vegetables affect plasma ß-carotene concentrations; however, most of this research was conducted in laboratory-based settings. These analyses investigated the relationship between soluble fiber and juiced versus whole fruits/vegetables to plasma ß-carotene concentrations in a free-living population.



This cross-sectional analysis used 12-month follow-up data from the Women's Healthy Eating & Living Study (1995-2006), a study to improve diet in breast cancer survivors in the Western United States. The dietary nutrients considered in this analysis included intake of soluble fiber (g), ß-carotene from fruit/vegetable juice (mg), and ß-carotene from whole fruits/vegetables (mg). A linear regression model was used to assess the relationship of the variables to plasma ß-carotene concentrations.



Out of 3,088 women enrolled in the Women's Healthy Eating & Living Study, 2,397 women had complete data (mean age = 54). The final model accounted for approximately 49% of the explained variance in plasma ß-carotene concentrations. Fruit/vegetable juice had the largest positive relation to plasma ß-carotene concentrations (standardized parameter estimate = 0.23, p < 0.01), followed by whole fruits/vegetables (standardized parameter estimate = 0.09, p < 0.01).



Soluble fiber may inhibit ß-carotene absorption; therefore, consumption of juice may increase plasma ß-carotene concentrations more than whole fruits/vegetables in free-living populations.
Efficacy and Safety of Vinpocetine as Part of Treatment for Acute Cerebral Infarction: A Randomized, Open-Label, Controlled, Multicenter CAVIN (Chinese Assessment for Vinpocetine in Neurology) Trial.

The objective of this study was to evaluate the efficacy and safety of intravenous vinpocetine administration as part of a comprehensive treatment for acute cerebral infarction in a Chinese population.



610 acute cerebral infarction patients were randomized into two groups: the vinpocetine group (469 patients) received cytidine disphosphate choline 0.4-0.5 g in combination with aspirin 75-100 mg or clopidogrel 75 mg once daily, plus vinpocetine 30 mg intravenously once daily for 7 days, while the control group (141 patients) received cytidine disphosphate choline 0.4-0.5 g in combination with aspirin 75-100 mg or clopidogrel 75 mg once daily for 7 days. Additionally, patients received medications for symptoms such as hypertension, hyperglycemia, hyperlipidemia, and intracranial hypertension when necessary. Mini-Mental State Examination (MMSE), National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale, and Barthel Index (BI) scores and transcranial doppler (TCD) were assessed at baseline, 7, 14, and 90 days after treatment. Adverse events (AEs) and abnormalities in blood, urine, liver, and kidney function were monitored.



MMSE, NIHSS, and BI scores were significantly higher in the vinpocetine group than in the control group 90 days after treatment, indicating significantly improved cognitive skill, neurological function, and quality of life (QOL) in the vinpocetine group versus the control group. Importantly, such effects of vinpocetine were maintained over time. In addition, TCD monitoring showed significantly increased cerebral blood flow associated with vinpocetine versus control. No significant difference in safety was noted between the two groups.



When used as part of treatment for acute cerebral infarction, vinpocetine improves patients' cerebral blood flow, cognitive quality, neurological functions, and QOL. Vinpocetine could be an effective and safe component of treatment regimen for acute cerebral infarction.
The partial positive allosteric GABA(A) receptor modulator EVT 201 is efficacious and safe in the treatment of adult primary insomnia patients.

To evaluate polysomnographic (PSG) and self-reported measures of the efficacy and safety of EVT 201 in patients with primary insomnia.



Following clinical and PSG screening, 75 patients (mean age: 45.1+/-11.2 y; 50 f, 25 m) meeting DSM-IV criteria for primary insomnia entered this crossover study and were randomly assigned to double-blind treatment sequences of 1.5 mg or 2.5 mg EVT 201, or placebo using a balanced Latin square design. For each study condition study medication was administered on two consecutive nights and PSG and self-reported data were collected. Safety assessments included physical examination, clinical laboratory measures, electrocardiogram, documentation of adverse events, and the digit symbol substitution test (DSST) and self-reported sleepiness/alertness ratings to detect residual sedation. Data were collected at five US sleep laboratories. Efficacy analyses were performed for the 67 patients completing the study. Safety analyses included all 75 randomized patients.



On PSG measures compared to placebo, EVT 201 1.5 mg and 2.5 mg increased total sleep time (TST; 33.1, 45.0 min; both p<0.0001), reduced wake after sleep onset (WASO; -16.7, -25.7 min; both p<0.0001), reduced latency to persistent sleep (LPS; -17.0, -20.7 min; both p<0.0001), and reduced the number of awakenings (-1.2, -2.6; both p<0.0001). Significant reduction of wake time was seen with 1.5 mg during each of the first three quarters of the night (p<0.0001-0.002), and with 2.5 mg in all four quarters (p<0.0001-0.0005). Both doses also improved all key self-reported measures of sleep including total sleep time (rTST; 51.9, 51.1 min; both p<0.0001), wake after sleep onset (rWASO; -29.3, -29.6 min; both p<0.0001), sleep latency (rSL; -24.0 min, p<0.004; -25.1 min, p<0.0002), and number of awakenings (rNAW; -1.1, -1.2; both p<0.0001). Sleep quality was also improved by both doses. Self-rated sleepiness in the morning did not differ from placebo for either dose; however, there was a small negative effect on the DSST for both doses. Both doses had similar effects on sleep architecture including an increase in Stage 2 sleep and REM latency and a small, but significant decrease in REM (REM -5.7, -8.3 min; p=0.0175, p=0.0006). No effect on other sleep architecture parameters, including SWS, was seen. EVT 201 was well tolerated. No serious or unexpected adverse events were reported.



This first study of EVT 201 in adult patients with primary insomnia demonstrated improved measures of sleep onset and sleep maintenance, including during the third and fourth quarters of the night. Adverse events were infrequent and all were mild to moderate in severity.
Cardiac fibrosis detected by magnetic resonance imaging on predicting time course diversity of left ventricular reverse remodeling in patients with idiopathic dilated cardiomyopathy

This study aimed to identify the association between the time course of left ventricular reverse remodeling (LVRR) and late gadolinium enhancement in cardiac magnetic resonance imaging (LGE-cMRI) in patients with idiopathic dilated cardiomyopathy (IDCM). We identified 214 IDCM patients treated by optimal pharmacotherapies. LVRR was defined as ≥10 % increment in LV ejection fraction along with ≥10 % reduction in LV end-diastolic dimension. Findings of LGE-cMRI focusing on presence and extent of LGE were evaluated at baseline. Echocardiographic evaluation for detecting LVRR was performed in all patients for 3 years. The primary endpoint was defined as composite events (CEs) including readmission for heart failure, detection of major ventricular arrhythmia, and all-cause mortality. LVRR was found at <1 year in 59 patients (28 %, early responder), ≥1 year in 56 patients (26 %, late responder), and was absent in 99 patients (46 %, non-responder). Multivariate Cox-proportional hazards analysis revealed that both early responders (P = 0.02) and late responders (P < 0.001) had lower incidence of CEs than non-responders. Among 66 subjects (23 %) with complete cMRI evaluation, LGE was detected more often in late and non- than early responders (65, 83 vs. 23 % P < 0.001, respectively), whereas the LGE area was smaller in both early and late than non-responders (2 ± 3, 4 ± 3 vs. 12 ± 10 %, P < 0.001, respectively). In conclusion, evaluating the presence and the extent of LGE is useful for predicting the clinical differences of LVRR time course and subsequent long-term outcomes.
An altered TH1/TH2 and pro-inflammatory cytokine profile in patients with end-stage renal disease detected by suspension array technology.

Patients with end-stage renal disease (ESRD) have an impaired immune response with a dysregulated Th1/Th2 cytokine network.



Twelve ESRD patients on HD were enrolled, and their data of cytokines alterations were divided into pre- and post-HD groups, while data from 12 healthy volunteers served as control. Th1/Th2 and pro-inflammatory cytokines were all measured by suspension array (SA) technology with interleukin (IL)-8 detected simultaneously by ELISA. The correlation between SA technology and ELISA for IL-8 was calculated to compare these two methods.



In ESRD patients, as compared with controls, the level of IL-10 increased just prior to HD and IL-1beta level decreased only following HD, while the levels of TNF-beta and IL-8 decreased both before and after HD. After HD, the levels of IL-1beta, IL-4, IL-8, and IL-10 in ESRD patients decreased when compared with those before HD. Statistical analysis by Spearman's rho's test showed significant correlations between SA technology and ELISA on IL-8 (p < 0.001, correlation coefficient 0.946).



ESRD patients on HD show an altered cytokine profile with an increase in Th2 cytokine IL-10 and a decrease in Th1 cytokine TNF-beta as well as a reduction in pro-inflammatory cytokine IL-8. HD did affect cytokine profile of ESRD patients, decreasing IL-1, IL-4, IL-8, and IL-10. SA technology is useful in the detection of cytokine changes within detection limits of this technology in ESRD patients.