nils-herrmann/clean_scirepeval huggingface dataset:
An association analysis of lipid profile and diabetic cardiovascular autonomic neuropathy in a Chinese sample

Recent studies have shown that triglyceride (TG), low-density lipoprotein cholesterol (LDL), and high-density lipoprotein cholesterol (HDL) are related to the prevalence of cardiovascular autonomic neuropathy (CAN). However, little is known about the association of lipid profile with diabetic cardiovascular autonomic neuropathy (DCAN), or its severity in the Chinese population. The purpose of this study is to explore the extent of this phenomenon using a Chinese sample. A subgroup analysis on 455 diabetic patients with undiagnosed DCAN was performed to evaluate the relationships of lipids profile and DCAN. DCAN was diagnosed if there were at least two abnormal cardiovascular autonomic reflex test results, based on short-term heart rate variability tests. Multivariable logistic regression (MLR)was carried out to control potential confounders for determining the independent association of variables with DCAN in different models. MLR analysis indicated that TG was significantly and independently associated with DCAN when controlling for confounding factors (P < 0.1 for two models). Additionally, TG combined with TC (LRS-1) and LDL (LRS-2) was associated with this outcome (P < 0.1 for LRS-1 and LRS-2). Our findings indicate that TG and the severity of lipids profile is significantly and independently associated with DCAN, respectively.
Pharmacokinetics of once-daily etravirine without and with once-daily darunavir/ritonavir in antiretroviral-naive HIV type-1-infected adults.

A pharmacokinetic trial was conducted to evaluate the potential for once-daily etravirine in antiretroviral regimens without and with darunavir/ritonavir.



During this multicentre, open-label, Phase IIa trial, treatment-naive patients aged > or =18 years with HIV type-1 (HIV-1) received etravirine 400 mg once daily with tenofovir disoproxil fumarate/emtricitabine 300/200 mg once daily from days 1-14; on days 15-28, darunavir/ritonavir 800/100 mg once daily was added. On day 29, etravirine was discontinued and patients continued with the other medications to day 42. Serial blood sampling for etravirine pharmacokinetics was performed over 24 h on day 14 and 28; patients fasted for > or =10 h prior to these visits.



Of 23 enrolled patients (male 87%, Caucasian 39%), pharmacokinetic profiles for etravirine were available for 21 and 20 patients on day 14 and 28, respectively. The plasma concentration-time profile and pharmacokinetics for etravirine were unchanged with or without darunavir/ritonavir. The mean maximum plasma concentration (C(max)) was reached 4 h after administration and was 790 and 801 ng/ml on day 14 and 28, respectively; mean area under the plasma concentration-time curve (AUC) from before administration to 24 h after administration was 10,410 ng*h/ml on day 14 and 10,720 ng*h/ml on day 28. In a post-hoc analysis, etravirine C(max) was higher, minimum plasma concentration was lower and AUC was similar when compared with etravirine 200 mg twice daily.



Addition of darunavir/ritonavir to etravirine, all dosed once daily, did not have a clinically significant effect on the pharmacokinetics of etravirine. Findings support further investigation of etravirine 400 mg once daily in HIV-1-infected patients.
[Validity of self-reported diabetes and its determinants: evidences from the Bambuí study].

To assess the validity of self-reported diabetes and its determinants in the elderly.



Cross-sectional study including 1,492 subjects aged >or= 60 years, which corresponds to 86% of all residents in this age group living in the municipality of Bambuí, Southeastern Brazil, in 1997. The validity of self-reported diabetes was assessed comparing to diabetes mellitus defined by medical criteria (fasting glucose > 126 mg/dl or current treatment). Multivariate analysis was carried out to assess factors independently associated with sensitivity and specificity.



The prevalence of diabetes mellitus and self-reported diabetes were 14.5% and 11.7%, respectively. Sensitivity and specificity of self-reported diabetes were 57.1% (95% CI: 50.3;63.8) and 96.9% (95% CI: 94.7;97.0), respectively. Medical visits in the previous two years (PR=3.78), as well as 1-3 (PR=1.90) and > 4 years (PR=1.55) of schooling were positively and independently associated with sensitivity. Medical visits in the previous two years (PR= 0.96) and female sex (PR = 0.97) were negatively and independently associated with specificity.



The study results indicated that self-reported diabetes should not be either used to estimate the prevalence of diabetes mellitus or to identify individuals with the disease in the study population. Schooling and medical visits were determinants of the elderly awareness of being diabetics, indicating that these modifiable characteristics may play a role in secondary and tertiary prevention.
Reliability, validity and responsiveness of the cross-culturally adapted Italian version of the core outcome measures index (COMI) for the neck

Evaluation of the psychometric properties of a cross-culturally adapted questionnaire, the Core Outcome Measurement Index for neck pain (COMI-neck). The COMI-neck was cross-culturally adapted for the Italian language using established procedures. The following psychometric properties of the instrument were then assessed in patients with chronic neck pain undergoing rehabilitation: test–retest reliability (intraclass correlation coefficient, ICC); construct validity by comparing COMI-neck with the Neck Pain and Disability Scale, a numerical pain rating scale, and the EuroQol-Five Dimension (Pearson’s correlations); and responsiveness by means of Standardized Response Mean (SRM), unpaired t tests, and Receiver Operating Characteristics (ROC) curves. The questionnaire was completed by 103 subjects. The COMI-neck summary score displayed no relevant floor or ceiling effects. Test–retest reliability was excellent (ICC = 0.87). With one exception (symptom-specific well-being), the individual COMI items and the COMI summary score correlated to the expected extent with the scores of the reference questionnaires (r = 0.40–0.80). The mean change scores for the Italian COMI-neck differed significantly between patients with a good global outcome and those with a poor outcome (p = 0.002); SRM for the good outcome group was 1.23, and for the poor outcome group 0.40. ROC analysis revealed an area under the curve of 0.73 (95 % CI: 0.62–0.85). This study provides evidence that the Italian version of the COMI-neck is a valid and responsive questionnaire in the population of patients examined. Its use is recommended for clinical and research purposes.
The efficacy of pneumatic compression stockings in the prevention of pulmonary embolism after cardiac surgery.

Pneumatic compression stocking (PCS) devices have been introduced to decrease the incidence of postoperative deep venous thrombosis (DVT). However, their role in the prophylaxis against pulmonary embolism (PE) remains unclear. This study was undertaken to compare the prophylactic effectiveness of subcutaneous heparin (SCH) alone vs the combined use of PCS and SCH in the prevention of PE following cardiac surgery.



We studied 2,551 consecutive patients who underwent cardiac surgery over a 10-year period. They were randomly allocated to two groups. Group A included 1,196 patients who were treated with 5,000 U of SCH every 12 h and group B included 1,355 patients treated with a combined prophylactic regimen of PCS and SCH.



The diagnosis of PE was established in 69 patients by either high-probability ventilation perfusion scan, pulmonary angiogram, or autopsy. The incidence of PE in group A patients was 4% (48/1,196) and in group B was 1.5% (21/1,355). The concomitant use of bilateral PCS and SCH reduced the frequency of postoperative PE in 62% in comparison to the prophylaxis with SCH alone (p < 0.001).



These data suggest that the combined prophylactic method of bilateral PCS and SCH is superior to SCH alone in the prevention of PE after cardiac surgery.
Treatment Extension of Pegylated Interferon Alpha and Ribavirin Does Not Improve SVR in Patients with Genotypes 2/3 without Rapid Virological Response (OPTEX Trial): A Prospective, Randomized, Two-Arm, Multicentre Phase IV Clinical Trial

Although sofosbuvir has been approved for patients with genotypes 2/3 (G2/3), many parts of the world still consider pegylated Interferon alpha (P) and ribavirin (R) as standard of care for G2/3. Patients with rapid virological response (RVR) show response rates >80%. However, SVR (sustained virological response) in non-RVR patients is not satisfactory. Longer treatment duration may be required but evidence from prospective trials are lacking. A total of 1006 chronic HCV genotype 2/3 patients treated with P/R were recruited into a German HepNet multicenter screening registry. Of those, only 226 patients were still HCV RNA positive at week 4 (non-RVR). Non-RVR patients with ongoing response after 24 weeks P-2b/R qualified for OPTEX, a randomized trial investigating treatment extension of additional 24 weeks (total 48 weeks, Group A) or additional 12 weeks (total 36 weeks, group B) of 1.5 μg/kg P-2b and 800-1400 mg R. Due to the low number of patients without RVR, the number of 150 anticipated study patients was not met and only 99 non-RVR patients (n=50 Group A, n=49 Group B) could be enrolled into the OPTEX trial. Baseline factors did not differ between groups. Sixteen patients had G2 and 83 patients G3. Based on the ITT (intention-to-treat) analysis, 68% [55%; 81%] in Group A and 57% [43%; 71%] in Group B achieved SVR (p= 0.31). The primary endpoint of better SVR rates in Group A compared to a historical control group (SVR 70%) was not met. In conclusion, approximately 23% of G2/3 patients did not achieve RVR in a real world setting. However, subsequent recruitment in a treatment-extension study was difficult. Prolonged therapy beyond 24 weeks did not result in higher SVR compared to a historical control group.
Peripheral blood leukocyte telomere length and mortality among 64,637 individuals from the general population.

Short telomeres in peripheral blood leukocytes are associated with older age and age-related diseases. We tested the hypotheses that short telomeres are associated with both increased cancer mortality and all-cause mortality.



Individuals (n = 64637) were recruited from 1991 onwards from two Danish prospective cohort studies: the Copenhagen City Heart Study and the Copenhagen General Population Study. All had telomere length measured by quantitative polymerase chain reaction and the genotypes rs1317082 (TERC), rs7726159 (TERT), and rs2487999 (OBFC1) determined. The sum of telomere-shortening alleles from these three genotypes was calculated. We conducted Cox regression analyses and instrumental variable analyses using the allele sum as an instrument. All statistical tests were two-sided.



Among 7607 individuals who died during follow-up (0-22 years, median = 7 years), 2420 had cancer and 2633 had cardiovascular disease as causes of death. Decreasing telomere length deciles were associated with increasing all-cause mortality (P(trend) = 2*10(-15)). The multivariable-adjusted hazard ratio of all-cause mortality was 1.40 (95% confidence interval [CI] = 1.25 to 1.57) for individuals in the shortest vs the longest decile. Results were similar for cancer mortality and cardiovascular mortality. Telomere length decreased 69 base pairs (95% CI = 61 to 76) per allele for the allele sum, and the per-allele hazard ratio for cancer mortality was 0.95 (95% CI = 0.91 to 0.99). Allele sum was not associated with cardiovascular, other, or all-cause mortality.



Short telomeres in peripheral blood leukocytes were associated with high mortality in association analyses. In contrast, genetically determined short telomeres were associated with low cancer mortality but not with all-cause mortality.
Modulation of molecular imprints in the antigen-experienced B cell repertoire by rituximab.

Transient B cell depletion by rituximab has recently gained more importance in the treatment of rheumatic disorders. Nevertheless, little is known about the reemerging B cells. We analyzed dynamic changes in the repopulating B cells, particularly the postswitch B cells, and studied the mutational patterns of Ig genes in antigen-experienced B cells.



Five patients with active rheumatoid arthritis (RA) were treated with rituximab. In 3 patients, B cell receptor (BCR) gene analysis was performed before treatment and during B cell recovery using genomic DNA. In 2 patients, B cell subsets were studied during the early recovery phase using single-cell technology. For comparison, immunophenotyping of B cell subsets was performed.



Early B cell recovery was marked by a relatively expanded population of highly mutated B cells, which were correlated with B cells with a plasmablast phenotype on comparative immunophenotyping. Analysis of the mutational pattern in these cells revealed increased RGYW/WRCY (where R = A/G, Y = C/T, and W = A/T) hotspot targeting (44% before rituximab versus 59% after) and elevated ratios of replacement to silent mutations within the complementarity-determining regions in Ig genes (1.87 before rituximab versus 2.67 after; P < or = 0.0025).



Our findings show that rituximab leads to qualitative changes in the imprints of highly mutated, antigen-experienced BCRs, representing the result of selection, whereas molecular processes such as Ig V rearrangements are not affected by this treatment.
Effects of pioglitazone on visceral fat metabolic activity in impaired glucose tolerance or type 2 diabetes mellitus.

Excess visceral fat is associated with chronic systemic inflammation and cardiovascular complications. Pioglitazone has been reported to variably influence visceral fat volume; however, its effect on metabolic activity of the visceral fat remains uncharacterized.



The aim of this study was to assess the effects of pioglitazone on glucose metabolism of fat tissue by using (18)F-fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography imaging.



FDG-PET and computed tomography imaging were performed in 56 patients with impaired glucose tolerance or type 2 diabetes mellitus; lipid and glycemic profiles and inflammatory biomarkers were obtained in all patients. These patients were randomized to treatment with either pioglitazone or glimepiride for 16 weeks.



The metabolic activity of the visceral fat tissues as assessed by FDG uptake was expressed as a target-to-background ratio (TBR) of blood-normalized standardized uptake value.



The study was completed in 32 pioglitazone-treated and 21 glimepiride-treated patients (40 men and 13 women; mean age, 67.7 ± 8.1 y; body mass index, 25.0 ± 3.6 kg/m(2); glycated hemoglobin, 6.78 ± 0.70%). Both treatments were well-tolerated and comparably improved glycemic control. At baseline, visceral fat exhibited a higher TBR value than subcutaneous fat (0.55 ± 0.14 vs 0.30 ± 0.07, P < .001). Pioglitazone, but not glimepiride, significantly decreased the visceral fat volume (130.5 ± 53.0 to 122.1 ± 51.0 cm(2), P = .013) and TBR values (0.57 ± 0.16 to 0.50 ± 0.11, P = .007). Neither pioglitazone nor glimepiride treatment showed any effect on the volume or TBR values of subcutaneous fat. After 16 weeks of treatment with pioglitazone, reduction in visceral fat TBR was correlated to the increase in high-density lipoprotein cholesterol levels.



Our study indicated that pioglitazone decreased the visceral fat volume and its metabolic activity in patients with impaired glucose tolerance or type 2 diabetes mellitus. The beneficial effects of pioglitazone on visceral fat may be independent of its glucose-lowering effect.
A cross-sectional study of blood pressure control in hypertensive patients in general practice (the I-TARGET study)

Despite the availability of multiple effective antihypertensive drugs, hypertension control rates remain poor. The reasons for this are complex, but increasingly, physician inertia has been identified as a crucial factor. In this study we attempted to define the level of blood pressure (BP) control and reasons for not achieving control in a survey of selected general practices within South Africa.



This was a multi-centre, cross-sectional disease study involving 15 selected general practices throughout South Africa. Treated hypertensive patients over 18 years old were eligible for inclusion. The study was approved by Pharma Ethics, and after informed consent, consecutive hypertensive patients at the participating general practice centres were included, with each centre enrolling 30 patients.



A total of 451 patients, from 15 sites in South Africa, were entered in the study. The mean age of the patients was 60.7 years, 56.3% were female and 15.7% were current smokers. The BP was reduced by 26.4/17.6 mmHg (p < 0.001) in 220 patients with a documented initial BP. Co-morbidities were present in 322 (71.4%) patients and overall, 37.9% had more than one co-morbidity. Lifestyle modification was not uniformly applied, with only 46.1, 59.6 and 56.8% receiving advice about weight loss, exercise and diet, respectively. Less than a third (30.7%) of patients were on monotherapy, 42.8% were on two drugs (25.9% on fixed-drug combination and 16.9% on free combination) and 26.5% were on more than two agents. Most (86.9%) practitioners used either international or local guidelines to determine target BP. Overall, 61.2% of patients were at goal (BP < 140/90 mmHg). If a stricter target BP <or= 130/80 mmHg) is applied to patients with co-morbidities, as recommended by the guidelines, 60.6% of patients did not reach goal. Of the 175 patients not at target BP, there was no action plan in 22.9%, while 39.4% were advised to undertake lifestyle changes only.



Control rates were quite good in comparison with other surveys within and outside South Africa. However we were able to define several important deficiencies: there was evidence of physician inertia and also practitioners need to be more cognisant of local and international guidelines to optimise treatment.
Resection of heterotopic ossification of the hip in spinal cord injured patients

Twenty nine spinal cord injury patients were treated by resection of heterotopic ossification in 41 hips. The average follow-up period after surgery was 4.2 years. The mean time to surgery after injury was 82.1 months. The indications for surgery were seating problems, loss of function, pressure sores and pain. The average preoperative motion in flexion and extension was 21.95°, the average intraoperative motion was 94.51°. The average motion at follow-up evaluation was 82.68°. Clinical relevant recurrence occurred in three patients. Complications excluding recurrence occurred in 10 hips, including deep and superficial wound infections, fracture, aneurysm and pressure ulcer. The operation was followed by a specific regime of physiotherapy and radiation therapy.
Dermoscopic changes in acral melanocytic nevi during digital follow-up.

To investigate changes in dermoscopic patterns of acquired acral melanocytic nevi (AAMN) over time.



Retrospective analysis of digital dermoscopic follow-up of 230 AAMN located on acral volar skin.



Outpatient clinics at university dermatology departments.  A total of 230 AAMN located on the soles (n = 149), fingers (n = 62), and palms (n = 19), of 230 white subjects 14 years or younger (n = 81), 15 to 30 years (n = 72), and older than 30 years (n = 77).



Comparison of baseline and follow-up dermoscopic patterns.



Individual AAMN had a digital follow-up of 6 months (n = 59), 12 months (n = 74), 18 months (n = 44), and 24 months (n = 53). Baseline dermoscopic images showed the following patterns: parallel furrow (48.8%), latticelike (16.1%), fibrillar (10.9%), nontypical (10.9%), homogeneous (4.8%), globular (3.5%), transition (3.5%), and reticular (2.6%). Dermoscopic changes over time were observed in 42 of the 230 AAMN (18.3%), with the greatest frequency of changes occurring in patients 14 years or younger (23 of 81 lesions; 28.4%) (P = .005). The parallel furrow pattern (25.9%) showed more variations over time than other dermoscopic patterns (11.0%) (P = .004). The frequency of change increased linearly over time (P = .001). Four of 7 clinically regressing nevi showed a homogeneous pattern at the last examination.



Dermoscopic changes of AAMN are most common in subjects younger than 14 years. The parallel furrow pattern appears to be the dermoscopic pattern most subject to change, while the homogeneous pattern may be seen also in AAMN showing clinical and dermoscopic involution.
Reducing the time period of steady state does not affect the accuracy of energy expenditure measurements by indirect calorimetry.

Achievement of steady state during indirect calorimetry measurements of resting energy expenditure (REE) is necessary to reduce error and ensure accuracy in the measurement. Steady state is often defined as 5 consecutive min (5-min SS) during which oxygen consumption and carbon dioxide production vary by +/-10%. These criteria, however, are stringent and often difficult to satisfy. This study aimed to assess whether reducing the time period for steady state (4-min SS or 3-min SS) produced measurements of REE that were significantly different from 5-min SS. REE was measured with the use of open-circuit indirect calorimetry in 39 subjects, of whom only 21 (54%) met the 5-min SS criteria. In these 21 subjects, median biases in REE between 5-min SS and 4-min SS and between 5-min SS and 3-min SS were 0.1 and 0.01%, respectively. For individuals, 4-min SS measured REE within a clinically acceptable range of +/-2% of 5-min SS, whereas 3-min SS measured REE within a range of -2-3% of 5-min SS. Harris-Benedict prediction equations estimated REE for individuals within +/-20-30% of 5-min SS. Reducing the time period of steady state to 4 min produced measurements of REE for individuals that were within clinically acceptable, predetermined limits. The limits of agreement for 3-min SS fell outside the predefined limits of +/-2%; however, both 4-min SS and 3-min SS criteria greatly increased the proportion of subjects who satisfied steady state within smaller limits than would be achieved if relying on prediction equations.
Effect of Valerian in Preventing Neuropsychiatric Adverse Effects of Efavirenz in HIV-Positive Patients: A Pilot Randomized, Placebo-Controlled Clinical Trial.

Several neuropsychiatric adverse effects of efavirenz are known. Preventing these adverse effects may improve patients' adherence to antiretroviral therapy (ART).



To evaluate the efficacy and safety of valerian in preventing neuropsychiatric adverse effects of efavirenz in HIV-positive patients.



In this pilot randomized, double-blinded, placebo-controlled, clinical trial, 51 HIV-positive patients who were receiving efavirenz were recruited into the valerian (n = 25) or placebo (n = 26) group. Patients received valerian (530 mg) or placebo nightly 1 hour before sleep for 4 weeks. The neuropsychiatric status (sleep, anxiety, depression, suicidal thought, and psychosis) of patients was assessed at baseline and week 4 using validated questionnaires.



Sleep ( P ≤ 0.001) and anxiety ( P = 0.001) significantly improved in the valerian group compared with the placebo group. Dizziness was the most common complaint of patients in first days of the intervention. In the valerian and placebo groups, 92% and 84.6% of patients experienced dizziness, respectively ( P = 0.35). Nausea was the second common adverse effect that 84% and 76.9% of patients in the valerian and placebo groups experienced ( P = 0.39).



In the first 4 weeks of ART including efavirenz, valerian significantly improved sleep and anxiety in HIV-positive patients. Valerian may be considered as a potential option in preventing neuropsychiatric adverse effects of efavirenz in HIV-positive patients.