nils-herrmann/clean_scirepeval huggingface dataset:
Arterial stiffness in hypertensives in relation to expression of angiopoietin-1 and 2 genes in peripheral monocytes

Angiopoietins (Angs) are important angiogenic and endothelial cell growth factors with many functions, including influence on the vascular wall. Pulse-wave velocity (pwv) is an independent marker of cardiovascular adverse outcome in hypertensives, although all the pathophysiological mechanisms that affect it have not yet been determined. We investigated the relationship between arterial stiffness and Ang-1 and Ang-2 gene expression in the peripheral blood monocytes of hypertensive patients. We studied 53 patients who had untreated grade-1 or grade-2 essential hypertension and no indications of other organic heart disease. Carotid–femoral (c–f) and carotid–radial (c–r) artery waveforms were measured and pwv was determined. The monocytes were isolated using anti-CD14+ antibodies and mRNAs were estimated by real-time quantitative reverse transcription–PCR. Ang-1 gene expression was strongly correlated with both c–f-pwv (r=0.952, P<0.001) and c–r-pwv (r=0.898, P<0.001). Similarly, Ang-2 gene expression was significantly correlated with both c–f-pwv (r=0.471, P=0.002) and c–r-pwv (r=0.437, P=0.003). Our data provide important evidence that Ang-1 and Ang-2 gene expression levels in peripheral monocytes are closely related with pwv in patients with essential hypertension. This positive correlation may suggest a link between angiogenesis and arterial stiffness in those patients.
The Dutch multicenter experience of the Endo-Sponge treatment for anastomotic leakage after colorectal surgery

Anastomotic leakage is a feared complication following colorectal surgery and is associated with early and long-term morbidity and mortality. The presacral cavity as the result of leakage can be treated with an endo-sponge (B-Braun Medical). The aim of this study was to assess the effectiveness of endo-sponge treatment of the presacral cavity as the result of anastomotic leakage in the Netherlands. Between July 2006 and April 2008, 16 patients (M/F = 9:7) with median age 64 years (range 19–78 years) who underwent surgery for rectal cancer (n = 13) or ulcerative colitis (n = 3) were treated with the endo-sponge treatment after anastomotic leakage. Of the 16 patients, eight patients started with the endo-sponge treatment within 6 weeks after the initial surgery. In these patients the endo-sponge was placed after a median of 24 days (range 13–39 days) following surgery. In the remaining eight patients the endo-sponge treatment was started later than 6 weeks after the initial surgery. In this group there was a median of 74 days (range 43–1,602 days) between surgery and the start of endo-sponge placement. There was closure in six out of eight patients (75%) in the group that started with the endo-sponge treatment within 6 weeks of surgery compared with three out of eight patients (38%) in the group that started later (p = 0.315). Closure was achieved in a median of 40 (range 28–90) days with a median number of 13 sponge replacements (range 8–17). Endo-sponge placement can be helpful in the treatment for anastomotic leakage after colorectal surgery and might prevent a chronic presacral sinus. However, it is not yet clear if this new treatment modality results in quicker healing.
Effects of Multisensory Stimulation on a Sample of Institutionalized Elderly People With Dementia Diagnosis: A Controlled Longitudinal Trial.

Long-term effects of multisensory stimulation were assessed using a "Snoezelen" room on older residents with dementia. Thirty patients were randomly assigned to 3 groups: multisensory stimulation environment (MSSE) group, individualized activities (activity) group, and control group. The MSSE and activity groups participated in two 30-minute weekly individualized intervention sessions over 16 weeks. Pre-, mid-, posttrial, and 8-week follow-up behavior, mood, cognitive, and functional impairment in basic activities of daily living were registered. Items included in the physically nonaggressive behavior factor improved significantly in post- versus pretrial in the MSSE group compared to the activity group, with no significant differences between MSSE and control groups. The MSSE and activity groups demonstrated behavior improvements and higher scores on the Cohen-Mansfield agitation inventory, verbal agitated behavior factor, and Neuropsychiatric Inventory-Nursing Home, with no significant differences between groups. The MSSE could have long-term positive effects on such neuropsychiatric symptoms in older people with dementia.
A cluster randomised trial of a school-based resilience intervention to decrease tobacco, alcohol and illicit drug use in secondary school students: study protocol

Whilst schools provide a potentially appropriate setting for preventing substance use among young people, systematic review evidence suggests that past interventions in this setting have demonstrated limited effectiveness in preventing tobacco, alcohol and other drug use. Interventions that adopt a mental wellbeing approach to prevent substance use offer considerable promise and resilience theory provides one method to impact on adolescent mental well-being. The aim of the proposed study is to examine the efficacy of a resilience intervention in decreasing the tobacco, alcohol and illicit drug use of adolescents.



A cluster randomised controlled trial with schools as the unit of randomisation will be undertaken. Thirty two schools in disadvantaged areas will be allocated to either an intervention or a control group. A comprehensive resilience intervention will be implemented, inclusive of explicit program adoption strategies. Baseline surveys will be conducted with students in Grade 7 in both groups and again three years later when the student cohort is in Grade 10. The primary outcome measures will include self-reported tobacco, alcohol, marijuana and other illicit drug use. Comparisons will be made post-test between Grade 10 students in intervention and control schools to determine intervention effectiveness across all measures.



To the authors' knowledge this is the first randomised controlled trial to evaluate the effectiveness of a comprehensive school-based resilience intervention, inclusive of explicit adoption strategies, in decreasing tobacco, alcohol and illicit drug use of adolescents attending disadvantaged secondary schools.
A randomized prospective study on the use of 2 g-IVIG or 1 g-IVIG as therapy for Kawasaki disease

A single, 2 g/kg dose of immune globulin (IG), denoted 2 g-intravenous (IV)IG, has become a standard regimen for treating Kawasaki disease (KD) because of its highly preventive effect on coronary arterial lesions (CAL). However, IG is obtained from blood specimens, a drawback to many patients, and is also very expensive. This randomized prospective study reported here was carried out with the aim of developing a treatment regimen that would reduce the total dose of IG. The study tested two protocols (A: 2 g-IVIG; B: 1 g-IVIG) that included the strategy of administering additional IVIG to IVIG-resistant patients based on the criteria we described previously. In protocol A, an additional 2 g-IVIG was administered only once;  One hundred and nine patients who were admitted before the seventh day of illness and had no CAL at the time of admission were enrolled in the study ( patients; B: 55 patients). In the protocol A group, 7.4% (4/54) of the patients received 4 g/kg IG. In protocol B, 41.8% (23/55) were treated only with 1 g/kg IG, and 10.9% (6/55) received 4 g/kg IG. No significant differences were observed between the patients of the two subgroups receiving 4 g/kg IG in each protocol group. Discriminate analysis also suggested that 52.4% of the patients in the protocol A group could be treated only with 1 g/kg IG. On the other hand, no significant difference was observed in the incidence of aneurysms between patients in the protocol A group (1/54) and those in the protocol B group (4/55). Our protocol based on 1 g-IVIG, including additional IVIG, was assessed to be an effective treatment and to provide a considerably useful means to reduce the total dose of IG.
Phase III study comparing oxaliplatin plus S-1 with cisplatin plus S-1 in chemotherapy-naïve patients with advanced gastric cancer.

We evaluated the efficacy and safety of S-1 plus oxaliplatin (SOX) as an alternative to cisplatin plus S-1 (CS) in first-line chemotherapy for advanced gastric cancer (AGC).



In this randomized, open-label, multicenter phase III study, patients were randomly assigned to receive SOX (80-120 mg/day S-1 for 2 weeks with 100 mg/m(2) oxaliplatin on day 1, every 3 weeks) or CS (S-1 for 3 weeks with 60 mg/m(2) cisplatin on day 8, every 5 weeks). The primary end points were noninferiority in progression-free survival (PFS) and relative efficacy in overall survival (OS) for SOX using adjusted hazard ratios (HRs) with stratification factors; performance status and unresectable or recurrent (+adjuvant chemotherapy) disease.



Overall, 685 patients were randomized from January 2010 to October 2011. In per-protocol population, SOX (n = 318) was noninferior to CS (n = 324) in PFS [median, 5.5 versus 5.4 months; HR 1.004, 95% confidence interval (CI) 0.840-1.199; predefined noninferiority margin 1.30]. The median OS for SOX and CS were 14.1 and 13.1 months, respectively (HR 0.958 with 95% CI 0.803-1.142). In the intention-to-treat population (SOX, n = 339; CS, n = 337), the HRs in PFS and OS were 0.979 (95% CI 0.821-1.167) and 0.934 (95% CI 0.786-1.108), respectively. The most common ≥grade 3 adverse events (SOX versus CS) were neutropenia (19.5% versus 41.8%), anemia (15.1% versus 32.5%), hyponatremia (4.4% versus 13.4%), febrile neutropenia (0.9% versus 6.9%), and sensory neuropathy (4.7% versus 0%).



SOX is as effective as CS for AGC with favorable safety profile, therefore SOX can replace CS.
Biomarker-calibrated dietary energy and protein intake associations with diabetes risk among postmenopausal women from the Women's Health Initiative.

Self-report of dietary energy and protein intakes has been shown to be systematically and differentially underreported.



We assessed and compared the association of diabetes among postmenopausal women with biomarker-calibrated and uncalibrated dietary energy and protein intakes from food-frequency questionnaires (FFQs).



The analyses were performed for 74,155 participants of various race-ethnicities from the Women's Health Initiative. Uncalibrated and calibrated energy and protein intakes from FFQs were assessed for associations with incident diabetes by using HR estimates based on Cox regression.



A 20% increment in uncalibrated energy consumption was associated with increased diabetes risk (HR) of 1.03 (95% CI: 1.01, 1.05), 2.41 (95% CI: 2.06, 2.82) with biomarker calibration, and 1.30 (95% CI: 0.96, 1.76) after adjustment for BMI. A 20% increment in uncalibrated protein (g/d) resulted in an HR of 1.05 (95% CI: 1.03, 1.07), 1.82 (95% CI: 1.56, 2.12) with calibration, and 1.16 (95% CI: 1.05, 1.28) with adjustment for BMI. A 20% increment in uncalibrated protein density (% of energy from protein) resulted in an HR of 1.13 (95% CI: 1.09, 1.17), 1.01 (95% CI: 0.75, 1.37) with calibration, and 1.19 (95% CI: 1.07, 1.32) with adjustment for BMI.



Higher protein and total energy intakes (calibrated) appear to be associated with a substantially increased diabetes risk that may be mediated by an increase in body mass over time. Diet-disease associations without correction of self-reported measurement error should be viewed with caution.
Histological evaluation of drill fragments obtained during osteoid osteoma radiofrequency ablation

Osteoid osteoma (OO) is a benign bone tumor diagnosed mainly on the basis of the patient’s history and radiological data. Histological evaluation may not be available before treatment. The aim of this study was to assess the diagnostic value of a histological evaluation of the bone fragments obtained during radiofrequency ablation (RFA). During a 2-year period, 39 patients diagnosed clinically with OO were entered into this study. The procedure was performed under computed tomography (CT) guidance. An 11-gauge needle was initially placed as a coaxial guide. After drill removal, RFA was performed. Bone fragments collected from the drill were examined by two experienced pathologists, independently. There was strong association between pathologists’ reports (P <0.001). In 27 cases (69.2%) this diagnosis was confirmed pathologically. No significant relationship was found between nidus diameter and positive histological findings (P = 0.35). Histological confirmation of OO based on drill fragments is similarly frequent as previously reported for standard bone biopsy.
Long-term cardiovascular effects of insulin sensitizer troglitazone on non-diabetic individuals with insulin resistance: double blind, prospective randomized study.

The study was undertaken to assess the long-term cardiovascular effects of troglitazone on non-diabetic individuals with insulin resistance.



It has been suggested that treatment with troglitazone or similar insulin-sensitizing agents may prevent cardiovascular complications in non-diabetic individuals with insulin resistance. However, the long-term cardiovascular effects of these agents on non-diabetic individuals remain to be defined.



A total of 137 African-American offspring of type 2 diabetic parents, with normal glucose tolerance and insulin resistance, were randomly divided to receive troglitazone 200 mg/day (n = 40), or placebo (n = 97) for 24 months. Brachial artery blood pressure (sphygmomanometry); aortic pulse wave velocity (carotid to femoral artery, Doppler), left ventricular diameters and mass (echocardiography); ascending and abdominal aortic distensibility (echocardiography, blood pressure); and metabolic and lipid profile were assessed at baseline, 12, and 24 months after randomization (delta 12, delta 24 respectively).



The pulse wave velocity increased significantly in the troglitazone group compared to placebo group (p < 0.05). Changes from baseline in the troglitazone group were significant (delta 12 = 1.09 +/- 0.36 m/sec, delta 24 = 2.08 +/- 0.45 m/sec, ANOVA p < 0.001), while pulse wave velocity remained unchanged in the placebo group. This increase in pulse wave velocity is consistent with a decrease in the elastic properties of the aorta.



Long-term administration of troglitazone to non-diabetic African-Americans with insulin resistance was associated with a decrease in the elastic properties of the aorta. Long-term therapy with troglitazone or similar agents for the prevention of cardiovascular complications in non-diabetic individuals with insulin resistance has to be critically evaluated.
Renal and metabolic clearance of N-acetyl-seryl-aspartyl-lysyl-proline (AcSDKP) during angiotensin-converting enzyme inhibition in humans.

We investigated the contributions of angiotensin-converting enzyme (ACE) and glomerular filtration to creating the new metabolic balance of the hemoregulatory peptide N-acetyl-seryl-aspartyl-lysyl-proline (AcSDKP) that occurs during acute and chronic ACE inhibition in healthy subjects. We also studied the effect of chronic renal failure on the plasma concentration of AcSDKP during long-term ACE inhibitor (ACEI) treatment or in its absence. In healthy subjects, a single oral dose of 50 mg captopril (n=32) and a 7-day administration of 50 mg captopril BID (n=10) resulted in a respective 42-fold (range, 18- to 265-fold) and 34-fold (range, 24-fold to 45-fold) increase in the ratio of urinary AcSDKP to creatinine accompanied by a 4-fold (range, 2- to 6.8-fold) and 4.8-fold (range, 2.6- to 11.8-fold) increase in plasma AcSDKP levels. Changes in plasma AcSDKP and in vitro ACE activity over time showed an intermittent reactivation of ACE between each captopril dose. In subjects with chronic renal failure (creatinine clearance<60 mL/min per 1.73 m2), plasma AcSDKP levels were 22 times higher (95% confidence interval, 15 to 33) in the ACEI group (n=35) than the control group (n=23); in subjects with normal renal function, they were only 4.1 times higher (95% confidence interval, 3.2 to 5.3) in the ACEI group (n=19) than the non-ACEI group (n=21). Renal failure itself led to a slight increase in plasma AcSDKP concentration. In conclusion, intermittent reactivation of ACE between doses of an ACEI is the major mechanism accounting for the lack of major AcSDKP accumulation during chronic ACE inhibition in subjects with normal renal function.
Clinical Characteristics and Treatment Outcomes of Cryptogenic Multifocal Ulcerous Stenosing Enteritis in Korea

Cryptogenic multifocal ulcerous stenosing enteritis (CMUSE) is a rare disease that is characterized by multiple, recurring small intestinal ulcers with stenosis of unknown causes. The aim of this study was to investigate the clinical characteristics and the treatment outcomes of patients with CMUSE in Korea. We performed a multicenter study to retrospectively analyze clinical data from 20 patients who suffered from CMUSE between 1984 and 2012. Their clinical characteristics and long-term disease courses were investigated. The most common initial symptom of CMUSE was abdominal pain (14/20, 70 %). Small bowel series (13/20, 65 %), double-balloon enteroscopy (12/20, 60 %), CT enterography (12/20, 60 %), and capsule endoscopy (10/20, 50 %) were used to diagnose CMUSE. The strictures of the patients were located in the jejunum (5/20, 25 %), ileum (7/20, 35 %), and both jejunum and ileum (6/20, 30 %). The number of patients in a state of remission, persistent disease, and relapse at the end of follow-up were 13/20 (65 %), 2/20 (10 %), and 5/20 (25 %), respectively. The median relapse-free survival was of 67.1 months. Seventy-five percent relapse-free survivals for female and male patients were 93 and 9 months, respectively (P = 0.031). CMUSE is difficult to diagnose and is an easily relapsing disease. Female patients might have a better prognosis than male patients in terms of the relapse-free time.
Is fecal DNA testing superior to fecal occult-blood testing for colorectal cancer screening?

The study was conducted at 81 private practice and university-based sites between August 2001 and March 2003. All participants were at least 50 years old. Exclusion criteria included iron-deficiency anemia, coexisting visceral cancer, recent gastrointestinal bleeding, change in bowel habits or abdominal pain, previous CRC or polyps or colon resection; colono scopy, sigmoidoscopy or double-contrast barium enema within the previous 10 years, or positive FOBT within the previous 6 months. Individuals provided a fecal sample for DNA testing and then completed three Hemoccult II® cards for FOBT before screening colono scopy. DNA analysis was performed on stool samples from all evaluable patients with invasive cancer or advanced adenoma, and subgroups of subjects with minor polyps (n = 600) and no polyps (n = 1,400). All analysis was blinded to fecal sample DNA test results and screening colonoscopy. Is fecal DNA testing superior to fecal occult-blood testing for colorectal cancer screening?
Contribution of income to self-management and health outcomes in pediatric type 1 diabetes.

Low income has been established as a risk factor for poorer outcomes in youth with type 1 diabetes; however, the effect of moderate income has not been studied. The purpose of this secondary analysis of baseline data from a multi-site study was to compare glycemic control, self-management, and psychosocial outcomes [depression, stress, and quality of life (QOL)] at different income levels in adolescents with type 1 diabetes. Youth (n = 320, mean age = 12.3 + 1.1, 55% female, 64% white, mean A1C = 8.3 ± 1.4) completed established self-management and psychosocial measures. A1C levels were collected from medical records. Caregivers reported annual family income, categorized as high (>$80K), moderate ($40-80K), or low (<$40K). Youth from high-income families had significantly lower A1C (mean = 7.9 ± 1.2) than those from the moderate-income group (8.6 ± 1.7, p < 0.001) or the low-income group (mean A1C = 8.6 ± 1.5, p = 0.003). Youth from the high-income group reported significantly better diabetes problem solving and more self-management goals than those from the moderate- or low-income groups (both p < 0.01). Youth from the high-income group also reported significantly fewer symptoms of depression, lower levels of perceived stress, and better QOL than those in the moderate or low-income groups (all p < 0.05). Multivariate linear regression models were used to test psychological and behavioral predictors of A1C and QOL. Parents' education status (p < 0.05) and self-management activities (p < 0.01) were significant predictors of hemoglobin A1c, while income (p < 0.01) and self-management activities (p < 0.05) were significant predictors of QOL.
Efficacy and safety of ezogabine/retigabine as adjunctive therapy to specified single antiepileptic medications in an open-label study of adults with partial-onset seizures

To assess efficacy/tolerability of ezogabine (EZG)/retigabine (RTG) in combination with specified monotherapy antiepileptic drug (AED) treatments in adults with uncontrolled partial-onset seizures using a flexible dosing regimen.



NCT01227902 was an open-label, uncontrolled study of flexibly dosed EZG/RTG. Adults with partial-onset seizures must have been taking either carbamazepine/oxcarbazepine (CBZ/OXC), lamotrigine (LTG), levetiracetam (LEV), or valproic acid (VPA). The study comprised a screening/baseline phase, a 4-week titration phase (initiation on 150mg/day [50mg three times daily (TID)] with weekly increases of 150mg/day [50mg TID] over 4 weeks to 600mg/day), and a flexible dose evaluation (FDE) phase (optional weekly dose changes of 50-150mg/day, to an optimal daily dosage [300-1200mg/day]). The primary efficacy endpoint was percentage of patients experiencing a ≥50% reduction from baseline in partial seizure frequency (responder rate) during the treatment phase (titration and FDE phases). Safety and tolerability were also assessed.



Patients (N=203) were enrolled and received ≥1 dose of EZG/RTG. The dose of EZG/RTG prescribed most frequently during the treatment phase was 600mg/day for all AED groups. Responder rates during the treatment phase were: 40.0% (CBZ/OXC), 32.0% (LTG), 50.0% (LEV), and 56.9% (VPA). Treatment-emergent adverse events occurred in 82% (CBZ/OXC), 76% (LTG), 73% (LEV), and 67% (VPA) of patients; most were of mild-to-moderate intensity.



EZG/RTG was effective as adjunctive therapy to CBZ/OXC, LTG, LEV, and VPA, using a flexible dosing regimen, in adults with partial-onset seizures; safety and tolerability were consistent with that previously observed.