nils-herrmann/clean_scirepeval huggingface dataset:
Effects of losartan/hydrochlorothiazide treatment, after change from ARB at usual dosage, on blood pressure and various metabolic parameters including high-molecular weight adiponectin in Japanese male hypertensive subjects.

Losartan, an angiotensin II receptor blocker (ARB), has been reported to increase serum level of high-molecular weight (HMW) adiponectin, which has beneficial effects on insulin resistance and atherosclerosis. On the other hand, treatment with diuretics was reported to decrease the adiponectin level. In the present study, we investigated the effects of changing the treatment to losartan/hydrochlorothiazide (HCTZ) on blood pressure (BP) and various metabolic parameters in Japanese male hypertensive subjects. This study included 15 subjects whose therapy was changed from a usual dosage of ARB to losartan 50mg/HCTZ 12.5mg daily, and also 14 subjects who continued losartan treatment (50mg/day). Serum HMW-adiponectin concentration was assayed using a commercially available HMW-specific ELISA kit. In the losartan/HCTZ patient group, systolic/diastolic BP decreased from 146/95 to 130/84 mmHg (P = 0.0012 for both). The HbA1c level tended to increase from 5.44 ± 0.39 to 5.55 ± 0.44% (P = 0.0554) and serum creatinine level slightly increased from 0.82 ± 0.12 to 0.87 ± 0.12 mg/dl (P = 0.0015). In contrast, serum TG (125 ± 77 to 149 ± 112 mg/dl), uric acid, and HMW-adiponectin levels (3.24 ± 2.97 to 3.36 ± 2.43 μg/ml) were unchanged. In the 14 patients who continued losartan treatment, systolic/diastolic BP was unchanged from 134/86 to 129/80 mmHg. The HbA1c level tended to increase from 5.26 ± 0.63 to 5.39 ± 0.71% (P = 0.0880), serum creatinine and uric acid levels were unchanged, serum lipids tended to improve, and serum HMW-adiponectin levels increased from 3.03 ± 1.06 to 3.46 ± 1.28 μg/ml (P = 0.0105). In summary, changing treatment to losartan/HCTZ, when changed from a usual dosage of ARB, exerted good BP control, while the HMW-adiponectin level was unchanged in male hypertensive subjects.
Time to improvement of pain and sleep quality in clinical trials of pregabalin for the treatment of fibromyalgia.

To determine the time to immediate and sustained clinical improvement in pain and sleep quality with pregabalin in patients with fibromyalgia.



A post hoc analysis of four 8- to 14-week phase 2-3, placebo-controlled trials of fixed-dose pregabalin (150-600 mg/day) for fibromyalgia, comprising 12 pregabalin and four placebo treatment arms.



A total of 2,747 patients with fibromyalgia, aged 18-82 years.



Pain and sleep quality scores, recorded daily on 11-point numeric rating scales (NRSs), were analyzed to determine time to immediate improvement with pregabalin, defined as the first of ≥2 consecutive days when the mean NRS score was significantly lower for pregabalin vs placebo in those treatment arms with a significant improvement at endpoint, and time to sustained clinical improvement with pregabalin, defined as a ≥1-point reduction of the baseline NRS score of patient responders who had a ≥30% improvement on the pain NRS, sleep NRS, or Fibromyalgia Impact Questionnaire (FIQ) from baseline to endpoint, or who reported "much improved" or "very much improved" on the Patient Global Impression of Change (PGIC) at endpoint.



Significant improvements in pain and sleep quality scores at endpoint vs placebo were seen in 8/12 and 11/12 pregabalin treatment arms, respectively (P < 0.05). In these arms, time to immediate improvements in pain or sleep occurred by day 1 or 2. Time to sustained clinical improvement occurred significantly earlier in pain, sleep, PGIC, and FIQ responders (P < 0.02) with pregabalin vs placebo.



Both immediate and sustained clinical improvements in pain and sleep quality occurred faster with pregabalin vs placebo.
Effect of a long-term oral l-arginine supplementation on glucose metabolism: a randomized, double-blind, placebo-controlled trial.

This study assessed the efficacy of long-term l-arginine (l-arg) therapy in preventing or delaying type 2 diabetes mellitus.



A mono-centre, randomized, double-blind, parallel-group, placebo-controlled, phase III trial (l-arg trial) was conducted on 144 individuals affected by impaired glucose tolerance (IGT) and metabolic syndrome (MS). l-Arg/placebo was administered (6.4 g/day) on a background structured lifestyle intervention for 18 months plus a 12-month extended follow-up period after study drug termination. Fasting glucose levels and glucose tolerance after oral glucose tolerance test were evaluated throughout the study.



After 18 months, l-arg as compared with placebo did not reduce the cumulative incidence of diabetes [21.4 and 20.8%, respectively, hazard ratio (HR), 1.04; 95% confidence interval (CI), 0.58-1.86] while the cumulative probability to become normal glucose tolerant (NGT) increased (42.4 and 22.1%, respectively, HR, 2.60; 95% CI, 1.51-4.46, p < 0.001). The higher cumulative probability to become of NGT was maintained during the extended period in subjects previously treated with l-arg (HR, 3.21; 95% CI, 1.87-5.51; p < 0.001). At the end of the extended period, the cumulative incidence of diabetes in subjects previously treated with l-arg was reduced as compared with placebo (27.2 and 47.1%, respectively, HR, 0.42; 95% CI, 0.24-0.75, p < 0.05). During both periods, l-arg significantly improved insulin sensitivity and β-cell function.



Among persons with IGT and MS, the supplementation of l-arg for 18 months does not significantly reduce the incidence of diabetes but does significantly increase regression to NGT.
Involvement of calcitonin gene-related peptide in migraine: regional cerebral blood flow and blood flow velocity in migraine patients

Calcitonin gene-related peptide (CGRP)-containing nerves are closely associated with cranial blood vessels. CGRP is the most potent vasodilator known in isolated cerebral blood vessels. CGRP can induce migraine attacks, and two selective CGRP receptor antagonists are effective in the treatment of migraine attacks. It is therefore important to investigate its mechanism of action in patients with migraine. We here investigate the effects of intravenous human alpha-CGRP (hαCGRP) on intracranial hemodynamics. In a double-blind, cross-over study, the effect of intravenous infusion of hαCGRP (2 μg/min) or placebo for 20 min was studied in 12 patients with migraine without aura outside attacks. Xenon-133 inhalation SPECT-determined regional cerebral blood flow (rCBF) and transcranial Doppler (TCD)-determined blood velocity (Vmean) in the middle cerebral artery (MCA), as well as the heart rate and blood pressure, were the outcome parameters. No change of rCBF was observed at the end of infusion [1.2% ± 1.7 with hαCGRP, vs. −1.6% ± 3.1 with placebo (mean ± SD)] (P = 0.43). Vmean in MCA decreased to 13.5% ± 3.6 with hαCGRP versus 0.6% ± 1.8 with placebo (P < 0.005). Since rCBF was unchanged, this indicates a dilation of the MCA. hαCGRP induced a decrease in MAP (12%) (P < 0.005) and an increase in heart rate (58%) (P < 0.0001). CGRP dilates cerebral arteries, but the effect is so small that it is unlikely to be the only mechanism of CGRP-induced migraine.
Longitudinal investigation of adenovirus 36 seropositivity and human obesity: the Cardiovascular Risk in Young Finns Study

Adenovirus-36 (Adv-36) infection is associated with exaggerated adipogenesis in cell culture and the development of obesity in animal models and humans, but a causal relationship remains unproven. Our objective was to determine whether serological evidence of Adv-36 infection in childhood and/or adulthood is associated with adult obesity.Paired plasma concentrations of Adv-36 antibodies were measured by a novel enzyme-linked immunosorbent assay in a subgroup (n=449) of the Cardiovascular Risk in Young Finns Study in childhood (mean age 11.9 years) and adulthood (mean age 41.3 years). The study group included (1) individuals who had maintained normal-weight status (2) those who became obese adults from a normal-weight status in childhood and (3) those that were overweight/obese as a child and obese as an adult.Mean (s.d.) time between baseline and follow-up was 29.4 (3.2) years (range 21–31 years). A total of 24.4% of individuals who were normal weight throughout life were seropositive for Adv-36 during child and/or adulthood as compared with 32.3% of those who became obese adults (P=0.11). Those who became obese in adulthood were more likely to be Adv-36 seropositive as adults compared with those who maintained normal weight (21.3% vs 11.6%, P=0.02). This difference was mediated by a decline in Adv-36 seropositivity between child and adulthood in those maintaining normal weight. No differences were observed in body mass index across the life course, nor in waist circumference in adult life, between those who were Adv-36 seronegative or seropositive at any age.Individuals who gained weight across the life course were more likely to be Adv-36 seropositive in adult life than those who did not gain weight. However, analysis of change in weight status in relation to Adv-36 positivity did not support a causal role for Adv-36 in the development of obesity.
Redefining renal dysfunction in trauma: implementation of the Acute Kidney Injury Network staging system.

Acute renal failure (ARF) in trauma patients is associated with high mortality rates. There is currently no consensus definition for renal failure, however, the American College of Surgeons' Committee on Trauma (ACSCOT) defines ARF as a serum creatinine > or =3.5, blood urea nitrogen > 100, or renal replacement therapy. We hypothesize that by using the Acute Kidney Injury Network (AKIN) staging system we would identify smaller changes in renal function that may impact outcome, and may serve as a marker for mortality and other organ dysfunction.



We retrospectively identified all trauma patients admitted to the surgical intensive care unit (SICU) for >48 hours during a 3-year period ending December 2007. Hourly urine output, serum creatinine, demographic data, trauma scores, admission vital signs, ICU and hospital length of stay, need for renal replacement therapy, organ failure, and death were collected and were stratified according to AKIN and ACSCOT renal dysfunction criteria. Trauma patients admitted to the SICU who did not develop renal dysfunction were used as controls.



A total of 571 patients were studied. Of those, only 17 patients (3.0%) were classified as having ARF by the ACSCOT criteria, whereas 170 (29.8%) had kidney injury using the AKIN criteria (146, stage 1; 15, stage 2; 9, stage 3). Compared with patients admitted to the ICU for > or =48 hours with normal renal function, patients meeting AKIN criteria had longer hospital and ICU length of stay (p < 0.001). Patients meeting AKIN criteria also had an increased incidence of multiple organ failure and death (p < 0.03).



Stratification using the AKIN criteria for acute kidney injury identifies an increased number of patients with renal dysfunction compared with the current ACSCOT criteria. Importantly, these patients have an increased risk of multiple organ failure and death. Inclusion into the AKIN criteria may be a marker for later morbidity and mortality.
Effects of recombinant interleukin-2 and revaccination for hepatitis B in previously vaccinated, non-responder, chronic uraemic patients. Collaborative Group of Girona.

Growing evidence suggests that it is possible to seroconvert chronic renal failure patients who are absolute non-responders to hepatitis B vaccine by means of either additional booster vaccine doses or associated IL-2 administration or both. We have studied the possibilities of hepatitis B seroconversion by revaccination and its dependence on vaccine dose, and the effects of a concurrent low-dose rHuIL-2 regime.



Forty known absolute non-responders with chronic renal failure were entered into a complete revaccination protocol. Patients were randomly assigned to two dosage groups of either 20 or 40 micrograms hepatitis B vaccine administered at 0, 1, 2 and 6 months. Further randomly selected patients from each dosage group were given 500,000 U of rHuIL-2 in the same deltoid area 4 h after vaccine administration.



Sixty-seven per cent of patients revaccinated with 40 micrograms attained antibody protecting levels compared to only 20% of those receiving doses of 20 micrograms (P < 0.025). When compared with initial values, the ThCD4/CD25 cell count was significantly reduced immediately after HuR-IL2 administration (P < 0.003) and significantly increased 1 month after the last dose was given (P < 0.0003). A definite rHuIL-2 effect on HBV antibody synthesis could not be demonstrated, nor was erythropoietin found to enhance seroconversion.



From these results we suggest that more intense and frequent antigenic stimulation as obtained by revaccination using four doses of 40 micrograms may effectively reduce the pool of hepatitis B vaccine nonresponders in chronic renal failure patients.
Disability and back muscle fatigability changes following two therapeutic exercise interventions in participants with recurrent low back pain

The level of disability and endurance of back muscles have been investigated, but there is conflicting evidence following specific exercise interventions for participants with recurrent low back pain (LBP). The purpose of this study was to compare the level of disability and slope of median frequency (MF) of thoracic and lumbar erector spinae (ES) muscles following core stabilization exercise (CSE) and spinal flexibility exercise (SFE).



In total, 46 individuals participated in this study. There were 25 participants in the CSE intervention group (average age of 47.7 ± 8.9 years) and 21 participants in the SFE group (average age of 53.1 ± 9.0 years). Each group participated in the specific exercise intervention program for 4 weeks while maintaining their current activity and/or exercise levels. The Oswestry Disability Index (ODI) was used to measure the level of disability changes. The fatigability of the ES back muscles was measured by the slope of MF, using a modified Sorensen test.



The disability level decreased significantly following CSE intervention (t=2.23, p<0.05). However, there was no significant difference in muscle fatigability changes in the 4-week intervention period for either group.



The CSE intervention reduced disability level following the 4-week intervention period. Further studies are needed to investigate the effectiveness of specific back muscle exercises in longer intervention periods for back muscle fatigability.
Early prediction of hepatitis C virus (HCV) infection relapse in nonresponders to primary interferon therapy by means of HCV RNA whole-blood analysis.

Routine analysis of serum and/or plasma specimens for hepatitis C virus (HCV) RNA does not always correctly reflect the response to antiviral therapy. Analysis of whole-blood specimens for detection of viral RNA should provide more-accurate prognostic information.



Whole-blood, serum, and plasma specimens (268 sample sets) were obtained from 56 patients who did not respond to initial interferon (IFN)- alpha 2b monotherapy (5 MU every 2 days for 3 months). Specimens were analyzed for HCV RNA by 4 different types of reverse-transcriptase polymerase chain reaction (RT-PCR) (Roche], LightCycler real-time PCR [Roche], and 2 in-house RT-PCRs) to determine whether specimen type can predict the rate of virologic response to high-dose treatment with IFN (10 MU every 2 days) and ribavirin (1-1.2 g/day).



Of the 56 patients who provided specimens, serum and plasma obtained from 18 tested negative for HCV RNA at the end of treatment, indicating a complete virologic response. In contrast, analysis of whole-blood specimens obtained at the same time revealed the presence of viral RNA in 12 of these 18 patients. All 12 subjects had relapse of HCV in serum and plasma: 11 relapsed a median of 4 weeks after the end of treatment, and 1 relapsed 20 weeks after the end of treatment. None of these 12 patients--all of whom consistently had whole-blood specimens that tested positive and plasma and serum specimens that tested negative for HCV RNA up to 20 weeks before the end of treatment--showed a sustained virologic response (P=.0002).



Results of whole-blood tests for detection of HCV RNA were highly predictive of viral relapse (positive predictive value, 100%) and thus may be useful tools for monitoring and tailoring IFN/ribavirin therapy. Testing of only serum or plasma specimens underestimates the true circulating HCV load and leads to an overestimation of antiviral response rates.
Embryonic Hematopoietic Progenitor Cells Reside in Muscle before Bone Marrow Hematopoiesis

In mice, hematopoietic cells home to bone marrow from fetal liver prenatally. To elucidate mechanisms underlying homing, we performed immunohistochemistry with the hematopoietic cell marker c-Kit, and observed c-Kit(+) cells localized inside muscle surrounding bone after 14.5 days post coitum. Flow cytometric analysis showed that CD45(+) c-Kit(+) hematopoietic cells were more abundant in muscle than in bone marrow between 14.5 and 17.5 days post coitum, peaking at 16.5 days post coitum. CD45(+) c-Kit(+) cells in muscle at 16.5 days post coitum exhibited higher expression of Gata2, among several hematopoietic genes, than did fetal liver or bone marrow cells. Colony formation assays revealed that muscle hematopoietic cells possess hematopoietic progenitor activity. Furthermore, exo utero transplantation revealed that fetal liver hematopoietic progenitor cells home to muscle and then to BM. Our findings demonstrate that hematopoietic progenitor cell homing occurs earlier than previously reported and that hematopoietic progenitor cells reside in muscle tissue before bone marrow hematopoiesis occurs during mouse embryogenesis.
Different fever definitions and the rate of fever and neutropenia diagnosed in children with cancer: a retrospective two-center cohort study.

The definition of fever, and thus fever and neutropenia (FN), varies between different pediatric oncology centers. Higher temperature limit should reduce FN rates, but may increase rates of FN with complications by delaying therapy. This study determined if different fever definitions are associated with different FN rates.


PROCEDURE
Two pediatric oncology centers had used three fever definitions in 2004-2011: ear temperature ≥38.5 °C persisting ≥2 hours (low definition); axillary temperature ≥38.5 °C ≥ 2 hours or ≥39.0 °C once (middle); and ear temperature ≥39.0 °C once (high). Clinical information was retrospectively extracted from charts. FN rates were compared using mixed Poisson regression.



In 521 pediatric patients with cancer, 783 FN were recorded during 6,009 months cumulative chemotherapy exposure time (501 years; rate, 0.13/month [95% CI, 0.12-0.14]), 124 of them with bacteremia (16%; 0.021/month [0.017-0.025]). In univariate analysis, the high versus low fever definition was associated with a lower FN rate (0.10/month [0.08-0.11] vs. 0.15/month [0.13-0.16]; rate ratio, 0.66 [0.45-0.97]; P = 0.036), the middle definition was intermediate (0.13/month [0.11-0.15]). This difference was not confirmed in multivariate analysis (rate ratio, 0.94 [0.67-1.33]; P = 0.74). The high versus low definition was not associated with an increased rate of FN with bacteremia (multivariate rate ratio, 1.39 [0.53-3.62]; P = 0.50).



A higher fever definition was not associated with a lower FN rate, nor with an increased rate of FN with bacteremia. These may be false negative findings due to methodological limitations. These questions, with their potential impact on health-related quality of life, and on costs, need to be assessed in prospective studies.
Diagnostic and prognostic stratification in the emergency department using urinary biomarkers of nephron damage: a multicenter prospective cohort study.

This study aimed to determine the diagnostic and prognostic value of urinary biomarkers of intrinsic acute kidney injury (AKI) when patients were triaged in the emergency department.



Intrinsic AKI is associated with nephron injury and results in poor clinical outcomes. Several urinary biomarkers have been proposed to detect and measure intrinsic AKI.



In a multicenter prospective cohort study, 5 urinary biomarkers (urinary neutrophil gelatinase-associated lipocalin, kidney injury molecule-1, urinary liver-type fatty acid binding protein, urinary interleukin-18, and cystatin C) were measured in 1,635 unselected emergency department patients at the time of hospital admission. We determined whether the biomarkers diagnosed intrinsic AKI and predicted adverse outcomes during hospitalization.



All biomarkers were elevated in intrinsic AKI, but urinary neutrophil gelatinase-associated lipocalin was most useful (81% specificity, 68% sensitivity at a 104-ng/ml cutoff) and predictive of the severity and duration of AKI. Intrinsic AKI was strongly associated with adverse in-hospital outcomes. Urinary neutrophil gelatinase-associated lipocalin and urinary kidney injury molecule 1 predicted a composite outcome of dialysis initiation or death during hospitalization, and both improved the net risk classification compared with conventional assessments. These biomarkers also identified a substantial subpopulation with low serum creatinine at hospital admission, but who were at risk of adverse events.



Urinary biomarkers of nephron damage enable prospective diagnostic and prognostic stratification in the emergency department.
The influence of cardiac rehabilitation on inflammation and metabolic syndrome in women with coronary heart disease.

Metabolic syndrome (MetS) and increased inflammatory markers, both predictors of future cardiovascular events, are more prevalent in women with coronary heart disease (CHD). The influence of cardiac rehabilitation (CR) on MetS and inflammatory biomarkers is not well characterized for women.



: The purpose of this article was to examine the effects of a 12-week behaviorally enhanced CR exclusively for women compared with traditional CR on components of the MetS and inflammatory markers in women with CHD.



The randomized clinical trial used 2 treatment groups, both receiving a comprehensive 12-week CR program, with 1 group receiving a motivationally enhanced intervention exclusively for women. A subset of 91 women (mean age, 61.6 years) from the parent study provided serum samples to examine the effects of CR on high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-alpha), and intercellular adhesion molecule-1 (ICAM-1).



After CR, the total sample of women demonstrated significant reductions in hsCRP (P =.002), IL-6 (P <.001), TNF-alpha (P =.010), and ICAM-1 (P =.016). Women in the gender-tailored CR program significantly improved all biomarker levels compared with baseline (P <.05 for all), whereas those in the traditional group improved only hsCRP (P <.05) and IL-6 (P <.05) levels. The combined study group demonstrated improvements in several components of MetS (triglycerides, waist circumference, and systolic blood pressure) but not in others (high-density lipoprotein cholesterol, fasting glucose, and diastolic blood pressure).



Cardiac rehabilitation promotes greater improvements in inflammatory biomarkers than in components of MetS for women with CHD. Improvements in body composition or weight may not be a precondition for the benefits of exercise because of loss of abdominal fat. Examining components of MetS as continuous variables is recommended to prevent lost information inherent in dichotomization.