nils-herrmann/clean_scirepeval huggingface dataset:
Effectiveness of transcendental meditation on functional capacity and quality of life of African Americans with congestive heart failure: a randomized control study.

To evaluate the effectiveness of a Transcendental Meditation (TM) stress reduction program for African Americans with congestive heart failure (CHF).



Randomized, controlled study



We recruited 23 African American patients > or = 55 years of age who were recently hospitalized with New York Heart Association class II or III CHF and with an ejection fraction of < .40. Participants were randomized to either TM or health education (HE) group.



Primary outcome measure was six-minute walk test; secondary outcomes were generic and disease-specific health-related quality of life, quality of well being, perceived stress, Center for Epidemiologic Studies Depression Scale (CES-D), rehospitalizations, brain natriuretic peptide, and cortisol. Changes in outcomes from baseline to three and six months after treatment were analyzed by using repeated measures analysis of variance, covarying for baseline score.



For the primary outcome of functional capacity, the TM group significantly improved on the six-minute walk test from baseline to six months after treatment compared to the HE group (P = .034). On the secondary outcome measures, the TM group showed improvements in SF-36 subscales and total score on the Minnesota Living with Heart Failure scale. On the CES-D, the TM group showed significant decrease from baseline to six months compared to the HE group (P = .03). Also, the TM group had fewer rehospitalizations during the six months of followup.



Results indicate that TM can be effective in improving the quality of life and functional capacity of African American CHF patients. Further validation of outcomes is planned via a large, multicenter trial with long-term follow-up.
Cognitive and academic outcomes after pediatric liver transplantation: Functional Outcomes Group (FOG) results.

This multicenter study examined prevalence of cognitive and academic delays in children following liver transplant (LT). One hundred and forty-four patients ages 5-7 and 2 years post-LT were recruited through the SPLIT consortium and administered the Wechsler Preschool and Primary Scale of Intelligence, 3rd Edition (WPPSI-III), the Bracken Basic Concept Scale, Revised (BBCS-R), and the Wide Range Achievement Test, 4th edition (WRAT-4). Parents and teachers completed the Behavior Rating Inventory of Executive Function (BRIEF). Participants performed significantly below test norms on intelligence quotient (IQ) and achievement measures (Mean WPPSI-III Full Scale IQ = 94.7 ± 13.5; WRAT-4 Reading = 92.7 ± 17.2; WRAT-4 Math = 93.1 ± 15.4; p < 0001). Twenty-six percent of patients (14% expected) had 'mild to moderate' IQ delays (Full Scale IQ = 71-85) and 4% (2% expected) had 'serious' delays (Full Scale IQ ≤ 70; p < 0.0001). Reading and/or math scores were weaker than IQ in 25%, suggesting learning disability, compared to 7% expected by CDC statistics (p < 0.0001). Executive deficits were noted on the BRIEF, especially by teacher report (Global Executive Composite = 58; p < 0.001). Results suggest a higher prevalence of cognitive and academic delays and learning problems in pediatric LT recipients compared to the normal population.
The ratio of CRP to prealbumin levels predict mortality in patients with hospital-acquired acute kidney injury

Animal and human studies suggest that inflammation and malnutrition are common in acute kidney injury (AKI) patients. However, only a few studies reported CRP, a marker of inflammation, albumin, prealbumin and cholesterol, markers of nutritional status were associated with the prognosis of AKI patients. No study examined whether the combination of inflammatory and nutritional markers could predict the mortality of AKI patients.



155 patients with hospital-acquired AKI were recruited to this prospective cohort study according to RIFLE (Risk, Injury, Failure, Lost or End Stage Kidney) criteria. C-reactive protein (CRP), and the nutritional markers (albumin, prealbumin and cholesterol) measured at nephrology consultation were analyzed in relation to all cause mortality of these patients. In addition, CRP and prealbumin were also measured in healthy controls (n = 45), maintenance hemodialysis (n = 70) and peritoneal dialysis patients (n = 50) and then compared with AKI patients.



Compared with healthy controls and end-stage renal disease patients on maintenance hemodialysis or peritoneal dialysis, patients with AKI had significantly higher levels of CRP/prealbumin (p < 0.001). Higher level of serum CRP and lower levels of albumin, prealbumin and cholesterol were found to be significant in the patients with AKI who died within 28 days than those who survived >28 days. Similarly, the combined factors including the ratio of CRP to albumin (CRP/albumin), CRP/prealbumin and CRP/cholesterol were also significantly higher in the former group (p < 0.001 for all). Multivariate analysis (Cox regression) revealed that CRP/prealbumin was independently associated with mortality after adjustment for age, gender, sepsis and sequential organ failure assessment (SOFA, p = 0.027) while the others (CRP, albumin, prealbumin, cholesterol, CRP/albumin and CRP/cholesterol) became non-significantly associated. The hazard ratio was 1.00 (reference), 1.85, 2.25 and 3.89 for CRP/prealbumin increasing according to quartiles (p = 0.01 for the trend).



Inflammation and malnutrition were common in patients with AKI. Higher level of the ratio of CRP to prealbumin was associated with mortality of AKI patients independent of the severity of illness and it may be a valuable addition to SOFA score to independent of the severity of illness and it may be a valuable addition to SOFA score to predict the prognosis of AKI patients.
Autologous Umbilical Cord Blood Transfusion in Young Children With Type 1 Diabetes Fails to Preserve C-Peptide

We conducted an open-label, phase I study using autologous umbilical cord blood (UCB) infusion to ameliorate type 1 diabetes (T1D). Having previously reported on the first 15 patients reaching 1 year of follow-up, herein we report on the complete cohort after 2 years of follow-up.



A total of 24 T1D patients (median age 5.1 years) received a single intravenous infusion of autologous UCB cells and underwent metabolic and immunologic assessments.



No infusion-related adverse events were observed. β-Cell function declined after UCB infusion. Area under the curve C-peptide was 24.3% of baseline 1 year postinfusion (P < 0.001) and 2% of baseline 2 years after infusion (P < 0.001). Flow cytometry revealed increased regulatory T cells (Tregs) (P = 0.04) and naive Tregs (P = 0.001) 6 and 9 months after infusion, respectively.



Autologous UCB infusion in children with T1D is safe and induces changes in Treg frequency but fails to preserve C-peptide.
EFFECT OF NEBULIZED IPRATROPIUM ON THE HOSPITALIZATION RATES OF CHILDREN WITH ASTHMA

A BSTRACT  Anticholinergic medications such as ipratropium improve the pulmonary function of patients with acute exacerbations of asthma, but their effect on hospitalization rates is uncertain.  We conducted a randomized, double-blind, placebo-controlled study of 434 children (2 to 18 years old) who had acute exacerbations of moderate or severe asthma treated in the emergency department. All the children received a nebulized solution of albuterol (2.5 or 5 mg per dose, depending on body weight) every 20 minutes for three doses and then as needed. A corticosteroid (2 mg of prednisone or prednisolone per kilogram of body weight) was given orally with the second dose of albuterol. Children in the treatment group received 500 m g (2.5 ml) of ipratropium bromide with the second and third doses of albuterol; children in the control group received 2.5 ml of normal saline at these times.  Overall, the rate of hospitalization was lower in the ipratropium group (59 of 215 children [27.4 percent]) than in the control group (80 of 219 [36.5 percent], P=0.05). For patients with moderate asthma (indicated by a peak expiratory flow rate of 50 to 70 percent of the predicted value or an asthma score of 8 to 11 on a 15-point scale), hospitalization rates were similar in the two groups (ipratropium: 8 of 79 children [10.1 percent]; control: 9 of 84 [10.7 percent]). For patients with severe asthma (defined as a peak expiratory flow rate of <50 percent of the predicted value or an asthma score of 12 to 15), the addition of ipratropium significantly reduced the need for hospitalization (51 of 136 children [37.5 percent], as compared with 71 of 135 [52.6 percent] in the control group; P=0.02).  Among children with a severe exacerbation of asthma, the addition of ipratropium bromide to albuterol and corticosteroid therapy significantly decreases the hospitalization rate. ( 1998;339:1030-5.
The Accuracy of Clinician Perceptions of “Usual” Blood Pressure Control

The term “clinical inertia” is used to describe the failure to manage a chronic condition aggressively enough to bring it under control. The underlying mechanisms for clinical inertia remain poorly understood. To describe one potential mechanism for clinical inertia, seen through the lens of clinician responses to a computerized hypertension reminder. Cohort study. A total of 509 hypertensive patients from 2 primary care clinics in urban Veterans Health Administration (VA) Medical Centers. All patients had elevated blood pressure (BP) values that triggered a computerized reminder. Given a set of possible responses to the reminder, clinicians asserted at least once for each patient that medication adjustments were unnecessary because the BP was “usually well controlled”. Using recent BP values from the electronic medical record, we assessed the accuracy of this assertion. In most instances (57%), recent BP values were not well controlled, with the systolic BP (56%) much more likely to be elevated than the diastolic BP (13%). Eighteen percent of recent systolic BP values were 160 mmHg or greater. When clinicians asserted that the BP was “usually well controlled”, objective evidence frequently suggested otherwise. This observation provides insight into one potential mechanism underlying clinical inertia.
Haemodynamic interactions of a new calcium sensitizing drug levosimendan and captopril

Levosimendan in a new inodilator drug that sensitises troponin C in heart muscle cells to calcium, thus improving contractility. In previous studies, a single 2 mg intravenous dose of levosimendan increased cardiac output (CO) in healthy volunteers by about 40% and decreased pulmonary capillary wedge pressure in heart failure patients by 40–50%. The aim of the present, double-blind study was to evaluate the safety of concomitant use of levosimendan and an ACE-inhibiting drug.  The haemodynamic effects of levosimendan, given with or without captopril, were evaluated by using 2-dimensional echocardiography, repeated blood pressure measurements and by ambulatory ECG recordings. Twenty-four male patients with stable NYHA II-III heart failure (EF<40%) after a previous myocardial infarct were given, in randomised order, a single IV infusion of levosimendan or placebo. The infusions were repeated after 2 weeks treatment with upto 50 mg b.i.d. of captopril. Twelve patients received levosimendan 1 mg and twelve received 2 mg.  Mean CO was increased from 6.0 to 6.81·min−1 in patients receiving 1 mg levosimendan compared to placebo, but only from 6.3 to 6.51·min−1 in patients receiving 2 mg. The increase in CO was statistically significant when all levosimendan patients were compared to placebo. Heart rate did not change after either dose. Mean stroke volume increased significantly after 1 mg but not after 2 mg of levosimendan. The addition of captopril did not change the effects of levosimendan. No additional decrease in systolic or diastolic blood pressure was observed when levosimendan and captopril were given concomitantly.  It seems that concomitant treatment with captopril does not change the haemodynamic effects of levosimendan. No adverse haemodynamic interactions were seen.
Effect of thumb joint mobilization on pressure pain threshold in elderly patients with thumb carpometacarpal osteoarthritis.

This study evaluated the effects of Maitland's passive accessory mobilization on local hypoalgesia and strength in thumb carpometacarpal osteoarthritis (TCOA).



Twenty-eight patients between 70 and 90 years old with secondary TCOA were randomized into glide mobilization and sham groups. This study was designed as a double-blind, randomized controlled trial. Therapy consisted of Maitland's passive accessory mobilization of the dominant hand during 4 sessions over 2 weeks. We measured pressure pain threshold (PPT) at the trapeziometacarpal joint (TMJ), the tubercle of the scaphoid bone, and the unciform apophysis of the hamate bone by algometry. The tip and tripod pinch strength was also measured. Grip strength was measured by a grip dynamometer. Measurements were taken before treatment and after 1 week (first follow-up [FU]) and 2 weeks (second FU).



All values in sham group remained unchanged along the treatment period. In the treated group, the PPT in the TMJ was 3.85 ± 0.35 kg/cm(2), which increased after treatment to 3.99 ± 0.37 and was maintained at the same level during the first FU 3.94 ± 0.39 and second FU 4.74 ± 0.40. In contrast, we found no differences in PPT in the other studied structures after treatment. Similarly, tip, tripod pinch, and grip strength remained without change after treatment.



Passive accessory mobilization increased PPT in the TMJ; however, it did not increase motor function in patients with TCOA.
The respiratory health effects of nitrogen dioxide in children with asthma.

There is growing evidence that asthma symptoms can be aggravated or events triggered by exposure to indoor nitrogen dioxide (NO(2)) emitted from unflued gas heating. The impact of NO(2) on the respiratory health of children with asthma was explored as a secondary analysis of a randomised community trial, involving 409 households during the winter period in 2006 (June to September). Geometric mean indoor NO(2) levels were 11.4 μg · m(-3), while outdoor NO(2) levels were 7.4 μg · m(-3). Higher indoor NO(2) levels (per logged unit increase) were associated with greater daily reports of lower (mean ratio 14, 95% CI 1.12-1.16) and upper respiratory tract symptoms (mean ratio 1.03, 95% CI 1.00-1.05), more frequent cough and wheeze, and more frequent reliever use during the day, but had no effect on preventer use. Higher indoor NO(2) levels (per logged unit increase) were associated with a decrease in morning (-17.25 mL, 95% CI -27.63- -6.68) and evening (-13.21, 95% CI -26.03- -0.38) forced expiratory volume in 1 s readings. Outdoor NO(2) was not associated with respiratory tract symptoms, asthma symptoms, medication use or lung function measurements. These findings indicate that reducing NO(2) exposure indoors is important in improving the respiratory health of children with asthma.
Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial

Urinary incontinence (UI) affects half of patients hospitalised after stroke and is often poorly managed. Cochrane systematic reviews have shown some positive impact of conservative interventions (such as bladder training) in reducing UI, but their effectiveness has not been demonstrated with stroke patients.



We conducted a cluster randomised controlled feasibility trial of a systematic voiding programme (SVP) for the management of UI after stroke. Stroke services were randomised to receive SVP (n = 4), SVP plus supported implementation (SVP+, n = 4), or usual care (UC, n = 4).Feasibility outcomes were participant recruitment and retention. The main effectiveness outcome was presence or absence of UI at six and 12 weeks post-stroke. Additional effectiveness outcomes included were the effect of the intervention on different types of UI, continence status at discharge, UI severity, functional ability, quality of life, and death.



It was possible to recruit patients (413; 164 SVP, 125 SVP+, and 124 UC) and participant retention was acceptable (85% and 88% at six and 12 weeks, respectively). There was no suggestion of a beneficial effect on the main outcome at six (SVP versus UC: odds ratio (OR) 0.94, 95% CI: 0.46 to 1.94; SVP+ versus UC: OR: 0.62, 95% CI: 0.28 to 1.37) or 12 weeks (SVP versus UC: OR: 1.02, 95% CI: 0.54 to 1.93; SVP+ versus UC: OR: 1.06, 95% CI: 0.54 to 2.09).No secondary outcomes showed a strong suggestion of clinically meaningful improvement in SVP and/or SVP+ arms relative to UC at six or 12 weeks. However, at 12 weeks both intervention arms had higher estimated odds of continence than UC for patients with urge incontinence.



The trial has met feasibility outcomes of participant recruitment and retention. It was not powered to demonstrate effectiveness, but there is some evidence of a potential reduction in the odds of specific types of incontinence. A full trial should now be considered.
Image Quality of Cardiac Magnetic Resonance Imaging in Patients With an Implantable Cardioverter Defibrillator System Designed for the Magnetic Resonance Imaging Environment.

Recently, magnetic resonance (MR)-conditional implantable cardioverter defibrillator (ICD) systems have become available. However, associated cardiac MR image (MRI) quality is unknown. The goal was to evaluate the image quality performance of various cardiac MR sequences in a multicenter trial of patients implanted with an MR-conditional ICD system.



The Evera-MRI trial enrolled 275 patients in 42 centers worldwide. There were 263 patients implanted with an Evera-MRI single- or dual-chamber ICD and randomized to controls (n=88) and MRI (n=175), 156 of whom underwent a protocol-required MRI (9-12 weeks post implant). Steady-state-free-precession (SSFP) and fast-gradient-echo (FGE) sequences were acquired in short-axis and horizontal long-axis orientations. Qualitative and quantitative assessment of image quality was performed by using a 7-point scale (grades 1-3: good quality, grades 6-7: nondiagnostic) and measuring ICD- and lead-related artifact size. Good to moderate image quality (grades 1-5) was obtained in 53% and 74% of SSFP and FGE acquisitions, respectively, covering the left ventricle, and in 69% and 84%, respectively, covering the right ventricle. Odds for better image quality were greater for right ventricle versus left ventricle (odds ratio, 1.8; 95% confidence interval, 1.5-2.2; P<0.0001) and greater for FGE versus SSFP (odds ratio, 3.5; 95% confidence interval, 2.5-4.8; P<0.0001). Compared with SSFP, ICD-related artifacts on FGE were smaller (141±65 versus 75±57 mm, respectively; P<0.0001). Lead artifacts were much smaller than ICD artifacts (P<0.0001).



FGE yields good to moderate quality in 74% of left ventricle and 84% of right ventricle acquisitions and performs better than SSFP in patients with an MRI-conditional ICD system. In these patients, cardiac MRI can offer diagnostic information in most cases.
Low plasma citrulline levels are associated with acute respiratory distress syndrome in patients with severe sepsis

The role of nitric oxide synthase (NOS) in the pathophysiology of acute respiratory distress syndrome (ARDS) is not well understood. Inducible NOS is upregulated during physiologic stress; however, if NOS substrate is insufficient then NOS can uncouple and switch from NO generation to production of damaging peroxynitrites. We hypothesized that NOS substrate levels are low in patients with severe sepsis and that low levels of the NOS substrate citrulline would be associated with end organ damage including ARDS in severe sepsis.



Plasma citrulline, arginine and ornithine levels and nitrate/nitrite were measured at baseline in 135 patients with severe sepsis. ARDS was diagnosed by consensus definitions.



Plasma citrulline levels were below normal in all patients (median 9.2 uM, IQR 5.2 - 14.4) and were significantly lower in ARDS compared to the no ARDS group (6.0 (3.3 - 10.4) vs. 10.1 (6.2 - 16.6), P = 0.002). The rate of ARDS was 50% in the lowest citrulline quartile compared to 15% in the highest citrulline quartile (P = 0.002). In multivariable analyses, citrulline levels were associated with ARDS even after adjustment for covariates including severity of illness.



In severe sepsis, levels of the NOS substrate citrulline are low and are associated with ARDS. Low NOS substrate levels have been shown in other disease states to lead to NOS uncoupling and oxidative injury suggesting a potential mechanism for the association between low citrulline and ARDS. Further studies are needed to determine whether citrulline supplementation could prevent the development of ARDS in patients with severe sepsis and to determine its role in NOS coupling and function.
Body mass index and metabolic parameters in patients with schizophrenia during long-term treatment with paliperidone palmitate

There is a strong association between weight gain and metabolic events in patients with schizophrenia receiving many of the second-generation antipsychotic agents. We explored the relationship between body mass index (BMI) and metabolic events in patients with schizophrenia receiving long-acting injectable paliperidone palmitate (PP) in a long-term trial.



We conducted a post hoc analysis of data from a PP study that included a 33-week open-label transition (TR) and maintenance phase; a variable duration, randomized, double-blind (DB), placebo-controlled phase and a 52-week open-label extension (OLE) phase. Overall, 644 patients received PP continuously from study entry through discontinuation or study completion and were grouped by baseline BMI (kg/m2): underweight (BMI <19; n = 29, 4.5%), normal-weight (BMI 19- < 25; n = 229, 35.6%), overweight (BMI 25- < 30; n = 232, 36.0%) and obese (BMI ≥ 30; n = 154, 23.9%). Metabolic treatment-emergent adverse events (TEAEs) and changes in related laboratory results from TR baseline were analyzed.



PP exposure was similar across BMI groups; overall mean (SD) dose/month was 70.3 (17.17) mg eq. [109.6 (26.78) mg]; median duration of exposure was 204 days (6 to 1009 days). Occurrences of metabolic TEAEs overall by group were 0% (underweight), 14.9% (normal-weight), 14.7% (overweight), and 24.0% (obese). The most common (≥ 2%) metabolic TEAE were weight gain and elevated blood levels of glucose, lipids, and insulin. Mean BMI and weight increased in normal-weight and overweight groups at DB endpoint, and in underweight, normal-weight and overweight groups at OLE endpoint (p ≤ 0.05). No consistent trend for increased metabolic-related laboratory values by baseline BMI group was observed. Homeostatic model assessments for insulin resistance indicated preexisting insulin resistance at baseline, with minimal changes at OLE endpoint across baseline BMI groups.



Occurrences of metabolic-related TEAEs trended with greater BMI status in patients with schizophrenia treated with PP; consistent trends in metabolic-related laboratory values were not observed.