nils-herrmann/clean_scirepeval huggingface dataset:
Early Diastolic Strain Rate in Relation to Systolic and Diastolic Function and Prognosis in Aortic Stenosis.

This study examined the impact of early mitral inflow velocity-to-early diastolic strain rate (E/SRe) ratio on long-term outcome after aortic valve replacement (AVR) in aortic stenosis (AS).



In AS, increased filling pressures are associated with a poor prognosis and can be estimated using the early diastolic mitral inflow velocity-to-early diastolic velocity of the mitral annulus (E/e') ratio. Recent studies suggest that the E/SRe ratio surpasses the E/e' ratio in estimating outcome.



Pre-operative evaluation was performed in 121 patients with severe AS (aortic valve area <1 cm(2)) and left ventricular ejection fraction (LVEF) of >40% who were scheduled for AVR. Patients were divided according to E/SRe median and followed for 5 years. The primary endpoint was overall mortality.



LVEF was lower (53 ± 7% vs. 56 ± 7%, respectively; p = 0.03) and a restrictive filling pattern more common (28% vs. 8%, respectively, p = 0.005) in patients with increased E/SRe ratio. Five-year overall mortality was increased in patients with high E/SRe (40% vs. 15%, respectively; p = 0.007). In univariate Cox regression analysis, E/SRe, age, European System for Cardiac Operative Risk Evaluation (EuroSCORE), LV mass index, left atrial volume index, LVEF, global longitudinal strain, E/e' ratio, and N-terminal pro-B-type natriuretic peptide level were univariate predictors of overall mortality, although when we adjusted for the predefined variables age, history of diabetes mellitus and LVEF, only E/SRe and left atrial volume index remained associated with overall mortality. Even when we included left atrial volume index in the multivariate model, E/SRe was significantly associated with overall mortality (hazard ratio [HR]: 2.2; 95% confidence interval [CI]: 1.1 to 4.4; p < 0.05); additionally, in a model with forward selection, E/SRe was the sole predictor (HR: 2.9; 95% CI: 1.6 to 5.5; p = 0.001. The overall log likelihood chi-square analysis of the predictive power of the multivariate model containing E/SRe was statistically superior to models based on the E/e' ratio.



Pre-operative E/SRe ratio was significantly associated with long-term post-operative survival and was superior to the E/e' ratio in patients with severe AS undergoing AVR.
Systemic absorption of oral vancomycin in patients with Clostridium difficile infection.

Oral vancomycin is utilized in the treatment of severe Clostridium difficile infection (CDI). We prospectively measured serum vancomycin concentrations (SVC) in patients treated with oral vancomycin. The SVC was measured by immunoassay prior to, and at least 3 days after, the administration of oral vancomycin 125 mg every 6 h. Patients treated with intravenous vancomycin were excluded. Fifty-seven patients with a mean age of 74 y (± 18) were enrolled. There was no detectable SVC in 56 patients (98%); 1 patient had a transient SVC of 6.7 μg/ml that was not detectable on subsequent testing. The severity of the CDI and/or renal failure did not have an effect on SVC. Orally administered vancomycin at 125 mg 4 times daily was not absorbed from the gastrointestinal tract.
Predictors of acceptance of offered care management intervention services in a quality improvement trial for dementia.

Care management approaches have been proven to improve outcomes for patients with dementia and their family caregivers (dyads). However, acceptance of services in these programs is incomplete, impacting effectiveness. Acceptance may be related to dyad as well as healthcare system characteristics, but knowledge about factors associated with program acceptance is lacking. This study investigates patient, caregiver, and healthcare system characteristics associated with acceptance of offered care management services.



This study analyzed data from the intervention arm of a cluster randomized controlled trial of a comprehensive dementia care management intervention. There were 408 patient-caregiver dyads enrolled in the study, of which 238 dyads were randomized to the intervention. Caregiver, patient, and health system factors associated with participation in offered care management services were assessed through bivariate and multivariate regression analyses.



Out of the 238 dyads, 9 were ineligible for this analysis, leaving data of 229 dyads in this sample. Of these, 185 dyads accepted offered care management services, and 44 dyads did not. Multivariate analyses showed that higher likelihood of acceptance of care management services was uniquely associated with cohabitation of caregiver and patient (p < 0.001), lesser severity of dementia (p = 0.03), and higher patient comorbidity (p = 0.03); it also varied across healthcare organization sites.



Understanding factors that influence care management participation could result in increased adoption of successful programs to improve quality of care. Using these factors to revise both program design as well as program promotion may also benefit external validity of future quality improvement research trials.
Prospective randomized trial of intravenous and intracoronary streptokinase in acute myocardial infarction.

To evaluate the relative thrombolytic efficacy and complications of intracoronary vs high-dose, short-term intravenous streptokinase infusion in patients with acute myocardial infarction, we performed baseline coronary arteriography and then randomly allocated 51 patients with acute myocardial infarction to receive either intracoronary (n = 25) or intravenous (n = 26) streptokinase. Patients getting the drug by the intracoronary route received 240,000 IU of streptokinase into the infarct-related artery over 1 hr, whereas those getting the drug by the intravenous route received either 500,000 IU of streptokinase over 15 min (n = 10) or 1 million IU of streptokinase over 45 min (n = 16). Angiographically observed thrombolysis occurred in 76% (19/25) of the patients receiving intracoronary streptokinase, in 10% (1/10) of the patients receiving 500,000 IU of streptokinase intravenously, and in 44% (7/16) of the patients receiving 1 million IU of streptokinase intravenously. Among patients in whom thrombolysis was observed, mean elapsed time from onset of streptokinase infusion until lysis was 31 +/- 18 min in patients receiving intracoronary streptokinase and 38 +/- 20 min in those receiving intravenous streptokinase (p = NS). Among patients in whom intravenous streptokinase "failed," intracoronary streptokinase in combination with intracoronary guidewire manipulation recanalized only 7% (1/15). Fibrinogen levels within 6 hr after streptokinase were significantly lower in the patients receiving intravenous streptokinase (39 +/- 17 mg/dl) than the levels in those receiving intracoronary streptokinase (88 +/- 70 mg/dl) (p less than .05) but were similar 24 hr after streptokinase in the two groups. Bleeding requiring transfusion occurred in one patient in each group. Thus, in this prospective randomized trial of intracoronary vs intravenous streptokinase, hemorrhagic complications were few, although both regimens produced a systemic lytic state. Although the thrombolytic efficacy of intracoronary streptokinase was superior to that of high-dose, short-term intravenous streptokinase, the higher-dose intravenous regimen (1 million IU over 45 min) achieved thrombolysis in a significant minority (44%) of patients and might be useful therapy for patients not having access to emergency catheterization.
Enhanced gait-related improvements after therapist- versus robotic-assisted locomotor training in subjects with chronic stroke: a randomized controlled study.

Locomotor training (LT) using a treadmill can improve walking ability over conventional rehabilitation in individuals with hemiparesis, although the personnel requirements often necessary to provide LT may limit its application. Robotic devices that provide consistent symmetrical assistance have been developed to facilitate LT, although their effectiveness in improving locomotor ability has not been well established.



Forty-eight ambulatory chronic stroke survivors stratified by severity of locomotor deficits completed a randomized controlled study on the effects of robotic- versus therapist-assisted LT. Both groups received 12 LT sessions for 30 minutes at similar speeds, with guided symmetrical locomotor assistance using a robotic orthosis versus manual facilitation from a single therapist using an assist-as-needed paradigm. Outcome measures included gait speed and symmetry, and clinical measures of activity and participation.



Greater improvements in speed and single limb stance time on the impaired leg were observed in subjects who received therapist-assisted LT, with larger speed improvements in those with less severe gait deficits. Perceived rating of the effects of physical limitations on quality of life improved only in subjects with severe gait deficits who received therapist-assisted LT.



Therapist-assisted LT facilitates greater improvements in walking ability in ambulatory stroke survivors as compared to a similar dosage of robotic-assisted LT.
Initial therapy, persistence and regimen change in a cohort of newly treated type 2 diabetes patients.

The aim was to describe the utilization of antidiabetic agents, in terms of persistence and regimen change, in the management of a cohort of newly treated type 2 diabetes patients and to investigate associated socio-demographic and treatment factors.



A population-based retrospective cohort study was conducted using the national pharmacy claims database in Ireland. Subjects were analyzed for persistence and regimen change. Cox proportional hazards regression examined associations of socio-demographic and treatment factors on treatment patterns. Hazard ratios (HR) and 95% CIs are presented.



A total of 20947 subjects were identified in the study over a 2 year period. Most were initiated on metformin (76%) or sulphonylureas (22%) and 77% were persistent with therapy 12 months after initiation. The likelihood of non-persistence was significantly lower in the youngest (40-49 years) age groups (reference 60-69 years) (HR 1.62, 95% CI 1.42, 1.84) and those on sulphonylureas (HR 1.49, 95% CI 1.36, 1.64). The likelihood of receiving a regimen change was significantly lower in the older (80+ years) age groups (HR 0.63, 95% CI 0.56, 0.71), females (HR 0.91, 95% CI 0.86, 0.95), and those with pre-existing CVD (1 vs. 0 CVD medicines) (HR 0.82, 95% CI 0.74, 0.90), and higher in those on sulphonylureas (HR 1.83, 95% CI 1.73, 1.94).



Type of treatment, pre-existing CVD and demographic factors are shown to be associated with the observed treatment patterns. Guideline recommended agents were widely used on treatment initiation though a substantial minority were not initiated on the recommended first line agent. Use of guideline recommended agents was not as evident during treatment progression. Further optimization of initial and subsequent antidiabetic agent prescribing may be possible.
Stroke and conversion to high risk in children screened with transcranial Doppler ultrasound during the STOP study.

The Stroke Prevention Trial in Sickle Cell Anemia (STOP) was a randomized multicenter controlled trial comparing prophylactic blood transfusion with standard care in sickle cell anemia (SCA) children aged 2 to 16 years selected for high stroke risk by transcranial Doppler (TCD). More than 2000 children were screened with TCD to identify the 130 high-risk children who entered the randomized trial. A total of 5613 TCD studies from 2324 children were evaluated. We also collected information on stroke. We describe the changes in TCD with repeated testing and report the outcome without transfusion in the STOP screened cohort. Risk of stroke was higher with abnormal TCD than with normal or conditional TCD (P <.001) or inadequate TCD (P =.002), and risk with conditional TCD was higher than with normal TCD (P <.001). Repeated TCD in 1215 children showed that the condition of 9.4% of children became abnormal during observation. Younger patients and those with higher initial flow velocities were most likely to convert to abnormal TCDs. Screening in STOP confirmed the predictive value of TCD for stroke. Substantial differences in the probability of conversion to abnormal TCD were observed, with younger children and those with higher velocity more likely to have an abnormal TCD with rescreening.
Influence of personalized therapeutic approach on quality of life and psychiatric comorbidity in patients with advanced colonic 
cancer requiring palliative care


Personalized medical care has been consistently proven in literature as contributing to the maintenance of psychological balance and quality of life in patients suffering from chronic conditions. However, limited research has investigated the role of personalized approach in improving these parameters in patients with advanced incurable diseases. The scope of this paper was to investigate the possible impact of personalized care condition in advanced colon cancer patients, requiring palliative care. 60 patients (32 M, 28 F) (mean age 64.6) suffering from this disease were randomly assigned to a standard or to a personalized care condition. The latest implied (a) frequent (at least 2 monthly) meetings with the doctor, (b) possibility to be involved in treatment decisions, (c) more information given about diagnosis and prognosis and (d) psychological support provided to the patient and his/her family members, to deal better with daily problems and needs. The design of the study was prospective and consisted of two successive evaluations of quality of life (SF-36 questionnaire) and anxiety and depression (HAD test). Cancer patients pertaining to the personalized treatment approach had both superior quality of life scores (p < 0.05) and lower anxiety (p < 0,01) and depression (p < 0.05) than the control group. A more detailed analysis showed significant differences of vitality and social functioning for subjects pertaining to the study group (p < 0.05), as well as a lower ratio between latent and manifest anxiety (p < 0,01). These results argue in favor of the benefits of a personalized treatment approach for patients with advanced incurable diseases.
Phase II study of MTX-HSA in combination with Cisplatin as first line treatment in patients with advanced or metastatic transitional cell carcinoma

To assess the efficacy, tolerability and safety of MTX-HSA (methotrexate (MTX) covalently linked to human serum albumin (HSA)) combined with cisplatin as first line therapy for advanced bladder cancer.  Patients (pat) were treated with a loading dose of 110 mg/m2 of MTX-HSA followed by a weekly dose of 40 mg/m2 starting on day 8. Cisplatin was given on day 2 of each 28 day cycle at a dose of 75 mg/m2.  Tumor response evaluation was possible in 7 patients. Complete response (CR) and partial response (PR) was observed in 1 patient each (overall response rate: 29%). Key toxicities included CTC Grade (G) 3/4 stomatitis in 6 patients, vomiting G3 in 1 patient, fatigue G3 in 1 patient and thrombocytopenia G3 in 3 patients.  The combination of MTX-HSA with cisplatin is feasible and shows antitumor activity against urothelial carcinomas combined with an acceptable toxicity profile.
Robot-assisted laparoscopic prostatectomy versus open: comparison of the learning curve of a single surgeon.

Because of the increased use of robot-assisted laparoscopic prostatectomy (RALP) for the management of localized prostate cancer, surgeons in training face the issues of developing skills in both open surgery and the robotic console. This study compares prospectively the safety and efficacy of the first 50 open radical retropubic prostatectomy (RRP) procedures and the first 50 RALP procedures, performed by the same surgeon in the same institution.



The patients' baseline demographic, clinical, and oncologic parameters were prospectively recorded. The study end points included oncologic outcome, functional outcomes (at 3 months), and perioperative parameters. Complications were classified according to the modified Clavien system.



No statistically significant differences were noted between the two groups in terms of preoperative patient characteristics and oncologic parameters. The operative time and mean estimated blood loss were lower in the RALP group (P<0.001), but no statistically significant difference was noted in regard to transfusion rates (P=0.362). Mean hospital stay was lower in the RALP group (P<0.001). The minor (Clavien I+II) and major (Clavien III+IV) complication rates were comparable between the two groups. The overall positive margin (PSM) rates were 20% and 18% for RRP and RALP, respectively (P=0.799), while for pT(3) disease, the PSM rates were 26.1% and 22.2%% for RRP and RALP, respectively (P=0.53). The 3-month continence rates were 88% and 90% for RRP and RALP, respectively (P=0.749). For preoperatively potent patients, 3-month potency rates were comparable between the two groups (60.6% and 62.1% in the RRP and the RALP group, respectively, P=0.893).



The early learning curve for RALP appears safe and results in equivalent functional and oncologic outcome, when compared with the results of open surgery.
No arguments for increased endothelial nitric oxide synthase activity in migraine based on peripheral biomarkers.

To assess whether migraine patients display a chronic nitric oxide synthase (NOS) hyperactivity by comparing the nitric oxide (NO) production before and following a loading dose of L-arginine between migraine patients (interictally) and matched healthy control subjects. In addition, we evaluated whether a loading dose of L-arginine triggers an acute migraine headache in migraineurs.



Twenty healthy subjects and 20 migraine patients participated in a 2-period, randomised, double-blind, placebo-controlled study. Each subject received a 30-min infusion, by peripheral vein, of 30 g L-arginine hydrochloride or placebo (i.e. an equal volume of 0.9% saline solution). Meanwhile, biomarkers associated with the L-arginine-NO pathway (i.e. exhaled NO/nasal NO), plasma citrulline and urinary excretion of nitrite/nitrate and cGMP were assessed before and for 6 h following the start of the infusion.



At baseline, exhaled NO and nasal NO were higher in migraineurs compared to healthy subjects (mean±95% confidence interval): 15.9 (8.8, 23.0) parts per billion (ppb) versus 10.8 (7.0, 14.5) ppb for exhaled NO (P=0.04) and 76.3 (61.2, 91.4) versus 61.6 (51.2, 72.0) ppb for nasal NO (P=0.03), respectively. The AUC0-6 in ppb for exhaled NO and nasal NO following L-arginine or saline infusion did not differ between both groups. The increase in L-citrulline, following L-arginine infusion, was smaller in migraine patients (15 (13, 18) µmol/l) compared to healthy volunteers (19 (16, 23) µmol/l; P=0.046). In healthy subjects, both nitrate and cGMP excretion were higher following L-arginine compared to placebo infusion: 132.63 (100.24, 165.02) versus 92.07 (66.33, 117.82) µmol/mmol creatinine for nitrate (P=0.014) and 50.53 (42.19, 58.87) versus 39.64 (33.94, 45.34) nmol/mmol creatinine for cGMP (P=0.0003), respectively. In migraineurs, excretion of these biomarkers was comparable following L-arginine or saline infusion.



The results of the present study do not support the idea of a generalised increase in NO synthase activity in migraine patients outside of a migraine attack. The smaller increase in plasma L-citrulline, urinary nitrate and cGMP excretion following L-arginine infusion in migraine patients might indicate dysfunction of endothelial NO synthase.
Hospital Strategy Uptake and Reductions in Unplanned Readmission Rates for Patients with Heart Failure: A Prospective Study

Despite recent reductions in national unplanned readmission rates, we have relatively little understanding of which hospital strategies are most associated with changes in risk-standardized readmission rates (RSRR). We examined associations between the change in hospital 30-day RSRR for patients with heart failure and the uptake of strategies over 12–18 months in a national sample of hospitals. We conducted a prospective study of hospitals using a Web-based survey at baseline (November 2010–May 2011, n = 599, 91.0 % response rate) and 12–18 months later (November 2011–October 2012, n = 501, 83.6 % response rate), with RSRR measured at the same time points. The final analytic sample included 478 hospitals. The study included hospitals participating in the Hospital-to-Home (H2H) and State Action on Avoidable Rehospitalizations (STAAR) initiatives. We examined associations between change in hospital 30-day RSRR for patients with heart failure and the uptake of strategies previously demonstrated to have increased between baseline and follow-up, using unadjusted and adjusted linear regression. The average number of strategies taken up from baseline to follow-up was 1.6 (SE = 0.06); approximately one-quarter (25.3 %) of hospitals took up at least three new strategies. Hospitals that adopted the strategy of routinely discharging patients with a follow-up appointment already scheduled experienced significant reductions in RSRR (reduction of 0.63 percentage point, p value < 0.05). Hospitals that took up three or more strategies had significantly greater reductions in RSRR compared to hospitals that took up only zero to two strategies (reduction of 1.29 versus 0.57 percentage point, p value < 0.05). Among the 117 hospitals that took up three or more strategies, 93 unique combinations of strategies were used. Although most individual strategies were not associated with RSRR reduction, hospitals that took up any three or more strategies showed significantly greater reduction in RSRR compared to hospitals that took up fewer than three strategies.
Randomized study to compare valsartan ± HCTZ versus amlodipine ± HCTZ strategies to maximize blood pressure control

Delays in achieving blood pressure (BP) control may increase morbidity and mortality in patients with hypertension. Thus, deciding which antihypertensive agent to use and at what dosage, in addition to determining when to initiate combination therapy and which agents to combine, is important for achieving BP control.



This randomized, double-blind, 14-week study was conducted to compare the efficacy and tolerability of various doses of valsartan +/- hydrochlorothiazide (HCTZ) versus amlodipine +/- HCTZ for maximizing BP control in 1,285 patients with uncontrolled hypertension. Patients with stage 1 hypertension and naïve to antihypertensive therapy (33.9%) started valsartan 160 mg or amlodipine 5 mg. Treatment-naïve patients with stage 2 hypertension (13.5%) or those uncontrolled on current antihypertensive monotherapy (52.6%) started valsartan 160 mg/HCTZ 12.5 mg or amlodipine 10 mg. At weeks 4, 8, and 11, patients not achieving BP control were up-titrated (maximum: valsartan 320 mg/HCTZ 25 mg, amlodipine 10 mg/HCTZ 25 mg).



At study end, 78.8% of patients on valsartan +/- HCTZ were controlled (BP <140/90 mmHg) and still on study medication versus 67.8% on amlodipine +/- HCTZ (P < 0.0001). Amlodipine-treated patients had a higher incidence of peripheral edema (22.4% vs 2.2%) and associated discontinuations (7.3% vs <1%). Initiating therapy earlier with valsartan/HCTZ, rather than titrating monotherapy to its maximum dose before adding a second agent, was superior to amlodipine monotherapy or amlodipine +/- HCTZ for achieving BP control, and avoided excessive treatment adjustments and maintained tolerability.