nils-herrmann/clean_scirepeval huggingface dataset:
Long-term safety and efficacy of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder.

Short-term, controlled studies of extended-release guanfacine (GXR), a selective alpha(2A)-adrenoreceptor agonist, demonstrate efficacy in treating attention-deficit/hyperactivity disorder (ADHD) symptoms as monotherapy. This 2-year open-label study was conducted to further assess the long-term safety and efficacy of GXR.



Study participants, aged 6-17 years with ADHD, had previously been exposed to GXR therapy alone or in combination with psychostimulants in one of two antecedent trials. In this study, doses were titrated to 1, 2, 3, or 4 mg/day of GXR alone or in combination with a psychostimulant. Safety and efficacy data collected at clinic visits over 24 months provided further evidence of the overall safety and efficacy of GXR for treating ADHD.



The majority of adverse events (AEs) were mild to moderate, and few patients discontinued the study because of an AE. Efficacy measures demonstrated significant improvement beginning in the first month and lasting through the end of the 24-month treatment period. Throughout the entire 2-year study, 202 subjects (77.1%) discontinued and 60 (22.9%) completed the study.



Overall, these data support that GXR monotherapy is generally safe and effective for treating ADHD.
Electrical stimulation and splinting were not clearly more effective than splinting alone for contracture management after acquired brain injury: a randomised trial.

Is electrical stimulation and splinting more effective than splinting alone for the management of wrist contracture following acquired brain injury?



A multi-centre randomised trial with concealed allocation, assessor blinding, and intention-to-treat analysis.



Thirty-six adults with first stroke or traumatic brain injury and mild to moderate wrist flexion contractures.



The experimental group received electrical stimulation to the wrist and finger extensor muscles for 1 hour a day over 4 weeks while the control group did not. Both groups wore a splint for 12 hours a day during this 4-week period.



The primary outcome was passive wrist extension measured with a 3Nm torque and with the fingers in extension. Secondary outcomes included passive wrist extension, wrist and finger extensor strength, wrist flexor spasticity, motor control of the hand, and Global Perceived Effect of Treatment, and perception of treatment credibility. Outcome measures were taken at baseline, at the end of the intervention period (4 weeks), and after a 2-week follow-up period (6 weeks).



At 4 and 6 weeks, the mean between-group difference (95% CI) for passive wrist extension was 7 degrees (-2 to 15) and -3 degrees (-13 to 7), respectively. Secondary outcomes were statistically non-significant or were of borderline statistical significance.



It is not clear whether electrical stimulation and splinting is more effective than splinting alone for the management of wrist contracture after acquired brain injury. Therapists' confidence in the efficacy of electrical stimulation for contracture management is not yet justified.
Prophylactic transfer of CD8-depleted donor lymphocytes after T-cell-depleted reduced-intensity transplantation.

Allogeneic hematopoietic stem cell transplantation (SCT) regimens incorporating the lymphocytotoxic CD52 antibody alemtuzumab demonstrate efficient engraftment and reduced graft-versus-host disease (GVHD). However, these protocols substantially impair posttransplantation antiviral and antitumor immunity. To accelerate immune reconstitution after alemtuzumab-based reduced-intensity SCT, we administered prophylactic CD8-depleted donor lymphocyte infusions (DLIs) starting on days 60 and 120 after transplantation. DLIs were processed in an immunomagnetic good manufacturing practice depletion procedure resulting in a 2.5- to 6-log reduction in CD8 T cells. Of 23 high-risk patients with hematologic malignancies, 11 received a total of 21 CD8-depleted DLIs. Five patients developed transient grade I acute GVHD following transfer. Only 2 patients with HLA-C-mismatched donors showed grade II and III acute GVHD and subsequently progressed to limited chronic GVHD. Following DLIs, 4 patients with declining hematopoietic donor chimerism converted to full chimeras. A 2.1-fold median increase of circulating CD4 T cells was observed within 2 weeks after infusion. Non-DLI patients did not show a comparable rise in CD4 counts. Four patients demonstrated enhanced frequencies of cytomegalovirus-specific CD4 and CD8 T cells following transfer. Our results suggest that prophylactic CD8-depleted DLIs accelerate immune reconstitution after lymphodepleted HLA-matched SCT and carry a low risk of inducing severe GVHD.
Long-Term Effectiveness of Antiretroviral Therapy in China: An Observational Cohort Study from 2003-2014.

In order to assess the effectiveness of the Chinese government's expanded access program, a cohort study on all adult HIV patients in Shenzhen was conducted from December 2003 to February 2014 to estimate the effects of antiretroviral therapy (ART) on mortality, tuberculosis and CD4 cell counts. Marginal structural regression models adjusted for baseline and time-varying covariates. Of the 6897 patients enrolled and followed up for a maximum of 178 months, 44.92% received ART. Among patients who commenced receiving ART during the study, there were 98 deaths and 59 new tuberculosis diagnoses, while there were 410 deaths and 201 new tuberculosis diagnoses among those without ART. ART was associated with both lower mortality (hazard ratio [HR] = 0.18; 95% confidence interval [CI] = 0.11-0.27) and the presence of tuberculosis (HR = 0.27; 95% CI = 0.19-0.37). Each month of ART was associated with an average increase in CD4 cell count of 6.52 cells/µL (95% CI = 6.08-7.12 cells/µL). In conclusions, the effectiveness of ART provided by China government health services is the same as that in higher-income countries. Accounting to higher mortality rates from the delay of starting ART, faster expansion and timely imitation of ART are urgent.
Validation of Omron HBP-1300 professional blood pressure monitor based on auscultation in children and adults

To determine whether the professional Omron HBP-1300 blood pressure (BP) monitor meets American Association for the Advancement of Medical Instrumentation (AAMI) accuracy standards in Chinese children and adults.



According to the AAMI protocol, simultaneous auscultatory measurements by two observers using a mercury manometer were obtained in participants using the Omron HBP-1300. Triple measurements were obtained after a minimum 5-min rest with a 1-min interval between adjacent measurements.



A total of 85 participants submitted to 255 doctor-measured BP and 255 successful professional monitor readings. The initial auscultation systolic BP was <100 mmHg in 25 participants (29.4%), 100-160 mmHg in 53 participants (62.4%), and >160 mmHg in seven participants (8.2%). All of the simultaneous measurements agreed to within ± 10 mmHg, while 95% agreed to within ± 4 mmHg for both systolic and diastolic BP, and the consistency between two observers was satisfactory. The difference between the devices was -1.3 ± 3.6 mmHg for systolic BP and 0.7 ± 3.8 mmHg for diastolic BP and by AAMI method 1, which met this guideline. The average difference between two devices by AAMI method 2 was 1.4 ± 3.2 mmHg for systolic BP and 1.0 ± 3.9 mmHg for diastolic BP, which met this guideline.



The professional BP monitor Omron HBP-1300 is desirable for measuring the BP for Chinese children and adults.
Treatment of heart failure in real-world clinical practice: findings from the REFLECT-HF registry in patients with NYHA class II symptoms and a reduced ejection fraction.

Optimal medical therapy (OMT) for patients with chronic heart failure and a reduced ejection fraction (HF-REF) includes angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, β-blockers, and mineralocorticoid receptor antagonists, plus a diuretic.



We hypothesized that OMT is less often prescribed in HF-REF patients (≤35%) with New York Heart Association (NYHA) class II symptoms compared with those with NYHA class III/IV symptoms.



This was a cross-sectional, observational, multicenter survey of hospital-based cardiologists, office-based cardiologists, and general practitioners in Germany.



Out of a total of 384 patients enrolled, 144 had REF ≤35%. Patients with REF had NYHA class II symptoms in 39.6% (n = 57) and NYHA class III/IV symptoms in 60.4% (n = 87). The REF/NYHA class II group had a higher proportion of males than the REF/NYHA class III/IV group. For angiotensin-converting enzyme inhibitors/angiotensin receptor blockers and β-blockers, prescription rates were high and comparable between groups. However, prescription rates for mineralocorticoid receptor antagonists were lower compared with other guideline-recommended treatments. Multivariate analyses indicated that OMT prescription was reduced for older patients and increased for patients cared for by an office-based cardiologist.



Given the high proportion of patients with reduced left ventricular systolic function but only minor symptoms, HF-REF appears to be underdiagnosed, and a higher proportion of patients than are currently recognized could potentially be candidates for OMT.
Differentiating Between Precursor and Control Variables When Analyzing Reasoned Action Theories

This paper highlights the distinction between precursor and control variables in the context of reasoned action theory. Here the theory is combined with structural equation modeling to demonstrate how age and past sexual behavior should be situated in a reasoned action analysis. A two wave longitudinal survey sample of African-American adolescents is analyzed where the target behavior is having vaginal sex. Results differ when age and past behavior are used as control variables and when they are correctly used as precursors. Because control variables do not appear in any form of reasoned action theory, this approach to including background variables is not correct when analyzing data sets based on the theoretical axioms of the Theory of Reasoned Action, the Theory of Planned Behavior, or the Integrative Model.
Prediction of incomplete primary debulking surgery in patients with advanced ovarian cancer: An external validation study of three models using computed tomography.

To test the ability of three prospectively developed computed tomography (CT) models to predict incomplete primary debulking surgery in patients with advanced (International Federation of Gynecology and Obstetrics stages III-IV) ovarian cancer.



Three prediction models to predict incomplete surgery (any tumor residual >1cm in diameter) previously published by Ferrandina (models A and B) and by Gerestein were applied to a validation cohort consisting of 151 patients with advanced epithelial ovarian cancer. All patients were treated with primary debulking surgery in the Eastern part of the Netherlands between 2000 and 2009 and data were retrospectively collected. Three individual readers evaluated the radiographic parameters and gave a subjective assessment. Using the predicted probabilities from the models, the area under the curve (AUC) was calculated which represents the discriminative ability of the model.



The AUC of the Ferrandina models was 0.56, 0.59 and 0.59 in model A, and 0.55, 0.60 and 0.59 in model B for readers 1, 2 and 3, respectively. The AUC of Gerestein's model was 0.69, 0.61 and 0.69 for readers 1, 2 and 3, respectively. AUC values of 0.69 and 0.63 for reader 1 and 3 were found for subjective assessment.



Models to predict incomplete surgery in advanced ovarian cancer have limited predictive ability and their reproducibility is questionable. Subjective assessment seems as successful as applying predictive models. Present prediction models are not reliable enough to be used in clinical decision-making and should be interpreted with caution.
A randomized study of the effects of exercise training on patients with atrial fibrillation.

Exercise training is beneficial in ischemic and congestive heart disease. However, the effect on atrial fibrillation (AF) is unknown.



Forty-nine patients with permanent AF (age [mean ± SD], 70.2 ± 7.8 years; male-to-female ratio, 0.75; body mass index [mean ± SD], 29.7 ± 4.3 kg/m(2)) were randomized to 12-week aerobic exercise training or a control group. Exercise capacity, 6-minute walk test (6MWT), cardiac output, quality of life, and natriuretic peptides were measured. Cardiac output was measured at rest and during ergometer testing, and atrial natriuretic peptide and N-terminal pro-B-type natriuretic peptide were measured before and after the training period. Quality of life was evaluated using the Short-Form 36 and Minnesota Living With Heart Failure (MLHF-Q) questionnaires.



Improved exercise capacity and 6MWT were observed in the active patients (P < .001), and at study end, there was a significant difference between the active patients and the controls (P = .002). Resting pulse decreased in the active patients (94.8 ± 22.4 to 86.3 ± 22.5 beats/min, P = .049) but remained unchanged in the controls. Cardiac output was unchanged from baseline to end-of-study period. The MLHF-Q score improved in the active group (21.1 ± 18.0 vs 15.4 ± 17.5, P = .03). Active patients showed progress in 3 of the 8 Short-Form 36 subscales: physical functioning (P = .02), general health perceptions (P = .001), and vitality (P = .02). Natriuretic peptides were unchanged.



Twelve weeks of exercise training increased exercise capacity and 6MWT and decreased resting pulse rate significantly in patients with AF. Overall quality of life increased significantly as measured by the cardiology-related MLHF-Q. Cardiac output and natriuretic peptides were unchanged in both groups.
Participation in medical decision-making: Attitudes of Italians with multiple sclerosis

Patient involvement in decisions regarding their care has been advocated, but preferences have not been adequately canvassed, particularly in people with multiple sclerosis (MS).



To cross-culturally adapt and validate the Italian version of the Control Preference Scale (CPS) subsequently used to assess preferences of people with MS.



Translation-adaptation into Italian of CPS from the original Canadian English followed by administration in 140 people with MS from five Italian centers (with re-administration in 35) and semi-structured interview.



Cross-cultural adaptation of CPS was successful. The 140 people with MS, who varied in clinical and general characteristics, considered the CPS clear and acceptable. Test-retest reliability was moderate (weighted Kappa 0.65; p<0.001). A collaborative role was preferred (61%), followed by passive (33%) and active (6%) roles. Education (odds ratio [OR] 2.43, 95% confidence limits [CI] 1.05-5.66) and length of follow-up at referral center (OR 0.36, 95% CI 0.14-0.92) were associated with choice of an active/collaborative role in the logistic model.



The Italian CPS was well accepted by our MS population. Our data indicate that a high proportion of Italians with MS prefer a more passive role and this should be considered during the clinical encounter.
Immunologic changes to autologous transfusion after operational trauma in malignant tumor patients: neopterin and interleukin-2.

To estimate the impact of autologous transfusion on the status of perioperative immune activation in malignant tumor patients. The Serum Neopterin and Interleukin-2 (IL-2) were measured.



Sixty patients undergoing elective radical resection for malignant stomach tumor were enrolled in the prospective study and assigned to the following groups: (1) Group A received autologous transfusion. (2) Group H received allogeneic transfusion. The perioperative course (Before induction of anesthesia, after operation and 5 d after operation) of Neopterin and IL-2 was compared.



In group A, Serum Neopterin was significantly lower than baseline after operation and IL-2 had no significant changes. In group H, both Serum Neopterin and IL-2 were significantly lower than baseline after operation and 5 d after operation. Compared with group A, Serum Neopterin was significantly lower than baseline after operation and 5 d after operation and IL-2 was significantly lower than baseline 5 d after operation.



Autologous transfusion decreased the perioperative immune suppression in malignant stomach tumor patients.
Diagnostic performance of duplex ultrasonography in the detection of high grade internal carotid artery stenosis.

to establish on a national basis whether the diagnostic accuracy of carotid duplex justifies carotid surgery without preoperative angiography.



prospective national multicentre study with 10 participating university and county hospitals.



one hundred and thirty-four patients, aged 69+/-9 years, were subjected to routine carotid duplex ultrasonography and angiography. The influence of relevant factors on the relation between ultrasonographic and angiographic variables was evaluated using multiple regression analysis. The capacity of carotid ultrasonography to detect internal carotid artery (ICA) stenosis > or =80% was assessed by receiver operating characteristic analysis.



the correlation between peak systolic velocity in ICA (PSV(ICA)) and the angiographic degree of stenosis was strong and significantly influenced only by the applied Doppler angle. Accordingly, the optimal PSV(ICA) cutpoint values for the diagnosis of ICA stenosis > or =80% (ECST method) differed substantially (2.1 and 3.2 m/s) between the two considered angle ranges (0-49 degrees and 50-62 degrees ), the ability to identify high grade ICA stenosis being significantly better at small Doppler angles (0-49 degrees ).



ultrasonographic duplex technique identifies high grade ICA stenosis with a high degree of accuracy, which can be further improved by the application of small Doppler angles and the use of angle range specific PSV(ICA) cut-off points.
The Pediatric Quality of Life Inventory™ (PedsQL™) family impact module: reliability and validity of the Brazilian version

Pediatric health-related quality of life (HRQOL) has emerged as an important health outcome in clinical trials and healthcare research, for which HRQOL assessment instruments have played an important role. However, these instruments are not available in all countries or all languages. The Pediatric Quality of Life Inventory (PedsQL) Family Impact Module is a multidimensional instrument developed to assess the impact of chronic medical conditions on the HRQOL of parents and family functioning. The objective of the present study was to evaluate the psychometric properties of the PedsQL Family Impact Module cross-culturally adapted for use in Brazil.



The PedsQL Family Impact Module was administered to 95 parents/guardians of children with cancer in active therapy from 2 to 18 years of age of both genders. Subjects were recruited by means of convenience samples from the Pediatric Hematology/Oncology Centers at two public hospitals. The 'in-patient' sample was defined as individuals who were hospitalized for the administration of chemotherapy. The 'out-patient' sample was defined as individuals who were receiving chemotherapy and were not hospitalized.



Test-retest reliability exhibited correlation values ranging from 0.81 to 0.96 for all subscales. Internal consistency reliability was demonstrated for the PedsQL Family Impact Module: Total Scale Score (alpha = 0.89), Parent Health-Related Quality of Life Summary Score (alpha = 0.83) and Family Summary Score (alpha = 0.73). The Total Impact Score for the in-patient and out-patient samples was 67.60 and 56.43, respectively (p < 0.01). The construct validity demonstrated that the PedsQL Family Impact Module proved capable of distinguishing between families whose children/adolescents were hospitalized and families of children/adolescents who are being taken care of at home.



The Brazilian version of the PedsQL Family Impact Module was considered reliable and valid for assessing the impact of a chronic pediatric health condition on the HRQOL of parents and family functioning. The instrument should be field tested on other chronic pediatric illnesses.
Association of perioperative risk factors and cumulative duration of low bispectral index with intermediate-term mortality after cardiac surgery in the B-Unaware Trial.

Current data suggest that mortality after noncardiac surgery may be associated with persistent hypotension and the cumulative duration of low processed electroencephalogram-based bispectral index (BIS). This study assessed the relationships among cumulative duration of low BIS (BIS < 45), intermediate-term mortality, and anesthetic dose after cardiac surgery.



The authors studied 460 patients (mean age, 63.0 +/- 13.1 yr; 287 men) who underwent cardiac surgery between September 2005 and October 2006 at Washington University Medical Center, St Louis, Missouri. By using multivariable Cox regression analysis, perioperative factors were evaluated for their potential association with intermediate-term all-cause mortality.



A total of 82 patients (17.8%) died during a median follow-up of 3 yr (interquartile range, 2.7-3.3 yr). Comparing patients who died with those who survived, there was no statistically significant difference in the relationship between end-tidal anesthetic gas concentrations during the anesthetic maintenance phase and the BIS. Cumulative duration of low BIS was independently associated with intermediate-term mortality. The 1.29 adjusted hazard ratio (95% CI, 1.12-1.49) for intermediate-term mortality with cumulative duration of low BIS translated into a 29% increased risk of death for every cumulative hour spent with a BIS less than 45. The final multivariable Cox regression model showed a good discriminative ability (c-index of 0.78).



This study found an association between cumulative duration of low BIS and mortality in the setting of cardiac surgery. Notably, this association was independent of both volatile anesthetic concentration and duration of anesthesia, suggesting that intermediate-term mortality after cardiac surgery was not causally related to excessive anesthetic dose.
Bendamustine in patients with rituximab-refractory indolent and transformed non-Hodgkin's lymphoma: results from a phase II multicenter, single-agent study.

Bendamustine hydrochloride is an alkylating agent with novel mechanisms of action. This phase II multicenter study evaluated the efficacy and toxicity of bendamustine in patients with B-cell non-Hodgkin's lymphoma (NHL) refractory to rituximab.



Patients received bendamustine 120 mg/m(2) intravenously on days 1 and 2 of each 21-day cycle. Outcomes included response, duration of response, progression-free survival, and safety.



Seventy-six patients, ages 38 to 84 years, with predominantly stage III/IV indolent (80%) or transformed (20%) disease were treated; 74 were assessable for response. Twenty-four (32%) were refractory to chemotherapy. Patients received a median of two prior unique regimens. An overall response rate of 77% (15% complete response, 19% unconfirmed complete response, and 43% partial) was observed. The median duration of response was 6.7 months (95% CI, 5.1 to 9.9 months), 9.0 months (95% CI, 5.8 to 16.7) for patients with indolent disease, and 2.3 months (95% CI, 1.7 to 5.1) for those with transformed disease. Thirty-six percent of these responses exceeded 1 year. The most frequent nonhematologic adverse events included nausea and vomiting, fatigue, constipation, anorexia, fever, cough, and diarrhea. Grade 3 or 4 reversible hematologic toxicities included neutropenia (54%), thrombocytopenia (25%), and anemia (12%).



Single-agent bendamustine produced durable objective responses with acceptable toxicity in heavily pretreated patients with rituximab-refractory, indolent NHL. These findings are promising and will serve as a benchmark for future clinical trials in this novel patient population.