nils-herrmann/clean_scirepeval huggingface dataset:
A randomized controlled trial of a self-guided, multimedia, stress management and resilience training program.

Stress is a common and costly behavioral health issue. Technology-based behavioral health programs (e.g., computer or web-based programs) are effective for treating anxiety or depression. These programs increase availability of evidence-based interventions to individuals who are not able or willing to receive such in-person treatments. Stress management training has empirical support, but little data exists on its efficacy with stressed but healthy individuals, and there are no prior studies employing a self-guided, multimedia intervention. We conducted a randomized controlled trial of a self-guided, multimedia stress management and resilience training program (SMART-OP) with a stressed but healthy sample.



Participants (N = 66) were randomized to SMART-OP or an attention control (AC) group that received marketed videos and published material on stress management. Participants were evaluated on self-report measures and Trier Social Stress Test (TSST) performance. Analyses were based on study completers (N = 59).



SMART-OP group reported significantly less stress, more perceived control over stress, and rated SMART-OP as significantly more useful than AC. During the TSST, the data suggests the SMART-OP group showed greater within-task α-amylase recovery at post-assessment.



SMART-OP is highly usable and is a more effective and useful stress management training program than an educational comparison.
Do high doses of AT(1)-receptor blockers attenuate central sympathetic outflow in humans with chronic heart failure?

In patients with CHF (chronic heart failure) sympathetic activity increases as cardiac performance decreases and filling pressures increase. We hypothesized that in patients with mild-to-moderate CHF, higher than conventional doses of an AT1-receptor [AngII (angiotensin II) type 1 receptor] antagonist would achieve greater central AT1-receptor blockade, resulting in diminished MSNA (muscle sympathetic nerve activity) and augmented MSNA variability, two indices of central effects on sympathetic outflow. In total, 13 patients with ischaemic cardiomyopathy [NYHA (New York Heart Association) class II-III] were weaned off all pharmacological RAS (renin-angiotensin system) modifiers, and then randomized to receive a low (50 mg/day) or high (200 mg/day) dose of losartan. Central haemodynamics, MSNA and its variability, plasma catecholamines, AngI (angiotensin I) and AngII and aldosterone were assessed both before and 3 months after randomization. Neither dose altered BP (blood pressure), PCWP (pulmonary capillary wedge pressure) or CI (cardiac index) significantly. Compared with 50 mg daily, losartan 200 mg/day decreased MSNA significantly (P<0.05), by approximately 15 bursts/min, and increased MSNA variability within the 0.27-0.33 Hz high-frequency range by 0.11 units(2)/Hz (P=0.06). PNE [plasma noradrenaline (norepinephrine)] fell in parallel with changes in MSNA (r=0.62; P<0.05). These findings support the hypothesis that higher than conventional doses of lipophilic ARBs (AT1-receptor blockers) can modulate the intensity and variability of central sympathetic outflow in patients with CHF. The efficacy and safety of this conceptual change in the therapeutic approach to heart failure merits prospective testing in clinical trials.
Short-latency crossed spinal responses are impaired differently in sub-acute and chronic stroke patients

Investigate if patients with supraspinal lesions have impaired interlimb spinal reflex pathways. The short-latency crossed spinal response will be investigated during sitting from the non-paretic to paretic and paretic to non-paretic extremities at different stimulation intensities in chronic and sub-acute stroke patients.



The ipsilateral tibial nerve of the paretic and non-paretic extremities were stimulated at motor threshold, 35% M-max and 85% M-max of the ipsilateral soleus while the contralateral soleus was contracted from 5% to 15% of the maximum voluntary contraction of the paretic soleus.



Chronic patients (from both extremities) had significantly less prominent inhibitory responses than healthy controls (post hoc tests: P<.01-P<.05). The responses were significantly modulated by stimulus intensity in healthy controls and chronic patients (P<.001-P<.05) but not sub-acute patients (P>.05). Some sub-acute patients had significantly more variable responses than chronic patients and healthy controls (P<.001-P⩽.05).



Short-latency interlimb reflexes are impaired differently in sub-acute vs. chronic patients, are impaired from the non-paretic and paretic extremity, and abnormal when compared to healthy controls.



The inappropriate coordination could result in an inability to quickly avoid obstacles following a mechanical disturbance to the ipsilateral extremity. It also indicates that bilateral descending projections affect the response.
Prognostic factors for recurrence and survival in anal cancer: generating hypotheses from the mature outcomes of the first United Kingdom Coordinating Committee on Cancer Research Anal Cancer Trial (ACT I).

Only 2 prospective studies have previously reported prognostic factors for anal cancer, European Organization for Research and Treatment of Cancer trial 22861 (EORTC 22861) and Radiation Therapy Oncology Group trial 98-11 (RTOG 98-11). Both of those trials reported that clinically positive lymph nodes and male sex predicted poorer overall survival (OS). The EORTC 22861 trial indicated that the same factors were prognostic for locoregional control. In the current report, the authors investigated potential prognostic factors from the first United Kingdom Coordinating Committee on Cancer Research Anal Cancer Trial (ACT I), in which patients were randomized to receive either radiotherapy alone or chemoradiation (CRT) with concurrent 5-fluorouracil/mitomycin C.



In the ACT I trial, associations between several baseline characteristics and 3 endpoints were investigated: locoregional failure (LRF), anal cancer death (ACD), and OS. The analyses were restricted to 292 patients who received CRT, which subsequently became standard treatment. A score was derived using multivariable Cox regression to identify the set of factors that, together, had the best prognostic performance. This score was then validated with a large, independent prospective trial (the ACT II trial).



Palpable, clinically positive lymph nodes were associated with LRF (P = .012), a greater risk of ACD (P = .031), and decreased OS (P = .006) in multivariable analyses. Men had worse outcomes than women for LRF (P = .036), ACD (P = .039), and OS (P = .008). On average, a lower hemoglobin level had an adverse effect on ACD (P = .008), and a higher white blood cell count had an adverse effect on OS (P = .001). However, external validation of the score was poor for LRF (area under the curve [AUC] = 54%) but was better for ACD (AUC = 67%) and OS (AUC = 63%).



The results from this analysis of the ACT I trial supported evidence for palpable lymph nodes and male sex as prognostic factors for LRF and OS, and lower hemoglobin levels and a higher white blood cell count were identified as prognostic factors for ACD and OS, respectively.
The Bethesda System for Reporting Thyroid Cytopathology: A Single-Center Experience over 5 Years

The Bethesda System for Reporting Thyroid Cytopathology (BSRTC) was developed to refine fine-needle aspiration (FNA) cytology definitions and improve clinical management. This study evaluates the impact of the BSRTC 5 years after its adoption at a single institution. A total of 1,625 patients undergoing thyroidectomy in the pre-BSRTC (Group 1: July 2007–January 2009) and post-BSRTC (Group 2: February 2009–September 2013) periods were reviewed. Cytologic diagnoses in Group 1 included non-diagnostic, benign, follicular neoplasm, suspicious for malignancy and malignant. Atypia/follicular lesion of undetermined significance (AUS/FLUS) was included in Group 2. The proportions of each FNA category and malignancy rate per cytologic diagnosis were compared. Fifty-four percent (187/347) of Group 1 patients had a preoperative FNA versus 61 % (777/1278) in Group 2 (p = 0.02). Group 1 FNA results included 3 % non-diagnostic, 48 % benign, 17 % follicular, 13 % suspicious for cancer, and 19 % cancer. Group 2 results included 3 % non-diagnostic, 36 % benign, 9 % follicular, 8 % suspicious for malignancy, 18 % malignant and 26 % AUS/FLUS. In Group 2, the proportions of benign, follicular and suspicious for malignancy FNAs decreased significantly (p < 0.05). In Group 2, there were more indeterminate FNA diagnoses overall (30 vs. 43 %; p < 0.001). The rate of cancer in suspicious for cancer FNA lesions increased from 44 to 65 % (p = 0.07). The AUS/FLUS malignancy rate was 15 %. Since the adoption of the BSRTC at our institution, the proportion of indeterminate FNAs has increased; however, the diagnostic accuracy of the suspicious for cancer category improved. We recommend periodic review of the utilization and malignancy rates per cytologic category at each institution to help tailor clinical management.
The efficacy and pattern of use of a computer-assisted programme for the treatment of anxiety: a naturalistic study using mixed methods in primary care in Spain.

Naturalistic studies to assess the efficacy and pattern of use of computer-delivered psychotherapy programmes in real daily clinical conditions are infrequent. Anxiety disorders are the most common mental disorders, and many of them do not receive adequate management, especially in primary care settings. The objective of this study is to assess the efficacy of an internet-delivered programme for anxiety in primary care.



Multicentre, naturalistic study. Patients with generalised anxiety disorder were recruited (N=229). The generalised anxiety disorder 7-item scale (GAD-7) was the only outcome measured. Qualitative methods were used to analyse patient-therapist interactions.



Only 13.5% of patients completed the programme. Analysis per intent-to-treat using Last Observation Carried Forward showed a significant GAD-7 decrease post-treatment (-2.17: SD=4.77; p=0.001) (Cohen׳s d=0.43) with a correlation between the number of sessions and decrease in anxiety (Rho=-0.34, p=0.001). The analysis per protocol showed significantly decreased GAD-7 (-4.13; SD=6.82; p=0.002) (d=0.80). Withdrawal was related to low programme friendliness, lack of a partner, and higher education. Only 17.47% of the patients consulted their therapists. Facilitators were patient demand for information and sufficient time. Barriers were lack of motivation and lack of connection with the programme.



The main limitations of this study included the use of an open trial design, the lack of follow-up, and the inclusion of only one outcome (GAD-7).



To our knowledge, this is the first study with computer-delivered psychotherapy (CDP) on GAD. CDP for anxiety is efficacious in naturalistic environments. Specific facilitators and barriers should be considered.
Discontinuation of statins in routine care settings: a cohort study.

Systematic data on discontinuation of statins in routine practice of medicine are limited.



To investigate the reasons for statin discontinuation and the role of statin-related events (clinical events or symptoms believed to have been caused by statins) in routine care settings.



A retrospective cohort study.



Practices affiliated with Brigham and Women's Hospital and Massachusetts General Hospital in Boston.



Adults who received a statin prescription between 1 January 2000 and 31 December 2008.



Information on reasons for statin discontinuations was obtained from a combination of structured electronic medical record entries and analysis of electronic provider notes by validated software.



Statins were discontinued at least temporarily for 57 292 of 107 835 patients. Statin-related events were documented for 18 778 (17.4%) patients. Of these, 11 124 had statins discontinued at least temporarily; 6579 were rechallenged with a statin over the subsequent 12 months. Most patients who were rechallenged (92.2%) were still taking a statin 12 months after the statin-related event. Among the 2721 patients who were rechallenged with the same statin to which they had a statin-related event, 1295 were receiving the same statin 12 months later, and 996 of them were receiving the same or a higher dose.



Statin discontinuations and statin-related events were assessed in practices affiliated with 2 academic medical centers. Utilization of secondary data could have led to missing or misinterpreted data. Natural-language-processing tools used to compensate for the low (30%) proportion of reasons for statin discontinuation documented in structured electronic medical record fields are not perfectly accurate.



Statin-related events are commonly reported and often lead to statin discontinuation. However, most patients who are rechallenged can tolerate statins long-term. This suggests that many of the statin-related events may have other causes, are tolerable, or may be specific to individual statins rather than the entire drug class.
Sleepiness in Spanish nursing staff--influence of chronotype and care unit in circadian rhythm impairment: research protocol.

To determine how prevalent circadian rhythm impairments are in nurses working in medical, surgical and intensive care units in five Spanish hospitals and how the quality of night-time sleeping and sleepiness affect the nurses' morning and evening chronotypes.



Shift work is a recognized work pattern for nurses in all countries. Given the important role that nurses play in hospital care, it is vital to establish what repercussions this has on the nurses' working schedules and how any disturbance in circadian rhythm affects patient safety.



A multicentre, observational, descriptive and cross-sectional study in seven hospitals in the Spanish National Health System.



A stratified sample of 1,300 nurses is being collected in three types of units: medical, surgical and intensive care. The 3-year study started in January 2012 and will continue until December 2014, with no exclusion criteria. The Kronowise(®) will be used to monitor the nurses' circadian rhythms, by recording their activity, position and wrist temperature. We will also use three questionnaires to evaluate sleep quality, daytime drowsiness and chronotype: (a) Pittsburg Sleep Quality Index; (b) Epworth Daytime Sleepiness Scale; and (c) Morning and Evening Questionnaire. Data will be collected from each hospital and statistical analysis will be carried out using the SPSS 19.0.



The study findings will show the current state of the nurses' circadian rhythms and how shift work can affect them and their job performance. Funding for this 3-year study was granted in December 2011 by the Spanish Health Research Fund (PI 11/00646, Health Ministry). This project is also funded by the Instituto de Salud Carlos III (RETICEF, RD12/0043/0011, RD12/0043/0006).
Long-term monotherapy with suplatast tosilate in patients with mild atopic asthma: a pilot comparison with low-dose inhaled fluticasone.

Suplatast tosilate is a Th2 cytokine inhibitor that is effective for controlling persistent asthma. However, the long-term efficacy of suplatast is unknown. We compared the clinical efficacy of long-term monotherapy with suplatast tosilate with a low dose of inhaled steroids in patients with mild atopic asthma.



A total of 32 patients with mild atopic asthma were randomly assigned to receive suplatast (n=15) or fluticasone (n=17). In the suplatast group, 100 mg of suplatast was given orally 3 times a day (total daily dose = 300 mg) for 2 years. In the fluticasone group, 100 pg of fluticasone was inhaled twice a day (total daily dose = 200 tg) for 2 years.



In the suplatast group, the improvements in peak expiratory flow (PEF) rate and forced expiratory volume in 1 second (FEV1) and the changes in the symptom diary scale and frequency of beta2 stimulant inhalation were generally similar to those in the fluticasone group, and efficacy was maintained for 2 years. Improvements in inflammatory indices, such as the sputum eosinophil cationic protein (ECP) level and exhaled nitric oxide concentration, were comparable in the suplatast and fluticasone groups. The improvement in airway hyperresponsiveness was also similar in the 2 groups. The peripheral blood eosinophil percent change, serum ECP level, and total IgE antibody titer improved only in the suplatast group.



Long-term treatment with suplatast significantly improved symptoms and inflammatory indices in patients with mild atopic asthma. Along with fluticasone, suplatast is considered a useful drug for the management of mild atopic asthma.
IRIS II study: intact proinsulin is confirmed as a highly specific indicator for insulin resistance in a large cross-sectional study design.

The cross-sectional IRIS-II study tried to assess the prevalence of insulin resistance and macrovascular disease in orally treated patients with Type 2 diabetes.



In total, 4,270 patients were enrolled into the study (2,146 male, 2,124 female; mean +/- SD age 63.9 +/- 11.1 years; body mass index 30.1 +/- 5.5 kg/m2; duration of disease 5.4 +/- 5.6 years; hemoglobin A1c 6.8 +/- 1.3%). The study consisted of a single morning visit with completion of a standardized questionnaire and collection of a fasting blood sample.



The mean intact proinsulin value was 11.4 +/- 12.4 pmol/L (normal range < 10 pmol/L). Homeostasis model assessment resulted in 1,147 insulin-sensitive patients (26.9%) and 3,123 patients (73.1%) with insulin resistance. Of the latter patients 1,465 (34.3% of all patients) had also elevated intact proinsulin values, while 1,658 (38.8%) had no proinsulin elevation. In contrast, 1,042 (24.4%) of the insulin-sensitive patients had normal intact proinsulin, and only 105 (2.4%) had elevated intact proinsulin concentrations (chi2 test P < 0.0001). A specificity of 93.2% (sensitivity 46.9%) was calculated for elevated intact proinsulin as an indirect marker for insulin resistance. Of the 1,451 patients treated with sulfonylurea 52% had elevated intact proinsulin values and increased prevalence of cardiovascular complications (odds ratio 1.45).



Type 2 patients with elevated fasting intact proinsulin values can be regarded as being insulin resistant. The results confirm that fasting intact proinsulin is a suitable measure for beta-cell dysfunction and insulin resistance in type 2 diabetes and may be used to support therapeutic decisions.
Radial PCI and the obesity paradox: Insights from Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).

To examine if transradial approach (TRA) negates the increased risk associated with femoral access in lean and morbidly obese patients undergoing percutaneous coronary intervention (PCI).



Patients at extremes of body mass are at increased risk of bleeding after PCI. TRA has been associated with lower overall rates of bleeding compared to femoral approach.



We studied patients undergoing emergent and elective PCI from 2010 to 2012 across 47 hospitals in Michigan who participate in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium PCI registry. The primary outcomes were the incidences of bleeding and postprocedure transfusion. Propensity matching (PM) was used to adjust for nonrandomized use of TRA. TRA was used in 10,235 procedures. In PM analyses, use of TRA was associated with a reduction in bleeding (0.80 vs. 1.9%, odds ratio [OR] = 0.41, 95% confidence interval [CI] = 0.32-0.54, P < 0.001) and need for transfusion (1.4 vs. 2.5%, OR = 0.56, 95% CI = 0.45-0.69, P < 0.001) compared with femoral access. The absolute difference in bleeding and transfusion associated with TRA was largest in patients with lean body mass (BMI < 25 kg/m(2)) and morbid obesity (BMI ≥ 40 kg/m(2)): Lean patients undergoing TRA had a rate of bleeding of 1.2 versus 2.8% for femoral access (OR = 0.43, 95% CI = 0.24-0.77, P = 0.002); and rate of transfusion of 2.4 versus 3.9% (OR = 0.61, 95% CI = 0.40-0.94, P = 0.019). The morbidly obese had a rate of bleeding of 0.8% for TRA versus 2.4% for femoral access (OR = 0.33, 95% CI = 0.44-0.72, P = 0.004); and rate of transfusion of 1.7 versus 3.0%, (OR = 0.55, 95% CI = 0.30-1.0, P = 0.051).



Compared with the femoral approach, TRA is associated with a reduction in bleeding across all patients undergoing PCI and the absolute benefit was greatest in those with extremely low or high BMI.
Electroacupuncture stimulation at sub-specific acupoint and non-acupoint induced distinct brain glucose metabolism change in migraineurs: a PET-CT study

Acupuncture has analgesic effect to most pain conditions. Many neuroimaging studies were conducted to explore acupoint specificity in pain and other condition, but till now there is still discrepancy. Based on our previous finding, this study investigated the brain metabolism changes of acupuncture analgesia induced by sub-specific acupoint and non-acupoint stimulation. 30 migraineurs were included and randomly assigned to 3 groups: Acupuncture Group (AG), Sham Acupuncture Group (SAG) and Migraine Group (MG). In AG, a combination sub-specific points of Shaoyang meridians, Luxi (TE19), San Yangluo (TE8), and Xi Yangguan(GB33) has been stimulated with electroacupuncture, while non-acupoints for SAG were used and MG received no treatment. Positron emission tomography with computed tomography (PET-CT) was used to identify differences in brain glucose metabolism between groups. In the AG, brain glucose metabolism increase compared with the MG was observed in the middle frontal gyrus, postcentral gyrus, the precuneus, parahippocampus, cerebellum and middle cingulate cortex (MCC), and decrease were observed in the left hemisphere of Middle Temporal Cortex (MTC).In the SAG, compared with MG, glucose metabolism increased in the poster cingulate cortex (PCC), insula, inferior temporal gyrus, MTC, superior temporal gyrus, postcentral gyrus, fusiform, inferior parietal lobe, superior parietal lobe, supramarginal gyrus, middle occipital lobe, angular and precuneus; while, decreased in cerebellum, parahippocampus. Acupuncture stimulation at both sub-specific acupoint and non-acupoint yields ameliorating effect to migraine pain, but with evidently differed central mechanism as measured by PET-CT. The pattern of brain glucose metabolism change in acupoint is pertinent and targeted, while in non-acupoint that was disordered and randomized. These finding may provide new perspectives into the validation of acupoint specificity, optimizing acupuncture analgesia and revealing central mechanism of acupuncture analgesia by neuroimaging measurement.
Stem cell mobilization by granulocyte-colony-stimulating factor in acute myocardial infarction: lessons from the REVIVAL-2 trial

Experimental studies and early-phase clinical trials suggest that mobilization of bone marrow stem cells by granulocyte-colony-stimulating factor (G-CSF) can be used to improve cardiac regeneration after acute myocardial infarction (AMI). In order to more fully evaluate this intervention in patients with AMI, we conducted the Regenerate Vital Myocardium by Vigorous Activation of Bone Marrow Stem Cells (REVIVAL-2) clinical trial. Following successful reperfusion by percutaneous coronary intervention for AMI, patients were randomly assigned to receive a subcutaneous daily dose of 10 µg/kg G-CSF or placebo for 5 days. Treatment with G-CSF produced a significant mobilization of stem cells. After 4–6 months the reduction in infarct size from baseline, as determined by technetium-99-labeled single-photon-emission CT, did not differ significantly between the G-CSF group and the placebo group. Furthermore, the improvement in left ventricular ejection fraction, as assessed by late-enhancement MRI, did not differ significantly between the two groups. G-CSF treatment did not increase the risk of adverse clinical events and did not promote restenosis. Our trial demonstrates that stem cell mobilization by G-CSF does not improve infarct size, left ventricular function, or coronary restenosis in patients with AMI who have had successful mechanical reperfusion.