nils-herrmann/clean_scirepeval huggingface dataset:
Somatosensory impairments are common after stroke but have only a small impact on post-stroke shoulder pain.

To investigate whether somatosensory impairments are more common in individuals with post-stroke shoulder pain than in those without post-stroke shoulder pain and healthy controls.



Descriptive analysis of a convenience sample.



Forty-nine individuals with stroke, 24 with and 25 without post-stroke shoulder pain (median age 65 years), and 11 age- and sex-matched healthy controls.



Perception and pain thresholds for cold, warm and heat (thermal thresholds), and pain thresholds for pressure and pin prick (mechanical thresholds) were assessed using quantitative sensory testing (QST). Passive range of motion, motor function, resistance to passive movements, light touch and proprioception were assessed in the upper extremities. Shoulder pain characteristics were recorded in the post-stroke shoulder pain group.



There were no significant differences between the group with post-stroke shoulder pain and the group without post-stroke shoulder pain in any of the QST assessments, but more participants in the post-stroke shoulder pain group reported abnormal cold sensation in the affected side. Both stroke groups had generally higher thermal thresholds and more extreme low or high mechanical thresholds than the healthy controls.



Somatosensory impairments are common among individuals with stroke compared with healthy controls. The non-significant differences in QST thresholds between the group with post-stroke shoulder pain and the group without post-stroke shoulder pain indicate that somatosensory impairments have only a small impact on post-stroke shoulder pain.
Controlled, blinded force platform analysis of the effect of intraarticular injection of autologous adipose-derived mesenchymal stem cells associated to PRGF-Endoret in osteoarthritic dogs

Adipose-derived mesenchymal stem cell (ADMSC) therapy in regenerative medicine is a rapidly growing area of research and is currently also being used to treat osteoarthritis (OA). Force platform analysis has been consistently used to verify the efficacy of different therapeutic strategies for the treatment of OA in dogs, but never with AD-MSC.The aim of this study was to use a force platform to measure the efficacy of intraarticular ADMSC administration for limb function improvement in dogs with severe OA.



Eight lame dogs with severe hip OA and a control group of 5 sound dogs were used for this study. Results were statistically analyzed to detect a significant increase in peak vertical force (PVF) and vertical impulse (VI) in treated dogs. Mean values of PVF and VI were significantly improved after treatment of the OA groups, reaching 53.02% and 14.84% of body weight, respectively, at day 180, compared with only 43.56% and 12.16% at day 0.



This study objectively demonstrated that intraarticular ADMSC therapy resulted in reduced lameness due to OA.
Response to combination therapy of interferon alfa-2b plus ribavirin in Hispanics with chronic hepatitis C.

To evaluate the response rate of Hispanics with chronic hepatitis C to combination therapy of interferon alfa-2b plus ribavirin and to assess its adverse events.



Hepatitis C virus may lead to chronic infection and multiple complications. Response to combination therapy of interferon plus ribavirin has been studied in many populations. African Americans have been found to have a lower response rate than Caucasians. However, little data exist for Hispanics.



Hispanic patients from Puerto Rico with chronic hepatitis C were eligible for the study between November 1997 and February 2000. The Institutional Review Boards of the participating institutions approved the study. Written informed consents were obtained. Combination therapy was given for 48 weeks and patients were followed for 24 weeks after treatment. Analysis of response to therapy was performed in an intention-to-treat basis.



The most frequent adverse event was anemia (89%), associated to ribavirin. Sustained response was 23% for naive patients, 45% for relapsers, and 8% for non-responders to previous interferon monotherapy (p < 0.001). Data to analyze response was not available in 27% of patients. Hispanic patients had a low response rate to combination therapy.



Response rates to combination therapy for Hispanic naive and previously non-responder patients are lower than in other reported populations. This may be due to a high prevalence of genotype 1 in Puerto Rico, which is associated to poor response. The higher response rate of relapsers, similar to those reported previously, was expected since these patients showed a previous response to interferon monotherapy. Ethnic factors may play a role in the response to therapy and should be further studied to determine proper treatment strategies for this population.
Efficacy of metformin in pregnant obese women: a randomised controlled trial

Increasing evidence suggests obesity has its origins prior to birth. There is clear correlation between maternal obesity, high birthweight and offspring risk of obesity in later life. It is also clear that women who are obese during pregnancy are at greater risk of adverse outcomes, including gestational diabetes and stillbirth. The mechanism(s) by which obesity causes these problems is unknown, although hyperglycaemia and insulin resistance are strongly implicated. We present a protocol for a study to test the hypothesis that metformin will improve insulin sensitivity in obese pregnant women, thereby reducing the incidence of high birthweight babies and other pregnancy complications.



The Efficacy of Metformin in Pregnant Obese Women, a Randomised controlled (EMPOWaR) trial is a double-masked randomised placebo-controlled trial to determine whether metformin given to obese (body mass index >30 kg/m(2)) pregnant women from 16 weeks' gestation until delivery reduces the incidence of high birthweight babies. A secondary aim is to test the mechanism(s) of any effect. Obese women with a singleton pregnancy and normal glucose tolerance will be recruited prior to 16 weeks' gestation and prescribed study medication, metformin or placebo, to be taken until delivery. Further study visits will occur at 28 and 36 weeks' gestation for glucose tolerance testing and to record anthropometric measurements. Birth weight and other measurements will be recorded at time of delivery. Anthropometry of mother and baby will be performed at 3 months postdelivery. As of January 2014, 449 women had been randomised across the UK.


ETHICS AND DISSEMINATION
The study will be conducted in accordance with the principles of Good Clinical Practice. A favourable ethical opinion was obtained from Scotland A Research Ethics Committee, reference number 10/MRE00/12. Results will be disseminated at conferences and published in peer-reviewed journals.
Health-related quality of life of Iranian children with attention deficit/hyperactivity disorder

The present study aimed to examine the psychometric properties of the Persian version of the 23-item PedsQL™ 4.0 Generic Core Scales in Iranian children with attention deficit hyperactivity disorder (ADHD). A clinical sample of seventy-two children aged 8–17 years with ADHD and their parents completed the questionnaire. The control group consisted of 140 children matched for age and gender selected from schools by cluster sampling method.  Factor analysis was conducted. Reliability analysis for the total scale score was 0.85 for the child report and it was 0.80 for parent report version. Factor loading for items of the questionnaire was very similar to its original version. The quality of life of children with ADHD was statistically lower than that of the control group. The Persian version of the scales has adequate reliability and validity. The HRQOL of children with ADHD is lower than that of the control group. It is lower than that of the community sample of ADHD children from USA or children with cancer.
Prevalence and association of somatic symptoms in patients with Major Depressive Disorder.

Painful and non-painful somatic symptoms are often reported in patients with depressive disorder. The proper identification of depression-relevant somatic symptoms is important for the accurate diagnosis of depression, development of treatment strategies and measurement of outcome. The objective of this study was to characterize the relationship between somatic symptoms and depression in patients diagnosed with Major Depressive Disorder (MDD), using data from randomized drug trials carried out by a pharmaceutical company.



Pooled 'blinded' data from 2191 patients enrolled in randomized, multicenter, double-blind placebo-controlled studies for the treatment of MDD were analyzed. Somatic symptoms were assessed using the Somatic Symptoms Inventory (SSI) and the Hamilton Depression Rating Scale (HAMD) was used to assess symptoms of depression.



The most common somatic symptom reported by patients with MDD was 'feeling fatigued, weak, or tired all over', with 78% of patients reporting 'moderate' levels or above. This was followed by 'feeling that not in as good physical health as most of your friends' (59%), 'not feeling well most of the time in the past few years' (54%), and 'feeling weak in parts of body' (45%). 'Headache' was the most common pain-related symptom with 43% reporting 'moderate' or above. Pearson's product-moment correlations revealed that somatic symptoms generally increased as a function of overall depressive (r=0.43), with 'feeling fatigued, weak, or tired all over' (r=0.50), 'feeling that not in as good physical health as most of your friends' (r=0.42), 'feeling weak in parts of body' (r=0.41), 'heavy feeling in arms and legs' (r=0.34), 'not feeling well most of the time in the past few years' (r=0.32), and 'headache' (r=0.31) showing the strongest correlation with overall HAMD scores. Non-parametric item response analyses showed that many somatic symptoms demonstrate good relationship between item response and the overall severity of depression. In particular, 'feeling fatigued, weak, or tired all over' exhibited good discriminative properties across the full range of severity for depression.



The analysis utilized data from a 'restricted' patient population in drug trials sponsored by a pharmaceutical company.



These results demonstrate a high prevalence and association of somatic symptoms in patients with MDD, including feelings of fatigue, physical malaise and pain-related symptoms, which could be potentially useful in the assessment of depression and in the evaluation of treatment strategies.
Left atrial remodeling and response to valsartan in the prevention of recurrent atrial fibrillation: the GISSI-AF echocardiographic substudy.

Left atrial (LA) dilation precedes or appears early after the onset of atrial fibrillation (AF) and factors in perpetuating the arrhythmia. Angiotensin receptor blockers were proposed for reversing LA remodeling. We evaluated the effect of valsartan on LA remodeling in patients with a recent episode of AF and the effect of LA size on AF recurrence (AFr).



LA and left ventricular (LV) echocardiographic variables were measured at baseline and 6 and 12 months in 340 patients from GISSI-AF, a trial testing valsartan prevention of AFr. Reversal of remodeling was considered as a decrease in LA size over 12 months. Changes in patients with and without recurrence and the relationship to duration of AFr were analyzed. Patients were 68.4±8.8 years old, with history of hypertension (85.3%) and cardioversion in the previous 2 weeks (87.4%) or ≥2 AFr in the previous 6 months (40.4%). Baseline LA maximal volume (LAVmax) was severely increased (>40 mL/m(2)); LV dimensions and function were relatively normal. Over 12 months, 54.4% of patients had AFr. LAVmax was unchanged by rhythm, time, or randomized treatment. Higher baseline LAVmax and lower LA emptying fraction were linearly related to increasing AFr duration during follow-up.



GISSI-AF patients in sinus rhythm and history of AF showed severely increased LAVmax with mostly normal LV volume, mass, and systolic and diastolic function. Valsartan for 1 year did not reverse LA remodeling or prevent AFr. Half of the patients without AFr had severe LA dilation; therefore, mechanisms other than structural remodeling triggered recurrence.
Fluoxetine in early poststroke depression: a double-blind placebo-controlled study.

Early poststroke depression (PSD) is a frequent and specific entity that impairs the rehabilitation and functional recovery of hemiplegic patients. This trial was designed to study the efficacy and tolerance of fluoxetine (FLX) in the treatment of early PSD.



This was a multicenter, double-blind, placebo-controlled study. Recent hemiplegic patients (<3 months) suffering from major depressive disorder (determined by International Classification of Diseases, 10th Revision, and Montgomery-Asberg Depression Rating Scale [MADRS] >19) were randomized to receive either 20 mg/d fluoxetine (FLX) or placebo for 6 weeks. Patients were evaluated by use of the Motricity Index, Mini-Mental State Examination, Functional Independence Measure, and MADRS. Statistical analysis was performed by using an intent-to-treat approach comparing the 2 groups at day 0 (baseline) and days 15, 30, and 45 (end point).



Of 121 patients screened, 31 were included in the study, 16 in the FLX group and 15 in the placebo group. There were no significant differences in baseline characteristics among the 2 groups. The FLX-treated patients compared with placebo-treated patients demonstrated significant improvement in mean MADRS scores at end point (11.8+/-6. 7 [mean+/-SD] versus 18.7+/-10.0, respectively; P=0.05). FLX-treated patients compared with placebo-treated patients also demonstrated greater response rate (62.5% versus 33.3%, respectively) and greater mean decrease of MADRS (16.6 versus 8.4, respectively; P=0.02). There were no differences in motor, cognitive, or functional improvement and no significant side effects after FLX treatment, except for a patient with a moderate and transient increase of transaminases.



FLX is an efficacious and well-tolerated treatment for early PSD. Further research is needed to evaluate the efficacy and safety of long-term treatment in this population.
Contrast-enhanced transcranial Doppler sonography in the follow-up of intracranial aneurysms after endovascular treatment

Two pilot studies on a small number of patients demonstrated the feasibility of transcranial Doppler ultrasound evaluation in the follow-up of intracranial aneurysms treated with detachable coils. This prospective study aimed to assess the sensitivity of contrast-enhanced transcranial echo-Doppler in detecting partial aneurysmal occlusion following endovascular treatment. Transcranial Doppler sonography (TCD) with contrast administration and magnetic resonance angiography (MRA) or angiography were carried out after endovascular treatment in 92 patients for 98 aneurysms of the anterior circulation. In 18% of cases, the quality of ultrasound exploration was deemed unsatisfactory for evaluation of the aneurysmal site. Results were concordant in 63% of patients (49/78). When occlusion appeared satisfactory at angiography or MRA, the result was concordant with TCD in 68% of cases (44/77). When a residual aneurysm was detected, TCD sensitivity was 38% (8/18). An analysis of subgroups failed to disclose anatomic or morphological aneurysm features in which transcranial echo-Doppler is sufficiently sensitive and specific to detect possible residual aneurysm or recanalisation. In our experience, even after contrast administration TCD is not sufficiently sensitive or specific in the detection of residual aneurysm to replace angiography or MRA.
Amelioration of small bowel injury by switching from nonselective nonsteroidal anti-inflammatory drugs to celecoxib in rheumatoid arthritis patients: a pilot study.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used in patients with rheumatoid arthritis (RA) but have several side effects including mucosal damage in the small intestine. We aimed to evaluate whether the small bowel injury is ameliorated by switching from nonselective NSAIDs to celecoxib in patients with RA.



Sixteen patients with RA who were treated with nonselective NSAIDs were enrolled in this study. Nonselective NSAIDs were converted to celecoxib for 12 weeks. Capsule endoscopy was performed before and after treatment with celecoxib. Videos were screened by gastroenterologists blinded to the patients' treatment.



Before the administration of celecoxib, reddened folds, denuded areas, petechiae/red spots and mucosal breaks were observed in 63, 63, 88 and 69% of the patients, respectively. In the 14 patients who completed this study, conversion to celecoxib significantly reduced the number of petechiae/red spots, the number of mucosal breaks, and Lewis scores. RA activity and cytokine levels in the peripheral blood were not significantly different before and after treatment with celecoxib.



The incidence of small bowel injury by nonselective NSAIDs is high in patients with RA. Conversion from nonselective NSAIDs to celecoxib can be useful for protecting patients with RA from small bowel injury.
Hemoglobin A(1c) in nondiabetic patients: an independent predictor of coronary artery disease and its severity.

To examine the association between hemoglobin A(1c) (HbA(1c)) and the presence, severity, and complexity of angiographically proven coronary artery disease (CAD) in nondiabetic patients.



We performed a single-center, observational, cross-sectional study of 1141 consecutive nondiabetic patients who underwent coronary angiography from January 1, 2011, through December 31, 2011. The study population was divided into 4 interquartiles according to HbA(1c) levels (<5.5%, 5.5%-5.7%, 5.8%-6.1%, and >6.1%).



Patients with higher HbA(1c) levels tended to be older, overweight, and hypertensive, had higher blood glucose levels, and had lower glomerular filtration rates. Higher HbA(1c) levels were associated in a graded fashion with the presence of CAD, disease severity (higher number of diseased vessels and presence of left main and/or triple vessel disease), and disease complexity (higher SYNTAX score, higher number of patients in intermediate or high SYNTAX tertiles, coronary calcium, and chronic total occlusions). After adjustment for major conventional cardiovascular risk factors, compared with patients with HbA(1c) levels less than 5.5%, the odds ratios of occurrence of CAD in the HbA(1c) quartiles of 5.5% to 5.7%, 5.8% to 6.1%, and greater than 6.1% were 1.8 (95% CI, 1.2-2.7), 3.5 (95% CI, 2.3-5.3), and 4.9 (95% CI, 3.0-8.1), respectively.



The HbA(1c) level has a linear incremental association with CAD in nondiabetic individuals. The HbA(1c) level is also independently correlated with disease severity and higher SYNTAX scores. Thus, HbA(1c) measurement could be used to improve cardiovascular risk assessment in nondiabetic individuals.
Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection Trial

Five to thirty percent of patients undergoing cardiac surgery present with chronic obstructive pulmonary disease (COPD) and have a 2- to 10-fold higher 30-day mortality risk. Cardiopulmonary bypass (CPB) creates a whole body systemic inflammatory response syndrome (SIRS) that could impair pulmonary function. Impaired pulmonary function can, however, be attenuated by pulmonary perfusion with oxygenated blood or custodiol HTK (histidine-tryptophan-ketoglutarate) solution.



The Pulmonary Protection Trial (PP-Trial) randomizes 90 patients undergoing CPB-dependent cardiac surgery to evaluate whether pulmonary perfusion with oxygenated blood or custodiol HTK solution reduces postoperative pulmonary dysfunction in COPD patients. Further, we aim for a non-randomized evaluation of postoperative pulmonary function after transcatheter aortic-valve implantation (TAVI). The primary outcome measure is the oxygenation index measured from anesthesia induction to the end of surgery and until 24 hours after anesthesia induction for a total of six evaluations.



Patients with COPD may be impaired by hypoxemia and SIRS. Thus, prolonged recovery and even postoperative complications and death may be reflected by the degree of hypoxemia and SIRS. The limited sample size does not aim for confirmatory conclusions on mortality, cardiovascular complications or risk of pneumonia and sepsis, but the PP-Trial is considered an important feasibility trial paving the road for a multicenter confirmatory trial.
Test-retest reliability of the Urge-Urinary Distress Inventory and Female Sexual Function Index in women with multiple sclerosis.

Test-retest reliability of the Urge-Urinary Distress Inventory (U-UDI) and the Female Sexual Function Index (FSFI) was assessed in women with multiple sclerosis (MS) because it was undetermined whether or not either instrument would yield reliable and valid results in this population. Data from this study suggest that these tools can be reliably used to assess community-dwelling women with mild gait disability and MS-associated symptoms of urinary distress and sexual dysfunction.
Diabetes and progression of carotid atherosclerosis: the insulin resistance atherosclerosis study.

We sought to determine the rate of progression of carotid atherosclerosis in persons with normal glucose tolerance, impaired glucose tolerance, and undiagnosed and diagnosed type 2 diabetes.



The Insulin Resistance Atherosclerosis Study (IRAS) is an observational cohort study in which 1192 men and women were examined at a 5-year interval. Participants of 3 ethnic groups (non-Hispanic white, African American, and Hispanic) were selected from the general population to represent a range of glucose tolerance. Baseline and follow-up ultrasound studies were obtained to estimate progression of common carotid artery (CCA) and internal carotid artery (ICA) intimal-medial thickness (IMT). Baseline glucose tolerance status was defined by an oral glucose tolerance test and World Health Organization criteria. In persons with normal glucose tolerance, progression of CCA IMT was 3.8 microm/y, and ICA IMT, 17.7 microm/y. In both CCA and ICA, progression of IMT, unadjusted for cardiovascular disease (CVD) risk factors, was approximately twice the rate in persons with diabetes than in those with normal or impaired glucose tolerance. Adjustment for CVD risk factors attenuated these differences somewhat in both sites of the carotid artery. Persons with undiagnosed diabetes had a greater ICA IMT progression rate than did persons with diagnosed diabetes (33.9 microm/y vs 26.6 microm/y, P=NS). Progression rates did not differ between persons with normal and impaired glucose tolerance.



Progression of carotid atherosclerosis is accelerated in persons with diabetes. Progression of ICA IMT is most pronounced in persons with undiagnosed diabetes. Early identification of diabetes and CVD risk factor control might reduce its atherosclerotic complications.