nils-herrmann/clean_scirepeval huggingface dataset:
The immunological phenotype of rituximab-sensitive chronic graft-versus-host disease: a phase II study.

Chronic graft-versus-host disease is the major long-term complication after allogeneic stem cell transplantation with a suboptimal response rate to current treatments. Therefore, clinical efficacy and changes in lymphocyte subsets before and after rituximab treatment were evaluated in a prospective phase II study in patients with steroid-refractory chronic graft-versus-host disease. Overall response rate was 61%. Only responding patients were found to have increased B-cell numbers prior to treatment. B cells had a naïve-antigen-presenting phenotype and were mainly CD5 negative or had a low CD5 expression. Normal B-cell homeostasis was reestablished in responding patients one year after ritxumab treatment and associated with a significant decline in skin-infiltrating CD8(+) T cells, suggesting that host B cells play a role in maintaining pathological CD8(+) T-cell responses. Imbalances in B-cell homeostasis could be used to identify patients a priori with a higher chance of response to rituximab treatment (Eudra-CT 2008-004125-42).
LV reverse remodeling imparted by aortic valve replacement for severe aortic stenosis; is it durable? A cardiovascular MRI study sponsored by the American Heart Association

In patients with severe aortic stenosis (AS), long-term data tracking surgically induced effects of afterload reduction on reverse LV remodeling are not available. Echocardiographic data is available short term, but in limited fashion beyond one year. Cardiovascular MRI (CMR) offers the ability to serially track changes in LV metrics with small numbers due to its inherent high spatial resolution and low variability.



We hypothesize that changes in LV structure and function following aortic valve replacement (AVR) are detectable by CMR and once triggered by AVR, continue for an extended period.



Twenty-four patients of which ten (67 ± 12 years, 6 female) with severe, but compensated AS underwent CMR pre-AVR, 6 months, 1 year and up to 4 years post-AVR. 3D LV mass index, volumetrics, LV geometry, and EF were measured.



All patients survived AVR and underwent CMR 4 serial CMR's. LVMI markedly decreased by 6 months (157 ± 42 to 134 ± 32 g/m2, p < 0.005) and continued trending downwards through 4 years (127 ± 32 g/m2). Similarly, EF increased pre to post-AVR (55 ± 22 to 65 ± 11%,(p < 0.05)) and continued trending upwards, remaining stable through years 1-4 (66 ± 11 vs. 65 ± 9%). LVEDVI, initially high pre-AVR, decreased post-AVR (83 ± 30 to 68 ± 11 ml/m2, p < 0.05) trending even lower by year 4 (66 ± 10 ml/m2). LV stroke volume increased rapidly from pre to post-AVR (40 ± 11 to 44 ± 7 ml, p < 0.05) continuing to increase non-significantly through 4 years (49 ± 14 ml) with these LV metrics paralleling improvements in NYHA. However, LVmass/volume, a 3D measure of LV geometry, remained unchanged over 4 years.



After initial beneficial effects imparted by AVR in severe AS patients, there are, as expected, marked improvements in LV reverse remodeling. Via CMR, surgically induced benefits to LV structure and function are durable and, unexpectedly express continued, albeit markedly incomplete improvement through 4 years post-AVR concordant with sustained improved clinical status. This supports down-regulation of both mRNA and MMP activity acutely with robust suppression long term.
Regression of left ventricular hypertrophy and improvement of renal hemodynamics in hypertensive patients treated with quinapril

Of 17 patients with mild to moderate essential hypertension, 8 showed echocardiographic evidence of left ventricular hypertrophy. Cardiac and renal function evaluated by glomerular filtration rate (GFR) were studied in all patients before and after 20 weeks of quinapril treatment. Systolic pressure decreased from 174.7±16.7 to 131.7±7.7 mmHg (p<.0001) and diastolic pressure decreased from 101.8±9.8 to 80±4.3 mmHg (p<.0001). Left ventricular mass index decreased in the eight patients with left ventricular hypertrophy (p<.01). Basal values of GFR were lower than normal in 41% of all patients; GFR increased significantly after 20 weeks of treatment (from 96.5±32.3 to 108.6±31.12 ml/min, p<.01); it decreased in only one patient. Patients reported few adverse effects to quinapril, and no important clinical laboratory abnormality was observed. Quinapril not only lowered arterial pressure, but it had a distinct effect on regression of left ventricular hypertrophy and favorable effects on renal function.
Double-blind, placebo-controlled first in human study to investigate an oral vaccine aimed to elicit an immune reaction against the VEGF-Receptor 2 in patients with stage IV and locally advanced pancreatic cancer

The investigational oral DNA vaccine VXM01 targets the vascular endothelial growth factor receptor 2 (VEGFR-2) and uses Salmonella typhi Ty21a as a vector. The immune reaction elicited by VXM01 is expected to disrupt the tumor neovasculature and, consequently, inhibit tumor growth. VXM01 potentially combines the advantages of anti-angiogenic therapy and active immunotherapy. This phase I trial examines the safety, tolerability, and immunological and clinical responses to VXM01. The randomized, placebo-controlled, double blind dose-escalation study includes up to 45 patients with locally advanced and stage IV pancreatic cancer. The patients will receive four doses of VXM01 or placebo in addition to gemcitabine as standard of care. Doses from 106 cfu up to 1010 cfu of VXM01 will be evaluated in the study. An independent data safety monitoring board (DSMB) will be involved in the dose-escalation decisions. In addition to safety as primary endpoint, the VXM01-specific immune reaction, as well as clinical response parameters will be evaluated. The results of this study shall provide the first data regarding the safety and immunogenicity of the oral anti-VEGFR-2 vaccine VXM01 in cancer patients. They will also define the recommended dose for phase II and provide the basis for further clinical evaluation, which may also include additional cancer indications. EudraCT No.: 2011-000222-29, NCT01486329, ISRCTN68809279
Validation of the spanish version of the multiple sclerosis international quality of life (musiqol) questionnaire

The Multiple Sclerosis International Quality Of Life (MusiQoL) questionnaire, a 31-item, multidimensional, self-administrated questionnaire that is available in 14 languages including Spanish, has been validated using a large international sample. We investigated the validity and reliability of the Spanish version of MusiQoL in Spain.



Consecutive patients with different types and severities of multiple sclerosis (MS) were recruited from 22 centres across Spain. All patients completed the MusiQoL questionnaire, the 36-Item Short Form (SF-36) health survey, and a symptoms checklist at baseline and 21 days later. External validity, internal consistency, reliability and reproducibility were tested.



A total of 224 Spanish patients were evaluated. Dimensions of MusiQoL generally demonstrated a high internal consistency (Cronbach's alpha: 0.70-0.92 for all but two MusiQoL domain scores). External validity testing revealed that the MusiQoL index score correlated significantly with all SF-36 dimension scores (Pearson's correlation: 0.46-0.76), reproducibility was satisfactory (intraclass correlation coefficient: 0.60-0.91), acceptability was high, and the time taken to complete the 31-item questionnaire was reasonable (mean [standard deviation]: 9.8 [11.8] minutes).



The Spanish version of the MusiQoL questionnaire appears to be a valid and reliable instrument for measuring quality of life in patients with MS in Spain and constitutes a useful instrument to measure health-related quality of life in the clinical setting.
Energy intake and sources of nutritional support in patients with head and neck cancer—a randomised longitudinal study

Malnutrition decreases the cancer patient’s ability to manage treatment, affects quality of life and survival, and is common among head and neck (HN) cancer patients due to the tumour location and the treatment received. In this study, advanced HN cancer patients were included and followed during 2 years in order to measure their energy intake, choice of energy sources and to assess problems with dysphagia. The main purpose was to explore when and for how long the patients had dysphagia and lost weight due to insufficient intake and if having a PEG (percutaneous endoscopic gastrostomy) in place for enteral nutrition made a difference.One hundred thirty-four patients were included and randomised to either a prophylactic PEG for early enteral feeding or nutritional care according to clinical praxis. At seven time points weight, dysphagia and energy intake (assessed as oral, nutritional supplements, enteral and parenteral) were measured.Both groups lost weight the first six months due to insufficient energy intake and used enteral nutrition as their main intake source; no significant differences between groups were found. Problems with dysphagia were vast during the 6 months. At the 6-, 12- and 24-month follow-ups both groups reached estimated energy requirements and weight loss ceased. Oral intake was the major energy source after 1 year.HN cancer patients need nutritional support and enteral feeding for a long time period during and after treatment due to insufficient energy intake. A prophylactic PEG did not significantly improve the enteral intake probably due to treatment side effects.
Randomized controlled trial of mindfulness-based stress reduction delivered to human immunodeficiency virus-positive patients in Iran: effects on CD4⁺ T lymphocyte count and medical and psychological symptoms.

To evaluate the immediate and long-term effectiveness of mindfulness-based stress reduction (MBSR) on biological and symptomatological markers of health among human immunodeficiency virus-positive (HIV+) patients in Tehran, Iran.



Using a randomized controlled trial design, data from 173 HIV+ patients (CD4 count > 250) not yet receiving antiretroviral therapy, who participated in either an 8-week MBSR (n = 87) or a brief education and support condition (n = 86) at the Imam Khomeini Hospital, were analyzed. Assessments included CD4 count, Symptom Checklist-90-Revised (SCL-90R), and Medical Symptom Checklist (MSCL) at baseline, immediate post-treatment, and at the 3-, 6-, 9-, and 12-month follow-up periods.



The treatment-adherent sample had a mean (standard deviation) age of 35.1 (6.5) years and 69% were male. Linear mixed-model estimates indicated that, in the MBSR condition, the mean CD4 count increased from baseline up to 9 months after treatment and then returned to baseline level at 12 months. Improvements in mean SCL-90R (up to 6 months) and MSCL (up to 12 months) scores were observed for the MBSR condition, whereas education and support condition scores remained the same over time; however, only MSCL improvements significantly differed between groups and these changes lasted up to the final assessment.



Findings suggest that among treatment-adherent Iranian HIV+ patients not yet receiving antiretroviral drug treatment, MBSR seems to have the strongest potential to improve self-reported medical symptoms.
Exercise training program in children and adolescents with cerebral palsy: a randomized controlled trial.

To evaluate the effects of an 8-month training program with standardized exercises on aerobic and anaerobic capacity in children and adolescents with cerebral palsy.



Pragmatic randomized controlled clinical trial with blinded outcome evaluation between July 2005 and October 2006.



Participants were recruited from 4 schools for special education in the Netherlands.



A total of 86 children with cerebral palsy (aged 7-18 years) classified at Gross Motor Function Classification System level I or II.



Participants were randomly assigned to either the training group (n = 32) or the control group (n = 33). The training group met twice per week for 45 minutes to circuit train in a group format that focused on aerobic and anaerobic exercises.



Aerobic capacity was assessed by the 10-m shuttle run test, and anaerobic capacity was assessed by the Muscle Power Sprint Test. Secondary outcome measures included agility, muscle strength, self-competence, gross motor function, participation level, and health-related quality of life.



A significant training effect was found for aerobic (P < .001) and anaerobic capacity (P = .004). A significant effect was also found for agility (P < .001), muscle strength (P < .001), and athletic competence (P = .005). The intensity of participation showed a similar effect for formal (P < .001), overall (P = .002), physical (P = .005), and skilled-based activities (P < .001). On the health-related quality of life measure, a significant improvement was found for the motor (P = .001), autonomy (P = .02), and cognition (P = .04) domains.



An exercise training program improves physical fitness, participation level, and quality of life in children with cerebral palsy when added to standard care.
Comparison of endoscopic gastric mucosa features after administration of piroxicam to meloxicam and their correlation with dyspepsia symptoms in elderly patient with knee osteoarthritis.

to know the effect of piroxicam (COX-1 and COX-2 inhibitor NSAID) and meloxicam (selective COX-2 inhibitor NSAID) against the gastric mucosa.



a random, double-blind-parallel study and repeat measurement against 20 elderly-patients with knee-OA was conducted. Patients were divided into 2 equal groups, every group got piroxicam 20 mg/day or meloxicam 15 mg/day for 3 weeks. On the second group, sukralfat 2 x 1 g/day were given. To examine the difference before and after treatment, we used Wilcoxon signed rank test, to examine the difference within those groups we used Mann-whitney U test, to examine the correlation between endoscopic score and dyspepsia, we used the Spearman correlation test with significant correlation interpretation by Guilford rules.



one of piroxicam group was resigned, so that there was 19 person left to complete this study. Piroxicam has caused elevation of endoscopic score in 78% subject compared to the beginning of study, and 22% of the subject has developed ulcers. Alteration of endoscopic feature after administration of this piroxicam was statistically significant (p< 0,05). Mild dyspepsia symptoms after piroxicam administration were positive on 67% subjects (p< 0,05). After administration of meloxicam, 40% subjects have elevated endoscopic score compared to beginning of the study (p< 0,05). Mild dyspepsia symptoms after meloxicam administration were positive on 40% subjects (p> 0,05). Meloxicam has less elevation of endoscopic score compared to the piroxicam (p< 0,05). By statistics, both of groups showed no difference in dyspepsia symptoms (p> 0,05). There was no significant correlation between elevation of endoscopic score and dyspepsia on both of groups. Nevertheless, it tends to have weak positive correlation (piroxicam group r= 0,306, p> 0,05, meloxicam group r= 0,330, p> 0,05).



on this study, we conclude that the administration of either piroxicam or meloxicam in elderly-patient with knee-OA has caused the gastric mucosa impairment. The impairment after meloxicam administration is milder than piroxicam. There is no significant difference of dyspepsia symptoms in both of groups. There is correlation between endoscopic gastric mucosa features with the dyspepsia symptoms.
Design and validation of a medication assessment tool for cancer pain management

A clinical tool to examine prescribing in cancer pain management may provide a means to help establish acceptable standards of adherence to treatment guidelines. The study aim was to design and validate a Medication Assessment Tool for Cancer Pain Management (MAT-CP). Hospitals in Northern Norway The MAT-CP was designed from guideline criteria based on a previously developed method. The tool was validated by peer review before and during field-testing on a study sample of cancer patients experiencing pain. Perceived relevance, utility, and clarity of individual criteria, and reliability of their application to clinical documentation. Frequency of adherence to agreed definitions of guideline criteria. The final tool comprised 36 criteria covering six different aspects of cancer pain management: (1) pain assessment and information transfer, (2) start of strong opioid therapy; (3) current continuous analgesia; (4) current intermittent analgesia; (5) follow-up of therapy, and; (6) other care issues. The tool was tested on 109 cancer patients experiencing pain (57 males), mean (SD) age 60.8 (11.5) years. Guideline adherence overall was 61% (n = 1704 applicable criteria). The field-testing informed the modification of the MAT-CP to optimise its clarity and utility when applied to patients’ clinical documentation. Good inter- and intra-rater reliability (Cohen’s kappa κ = 0.86 and κ = 0.95, respectively) were demonstrated in the application. The preliminary application of the tool during field-testing has highlighted the following for further study: (a) Low adherence (<50%) to 14 standards concerning start of opioid treatment and pain therapy follow-up, clinical assessment of risk of gastro-intestinal adverse effects among patients on non-steroidal anti-inflammatory drugs (NSAID), current treatment of breakthrough pain, management of nausea/vomiting; (b) High adherence (>75%) to standards of prescribing of continuous analgesia. A clinical tool to examine prescribing in cancer pain management has been designed. Face and content validity have been informed by field-testing. The tool requires further study among palliative care specialists as part of the validation required before it can be recommended for clinical use.
National Trends and In-Hospital Outcomes in Pregnant Women With Heart Disease in the United States.

Investigation of trends and outcomes in heart disease (HD) and pregnancy has been limited. We chose to identify the prevalence, trends, and outcomes of pregnant women with different forms of HD in the United States. Healthcare Cost and Utilization Project's National Inpatient Sample was screened for hospital admissions for delivery in pregnant women with HD from 2003 to 2012. Maternal clinical characteristics and outcomes were identified in women with and without HD, and in HD subtypes: congenital (CHD), valvular HD, cardiomyopathy, and pulmonary hypertension (PH). Primary outcomes of interest were prevalence, trends, and major adverse cardiac events (MACEs), a composite of in-hospital death, acute myocardial infarction, heart failure, arrhythmia, cerebrovascular event, embolic events, or cardiac complications of anesthesia. We studied 81,295 patients with HD and 39,894,032 without. CHD was the most frequent type (41.8%, 33,982 of 81,295 patients), followed by valvular HD (30.9%, 25,138 of 81,295 patients), cardiomyopathy (20.8%, 16,926 of 81,295 patients), and PH (6.5%, 5,250 of 81,295 patients). MACE was highest among women with cardiomyopathy and lowest among women with CHD (44.0%, 7,449 of 16,926 vs 6.2%, 2,102 of 33,982; p <0.0001). PH patients had the highest in-hospital death, followed by cardiomyopathy patients (1.0%, 51 of 5,250 and 0.7%, 124 of 16,926, respectively). Pregnant women with HD significantly increased by 24.7%, related to increases in cardiomyopathy, CHD, and PH from 2003 to 2012. MACE significantly increased by 18.8%. In conclusion, pregnancy in women with HD is increasing, particularly for high risk conditions such as cardiomyopathy and PH. There is a significant and gradual increase in MACE for women with HD.
The supplementation of acetyl-L-carnitine decreases fatigue and increases quality of life in patients with hepatitis C treated with pegylated interferon-α 2b plus ribavirin.

The aim of this study was to evaluate whether supplementation of acetyl-L-carnitine (ALC) to pegylated-interferon-α 2b (Peg-IFN-α 2b) and ribavirin (RBV) improves the health-related quality of life during the treatment for chronic hepatitis C, thereby decreasing the risk of treatment discontinuation. Sixty patients with chronic hepatitis C underwent treatment with Peg-IFN-α 2b + RBV (group A; n = 29) or Peg-IFN-α 2b + RBV + ALC (group B; n = 31) for 12 months. At the end of the study, the comparison between group A and group B showed significant differences in aspartate aminotransferase (AST) (-80.9 versus -110.3; P < 0.001), alanine aminotransferase (-111.6 versus -134.7; P < 0.001), Viremia (-3.26 versus -3.82; P < 0.05), mental health (0 versus 11; P < 0.001), physical functioning (-1 versus 8; P < 0.001), role-physical (1 versus 13; P < 0.001), bodily pain (1 versus 12; P < 0.001), general health (3 versus 12; P < 0.001), vitality (3 versus 13; P < 0.001), social functioning (3 versus 10; P < 0.001), physical fatigue (2.1 versus -5.4; P < 0.001), mental fatigue (-0.7 versus -2.7; P < 0.001), and fatigue severity scale (-3.4 versus -12; P < 0.001). ALC supplementation reduced both mental and physical fatigue, improved health-related quality of life, and, therefore, has the potential to increase patient adherence to the combination regimen. This, in turn, may increase the percentage of patients achieving a sustained virological response.
Chest physiotherapy does not improve the outcome in laparoscopic fundoplication and vertical-banded gastroplasty

Chest physiotherapy is a common practice after open reflux and obesity surgery. It is now possible to perform fundoplication and vertical banded gastroplasty (VBG) by the laparoscopic technique. The aim of this study was to evaluate in a prospective, randomized, controlled trial whether chest physiotherapy affects the postoperative course.  A series of 40 patients underwent laparoscopic fundoplication; another 40 underwent laparoscopic VBG. Twenty patients in each series received prophylactic chest physiotherapy; the other 20 served as control patients and were not given any information or training.  Postoperatively, all patients had a significant reduction in respiratory function, measured as oxygen saturation, forced vital capacity, and peak expiratory flow, but the differences between the groups within each series were not significant. Postoperatively, one patient in the VBG treatment group had hypoxemia (SaO2 <92%) versus two control patients. One control patient developed postoperative pneumonia.  This study indicates that routine chest physiotherapy is not necessary in patients undergoing laparoscopic upper gastrointestinal surgery, such as fundoplication and VBG.