nils-herrmann/clean_scirepeval huggingface dataset:
Case-control study on analgesics and nephropathy (SAN): protocol

The association between intake of non-phenacetin-containing analgesics and the occurrence of chronic renal failure is still controversially discussed. A new epidemiologic study was planned and conducted in Germany and Austria.



The objective of the international, multicenter case-control study was to evaluate the association between end-stage renal disease (ESRD) and use of non-phenacetin-containing analgesics with particular emphasis on combined formulations. A targeted sample of 1000 new (incident) dialysis patients, aged less than 50 years, was planned to recruit between January 1, 2001 and December 31, 2004. The age limit was chosen to avoid contamination of the study population with phenacetin-containing analgesics to the extent possible. Four control subjects per ESRD case, matched by age, sex, and region were selected from the population living in the region the case came from. Lifetime exposure to analgesics and potential renal risk factors were recorded in a single face-to-face interview. A set of aids was introduced to reinforce the memory of study participants. A standardized, pre-tested interview questionnaire (participants), a medical documentation sheet (physicians in dialysis centres), a logbook for all activities (dialysis centres) were used to collect the necessary data. Quality management consisted of the standardized procedures, (re-) training and supervision of interviewers, regular checks of all incoming data for completeness and plausibility. The study is scientifically independent and governed by a international Scientific Advisory Committee that bridged the gap between the sponsoring companies and the investigators. Also other advisory groups assisted the managing committee of the study. All relevant German and Austrian nephrological associations supported the study, and the study design was carefully reviewed and approved by the Kidney Foundation of Germany.



The study is expected to answer the main research question by end 2005. There is however a high potential for various biases that we tried to address with adequate measure. One limitation however cannot be overcome: The methodologically needed age-limitation of the study will make it not easy to generalize the results to age groups over 50 years. It might be suggested to repeat the study for persons over 50 years in 10 years when contamination with phenacetin use early in life is likely to be outgrown.
The effect of aprepitant and race on the pharmacokinetics of cyclophosphamide in breast cancer patients

The prodrug cyclophosphamide is metabolized by cytochrome P450(CYP)2B6 to the active metabolite, 4-hydroxycyclophosphamide (4-OH), and by CYP3A4/5 to toxic chloracetaldehyde and 2-dechloroethylcyclophosphamide (DCE). Since aprepitant is a moderate inhibitor of CYP3A4, the study was designed to determine whether its concurrent use alters the pharmacokinetics (PK) of cyclophosphamide. In addition, we sought to determine the effect of race and pharmacogenomics on cyclophosphamide PK. Eighteen patients with localized breast cancer were randomized in this double-blinded cross-over study to receive aprepitant or placebo in addition to cyclophosphamide 600 mg/m2 and doxorubicin 60 mg/m2. Blood samples were collected for both PK analysis of cyclophosphamide and metabolites and pharmacogenomic analysis. Single nucleotide polymorphisms genotyped were CYP3A4*1B, CYP3A5*3, and CYP2B6*6. The geometric mean area under concentration–time curve (AUC0−t μg/mL h) for cyclophosphamide was 282 following aprepitant and 230 following placebo (ratio 1.23; 90% CI 1.13, 1.33). 4-OH AUC0−t (μg/mL h) was 6.80 following aprepitant and 6.96 following placebo (ratio 0.98; 90% CI 0.88, 1.08). DCE AUC0−t (μg/mL h) was 6.76 following aprepitant and 9.37 following placebo (ratio 0.72; 90% CI 0.64, 0.81). Genotype analysis was confounded by race. Race was a significant predictor of DCE lnAUC0−t (P = 0.0169) as African Americans had approximately a 2-fold higher DCE AUC than Caucasians. Aprepitant altered the exposure of cyclophosphamide and DCE but not the active 4-OH metabolite, making it unlikely that aprepitant would change the clinical efficacy of cyclophosphamide. African Americans were also found to have altered PK compared with Caucasian patients.
Left ventricular dyssynchrony resulting from right ventricular apical pacing: relevance of baseline assessment.

Evaluation of left ventricular (LV) dyssynchrony in patients undergoing short-term right ventricular apical (RVA) pacing and correlation with baseline echocardiographic and clinical characteristics.



RVA pacing causes abnormal ventricular depolarization that may lead to mechanical LV dyssynchrony. The relationships between pacing-induced LV dyssynchrony and baseline echocardiographic and clinical variables have not been fully clarified.



Tissue Doppler echocardiography was performed in 153 patients before and after RVA pacing. LV dyssynchrony was measured by the time between the shortest and longest electromechanical delays in the five basal LV segments (intra-LV). The prevalence and degree of LV dyssynchrony after RVA pacing was evaluated in three groups: baseline LV ejection fraction (LVEF) <35%, 35-55%, and >or=55%. The intrapatient effect of RVA pacing was determined as the percent increase in intra-LV value (Deltaintra-LV%). The pacing-induced intra-LV was correlated with baseline variables.



The prevalence and degree of LV dyssynchrony after RVA pacing was significantly higher in patients with lower LVEF (P < 0.001). DeltaIntra-LV% was inversely correlated with baseline intra-LV and LVEF (B =-2.6, B =-4.2, P < 0.001). Baseline intra-LV and LV end-systolic volume correlated positively with intra-LV after RVA pacing (B = 0.49, B = 0.6, P < 0.001), whereas LVEF showed an inverse correlation.



The degree of LV dyssynchrony induced by RVA is variable. Patients with higher baseline LV dyssynchrony, more dilated LV, and more depressed LVEF showed a higher degree of LV dyssynchrony during pacing. These findings may assume importance in predicting the risk of heart failure in pacemaker patients.
Effects of multiple-dose pegylated interferon alfa-2b on the activity of drug-metabolizing enzymes in persons with chronic hepatitis C

To examine the effect of pegylated interferon (PEG-IFN) alfa-2b on the activity of major drug-metabolizing enzymes. This nonrandomized, open-label, multiple-dose study examined the effects of PEG-IFN alfa-2b on the activity of CYP450 1A2, 2 C8/9, 2D6, and 3A4 enzymes and N-acetyltransferase in subjects with chronic hepatitis C. Eligible subjects received PEG-IFN alfa-2b 1.5 μg/kg subcutaneously once weekly for 4 weeks (days 3, 10, 17, and 24). Oral probe substrates (dextromethorphan hydrobromide 45 mg, caffeine 200 mg, tolbutamide 500 mg, and dapsone 100 mg) were administered after a 10-h fast on days 1 and 25. Midazolam 4 mg was administered orally on days 2 and 26. Enzyme activity for each CYP450 isozyme and for N-acetyltransferase was estimated based on the ratios of the observed concentrations of the substrates and metabolites in plasma or urine samples. Twenty-six subjects enrolled in the study. Mean age was 44.3 years, mean weight was 78.9 kg, and mean body mass index was 26.3 kg/m2. Multiple doses of PEG-IFN alfa-2b inhibited CYP1A2 activity to a limited extent (point estimate = 84.2%, 90% confidence interval [CI] 79–90), increased CYP2C8/9 activity to a limited extent (point estimate = 127.6%, 90% CI 115–142), increased CYP2D6 activity (point estimate = 167%, 90% CI 125–223), and had no effect on the activity of CYP3A4 or N-acetyltransferase. Weekly administration of PEG-IFN alfa-2b to subjects with chronic hepatitis C increased CYP2C8/9 and CYP2D6 activity in some individuals.
Strategy for purification and mass spectrometry identification of SELDI peaks corresponding to low-abundance plasma and serum proteins.

Analysis by SELDI-TOF-MS of low abundance proteins makes it possible to select peaks as candidate biomarkers. Our aim was to define a purification strategy to optimise identification by MS of peaks detected by SELDI-TOF-MS from plasma or serum, regardless of any treatment by a combinatorial peptide ligand library (CPLL). We describe 2 principal steps in purification. First, choosing the appropriate sample containing the selected peak requires setting up a databank that records all the m/z peaks detected from samples in different conditions. Second, the specific purification process must be chosen: separation was achieved with either chromatographic columns or liquid-phase isoelectric focusing, both combined when appropriate with reverse-phase chromatography. After purification, peaks were separated by gel electrophoresis and the candidate proteins were analyzed by nano-liquid-chromatography-MS/MS. We chose 4m/z peaks (9400, 13,571, 13,800 and 15,557) selected for their differential expression between two conditions, as examples to explain the different strategies of purification, and we successfully identified 3 of them. Despite some limitations, our strategy to purify and identify peaks selected from SELDI-TOF-MS analysis was effective.
Acid-Suppressive Therapy With Esomeprazole for Relief of Unexplained Chest Pain in Primary Care: A Randomized, Double-Blind, Placebo-Controlled Trial

High-quality data regarding the efficacy of acid-suppressive treatment for unexplained chest pain are lacking. The aim of this study was to evaluate the efficacy of esomeprazole in primary-care treatment of patients with unexplained chest pain stratified for frequency of reflux/regurgitation symptoms.Patients with a ≥2-week history of unexplained chest pain (unrelated to gastroesophageal reflux) who had at least moderate pain on ≥2 of the last 7 days were stratified by heartburn/regurgitation frequency (≤1 day/week (stratum 1) vs. ≥2 days/week (stratum 2)) and randomized to 4 weeks of double-blind treatment with twice-daily esomeprazole 40 mg or placebo. Chest pain relief during the last 7 days of treatment (≤1 day with minimal symptoms assessed daily using a 7-point scale) was analyzed by stratum in keeping with the predetermined analysis plan.Overall, 599 patients (esomeprazole: 297, placebo: 302) were randomized. In stratum 1, more esomeprazole than placebo recipients achieved chest pain relief (38.7% vs. 25.5%; P=0.018); no between-treatment difference was observed in stratum 2 (27.2% vs. 24.2%; P=0.54). However, esomeprazole was superior to placebo in a post-hoc analysis of the whole study population (combined strata; 33.1% vs. 24.9%; P=0.035).CONCLUSIONS:A 4-week course of high-dose esomeprazole provided statistically significant relief of unexplained chest pain in primary-care patients who experienced infrequent or no heartburn/regurgitation, but there was no such significant reduction in patients with more frequent reflux symptoms.
Developing a measure of eating attitudes and behaviours in cystic fibrosis.

Eating disorders or disturbed eating attitudes and behaviours (EABs) may contribute to poor nutritional status in Cystic Fibrosis (CF). Existing measures of disturbed EABs can have different meanings in this population and do not assess CF-related EABs. A self-report measure of EABs in CF was developed to highlight areas of eating disturbance.



The content validity of a draft measure was evaluated via expert evaluation and literature review and an amended measure piloted with 8 CF patients using cognitive interviewing. A further amended measure was administered to 155 CF patients (11-62 years) attending CF clinics.



Principal components analyses revealed a three-factor structure ('Desire for thinness and weight loss', 'Disturbed EABs', and 'Appetite') with good internal consistencies for subscales and the 21-item whole measure.



The measure looks promising as a tool to highlight EAB disturbance in CF. Further work will establish its construct validity and clarify interpretation of subscales.
Barriers for individuals with spinal cord injury returning to the community: a preliminary classification.

With decreased length of stay for inpatient rehabilitation, individuals with newly acquired spinal cord injury (SCI) might be discharged back into the community without the level of knowledge and functional skills necessary to live successfully post injury. This research studied the course of recovery and outcomes after the delivery of a coordinated inpatient rehabilitation system of care for individuals with SCI.



Individuals with newly acquired SCI face numerous barriers during reintegration into the community. The purpose of this article is to identify and develop a preliminary classification of barriers to community reintegration that persons with SCI experience during the post-acute period.



This 1-year study is the qualitative arm of a randomized controlled pilot study. Twenty-six people with SCI participated (mean age 40.6 years, 81% male and 54% tetraplegic). Self-reported data were collected during the first year post discharge from inpatient rehabilitation.



The three most common categories of self-reported barriers were mobility and equipment issues (23%), lack of environmental, and home assistance (20%), and insurance issues (18%). The two most common specific barriers were lack of insurance coverage (6.5% of all reported barriers) and residing in a nursing home (5.4%).



Our findings provide a preliminary classification of the barriers newly injured persons with SCI encounter during the post-acute period.
A comparison of the national registry of myocardial infarction 2 with the cooperative cardiovascular project.

This study was performed to evaluate whether or not the simpler case identification and data abstraction processes used in National Registry of Myocardial Infarction two (NRMI 2) are comparable with the more rigorous processes utilized in the Cooperative Cardiovascular Project (CCP).



The increased demand for quality of care and outcomes data in hospitalized patients has resulted in a proliferation of databases of varying quality. For patients admitted with myocardial infarction, there are two national databases that attempt to capture critical process and outcome data using different case identification and abstraction processes.



We compared case ascertainment and data elements collected in Medicare-eligible patients included in the industry-sponsored NRMI 2 with Medicare enrollees included in the Health Care Financing Administration-sponsored CCP who were admitted during identical enrollment periods. Internal and external validity of NRMI 2 was defined using the CCP as the "gold standard."



Demographic and procedure use data obtained independently in each database were nearly identical. There was a tendency for NRMI 2 to identify past medical histories such as prior infarct (29% vs. 31%, p < 0.001) or heart failure (21% vs. 25%, p < 0.001) less frequently than the CCP. Hospital mortality was calculated to be higher in NRMI 2 (19.7% vs. 18.1%, p < 0.001) due mostly to the inclusion of noninsured patients 65 years and older in NRMI 2.



We conclude that the simpler case ascertainment and data collection strategies employed by NRMI 2 result in process and outcome measures that are comparable to the more rigorous methods utilized by the CCP. Outcomes that are more difficult to measure from retrospective chart review such as stroke and recurrent myocardial infarction must be interpreted cautiously.
Proton therapy for breast cancer after mastectomy: early outcomes of a prospective clinical trial.

Dosimetric planning studies have described potential benefits for the use of proton radiation therapy (RT) for locally advanced breast cancer. We report acute toxicities and feasibility of proton delivery for 12 women treated with postmastectomy proton radiation with or without reconstruction.



Twelve patients were enrolled in an institutional review board-approved prospective clinical trial. The patients were assessed for skin toxicity, fatigue, and radiation pneumonitis during treatment and at 4 and 8 weeks after the completion of therapy. All patients consented to have photographs taken for documentation of skin toxicity.



Eleven of 12 patients had left-sided breast cancer. One patient was treated for right-sided breast cancer with bilateral implants. Five women had permanent implants at the time of RT, and 7 did not have immediate reconstruction. All patients completed proton RT to a dose of 50.4 Gy (relative biological effectiveness [RBE]) to the chest wall and 45 to 50.4 Gy (RBE) to the regional lymphatics. No photon or electron component was used. The maximum skin toxicity during radiation was grade 2, according to the Common Terminology Criteria for Adverse Events (CTCAE). The maximum CTCAE fatigue was grade 3. There have been no cases of RT pneumonitis to date.



Proton RT for postmastectomy RT is feasible and well tolerated. This treatment may be warranted for selected patients with unfavorable cardiac anatomy, immediate reconstruction, or both that otherwise limits optimal RT delivery using standard methods.
A robotic device as a sensitive quantitative tool to assess upper limb impairments in stroke patients: a preliminary prospective cohort study.

To compare kinematic indices in age-matched healthy subjects and stroke patients, by evaluating various tasks performed with a robotic device, and to provide an objective and standardized protocol to assess upper limb impairments in stroke patients.



A prospective cohort study.



Age-matched healthy subjects (n = 10) and stroke patients (n = 10).



Various kinematic indices were analysed from 3 randomly assigned tasks performed by the affected arm in stroke patients and the dominant arm in healthy subjects. These tasks, composed of large-amplitude, targeted and geometrical movements, were standardized and performed with the ReaPLAN robotic device.



For large-amplitude movements, the stroke patients' path lengths were less constant in amplitude, less rectilinear and less smooth than those for healthy subjects (p < 0.001). For the targeted movements, the stroke patients' path lengths were less rectilinear than those of the healthy subjects (p < 0.001). For the geometrical movements, the stroke patients had greater difficulty making the requested shapes compared with the healthy subjects (p < 0.01).



Our study proposes an objective and standardized protocol to assess stroke patients' upper limbs with any robotic device. We suggest that further randomized controlled trials could use this quantitative tool to assess the efficacy of treatments such as robot-assisted therapy.
Prognostic impact of day 15 blast clearance in risk-adapted remission induction chemotherapy for younger patients with acute myeloid leukemia: long-term results of the multicenter prospective LAM-2001 trial by the GOELAMS study group.

Early response to chemotherapy has a major prognostic impact in acute myeloid leukemia patients treated with a double induction strategy. Less is known about patients treated with standard-dose cytarabine and anthracycline. We designed a risk-adapted remission induction regimen in which a second course of intermediate-dose cytarabine was delivered after standard "7+3" only if patients had 5% or more bone marrow blasts 15 days after chemotherapy initiation (d15-blasts). Of 823 included patients, 795 (96.6%) were evaluable. Five hundred and forty-five patients (68.6%) had less than 5% d15-blasts. Predictive factors for high d15-blasts were white blood cell count (P<0.0001) and cytogenetic risk (P<0.0001). Patients with fewer than 5% d15-blasts had a higher complete response rate (91.7% vs. 69.2%; P<0.0001) and a lower induction death rate (1.8% vs. 6.8%; P=0.001). Five-year event-free (48.4% vs. 25%; P<0.0001), relapse-free (52.7% vs. 36.9%; P=0.0016) and overall survival (55.3% vs. 36.5%; P<0.0001) were significantly higher in patients with d15-blasts lower than 5%. Multivariate analyses identified d15-blasts and cytogenetic risk as independent prognostic factors for the three end points. Failure to achieve early blast clearance remains a poor prognostic factor even after early salvage. By contrast, early responding patients have a favorable outcome without any additional induction course.
[Short-term impact of an ambulatory cardiac rehabilitation program on arterial rigidity].

If the positive impact of cardiac rehabilitation on metabolic profile and exercise tolerance is well documented in the literature, very few studies evaluated the impact of these rehabilitation programs on arterial rigidity.



The main objective of this study was to determine if a short and intense 4-week cardiac rehabilitation program could yield a positive impact on arterial rigidity.



A cohort study was performed on Leopold Bellan Foundation. All patients referred for cardiac rehabilitation program after an acute event (surgery, technical gesture or acute decompensate heart failure) were included in this study. Our CR program consists of four sessions per week for five weeks (total of 20 sessions) and includes both exercise and health and nutrition education sessions. In addition to clinical and therapeutic data collection, biochemical analysis for carbohydrate and lipid metabolism and exercise capacity measurements, carotid femoral pulse wave velocity (PWV) were measured in a quiet room in the morning of their first and last day prior to any exercise.



One hundred and ninety-eight cardiac patients have participated in this study, of which 79% were male, mean age 60 ± 10, 50 (25%) were diabetic, 103 (52%) were hypertensive, 60 (30%) were current smokers, 98 (50%) had dyslipidemia, and 140 (71%) were referred for cardiac rehabilitation after acute coronary syndrome. Arterial stiffness is defined by a VPWV value greater or equal to 10. At the beginning, 59% of our patients have rigid arteries. After 20 sessions of cardiac rehabilitation, this number is significantly reduced to 51% (P=0.12). Patients with arterial stiffness have accumulated more major cardiovascular risk factors, and have had less exercise capacity than others. However they benefit similarly from the cardiovascular rehabilitation program.



In the present study, we observed that arterial stiffness, as reflected by the PWV, tends to decrease after short-term ambulatory cardiac rehabilitation program.
Detection of Faces of Various Directions in Complex Backgrounds

This paper describes the detection of faces in complex backgrounds where their sizes, positions and directions are arbitrary. We detect the faces by extracting face components such as eyes, a mouth and so on. We first extract face features and then calculate their likelihoods as each face component. Second we detect the face features which satisfy geometrical relations of the face. In order to reduce the number of combinations of all labels for all features, we determine face candidate regions using generalized Hough transform and then apply a relaxation method to each candidate region.