nils-herrmann/clean_scirepeval huggingface dataset:
A phase I study of bi-weekly docetaxel for recurrent or advanced gastric cancer patients whose disease progressed by prior chemotherapy.

Although docetaxel is active against gastric cancer, Grade 3 or 4 neutropenia occurs in the majority of patients in Japan when administered at 60 mg/m(2) every 3 weeks. To determine a more convenient and tolerable schedule than the tri-weekly schedule, we conducted a dose-escalation study of bi-weekly docetaxel. In this study, we investigated the maximum-tolerated dose and recommended dose.



Patients with advanced gastric cancer who had received prior chemotherapy were enrolled between April 2004 and March 2007. This study was designed to evaluate the escalated dose of docetaxel starting at 35 mg/m(2) (Level 1) given every 2 weeks. The dose was escalated in a stepwise fashion to 40 mg/m(2) (Level 2), 45 mg/m(2) (Level 3) and 50 mg/m(2) (Level 4).



Fifteen patients completed at least two cycles of the therapy. Three episodes of Grade 3 neutropenia occurred in all patients and Grade 4 neutropenia was observed at Level 4 in six patients. Grade 3 or 4 thrombocytopenia and anemia were not observed. Grade 3 aspartate aminotransferase/alanine aminotransferase elevation (n= 1) and Grade 3 stomatitis (n = 1) were noted at Level 4. There was no other Grade 3 or 4 non-hematologic toxicity. The definition of dose-limiting toxicities of this docetaxel schedule at Level 4 are Grade 4 neutropenia, Grade 3 aspartate aminotransferase/alanine aminotransferase elevation and Grade 3 stomatitis.



The maximum-tolerated dose of docetaxel when administrated following the bi-weekly schedule was 50 mg/m(2) and the recommended dose was 45 mg/m(2). Bi-weekly administration of docetaxel may provide a better tolerated and efficacious use in gastric cancer.
Rapid assessment of left ventricular systolic function in a pacemaker clinic using a hand-carried ultrasound device

Pacemaker recipients with left ventricular (LV) dysfunction are potential candidates for upgrades to implantable defibrillators or cardiac resynchronization devices. This study sought to determine if a hand-carried ultrasound (HCU) device could be used for rapid, inexpensive identification of LV dysfunction in a busy pacemaker clinic. Eighty patients undergoing routine pacemaker check were enrolled. Patients underwent HCU imaging in the sitting position during device interrogation, by an internist who had 20 h of didactic training and 20 practice examinations. LV dysfunction was defined as ejection fraction (EF) <40%. Patients also underwent echocardiography limited to EF assessment by a sonographer using a full-feature platform. The mean age was 75 ± 13 years; 49% were female. Coronary artery disease was present in 29%; 82% were NYHA class I or II. At the time of HCU imaging, 48% of patients were receiving RV pacing. HCU images were interpretable in 91% (73/80) and required 3.7 ± 0.9 min to complete. Based on the full-feature echo, LV dysfunction prevalence was 17/80 (21%); 25% of these patients were NYHA class I. The sensitivity of the HCU exam was 75%, specificity was 91%, negative predictive value was 93%, positive predictive value was 71%, and accuracy was 88%. HCU screening in a pacemaker clinic by a non-cardiologist can rapidly and accurately identify pacemaker recipients with at least moderate LV dysfunction who might be candidates for device upgrades. Ventricular dyssynchrony associated with RV pacing does not limit HCU identification of LV dysfunction.
The ALERT scale: an observational study of early prediction of adverse hospital outcome for medical patients

Some medical patients are at greater risk of adverse outcomes than others and may benefit from higher observation hospital units. We constructed and validated a model predicting adverse hospital outcome for patients. Study results may be used to admit patients into planned tiered care units. Adverse outcome comprised death or cardiac arrest during the first 30 days of hospitalisation, or transfer to intensive care within the first 48 h of admission.



The study took place at two tertiary teaching hospitals and two community hospitals in Winnipeg, Manitoba, Canada.



We analysed data from 4883 consecutive admissions at a tertiary teaching hospital to construct the Early Prediction of Adverse Hospital Outcome for Medical Patients (ALERT) model using logistic regression. Robustness of the model was assessed through validation performed across four hospitals over two time periods, including 65,640 consecutive admissions.



Receiver-operating characteristic curves (ROC) and sensitivity and specificity analyses were used to assess the usefulness of the model.



9.3% of admitted patients experienced adverse outcomes. The final model included gender, age, Charlson Comorbidity Index, Activities of Daily Living Score, Glasgow Coma Score, systolic blood pressure, respiratory rate, heart rate and white cell count. The model was discriminative (ROC=0.83) in predicting adverse outcome. ALERT accurately predicted 75% of the adverse outcomes (sensitivity) and 75% of the non-adverse outcomes (specificity). Applying the same model to each validation hospital and time period produced similar accuracy and discrimination to that in the development hospital.



Used during initial assessment of patients admitted to general medical wards, the ALERT scale may complement other assessment measures to better screen patients. Those considered as higher risk by the ALERT scale may then be provided more effective care from action such as planned tiered care units.
Age-specific mortality patterns in HIV-infected individuals: a comparative analysis of African community study data.

Describe age-specific mortality patterns of HIV-infected adults in African communities before introduction of HAART.



Mortality data (deaths and person-years observed) for HIV-positive subjects aged 15-65 from six African community studies in five different countries were pooled, combining information from 1793 seroconverters and 8534 HIV positive when first tested. Age-specific mortality hazards were modelled using parametric regression based on the Weibull distribution, to investigate effects of sex, and site-specific measures of mean age at incidence, crude mortality rate of uninfected, and measures of epidemic maturity.



The combined studies yielded a total of 31 777 person-years of observation for HIV-positive subjects, during which time 2602 deaths were recorded. Mortality rates rose almost linearly with age, from below 50/1000 at ages < 20 years, up to 150/1000 at 50 years +. There was no significant difference between men and women in level or age pattern of mortality. Weibull regression analysis suggested that intersite variation could be explained by HIV prevalence trend, and by the ratio of HIV proportional mortality to current HIV prevalence. A model representation was constructed with a common age pattern of mortality, but allowing the level to be adjusted by specifying HIV prevalence indicators.



The linear age trend of mortality in HIV-infected populations was satisfactorily represented by a Weibull function providing a parametric model adaptable for representing different levels of HIV-related mortality. This model might be simpler to use in demographic projections of HIV-affected populations than models based on survival post-infection.
Factors influencing the reinforcing and subjective effects of ephedrine in humans

There has been little study of the abuse liability of ephedrine, a naturally occurring drug used in medicine for thousands of years and currently sold as a “legal” stimulant. The present study measured the reinforcing and subjective effects of ephedrine in a group of 27 adults (18 females and 9 males) with no history of drug dependence. A discrete-trial choice procedure was used to assess the reinforcing effects of a single oral dose of ephedrine selected to produce a moderate subjective response in each subject (range: 37.5-75 mg). A number of variables (gender, current and past drug use, personality, and baseline mood and arousal) were examined in an attempt to identify sources of variability in response to ephedrine. Of the 27 subjects, 5 chose ephedrine on either 2 or 3 out of a possible 3 occasions; overall, ephedrine was chosen on 17% of occasions. In the group as a whole, ephedrine had no effect on ratings of drug liking, but did increase ratings of “high” and scores on the MBG (“euphoria”) scale of the Addiction Research Center Inventory. Ephedrine also increased scores on a number of mood scales reflecting CNS stimulation and anxiety. Ephedrine choice was positively associated with current use of marijuana and lower levels of baseline anxiety and hunger, as well as with lower scores on two scales measuring dimensions of the personality trait of harm avoidance. Males and females differed in their response to ephedrine — males chose ephedrine more frequently than females and showed a more positive mood response to the drug. When compared to the results of a prior study of the same design withd-amphetamine, these results demonstrate that ephedrine produces a different profile of subjective effects and is a less efficacious reinforcer than amphetamine, suggesting that ephedrine has a lower liability for abuse.
The Effect of Tamoxifen Dose Increment in Patients With Impaired CYP2D6 Activity.

The effect of tamoxifen dose elevation on endoxifen serum concentration was investigated in patients with reduced CYP2D6 activity resulting from genetic variation and/or CYP2D6 inhibitor use. Additionally, baseline differences in endoxifen concentrations between the different CYP2D6 phenotypes were studied.



Patients, treated with tamoxifen 20 mg once daily (QD) for at least 4 weeks, were classified as phenotypic extensive (EM), intermediate (IM), or poor (PM) metabolizer based on their genotype and comedication. In patients with an IM or PM phenotype, the tamoxifen dose was increased to 40 mg QD for 4 weeks. Tamoxifen, 4-OH-tamoxifen, N-desmethyltamoxifen, and endoxifen serum concentrations were measured at baseline and 4 weeks after the dose increment. Side effects of tamoxifen were assessed using the validated Functional Assessment of Cancer Therapy-Endocrine Symptom subscale (FACT-ESS-19).



The median baseline endoxifen concentration differed between EMs (11.4 mcg/L: n = 19), IMs (8.3 mcg/L: n = 16), and PMs (4.0 mcg/L: n = 7), P = 0.040. Tamoxifen dose elevation significantly increased the median endoxifen concentrations in 12 IMs from 9.5 to 17.4 mcg/L (P < 0.001) and in 4 PMs from 3.8 to 7.8 mcg/L (P = 0.001), without influencing median FACT-ESS-19 scores.



Raising the tamoxifen dose to 40 mg QD significantly increased endoxifen concentrations in IMs and PMs without increasing side effects. The tamoxifen dose increment in PMs was insufficient to reach endoxifen concentrations equal to those observed in EMs. Future studies will clarify the direct effect of endoxifen exposure on tamoxifen efficacy and may reveal a threshold endoxifen concentration that is critical for its efficacy.
Is NICE guidance for identifying lumbar nerve root compression misguided?

To determine the extent to which the clinical manifestations of a cohort of people undergoing surgery for lumbosacral nerve root compression satisfy those described in The National Institute for Health and Care Excellence (NICE) guidance. We studied consecutive admissions for lumbar nerve root decompression surgery at two neurosurgical units. Pre-operatively, each person’s clinical manifestations were documented and compared with NICE’s description. Post-operatively, at three time points (within 48 h, 3 months, 12 months), each person rated their symptoms as either better, the same, or worse. Pre-operatively, one person (0.8 %), from 123 admissions, under 20 different consultant neurosurgeons, had manifestations consistent with NICE’s clinical description of lumbar nerve root compression. Post-operatively, self-reported benefit associated with surgery appeared high, at all three time points (78–91 %), supporting the diagnosis of symptomatic nerve root compression and the value of surgery. In this small sample, from two units, NICE’s description of the clinical manifestations of lumbar nerve root compression did not describe 99 % of people having surgery for it. Using NICE’s definition to triage people with low back pain could result in prolonged symptoms and delayed treatment. Diagnosing lumbar nerve root compression is complex. NICE’s guidance requires examination.
Electrocardiographic safety evaluation of dihydroartemisinin piperaquine in the treatment of uncomplicated falciparum malaria.

Dihydroartemisinin-piperaquine (DP) could become a leading fixed combination malaria treatment worldwide. Although there is accumulating evidence of efficacy and safety from clinical trials, data on cardiotoxicity are limited. In two randomized controlled trials in Thailand, 56 patients had ECGs performed before treatment, 4 hours after the first dose, and 4 hours after the last dose. The mean (95% CI) changes in QTc interval (Bazett's correction) were 2 (-6 to 9) ms and 14 (7 to 21) ms, respectively. These small changes on the third day of treatment are similar to those observed elsewhere in the convalescent phase following antimalarial treatment with drugs known to have no cardiac effects and are therefore likely to result from recovery from acute malaria and not the treatment given. At therapeutic doses, DP does not have clinically significant effects on the electrocardiogram.
Impact of qigong exercise on self-efficacy and other cognitive perceptual variables in patients with essential hypertension.

The purpose of this study was to investigate the impact of practicing qigong on middle-age subjects with essential hypertension. Impacts on blood pressure, reported self-efficacy, perceived benefit, and emotion were observed.



Thirty-six (36) adult volunteers were assigned to either a waiting list control or a qigong group that practiced two 30-minute qigong programs per week over 8 consecutive weeks.



Systolic and diastolic blood pressure was significantly reduced in members of the qigong group after 8 weeks of exercise. Significant improvements in self-efficacy and other cognitive perceptual efficacy variables were also documented in the qigong group compared to the original situation described above.



This pilot study demonstrates the positive effects of practicing qigong on controlling blood pressure and enhancing perceptions of self-efficacy.
Midgut neuroendocrine tumor presenting with acute intestinal ischemia

Neuroendocrine tumors represent a heterogeneous group of neoplasms that arise from neuroendocrine cells and secrete various peptides and bioamines. While gastrointestinal neuroendocrine tumors, commonly called carcinoids, account for about 2/3 of all neuroendocrine tumors, they are relatively rare. Small intestine neuroendocrine tumors originate from intestinal enterochromaffin cells and represent about 1/4 of small intestine neoplasms. They can be asymptomatic or cause nonspecific symptoms, which usually leads to a delayed diagnosis. Imaging modalities can aid diagnosis and surgery remains the mainstay of treatment. We present a case of a jejunal neuroendocrine tumor that caused nonspecific symptoms for about 1 year before manifesting with acute mesenteric ischemia. Abdominal X-rays revealed pneumatosis intestinalis and an abdominal ultrasound and computed tomography confirmed the diagnosis. The patient was submitted to segmental enterectomy. Histopathological study demonstrated a neuroendocrine tumor with perineural and arterial infiltration and lymph node metastasis. The postoperative course was uneventful and the patient denied any adjuvant treatment.
Nonmuscle-invasive and Muscle-invasive Urinary Bladder Cancer

This study compared the imaging quality, diagnostic accuracy, and apparent diffusion coefficient (ADC) values of reduced field-of-view (rFOV) diffusion-weighted imaging (DWI) and full field-of-view (fFOV) single-shot echo-planar imaging with regard to patients with nonmuscle-invasive or muscle-invasive bladder cancer.Thirty-nine patients with 60 bladder tumors underwent rFOV and fFOV DWI in this internal review board-approved study. Pathologic and histologic grades were determined for all tumors. Two observers rated DWI image quality using a 4-point scale. Two radiologists who were blinded to the pathology findings reviewed 3 image sets (T2-weighted alone, T2-weighted plus fFOV DWI, and T2-weighted plus rFOV DWI) and assigned T stages and confidence levels for tumors of stage T2 or higher. The image quality scores for the 2 DWI sequences were assessed using the Wilcoxon signed-rank test. Differences in the diagnostic accuracy, sensitivity, and specificity for each image set were evaluated using the McNemar test. Differences in performance were analyzed by comparing the areas under the receiver-operating characteristic curves (ie, the Az values). A Mann-Whitney U test was used to compare the mean ADCs and the relationship between tumor stage and histologic grade.Image quality scores were significantly higher for rFOV (mean = 3.62) than for fFOV DWI (2.98; P < 0.001). The pooled diagnostic accuracies were 57%, 70%, and 78% for the T2-weighted alone images, the T2-weighted plus fFOV DWI images, and the T2-weighted plus rFOV DWI images, respectively. The overall accuracy, specificity, and Az for diagnosing T2 or higher stages were significantly improved by adding rFOV DWI (P < 0.05). The mean ADC values of the muscle-invasive and G3 grade bladder cancers were significantly lower than those of the nonmuscle-invasive tumors and G1 grade cancers, regardless of DWI sequence (P < 0.01).rFOV DWI is superior to fFOV DWI with respect to image quality and diagnostic accuracy. ADC values might be useful for distinguishing nonmuscle-invasive from muscle-invasive cancers, and G1 from G3 grade lesions.
The Centers for Medicare and Medicaid Services (CMS) community-acquired pneumonia core measures lead to unnecessary antibiotic administration by emergency physicians.

The objectives were to assess emergency physician (EP) understanding of the Centers for Medicare and Medicaid Services (CMS) core measures for community-acquired pneumonia (CAP) guidelines and to determine their self-reported effect on antibiotic prescribing patterns.



A convenience sample of EPs from five medical centers in North Carolina was anonymously surveyed via a Web-based instrument. Participants indicated their level of understanding of the CMS CAP guidelines and the effects on their prescribing patterns for antibiotics.



A total of 121 EPs completed the study instrument (81%). All respondents were aware of the CMS CAP guidelines. Of these, 95% (95% confidence interval [CI] = 92% to 98%) correctly understood the time-based guidelines for antibiotic administration, although 24% (95% CI = 17% to 31%) incorrectly identified the onset of this time period. Nearly all physicians (96%; 95% CI = 93% to 99%) reported institutional commitment to meet these core measures, and 84% (95% CI = 78% to 90%) stated that they had a department-based CAP protocol. More than half of the respondents (55%; 95% CI = 47% to 70%) reported prescribing antibiotics to patients they did not believe had pneumonia in an effort to comply with the CMS guidelines, and 42% (95% CI = 34% to 50%) of these stated that they did so more than three times per month. Only 40% (95% CI = 32% to 48%) of respondents indicated a belief that the guidelines improve patient care. Of those, this was believed to occur by increasing pneumonia awareness (60%; 95% CI = 52% to 68%) and improving hospital processes when pneumonia is suspected (86%; 95% CI = 80% to 92%).



Emergency physicians demonstrate awareness of the current CMS CAP guidelines. Most physicians surveyed reported the presence of institutional protocols to increase compliance. More than half of EPs reported that they feel the guidelines led to unnecessary antibiotic usage for patients who are not suspected to have pneumonia. Only 40% of EPs believe that CAP awareness and expedient care resulting from these guidelines has improved overall pneumonia-related patient care. Outcome-based data for non-intensive care unit CAP patients are lacking, and EPs report that they prescribe antibiotics when they may not be necessary to comply with existing guidelines.
A case-control study of vanishing twin as a risk factor for cerebral palsy.

It has been hypothesized that cerebral palsy of unknown etiology is the result of the death of an unrecognized co-twin--a vanishing twin--in early gestation. We conducted a case-control study of vanishing twin as a risk factor for cerebral palsy of unknown etiology in women who had an obstetric ultrasound during pregnancy. Among mothers of cases, one of 86 had evidence of a vanishing twin on ultrasound, as compared to two of 381 control mothers (odds ratio [OR] 2.2, 95% confidence interval [CI] 0.2-24.8; p = 0.5). Bleeding in early pregnancy, which may indicate the loss of a co-twin, was reported by 14 case mothers and 46 control mothers (OR 1.6, 95% CI 0.8-3.0; p = 0.3). On the basis of results presented here, the vanishing twin syndrome is unlikely to account for a high proportion of cases of cerebral palsy, but there is insufficient statistical power to draw firm conclusions.
Development and Validation of a Pain Behavior Assessment in Patients with Chronic Low Back Pain

High levels of pain behavior adversely affect the success of multidisciplinary rehabilitation of patients with chronic nonspecific low back pain (CNSLBP). Functional capacity evaluation (FCE) assessment should detect high levels of pain behavior to prevent the inclusion of unsuitable patients to functional rehabilitation programs. The aim of this study was to develop a Pain Behavior Assessment (PBA) and to evaluate its construct validity.  The PBA was developed by experts in the field and is literature-based. Inclusion criteria for participants of the validation study were: CNSLBP, age 20–60 years, referral for fitness-for-work evaluation. The PBA was applied by physiotherapists during FCE. Rasch analysis was performed to evaluate the construct validity of the PBA. Internal consistency was indicated by the person separation index (PSI), which corresponds to Cronbach’s alpha.  145 male (72.5 %) and 55 female patients were included. Rasch analysis removed 11 items due to misfit and redundancy, resulting in a final PBA of 41 items. Item mean fit residual was −0.33 (SD 1.06) and total item Chi square 100.39 (df = 82, p = 0.08). The PSI value was 0.83. DIF analysis for age and gender revealed no bias.  The PBA is a valid assessment tool to describe pain behavior in CNSLBP patients. The high PSI-value justifies the use of the PBA in individuals. The PBA may help to screen patients for high levels of pain behavior.
What relation is there between deep brain stimulation and coping strategies in Parkinson's disease?

We investigated the effect of the deep brain stimulation (DBS) on coping strategies while taking depression into account. Patients with Parkinson's disease (PD) were divided into three groups matched for sex, age, and disease severity: one, just before DBS, another at 12 months post DBS, and a group of patients not being considered for DBS. Each patient was asked to complete two self-reports about their coping styles: The ways of coping check list and the coping with health, injuries, and problems scale. The Montgomery and Asberg depression rating scale was assessed by a psychologist. After control for depression, significant differences were noticed concerning two coping strategies: instrumental (P < 0.01) and emotional (P < 0.05) ones, with higher instrumental coping strategies (seeking more information) for patients prior DBS and higher emotional strategies (avoidance, emotional preoccupation) for patients not being considered for surgery. These results confirmed our clinical impression that coping strategies differ as a function of the surgical status of PD patients.