nils-herrmann/clean_scirepeval huggingface dataset:
The influence of fenflumizole on platelet aggregation in patients with unstable angina pectoris

We have studied the antiaggregatory effect of fenflumizole, a new non-steroidal antiinflammatory imidazole derivative, in ten patients with unstable angina pectoris. We have measured the aggregation induced by arachidonic acid (AA), ADP, and collagen, and serum or plasma concentrations of β-thromboglobulin (β-TG), platelet factor 4 (PF-4), thromboxane B2 (TXB2), and fenflumizole before, during, and after treatment with fenflumizole in two different regimens either as 10 mg b.i.d. for four days followed by 10 mg daily for six days (Group I,n=5), or as 20 mg b.i.d. for four days followed by 20 mg daily for six days (Group II,n=5). The threshold concentration of AA-induced platelet aggregation increased in both groups by the first day of treatment, the mean increase being significantly higher in Group II than in Group I. There was close correlation between serum fenflumizole and the threshold concentration of AA-induced platelet aggregation (r=0.95). A significant fall in TXB2 occurred in both groups. In group I TXB2 concentrations subsequently increased to initial values during treatment, whereas it remained significantly reduced in Group II. There were no significant changes in collagen and ADP aggregation, and β-TG and PF-4 concentrations remained unchanged during and after the administration of fenflumizole.
Long-Term Impact of a Community Health Worker Intervention on Diabetes Control in American Samoa

Diabetes Care in American Samoa (DCAS) was a randomized controlled trial of a 12-month intervention facilitated by community health workers (CHWs) that demonstrated improved HbA1c levels compared with usual care at trial completion. We sought to evaluate the long-term impact of this intervention on diabetes control.



We retrospectively collected HbA1c measurements from medical records of DCAS participants (n = 268). The study group received the intervention during the trial, and the control group received the intervention after the trial. We used mixed-effects longitudinal regression models to assess change in HbA1c within each trial arm during 3 time periods: DCAS (12 months of the study group's intervention), the first year after DCAS (control group's intervention), and the second year after DCAS. Models were adjusted for baseline characteristics that differed significantly for participants with a low number of HbA1c measurements from those with a high number of HbA1c measurements.



After adjustment for confounders, the experiment group experienced a decrease in HbA1c of 0.28 units per year (95% confidence interval [CI], -0.64 to 0.07) during DCAS (intervention). HbA1c decreased by 0.88 units per year (95% CI, -1.31 to -0.45) during the year after the intervention. No significant change was observed the following year. HbA1c of the control group did not significantly change during DCAS (usual care) but decreased by 1.31 units per year (95% CI, -1.72 to -0.91) during its intervention. During the year after the control group's intervention, HbA1c increased by 1.18 units per year (95% CI, 0.42 to 1.93).



Both groups had initial improvements in glycemic control, but HbA1c later plateaued or increased. These results suggest that time-limited CHW programs improve diabetes control in the short term, but ongoing programs are needed for sustained impact.
Predicting 12-month mortality for persons with dementia.

We develop and test a model of 12-month mortality among persons (N=3858) with organic dementia.



Data are from caregiver interviews and claims records for persons enrolled in the Medicare Alzheimer's Disease Demonstration Evaluation. Information covers the year prior to enrollment through 36 months. We used Proportional hazards models to predict time to death. We estimated two starting points: first, the date of randomization, and second, the date of maximum difficulty in performing two or more activities of daily living (ADLs).



The final model includes age, gender, ADL difficulty, medical conditions, prior year hospitalizations, and whether a daughter was the primary caregiver. We combined hazard ratios to produce a cumulative mortality risk score. Model discrimination is reasonable for both models (c statistics of.72 and.69, respectively), and calibration tests were nonsignificant.



The model's efficiency, as measured by the ratio of false positives (those predicted to die, but who lived) to true positives (those predicted to die and who did die) ranged from fewer than 1:1 to more than 4:1 as the model's sensitivity increased. This ratio was lower in the two or more ADL difficulty model. A validation test of the prediction model found comparable sensitivity and specificity (c statistic of.69) to the reference model.
Impact of lifestyle and psychological stress on the development of early onset breast cancer

The present study aimed to investigate risk factors for early onset breast cancer that are related to lifestyle and psychological stress. A comparative case-control study was performed among patients from the Department of Breast Surgery in Shanghai Cancer Center of Fudan University. The information regarding risk factors associated with the development of early onset breast cancer was collected using a questionnaire in a face-to-face interview. The distribution of the risk factors associated with the development of early onset breast cancer between the patient group and the control group was analyzed with logistic regression. A total of 582 cases of young patients (≤40 years old) with breast cancer and 540 controls of young patients (≤40 years old) with benign breast disease were included in this study. The risk factors for breast cancer in young women include age at first birth (odds ratio [OR] = 0.93, 95% confidence interval [CI]: 0.88-0.98), history of breast cancer in an immediate family member (OR = 2.36, 95% CI: 1.14-4.89), history of genital surgery (OR = 2.11, 95% CI: 1.16-3.82), active and passive smoking in daily life or the environment (OR = 1.64, 95% CI: 1.19-2.25), weekly intake of soy products (OR = 1.24, 95% CI: 1.02-1.49), use of household cooking oil (OR = 2.04, 95% CI: 1.04-4.00), disharmonious marital status (OR = 1.16, 95% CI: 1.06-1.26), frequent depression (OR = 1.32, 95% CI: 1.00-1.75), and negative emotional experiences (OR = 1.15, 95% CI: 1.03-1.29). Our study could provide the basis for risk assessment and preventive interventions for early onset breast cancer.
Preliminary results of a phase I/II study of simultaneous boost irradiation radiotherapy for locally advanced nasopharyngeal carcinoma.

The purpose of this article is to present preliminary results of simultaneous boost irradiation radiotherapy for locally advanced nasopharyngeal carcinoma (NPC).



Fifty-eight patients who underwent simultaneous boost irradiation radiotherapy for NPC in Cancer Center of Sun Yat-sen University between September 2004 and December 2009 were eligible. Acute and late toxicities were scored weekly according to the Radiation Therapy Oncology Group (RTOG) acute and late radiation morbidity scoring schemes. An especial focus was on evidence of post-radiation brain injury. Also quality of life was analysed according to the EORTC (European Organisation for Research and Treatment of Cancer) recommendations. Discrete variables were compared by ?2 test. The Kaplan-Meier method was used to calculate the survival rates and generate survival curves.



A total of 58 patients with a mean follow-up time of 36 months completed clinical trials.Fifty- seven patients (98.3) achieved complete remission in the primary sites and cervical lymph nodes, with only one patient (1.7%) showing partial remission.The most frequently observed acute toxicities during the concurrent chemoradiotherapy were mucositis and leucopenia. Four patients (6.9%) had RTOG grade 3 mucositis, whereas four patients (6.9%) had grade 3 leucopenia. No patient had grade 4 acute toxicity. Three (5.17%) of the patients exhibited injury to the brain on routine MRI examination, with a median observation of 32 months (range, 25-42months). All of them were RTOG grade 0. The 3-year overall, regional-free and distant metastasis-free survival rates were 85%, 94% and 91%, respectively.



Simultaneous boost irradiation radiotherapy is feasible in patients with locally advanced nasopharyngeal carcinoma. The results showed excellent local control and overall survival, with no significant increase the incidence of radiation brain injury or the extent of damage. A larger population of patients and a longer follow-up period are needed to evaluate ultimate tumor control and late toxicity.
Cortical hyperexcitability in migraine patients before and after sodium valproate treatment.

DC-magnetoencephalography (DC-MEG)waveforms arising during migraine aura were used to determine the effectiveness of prophylactic medication therapy on neuronal hyperexcitability. Nine patients were prescribed valproate (Depakote) for migraine prophylaxis. MEG scans were recorded during visual stimulation before commencing medication and again after 30 days of daily use of valproate. Cortical brain activity was recorded during stimulation with a black-and-white circular checkerboard pattern alternating at 8 Hz and were analyzed with MR-FOCUSS. Large-amplitude DC-MEG signals, imaged to extended areas of occipital cortex, were seen before therapy. After 30 days of prophylactic treatment, reduced DC-MEG shifts in the occipital cortex and reduced incidence of migraine attacks were observed. Using visual stimulation, the authors demonstrated the hyperexcitability of widespread regions throughout occipital cortex in migraine patients, explaining the susceptibility for triggering spreading cortical depression and migraine aura. This study confirms that MEG can noninvasively determine the status of neuronal excitability before and after therapy. This finding may be helpful in determining which prophylactic medications will be most effective in reducing hyperexcitability in particular patients.
Graft loss following renal transplantation in Australia: is there a centre effect?

Assessment of centre variation in renal transplantation outcome provides an opportunity to examine differences in quality of care between centres. However, differences in outcome may represent differences in patient factors between centres and be biased by sampling variability and inadequate data ascertainment.



Differences in 12-month graft survival in 1986 primary renal transplant adult recipients from 16 centres in Australia between 1993 and 1998 were examined. Fifteen recipient and donor factors known prior to transplantation were examined to determine factors independently predictive of graft survival. Differences between centres in these factors were examined. Unadjusted and multivariable adjusted outcomes for each centre were compared to the average for all centres. Multivariable hierarchical modelling was employed to account for potential bias due to sampling variability.



Factors predictive of reduced 12-month graft survival on multivariable analysis that were significantly different between centres were time on dialysis prior to transplantation, donor age, organ source, and number of human lymphocyte antigen mismatches. Unadjusted 12-month graft survival for all centres was 91.7% and ranged from 83.1 to 96.4%. Although two centres performed significantly lower than average, this poorer outcome was accounted for in one of these two centres after adjusting for factors shown to be independently predictive of outcome. However, multivariable hierarchical modelling failed to identify any centre as performing significantly different to average, with 12-month graft survival ranging from 89.2 to 92.2%. Outcome in patients excluded from the study due to inadequate data ascertainment was significantly worse than patients who were included.



There was no evidence of centre variation after accounting for variation in risk factors predictive of poor outcome between centres, as well as potential bias due to sampling variability. Exclusion of patients due to inadequate data remains an important source of bias in estimating accurate outcomes. Appropriate analytical strategies and consideration of sources of bias are important for the valid identification of centres with poorer outcomes.
Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis: A Single-Center Open-Label Prospective Study.

Chinese herbal medicine Qing-Dai (also known as indigo naturalis) has been used to treat various inflammatory conditions. However, not much has been studied about the use of oral Qing-Dai in the treatment for ulcerative colitis (UC) patients. Studies exploring alternative treatments for UC are of considerable interest. In this study, we aimed at prospectively evaluating the safety and efficacy of Qing-Dai for UC patients.



The open-label, prospective pilot study was conducted at Keio University Hospital. A total of 20 patients with moderate UC activity were enrolled. Oral Qing-Dai in capsule form was taken twice a day (daily dose, 2 g) for 8 weeks.



At week 8, the rates of clinical response, clinical remission, and mucosal healing were 72, 33, and 61%, respectively. The clinical and endoscopic scores, CRP levels, and fecal occult blood results were also significantly improved. We observed 2 patients with mild liver dysfunction; 1 patient discontinued due to infectious colitis and 1 patient discontinued due to mild nausea.



This is the first prospective study indicating that oral Qing-Dai is effective for inducing remission in patients with moderate UC activity and can be tolerated. Thus, Qing-Dai may be considered an alternative treatment for patients, although further investigation is warranted.
Validation of cytoplasmic-to-nuclear ratio of survivin as an indicator of improved prognosis in breast cancer

Conflicting data exist regarding the prognostic and predictive impact of survivin (BIRC5) in breast cancer. We previously reported survivin cytoplasmic-to-nuclear ratio (CNR) as an independent prognostic indicator in breast cancer. Here, we validate survivin CNR in a separate and extended cohort. Furthermore, we present new data suggesting that a low CNR may predict outcome in tamoxifen-treated patients. Survin expression was assessed using immunhistochemistry on a breast cancer tissue microarray (TMA) containing 512 tumours. Whole slide digital images were captured using an Aperio XT scanner. Automated image analysis was used to identify tumour from stroma and then to quantify tumour-specific nuclear and cytoplasmic survivin. A decision tree model selected using a 10-fold cross-validation approach was used to identify prognostic subgroups based on nuclear and cytoplasmic survivin expression. Following optimisation of the staining procedure, it was possible to evaluate survivin protein expression in 70.1% (n = 359) of the 512 tumours represented on the TMA. Decision tree analysis predicted that nuclear, as opposed to cytoplasmic, survivin was the most important determinant of overall survival (OS) and breast cancer-specific survival (BCSS). The decision tree model confirmed CNR of 5 as the optimum threshold for survival analysis. Univariate analysis demonstrated an association between a high CNR (>5) and a prolonged BCSS (HR 0.49, 95% CI 0.29-0.81, p = 0.006). Multivariate analysis revealed a high CNR (>5) was an independent predictor of BCSS (HR 0.47, 95% CI 0.27-0.82, p = 0.008). An increased CNR was associated with ER positive (p = 0.045), low grade (p = 0.007), Ki-67 (p = 0.001) and Her2 (p = 0.026) negative tumours. Finally, a high CNR was an independent predictor of OS in tamoxifen-treated ER-positive patients (HR 0.44, 95% CI 0.23-0.87, p = 0.018). Using the same threshold as our previous study, we have validated survivin CNR as a marker of good prognosis in breast cancer in a large independent cohort. These findings provide robust evidence of the importance of survivin CNR as a breast cancer biomarker, and its potential to predict outcome in tamoxifen-treated patients.
Cardiac dysfunction associated with a nucleotide polymerase inhibitor for treatment of hepatitis C.

Treatment for chronic hepatitis C virus (HCV) infection is evolving from interferon (IFN)-based therapy to direct-acting antiviral (DAA) agents, yet some safety concerns have arisen involving cardiac toxicity. In this study, we sought to better understand the potential off-target toxicities of new DAAs. We retrospectively evaluated the clinical and pathological findings of the sentinel case in a phase II study that led to clinical development discontinuation for BMS-986094, an HCV nucleotide polymerase (nonstructural 5B) inhibitor. We also report on outcomes from other patients in the same study, including electrocardiogram changes, cardiovascular biomarkers, and transthoracic echocardiograms. Thirty-four patients received IFN-free BMS-986094 regimens. Six patients had left ventricular ejection fractions (LVEFs) <30%, 8 had LVEFs 30%-50%, and 11 required hospitalization for suspected cardiotoxicity. Of the patients with LVEF <50%, 6 had normalization of systolic function after a median of 20 days. T-wave inversions were the most sensitive predictor of LVEF dysfunction. B-type natriuretic peptide levels increased over time and correlated with the degree of LVEF dysfunction. Pathological analysis of cardiac tissue revealed severe myocyte damage with elongated myofibrils without gross necrosis. These findings were consistent with some results of recent primate studies that were conducted to further investigate the potential mechanisms of BMS-986094 toxicity.



A novel nucleotide analog polymerase inhibitor developed for HCV treatment may cause a toxic cardiomyopathy. Ongoing surveillance of DAAs for cardiotoxicities may be beneficial, especially among patients at higher risk for cardiovascular disease.
Economic evaluation of home blood pressure monitoring with or without telephonic behavioral self-management in patients with hypertension.

The Take Control of Your Blood Pressure trial evaluated the effect of a multicomponent telephonic behavioral lifestyle intervention, patient self-monitoring, and both interventions combined compared with usual care on reducing systolic blood pressure during 24 months. The combined intervention led to a significant reduction in systolic blood pressure compared with usual care alone. We examined direct and patient time costs associated with each intervention.



We conducted a prospective economic evaluation alongside a randomized controlled trial of 636 patients with hypertension participating in the study interventions. Medical costs were estimated using electronic data representing medical services delivered within the health system. Intervention-related costs were derived using information collected during the trial, administrative records, and published unit costs.



During 24 months, patients incurred a mean of $6,965 (s.d., $22,054) in inpatient costs and $8,676 (s.d., $9,368) in outpatient costs, with no significant differences among the intervention groups. With base-case assumptions, intervention costs were estimated at $90 (s.d., $2) for home blood pressure monitoring, $345 (s.d., $64) for the behavioral intervention ($31 per telephone encounter), and $416 (s.d., $93) for the combined intervention. Patient time costs were estimated at $585 (s.d., $487) for home monitoring, $55 (s.d., $16) for the behavioral intervention, and $741 (s.d., $529) for the combined intervention.



Our analysis demonstrated that the interventions are cost-additive to the health-care system in the short term and that patients' time costs are nontrivial.
Enabling the diagnosis of occult psychiatric illness in the emergency department: a randomized, controlled trial of the computerized, self-administered PRIME-MD diagnostic system.

Undiagnosed mental illness is highly prevalent and produces needless morbidity. Emergency department patients with vague or longstanding complaints are at risk for occult mental illness, but are seldom diagnosed. We conducted this study to determine whether a previously validated, self-administered, computerized psychiatric interview (Primary Care Evaluation of Mental Disorders [PRIME-MD]) could increase the detection of occult psychiatric illness in the ED.



This was a randomized, controlled trial of consecutive patients enrolled during convenient times at a university teaching hospital ED with an annual census of 38,000. ED house staff and attending physicians participated. Patients were those with nonspecific complaints potentially associated with occult psychiatric illness (eg, long-standing headache, abdominal or back pain). Exclusion criteria were known psychiatric illness, complaint, or medication; and straightforward reason for the ED visit. Consenting subjects completed the PRIME-MD questionnaire in the waiting room, and were randomly assigned to either the "report" (report results given to physician) or "no-report" groups. PRIME-MD results were clipped to the front of the chart of report group patients. There was no other intervention. The main outcome measures were the percentage of all patients and percentage of patients with a PRIME-MD diagnosis who received a psychiatric diagnosis, consultation, or referral from the emergency physician.



A total of 339 (5.1%) of all patients were approached; 230 consented to participate in the study, and 218 completed the PRIME-MD session and were randomly assigned to study groups. Ninety-two patients in the report group and 98 cases in the no-report group were analyzed. Patients were omitted for the following reasons: left without being seen (8), mistakenly enrolled (10), or unretrievable medical records (10). Seventy-nine (42%) patients received a psychiatric diagnosis from PRIME-MD and 9 (5%) from the physician. The frequencies of physician psychiatric diagnosis and referral did not differ between groups (diagnosis: report 9%, no report 9%, Delta 0%, 95% confidence interval [CI] -13, 14; referral: report 9%, no report 7%, Delta 2%, 95% CI -11, 16).



ED patients willingly completed the PRIME-MD questionnaire (in a median time of 7 minutes), which frequently diagnosed psychiatric conditions. Despite this, physicians rarely diagnosed or treated these conditions regardless of whether they were provided with the PRIME-MD diagnoses.
Short- and long-term black tea consumption reverses endothelial dysfunction in patients with coronary artery disease.

Epidemiological studies suggest that tea consumption decreases cardiovascular risk, but the mechanisms of benefit remain undefined. Endothelial dysfunction has been associated with coronary artery disease and increased oxidative stress. Some antioxidants have been shown to reverse endothelial dysfunction, and tea contains antioxidant flavonoids.  To test the hypothesis that tea consumption will reverse endothelial dysfunction, we randomized 66 patients with proven coronary artery disease to consume black tea and water in a crossover design. Short-term effects were examined 2 hours after consumption of 450 mL tea or water. Long-term effects were examined after consumption of 900 mL tea or water daily for 4 weeks. Vasomotor function of the brachial artery was examined at baseline and after each intervention with vascular ultrasound. Fifty patients completed the protocol and had technically suitable ultrasound measurements. Both short- and long-term tea consumption improved endothelium- dependent flow-mediated dilation of the brachial artery, whereas consumption of water had no effect (P<0.001 by repeated-measures ANOVA). Tea consumption had no effect on endothelium-independent nitroglycerin-induced dilation. An equivalent oral dose of caffeine (200 mg) had no short-term effect on flow-mediated dilation. Plasma flavonoids increased after short- and long-term tea consumption.



Short- and long-term black tea consumption reverses endothelial vasomotor dysfunction in patients with coronary artery disease. This finding may partly explain the association between tea intake and decreased cardiovascular disease events.