nils-herrmann/clean_scirepeval huggingface dataset:
Chemosensitivity and stratification by a five monoclonal antibody immunohistochemistry test in the NSABP B14 and B20 trials.

To test the association between risk stratification and outcome in a prospectively designed, blinded retrospective study using tissue arrays of available paraffin blocks from the estrogen receptor-expressing, node-negative samples from the National Surgical Adjuvant Breast and Bowel Project B14 and B20 tamoxifen and chemotherapy trials.



Tissue arrays were stained by immunohistochemistry targeting p53, NDRG1, SLC7A5, CEACAM5, and HTF9C. Risk stratification was done using predefined scoring rules, algorithm for combining scores, and cutoff points for low-risk, moderate-risk, and high-risk patient strata.



In a univariate Cox model, this test was significantly associated with recurrence-free interval [HR, 1.3 (95% confidence interval, 1.1-1.6); P = 0.006]. In a multivariate model it contributed information independent of age, tumor size, and menopausal status (P = 0.007). The Kaplan-Meier estimates of the proportion of recurrence-free after 10 years were 73%, 86%, and 85% for the high-risk, moderate-risk, and low-risk groups (P = 0.001). The Kaplan-Meier estimates of the breast-cancer-specific-death rate were 23%, 10%, and 9% (P < 0.0001). Exploratory analysis in patients >/=60 years old showed Kaplan-Meier estimates of the proportion of recurrence-free of 78%, 89%, and 92%. Both high-risk and low-risk groups showed significant improvement on treatment with cytotoxic chemotherapy.



Immunohistochemistry using five monoclonal antibodies assigns breast cancer patients to a risk index that was significantly associated with clinical outcome among the estrogen receptor-expressing, node-negative tamoxifen-treated patients. It seems that the test may be able to identify patients who have greater absolute benefit from adjuvant chemotherapy compared with unstratified patient populations. Exploratory analysis suggests that this test will be most useful in clinical decision making for postmenopausal patients.
The relationships of left ventricular ejection fraction, end-systolic volume index and infarct size to six-month mortality after hospital discharge following myocardial infarction treated by thrombolysis.

We sought to relate left ventricular ejection fraction (EF), end-systolic volume index (ESVI) and infarct size (IS), as measured in a single randomized trial, to six-month mortality after myocardial infarction (MI) treated with thrombolysis.



These three prognostic indicators have never been compared in the same study group.



Radionuclide angiographic and single-photon emission computed tomographic sestamibi measurements of IS were performed in 1,194 and 1,181 patients, respectively, of the 2,948 patients enrolled in the Collaborative Organization for RheothRx Evaluation (CORE) trial. Ejection fraction, ESVI and IS, as measured by central laboratories in these radionuclide substudies, were tested for their association with six-month mortality.



Ejection fraction (n = 1,137; p < 0.0001), ESVI (n = 945; p = 0.055) and IS (n = 1,164; p = 0.03) were all associated with six-month mortality. Each of these measurements was significantly correlated with the other two, regardless of MI location. In an "overlap" group of 753 patients (25.5% of the population; 13 deaths) in whom all three measurements were available, EF (p = 0.001) was a stronger predictor than ESVI (p = 0.005) or IS (p = 0.01). Neither of the other two measurements added independent prognostic information. The highest risk subgroup (EF < 30%) had an 11% six-month mortality, but comprised only 95 patients (8.3%).



Ejection fraction, ESVI and IS measurements performed one to two weeks after MI can each predict six-month mortality. Ejection fraction was superior to the other two measurements. However, this study had limited power to detect independent significance of ESVI or IS.
Harbinger I: The Development and Evaluation of the First PACT Replication

While Assertive Community Treatment (originally known as the PACT program) is now recognized around the world as an effective model for rehabilitation of persons with severe mental illness, this was not the case 20 years ago. Harbinger of Grand Rapids, in Kent County, Michigan, was the first replication of the PACT model which sought fidelity and included an experimental design for assessing effectiveness. The design and results are presented from an initial 30-month and a follow-up 66-month evaluation of Harbinger. The 30-month evaluation showed significant differences favoring Harbinger vs. the control group on independent living, employment, and client functioning. At 66-months, there were fewer experimental-control group differences. The differences in results are analyzed in terms of design and data collection problems, changes in the treatment environment for the control group, and the longitudinal course of mental illness. The discussion focuses on next steps in ACT research, utilizing program theory to better establish the mechanisms for successful intervention models.
Effect of composite yogurt enriched with acacia fiber and Bifidobacterium lactis.

To investigate whether composite yogurt with acacia dietary fiber and Bifidobacterium lactis (B. lactis) has additive effects in irritable bowel syndrome (IBS).



A total of 130 patients were randomly allocated to consume, twice daily for 8 wk, either the composite yogurt or the control product. The composite yogurt contained acacia dietary fiber and high-dose B. lactis together with two classic yogurt starter cultures. Patients were evaluated using the visual analog scale via a structured questionnaire administered at baseline and after treatment.



Improvements in bowel habit satisfaction and overall IBS symptoms from baseline were significantly higher in the test group than in the control group (27.16 vs 15.51, P = 0.010, 64.2 ± 17.0 vs 50.4 ± 20.5, P < 0.001; respectively). In constipation-predominant IBS, improvement in overall IBS symptoms was significantly higher in the test group than in the control group (72.4 ± 18.4 vs 50.0 ± 21.8, P < 0.001). In patients with diarrhea-predominant IBS, improvement in bowel habit satisfaction from baseline was significantly higher in the test group than in the control group (32.90 vs 7.81, P = 0.006).



Our data suggest that composite yogurt enriched with acacia fiber and B. lactis has greater therapeutic effects in patients with IBS than standard yogurt.
The effects of locomotor training with a robotic-gait orthosis (Lokomat) on neuromuscular properties in persons with chronic SCI

We studied the effects of robotic-assisted locomotor (LOKOMAT) training on neuromuscular abnormality associated with spasticity in persons with incomplete Spinal Cord Injury (SCI). LOKOMAT training was performed 3 days/week for 4 weeks, with up to 45 minutes of training per session. Subjects were evaluated before and after 1, 2, and 4 weeks of training, and the effects of training on the intrinsic (muscular) and reflexive components of the neuromuscular properties were quantified over the ankle range-of-motion. A linear (slope&intercept) regression was fit to the stiffness-angle curve. “Growth mixture” modeling was used to identify recovery classes for these parameters over the training period. Two distinct classes were observed. Class 1 subjects had initially higher reflex stiffness parameters (i.e., intercept and slope vs. ankle position) and reduced significantly over the training period. Class 2 subjects initially had lower reflex stiffness parameters and experienced non-significant reductions. Similar results were observed for the intrinsic stiffness intercept; however, intrinsic slope showed no significant improvement over training for either class. These findings demonstrate that LOKOMAT training is effective in reducing reflex and intrinsic stiffness (which abnormally increase in SCI) and improving the abnormal modulation of reflexes over the ankle range-of-motion.
Effects of prepulses and d-amphetamine on performance and event-related potential measures on an auditory discrimination task

Prepulse inhibition (PPI) of the startle reflex is a measure of sensorimotor gating, that is the processing of the startle stimulus (S2) is inhibited by the interfering processing of a closely preceding prepulse (S1). It has been demonstrated that PPI is disrupted in a variety of mental disorders and that several neurotransmitter systems, including dopamine, participate in the modulation of sensorimotor gating. Previous studies have also shown that a task-relevant S1 enhances PPI in healthy subjects but not in schizophrenic patients. These findings indicate an influence of attentional processes on sensorimotor gating and an impairment of this modulation in schizophrenia.  Assuming a dopamine-mediated suppression of S1 processing as a mechanism of resource management and selective attention, which might be impaired in certain mental disorders, the present study investigated the effects of the indirect dopaminergic agonist d-amphetamine on prepulse-altered S2 discrimination and event related potentials (ERPs).  Twelve healthy volunteers were tested in a double-blind, placebo-controlled experimental design. Here, S2 is the target in a difficult Go/NoGo auditory discrimination task.  Confirming our previous results, S2 processing is ”accentuated” by a weak acoustic prepulse in healthy subjects, thus leading to a lower rate of errors of omission but also to more false alarms (i.e. a liberal response bias). This performance change correlated with a prepulse-induced increase in the amplitude of the P3 ERP towards non-targets (”prepulse-induced non-target positivity”; PINTP). In addition, the results of the present study show that under prepulse conditions amphetamine disrupts ”S2 accentuation” associated with a dose-related reduction of the P2 component of the S1 response and a plasma level related reduction of PINTP.  These data suggest an involuntary attentional shift towards S1 processing with increasing dopamine-release similar to that observed in patients with schizophrenia or OCD. It is concluded that sensory gating alters selective attention via dopaminergic modulation.
Cost-effectiveness of sensor-augmented pump therapy in adults with type 1 diabetes in the United States.

A recent randomized trial demonstrated significant reductions in hemoglobin A(1c) levels with sensor-augmented pump therapy (SAPT) compared with multiple daily injections of insulin (MDI) in type 1 diabetes. We analyzed resource use in the trial and estimated the long-term cost-effectiveness of SAPT from the perspective of the US health care system.



We undertook a cost-effectiveness analysis combining estimates from the trial and the literature to populate the previously validated Center for Outcomes Research (CORE) Diabetes Model. Results represent the use of 3-day sensors, as in the trial, and 6-day sensors, approved in most markets but not yet approved in the United States.



Within-trial hospital days, emergency department visits, and outpatient visits did not differ significantly between the treatment groups. Assuming 65% use of 3-day sensors, treatment-related costs in year 1 were an estimated $10,760 for SAPT and $5072 for MDI. Discounted lifetime estimates were $253,493 in direct medical costs and 10.794 quality-adjusted life-years (QALYs) for SAPT and $167,170 in direct medical costs and 10.418 QALYs for MDI. For 3-day and 6-day sensors, the incremental cost-effectiveness ratios were $229,675 per QALY (95% confidence interval $139,071-$720,865) and $168,104 per QALY (95% confidence interval $102,819-$523,161), respectively. The ratios ranged from $69,837 to $211,113 per QALY with different strategies for incorporating utility benefits resulting from less fear of hypoglycemia with SAPT.



Despite superior clinical benefits of SAPT compared with MDI, SAPT does not appear to be economically attractive in the United States for adults with type 1 diabetes in its current state of development. However, further clinical developments reducing disposable costs of the system could significantly improve its economic attractiveness.
Physical activity, sedentary behavior, and aerobic capacity in persons with multiple sclerosis

There is substantial evidence that exercise training improves aerobic capacity among people with multiple sclerosis (MS), but less is known about the associations between physical activity and sedentary behaviors with aerobic capacity.



This study examined if objectively-measured moderate-to-vigorous (MVPA) and light (LPA) physical activity and sedentary behavior were associated with peak aerobic capacity (VO2peak) measured using an established protocol for conducting a maximal, incremental exercise test in persons with MS.



The study involved a cross-sectional, observational study design and included 49 persons with MS. Participants wore an accelerometer around the waist during the waking hours for a 7-day period as a measure of physical activity and sedentary behaviors, and completed a maximal, incremental exercise test on an electronically-braked, computer-controlled cycle ergometer with open-circuit spirometry for measuring VO2peak.



VO2peak was significantly correlated with MVPA (r=0.53, p<0.001) and LPA (r=0.39, p<0.01), but not sedentary behavior (r=-0.12, p=0.44). Linear regression analysis indicated that MVPA (B=0.19, SE B=0.04, β=0.51, p<0.001) and LPA (B=0.02, SE B=0.01, β=0.30, p<0.05), but not sedentary behavior (B=-0.01, SE B=0.01, β=-0.14, p=0.26), explained significant variance in VO2peak (R2=0.40).



We provide the first evidence that MVPA and LPA represent concurrent correlates of VO2peak and both could be targeted for improving aerobic capacity in persons with MS.
Prediction of the clinical course of chronic obstructive pulmonary disease, using the new GOLD classification: a study of the general population.

The new Global Initiative for Obstructive Lung Disease (GOLD) stratification of chronic obstructive pulmonary disease (COPD) into categories A, B, C, and D is based on symptoms, level of lung function, and history of exacerbations.



To investigate the abilities of this stratification to predict the clinical course of COPD.



Two similar population studies were performed in an area of Copenhagen including 6,628 individuals with COPD.



The patients were monitored for an average period of 4.3 years regarding COPD exacerbations, hospital admissions, and mortality. The percentages of individuals experiencing a COPD exacerbation during the first year of observation were 2.2% in group A, 5.8% in group B, 25.1% in group C, and 28.6% in group D. One- and 3-year mortality rates were 0.6 and 3.8%, respectively, in group A, 3.0 and 10.6% in group B, 0.7 and 8.2% in group C, and 3.4 and 20.1% in group D. Groups B and D, characterized by a higher degree of dyspnea than groups A and C, had five to eight times higher mortality from cardiovascular disease and cancer than did groups A and C.



The new stratification performs well by identifying individuals at risk of exacerbations. Surprisingly, subgroup B, characterized by more severe dyspnea, had significantly poorer survival than group C, in spite of a higher FEV(1) level. This subgroup warrants special attention, as the poor prognosis could be caused by cardiovascular disease or cancer, requiring additional assessment and treatment.
Population-based tobacco treatment: study design of a randomized controlled trial

Most smokers do not receive comprehensive, evidence-based treatment for tobacco use that includes intensive behavioral counseling along with pharmacotherapy. Further, the use of proven, tobacco treatments is lower among minorities than among Whites. The primary objectives of this study are to: (1) Assess the effect of a proactive care intervention (PRO) on population-level smoking abstinence rates (i.e., abstinence among all smokers including those who use and do not utilize treatment) and on utilization of tobacco treatment compared to reactive/usual care (UC) among a diverse population of smokers, (2) Compare the effect of PRO on population-level smoking abstinence rates and utilization of tobacco treatments between African American and White smokers, and (3) Determine the cost-effectiveness of the proactive care intervention.



This prospective randomized controlled trial identifies a population-based sample of current smokers from the Department of Veterans Affairs (VA) electronic medical record health factor dataset. The proactive care intervention combines: (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or face-to-face). Proactive outreach includes mailed invitation materials followed by an outreach call that encourages smokers to seek treatment with choice of services. Proactive care participants who choose telephone care receive VA telephone counseling and access to pharmacotherapy. Proactive care participants who choose face-to-face care are referred to their VA facility's smoking cessation clinic. Usual care participants have access to standard smoking cessation services from their VA facility (e.g., pharmacotherapy, smoking cessation clinic) and from their state telephone quitline. Baseline data is collected from VA administrative databases and participant surveys. Outcomes from both groups are collected 12 months post-randomization from participant surveys and from VA administrative databases. The primary outcome is self-reported smoking abstinence, which is assessed at the population-level (i.e., among those who utilize and those who do not utilize tobacco treatment). Primary analyses will follow intention-to-treat methodology.



This randomized trial is testing proactive outreach strategies offering choice of smoking cessation services, an innovation that if proven effective and cost-effective, will transform the way tobacco treatment is delivered. National dissemination of proactive treatment strategies could dramatically reduce tobacco-related morbidity, mortality, and health care costs.
Accuracy of frozen section of sentinel lymph nodes: a prospective analysis of 659 breast cancer patients of the Swiss multicenter study

To assess the accuracy of sentinel lymph node (SLN) frozen section in a prospective multicenter study of early-stage breast cancer patients.  The decision to perform an immediate completion axillary node dissection (ALND) is based on results of SLN frozen section. However, SLN frozen sections are not routinely performed in all centers. Moreover, the accuracy of SLN frozen section remains a matter of great debate.  Prospective multicenter trial analyzing 659 early stage breast cancer patients (pT1 and pT2 ≤ 3 cm, cN0) enrolled between January 2000 and December 2003. SLN were intraoperatively examined by frozen section. Final histopathology consisted in performing step sectioning as well as staining with H&E and immunohistochemistry.  SLN were identified in 98.3% (648/659) of all patients. The accuracy of frozen section was 90.1% (584/648), the sensitivity for SLN macro-metastases 98% (142/145), and the specificity 100%. A total of 47 patients with SLN micro-metastases (n = 36) or isolated tumor cells (n = 11) underwent a delayed completion ALND. In 96% (45/47) of these patients the ALND specimens were free of macro-metastases.  SLN frozen section provides highly accurate information regarding identification of SLN macro-metastases, a delayed completion ALND can be avoided in 98% of these patients. More importantly, in the present investigation the vast majority (96%) of patients with SLN micro-metastases or isolated tumor cells undergoing delayed completion ALND did not benefit from the second operation as ALND specimens were free of macro-metastases. We strongly recommend the routine use of SLN frozen section in early stage breast cancer patients.
Phase II TPDCV protocol for pediatric low-grade hypothalamic/chiasmatic gliomas: 15-year update

To report long-term results for children with low-grade hypothalamic/chiasmatic gliomas treated on a phase II chemotherapy protocol. Between 1984 and 1992, 33 children with hypothalamic/chiasmatic LGGs received TPDCV chemotherapy on a phase II prospective trial. Median age was 3.0 years (range 0.3–16.2). Twelve patients (36%) underwent STRs, 14 (42%) biopsy only, and seven (21%) no surgery. Twenty patients (61%) had pathologic JPAs, nine (27%) grade II gliomas, and four (12%) no surgical sampling. Median f/u for surviving patients was 15.2 years (range 5.3–20.7); 20 of the 23 surviving patients had 14 or more years of follow-up. Fifteen-year PFS and OS were 23.4 and 71.2%, respectively. Twenty-five patients progressed, of whom 13 are NED, two are AWD, and 10 have died. All children who died were diagnosed and first treated at age three or younger. Age at diagnosis was significantly associated with relapse and survival (P = 0.004 for PFS and P = 0.037 for OS). No PFS or OS benefit was seen with STR versus biopsy/no sampling (P = 0.58 for PFS, P = 0.59 for OS). For patients with JPAs and WHO grade II tumors, the 15-year PFS was 18.8 and 22.2% (P = 0.95) and 15-year OS was 73.7 and 55.6% (P = 0.17), respectively. Upfront TPDCV for children with hypothalamic/chiasmatic LGGs resulted in 15-year OS of 71.2% and 15-year PFS of 23.4%. No survival benefit is demonstrated for greater extent of resection. Age is a significant prognostic factor for progression and survival.
Clinical Pharmacology and Economics of Recombinant Human Erythropoietin in End-Stage Renal Disease : The Case for Subcutaneous Administration 1

The clinical pharmacology of human recombinant erythropoietin (epoetin) was studied in order to compare the effectiveness of various routes and dosing schedules in dialysis patients. Thirty-six patients received epoietin beta three times a week i.v. for at least 12 wk. The mean dose needed to achieve target hemoglobin was 225 ± 36 U/kg per week (median dose, 180 U/kg per week). Twenty-eight of 36 patients who were converted to a once-a-week i.v. schedule increased their requirements to 429 ± 50 U/kg per week in order to maintain a target hematocrit of 33 to 40 vol%. Twelve of 28 patients could maintain their target hematocrit when dosed once a week s.c. at 84 ± 10 U/kg. The other 16 patients required 137 ± 15 U/kg per week divided into two doses. In the entire group of 28 patients, the weekly requirement for epoetin was reduced by 50% when the s.c. route was used two or three times a week. Pharmacokinetic studies performed during chronic therapy indicated rapid clearance of erythropoietin (t#{189}of 6.8 ± 0.3 h). Single i.v. doses >150 U/kg were required to increase basal erythropoietin by 30 mU/ 1 Received January 30, 1991.  1991. 2 Correspondence to Dr. A. Besarab, Room 1028A College Building, Division of Nephrology, Department of Medicine. 1015 Walnut Street. Philadelphia, PA 19107. 1046-6673/0209-1405$03.00/0 Journal of the American Society of Nephrology Copyright C 1992 by the American Society of Nephrology ml at 44 h postdosing. With s.c. dosing, such increments in erythropoietin levels frequently persisted beyond 60 h because of prolonged and slow absorption. Pharmacokinetic simulations in conjunction with clinical correlation of the erythropoietic response suggest that the duration that the erythropoietin levels are maintained, and not the absolute peaks, is the primary determinant of efficacy. This may result from nonlinearity in the dose response. Pharmacokinetic simulation also indicated that iv. dosing could not maintain adequate interdialytic erythropoietin levels, whereas s.c. dosing could. Cost analysis indicated that the use of s.c. dosing two or three times a week at an average total weekly dose of I I 0 to I 20 U/kg is effective treatment of anemia in most dialysis patients.