nils-herrmann/clean_scirepeval huggingface dataset:
Decline in lung function does not predict future decline in lung function in cystic fibrosis patients.

Despite the attention paid to minimizing lung function decline among cystic fibrosis (CF) patients, the effect of rate of decline on subsequent disease progression is poorly understood. We aimed to describe the rate of decline of FVC, FEV1 , and FEF25-75 and to test the hypothesis that rate of decline of each spirometric variable predicts subsequent rate of decline in that variable and each other variable.



Data were from the Epidemiologic Study of CF, an observational study of North American CF patients from 1994 to 2005. For each year of age, patients' best percent predicted FEV1 and associated FVC and FEF25-75, were used to calculate 2-year slopes for each spirometric variable. Pearson correlations were calculated between reference slopes and follow-up slopes up to 8 years later and, for FEV1 , between reference slopes and level (not slope) of lung function up to 5 years later.



Twenty six thousand, three hundred and ninety-three patients contributed 427,063 spirometries. Median 2-year slopes of all variables were negative for all ages >6 years and the magnitude varied with age, being greatest among 13-17 year olds, especially for FEF25-75 . There was no correlation (r < 0.10) between reference slopes and subsequent slopes 3-8 years later, either within or across variables. The correlation between 2-year FEV1 slopes and FEV1 level even 5 years later was moderate (0.37-0.49) across disease stage categories.



Contrary to our hypothesis, rate of lung function decline did not predict future rate of decline either within or across spirometric variables. In contrast, FEV1 slope did have moderate predictive ability for subsequent FEV1 level. These findings are relevant for clinical care and for clinical trial design.
Family Support in Assertive Community Treatment: An Analysis of Client Outcomes

Assertive Community Treatment (ACT) is an outreach-based case management model that assists people with severe mental illness through an intensive and integrated approach. In this program, a multidisciplinary team provides medical and psychosocial services. The purpose of this study was to examine the effectiveness of the following two ACT intervention strategies: “replacement” (supporting the clients) versus “backup” (supporting family members who provide care to clients). Admission days, psychiatric symptoms, quality of life, self-efficacy, and service satisfaction ware evaluated as outcome variables. To identify effective methods of supporting family members, clients living with family were divided into two groups based on the amount and types of services received—the backup group and the replacement group. ANCOVA was used to compare the outcomes between the two groups. The replacement group displayed significantly better psychiatric symptoms, social functioning, self-efficacy, and service satisfaction scores. No differences in admission days or quality of life were found. Clients provided more support directly to clients themselves than to family members was found to have better client outcomes in improving psychiatric symptoms, social functioning, and self-efficacy, resulting in higher levels of service satisfaction. This indicates that society should reduce the responsibility of the family and share responsibility for the care of people with mental illness to effectively improve outcomes for people with mental illnesses.
Early Postoperative Chemotherapy After Complete Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Isolated Peritoneal Carcinomatosis of Colon Cancer: A Multicenter Study

The prognosis of peritoneal carcinomatosis (PC) from colorectal cancer has been improved with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). However, benefits of postoperative chemotherapy (CT) are unclear. This retrospective, multicenter study included 231 patients treated by CRS and HIPEC for isolated PC of colon cancer in four expert’s centers. Overall survival (OS), progression-free survival (PFS), and peritoneal recurrence-free survival (PRFS) were compared between patients with adjuvant CT (started within 3 months after surgery) and patients with surveillance only. After exclusion of 10 patients for early postoperative death (4 %), 221 patients were included (CT group: n = 151; surveillance group: n = 70). Main postoperative CT regimens (median of 6 cycles) were Folfox (28 %), Folfiri bevacizumab (24.5 %), Folfiri (16 %), and Folfiri cetuximab (12.5 %). The median OS after surgery was 43.3 months with no difference between CT and surveillance groups. In multivariate analysis, a low peritoneal cancer index (p < 0.0001) and a long delay between diagnosis of CP and HIPEC (p = 0.001) were associated with increased OS. The median PFS and PRFS were 12.4 and 17 months, respectively. At 1 year, more patients were without progression (p = 0.001) or PC recurrence (0.0004) in the CT group, but with prolonged follow-up this difference was no longer significant. Early postoperative CT does not improve OS after CRS and HIPEC for colon carcinomatosis. However, a transient effect on PFS and PRFS was observed. A subgroup of patients who may benefit more from CT remain to be defined.
Long-term results of three randomized trials (58831, 58832, 58881) in childhood acute lymphoblastic leukemia: a CLCG-EORTC report

We present here the long-term results of three randomized clinical trials conducted on children with newly diagnosed acute lymphoblastic leukemia (ALL) between 1983 and 1998 by the Children Leukemia Cooperative Group (CLCG) from EORTC. In study 58831/32, the overall event-free survival (EFS) rates (± s.e.) at 6 and 10 years were 66% ± 1.8% and 65% ± 1.8%, respectively, and the risk of isolated central nervous system (CNS) relapse was 6% ± 1% and 7% ± 1%, respectively. In patients with a standard risk of relapse the omission of cyclophosphamide had no adverse effect on disease-free survival rates at 10 years (trial 58831). In medium- and high-risk patients the omission of radiotherapy did not increase the risk of CNS or systemic relapse (trial 58832). In study 58881 (1989–1998) the overall EFS rate at 8 years was 68.4% ± 1.2% and the risk of isolated CNS relapse was 4.2% ± 0.5%. In this trial which adressed three randomized questions, the following results were obtained: the combination of cytarabine at high doses with methotrexate at high doses during interval therapy did not improve prognosis. The addition of 6-mercaptopurine iv during maintenance increased the risk of late relapse. E. coli asparaginase was more toxic and has a higher efficacy than erwinia asparaginase. leukocyte counts >100 × 109/l, specific genetic abnormalities, a poor initial response to steroids or a high level of minimal residual disease at early time points were consistently associated with an adverse prognosis in the 58881 trial.
Treatment of primary chronic glomerulonephritis with Rehmannia glutinosa acteosides in combination with the angiotensin receptor blocker irbesartan: a randomized controlled trial.

This study aims to assess the efficacy and safety of Rehmannia glutinosa acteosides used in combination with the angiotensin receptor blocker irbesartan to treat primary chronic glomerulonephritis. A total of 479 patients diagnosed with primary chronic glomerulonephritis were recruited from outpatient clinics and were randomly assigned to the treatment group (Rehmannia glutinosa acteosides, two 200-mg capsules, bid; and irbesartan, one 150-mg tablet, qd) or the control group (irbesartan, one 150-mg tablet, qd). The primary outcome was 24-h urinary protein. Secondary outcome measures included blood pressure, estimated glomerular filtration rate, erythrocyturia, serum alanine aminotransferase, aspartate transaminase and electrolytes. After 8 weeks of treatment, the treatment group showed a mean reduction in 24-h proteinuria of 36.42% compared to baseline, which was significantly higher than the mean reduction from baseline of 27.97% in the control group (P = 0.0278).Adverse drug reactions occurred at a similarly low rate in the treatment group (0.4%) and control group (1.2%, P = 0.3724). In the treatment of chronic glomerulonephritis, the combination of Rehmannia glutinosa acteosides and irbesartan can reduce proteinuria more effectively than irbesartan alone.
C-arm CT during hepatic arteriography tumour-to-liver contrast: intraindividual comparison of three different contrast media application protocols

To compare tumour-to-liver contrast (TLC) of C-arm CT during hepatic arteriography (CACTHA) acquired using three protocols in patients with HCC. This prospective study was IRB approved and informed consent was obtained from each patient. Twenty-nine patients (mean age, 68 ± 7 years; 27 men) with 55 HCCs (mean diameter, 2.6 ± 1.5 cm) underwent three different CACTHA protocols in random order before chemoembolisation. Contrast medium (100 mg iodine/ml) was injected into the common hepatic artery (flow rate 4 ml/s). The imaging delay for the start of the CACTHA examination was 4 s (protocol A), 8 s (protocol B) and 12 s (protocol C) (total amount of injected contrast medium: 48 ml, 64 ml, 80 ml). TLC was measured by placing regions of interest (ROIs) in the HCC and liver parenchyma. Mixed model ANOVAs and Bonferroni corrected post hoc tests were used for statistical analysis. Mean values for TLC were 132 ± 3.3 HU, 186 ± 5.8 HU and 168 ± 2.8 HU for protocols A, B and C. Protocol B provided significantly higher TLC than protocols A and C (p < 0.001). TLC was significantly higher using an imaging delay of 8 s compared with a delay of 4 or 12 s. • C-arm cone-beam CT (CACT) angiography offers additional information during hepatic intervention. • CACT hepatic arteriography tumour-to-liver contrast is highest with an 8-s delay. • An 8-s delay is recommended for early arterial phase CACTHA for hepatocelullar carcinoma.
Comparison of prasugrel and ticagrelor loading doses in ST-segment elevation myocardial infarction patients: RAPID (Rapid Activity of Platelet Inhibitor Drugs) primary PCI study.

This study sought to compare the action of prasugrel and ticagrelor in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PPCI).



It has been documented that prasugrel and ticagrelor are able to provide effective platelet inhibition 2 h after a loading dose (LD). However, the pharmacodynamic measurements after prasugrel and ticagrelor LD have been provided by assessing only healthy volunteers or subjects with stable coronary artery disease.



Fifty patients with STEMI undergoing PPCI with bivalirudin monotherapy were randomized to receive 60 mg prasugrel LD (n = 25) or 180 mg ticagrelor LD (n = 25). Residual platelet reactivity was assessed by VerifyNow at baseline and 2, 4, 8, and 12 h after LD.



Platelet reactivity units (PRU) 2 h after the LD (study primary endpoint) were 217 (12 to 279) and 275 (88 to 305) in the prasugrel and ticagrelor groups, respectively (p = NS), satisfying pre-specified noninferiority criteria. High residual platelet reactivity (HRPR) (PRU ≥240) was found in 44% and 60% of patients (p = 0.258) at 2 h. The mean time to achieve a PRU <240 was 3 ± 2 h and 5 ± 4 h in the prasugrel and ticagrelor groups, respectively. The independent predictors of HRPR at 2 h were morphine use (odds ratio: 5.29; 95% confidence interval: 1.44 to 19.49; p = 0.012) and baseline PRU value (odds ratio: 1.014; 95% confidence interval: 1.00 to 1.03; p = 0.046).



In patients with STEMI, prasugrel showed to be noninferior as compared with ticagrelor in terms of residual platelet reactivity 2 h after the LD. The 2 drugs provide an effective platelet inhibition 2 h after the LD in only a half of patients, and at least 4 h are required to achieve an effective platelet inhibition in the majority of patients. Morphine use is associated with a delayed activity of these agents. (Rapid Activity of Platelet Inhibitor Drugs Study, NCT01510171).
Post-therapy surveillance of patients with uterine cancers: value of integrated FDG PET/CT in the detection of recurrence

The purpose of this study was to prospectively determine the diagnostic accuracy of PET/CT in the detection of recurrence in patients with treated uterine cancers. Twenty-five women, ranging in age from 37 to 79 years (mean 58.9 years), who underwent primary surgical treatment for either a cervical or an endometrial cancer met the inclusion criterion of the study, which was suspicion of recurrence based on results of routine follow-up procedures. PET/CT was performed after administration of 18F-fluorodeoxyglucose (FDG); two readers interpreted the images in consensus. Histopathological findings or correlation with results of subsequent clinical and imaging follow-up examinations served as the reference standard. Diagnostic accuracy of PET/CT was reported in terms of the proportion of correctly classified patients and lesion sites. Tumour recurrence was found at histopathological analysis or follow-up examinations after PET/CT in 14 (56%) of the 25 patients. Patient-based sensitivity, specificity, positive predictive value, negative predictive value and accuracy of PET/CT for detection of tumour recurrence were 92.9%, 100.0%, 100.0%, 91.7% and 96.0%, respectively. Lesion site-based sensitivity, specificity, positive predictive value, negative predictive value and accuracy of PET/CT were 94.7%, 99.5%, 94.7%, 99.5% and 99.0%, respectively. This preliminary study shows that PET/CT may be an accurate method for the evaluation of recurrence in patients who have been treated for uterine cancers and are undergoing follow-up.
Prospective study of the immune effects of normalizing the hemoglobin concentration in hemodialysis patients who receive recombinant human erythropoietin.

Partial correction of anemia by erythropoietin improves hemodialysis (HD)-associated immunosuppression. It is not known whether hemoglobin normalization improves immune status further. The authors prospectively compared the immune function of HD patients with congestive heart failure or ischemic heart disease on erythropoietin therapy randomized to normal versus anemic blood hemoglobin concentration. HD patients were randomized into a normal hemoglobin group (n = 17, target hemoglobin of 14 +/- 1 g/dl) or an anemic hemoglobin group (n = 18, target hemoglobin 10 +/- 1 g/dl). Delayed-type hypersensitivity, CD4 and CD8 counts, anti-tetanus toxoid antibody levels, erythrocyte complement receptor 1 expression, and lymphocyte proliferative responsiveness were measured. The observation period was 1 yr, and the trial was open label. Target hemoglobin was achieved and maintained in both groups. Significantly improved cutaneous reactivity was seen in the normal hemoglobin group (P = 0.003). The prevalence of anergy decreased in the normal hemoglobin group (from 60 to 20%) but increased in the anemic hemoglobin group (from 57 to 86%). The anemic hemoglobin group had higher CD8 counts compared with baseline (P = 0.0001) and compared with the normal hemoglobin group (P = 0.038). Both groups had significant increases in tetanus toxoid antibody levels after vaccination but without significant differences between groups. The anemic hemoglobin group had a progressive increase in erythrocyte complement receptor 1 levels compared with baseline (P = 0.002) and relative to the normal hemoglobin group (P = 0.023). There was no consistent pattern of altered proliferative responsiveness of lymphocytes. The data suggest that certain aspects of immune function, particularly delayed-type hypersensitivity, may be improved in HD patients by normalization of hemoglobin through the administration of increased doses of erythropoietin.
Longitudinal association of carotid plaque presence and intima-media thickness with depressive symptoms in the elderly: the three-city study.

To investigate prospectively whether subclinical vascular disease is associated with future depressive symptoms in the elderly.



A multicenter cohort of community-dwelling individuals aged 65 to 85 years was examined for carotid plaque presence and common carotid artery intima-media thickness at baseline and followed up after 2, 4, 7, and 10 years. At baseline and follow-up examinations, depressive symptoms were assessed using the Center for Epidemiologic Studies Depression Scale (CES-D). High level of depressive symptoms was defined as a CES-D score >16 in men and >22 in women. Among 4125 participants (58% women) at baseline, men more frequently showed carotid plaque presence and had higher mean common carotid artery intima-media thickness than women. After adjustment for major cardiovascular risk factors, carotid plaque presence was associated with a higher CES-D score at the 10-year follow-up in men (+1.46; 95% confidence interval, 0.71-2.20; P<0.001), but not in women. When restricting analyses to individuals without cardiovascular disease at baseline, carotid plaque presence increased the likelihood of high level of depressive symptoms at follow-up examinations in men (odds ratio, 1.47; 95% confidence interval, 1.06-2.05; P=0.022), but not in women. One SD increase in log-transformed common carotid artery intima-media thickness was associated with a higher CES-D score at the 10-year follow-up in women (+0.55; 95% confidence interval, 0.16-0.95; P=0.006) and men (+0.40; 95% confidence interval, 0.02-0.78; P=0.037). Common carotid artery intima-media thickness did not increase the likelihood of high level of depressive symptoms at follow-up in both sexes.



Subclinical vascular disease is associated with the progression of depressive symptoms in elderly men and women and the occurrence of high level of depressive symptoms in elderly men.
Antihypertensive efficacy of pinacidil — Automatic ambulatory blood pressure monitoring

Forty-three patients with mild essential hypertension were randomized into two double-blind studies: pinacidil vs. placebo or pinacidil vs. hydralazine. Pinacidil (62±18 mg/day) decreased office systolic and diastolic blood pressures from 145 to 137 mm Hg and from 98 to 89 mm Hg, respectively, after 6 weeks of therapy. Similarly, hydralazine (128±28 mg/day) reduced supine systolic blood pressure from 140 to 134 mm Hg and supine diastolic blood pressure from 93 mm Hg to 84 mm Hg. Significant tachycardia was not noted with either drug. Ambulatory blood pressure was monitored for 24 h during the placebo-washout and efficacy phases with both pinacidil and hydralazine. Mean 24-h blood pressure was 128 systolic and 81 diastolic with pinacidil and 121 systolic and 76 diastolic with hydralazine. Reduction in awake hypertensive diastolic blood pressure was significant for both pinacidil and hydralazine. Normal sleep diastolic blood pressure was not reduced by pinacidil but was reduced by hydralazine. Side-effects with both drugs included edema, headache, and palpitations. These data demonstrate that pinacidil is as effective an antihypertensive agent as hydralazine.
Why Johnny can't opt out: a usability evaluation of tools to limit online behavioral advertising

We present results of a 45-participant laboratory study investigating the usability of nine tools to limit online behavioral advertising (OBA). We interviewed participants about OBA and recorded their behavior and attitudes as they configured and used a privacy tool, such as a browser plugin that blocks requests to specific URLs, a tool that sets browser cookies indicating a user's preference to opt out of OBA, or the privacy settings built into a web browser. We found serious usability flaws in all tools we tested. Participants found many tools difficult to configure, and tools' default settings were often minimally protective. Ineffective communication, confusing interfaces, and a lack of feedback led many participants to conclude that a tool was blocking OBA when they had not properly configured it to do so. Without being familiar with many advertising companies and tracking technologies, it was difficult for participants to use the tools effectively.
Prognostic significance of foveal capillary drop-out and previous panretinal photocoagulation for diabetic macular oedema treated with ranibizumab.

To investigate the prognostic significance of macular capillary drop-out and previous panretinal laser photocoagulation in diabetic macular oedema treated with intravitreal ranibizumab.



Retrospective observational case series. Treatment-naive patients with diabetic macular oedema that had been treated with intravitreal ranibizumab as per the RESTORE study protocol for at least 12 months were included. Some patients (n=15) had previous panretinal laser photocoagulation. Best-corrected visual acuity and central retina thickness were recorded monthly. The foveal avascular zone and the perifoveal capillaries were quantitatively and qualitatively assessed on fluorescein angiography on two occasions during the observational period.



From the 46 eyes (46 patients) in this study, 13 (28%) had evidence of perifoveal capillary drop-out. Central retinal thickness was significantly thinner at baseline (p=0.02) and throughout the study period in these eyes compared with those with normal perifoveal capillaries. Both groups responded with a significant gain of best-corrected visual acuity to ranibizumab treatment (7.6±3.3 and 6.3±1.3 ETDRS letters, respectively). Eyes with previous panretinal laser photocoagulation displayed a comparable final outcome regarding function and morphology, requiring a similar intensity of intravitreal injections.



Perifoveal capillary drop-out did not limit the gain of visual acuity from intravitreal ranibizumab treatment. The reduction of central retina thickness was similar to that seen in eyes with normal perifoveal capillaries. Central retinal thickness in eyes with perifoveal capillary drop-out was generally reduced. However, this did not affect their benefit from treatment. Ranibizumab did not increase the amount of perifoveal capillary loss.
Prospective evaluation of quality of life effects in patients undergoing palliative radiotherapy for brain metastases

Recently published results of quality of life (QoL) studies indicated different outcomes of palliative radiotherapy for brain metastases. This prospective multi-center QoL study of patients with brain metastases was designed to investigate which QoL domains improve or worsen after palliative radiotherapy and which might provide prognostic information. From 01/2007-01/2009, n=151 patients with previously untreated brain metastases were recruited at 14 centers in Germany and Austria. Most patients (82 %) received whole-brain radiotherapy. QoL was measured with the EORTC-QLQ-C15-PAL and brain module BN20 before the start of radiotherapy and after 3 months. At 3 months, 88/142 (62 %) survived. Nine patients were not able to be followed up. 62 patients (70.5 % of 3-month survivors) completed the second set of questionnaires. Three months after the start of radiotherapy QoL deteriorated significantly in the areas of global QoL, physical function, fatigue, nausea, pain, appetite loss, hair loss, drowsiness, motor dysfunction, communication deficit and weakness of legs. Although the use of corticosteroid at 3 months could be reduced compared to pre-treatment (63 % vs. 37 %), the score for headaches remained stable. Initial QoL at the start of treatment was better in those alive than in those deceased at 3 months, significantly for physical function, motor dysfunction and the symptom scales fatigue, pain, appetite loss and weakness of legs. In a multivariate model, lower Karnofsky performance score, higher age and higher pain ratings before radiotherapy were prognostic of 3-month survival. Moderate deterioration in several QoL domains was predominantly observed three months after start of palliative radiotherapy for brain metastases. Future studies will need to address the individual subjective benefit or burden from such treatment. Baseline QoL scores before palliative radiotherapy for brain metastases may contain prognostic information.