nils-herrmann/clean_scirepeval huggingface dataset:
Prevalence and 1-year prognosis of transient heart failure following coronary revascularization.

The occurrence of heart failure during the whole pre-discharge course of coronary revascularization, as far as its influence on subsequent prognosis, is poorly understood. The present study examined the effect of transient heart failure (THF) developing in the acute and rehabilitative phase on survival after coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI). Patients in the Italian survey on cardiac rehabilitation and secondary prevention after cardiac revascularization (ICAROS) were analyzed for THF, the latter being defined either as signs and symptoms consistent with decompensation or cardiogenic shock. ICAROS was a prospective, multicenter registry of 1,262 consecutive patients discharged from 62 cardiac rehabilitation (CR) facilities, providing data on risk factors, lifestyle habits, drug treatments, and major cardiovascular events (MACE) during a 1-year follow-up. Records were linked to the official website of the Italian Association of Cardiovascular Prevention and Rehabilitation (GICR-IACPR). The overall prevalence of pre-discharge THF was 7.6%, with 69.8% of cases in acute wards, 22.9% during CR, and 7.3% in both settings. THF affected more frequently patients with chronic cardiac condition (42.7 vs. 30.6%; p < 0.05), age ≥75 years (33.3 vs. 23.1%; p < 0.005), COPD (19.8 vs. 12.3%; p < 0.05), and chronic kidney disease (17.7 vs. 7%; p < 0.001). After discharge, THF patients showed good maintenance rates of RAAS modulators (90.6%) and beta-blockers (83.3%), while statin therapy significantly decreased from 81.3 to 64.6% (p < 0.05). The pursuit of secondary prevention targets, as far as self-reported drug adherence, was not different among groups. Patients with THF had increased 1-year mortality (8.3 vs. 1.6%, p < 0.001). Moreover, THF independently predicted adverse outcome with OR for recurrent events (mainly further episodes of decompensation) of 2.4 (CI 1.4-4.3). Patients who experienced THF after coronary revascularization had increased post-discharge mortality and cardiovascular events. Hemodynamic instability, rather than recurrent myocardial ischemia, seems to be linked with worse prognosis.
Does timing of adjuvant chemotherapy influence the prognosis after early breast cancer? Results of the Danish Breast Cancer Cooperative Group (DBCG)

The purpose of this study was to examine the effect on survival of delaying the start of adjuvant chemotherapy for early breast cancer for up to 3 months after surgery. In the nation-wide clinical trials of the Danish Breast Cancer Cooperative Group, 7501 breast cancer patients received chemotherapy within 3 months of surgery between 1977 and 1999: 352 with classical cyclofosfamide, metotrexate and 5-fluorouracil (CMF); 6065 with CMF i.v. and 1084 with cyclofosfamide, epirubicin and 5-fluorouracil. For the analysis, the time between surgery and the start of chemotherapy was divided into four strata (1–3, 4, 5 and 6–13 weeks). The results show that within the three groups of chemotherapy, there was an even distribution of known prognostic factors across the four strata of initiation of chemotherapy. There was no pattern indicating a benefit from early start of chemotherapy. No significant interactions were found for subgroups of patients with a poorer prognosis (many involved lymph nodes, high-grade malignancies or hormone receptor negative disease). In conclusion, we have found no evidence for a survival benefit due to early initiation of adjuvant chemotherapy within the first 2–3 months after surgery.
French maritime pine bark extract Pycnogenol dose-dependently lowers glucose in type 2 diabetic patients.

P ycnogenol, a standardized extract from the bark of the French maritime pine, consists of phenolic compounds including catechin, taxifolin, procyanidins, and phenolic acids (1). We investigated whether Pycnog-enol has a glucose-lowering effect because of personal verbal communication from patients reporting no need for insulin following supplementation with Pycnogenol. The study was designed as an open, controlled, dose-finding study and was approved by the ethical committee of Guangnamen Hospital. Patients gave written informed consent. We recruited 18 men and 12 women among outpatients of the Guangnamen Hospital and Municipal Dental Hospital. Patients were 28 – 64 years of age and had a BMI 22–34 kg/m 2. Patients with type 2 diabetes were included with fasting plasma glucose between 7 and 10 mmol/l after participation in a diet and sports program for 1 month. Exclusion criteria were type 1 diabetes, manifest or malignant hypertension and any diseases requiring continuous treatment with drugs, and pregnant or lactat-ing women. During the first and last visit, a physical examination and assessment of demographic data, medical history, body weight, height, vital signs, blood pressure , electrocardiogram, diet, and medication was carried out. Samples for fasting blood glucose, HbA 1c , insulin, and endo-thelin-1 were taken. Blood samples were taken to measure postprandial blood glucose 2 h after breakfast. Glucose was measured enzymatically, HbA 1c by high-performance liquid chromatography , and insulin and endothe-lin-1 by immunoassays. Statistical analysis was done with SPSS 16.0 software using one-factorial ANOVA with Fisher projected least significant difference test. Patients received in succession 50, 100, 200, and 300 mg Pycnogenol in intervals of 3 weeks. Every 3 weeks, fasting and postprandial glucose, endothe-lin-1, HbA 1c , and insulin were analyzed. No changes were observed in vital signs, electroencephalogram, or blood pressure over the 12-week period. Fasting blood glucose was lowered dose dependently until a dose of 200 mg Pycnogenol was administered. Increasing the dose from 200 to 300 mg did not further decrease blood glucose. Compared with baseline, 100 –300 mg lowered fasting glucose significantly from 8.64 Ϯ 0.93 to 7.54 Ϯ 1.64 mmol/l (P Ͻ 0.05). Fifty milligrams of Pycnogenol lowered postprandial glucose significantly from 12.47 Ϯ 1.06 to 11.16 Ϯ 2.11 mmol/l (P Ͻ 0.05). Maximum decrease of post-prandial glucose was observed with 200 mg to 10.07 Ϯ 2.69 mmol/l; 300 mg had no stronger effect. HbA 1c levels decreased continuously from 8.02 Ϯ 1.04 to 7.37 Ϯ 1.09%. …
Assessment of glenohumeral subluxation in poststroke hemiplegia: comparison between ultrasound and fingerbreadth palpation methods.

Glenohumeral subluxation (GHS) is a common poststroke complication. Treatment of GHS is hampered by the lack of objective, real-time clinical measurements.



The aims of this study were: (1) to compare an ultrasound method of GHS measurement with the fingerbreadth palpation method using a receiver operating characteristic curve (ROC) and (2) to report the sensitivity and specificity of this method.



A prospective study was conducted.



The study was conducted in local hospitals and day centers in the southwest of England.



One hundred five patients who had one-sided weakness following a first-time stroke (51 men, 54 women; mean age=71 years, SD=11) and who gave informed consent were enrolled in the study.



Ultrasound measurements of acromion-greater tuberosity (AGT) distance were used for the assessment of GHS. Measurements were undertaken on both shoulders by a research physical therapist trained in shoulder ultrasound with the patient seated in a standardized position. Fingerbreadth palpation assessment of GHS was undertaken by a clinical physical therapist based at the hospital, who also visited the day centers.



The area under the ROC curve was 0.73 (95% confidence interval [95% CI]=0.63, 0.83), suggesting that the ultrasound method has good agreement compared with the fingerbreadth palpation method. A cutoff point of ≥0.2 cm AGT measurement difference between affected and unaffected shoulders generated a sensitivity of 68% (95% CI=51%, 75%), a specificity of 62% (95% CI=47%, 80%), a positive likelihood ratio of 1.79 (95% CI=1.1, 2.9), and a negative likelihood ratio of 0.55 (95% CI=0.4, 0.8).



Clinical therapists involved in the routine care of patients conducted the fingerbreadth palpation method. It is likely that they were aware of the patients' subluxation status.



The ultrasound method can detect minor asymmetry (≤0.5 cm) and has the potential advantage over the fingerbreadth palpation method of identifying patients with minor subluxation.
Early rehabilitation in patients with acute aneurysmal subarachnoid hemorrhage.

The aim of this study was to describe and quantify the content of early rehabilitation adapted to patients with acute aneurysmal subarachnoid hemorrhage (aSAH) and to assess its feasibility.



This was a prospective, observational study including 37 aSAH patients. Early rehabilitation was applied according to a mobilization algorithm. Clinical parameters, the time that rehabilitation team used on early rehabilitation and progression in mobilization were recorded. The patients' clinical conditions were graded according to the World Federation of Neurological Surgeons scale (WFNS).



Poor-grade patients (WFNS 3, 4, 5) (n = 12) received more rehabilitation (median 412 min) than did good-grade patients (WFNS 1, 2) (median 240 min). Mobilization to 60° of head elevation in good-grade patients began on day one after securing the aneurysm. Out-of-bed mobilization was possible on day three. Poor-grade patients were mobilized to 60° after two days and were out of bed on day seven. At discharge, 67% of poor-grade patients were mobilized to walking versus 78% of good-grade patients. No serious adverse effects to early rehabilitation were observed.



Early rehabilitation in aSAH patients is feasible from the first day after securing the aneurysm. The rehabilitation content varied according to the patient's clinical grade. Implications for Rehabilitation Early rehabilitation is feasible from the first day after securing the ruptured aneurysm in patients with aneurysmal subarachnoid hemorrhage (aSAH). Early rehabilitation requires close monitoring and continuous adjustment for the content and amount according to the patient's clinical condition. Interdisciplinary collaboration is recommended to match the rehabilitation needs to the medical condition on a daily basis.
Better effect of methotrexate on C-reactive protein during daily compared to weekly treatment in rheumatoid arthritis

Treatment with methotrexate (MTX) is well established in rheumatoid arthritis (RA), but dosing remains arbitrary as studies on the effect of different dosing schedules are lacking. In a randomised crossover design of 20 patients with RA, the effect of low (2.5mg) oral daily doses of MTX (15 mg weekly) was compared to intermittent weekly dosing (15 mg). C-reactive protein (CRP) values were lower and more stable on daily dosing compared to the significant (p<0.05) changes in CRP observed during treatment with the same weekly dose. It may be postulated that nonresponders or patients with dose-dependent side effects may have clinical advantage from daily MTX dosing if hepatotoxicity and other side effects are not increased.
Cardioprotective effects of single oral dose of nicorandil before selective percutaneous coronary intervention

Nicorandil, an opener of ATP-sensitive K+ channels, was used to treat angina in patients with coronary artery disease. In this study, we aim to investigate the cardioprotective effects of single oral dose of nicorandil in patients undergoing selective percutaneous coronary intervention (PCI).



One hundred and thirty-eight patients with acute coronary syndrome undergoing PCI from July 2011 to October 2012 were randomly divided into control group (group 1, n = 47), 10 mg oral nicorandil group (group 2, n = 45), and 20 mg oral nicorandil group (group 3, n = 46) about 2 hours before procedure, respectively. Cardiac troponin I (cTnI) levels were determined at 20 ~ 24 hours after PCI.



There was a significant difference in the rate of any cTnI elevation among the three groups (group 1: 36.17%, group 2: 20.00%, group 3: 15.22%, p = 0.0176). With respect to the frequency of cTnI elevation ≥ 3 and 5 × the upper limit of normal (ULN), there also had statistical difference among the three groups (17.02% in group 1, 8.89% in group 2, and 4.35% in group 3, respectively for cTnI elevation ≥ 3 × ULN, p = 0.0428; 12.77% in group 1, 6.67% in group 2, and 2.17% in group 3, respectively, for cTnI elevation ≥ 5 × ULN, p = 0.0487). Logistic regression analysis showed that LVEF (OR = 0.915, 95% CI = 0.853-0.981) and the use of nicorandil (OR = 0.516, 95% CI = 0.267-0.996) before PCI were independent protective factors of myocardial injury.



Single oral dose of nicorandil (10 mg, 20 mg) 2 hours before the PCI procedure could decrease the incidence of peri-procedure myocardial injury and PCI-related myocardial infarction.
Pain intensity variability and its relationship with quality of life in youths with juvenile idiopathic arthritis.

To describe variability of pain intensity experienced by youths with juvenile idiopathic arthritis (JIA) and examine factors related to within-day patterns of pain and the relationship between magnitude of pain variability and quality of life.



Pain intensity was self-reported on a visual analog scale (VAS; range 0-100) by 112 youths with JIA ages 8-18 years using electronic diaries 3 times per day for 7 days. Average absolute change in pain (AAC) was computed as a measure of the magnitude of pain variability for each participant. Logistic regression was used to examine the relationship between demographic and disease characteristics and the probability of having high pain variability (AAC ≥10 VAS units). Linear regression was used to examine the relationship between quality of life (assessed by the Pediatric Quality of Life Inventory) and AAC. The generalized estimating equations approach was used to examine the relationship between the time of day and pain intensity.



The mean ± SD AAC was 15.6 ± 10.5. The majority of youths (65%) had high AAC (≥10 VAS units). Disease severity predicted high pain variability (β = 0.02, P = 0.044). Higher AAC predicted lower quality of life (adjusted R(2) = 0.194, β = -0.59, P = 0.003). Within-day patterns of pain intensity varied by JIA subtype and sex.



This study characterized the pain intensity variability experienced by youths with JIA. Pain variability throughout the day was common, varied by JIA subtype and sex, and was related to quality of life. These findings have implications for future pain research, patient education, and development of clinical interventions for this population.
Results of the Southwest Oncology Group phase II evaluation (study S0031) of ZD1839 for advanced transitional cell carcinoma of the urothelium.

Prognosis (inception cohort).



To evaluate the epidermal growth factor receptor (EGFR)-targeted agent ZD1839 in patients who failed one previous chemotherapeutic regimen for metastatic transitional cell carcinoma (TCC), and to correlate patterns of response with the expression of EGFR.



Thirty-one patients with metastatic TCC of the urothelial tract were treated with ZD1839 500 mg oral daily. Patients were required to have a pretreatment biopsy to assess EGF expression.



The median progression-free survival was 2 months, with only two patients (6.5%) surviving past 6 months with no disease progression. Thirty patients were evaluable for toxicity; there was grade 4 cerebrovascular ischaemia and an increase in creatinine level. All patients were evaluable for response, with one confirmed partial response (3%; 95% confidence interval, CI, 0-17%) in a patient with pulmonary metastases. All patients have died, and the estimated median (95% CI) survival is 3 (2-7) months.



ZD1839 is ineffective as a second-line agent for urothelial carcinoma.
Efficacy and safety of duloxetine 30 mg/d in patients with fibromyalgia: a randomized, double-blind, placebo-controlled study.

To evaluate the efficacy and safety of duloxetine 30 mg/d in adults with fibromyalgia.



This 12-week, randomized, double-blind, placebo-controlled study was conducted in the United States, Mexico, Argentina, and Israel and enrolled patients meeting the criteria for primary fibromyalgia as defined by the American College of Rheumatology. The primary endpoint was the average pain severity item from the Brief Pain Inventory (BPI)-Modified Short Form, assessed by an analysis of covariance model using change from baseline to the modified baseline-observation-carried-forward endpoint. Secondary endpoints included the Patient Global Impression of Improvement (PGI-I) score and the Fibromyalgia Impact Questionnaire (FIQ) total score and those measuring pain, depression, anxiety, health outcomes, and safety.



Patients (mean age, 51 y; 95% female; 87% White; 22% with major depressive disorder) received duloxetine 30 mg/d (N=155) or placebo (N=153). Duloxetine-treated patients did not have a statistically significant BPI-Modified Short Form average pain severity reduction versus placebo-treated patients (-2.04 vs. -1.70; P=0.202). There was a significant difference between duloxetine-treated and placebo-treated patients (P<0.05) for the PGI-I endpoint score (2.97 vs. 3.35) and the changes in FIQ total score (-14.62 vs. -9.75) and the Short-Form Health Survey (SF)-36 mental component score. Discontinuations due to adverse events did not differ significantly between treatment groups; nausea and dry mouth were the only adverse events with a significantly higher incidence with duloxetine versus placebo.



Duloxetine 30 mg/d did not significantly reduce pain severity in patients with fibromyalgia. However, duloxetine-treated patients reported global improvement in symptoms and function. Safety findings were consistent with the known duloxetine safety profile.
Pharmacokinetics, pharmacodynamics, and safety of clevidipine after prolonged continuous infusion in subjects with mild to moderate essential hypertension

Clevidipine is a rapidly-acting intravenous dihydropyridine antihypertensive acting via calcium channel blockade. This was a randomized, single-blind, parallel-design study of a 72-h continuous clevidipine infusion. Doses of 2, 4, 8, or 16.0 mg/h or placebo were evaluated in 61 subjects with mild to moderate essential hypertension. IV clevidipine or placebo was initiated at 2.0 mg/h and force-titrated in doubling increments every 3 min to target dose, then maintained for 72 h. Blood pressure and heart rate were measured during infusion, and for 4, 6 and 8 h after termination of infusion, although oral therapy could be restarted at 4 h. Clevidipine blood levels were obtained during infusion and for 1 hour after termination. Rapid onset of drug effect occurred at all clevidipine dose levels, with consistent pharmacokinetics and rapid offset after 72-h infusion. No evidence of tolerance to the clevidipine drug effect was observed at any dose level over the 72-h infusion. No evidence of rebound hypertension was found for either 4 or 6 h after termination of the clevidipine infusion. At 8 h following cessation of clevidipine, blood pressure was not significantly higher than at baseline. Placebo-treated subjects had blood pressures lower than baseline at 8 h following infusion termination; hence, placebo-adjusted blood pressures tended to be slightly higher than baseline. This study supports the use of up to 72 h of IV clevidipine therapy for the management of blood pressure, with consistent pharmacokinetic/pharmacodynamic characteristics and context insensitive half-life across the dose ranges evaluated.
Intensive chemotherapy for elderly patients with acute myelogeneous leukemia: a propensity score analysis by the Japan Hematology and Oncology Clinical Study Group (J-HOCS)

The prognosis of acute myelogenous leukemia (AML) in the elderly patients is extremely poor. Although several previous studies have suggested that intensive chemotherapy is associated with a better prognosis, there may have been a selection bias. Therefore, we retrospectively evaluated the impact of intensive chemotherapy for AML in the elderly by stratifying patients according to a propensity score. Eighty-one AML patients aged 70 years or more were included in this study. Patients with acute promyelocytic leukemia were not included. A propensity score for the use of intensive chemotherapy was calculated from four factors at diagnosis. Forty-five patients received intensive chemotherapy, whereas 36 received low-dose or no chemotherapy. We stratified the patients into quartiles based on the propensity score. The numbers of patients in the first, second, third, and forth quartiles who received intensive chemotherapy were 5 of 21, 10 of 20, 12 of 20, and 18 of 20, respectively. A stratified log-rank test showed significantly better overall survival in the intensive chemotherapy group (P = 0.0088). Especially, in the combined second and third quartiles, which showed an equal tendency for intensive and non-intensive strategies; overall survival at 3 years was 37.5 % for the intensive chemotherapy group and 13.0 % for the non-intensive chemotherapy group (P = 0.0022). A conventional multivariate analysis confirmed that intensive chemotherapy was beneficial (hazard ratio 0.50, 95 % confidence interval 0.27–0.93, P = 0.028). In conclusion, intensive chemotherapy may prolong overall survival in elderly AML patients who are considered to be able to tolerate such treatment based on factors at diagnosis.
Cost Effectiveness of Paclitaxel/Cisplatin Compared with Cyclophosphamide/Cisplatin in the Treatment of Advanced Ovarian Cancer in Belgium

To assess the economic impact of two polychemotherapy regimens for patients with advanced ovarian cancer from the perspective of the Belgian health insurance and financing system.  An economic evaluation was integrated in an intergroup randomised controlled trial (EORTC 55931) in which patients were randomised to receive the new treatment of paclitaxel and cisplatin or the standard therapy of cyclophosphamide and cisplatin. Data on the use of medical resources were collected prospectively for the 231 European Organization for Research and Treatment of Cancer (EORTC) patients in the trial and costs were valued by using unit prices. The outcome for the economic evaluation was mean survival time as determined by the so-called restricted means method, with the time point of restriction fixed by statistical criteria. A correction of censoring of the cost data collected in the trial was also performed. Main outcome measures and results: The paclitaxel and cisplatin group experienced a statistically significant improvement in mean survival time of 4 months, which was associated with an increase in the average total cost per patient of 6795 euros (EUR; 1998 values), when costs were assessed over the same period as the gain in mean survival time. This corresponds to a point estimate of the incremental cost-effectiveness ratio of EUR20 385 per life-year gained. The impact of uncertainty was assessed by using a bias-corrected and accelerated bootstrap method with 5000 resamples, and the final results of the analysis are expressed in terms of a cost-effectiveness acceptability curve.  The present economic evaluation has shown that the substitution of paclitaxel for cyclophosphamide in the chemotherapy regimen for women with advanced ovarian cancer leads to a significant improvement in patient survival, which is associated with an increase in costs for the Belgian health insurance system.