nils-herrmann/clean_scirepeval huggingface dataset:
Wrapping of the omental pedicle flap around esophagogastric anastomosis after esophagectomy for esophageal cancer.

Esophagogastrectomy for esophageal cancer is the standard surgical treatment as a curative measure or for palliation. Esophagogastric anastomotic leakage and stricture are common life-threatening postoperative complications (more so if the leakage occurs in the chest), and the success of the anastomosis created in the reconstruction of the resected esophagus can highly influence morbidity and mortality.



A prospective, randomized study was undertaken on 291 patients treated for carcinoma of the esophagus between January 2004 and December 2008. The study excluded 36 patients (12%) who were inoperable. Patients were assigned to 2 treatment groups that consisted of 128 patients in group A and 127 patients in group B according to a restricted, permuted block randomization plan. Patients in group A underwent an esophagogastrectomy with wrapping of the pedicle omental flap around the esophagogastric anastomosis. Group B patients underwent an esophagogastrectomy with only a stapled technique.



Of all 255 patients who received an esophagogastric anastomosis, 226 (89%) were discharged from the hospital within 15 days of operation. There was no significant difference between these 2 groups in regard to the incidence of pulmonary complications, abdominal or thoracic infections, and days of hospital stay. Anastomotic leaks occurred in a single patient from group A (1%) and in 7 patients from group B (6%). In group A, 33 patients underwent transhiatal esophagogastrectomy and 95 had thoracic esophagogastrectomy, which resulted in an anastomotic leakage in 1 (3%) and 0 (0%) patients, respectively. In group B, 42 patients had transhiatal esophagogastrectomy and 85 had thoracic esophagogastrectomy, which resulted in anastomotic leakage in 5 (12%) and 2 (2%) patients, respectively. The leakage ratio of group B was significant greater than that of group A (P < .05). Two patients were excluded during the evaluation of the benign stricture due to hospital mortality. Anastomotic strictures were noted in 8 patients from group A (6%) and 20 patients from group B (16%), and the difference in the incidence of anastomotic strictures between these 2 groups was statistically significant (P < .05).



Wrapping of the pedicle omental flap around the esophagogastric stapled anastomosis site decreases the incidence of anastomotic leakage and stricture rate after esophagectomy for esophageal cancer, thereby decreasing the morbidity and mortality of the procedure.
Feasibility study of stereotactic body radiotherapy for peripheral lung tumors with a maximum dose of 100 Gy in five fractions and a heterogeneous dose distribution in the planning target volume

We evaluated toxicity and outcomes for patients with peripheral lung tumors treated with stereotactic body radiation therapy (SBRT) in a dose-escalation and dose-convergence study. A total of 15 patients were enrolled. SBRT was performed with 60 Gy in 5 fractions (fr.) prescribed to the 60% isodose line of maximum dose, which was 100 Gy in 5 fr., covering the planning target volume (PTV) surface (60 Gy/5 fr. - (60%-isodose)) using dynamic conformal multiple arc therapy (DCMAT). The primary endpoint was radiation pneumonitis (RP) ≥ Grade 2 within 6 months. Toxicities were graded according to the Common Terminology Criteria for Adverse Events, version 4.0. Using dose-volumetric analysis, the trial regimen of 60 Gy/5 fr. - (60%-isodose) was compared with our institutional conventional regimen of 50 Gy/5 fr. - . The enrolled consecutive patients had either a solitary peripheral tumor or two ipsilateral tumors. The median follow-up duration was 22.0 (12.0-27.0) months. After 6 months post-SBRT, the respective number of RP Grade 0, 1 and 2 cases was 5, 9 and 1. In the Grade 2 RP patient, the image showed an organizing pneumonia pattern at 6.0 months post-SBRT. No other toxicity was found. At last follow-up, there was no evidence of recurrence of the treated tumors. The target volumes of 60 Gy/ 5 fr. - (60%-isodose) were irradiated with a significantly higher dose than those of 50 Gy/5 fr. - , while the former dosimetric parameters of normal lung were almost equivalent to the latter. SBRT with 60 Gy/5 fr. - (60%-isodose) using DCMAT allowed the delivery of very high and convergent doses to peripheral lung tumors with feasibility in the acute and subacute phases. Further follow-up is required to assess for late toxicity.
The Revised Behavior and Symptom Identification Scale (BASIS-R): reliability and validity.

To assess outcomes of health services, providers need brief, responsive, reliable, and valid measures that can be implemented in clinical settings with minimal cost and burden. The Behavior and Symptom Identification Scale (BASIS-32) is a self-report measure developed in 1984 to assess mental health treatment outcomes. During the past 3 years, multiple methods were used to revise the instrument to improve reliability, validity, and applicability to diverse groups of mental health service recipients.



The objective of this study was to field test the revised instrument, make further changes based on analysis of the field test data, and assess reliability and validity of the final version (BASIS-24).



A field test was implemented at 27 treatment sites across the United States. A total of 2656 inpatients and 3222 outpatients participated. Factor analytic methods, classic test theory, and item response theory modeling were used to select the most discriminating, nonredundant items for inclusion in the final version of the instrument and to assess its reliability and validity. Item response theory modeling was used to score the instrument.



The final instrument includes 24 items assessing 6 domains: depression/ functioning, interpersonal relationships, self-harm, emotional lability, psychosis, and substance abuse. Test-retest and internal consistency reliability were acceptable. Tests of construct and discriminant validity supported the instrument's ability to discriminate groups expected to differ in mental health status, and its correlation with other measures of mental health.



Analyses of the BASIS-24 supported its reliability and validity for assessing mental health status from the patient's perspective.
Value of Implantable Loop Recorders in Monitoring Efficacy of Radiofrequency Catheter Ablation in Atrial Fibrillation

The aim of this study was to evaluate the value of the implantable loop recorder (ILR) in diagnosing atrial fibrillation (AF) and assessing the postoperative efficacy of radiofrequency catheter ablation (RFCA).  A total of 32 patients who successfully underwent RFCA were selected. These patients discontinued antiarrhythmic medication with no AF recurrence for more than 3 months after RFCA, and underwent ILR placement by a conventional method. The clinical manifestations and information on arrhythmias recorded by the ILR were followed up to assess the efficacy of AF RFCA.  The mean follow-up period was 24.7±12.5 months. Of 32 patients with ILR information, 27 had successful RFCA and 5 had recurrent AF. The follow-up results obtained by traditional methods showed 29 patients with successful RFCA and 3 with recurrent AF (P<0.05). Among the 18 patients with clinical symptoms, 13 had recorded cardiac arrhythmic events (72.2%) and 5 showed sinus rhythm (27.8%). The ILRs recorded 18 patients with arrhythmic events (56.3%), including 12 cases of atrial arrhythmias, among whom 5 recurred at 9, 12, 16, 17, and 32 months after AF RFCA; there were also 2 patients with ventricular tachycardia (VT) and 4 with bradycardia.  The value of ILR in assessing the efficacy of AF RFCA was superior to that of traditional methods. ILR can promptly detect asymptomatic AF, and can monitor electrocardiogram features after RFCA, thus providing objective evidence of efficacy.
Enhancing adherence to antiretroviral therapy at the HIV clinic in resource constrained countries; the Tanzanian experience.

To evaluate various strategies aimed at improving adherence to antiretroviral therapy (ART).



Patients initiated on ART at Muhimbili National Hospital HIV clinic were randomly assigned to either regular adherence counseling, regular counseling plus a calendar, or regular counseling and a treatment assistant. Patients were seen monthly; during these meetings self-reported adherence to treatment was recorded. Disease progression was monitored clinically and immunologically.



Of the 621 patients randomized, 312 received regular counseling only, 242 regular counseling and calendars, while 67 had treatment assistants in addition to regular counseling. The mean (SD) follow-up time was 14.5 (4.6) months. During follow-up 20 (3.2%) patients died, and 102 (16.4%) were lost to follow-up; this was similar in all groups. In 94.8% of all visits, patients reported to have adhered to treatment. In only 39 (0.7%) visits did patients report a < or = 95% adherence. There were no differences in adherence (P = 0.573) or differences in CD4 count and weight changes over time in the interventions.



Good adherence to ART is possible in resource constrained countries. Persistent adherence counseling in clinic settings by itself may be effective in improving adherence to ART.
Impact of prior virological failure and nucleos(t)ide genotypic resistance mutations on the efficacy of switching from ritonavir-boosted protease inhibitors to raltegravir.

The virological efficacy of switching from a ritonavir-boosted protease inhibitor (PI/r)- to a raltegravir (RAL)-containing regimen remains controversial according to the results of SWITCHMRK and SPIRAL studies. The aim of this analysis is to assess the impact of prior resistance mutations to nucleos(t)ides and other potential factors on the virological outcome.



This was a substudy of the prospective, open-label, multicentre SPIRAL study. Demographic, virological variables, prior episodes of virological failures (VF) and archived resistance mutations to nucleos(t)ides were identified from databases and its impact measured by genotypic sensitive scores (GSS) according to the genotypic resistance interpretation algorithm from the Stanford HIV Drug Resistance Database on outcome was analysed.



Of 250 patients (128 RAL and 122 PI/r) included in the main SPIRAL study, 74 (30%) had previous VF with prior genotypic resistance tests (GRT). Median time of virological suppression prior to inclusion in SPIRAL study was 63.5 months. GSS for backbone nucleos(t)ides was <1 in 15/38 (39%) in the RAL arm and in 9/36 (25%) in the PI/r arm (P=0.13). Among those with nucleos(t)ides GSS <1, 0/15 (0%) in the RAL versus 2/9 (22%) in the PI/r arm developed VF (P=0.13). Moreover 0/11 subjects with null or residual (GSS≤0.5) backbone activity developed VF in the RAL arm.



The 48-week virological efficacy of switching from a PI/r to RAL in subjects with long-term virological suppression was not compromised by a reduction of the nucleos(t)ide backbone activity.
The Effect of Telephone-Facilitated Depression Care on Older, Medically Ill Patients

The objective of this study was to determine the effectiveness of a telephone-facilitated depression care protocol in older, medically ill adults compared to routine care. A 12-week double blind randomized controlled trial was conducted in recently discharged primary care patients (N = 124). Depression was assessed with the Patient Health Questionnaire-9. Primary care providers were notified of the level of depression severity and indications for treatment, but neither they nor the patients were contacted by a psychiatrist or other mental health professional. The primary outcome was initiation of treatment. Secondary outcomes were symptoms reduction and depression remission rates. There were no significant outcome differences between the facilitated and routine care groups. This study showed that older, medically ill adults may require a level of depression care that goes beyond a telephone-facilitated protocol.
Toward a new approach for the detection of pain in adult patients undergoing cardiac surgery: near-infrared spectroscopy--a pilot study.

This pilot study examined the discriminant validity and criterion validity of regional cerebral oxygenation measurement (rSO₂), using the near-infrared spectroscopy (NIRS) technique (INVOS-4100 system, Somanetics, Troy, MI) for measuring pain during nociceptive procedures in adults undergoing cardiac surgery.



A repeated-measures, within-subjects design was used, and 40 adult patients participated. Data collection was completed during 2 test periods: (1) while patients were awake, before the induction of anesthesia (first test period); and (2) after the induction of anesthesia, while patients remained under the effects of anesthesia (second test period). Each test period included a baseline, a tactile stimulus (skin disinfection), nociceptive stimuli (e.g., intravenous and arterial line insertions, sternal bone incision and thorax opening), and a postprocedure evaluation.



Increased rSO₂ values (P < .001) were acquired during nociceptive procedures in both test periods. No significant associations were evident between rSO₂, pain behaviors, and the patient's self-report of pain intensity, but this may be attributable to a low range of variability.



Although further research is needed in critically ill adult patients undergoing more painful procedures, the NIRS may become a promising technique for assessing pain.
The potential of 4D sonography in the assessment of fetal neurobehavior--multicentric study in high-risk pregnancies.

An evolving challenge for obstetrician is to better define normal and abnormal fetal neurological function in utero in order to better predict antenatally which fetuses are at risk for adverse neurological outcome.



Prenatal neurological assessment in high-risk fetuses using four-dimensional ultrasound applying the recently developed Kurjak antenatal neurodevelopmental test (KANET). Postnatal neurological assessment was performed using Amiel Tison's neurological assessment at term (ATNAT) for all live-borns and general movement (GM) assessment for those with borderline and abnormal ATNAT.



Inclusion criteria were met by 288 pregnant women in four centers of whom 266 gave birth to a live-born baby. It was revealed that 234 fetuses were neurologically normal, 7 abnormal and 25 borderline. Out of 7 abnormal fetuses ATNAT was borderline in 5 and abnormal in 2, whereas GM assessment was abnormal in 5 and definitely abnormal in 2. Out of 25 KANET borderline fetuses, ATNAT was normal in 7, borderline in 17 and abnormal in 1, whereas the GM assessment was as follows: normal optimal in 4, normal suboptimal in 20, and abnormal in 1. In summary, out of 32 borderline and abnormal fetuses ATNAT was normal in 7, borderline in 22 and abnormal in 3; GM assessment was normal optimal in 4, normal suboptimal in 20, abnormal in 6 and definitely abnormal in 2.



The sonographic test requires further studies before being recommended for wider clinical practice.
Fulvestrant 500 mg versus anastrozole 1 mg for the first-line treatment of advanced breast cancer: follow-up analysis from the randomized ‘FIRST’ study

Fulvestrant fIRst-line Study comparing endocrine Treatments is a phase II, randomized, open-label study comparing fulvestrant 500 mg with anastrozole 1 mg as first-line endocrine therapy for postmenopausal women with hormone receptor-positive (HR+) advanced breast cancer. At data cut-off, only 36 % of patients had progressed and the median time to progression (TTP) had not been reached for fulvestrant. Here, we report follow-up data for TTP for fulvestrant 500 mg versus anastrozole 1 mg. Key inclusion criteria were postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive locally advanced or metastatic breast cancer and no prior endocrine therapy. Key exclusion criteria were presence of life-threatening metastases and prior treatment with a non-approved drug. Fulvestrant was administered 500 mg/month plus 500 mg on day 14 of month 1; anastrozole was administered 1 mg/day. TTP was defined by modified Response Evaluation Criteria in Solid Tumors v1.0 before data cut-off for the primary analysis, and investigator opinion after data cut-off. Best overall response to subsequent therapy and serious adverse events are also reported. In total, 205 patients received fulvestrant 500 mg (n = 102) or anastrozole (n = 103). Follow-up analysis was performed when 79.5 % of patients had discontinued study treatment. Median TTP was 23.4 months for fulvestrant versus 13.1 months for anastrozole; a 34 % reduction in risk of progression (hazard ratio 0.66; 95 % confidence interval: 0.47, 0.92; P = 0.01). Best overall response to subsequent therapy and clinical benefit rate for subsequent endocrine therapy was similar between the treatment groups. No new safety concerns for fulvestrant 500 mg were documented. These longer-term, follow-up results confirm efficacy benefit for fulvestrant 500 mg versus anastrozole as first-line endocrine therapy for HR+ advanced breast cancer in terms of TTP, and, importantly, show similar best overall response rates to subsequent endocrine therapy.
Ultrasound-assisted versus conventional catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis.

For patients with acute iliofemoral deep vein thrombosis, it remains unclear whether the addition of intravascular high-frequency, low-power ultrasound energy facilitates the resolution of thrombosis during catheter-directed thrombolysis.



In a controlled clinical trial, 48 patients (mean age 50 ± 21 years, 52% women) with acute iliofemoral deep vein thrombosis were randomized to receive ultrasound-assisted catheter-directed thrombolysis (N = 24) or conventional catheter-directed thrombolysis (N = 24). Thrombolysis regimen (20 mg r-tPA over 15 hours) was identical in all patients. The primary efficacy end point was the percentage of thrombus load reduction from baseline to 15 hours according to the length-adjusted thrombus score, obtained from standardized venograms and evaluated by a core laboratory blinded to group assignment. The percentage of thrombus load reduction was 55% ± 27% in the ultrasound-assisted catheter-directed thrombolysis group and 54% ± 27% in the conventional catheter-directed thrombolysis group (P = 0.91). Adjunctive angioplasty and stenting was performed in 19 (80%) patients and in 20 (83%) patients, respectively (P > 0.99). Treatment-related complications occurred in 3 (12%) and 2 (8%) patients, respectively (P > 0.99). At 3-month follow-up, primary venous patency was 100% in the ultrasound-assisted catheter-directed thrombolysis group and 96% in the conventional catheter-directed thrombolysis group (P = 0.33), and there was no difference in the severity of the post-thrombotic syndrome (mean Villalta score: 3.0 ± 3.9 [range 0-15] versus 1.9 ± 1.9 [range 0-7]; P=0.21), respectively.



In this randomized controlled clinical trial of patients with acute iliofemoral deep vein thrombosis treated with a fixed-dose catheter thrombolysis regimen, the addition of intravascular ultrasound did not facilitate thrombus resolution.
Intravitreal triamcinolone acetonide injection at the end of vitrectomy for diabetic vitreous hemorrhage: a randomized, clinical trial.

To evaluate the clinical outcome and complications of intravitreal injections of triamcinolone acetonide in patients undergoing pars plana vitrectomy for treatment of diabetic nonclearing vitreous hemorrhage.



This prospective, randomized clinical trial study included 72 consecutive patients (72 eyes) who underwent pars plana vitrectomy for treatment of diabetic nonclearing vitreous hemorrhage. 38 patients received an intravitreal injection of 4 mg (0.1 cc) of triamcinolone acetonide at the end of surgery. Main outcome measures were rate of recurrent early vitreous hemorrhage, reoperation, intraocular pressure, visual acuity, and incidence of cataract formation. Mean follow-up time was 6 months.



Rate of early rebleeding and reoperation were lower in patients taking intravitreal triamcinolone (P = 0.003 and 0.03, respectively). Visual acuity 6 months after operation was better in study group (P < 0.001). Mean intraocular pressure was higher 1 day and 1 week after procedure in study group compared with control group (P < 0.001 and 0.002, respectively); however, in other times its differences were not significant. No significant difference in rate of nuclear sclerosis and cortical cataract formation and other complication was noted between the two groups. However, there was a significantly increased rate of posterior subcapsular progression in a dose dependent manner in the study group versus control (P = 0.011).



The present clinical study suggests that intravitreal injection of triamcinolone acetonide is effective in the prevention of rebleeding in eyes undergoing pars plana vitrectomy for treatment of diabetic vitreous hemorrhage.
Validation of the English language Forgotten Joint Score-12 as an outcome measure for total hip and knee arthroplasty in a British population.

To validate the English language Forgotten Joint Score-12 (FJS-12) as a tool to evaluate the outcome of hip and knee arthroplasty in a United Kingdom population.



All patients undergoing surgery between January and August 2014 were eligible for inclusion. Prospective data were collected from 205 patients undergoing total hip arthroplasty (THA) and 231 patients undergoing total knee arthroplasty (TKA). Outcomes were assessed with the FJS-12 and the Oxford Hip and Knee Scores (OHS, OKS) pre-operatively, then at six and 12 months post-operatively. Internal consistency, convergent validity, effect size, relative validity and ceiling effects were determined.



Data for the TKA and THA patients showed high internal consistency for the FJS-12 (Cronbach α = 0.97 in TKAs, 0.98 in THAs). Convergent validity with the Oxford Scores was high (r = 0.85 in TKAs, r = 0.79 for THAs). From six to 12 months, the change was higher for the FJS-12 than for the OHS in THA patients (effect size d = 0.21 versus -0.03). Ceiling effects at one-year follow-up were low for the FJS-12 with just 3.9% (TKA) and 8.8% (THA) of patients achieving the best possible score.



The FJS-12 has strong measurement properties in terms of validity, internal consistency and sensitivity to change in TKA and THA patients. Low ceiling effects and good relative validity allow the monitoring of longer term outcomes, particularly in well-performing groups after total joint arthroplasty.
Distributed Non-binary Constraints

Nowadays many real problems can be modeled as Constraint Satisfaction Problems (CSPs). In many situations, it is desirable to be able to state both hard constraints and soft constraints. Hard constraints must hold while soft constraints may be violated but as many as possible should be satisfied. Although the problem constraints can be divided into two groups, the order in which these constraints are studied can improve efficiency, particulary in problems with non-binary constraints. In this paper, we carry out a classification of hard and soft constraints in order to study the tightest hard constraints first and to obtain ever better solutions. In this way, inconsistencies can be found earlier and the number of constraint checks can be significantly reduced.