nils-herrmann/clean_scirepeval huggingface dataset:
The COPD Italian Lung Information Needs Questionnaire (LINQ): development, preliminary validation, and findings.

Chronic obstructive pulmonary disease (COPD) patients have poor knowledge about the disease. Until now, it has not been possible to check the information needs of these patients. The Lung Information Needs Questionnaire (LINQ), however, could fill this particular need. The aims of this study were to identify patient perceptions about COPD, and what information patients need, and to verify whether the questionnaire is comprehensible. Data demonstrate that LINQ is easily understood: 82% answered all questions with "I have properly understood the question". LINQ is quick to apply (approx. 6 min to complete). Sixty-seven per cent of patients had incorrect knowledge about their prognosis. Thirty-six per cent did not know when to call an ambulance. Eight per cent of smokers said that no one had ever told them to stop smoking. Compliance with therapy results was not sufficient. Patients had poor knowledge of the causes of COPD, and they knew little about the whys and wherefores of COPD treatment. LINQ represents a valid means of investigating patients afflicted with COPD and managing pathology control by the doctor and by the patient. LINQ represents a fundamental means of investigating otherwise-unknown COPD issues.
Functional outcome after computer-assisted total knee arthroplasty using measured resection versus gap balancing techniques: a randomised controlled study.

To compare the 2-year outcome of total knee arthroplasty (TKA) using the measured resection versus the gap balancing techniques.



21 men and 31 women aged 41 to 89 (mean, 73) years who underwent primary TKA by a single surgeon for osteoarthritis and had an American Society of Anesthesiologists I or II physical status were prospectively studied. Patients were randomised to undergo computer-assisted TKA using the measured resection technique (n=26) or the gap balancing technique (n=26). At the 2-year follow-up, patients were assessed by a single orthopaedic registrar blinded to the type of surgery using the Knee Society score (KSS), functional Knee Society score (FKSS), and revised Oxford Knee score (ROKS).



In the measured resection group, the mean KSS, FKSS, and ROKS increased from 34.3, 48, and 21 to 85.9, 89.6, and 36.5, respectively. In the gap balancing group, the respective scores increased from 35.4, 50, and 22.5 to 89.1, 92.4, and 40.6. Postoperative increases in the respective scores were slightly better with the gap balancing technique; the respective p values were 0.46, 0.44, and 0.12.



Improvements in the knee scores were comparable with the 2 techniques.
Factors related to renal cortical atrophy development after glucocorticoid therapy in IgG4-related kidney disease: a retrospective multicenter study

In immunoglobulin G4-related kidney disease (IgG4-RKD), focal or diffuse renal cortical atrophy is often observed in the clinical course after glucocorticoid therapy. This study aimed to clarify the factors related to renal atrophy after glucocorticoid therapy in IgG4-RKD.



We retrospectively evaluated clinical features including laboratory data and computed tomography (CT) findings before and after glucocorticoid therapy in 23 patients diagnosed with IgG4-RKD, all of whom were followed up for more than 24 months.



Seventeen patients were men, and six were women (average age 62.0 years). Average follow-up period was 54.9 months. The average estimated glomerular filtration rate (eGFR) at diagnosis was 81.7 mL/min/1.73 m2. All patients had had multiple low-density lesions on contrast-enhanced CT before glucocorticoid therapy, and showed disappearance or reduction of these lesions after it. Pre-treatment eGFR and serum IgE level in 11 patients in whom renal cortical atrophy developed 24 months after the start of glucocorticoid therapy were significantly different from those in 12 patients in whom no obvious atrophy was found at that time (68.9 ± 30.1 vs 93.5 ± 14.1 mL/min/1.73 m2, P = 0.036, and 587 ± 254 vs 284 ± 263 IU/mL, P = 0.008, respectively). Pre-treatment eGFR and serum IgE level were also significant risk factors for renal atrophy development 24 months after the start of therapy with an odds ratio of 0.520 (per 10 mL/min/1.73 m2, 95% confidence interval (CI) 0.273-0.993, P = 0.048) and 1.090 (per 10 IU/mL, 95% CI: 1.013-1.174, P = 0.022), respectively, in age-adjusted, sex-adjusted, serum IgG4 level-adjusted logistic regression analysis. Receiver operating characteristic curve analysis showed that eGFR of less than 71.0 mL/min/1.73 m2 and serum IgE of more than 436.5 IU/mL were the most appropriate cutoffs and yielded sensitivity of 63.6% and specificity of 100%, and sensitivity of 90.9% and specificity of 75.0%, respectively, in predicting renal atrophy development.



This study suggests that pre-treatment renal insufficiency and serum IgE elevation predict renal atrophy development after glucocorticoid therapy in IgG4-RKD.
Phase I trial of Uracil-Tegafur (UFT) plus oral leucovorin: 14-day schedule

We previously reported results of a Phase II trial of UFT [Taiho Pharmaceutical Ltd., Tokyo, Japan; (BMS-200604) Bristol-Myers Squibb, Princeton, NJ], an oral 4:1 molar concentration of uracil and tegafur, plus oral leucovorin for metastatic colorectal carcinoma (Pazdur et al,  1994]. Our results demonstrated that a 28-day schedule of this combination produced a response rate similar to that obtained with conventional intravenous fluorouracil (5-FU)-plus-leucovorin regimens but without the severe or life-threatening neutropenia or oral mucositis that complicates intravenous 5-FU regimens. The current Phase I trial examines the dose-limiting toxic effects and maximum tolerated dose of a 14-consecutive-day schedule of UFT plus oral leucovorin in 14 patients who had histologically proven cancer and had received prior chemotherapy. The daily UFT plus leucovorin dose was divided into three doses administered orally every 8 hours. In this study, the UFT dose was escalated while the leucovorin dose remained at 150 mg/day. Of the 14 patients, 4 were initially treated at the 350-mg/m2/day UFT level for 14 days without any dose-limiting toxic reactions. Subsequently, another 7 patients were treated at the 400-mg/m2/day level; grade 3 diarrhea developed in 3 of these 7 (with severe abdominal cramping in 2 cases and severe nausea and vomiting unresponsive to antiemetics in the third). To better define the starting dose for phase II studies, an additional 3 patients were treated at the 350-mg/m2/day dose level. Of the total 7 patients treated at 350 mg/m2/day, grade 3 toxic events (diarrhea) developed in 2 patients. Grade 1-2 toxic effects noted at this level included fatigue, stomatitis, skin rash, abdominal pain, nausea, and vomiting. Neither partial nor complete responses were observed in this trial. The maximum tolerated dose of this schedule is 350 mg/m2/day UFT plus 150 mg/day oral leucovorin. However, because of this schedule's inferior dose intensity compared with that of the 28-day schedule of UFT plus leucovorin, subsequent development of UFT in the United States has focused on the 28-day regimen.
Improved oxygenation utilizing a prone positioner in patients with acute respiratory distress syndrome

(a) To determine whether placing patients with acute respiratory distress syndrome in the prone position by a light-weight portable support frame improves oxygenation, (b) whether one can determine which patients benefit from prone positioning, and (c) to determine an effective technique for prone positioning of patients. Prospective, controlled trial without blinding. Medical intensive care units in two urban university-affililated hospitals. Fifteen patients meeting a standard definition for acute respiratory distress syndrome were studied prospectively. Each patient acted as his own control for purposes of comparison. Patients were assigned randomly to begin in either supine or prone positions. The positioning frame was used to turn patients from one position to the other, and oxygenation, ventilation, respiratory mechanics, and hemodynamics were measured. Significantly better oxygenation was seen in the prone positions than in the supine (P<0.05). In the overall population there was a decrease in AaDO2 of 21 mmHg when the patients were placed prone. The groups were then divided into responders (n=9) and nonresponders (n=6). There were significant differences between the groups (but not between positions) regarding PaO2, baseline, PaCO2, pulmonary artery pressures, and peak inspiratory pressures on the ventilator and in ICU length of stay and time on mechanical ventilatory support. Prone positioning improves oxygenation in the majority of patients studied and can be achieved relatively easily.
VX-222, a non-nucleoside NS5B polymerase inhibitor, in telaprevir-based regimens for genotype 1 hepatitis C virus infection.

To investigate in this phase 2a study (ZENITH) the safety, tolerability, and antiviral activity of VX-222, a selective, non-nucleoside inhibitor of hepatitis C virus (HCV) NS5B polymerase, combined with various telaprevir-based regimens for treatment of genotype 1 HCV.



In total, 152 treatment-naive patients received VX-222+telaprevir ('DUAL' regimen; n=47), with ribavirin ('TRIPLE' regimen; n=46), or with peginterferon+ribavirin ('QUAD' regimen; n=59) for 12 weeks. Patients with detectable HCV RNA at weeks 2 and/or 8 received peginterferon+ribavirin for 24 (DUAL and TRIPLE) or 12 (QUAD) additional weeks.



VX-222 (100 or 400 mg twice daily) was well tolerated, with an increased rate of gastrointestinal adverse events observed with the higher dose. Across VX-222 400-mg twice-daily regimens, the QUAD was associated with the highest frequency of grade 3/4 adverse events. The DUAL was discontinued because of high viral breakthrough before week 12. Sustained virologic response (SVR) 24 weeks after end of treatment (SVR24), including patients treated with 12 or 24 additional weeks of peginterferon+ribavirin, was 67% for TRIPLE (VX-222 400 mg twice daily) and 79 and 90% for QUAD (VX-222 100 and 400 mg twice daily, respectively).



These results provide valuable information regarding the safety, tolerability, and efficacy of telaprevir combined with a non-nucleoside polymerase inhibitor, as dual therapy or with ribavirin without or with peginterferon. Telaprevir and VX-222, alone or with ribavirin without or with peginterferon, were generally well tolerated, with improved tolerability without peginterferon. SVR24 rates achieved with TRIPLE and QUAD regimens containing telaprevir and VX-222 were comparable to those observed with telaprevir-based therapy.
A dose-finding and pharmacokinetic study of reversal of multidrug resistance with SDZ PSC 833 in combination with doxorubicin in patients with solid tumors.

Forty-two patients with advanced solid tumors were entered into a dose-finding study of the combination of doxorubicin with the cyclosporin analogue SDZ PSC 833 (PSC), given by oral route. Patients received PSC at escalating doses, ranging from 2.5 to 25 mg/kg/day, for 5 days, in doses given every 12 h. Doxorubicin was given by i.v. push on day 3 of PSC administration, 4 h after the morning dose of PSC. Pharmacokinetic analyses of PSC and doxorubicin were performed. A total of 38 patients received a combination of PSC and doxorubicin, and 27 received doxorubicin alone in the first course. The major toxicity of the combination was hematological and was significantly more severe than that with doxorubicin alone; severe myelosuppression was already observed at the first PSC dose level, which required doxorubicin dose reduction from 50 to 35 mg/m2. At all dose levels of PSC, up to 17.5 mg/kg/day, there were at least two patients with grade 3 or 4 hematological toxicity, which was manageable in less heavily pretreated patients. A further PSC dose escalation was performed to 25 mg/kg/day, together with doxorubicin, at a further reduced dose of 20 mg/m2. At this dose, central nervous system toxicity became the most relevant side effect. The increase of toxicity in the combined treatment was supported by a significant increase of the area under the plasma concentration-time curve to infinity of doxorubicin (54%) and a 10-fold increase of the area under the plasma concentration-time curve to infinity of doxorubicinol. The pharmacological interaction was not dependent on the plasma concentration of PSC. The total body clearance of doxorubicin decreased by 30%. PSC plasma concentrations of >1 microM at the time of doxorubicin administration were, in general, found at a dose of 7.5 mg/kg/day or higher. One patient had a partial response. In conclusion, PSC plasma concentrations that can revert multidrug resistance in experimental models could be achieved in patients who have solid tumors and who are treated with doxorubicin. However, a marked pharmacological interaction was found between doxorubicin and PSC, which led to substantial increase in hematological toxicity and required marked reduction of the doxorubicin dose. Further study of PSC may be warranted, in association with the investigation of P-glycoprotein expression and concentration of drugs in the tumor tissues.
Increased infiltration of activated tumor-infiltrating lymphocytes after high intensity focused ultrasound ablation of human breast cancer.

Previous studies have shown that high intensity focused ultrasound (HIFU) ablation can induce a distinct inflammatory reaction with marked infiltration of lymphocytes after direct tumor destruction. In this study, we investigated the status of tumor-infiltrating lymphocytes (TILs) after HIFU ablation of human breast cancer and explored mechanisms that may be involved in HIFU-triggered, antitumor immune response.



A total of 48 female patients with biopsy-proven breast cancer were divided randomly into 1 of 2 groups: control group (n = 25), in which only modified radical mastectomy was performed, or HIFU group (n = 23), in which HIFU ablation of the primary breast cancer was performed prior to modified radical mastectomy. Using semiquantitative immunohistochemical analysis, tumor-infiltrating T lymphocytes and subsets, B lymphocytes, and natural killer (NK) cells were assessed in all patients. Expression of Fas ligand (FasL), granzyme, and perforin on TILs was also studied in both groups.



TILs infiltrated along the margins of the ablated region in all HIFU-treated neoplasms, and the numbers of tumor-infiltrating CD3, CD4, CD8, CD4/CD8, B lymphocytes, and NK cells was increased significantly in the HIFU group. The number of FasL(+), ), and ) TILs was significantly greater in the HIFU group than in the control group.



HIFU ablation induced marked infiltration of CD3, CD4, CD8, B lymphocytes, and NK cells in the treated breast lesions. The number of FasL(+), ), and ) TILs was significantly increased after HIFU treatment.
Double-contrast, single-phase computed tomography angiography for ruling out left atrial appendage thrombus prior to atrial fibrillation ablation

Prior to atrial fibrillation (AF) ablation, computed tomography angiography (CTA) is increasingly used for left atrial appendage (LAA) thrombus detection. LAA filling defects on CTA may represent thrombus or incomplete contrast mixing with blood. A pre-bolus of contrast material with delay before the CTA contrast bolus can help distinguish between thrombus and incomplete contrast mixing. We present results from a double-contrast, single-phase CTA protocol used in our daily clinical practice. In patients who underwent AF ablation between 2011 and 2015, double-contrast, single-phase CTA was performed prior to ablation. Two contrast boluses (30 and 70 ml) with 25-s interbolus delay were administered followed by prospectively triggered cardiac CTA. Only patients with left atrial (LA) or LAA filling defects underwent transesophageal echocardiography (TEE) to rule out thrombus. Prior to ablation, 605 CTA-scans were performed (median radiation dose: 3.1 mSv). In 579 CTA-scans (95.7 %), the LA and LAA completely filled with contrast. In 26 CTA-scans (4.3 %) the LAA showed a filling defect whereby thrombus could not be excluded. In 2 of those 26 patients (7.7 % and 0.3 % of the total population), TEE verified LAA thrombus. Low-risk LAA filling defects on CTA (n = 7/26) with an inhomogeneous aspect, Houndsfield Unit values >100, and an indefinite border were all caused by incomplete contrast mixing. No thromboembolic complications occurred perioperatively or during 6 months follow-up. Prior to AF ablation, incidence of LAA filling defects on double-contrast, single-phase CTA is low. TEE remains warranted in all but low-risk filling defects to rule out thrombus.
PET/CT for differentiating between tuberculous peritonitis and peritoneal carcinomatosis

Tuberculous peritonitis (TBP) mimics peritoneal carcinomatosis (PC). We aimed to investigate the discriminative use of PET/CT findings in the parietal peritoneum.



Parietal peritoneal PET/CT findings from 76 patients with TBP (n = 25) and PC (n = 51) were retrospectively reviewed. The lesion locations were noted as right subdiaphragmatic, left subdiaphragmatic, right paracolic gutters, left paracolic gutters, and pelvic regions. The distribution characteristic consisted of a dominant distribution in the pelvic and/or right subdiaphragmatic region (susceptible area for peritoneal implantation, SAPI) (SAPI distribution), a dominant distribution in the remaining regions (less-susceptible area for peritoneal implantation, LSAPI) (LSAPI distribution), or a uniform distribution. PET morphological patterns were classified as F18-fluorodeoxyglucose (F-FDG) uptake in a long beaded line (string-of-beads F-FDG uptake) or in a cluster (clustered F-FDG uptake) or focal F-FDG uptake. CT patterns included smooth uniform thickening, irregular thickening, or nodules.



More common findings in the parietal peritoneum corresponding to TBP as opposed to PC were (a) ≥4 involved regions (80.0% vs 19.6%), (b) uniform distribution (72.0% vs 5.9%), (c) string-of-beads F-FDG uptake (76.0% vs 7.8%), and (d) smooth uniform thickening (60.0% vs 7.8%) (all P < 0.001), whereas more frequent findings in PC compared with TBP were (a) SAPI distribution (78.4% vs 28.0%), (b) clustered F-FDG uptake (56.9% vs 20.0%), (c) focal F-FDG uptake (21.6% vs 4.0%), (d) irregular thickening (51.0% vs 12.0%), and (e) nodules (21.6% vs 4.0%) (P < 0.001, P < 0.05, P > 0.05, P < 0.05, P > 0.05, respectively).



Our data show that PET/CT findings in the parietal peritoneum are useful for differentiating between TBP and PC.
Development and validation of a clinical score for prognosis stratification in patients requiring antiretroviral therapy in sub-Saharan Africa: a prospective open cohort study

Mortality rates among patients initiating antiretroviral therapy (ART) in sub-Saharan Africa continue high. Also HIV treatment services from the region are affronting the challenges of been attending more patients than never. In this scenario, there are no integrated scoring systems capable of an adequate risk identification/ prognostic stratification among patients requiring ART; in order of optimize actual programmes outcomes. Several independent risk factors at baseline are associated with a poor prognosis after ART initiation. These include: male sex, low body mass index, anemia, low CD4 count and stage-4 WHO disease. The aim of this research was evaluate prospectively a new scoring system composed by these factors.



An open cohort study was conducted in 1769 patients from May 2008 to December 2010 at two HIV clinics of Zimbabwe. A new clinical model (MASIB score) was applied at ART initiation and patients were followed for 4 months. After that, validation characteristics of the score were examined.



Patients selected in this cohort exhibited similar baseline characteristics that the patients selected in previous cohorts from the region. Overall performance for mortality prediction of MASIB score was accurate, as reflected by the Brier score test result 0.084 (95%CI: 0.080-0.088). Calibration was adequate taking in consideration a p>0.05 in the Hosmer Lemeshow test and discrimination was also good (Area Under Curve: 0.915, 95%CI: 0,901- 0,928).



The new model developed exhibited adequate validation characteristics supporting the clinical use. Further evaluations of this model in others scenarios from the sub-Saharan region are needed.
Does low-dose seretide reverse chronic obstructive pulmonary disease and are the benefits sustained over time? An open-label Swedish crossover cohort study between 1999 and 2005.

Chronic obstructive pulmonary disease (COPD) still poses a formidable challenge to patients and clinicians alike. A fixed-dose dry powder combination inhaler, Seretide/Advair, containing salmeterol and fluticasone, is licensed in the European Community for the treatment of moderate to severe COPD in the strength of 50/500 microg twice daily (BID). Several studies have investigated the effects of this combination and show improved forced expiratory volume in 1 s (FEV(1)), quality of life, and a decrease of exacerbations. Most of the studies have run for less than 1 year. The aim of this investigator-initiated, independent study was to elucidate if the combination containing 50 microg of salmeterol and 250 microg of fluticasone BID could be shown to have the same beneficial effect as the higher dosage, and if the effect could be sustained over time.
A Validation Study of a Smartphone-Based Finger Tapping Application for Quantitative Assessment of Bradykinesia in Parkinson’s Disease

Most studies of smartphone-based assessments of motor symptoms in Parkinson's disease (PD) focused on gait, tremor or speech. Studies evaluating bradykinesia using wearable sensors are limited by a small cohort size and study design. We developed an application named smartphone tapper (SmT) to determine its applicability for clinical purposes and compared SmT parameters to current standard methods in a larger cohort.



A total of 57 PD patients and 87 controls examined with motor UPDRS underwent timed tapping tests (TT) using SmT and mechanical tappers (MeT) according to CAPSIT-PD. Subjects were asked to alternately tap each side of two rectangles with an index finger at maximum speed for ten seconds. Kinematic measurements were compared between the two groups.



The mean number of correct tapping (MCoT), mean total distance of finger movement (T-Dist), mean inter-tap distance, and mean inter-tap dwelling time (IT-DwT) were significantly different between PD patients and controls. MCoT, as assessed using SmT, significantly correlated with motor UPDRS scores, bradykinesia subscores and MCoT using MeT. Multivariate analysis using the SmT parameters, such as T-Dist or IT-DwT, as predictive variables and age and gender as covariates demonstrated that PD patients were discriminated from controls. ROC curve analysis of a regression model demonstrated that the AUC for T-Dist was 0.92 (95% CI 0.88-0.96).



Our results suggest that a smartphone tapping application is comparable to conventional methods for the assessment of motor dysfunction in PD and may be useful in clinical practice.