nils-herrmann/clean_scirepeval huggingface dataset:
Exploratory use of cardiac magnetic resonance imaging in liver transplantation; a one-stop shop for preoperative cardio-hepatic evaluation

Preoperative cardiovascular (CV) risk stratification in liver transplant (LvTx) candidates has proven challenging due to limitations of current noninvasive modalities. Additionally, the evaluation can be cumbersome and expensive given the need for separate cardiac, vascular and abdominal imaging. Over the last decade cardiovascular MRI (CMR) has emerged as the ‘gold standard’ for many important CV metrics used to define such risk due to its unparalleled spatial resolution, lack of ionizing radiation and intrinsic 3D capabilities.
Bedside adjustment of proportional assist ventilation to target a predefined range of respiratory effort.

During proportional assist ventilation with load-adjustable gain factors, peak respiratory muscle pressure can be estimated from the peak airway pressure and the percentage of assistance (gain). Adjusting the gain can, therefore, target a given level of respiratory effort. This study assessed the clinical feasibility of titrating proportional assist ventilation with load-adjustable gain factors with the goal of targeting a predefined range of respiratory effort.



Prospective, multicenter, clinical observational study.



Intensive care departments at five university hospitals.



Patients were included after meeting simple criteria for assisted mechanical ventilation.



Patients were ventilated in proportional assist ventilation with load-adjustable gain factors. The peak respiratory muscle pressure, estimated in cm H2O as (peak airway pressure-positive end-expiratory pressure)×[(100-gain)/gain], was calculated from a grid at the bedside. The gain adjustment algorithm was defined to target a peak respiratory muscle pressure between 5 and 10 cm H2O. Additional recommendations were available in case of hypoventilation or hyperventilation.



Fifty-three patients were enrolled. Median time spent under proportional assist ventilation with load-adjustable gain factors was 3 days (interquartile range, 1-5). Gain was adjusted 1.0 (0.7-1.8) times per day, according to the peak respiratory muscle pressure target range in 91% of cases and because of hypoventilation or hyperventilation in 9%. Thirty-four patients were ventilated with proportional assist ventilation with load-adjustable gain factors until extubation, which was successful in 32. Eighteen patients required volume assist-controlled reventilation because of clinical worsening and need for continuous sedation. One patient was intolerant to proportional assist ventilation with load-adjustable gain factors.



This first study assessing the clinical feasibility of titrating proportional assist ventilation with load-adjustable gain factors in an attempt to target a predefined range of effort showed that adjusting the level of assistance to maintain a predefined boundary of respiratory muscle pressure is feasible, simple, and often sufficient to ventilate patients until extubation.
[German observational trial on secondary hyperparathyroidism therapy with cinacalcet (EARLY)].

The calcimimetic cinacalcet (Mimpara) was approved in the European Union in 2004 for treatment of secondary hyperparathyroidism (sHPT). This observational trial was conducted to investigate efficacy of cinacalcet and practices of sHPT treatment under routine clinical conditions.



913 patients on maintenance hemodialysis were recruited from 136 German kidney centers. 662 patients who fulfilled the entry criteria of moderate to severe sHPT (intact parathyroid hormone, iPTH: 300 - 800 pg/mL or 32 - 85 pmol/l) were included in the trial. Primary objective was to investigate efficacy of cinacalcet in patients treated for at least 160 days (efficacy collective, N = 555). The primary endpoint was defined as the percentage of patients with a iPTH within 150 - 300 pg/ml and a calcium-phosphate product (CaxP) ≤ 4.44 mmol (2)/l (2) (55 mg (2)/dl (2)) after 6 months of treatment. Further objectives were the course of calcium (Ca) and phosphate (P) as well as the use of phosphate binders and vitamin D in treatment of bone metabolism disorders.



According to the predefined entry criteria none of the patients reached the combined target criterion for iPTH and CaxP at baseline. The mean initial iPTH and CaxP were 530.0 ± 134.3 pg/mL and 4.82 mmol (2)/L (2) (mean ± SD) respectively. In spite of the unfavorable prognostic factors 25 % of the recruited patients met the combined target at the end of the trial. The mean reduction per patient for iPTH was 203.6 pg/mL [95 % confidence interval (CI) 183.3 - 224.0] and 0.69 mmol (2)/L (2) [95 %-CI 0.57 - 0.79] for CaxP. Ca and P were reduced by 5.3 % [95 %-CI 4.3 - 6.3] and 5.5 % [95 %-CI 3.4 - 7.7], respectively. The mean daily dose of cinacalcet at trial end was 44.9 ± 25.0 mg (mean ± SD). At baseline, 90 % of patients who were analyzed for efficacy (n = 500/555) were treated with phosphate binders, 57 % were treated with a calcium-based phosphate binder (n = 317/555). The use of active Vitamin D (all active Vitamin D compounds) was recorded for 59 % of the patients (n = 328/555). No relevant changes of these treatments were observed in the course of the trial. Tolerability of cinacalcet was good, 94 adverse drug reactions were recorded in 57 of the 913 enrolled patients (6 %).



One out of four patients reached the combined target of iPTH and CaxP with relatively low dose cinacalcet after 6 months of treatment. iPTH, Ca and P were reduced. The results confirm the high efficacy of cinacalcet in treatment of sHPT and underline the role of cinacalcet in the control of Ca and P.
Corticosteroid injections for greater trochanteric pain syndrome: a randomized controlled trial in primary care.

We undertook a study to evaluate the effectiveness of corticosteroid injections in primary care patients with greater trochanteric pain syndrome (GTPS).



We evaluated the effect of corticosteroid injections compared with expectant treatment (usual care) in a pragmatic, multicenter, open-label, randomized clinical trial in the Netherlands. Patients (aged 18 to 80 years) with GTPS visiting 81 participating primary care physicians were randomly allocated to receive either local corticosteroid injections (n = 60) or usual care (n = 60). Primary outcomes of pain severity (numerical rating scale 0 to 10) and recovery (yes or no total or major recovery) were evaluated at 3-month and 12-month follow-up visits. Adverse events were collected at 6 weeks.



At the 3-month follow-up visit, 34% of the patients in the usual care group had recovered compared with 55% in the injection group (adjusted OR = 2.38; 95% CI, 1.14-5.00, number needed to treat = 5). Pain severity at rest and on activity decreased in both groups, but the decrease was greater in the injection group, for an adjusted difference in pain at rest of 1.18 (95% CI, 0.31-2.05) and in pain with activity of 1.30 (95% CI, 0.32-2.29). At the 12-month follow-up, 60% of the patients in the usual care group had recovered compared with 61% in the injection group (OR = 1.05; 95% CI, 0.50-2.27). Pain severity at rest and on activity decreased in both groups and the 12-month follow-up showed no significant differences, with adjusted differences of 0.14 (95% CI, -0.75 to 1.04) for pain at rest and 0.45 (95% CI, -0.55 to 1.46) for pain with activity. Aside from a short period with superficial pain at the site of the injection, no differences in adverse events were found.



In this first randomized controlled trial assessing the effectiveness of corticosteroid injections vs usual care in GTPS, a clinically relevant effect was shown at a 3-month follow-up visit for recovery and for pain at rest and with activity. At a 12-month follow-up visit, the differences in outcome were no longer present.
Comparison between on-label versus off-label use of drug-eluting coronary stents in clinical practice: results from the German DES.DE-Registry

Observational studies from the USA have demonstrated that off-label use of drug-eluting stents (DES) is common. Data on off-label use in Western Europe are limited. We analyzed the data of consecutive patients receiving DES prospectively enrolled in the multicenter German DES.DE registry (Deutsches Drug-Eluting Stent Register) between October 2005 and October 2006. Off-label use was defined in the presence of one of the following criteria: ST-elevation myocardial infarction, in-stent stenosis, chronic total occlusion, lesions in a bypass graft, in bifurcation or left main stem, stent length per lesion ≥32 mm, and vessel diameter <2.5 or >3.5 mm. Overall, 4,295 patients were included in this analysis and divided into two groups: 2,366 (55.1%) received DES for off-label and 1,929 (44.9%) for on-label indications. There were substantial differences in the rates of off-label use at the participating hospitals. Patients with off-label DES more often presented with high-risk features such as acute coronary syndrome, cardiogenic shock, congestive heart failure, and more complex coronary anatomy. Among hospital survivors, the incidence of the composite endpoint of death, myocardial infarction and stroke (MACCE) (9.2 vs. 7.4%, p < 0.05), and target vessel revascularization (TVR) (11.3 vs. 9.1%, p < 0.05) was increased in the off-label group at the 1-year follow-up. However, in the multivariate analysis off-label use was not linked with an elevated risk for MACCE (hazard ratio 0.86, 95% confidence interval 0.62–1.18) and TVR (hazard ratio 1.05, 95% confidence interval 0.78–1.42). In clinical practice, DES was very frequently used off-label. After adjustment for confounding variables, off-label use was not associated with an increase of adverse events.
Epoetin delta in the management of renal anaemia: results of a 6-month study.

Epoetin delta is an epoetin that, unlike existing agents, is produced in a human cell line. The present study investigated the efficacy and tolerability of intravenous (i.v.) epoetin delta compared with i.v. epoetin alfa.



This was a 6-month, multicentre, randomized, double-blind trial in haemodialysis patients previously receiving epoetin alfa. Haematological parameters were assessed, and adverse events monitored. Equivalent efficacy was defined as a difference in mean haemoglobin between the two agents over weeks 12-24 of < or = 1 g/dl with a 90% confidence interval (CI) within the range -1 to 1 g/dl.



In total, 560 patients received epoetin delta while 192 received epoetin alfa, and 76.8% and 79.7% of patients, respectively, completed the study. Both agents showed similar efficacy in controlling anaemia: the point estimate for the difference in mean haemoglobin over weeks 12-24 was 0.01 g/dl (90% CI, -0.13, 0.15 g/dl), confirming equivalence. Adverse events were those expected in dialysis patients. Events possibly related to treatment occurred in 9.2% of patients receiving epoetin delta and 8.4% receiving epoetin alfa. Serious adverse events (SAEs) occurred in 33.0% and 26.7% of patients in the epoetin delta and epoetin alfa groups, respectively. Six patients in the epoetin delta group experienced an SAE considered possibly related to treatment (mostly access-related clotting), compared with no patient in the epoetin delta group. None of these SAEs were life threatening.



Epoetin delta was shown to have an equivalent efficacy and safety profile to epoetin alfa in this 6-month study.
External Beam Radiotherapy for Head and Neck Cancers Is Associated with Increased Variability in Retinal Vascular Oxygenation

Radiation retinopathy is a possible post-treatment complication of radiation therapy. The pathophysiologic mechanism is hypothesized to be microvascular in origin, but evidence is limited. In an effort to study retinal oxygenation in these patients, we herein evaluate the repeatability and variability of retinal oximetry measurements in subjects who had previously received radiation and make comparisons to a cohort of unirradiated subjects.



Using retinal oximetry, a non-invasive imaging modality, we performed in vivo measurements of arteriole (SaO2) and venule SO2 (SvO2) in subjects (n = 9, 18 retinas) who had received incidental radiation to their retinas (≥ 45 Gy to one retina) and in healthy subjects (n = 20, 40 retinas). A total of 1367 SO2 observations on 593 vessels in 29 persons were analyzed to assess three sources of variance in vessel SO2: 1) variance in repeated measurements of the same vessel ("repeatability"), 2) variance in different vessels within the same subject ("within-subject variability"), and 3) variance between subjects ("between-subject variability").



Retinal oximetry measurements were highly repeatable in both irradiated patients and unirradiated subjects. The within-subject variability of SvO2 and SaO2 measurements constituted the highest component of variance in both groups and was significantly higher in venules vs. arterioles (relative effect size 1.8, p<0.001) and in irradiated subjects vs. unirradiated subjects (relative effect size 1.6, p<0.001).



Retinal oximetry is a highly repeatable technology and can be reliably used to study vascular oxygenation in irradiated subjects. Different vessels within the same subject exhibit a high degree of variability, suggesting that pooled analyses of multiple vessels are most likely to be informative of regional retinal oxygenation. Finally, irradiated subjects exhibited significantly higher within-subject variability in SO2 measurements, suggesting that radiation may cause regional alterations in retinal oxygen delivery and/or metabolism.
Dermoscopy of dermatofibrosarcoma protuberans: a study of 15 cases.

Dermatofibrosarcoma protuberans (DFSP) is a rare malignant cutaneous tumour of which diagnosis is often delayed because of the lack of early clinical clues.



To describe the main dermoscopic features of DFSP.



We performed dermoscopic examination in 15 unselected, consecutive cases of biopsy-proven DFSP. Firstly, six dermoscopic features were identified collegially, then all cases were reviewed separately by six experienced dermoscopists. In a given lesion, features recognized only by all dermoscopists were taken into account.



The median number of dermoscopic features was four per lesion. The following dermoscopic features were found: delicate pigmented network (87%), vessels (80%), structureless light brown areas (73%), shiny white streaks (67%), pink background coloration (67%) and structureless hypo- or depigmented areas (60%). When detected, vessels were of arborizing type in 11 of 12 cases, and presented as either unfocused only, or both unfocused and focused.



This first study of the dermoscopic spectrum of DFSP identifies six dermoscopic features (often associated in a multicomponent pattern) and a peculiar vascular pattern. Whether dermoscopy can help to identify suspected DFSP remains to be established by further studies.
Perfusion-weighted MRI to evaluate cerebral autoregulation in aneurysmal subarachnoid haemorrhage

The aim of this study was to evaluate autoregulatory mechanisms in different vascular territories within the first week after aneurysmal subarachnoid haemorrhage (SAH) by perfusion-weighted magnetic resonance imaging (PW-MRI). For this purpose, regional cerebral blood flow and volume (rCVF and rCBV) were measured in relation to different degrees of angiographically visible cerebral vasospasm (CVS). In 51 SAH patients, PW-MRI and digital subtraction angiography were performed about 5 days after onset of SAH. Regional CBF and rCBV were analysed in the territories of the anterior cerebral artery (ACA), the middle cerebral artery (MCA) and the basal ganglia of each hemisphere in relationship to the degree of CVS in the particular territory. Correlations between rCBF, rCBV and CVS were analysed. CVS was found in 22 out of 51 patients in at least one territory. In all territories, rCBV decreased with increasing degree of CVS, correlated with a decrease of rCBF. In the ACA territories, SAH patients with severe CVS had significantly lower rCBF compared to healthy subjects and to SAH patients without CVS. In the basal ganglia, rCBF and rCBV of the control group were significantly higher compared to the patients without and with moderate vasospasms. PW-MRI showed simultaneous decrease of rCBF and rCBV in patients with SAH. The fact that rCBV did not increase in territories with CVS to maintain rCBF reveals dysfunctional vascular autoregulation. Vasospasms in the microvasculature are most evident in the basal ganglia, showing decreased rCBV and rCBF even in SAH patients without CVS.
Challenges of hepatitis C treatment in Native Americans in two North Dakota medical facilities.

The prevalence of chronic liver disease (CLD) in the Aboriginal North American population is disproportionately higher than that of the non-indigenous population. Hepatitis C virus (HCV) is the second leading cause of CLD in American Indians or Alaska Natives (AIANs). This study described the experience of two teaching community medical centers in North Dakota in treating HCV infection among AIANs and compared treatment outcomes to a cohort of Caucasian patients.



The retrospective study described the characteristics and proportion of AIAN patients with HCV who received treatment. Documented reasons for not receiving treatment were analyzed. For those AIAN patients treated for HCV infection, responses to treatment, including rapid, early and sustained virological responses (SVRs), were compared with those of Caucasians.



Only 22 (18%) of 124 AIANs with HCV infection received treatment. Common reasons for not receiving treatment include lack of access to specialists, concomitant or decompensated liver disease, alcohol and drug abuse and cost. There were no significant differences in the baseline characteristics and key predictors of SVR in AIANs compared to Caucasian controls.



Most AIAN patients with HCV infection do not receive treatment despite comparable treatment response rates to Caucasians. Further population-based studies, addressing access to specialized hepatitis C treatment and public health concerns are warranted, as it is crucial to treat chronic HCV infection to decrease the burden of disease in the AIAN community.
Hyperresponsiveness of airway muscle to acetylcholine in asthmatic and non-asthmatic subjects.

Despite a long-standing recognition, the bronchial hyperresponsiveness (BHR) of airway smooth muscle, in asthmatic and non-asthmatic subjects is still under investigation.



In order to better understand the mechanism regulating the airway function, some results obtained with cellular physiology techniques are compared, for some non-asthmatic without BHR subjects and other subjects suffering from real bronchial asthma.



Eighteen subjects without chronic or acute bronchopathy and seven patients with a typical history of bronchial asthma were considered. All of them were non-smokers, with a wide range of in vivo hyperresponsiveness to Acetylcholine (ACh). Owing to neoplastic lesions, all patients underwent a thoracic surgery.



In vitro hyperresponsiveness of airway-smooth-muscle chains was assessed with isotonic contractions to incremental doses of ACh, in accordance with a non-cumulative dose-response technique. Regression between muscle contractions and ACh doses was studied for both groups, and it turned out to be linear in both cases. The slopes and elevations of the regression lines of the two groups were statically identical. There was no correlation between in vivo hyperresponsiveness (as PD20-ACh-FEV1) and in vitro responses (as EC50), for both asthmatic and non-asthmatic group.



(i) in vitro, the same BHR of smooth-muscle resulted, for both asthmatic and non-asthmatic subjects, (ii) in vivo, a different BHR of the former group resulted. This can be explained with the peculiarity of the micro-environmental surrounding the bronchial tissue, not with an intrinsic defect of the isolated bronchial tissue.
Gender- and age-related differences in clinical presentation and management of outpatients with stable coronary artery disease.

Contemporary generalizable data on the demographics and management of outpatients with stable coronary artery disease (CAD) in routine clinical practice are sparse. Using the data from the CLARIFY registry we describe gender- and age-related differences in baseline characteristics and management of these patients across broad geographic regions.



This international, prospective, observational, longitudinal registry enrolled stable CAD outpatients from 45 countries in Africa, Asia, Australia, Europe, the Middle East, and North, Central, and South America.



Baseline data were available for 33280 patients. Mean (SD) age was 64 (10.5) years and 22.5% of patients were female. The prevalence of CAD risk factors was generally higher in women than in men. Women were older (66.6 vs 63.4 years), more frequently diagnosed with diabetes (33% vs 28%), hypertension (79% vs 69%), and higher resting heart rate (69 vs 67 bpm), and were less physically active. Smoking and a history of myocardial infarction were more common in men. Women were more likely to have angina (28% vs 20%), but less likely to have undergone revascularization procedures. CAD was more likely to be asymptomatic in older patients perhaps because of reduced levels of physical activity. Prescription of evidence-based medication for secondary prevention varied with age, with patients ≥ 75 years treated less often with beta blockers, aspirin and angiotensin-converting enzyme inhibitors than patients <65 years.



Important gender-related differences in clinical characteristics and management continue to exist in all age groups of outpatients with stable CAD.
Efficacy of CBT for benzodiazepine discontinuation in patients with panic disorder: Further evaluation.

Despite its acute efficacy for the treatment of panic disorder, benzodiazepines (BZs) are associated with a withdrawal syndrome that closely mimics anxiety sensations, leading to difficulty with treatment discontinuation and often disorder relapse. An exposure-based cognitive-behavioral treatment for BZ discontinuation, Panic Control Treatment for BZ Discontinuation (CBT) targets the fear of these sensations and has demonstrated efficacy in preventing disorder relapse and facilitating successful BZ discontinuation among patients with panic disorder. In this randomized controlled trial, CBT was compared to taper alone and a taper plus a relaxation condition to control for the effect of therapist contact and support among 47 patients with panic disorder seeking taper from BZs. Based on the primary outcome of successful discontinuation of BZ use, results indicate that adjunctive CBT provided additive benefits above both taper alone and taper plus relaxation, with consistently medium and large effect sizes over time that reached significance at the six month follow-up evaluation. The efficacy of CBT relative to either of the other taper conditions reflected very large and significant effect sizes at that time. These findings suggest that CBT provides specific efficacy for the successful discontinuation from BZs, even when controlling for therapist contact and relaxation training.