nils-herrmann/clean_scirepeval huggingface dataset:
Instrumented measurements of knee laxity: KT-1000 versus navigation

The KT-1000 is widely accepted as a tool for the instrumented measurement of the antero-posterior (AP) tibial translation. The aim of this study is to compare the data obtained with the KT-1000 in ACL deficient knees with the data obtained using a navigation system during “in vivo” ACL reconstruction procedures and to validate the accuracy of the KT-1000. An ACL reconstruction was performed using computer aided surgical navigation (Orthopilot, B-Braun, Aesculap, Tuttlingen, Germany) in 30 patients. AP laxity measurements were obtained for all patients using KT-1000 arthrometer (in a conscious state and under general anaesthesia) and during surgery using the navigation system, always at 30° of knee flexion. The mean AP translation was 14 ± 4 and 15.6 ± 3.8 mm using the KT-1000 in conscious and under general anaesthesia, respectively (P = 0.02) and 16.1 ± 3.7 mm using navigation. Measurements obtained with the KT-1000 under general anaesthesia were no different from those obtained “in vivo” with the navigation system (P = 0.37). In conclusion this study validates the accuracy of the KT-1000 to exactly calculate AP translation of the tibia, in comparison with the more accurate measurements obtained using a navigation system.
Multicenter pilot treatment trial for psychogenic nonepileptic seizures: a randomized clinical trial.

There is a paucity of controlled treatment trials for the treatment of conversion disorder, seizures type, also known as psychogenic nonepileptic seizures (PNES). Psychogenic nonepileptic seizures, the most common conversion disorder, are as disabling as epilepsy and are not adequately addressed or treated by mental health clinicians.



To evaluate different PNES treatments compared with standard medical care (treatment as usual).



Pilot randomized clinical trial at 3 academic medical centers with mental health clinicians trained to administer psychotherapy or psychopharmacology to outpatients with PNES. Thirty-eight participants were randomized in a blocked schedule among 3 sites to 1 of 4 treatment arms and were followed up for 16 weeks between September 2008 and February 2012; 34 were included in the analysis.



Medication (flexible-dose sertraline hydrochloride) only, cognitive behavioral therapy informed psychotherapy (CBT-ip) only, CBT-ip with medication (sertraline), or treatment as usual.



Seizure frequency was the primary outcome; psychosocial and functioning measures, including psychiatric symptoms, social interactions, quality of life, and global functioning, were secondary outcomes. Data were collected prospectively, weekly, and with baseline, week 2, midpoint (week 8), and exit (week 16) batteries. Within-group analyses for each arm were performed on primary (seizure frequency) and secondary outcomes from treatment-blinded raters using an intention-to-treat analysis.



The psychotherapy (CBT-ip) arm showed a 51.4% seizure reduction (P = .01) and significant improvement from baseline in secondary measures including depression, anxiety, quality of life, and global functioning (P < .001). The combined arm (CBT-ip with sertraline) showed 59.3% seizure reduction (P = .008) and significant improvements in some secondary measures, including global functioning (P = .007). The sertraline-only arm did not show a reduction in seizures (P = .08). The treatment as usual group showed no significant seizure reduction or improvement in secondary outcome measures (P = .19).



This pilot randomized clinical trial for PNES revealed significant seizure reduction and improved comorbid symptoms and global functioning with CBT-ip for PNES without and with sertraline. There were no improvements in the sertraline-only or treatment-as-usual arms. This study supports the use of manualized psychotherapy for PNES and successful training of mental health clinicians in the treatment. Future studies could assess larger-scale intervention dissemination.
IGHV3-21 gene usage is associated with high TCL1 expression in chronic lymphocytic leukemia.

T-cell leukemia/lymphoma protein 1 (TCL1) was recently shown to display an expression pattern in chronic lymphocytic leukemia (CLL) corresponding to molecular subtypes, where poor-risk patients demonstrated higher expression levels. Here, we examined the mRNA expression pattern of TCL1 in 144 patients with CLL, including 67 immunoglobulin heavy-chain variable (IGHV) mutated, 58 IGHV unmutated and 19 patients with IGHV3-21 usage. A higher TCL1 expression level was detected in patients with CLL with unmutated vs. mutated IGHV genes (P < 0.001), whereas no difference was demonstrated within the IGHV3-21 cohort (i.e., mutated vs. unmutated and stereotyped vs. non-stereotyped complementarity determining region 3). The IGHV3-21 subgroup displayed high TCL1 mRNA expression, differing significantly from other IGHV mutated cases (P < 0.001), although 11/19 had mutated IGHV genes. Furthermore, high TCL1 expression levels were associated with significantly shorter overall survival (P < 0.001). Altogether, we show that TCL1 mRNA expression may predict clinical outcome in CLL and that the IGHV3-21 subset, regardless of mutational status, displays high TCL1 expression.
A randomized double-blind, placebo-controlled study to establish the effects of spirulina in elderly Koreans.

This study was conducted to determine the antioxidant capacity, immunomodulatory and lipid-lowering effects of spirulina in healthy elderly subjects and to document the effectiveness of spirulina as a functional food for the elderly.



A randomized double-blind, placebo-controlled study was performed. The subjects were 78 individuals aged 60-87 years and were randomly assigned in a blinded fashion to receive either spirulina or placebo. The elderly were instructed to consume the spirulina or placebo at home, 8 g/day, for 16 consecutive weeks.



In male subjects, a significant plasma cholesterol-lowering effect was observed after the spirulina intervention (p < 0.05). Spirulina supplementation resulted in a significant rise in plasma interleukin (IL)-2 concentration, and a significant reduction in IL-6 concentration. A significant time-by-treatment intervention for total antioxidant status was observed between spirulina and placebo groups (p < 0.05). In female subjects, significant increases in IL-2 level and superoxide dismutase activity were observed (p < 0.05) after spirulina supplementation. There were significant reductions in total cholesterol in female subjects.



The results demonstrate that spirulina has favorable effects on lipid profiles, immune variables, and antioxidant capacity in healthy, elderly male and female subjects and is suitable as a functional food.
Patients taking medications for bipolar disorder are more prone to metabolic syndrome than Korea's general population

Despite growing concerns about the co-morbidity of metabolic syndrome (MetS) and bipolar disorder, few studies have been conducted on this topic in Asian populations. This study examined Korean patients with bipolar disorder to assess its co-morbidity with MetS and to compare the prevalence of MetS in patients with medication for bipolar disorder with that of healthy patients. We used cross-sectional data from the medical records of patients with bipolar disorder who presented to the psychiatric clinic in Seoul National University Hospital between June 2007 and June 2008. The control group, matched for age and gender, was randomly drawn from visitors to the Health Promotion Center at the same hospital during the same period. We compared the prevalence of MetS between these two groups with independent sample t-tests and chi-squared tests. We also calculated the indirectly standardized prevalence ratio (ISPR) with a standardization that used the Fourth Korean National Health and Nutrition Examination Survey (KNHNES, 2007). The prevalence of MetS in patients who took medication for bipolar disorder (N=152) was 27.0%, 25.0% and 25.7%, based on the definitions of the American Heart Association and the National Heart, Lung and Blood Institute's adaptation of the Adult Treatment Panel III (AHA), the National Cholesterol Education Program for Adult Treatment Panel III (ATPIII) and the International Diabetes Federation (IDF), respectively. The present study determined that the prevalence of MetS was significantly higher in patients with bipolar disorder than in the control group; the odds ratios (OR) (95% CI) were 2.44 (1.35-4.40), 2.48 (1.34-4.59) and 2.57 (1.40-4.74), based on the definition of the AHA, ATPIII and IDF, respectively. The ISPR (95% CI) was 1.48 (1.02-1.93), 1.54 (1.05-2.03) and 1.98 (1.36-2.60), respectively. Patients with medications for bipolar disorder showed a significantly higher prevalence of increased waist circumference, elevated triglycerides, and reduced HDL-cholesterol than the control group. The prevalence of MetS in patients taking medication for bipolar disorder was higher than that in the general population. Obesity and dyslipidemia were particularly prevalent in patients with bipolar disorder.
Transdermal nitroglycerin: clinical and pharmacokinetic consequences of renewing the patch and the application site

We examined whether nitroglycerin (glyceryl trinitrate, GTN) patch treatment for 24 h could induce local cutaneous changes that impaired drug delivery and clinical efficacy.  Twenty angina patients were exercise-tested after 2 and 24 h of treatment and then 2 h after patch renewal. The patch was either renewed on a new skin location or on the previous application site in a randomised, double-blind, cross-over protocol. GTN plasma concentrations and finger plethysmography were obtained before and after each exercise test.  The clinical efficacy, the effect seen on plethysmography and the GTN plasma concentrations tended to increase after patch renewal, regardless of the application site of the renewed patch. Hence, cutaneous changes of clinical importance could not be demonstrated.
International differences in acute coronary syndrome patients' baseline characteristics, clinical management and outcomes in Western Europe: the EURHOBOP study.

We aimed to describe current characteristics of patients admitted for acute coronary syndrome (ACS) in Western Europe and to analyse whether international in-hospital mortality variations are explained by differences in patients' baseline characteristics and in clinical management.



We studied a population-based longitudinal cohort conducted in Finland, France, Germany, Greece, Portugal and Spain, and comprising 12 231 consecutive ACS patients admitted in 53 hospitals between 2008 and 2010. Baseline characteristics, clinical management and inhospital outcomes were recorded. Contextual effect of country on death was analysed through multilevel analysis.



Of all patients included, 8221 (67.2%) had NSTEMI (non-ST-elevation myocardial infarction), and 4010 (32.8%) had STEMI (ST-elevation myocardial infarction). Inhospital mortality ranged from 15.1% to 4.9% for German and Spanish STEMI patients, and from 6.8% to 1.9% for Finnish and French NSTEMI patients (p<0.001 for both). These international variations were explained by differences in patients' baseline characteristics (older patients more likely to have cardiogenic shock in Germany) and in clinical management, with differences in rates of thrombolysis (less performed in Germany) and primary percutaneous coronary intervention (high in Germany, low in Greece). A remaining contextual effect of country was identified after extensive adjustment.



Inhospital mortality rates of STEMI and NSTEMI patients were two to three times higher in Finland, Germany and Portugal than in Greece and Spain, with intermediate values for France. Differences in baseline characteristics and clinical management partly explain differences in outcome. Our data also suggest an impact of the healthcare system organisation.
Effects of unsupported arm training on arm exercise-related perception in COPD patients

We hypothesized that arm training might affect unsupported arm exercise-related perception by decreasing motor output to arm/torso muscles in patients with chronic obstructive pulmonary disease (COPD). Eleven patients were studied at 80% of peak incremental arm exercise, before and after unsupported arm training. Training increased endurance time, decreased respiratory effort and much more arm effort (by Borg scale) without affecting chest wall dynamic hyperinflation or configuration. Ventilatory response to carbon dioxide output was the same before and after training so that at isotime the reduction in ventilation correlated strongly with a simultaneous reduction in metabolic output. These changes reflect a reduced ventilatory drive. We conclude that: (i) a reduced level of ventilation, relative to a decrease in central motor output, is the contribution of arm training to symptom alleviation during unsupported arm exercise in COPD patients, and (ii) arm training improved patients' exercise-related perception without affecting chest wall operational volumes or configuration.
Ultra-Brief Intervention for Problem Drinkers: Results from a Randomized Controlled Trial

There are a number of evidence-based, in-person clinical inteventions for problem drinkers, but most problem drinkers will never seek such treatments. Reaching the population of non-treatment seeking problem drinkers will require a different approach. Accordingly, this randomized clinical trial evaluated an intervention that has been validated in clinical settings and then modified into an ultra-brief format suitable for use as an indicated public health intervention (i.e., targeting the population of non-treatment seeking problem drinkers).



Problem drinkers (N = 1767) completed a baseline population telephone survey and then were randomized to one of three conditions - a personalized feedback pamphlet condition, a control pamphlet condition, or a no intervention control condition. In the week after the baseline survey, households in the two pamphlet conditions were sent their respective interventions by postal mail addressed to 'Check Your Drinking.' Changes in drinking were assessed post intervention at three-month and six-month follow-ups. The follow-up rate was 86% at three-months and 76% at six-months. There was a small effect (p = .04) in one of three outcome variables (reduction in AUDIT-C, a composite measure of quantity and frequency of drinking) observed for the personalized feedback pamphlet compared to the no intervention control. No significant differences (p>.05) between groups were observed for the other two outcome variables - number of drinks consumed in the past seven days and highest number of drinks on one occasion.



Based on the results of this study, we tentatively conclude that a brief intervention, modified to an ultra-brief, public health format can have a meaningful impact.
Assessment of differential doses of buprenorphine for long term pharmacotherapy among opiate dependent subjects.

The aim of the present study was to evaluate, two different doses of sublingual buprenorphine (2 mg and 4 mg) among patients on maintenance treatment and to assess the relationship of steady state plasma level with craving. Twenty three male opioid dependent (ICD-10 DCR) subjects, were assigned to double blind randomized controlled trial of 2 and 4 mg/day doses of buprenorphine in an inpatient setting. They were evaluated thrice (2nd, 7th and 14th day) in 2 weeks for withdrawal symptoms (acute and protracted), sedation, euphoria, craving, side effects, global rating of well being and for measurement of plasma levels of buprenorphine. The data showed that there were no significant difference in scores of euphoria and sedation, protracted withdrawal symptoms and side effects, craving and overall well being and plasma level of buprenorphine among the subjects. However, both the groups had significant difference in score on almost all the measurements on final observation in comparison to initial observation. Both 2 mg/day and 4 mg/day dose of buprenorphine were effective in long term pharmacotherapy of opioid dependence without significant difference as compared by different measures used in the study.
Segmental pulmonary vein isolation in atrial fibrillation: new insights from the high density mesh mapper technique in an electrophysiologically guided approach

As opposed to fundamental investigations into the nature of atrial fibrillation (AF) current clinical studies of AF ablation techniques sometimes only contain sparse information about the underlying electrophysiological properties. The purpose of this prospective, pilot study was to evaluate acute therapeutic success and clinical outcome after 6 month of segmental ostial ablation (SOA) using the High Density Mesh Mapper catheter (HDMM, BARD Electrophysiology, Lowell, MA, USA) for an electrophysiological guided approach. The HDMM is a novel, single expandable basket electrode catheter for high resolution recordings at the left atrium/pulmonary vein (PV) junction. SOA was performed by irrigated radiofrequency (RF) application around the HDMM. Entry- and exit conduction block, as well as decreased local electrode amplitude, were endpoints for short-term successful ablation. Seventy-two patients with highly symptomatic paroxysmal AF (PAF; 47, 65.2%), persistent AF (12, 16.7%) and permanent AF (13, 18.1%) were studied. Entrance conduction block was obtained in 93%, exit conduction block in 81% of all PV. After 6 month no PV stenosis was observed, 62 patients (86.1%) improved clinically, whereas 52 patients (72.2%) were free from arrhythmias and sinus rhythm was present favoring patients with PAF. In this first prospective study of PV isolation using the HDMM, our findings suggest, that this method is safe and yields good primary success rates and favourable clinical outcome at 6 month. The new technology based on high resolution recordings, offers beside good anatomical orientation a direct electrophysiological control for monitoring of bidirectional conduction block.
A measure of quality of life for clinical trials in chronic lung disease.

Since the relationships between pulmonary function, exercise capacity, and functional state or quality of life are generally weak, a self report questionnaire has been developed to determine the effect of treatment on quality of life in clinical trials. One hundred patients with chronic airflow limitation were asked how their quality of life was affected by their illness, and how important their symptoms and limitations were. The most frequent and important items were used to construct a questionnaire evaluating four dimensions: dyspnoea, fatigue, emotional function, and the patient's feeling of control over the disease (mastery). Reproducibility, tested by repeated administration to patients in a stable condition, was excellent: the coefficient of variation was less than 12% for all four dimensions. Responsiveness (sensitivity to change) was tested by administering the questionnaire to 13 patients before and after optimisation of their drug treatment and to another 28 before and after participation in a respiratory rehabilitation programme. In both cases large, statistically significant improvements in all four dimensions were noted. Changes in questionnaire score were correlated with changes in spirometric values, exercise capacity, and patients' and physicians' global ratings. Thus it has been shown that the questionnaire is precise, valid, and responsive. It can therefore serve as a useful disease specific measure of quality of life for clinical trials.
5-year follow-up of cytotoxic chemotherapy as an adjuvant to surgery in carcinoma of the bronchus.

This report gives the 5-year findings of a double-blind study of long-term cytotoxic chemotherapy as an adjuvant to surgery in patients receiving busulphan or cyclophosphamide for carcinoma of the bronchus compared with a group receiving a placebo. Of 243 patients initially allocated busulphan, 234 cyclophosphamide and 249 placebo, 28%, 27% and 34% respectively were alive at 5 years. There were significant associations between mortality from bronchial carcinoma and histological involvement of the resected intrathoracic nodes and the histology of the tumour. Haematological toxicity, especially thrombocytopenia, was frequent and severe in the busulphan series, and low platelet counts continued long after chemotherapy was stopped.
Ruxolitinib in corticosteroid-refractory graft-versus-host disease after allogeneic stem cell transplantation: a multicenter survey

Despite major improvements in allogeneic hematopoietic cell transplantation over the past decades, corticosteroid-refractory (SR) acute (a) and chronic (c) graft-versus-host disease (GVHD) cause high mortality. Preclinical evidence indicates the potent anti-inflammatory properties of the JAK1/2 inhibitor ruxolitinib. In this retrospective survey, 19 stem cell transplant centers in Europe and the United States reported outcome data from 95 patients who had received ruxolitinib as salvage therapy for SR-GVHD. Patients were classified as having SR-aGVHD (n=54, all grades III or IV) or SR-cGVHD (n=41, all moderate or severe). The median number of previous GVHD-therapies was 3 for both SR-aGVHD (1–7) and SR-cGVHD (1–10). The overall response rate was 81.5% (44/54) in SR-aGVHD including 25 complete responses (46.3%), while for SR-cGVHD the ORR was 85.4% (35/41). Of those patients responding to ruxolitinib, the rate of GVHD-relapse was 6.8% (3/44) and 5.7% (2/35) for SR-aGVHD and SR-cGVHD, respectively. The 6-month-survival was 79% (67.3–90.7%, 95% confidence interval (CI)) and 97.4% (92.3–100%, 95% CI) for SR-aGVHD and SR-cGVHD, respectively. Cytopenia and cytomegalovirus-reactivation were observed during ruxolitinib treatment in both SR-aGVHD (30/54, 55.6% and 18/54, 33.3%) and SR-cGVHD (7/41, 17.1% and 6/41, 14.6%) patients. Ruxolitinib may constitute a promising new treatment option for SR-aGVHD and SR-cGVHD that should be validated in a prospective trial.