nils-herrmann/clean_scirepeval huggingface dataset:
An RCT into the effects of neurofeedback on neurocognitive functioning compared to stimulant medication and physical activity in children with ADHD

Neurofeedback (NFB) is a potential alternative treatment for children with ADHD that aims to optimize brain activity. Whereas most studies into NFB have investigated behavioral effects, less attention has been paid to the effects on neurocognitive functioning. The present randomized controlled trial (RCT) compared neurocognitive effects of NFB to (1) optimally titrated methylphenidate (MPH) and (2) a semi-active control intervention, physical activity (PA), to control for non-specific effects. Using a multicentre three-way parallel group RCT design, children with ADHD, aged 7–13, were randomly allocated to NFB (n = 39), MPH (n = 36) or PA (n = 37) over a period of 10–12 weeks. NFB comprised theta/beta training at CZ. The PA intervention was matched in frequency and duration to NFB. MPH was titrated using a double-blind placebo controlled procedure to determine the optimal dose. Neurocognitive functioning was assessed using parameters derived from the auditory oddball-, stop-signal- and visual spatial working memory task. Data collection took place between September 2010 and March 2014. Intention-to-treat analyses showed improved attention for MPH compared to NFB and PA, as reflected by decreased response speed during the oddball task [η p 2  = 0.21, p < 0.001], as well as improved inhibition, impulsivity and attention, as reflected by faster stop signal reaction times, lower commission and omission error rates during the stop-signal task (range η p 2  = 0.09–0.18, p values <0.008). Working memory improved over time, irrespective of received treatment (η p 2  = 0.17, p < 0.001). Overall, stimulant medication showed superior effects over NFB to improve neurocognitive functioning. Hence, the findings do not support theta/beta training applied as a stand-alone treatment in children with ADHD.
Efficacy and safety of leflunomide alone and in combination with methotrexate in the treatment of refractory rheumatoid arthritis.

Rheumatoid arthritis patients who develop refractoriness are left with no alternatives other than leflunomide and costly biological response modifiers. Leflunomide, though effective, was associated with adverse events and has not been extensively studied in the Indian population.



Determination of safety and efficacy of leflunomide alone and if not useful, in combination with methotrexate in patients refractory to conventional disease-modifying agents.



Open labeled clinical trial with leflunomide [100 mg, OD x 3 days followed by 20 mg, OD x 6 months], if no improvement at three months, combined with methotrexate [5-7.5 mg, OD x 3 months] at a tertiary care hospital.



The primary endpoint in the improvement in EULAR criteria and secondary endpoints were patient and physician global evaluation, incidence of remission and biochemical and clinical adverse events.



Chi square test or Fisher's exact test and parametric and non-parametric repeat measure ANOVA were used for analysis.



Among 84 patients who were included in the study, leflunomide showed improvement and remission in 52 [62%] and 6 [7%] in six months, by intention to treat analysis. Adverse events were observed in 15, discontinuation in 5 and 24 dropped out. With combination in 11 patients, there was improvement and remission in nine [91%] and one [9%] after three months. Adverse events were observed in six and one discontinued.



If regular monitoring of hepatic function and hematological parameters are performed, leflunomide is an effective and safe drug in the Indian population in resistant rheumatoid arthritis patients, especially if used alone.
A comparison of spinal anesthesia with small-dose lidocaine and general anesthesia with fentanyl and propofol for ambulatory prostate biopsy procedures in elderly patients.

To compare operating conditions, intraoperative adverse events, recovery profiles, postoperative adverse effects, patient satisfaction, and costs of small-dose lidocaine spinal anesthesia with those of general anesthesia using fentanyl and propofol for elderly outpatient prostate biopsy.



Prospective, randomized, blind study.



Outpatient anesthesia unit at a municipal hospital.



80 ASA physical status I and II patients, aged 65 to 80 years, scheduled for outpatient prostate biopsy.



Patients were assigned to receive either spinal anesthesia with 10 mg of hyperbaric 1% lidocaine (L group, n=40) or anesthetic induction with fentanyl 1 microg.kg-1 IV and 1.0 mg.kg-1 propofol injected at 90 mg.kg-1.h-1, followed by continuous infusion at 6 mg.kg-1.h-1 (F/P group, n=40).



Both anesthetic techniques provided acceptable operating conditions for the surgeon. However, a significantly higher frequency of intraoperative hypotension was found in the F/P group than in the L group (P<0.05). Time to home readiness was shorter in the F/P group (P<0.05). Both techniques had no major postoperative adverse effects and resulted in a high rate of patient satisfaction. Total costs were significantly lower in the L group than in the F/P group (P<0.01).



Spinal anesthesia with 10 mg of hyperbaric 1% lidocaine may be a more suitable alternative to general anesthesia with fentanyl and propofol for ambulatory elderly prostate biopsy in terms of safety and costs.
Association between prehospital delay and subsequent clinical course in patients with/hospitalized for heart failure.

The clinical consequences of prehospital delay in heart failure (HF) patients are unknown. This study explores the relationship between prehospital delay of HF patients and length of hospital stay, plasma values of brain natriuretic peptides (BNP) as well as the association of delay with all-cause mortality, readmission for HF, or all-cause readmissions during short- (60 days) and long-term (18 months) follow-up.



Data from 1023 hospitalized HF patients mean aged 71 years from the Coordinating study evaluating Outcomes of Advising and Counselling in HF study were analyzed.



Patients who delayed less than 1 day had significantly shorter stay in hospital (10 days vs. 11 days, P = 0.033). They also had significantly (P = 0.004) lower median plasma values of BNP (377 pg/mL) at discharge compared to patients who delayed >24 hours (492 pg/mL). Delay was not related to all-cause mortality and/or readmissions for HF.



Although patients with a prehospital delay less than 1 day were more symptomatic on admission, they had a shorter hospital stay as well as lower plasma values of BNP at discharge. Delay was not associated hospital readmissions or mortality after discharge.
Vessel Architectural Imaging Identifies Cancer Patient Responders to Anti-angiogenic Therapy

Measurement of vessel caliber by magnetic resonance imaging (MRI) is a valuable technique for in vivo monitoring of hemodynamic status and vascular development, especially in the brain. Here, we introduce a new paradigm in MRI termed vessel architectural imaging (VAI) that exploits an overlooked temporal shift in the magnetic resonance signal, forming the basis for vessel caliber estimation, and show how this phenomenon can reveal new information on vessel type and function not assessed by any other noninvasive imaging technique. We also show how this biomarker can provide new biological insights into the treatment of patients with cancer. As an example, we demonstrate using VAI that anti-angiogenic therapy can improve microcirculation and oxygen saturation and reduce vessel calibers in patients with recurrent glioblastomas and, more crucially, that patients with these responses have prolonged survival. Thus, VAI has the potential to identify patients who would benefit from therapies.
Oral sarpogrelate can improve endothelial dysfunction as effectively as oral cilostazol, with fewer headaches, in active young male smokers

Sarpogrelate and cilostazol are two commonly used adjunctive antiplatelet agents that also can be used to improve endothelial dysfunction. We compared the effects of sarpogrelate and cilostazol on endothelial dysfunction in active male smokers with flow-mediated dilatation (FMD). We enrolled and compared baseline and follow-up FMD in 20 young male smokers without any known cardiovascular diseases. Two participants who were initially medicated with cilostazol dropped out because of severe headache after taking medication. However, they continued the other experiment with sarpogrelate medication. Baseline endothelium-dependent dilatation (EDD) after reactive hyperemia was 7.5 % ± 1.9 % and endothelium-independent dilatation (EID) after sublingual administration of nitroglycerin was 13.3 % ± 3.4 %. After a 2-week treatment of cilostazol, follow-up EDD significantly increased (7.7 % ± 1.9 to 8.8 ± 2.0 %, P = 0.016), but follow-up EID changed insignificantly (13.2 % ± 3.5 to 12.5 % ± 3.9 %, P = 0.350). With the sarpogrelate treatment, follow-up EDD was significantly increased (7.4 % ± 1.9 % to 8.8 % ± 1.9 %, P = 0.021), but follow-up EID was similar (13.5 % ± 3.5 to 14.0 % ± 3.2 %, P = 0.427). There was no clinical significance between the two groups on follow-up EDD and EID (P = 0.984 and 0.212, respectively). However, the mean score of intensity of headache was significantly higher in the cilostazol group than in the sarpogrelate group (3.8 % ± 2.5 % vs 1.4 % ± 2.2 %, P = 0.005). EDD showed a similar significant increase with 2-week treatment of cilostazol and sarpogrelate. However, intensity of headaches was significantly higher in the cilostazol group.
Absorptiometric assessment of muscle-bone relationships in humans: reference, validation, and application studies

This report summarizes some preliminary absorptiometric (DXA, QCT/pQCT) studies from our laboratory, supporting the following assumptions. 1. InHomo sapiens at all ages, natural proportionality between DXA-assessed bone mineral mass (bone mineral content, BMC) and muscle mass (lean mass, LM) of the whole body or limbs is specific for ethnicity, gender, and reproductive status, but not for body weight, height, or body mass index. 2. This proportionality is sensitive to many kinds of endocrine-metabolic perturbations. 3. Percentilized or Z-scored charts of the BMC/LM correlations as determined in large samples of healthy individuals can provide a diagnostic reference for evaluating proportionality in different conditions. 4. Employing exclusively DXA, this methodology can be applied to discriminate between “disuse-related” and “metabolic” osteopenias based on the finding of normal or low BMC/LM percentiles or Z-scores respectively, with important therapeutic and monitoring implications.
Results at 1 year of outpatient multidisciplinary pulmonary rehabilitation: a randomised controlled trial

Pulmonary rehabilitation seems to be an effective intervention in patients with chronic obstructive pulmonary disease. We undertook a randomised controlled trial to assess the effect of outpatient pulmonary rehabilitation on use of health care and patients' wellbeing over 1 year.



200 patients with disabling chronic lung disease (the majority with chronic obstructive pulmonary disease) were randomly assigned a 6-week multidisciplinary rehabilitation programme (18 visits) or standard medical management. Use of health services was assessed from hospital and general-practice records. Analysis was by intention to treat.



There was no difference between the rehabilitation (n=99) and control (n=101) groups in the number of patients admitted to hospital (40 vs 41) but the number of days these patients spent in hospital differed significantly (mean 10.4 [SD 9.7] vs 21.0 [20.7], p=0.022). The rehabilitation group had more primary-care consultations at the general-practitioner's premises than did the control group (8.6 [6.8] vs 7.3 [8.3], p=0.033) but fewer primary-care home visits (1.5 [2.8] vs 2.8 [4.6], p=0.037). Compared with control, the rehabilitation group also showed greater improvements in walking ability and in general and disease-specific health status.



For patients chronically disabled by obstructive pulmonary disease, an intensive, multidisciplinary, outpatient programme of rehabilitation is an effective intervention, in the short term and the long term, that decreases use of health services.
Interaction of sorafenib and cytochrome P450 isoenzymes in patients with advanced melanoma: a phase I/II pharmacokinetic interaction study

In vitro data indicate that the sorafenib is a moderate inhibitor of cytochrome P450 (CYP) enzymes, including CYP3A4, CYP2C19, and CYP2D6. This phase I/II study in patients with advanced melanoma evaluated the potential effect of sorafenib on the pharmacokinetics of midazolam, omeprazole, and dextromethorphan, specific substrates of CYP3A4, CYP2C19, and CYP2D6, respectively. Twenty-one patients received sorafenib 400 mg twice daily for 28 consecutive days. On days 1 and 28, a cocktail containing midazolam 2 mg, omeprazole 20 mg, and dextromethorphan 30 mg was administered. Pharmacokinetic analyses were performed on day 1 without sorafenib and day 28 after steady-state sorafenib exposure; sorafenib pharmacokinetics were evaluated on day 28. We defined an interaction to be excluded if the 90% confidence interval of the ratio of all day 28:day 1 analyses fell within a range from 0.80 to 1.25. In all, 18 patients were evaluable. On day 28, area under the plasma concentration–time curve from time 0 to 12 h (AUC0–12) and maximum plasma concentration (Cmax) for sorafenib were 38.1 mg h/l and 4.9 mg/l, respectively. Day 28:day 1 ratios for AUC from time 0 extrapolated to infinity (AUC0–inf) and Cmax for midazolam were 0.85 and 0.98, respectively. Day 28:day 1 ratio for 5-OH-omeprazole:omeprazole plasma concentration at 3 h postdose was 1.26, slightly outside of the 0.80–1.25 range. Thus, an interaction could not be excluded, but is considered unlikely to be clinically significant. day 1 ratio for dextromethorphan:dextrorphan concentration in urine was 0.94. Sorafenib had an acceptable safety profile. The most frequently observed grade 3–4 toxicities in cycle 1 included elevated lipase (19%) and hypertension (10%). In this patient population, our results demonstrate that exposures of probes of CYP3A4, CYP2D6, or CYP2C19 activity are potentially altered by administration of sorafenib at 400 mg twice daily. However, these differences are sufficiently small that a clinically significant inhibition or induction of these important drug metabolizing P450 isoenzymes is unlikely. Clinical and, where possible, drug level monitoring may still be appropriate for drugs of narrow therapeutic range co-administered with sorafenib.
Cardiac device implantation in Fabry disease

The incidence and predictive factors of arrhythmias and/or conduction abnormalities (ACAs) requiring cardiac device (CD) implantation are poorly characterized in Fabry disease (FD). The aim of our retrospective study was to determine the prevalence, incidence, and factors associated with ACA requiring CD implantation in a monocentric cohort of patients with confirmed FD who were followed up in a department of internal medicine and reference center for FD.Forty-nine patients (20M, 29F) were included. Nine patients (4M, 5F; 18%) had at least one episode of ACA leading to device therapy. Six patients (4M/2F) required a pacemaker (PM) for sinus node dysfunction (n = 4) or atrioventricular disease (n = 2). One female patient required an internal cardioverter-defibrillator (ICD) to prevent sudden cardiac death because of nonsustained ventricular tachycardia (nSVT). One female patient required PM-ICD for sinus node dysfunction and nSVT. One patient underwent CD implantation before the diagnosis of FD. The annual rate of CD implantation was estimated at 1.90 per 100 person years. On univariate analysis at the end of the follow-up period, the factors associated with ACAs requiring CD implantation were as follows: delayed diagnosis of FD, delayed initiation of enzyme replacement therapy, age at the last follow-up visit, and severe multiorgan phenotype (hypertrophic cardiomyopathy, chronic kidney disease, and/or sensorineural hearing loss). On multivariate analysis, age at diagnosis of FD and age at the last follow-up visit were independently associated with an increased risk of ACAs requiring CD (P < 0.05).Considering the high frequency of ACAs requiring CD implantation and the risk of sudden death in patients with FD, regular monitoring is mandatory, especially in patients with a late diagnosis of FD and/or with a severe phenotype. Regular Holter ECGs, therapeutic education of patients, and deliverance of an emergency card including a phenotype summary are crucial in the care of FD patients.Available guidelines for device therapy and the efficacy of enzyme replacement therapy for arrhythmias or conduction abnormalities are discussed.
THE EFFECT OF EXTENDED-RELEASE METOPROLOL SUCCINATE ON C-REACTIVE PROTEIN LEVELS IN PERSONS WITH HYPERTENSION -

The objective of this study was to determine whether 3 months of treatment with extended-release metoprolol succinate would reduce Creac-tive protein (CRP) levels. Seventy-five patients aged 30–65 years with uncontrolled hypertension were treated with extended-release metoprolol at 25–50 mg, titrated up to 100–200 mg daily. CRP was evaluated at baseline and at 1 and 3 months. In the 61 hypertensive patients who completed the study, CRP decreased from 6.2±7.5 mg/L at baseline to 5.4±7.0 mg/L (p=0.03) at 1 month and showed no further change at 3 months (5.6±6.5 mg/L; p=0.13). The 13 patients who received 200 mg of extended-release metoprolol had a 32% decline in CRP from 7.0±9.0 mg/L to 4.8±6.6 mg/L (–2.2 mg/L) (p=0.005) over the 3-month period, whereas lower doses did not reduce CRP (p>0.05). Age, sex, and change in blood pressure were not related to the reduc-tion in CRP in multivariate analysis. If CRP evolves into a confirmed modifiable risk factor,a β blocker such as metoprolol may be a useful addition to pharmacotherapy options.
Correlations between radiographic assessments and MRI features of knee osteoarthritis--a cross-sectional study.

To assess correlations between Kellgren & Lawrence (KL) gradings, minimum joint space width (mJSW) measurements and the Boston Leeds Osteoarthritis Knee Score (BLOKS) within a cohort of obese patients with knee osteoarthritis (KOA).



192 Participants were recruited from an outpatient clinic (ClinicalTrials.gov: NCT00655941). Inclusion criteria were age ≥50 years, body mass index (BMI) ≥30 kg/m(2) plus symptomatic and verified KOA. 1.5 T magnetic resonance imaging (MRI) scans were assessed using BLOKS and bi-plane radiography by mJSW and KL. Statistics used were Spearman rank correlation coefficients.



The average patient was 63 years of age, female and had a BMI of 37. KL gradings correlated to cartilage damage, bone marrow lesions and meniscus pathology (r = 0.15-0.76) and similar results were found for the relationship between BLOKS and mJSW. BLOKS assessed knee joint pathology co-segregated with compartment and grade specific KL (P < 0.0001). BLOKS variables were statistically significant correlated, particularly in the medial tibiofemoral compartment (r = 0.42-0.80). Adjusting for age, gender and BMI did not alter these associations.



Extensive pathological damage is present even in mild radiographic KOA and BLOKS gradings and KL scores increase together. Analyses of compartment specific KL scores revealed differences in their relationship to the assessed MRI variables. Our study displays the segregation of MRI gradings with respect to location and level of radiographic scores, reveals a high inter-dependency of MRI-assessed structures, and describes some redundancy of specific BLOKS variables.
ff ects of low-dose nifedipine on urinary protein excretion rate in patients with renal disease

(1) Nifedipine 10 mg orally did not impair tubular protein reabsorption. (2) Nifedipine Background. The observation that proteinuria is an important determinant of the progression of renal had no immediate antiproteinuric effect despite the observed blood pressure reduction. (3) Nifedipine disease has prompted numerous studies on the effects of antihypertensive agents on protein excretion. increased proteinuria in ambulatory urine collections. This latter observation might explain the seemingly Reports on the proteinuric effects of calcium-channel blockers are quite controversial. It has been suggested different effects of dihydropyridine calcium-channel blockers as reported in previous studies. that the short-acting dihydropyridine calcium-channel blocker nifedipine increases protein excretion by inter
Prospective phase II study of rituximab with alternating cycles of hyper-CVAD and high-dose methotrexate with cytarabine for young patients with high-risk diffuse large B-cell lymphoma.

We conducted a prospective randomized phase II study to evaluate two chemotherapy regimens: (i) rituximab plus hyperfractionated cyclophosphamide, vincristine, doxorubicin and dexamethasone (R-HCVAD) alternating with rituximab, high-dose methotrexate, and cytarabine (R-MA) and (ii) rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in diffuse large B-cell lymphoma (DLBCL). This study randomized patients aged ≤60 years with DLBCL and an age-adjusted international prognostic index ≥2 to R-HCVAD/R-MA or R-CHOP based on a Bayesian adaptive algorithm. Interim analysis of the first 26 eligible patients showed that the complete response rate (CRR) was higher with R-HCVAD/R-MA than R-CHOP (P = 0·03); thus, R-CHOP arm was closed. In the final analysis, 49 and 10 eligible patients were treated in R-HCVAD/R-MA and R-CHOP arms respectively; CRR were 82% and 60% respectively (P = 0·13); 3-year progression-free survival (PFS) rates were 75·7% and 77·8% respectively (P = 0·53). In the R-HCVAD/R-MA arm, 3-year PFS rates in patients aged 46-60 years and ≤45 years were 70·3% and 87·1% respectively (P = 0·13), and the treatment-associated early mortality rate in patients >45 years was 12%. In conclusion, R-HCVAD/R-MA is associated with excellent outcome in patients ≤45 years old. However, in patients >45 years old, R-HCVAD/R-MA is associated with unacceptable mortality rates.
Fibrinolytic therapy versus craniotomy for anticoagulant-associated intracerebral hemorrhage

OBJECT
Anticoagulant-associated intracerebral hemorrhages (AAICH) have a high morbidity and mortality, necessitating urgent treatment. We examined outcomes after conventional craniotomy and stereotactic fibrinolytic therapy in a series of patients with anticoagulant-associated hemorrhages.



Among 129 consecutive surgically treated patients with supratentorial intracerebral hemorrhage, 27 patients with AAICH were identified (mean age 62; range 36-79). Thirteen patients underwent craniotomy for surgical hematoma evacuation, and 14 patients hematoma puncture and catheter placement for clot lysis. The groups had comparable major prognostic factors such as hematoma volume, age, and Glasgow coma scale (GCS) score at admission.



Nine patients died despite treatment (mortality=33%). Mortality in the craniotomy group was comparable to that of the lysis group (46% versus 21%; p=0.13). Good outcomes (Glasgow outcome score of 4 or 5) were seen in 3 craniotomy patients (23%) and 2 fibrinolysis patients (14%). Half the patients survived with major neurological deficits (GOS 2 or 3) (n=13; 48%). One rebleed was observed two days after uneventful craniotomy and hematoma removal, while no patient who underwent fibrinolysis had rebleeding.



Approximately one-fifth of patients with AAICH managed surgically may have good outcomes. Mortality and favourable outcome rates are comparable between craniotomy and fibrinolytic therapy. Fibrinolytic therapy appears to be a reasonable less invasive alternative treatment modality for intracerebral hemorrhage in the anticoagulated patient.