nils-herrmann/clean_scirepeval huggingface dataset:
New Mapping Technology for Atrial Tachycardias

Prerequisite for succesful radiofrequency catheter ablation of tachycardias is the exact mapping during the electrophysiological study. The new mapping system CARTO allows a three-dimensional color-coded electroanatomic map of impulse propagation using electromagnetic technology. The aim of this study was to determine the feasibility and safety of the new electromagnetic mapping technology CARTO for atrial tachycardias.  Electrophysiologic study and CARTO mapping was performed in 38 atrial tachycardias. The mapping procedure took 26 ± 23 min. We created 33 maps within the right atrium and 5 maps within the left atrium with a mean of 74 ± 38 different catheter positions. The mechanism was determined as reentrant in 9, junctional in 1 and focal in 28 tachycardias. In focal tachycardias the tachycardia cycle length (CL) and the total atrial activation time (AT) were clearly different (352 ± 98 ms vs 99 ± 25 ms). Reentrant tachycardias had a comparable CL and AT (236 ± 44 ms vs 240 ± 56 ms). In 83% of the focal tachycardias and in 67% of the reentrant tachycardias, ablation was performed successfully. No complications occured.  The electroanatomic mapping system allows high resolution visualization of electrical activity and may therefore improve precision and simplify the determination of the arrhythmogenic substrate during tachycardias for successful catheter ablation.
ASIA impairment scale conversion in traumatic SCI: is it related with the ability to walk? A descriptive comparison with functional ambulation outcome measures in 273 patients

Prospective multicenter longitudinal cohort study.To determine the relationship between improvements of the American Spinal Injury Association/International Spinal Cord Society (ASIA/ISCoS) neurological standard scale (AIS) outcome measure and improvements of functional ambulatory outcome measures in patients with traumatic spinal cord injury (European multicenter study of human SCI (EM-SCI).Methods:In 273 eligible patients with traumatic SCI, acute (0–15 days) and chronic phase (6 or 12 months) AIS grades, timed up and go (TUG) test and 10-m walk test (10MWT) outcome measurements were analyzed. Subanalysis of those patients who did have AIS conversion was performed to assess its relation with functional ambulatory outcomes.Studied population consisted of 161 acute phase AIS grade A patients; 37 grade B; 43 grade C and 32 acute phase AIS grade D patients. Forty-two patients (26%) converted from AIS grade A, 27 (73%) from grade B, 32 (75%) from grade C and five patients (16%) from AIS grade D. The frequencies of AIS conversions and functional ambulation recovery outcomes were significantly different (P<0.001) in patients with motor complete SCI. The ratio of patients with both recovery of ambulatory function and AIS conversion (n=101) differed significantly (P<0.001) between the acute phase AIS grade scores; AIS grade A (6/40 patients, 15%), B (9/27 patients, 33%), C (23/29 patients, 79%) and D (5/5 patients The AIS conversion outcome measure is poorly related to the ability to walk in traumatic SCI patients. Therefore, the authors recommend the use of functional ambulation recovery outcome measures in prognosticating the recovery of walking capacity and performance of patients with SCI.
Time to treatment and the impact of a physician on prehospital management of acute ST elevation myocardial infarction: insights from the ASSENT-3 PLUS trial.

To assess the impact of variation in prehospital care across distinct health care environments in ASSENT (assessment of the safety and efficacy of a new thrombolytic) -3 PLUS, a large (n = 1639) contemporary multicentred international trial of prehospital fibrinolysis. Specifically, the objectives were to assess predictors of time to treatment, whether components of time to treatment vary across countries, and the impact of physician presence before hospitalisation on time to treatment, adherence to protocol, and clinical events.



Patient characteristics associated with early treatment (< or = 2 hours), comparison of international variation in time to treatment, and components of delay were assessed. Trial specific patient data were linked with site specific survey responses.



Younger age, slower heart rate, lower systolic blood pressure, and prior percutaneous coronary intervention were associated with early treatment. Country of origin accounted for the largest proportion of variation in time. Intercountry heterogeneity was shown in components of elapsed time to treatment. Physicians in the prehospital setting enrolled 63.8% of patients. The presence of a physician was associated with greater adherence to protocol mandated treatments and procedures but with delay in time to treatment (120 v 108 minutes, p < 0.001).



Country of enrollment accounted for the largest proportion of variation in time to treatment and intercountry heterogeneity modulated components of delay. The effectiveness and safety of prehospital fibrinolysis was not influenced by the presence of a physician. These data, acquired in diverse health care environments, provide new understanding into the components of prehospital treatment delay and the opportunities to further reduce time to fibrinolysis for patients with ST elevation myocardial infarction.
Acute back pain: A control-group comparison of behavioral vs traditional management methods

Back-pain patients with onset in the preceding 1–10 days and comparable on a back examination were randomly assigned to traditional management (A regimen) and behavioral treatment methods (B regimen). Patients were compared at 6 weeks and 9–12 months on a set of “Sick/Well” scores derived from patient reported vocational status (V), health-care utilization (HCU), claimed impairment (CI), and pain drawings (D) and on two measures of activity level. No differences were found at 6 weeks, but at 9–12 months, A-group S's were more “sick.” No A/B differences were found on activity-level measures. Group A S's showed significant increases in claimed impairment from preonset to follow-up, whereas Group B S's had returned at follow-up to preonset levels
Long-term clinical effect of Tangyiping Granules () on patients with impaired glucose tolerance.

To evaluate the long-term clinical effect of Tangyiping Granules (, TYP) on patients with impaired glucose tolerance (IGT) to achieve normal glucose tolerance (NGT) and hence preventing them from conversion to diabetes mellitus (DM).



In total, 127 participants with IGT were randomly assigned to the control (63 cases, 3 lost to follow-up) and treatment groups (64 cases, 4 lost to follow-up) according to the random number table. The control group received lifestyle intervention alone, while the patients in the treatment group took orally 10 g of TYP twice daily in addition to lifestyle intervention for 12 weeks. The rates of patients achieving NGT or experiencing conversion to DM as main outcome measure were observed at 3, 12, and 24 months after TYP treatment. The secondary outcome measures included fasting plasma glucose (FPG), 2-h postprandial plasma glucose (2hPG), glycosylated hemoglobin (HbA1c), fasting insulin (FINS), 2-h insulin (2hINS), homeostatic model assessment of insulin resistance (HOMA-IR), blood lipid and patients' complains of Chinese medicine (CM) symptoms before and after treatment.



A higher proportion of the treatment group achieved NGT compared with the control group after 3-, 12- and 24-month follow-up (75.00% vs. 43.33%, 58.33% vs. 35.00%, 46.67% vs. 26.67%, respectively, P<0.05). The IGT to DM conversion rate of the treatment group was significantly lower than that of the control group at the end of 24-month follow-up (16.67% vs. 31.67%, P<0.05). Before treatment, FPG, 2hPG, HbA1c, FINS, 2hINS, HOMA-IR, triglyceride (TG), total cholesterol, low- and high-density lipoprotein cholesterol levels had no statistical difference between the two groups (P>0.05). After treatment, the 2hPG, HbA1c, HOMA-IR, and TG levels of the treatment group decreased significantly compared with those of the control group (P<0.05). CM symptoms such as exhaustion, irritability, chest tightness and breathless, spontaneous sweating, constipation, and dark thick and greasy tongue were significantly improved in the treatment group as compared with the control group (P<0.05). No severe adverse events occurred.



TYP administered at the IGT stage with a disciplined lifestyle delayed IGT developing into type 2 DM.
Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease.

Melevodopa hydrochloride plus carbidopa in effervescent tablets (M/C) is a readily soluble antiparkinsonian tablet formulation. A total of 221 patients with Parkinson's disease and motor fluctuations entered a randomized, double-blind, double-dummy, controlled parallel group study, which compared the effectiveness of oral M/C effervescent tablets with standard oral formulation levodopa/carbidopa tablets (L/C; Sinemet) in reducing total daily OFF time. The difference of total daily OFF time (intention-to-treat population) between the two groups was not statistically significant (P = 0.07): -39.4 minutes (95%CI: -67.08 to -11.73) in M/C group vs. +3.5 minutes (95%CI: -36.19 to +43.26) in the L/C group. In the intragroup analysis, M/C significantly reduced the baseline daily OFF, which remained unchanged in the L/C group. There were no unexpected adverse events in either treatment arms, and discontinuation rates due to adverse events did not differ between the two groups [M/C: 2 patients (1.3%); L/C: 1 patient (1.4%)]. This study failed to meet the primary endpoint (P = 0.07); however, there was a trend in favour of the M/C preparation, which deserves further attention.
A family booklet about comfort care in advanced dementia: three-country evaluation.

To evaluate a booklet on comfort care in dementia from the perspective of family with relevant experience, and assess nursing home resident and family factors associated with evaluations.



Retrospective study.



Long term care facilities in French-speaking Canada, and the Netherlands and Italy.



Bereaved family (n = 138).



An 8-item scale assessed the booklet's acceptability. Usefulness was rated on a 0 to 10 scale, and perceived usefulness referred to usefulness if family had had the booklet during the resident's stay. Families indicated preferred ways of obtaining, and the most appropriate time to get the booklet.



Almost all families (94%) perceived the booklet as useful. Canadian and Dutch families evaluated the booklet's contents and format favorably, whereas Italian families' evaluations were less favorable. Almost all families endorsed roles for physicians or nurses and about half additionally accepted availability through own initiative, in print or through the Internet. Preference of timing was highly variable. Better acceptability, usefulness, and availability through own initiative were independently associated with non-Italian nationality, presence of more physical signs discussed in the booklet, feeling ill-prepared, and higher satisfaction with care. A preference of receiving the booklet early was more likely in Italian families, those without university education, and those involved with older residents.



The booklet is suitable to inform Dutch and Canadian families on comfort care in dementia, but implementation in Italy requires further consideration. The booklet may be integrated in advance care planning in long term care, and made available outside long term care settings to serve families who wish to be informed early.
Acute effects of moderate intensity aerobic exercise on affective withdrawal symptoms and cravings among women smokers.

A growing number of laboratory studies have shown that acute bouts of aerobic exercise favorably impact affect and cravings among smokers. However, randomized trials have generally shown exercise to have no favorable effect on smoking cessation or withdrawal symptoms during quit attempts. The purpose of the present study was to explore this apparent contradiction by assessing acute changes in affect and cravings immediately prior to and following each exercise and contact control session during an eight-week smoking cessation trial. Sixty previously low-active, healthy, female smokers were randomized to an eight-week program consisting of brief baseline smoking cessation counseling and the nicotine patch plus either three sessions/week of moderate intensity aerobic exercise or contact control. Findings revealed a favorable impact of exercise on acute changes in positive activated affect (i.e., energy), negative deactivated affect (i.e., tiredness), and cigarette cravings relative to contact control. However, effects dissipated from session to session. Results suggest that aerobic exercise has potential as a smoking cessation treatment, but that it must be engaged in frequently and consistently over time in order to derive benefits. Thus, it is not surprising that previous randomized controlled trials-in which adherence to exercise programs has generally been poor-have been unsuccessful in showing effects of aerobic exercise on smoking cessation outcomes.
Normal Myocardial Flow Reserve in HIV-Infected Patients on Stable Antiretroviral Therapy

Studies have found HIV-infected patients to be at increased risk of myocardial infarction, which may be caused by coronary microvascular dysfunction. For the first time among HIV-infected patients, we assessed the myocardial flow reserve (MFR) by Rubidium-82 (82Rb) positron emission tomography (PET), which can quantify the coronary microvascular function. MFR has proved highly predictive of future coronary artery disease and cardiovascular events in the general population.In a prospective cross-sectional study, HIV-infected patients all receiving antiretroviral therapy (ART) with full viral suppression and HIV-uninfected controls were scanned using 82Rb PET/computed tomography at rest and adenosine-induced stress, thereby obtaining the MFR (stress flow/rest flow), stratified into low ≤1.5, borderline >1.5 to 2.0, or normal >2.0.Fifty-six HIV-infected patients and 25 controls were included. The HIV-infected patients had a mean age of 53 years (range 37-68 years) with 23% active smokers. The controls had a mean age of 52 years (range 36-68 years) and 26% active smokers. In the HIV-infected group 73% had a normal MFR, 17% borderline, and 10% low values of MFR. Among controls these values were 71%, 19%, and 10%, respectively (P = 0.99). However, the HIV-infected group had lower values of stress myocardial blood flow (MBF) (2.63 ± 0.09 mL/g/min vs 2.99 ± 0.14 mL/g/min; P = 0.03). We found no evidence of decreased MFR as assessed by 82Rb PET among HIV-infected patients on stable ART with full viral suppression compared with HIV-uninfected controls. We did notice a decreased MBF during stress.
Health-related quality of life and psychological distress of breast cancer patients after surgery during a phase III randomized trial comparing continuation of tamoxifen with switching to anastrozole after adjuvant tamoxifen for 1–4 years: N-SAS BC 03

To investigate whether the health-related quality of life (HRQOL) of patients switching from tamoxifen to anastrozole in a randomized trial is identical to that of those who continued tamoxifen after 1–4 years of adjuvant tamoxifen in Japanese postmenopausal breast cancer patients. Eligible patients for the randomized trial, the National Surgical Adjuvant Study of Breast Cancer 03, were recurrence-free postmenopausal women who had received definitive surgery for primary breast cancer with positive hormone receptor(s), and had been taking tamoxifen for 1–4 years postoperatively. They were randomly assigned to continue tamoxifen or to switch to anastrozole for a total duration of five years. Subjects were asked to reply to a self-administered QOL questionnaire survey to assess HRQOL (FACT-B [breast cancer scale], FACT-ES [endocrine symptom scale]) and psychological distress (CES-D: Center for Epidemiologic Studies Depression scale) at randomization (baseline), 3 months, 1, and 2 years after randomization, respectively. At baseline 694 patients (346 in the tamoxifen group and 348 in the anastrozole group) responded to the survey. The total scores of FACT-G, FACT-ES, and those of the FACT-G physical well-being subscale were statistically significantly better in the tamoxifen group than in the anastrozole group (P = 0.042, 0.038, and 0.005, respectively). However, there was no statistically significant difference between the treatment groups in the CES-D scores. Continuation of tamoxifen treatment after adjuvant tamoxifen for 1–4 years may provide Japanese breast cancer patients with better HRQOL than by switching to anastrozole.
Combined chemoradiotherapy with gemcitabine in patients with locally advanced inoperable transitional cell carcinoma of the urinary bladder and/or in patients ineligible for surgery: a phase I trial.

We conducted a phase I trial of gemcitabine (gem) with concurrent radiotherapy in patients with muscle-invasive bladder cancer (BC) ineligible for surgery or cisplatin or refusing organ loss.



Patients with urothelial cancer, cT2-T4, cN0-1, M0, ineligible for surgery due to local tumor extension, PS, age or co-morbidities or who refused surgery were included. After maximal transurethral resection, the treatment schedule included: twice-weekly i.v. infusion of gem [dose levels (DL) 1-6: 20, 27, 30, 33, 50 and 40 mg/m(2), respectively] for 30 min and concurrent radiotherapy (RT) to the bladder with 55.5 Gy. The primary end point was to determine the maximum-tolerated dose (MTD) and the dose recommended (RD) for further studies of this gem schedule. The secondary end point was late toxicity. The MTD was defined by dose-limiting toxicity (DLT) in 2 or more of 6 patients, discontinuation of RT and/or gem for >1 week in 2 or more of 6 patients due to grade (G) 3/4 acute and/or late toxicity in more than 2 of 18 patients.



Thirty-five of 44 patients were assessable for toxicity and thus the primary end point. DLTs occurred in two of five patients at dose level 5: one G3 alanine aminotransferase elevation and one G3 fatigue. The MTD, therefore, was 50 mg/m(2) gem twice weekly. At DL 6 with 40 mg/m(2), the RD was established: only one of six patients developed G3 fatigue and diarrhea. Late toxicity was rare and of low grade (only G1-2). The 2-year locoregional failure rate was 32% (9/28); 10 of 28 patients (38%) were alive with an intact bladder and no evidence of recurrent disease, 9 patients developed distant metastases and 6 died of their disease.



Gemcitabine in combination with RT is well tolerated in BC patients ineligible for surgery and/or cisplatin. The RD of gemcitabine for subsequent trials is 40 mg/m(2) twice weekly with concurrent radiation.
Sexuality of men with fibromyalgia: what are the factors that cause sexual dysfunction?

The purpose of the present study is to compare male patients with the fibromyalgia syndrome (FMS) with healthy individuals in terms of the sexual function. For the purposes of this study, 37 sexually active male FMS patients and 30 healthy controls were enrolled. The demographic data of the patients were recorded, and the widespread pain observed in FMS was graded with the help of the visual analogue scale (VAS 0–100 mm). Sexual function was assessed according to the international index of erectile function (IIEF) scoring system. The disease-related quality of life was measured with the help of the Short Form-36 quality of life questionnaire (SF-36 QoL). Levels of anxiety and depression observed in the patients were graded through the Hospital Anxiety and Depression Scale (HADS). Patients with FMS had significantly lower scores in each of the five domains of the IIEF in comparison with the healthy control group (p < 0.001). Patients’ age and widespread pain were negatively correlated with the IIEF scores (p < 0.05). The SF-36 scores (physical functioning, role limitations due to physical problems, pain and general health perception) were observed to be positively correlated with the IIEF scores (p < 0.05). No significant relationship has been observed between the scores obtained from the domains of IIEF and the psychological status (p > 0.05). FMS leads to an impairment in the sexual function in male patients, which is especially strongly associated with the age, widespread pain and the quality of life.
The impact of pharmaceutical care on improving outcomes in patients with type 2 diabetes mellitus from China: a pre- and postintervention study

To evaluate the effectiveness of pharmaceutical care services in management teams by assessing the change in hemoglobin A1c (A1C), cholesterol, and blood pressure for patients with type 2 diabetes in a diabetes ward.  Tongde hospital of Zhejiang province, a 1,200 bed South China teaching hospital, serving the local community.  A single-center, 2-phase (pre-/postintervention phase) designs was performed. Patients in postintervention phase (July 2013 to December 2013) received pharmaceutical care from a clinical pharmacist, while patients in the preintervention phase (January 2013 to June 2013) received routine medical care. The pre- and postintervention phases were then compared to evaluate the outcomes of pharmaceutical care services.  The primary end point was the absolute change in A1C versus baseline, the change in cholesterol and blood pressure and the number of patients to achieve Chinese Diabetes Society (CDS) goals at the baseline and at the end of pharmaceutical care were the main outcome measures.  During the 6-month study period, the postintervention phase showed a greater percent change in A1C (−1.45 vs. −0.43 %, P = 0.03). Another end points for achieving CDS goals were statistically significantly different in low-density lipoprotein, triglycerides and blood pressure. In the phase that received the participation of pharmacists, the number of patients that improved in A1C increased from 327 to 406 (P = 0.02); the number of rehospitalization was 29 for the postintervention phase and 75 for the preintervention phase (P = 0.05).The drug cost per patient day decreased from € 254.74 to € 219.85 (P = 0.095), and the Length of stay (LOS) did not change significantly (16.35 vs. 15.91 days; P = 0.15).Conclusion Including a pharmacist as a part of the diabetes management team may result in lower A1C, cholesterol and blood pressure in patients versus a health care.
A phase I study of oral ixabepilone in patients with advanced solid tumors

Intravenous infusion of ixabepilone is Food and Drug Administration-approved for treatment of patients with metastatic breast cancer. The aim of this study was to establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), safety, and pharmacokinetics (PK) of a novel oral formulation of ixabepilone in patients with advanced solid tumors. Forty-four patients received one of six daily doses of oral ixabepilone (5, 10, 15, 20, 25, or 30 mg) on days 1–5 of a 21-day cycle. PK parameters were evaluated in cycle 1 for all treated patients and in cycle 1 and cycle 2 for patients participating in assessments of food and gastric pH effects. The most common DLTs (reported in at least one patient) were neutropenia, neutropenic fever, diarrhea, ileus, and hypokalemia. The MTD of oral ixabepilone was 25 mg. Plasma concentrations of ixabepilone showed high variability; coefficients of variation for the area under the curve and the peak plasma concentration ranged from 61 to 131 % and from 17 to 172 %, respectively. The mean half-life of ixabepilone calculated after day 5 of cycle 1 ranged from 24 to 47 h. Ixabepilone exposure was higher when administered with a low-fat meal compared with the fasted state, and when administered 2 h after the histamine H2 receptor antagonist famotidine. The MTD of oral ixabepilone when administered once daily for five consecutive days every 21 days was 25 mg. Ixabepilone exposure was highly variable; therefore, safety and efficacy of this novel oral formulation might not be reliably predicted.