nils-herrmann/clean_scirepeval huggingface dataset:
The effect of hemodynamically-guided hypotensive therapy in one-year observation: Randomized, prospective and controlled trial (FINEPATH study).

The use of impedance cardiography (ICG) revealed to provide beneficial blood pressure (BP) lowering effect. However, the follow-up in previous trials was short and brachial BP was the only evaluated hemodynamic variable. Thus, we aimed to estimate the influence of ICG-guided therapy on brachial and central BP, impedance-derived hemodynamic profile and echocardiographic features after 12 months in a randomized, prospective and controlled trial (NCT01996085).



One hundred and forty-four hypertensives were randomly assigned to groups of empiric (GE) and ICG-guided therapy (HD). Office BP, ambulatory BP monitoring, central BP and echocardiography (left ventricular hypertrophy and diastolic function assessment) were performed before and after 12 months of treatment.



Blood pressure reduction was higher in HD (office BP: 21.8/14.1 vs. 19.9/11.8 mm Hg; mean 24-h BP: 19.0/10.9 vs. 14.4/9.2 mm Hg). However, the only statistically significant differences were: percentage of patients achieving BP reduction of minimum 20 mm Hg for of-fice diastolic BP (27.3% vs. 12.1%; p = 0.034) and mean 24-h systolic BP (49.1% vs. 27.3%; p = 0.013). More pronounced improvement in the left ventricular diastolic dysfunction (delta E/A 0.34 vs. 0.12, p = 0.017) was the only other beneficial hemodynamic effect.



Beneficial BP lowering effect of hemodynamically-guided pharmacotherapy, observed previously in short-term observation, persists over time. Hemodynamic effects of such a treatment approach, especially those of prognostic value (central BP, myocardial hypertrophy), should be evaluated in further studies including patients with resistant hypertension, heart failure, diabetes mellitus and chronic kidney disease.
The Effectiveness and Cost‐Effectiveness of Spinal Cord Stimulation for Refractory Angina (RASCAL Study): A Pilot Randomized Controlled Trial

Patients with "refractory angina" (RA) unsuitable for coronary revascularization experience high levels of hospitalization and poor health-related quality of life. Randomized trials have shown spinal cord stimulation (SCS) to be a promising treatment for chronic stable angina and RA; however, none has compared SCS with usual care (UC). The aim of this pilot study was to address the key uncertainties of conducting a definitive multicenter trial to assess the clinical and cost-effectiveness of SCS in RA patients, i.e., recruitment and retention of patients, burden of outcome measures, our ability to standardize UC in a UK NHS setting.



RA patients deemed suitable were randomized in a 1:1 ratio to SCS plus UC (SCS group) or UC alone (UC group). We sought to assess: recruitment, uptake, and retention of patients; feasibility and acceptability of SCS treatment; the feasibility and acceptability of standardizing UC; and the feasibility and acceptability of the proposed trial outcome measures. Patient outcomes were assessed at baseline (prerandomization) and three and six months postrandomization.



We failed to meet our planned recruitment target (45 patients) and randomized 29 patients (15 SCS group, 14 UC group) over a 42-month period across four sites. None of the study participants chose to withdraw following consent and randomization. With exception of two deaths, all completed evaluation at baseline and follow-up. Although the study was not formally powered to compare outcomes between groups, we saw a trend toward larger improvements in both primary and secondary outcomes in the SCS group.



While patient recruitment was found to be challenging, levels of participant retention, outcome completion, and acceptability of SCS therapy were high. A number of lessons are presented in order to take forward a future definitive pragmatic randomized trial.
Transciliary supraorbital keyhole approach in the management of aneurysms of anterior circulation: Operative nuances.

With improvement in neuroimaging, instrumentation and operative microscope optics, and with better understanding of microneuroanatomy, it is now possible to approach intracranial aneurysms of anterior circulation through a small eyebrow incision.



The objective of the study is to highlight the advantages and limitations of transciliary supraorbital keyhole craniotomy for clipping of these aneurysms.



We present our experience with 55 intracranial aneurysms in the anterior circulation in 52 consecutive patients (23 females and 29 males, age range 22-70 years) operated between 2003 and 2009. All these aneurysms were clipped by a supraorbital transciliary incision and a craniotomy measuring 2.5 x 1.5 cm. One patient required bilateral keyhole craniotomies for bilateral aneurysms.



Of the 52 patients, 37 patients were in Grade I/II, and the rest were in Grade III-IV. Clipping could be done in all the patients, and in twelve patients there was intraoperative rupture of the aneurysm. While there was a learning curve, no limitations were apparent, and none of the patients required revision of the procedure or wrapping. None of the patients had suboptimal clip application. Postoperative check angiogram showed obliteration of the aneurysm in all the patients. Patients with preoperative Grade I/II could be discharged from the hospital within seven days, and cosmetic result was excellent in all the patients. Four patients with preoperative Grade IV died in the postoperative period due to vasospasm.



The transciliary supraorbital approach offers clipping of intracranial aneurysm in anterior circulation with low approach related morbidity as compared to standard approach.
Can electroacupuncture or transcutaneous nerve stimulation influence cognitive and emotional outcome after stroke?

The authors know of no controlled randomized studies on the cognitive effects of acupuncture following stroke. The aim of this study is to assess the effects of acupuncture combined with electroacupuncture and transcutaneous electrical nerve stimulation on emotional and cognitive functioning.



Five to 10 days after stroke, 54 patients with moderate or severe functional impairment were randomized to 1 of 3 interventions: (i) acupuncture, including electroacupuncture; (ii) sensory stimulation with high-intensity, low-frequency transcutaneous electrical nerve stimulation that induced muscle contractions; and (iii) low-intensity (subliminal) high-frequency transcutaneous electrical nerve stimulation (control group). Twenty treatment sessions were performed over 10 weeks. Outcome measures included cognitive performance and emotional functioning. Measures were obtained prior to any stimulation treatment and at 3 and 12 months.



At baseline, groups were comparable with regard to demographic, medical, emotional and functional status. The control group demonstrated lower cognitive performances, but this difference did not remain at 3 or 12 months. There were no treatment effects on emotional status. When pooling treatment groups, there were significant cognitive and emotional improvements.



Although patients from all 3 groups demonstrated cognitive and emotional improvements, the present study does not suggest any treatment effects on emotional status or cognitive functioning.
Ambulatory arterial stiffness index in Turner syndrome: the impact of sex hormone replacement therapy.

Morbidity and mortality from congenital and acquired cardiovascular (CV) disease is increased in Turner syndrome (TS), where traditional indices of CV risk are widely present but the single most common feature remains estrogen deficiency.



To investigate CV risk in TS as expressed by the widely available ambulatory arterial stiffness index (AASI) and the impact of female sex hormone replacement therapy (HRT) hereon.



TS women (n = 26) were examined following HRT washout and again during 6 months of HRT. Age-matched healthy female controls (n = 24) were examined once. 24-Hour ambulatory blood pressures, AASI in addition to metabolic and anthropometric indices of CV risk were measured.



The relatively tachycardic TS women had higher systolic and diastolic blood pressures. HRT reduced diastolic blood pressures with an increase in physical fitness, worsening of glucose tolerance, and a reduction in high-density lipoprotein. AASI was significantly elevated in TS when compared to controls (0.36 (0.02) vs. 0.26 (0.03), p = 0.01) but unaffected by HRT. Major explanatory variables to AASI were status (being TS or not), age, and diurnal pulse variability.



AASI was elevated in TS, possibly indicating elevated CV risk with no impact of short-term HRT.
Pixantrone dimaleate in combination with fludarabine, dexamethasone, and rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma: phase 1 study with a dose-expansion cohort.

Pixantrone dimaleate (pixantrone) has been shown to have antitumor activity in leukemia and lymphoma in vitro models and to lack delayed cardiotoxicity associated with mitoxantrone in animal models. FND-R, a combination regimen of fludarabine, mitoxantrone, dexamethasone, and rituximab, has been shown to be an effective regimen for low-grade lymphomas.



This dose-escalation study, with an expansion cohort, was conducted to evaluate the safety and preliminary efficacy of FPD-R, in which pixantrone was substituted for mitoxantrone in the FND-R regimen, in patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL). Escalated doses of pixantrone were administered to newly enrolled patients on day 2 of each 28-day cycle of FPD-R.



Twenty-eight of 29 enrolled patients received at least 1 cycle of FPD-R (median, 5 cycles). Pixantrone 120 mg/m(2) was identified as the recommended dose in this regimen. Grade 3-4 adverse events were primarily hematologic; grade 3-4 lymphopenia occurred in 89% of patients and leukopenia in 79%. No patients developed congestive heart failure or grade 3-4 cardiac adverse events. Left ventricular ejection fraction decreases occurred in 8 (29%) patients, and most were grade 1 or 2, transient, and asymptomatic. The overall response rate was 89%. Estimated survival was 96% after 1 year and 92% after 3 years.



The FPD-R regimen was well-tolerated and highly active in patients with relapsed or refractory indolent NHL.
Effect of medication review and cognitive behaviour treatment by community pharmacists of patients discharged from the hospital on drug related problems and compliance: design of a randomized controlled trial

Drug related problems (DRPs) are common among elderly patients who are discharged from the hospital and are using several drugs for their chronic diseases. Examples of drug related problems are contra-indications, interactions, adverse drug reactions and inefficacy of treatment. Causes of these problems include prescription errors and non-compliance with treatment. The aim of this study is to examine the effect of medication review and cognitive behaviour therapy of discharged patients by community pharmacists to minimize the occurrence of drug related problems.



A randomized controlled trial will be performed. Community pharmacists will be randomized into a control group and an intervention group.  Patients, aged over 60 years, discharged from general and academic hospitals, using five or more prescription drugs for their chronic disease will be asked by their pharmacy to participate in the study. Patients randomized to the control group will receive usual care according to the Dutch Pharmacy Standard. The medication of patients randomised to the intervention group will be reviewed by the community pharmacist with use of the national guidelines for the treatment of diseases, when patients are discharged from the hospital. The Pharmaceutical Care network Europe Registration form will be used to record drug related problems. Trained pharmacy technicians will counsel patients at home at baseline and at 1,3,6,9 and 12 months, using Cognitive Behaviour Treatment according to the Theory of Planned Behaviour. The patient's attitude towards medication and patient's adherence will be subject of the cognitive behaviour treatment. The counselling methods that will be used are motivational interviewing and problem solving treatment. Patients adherence towards drug use will be determined with use of the Medication Adherence Report Scale Questionnaire. There will be a follow-up of 12 months.The two primary outcome measures are the difference in occurrence of DRPs between intervention and control group and adherence with drug use. Secondary endpoints are attitude towards drug use, incidence of Re-hospitalisations related to medicines, functional status of the patient, quality of life and the cost-effectiveness of this intervention.



Combining both medication review and Cognitive Behaviour Treatment may decrease DRPs and may result in more compliance with drug use among patients discharged from the hospital and using 5 or more chronic drugs.
Triaxial coil embolization using Guglielmi detachable coils with the voltage-dependent coil-detaching technique.

A triple co-axial (triaxial) system, consisting of a 1.9-Fr non-tapered microcatheter with one marker, a 2.7-Fr microcatheter, and a 4-Fr catheter, has been recently developed, and can be used in coil embolizations using 0.010-inch Guglielmi detachable coils (GDCs) with a voltage-dependent coil-detaching technique.



To describe this new technique and evaluate its technical feasibility and clinical efficacy.



Twenty patients underwent this procedure. Diseases were gastrointestinal bleeding in five patients, traumatic bleeding in three patients, and other diseases in 12 patients. The technical success rate, clinical success rate, and complications of this procedure were evaluated. Technical success was defined as the successful delivery and detachment of a GDC, and clinical success was defined as the immediate postembolic complete cessation of blood flow confirmed by digital subtraction angiography.



A total of 140 GDCs were used and 20 arteries were embolized. The technical success rate was 94% (131/140) and clinical success rate was 95% (19/20). No major complications were reported.



The triaxial system in coil embolization using a GDC by monitoring the voltage for coil-detaching appeared to be safe and effective.
Imaging in gynecological disease (5): clinical and ultrasound characteristics in fibroma and fibrothecoma of the ovary.

To describe the clinical and ultrasound features of fibroma and fibrothecoma of the ovary.



Sixty-eight women with a histological diagnosis of fibroma or fibrothecoma of the ovary who had undergone a preoperative ultrasound examination between 1999 and 2007 were identified from the databases of four ultrasound centers. The tumors were characterized on the basis of ultrasound images, ultrasound reports and research protocols (when applicable) using the terms and definitions of the International Ovarian Tumor Analysis (IOTA) group. In 51 patients, ultrasound information had been collected prospectively; in the remaining 17 cases it was retrieved retrospectively from ultrasound reports and images. In 44 cases, electronic ultrasound images of good quality were available. These were reviewed by two observers, who described them using pattern recognition.



Of the 68 patients identified, 53 had fibroma and 15 had fibrothecoma. The mean patient age was 54 (range, 17-80) years. Sixty-three percent (41/65) were postmenopausal and 60% (39/65) had no symptoms. Most (75%; 51/68) fibromas/fibrothecomas were solid tumors and most (75%; 51/68) manifested minimal or moderate blood flow on color Doppler examination. Using pattern recognition, all solid fibromas/fibrothecomas were described as round, oval or slightly lobulated tumors. Most (66%; 29/44) were solid tumors, with regular or slightly irregular internal echogenicity with stripy shadows, and some contained cystic spaces. Others (23%, 10/44) were solid tumors with regular or slightly irregular internal echogenicity without stripy shadows and with or without cystic spaces. Two were solid tumors that were so dense it was difficult to assess their internal echogenicity, two were multilocular solid tumors with large cystic spaces and one was described as being mainly cystic. Half of the women with fibroma/fibrothecoma had fluid in the pouch of Douglas and 16% (11/68) had ascites; CA 125 titers > or =35 U/mL were found in 34% (17/50) of the cases in which CA 125 results were available.



Most fibromas and fibrothecomas are round, oval or lobulated solid tumors that cast stripy shadows and are associated with fluid in the pouch of Douglas, and most manifest minimal to moderate vascularization. A fibroma/fibrothecoma with atypical ultrasound appearance may be mistaken for a malignancy, in particular if associated with fluid in the pouch of Douglas or ascites, high color content and raised CA 125 levels.
Effects of new fish oil derivative on fatty acid phospholipid-membrane pattern in a group of Crohn's disease patients

Fish oil has been recently proposed as a possible effective treatment in inflammatory bowel disease (IBD); however, a lot of annoying side effects (ie, belching, halitosis, diarrhea, etc) affect patient compliance. We carried out a study of patient tolerance in a group of Crohn's disease (CD) patients with a new fish oil derivative consisting of 500-mg capsules of eicosapentaenoic-docosahexaenoic (EPA 40%-DHA 20%), a free fatty acid mixture (Purepa), and we also evaluated its incorporation into phospholipids, both in plasma and in red cell membranes. Five groups of 10 CD patients in remission received nine Purepa capsules daily in four different preparations (A: uncoated, B: coated, pH 5.5; C: coated, pH 5.5, 60 min time release; D: coated, pH 6.9) and 12 × 1-g capsules daily of a triglyceride preparation (Max-EPA, EPA 18%-DHA 10%), respectively. We coated three of the four Purepa preparations in order to delay the release of contents in an attempt to minimize the side effects. After six weeks of treatment, the group taking Purepa capsules, coated, pH 5.5, 60 min time release (group C) showed the best incorporation of EPA and DHA in red blood cell phospholipid membranes (EPA from 0.2 to 4.4%, DHA from 3.7 to 6.3%), and no side effects were registered, whereas in all other groups side effects were experienced in 50% or more of subjects. This new preparation will make it possible to treat patients for long periods.
Telephone counseling and attendance in a national mammography-screening program a randomized controlled trial.

In Germany, a mammography-screening program (MSP) was implemented on a national level. It complies with all criteria of the European guidelines for quality assurance in screening mammography; however, the attendance rate is 54%, falling short of the target attendance rate of 70%. The aim of this study was to investigate whether additional telephone counseling improves attendance among nonresponders and the level of satisfaction with telephone counseling.



In a prospective RCT, women identified as nonresponders in the MSP were randomized to a control group that received written reminders or to an intervention group that additionally received telephone counseling. In a follow-up, a subset of the intervention group was contacted by telephone regarding their satisfaction with telephone counseling.



In 2008, a total of 5477 women aged 50-69 years who were eligible for the German MSP but had not participated up to 6 weeks after the first invitation were included in the study.



Individual telephone counseling consisted of scripted calls from a trained counselor who provided information on MSP and answered the woman's questions.



Report of mammography use provided by the screening unit 3 months after the reminder was sent.



Analysis was conducted in 2009. Comparison of screening attendance revealed a significantly higher attendance rate in the intervention group compared with controls (29.7% vs 26.1%, p=0.0035). When only women for whom telephone numbers were available were analyzed, attendance was even better (35.5% vs 29.7%, p=0.0004). In the follow-up, 278 of 404 women were actually surveyed. Of those, 33% stated that telephone counseling had influenced their decision, 56% stated that they had undergone screening mammography, and 77% agreed that personal telephone counseling should be used routinely to encourage nonresponders to go for screening.



Individual telephone counseling for nonresponders to a national program for breast cancer screening was well accepted by participants and effective.
Pharmacokinetics of linezolid in septic patients with and without extended dialysis

Linezolid is an option for the treatment of infections caused by multiresistant Gram-positive bacteria. The survival of critically ill patients with acute renal failure (ARF) can be improved by increasing the dose of renal replacement therapy. Extended (daily) dialysis (ED) is a new and important approach to renal replacement therapy in intensive care units. The aim of the study was to evaluate the pharmacokinetics of linezolid in septic patients without ED and on ED, respectively. We studied the pharmacokinetics of linezolid in adult intensive care patients with sepsis (n = 5) and anuric septic patients with ARF being treated with ED (n = 10). Linezolid 600 mg was administered intravenously twice daily. The pharmacokinetic parameters, their variability, and possible covariates were analyzed using NONMEM. The pharmacokinetics of linezolid followed a two-compartment model with clearance (Cl) = 0.159 L h−1 kg−1 ± 51% (population mean ± interindividual variability), central volume of distribution (V1) = 0.273 L/kg ± 21%, intercompartmental clearance (Q) = 0.369 L h−1 kg−1, and peripheral volume of distribution (V2) = 0.271 L/kg. The clearance in ED patients while on dialysis was increased by 3.5 L/h, and patients with liver transplantation/resection had their clearance reduced by 60%. Intra-individual variability was much smaller than inter-individual variability. Our results suggest that linezolid pharmacokinetics in critically ill patients with ARF undergoing ED is not comparable to that in healthy subjects and patients without ARF. The best method of managing linezolid dosage in such a complex group of patients, whose physiology can vary daily, would be to use therapeutic drug monitoring.