nils-herrmann/clean_scirepeval huggingface dataset:
Ciprofibrate therapy improves endothelial function and reduces postprandial lipemia and oxidative stress in type 2 diabetes mellitus.

Exaggerated postprandial lipemia (PPL) is a factor in atherogenesis, involving endothelial dysfunction and enhanced oxidative stress. We examined the effect of ciprofibrate therapy on these parameters in type 2 diabetes mellitus.



Twenty patients entered a 3-month, double-blind, placebo-controlled study. Each subject was studied fasting and after a fatty meal, at baseline, and after 3 months of treatment. Glucose and lipid profiles were measured over an 8-hour postprandial period. Endothelial function (flow-mediated endothelium-dependent vasodilatation [FMD]) and oxidative stress (electron paramagnetic resonance spectroscopy) were measured after fasting and 4 hours postprandially. At baseline, both groups exhibited similar PPL and deterioration in endothelial function. After ciprofibrate, fasting and postprandial FMD values were significantly higher (from 3.8+/-1. 8% and 1.8+/-1.3% to 4.8+/-1.1% and 3.4+/-1.1%; P<0.05). This was mirrored by a fall in fasting and postprandial triglycerides (3. 1+/-2.1 and 6.6+/-4.1 mmol/L to 1.5+/-0.8 and 2.8+/-1.3 mmol/L, P<0. 05). Fasting and postprandial HDL cholesterol was also elevated (0. 9+/-0.1 and 0.8+/-0.1 mmol/L and 1.2+/-0.2 and 1.2+/-0.1 mmol/L, P<0. 05). There were no changes in total or LDL cholesterol. Fasting and postprandial triglyceride enrichment of all lipoproteins was attenuated, with cholesterol depletion of VLDL and enrichment of HDL. There were similar postprandial increases in oxidative stress in both groups at baseline, which was significantly attenuated by ciprofibrate (0.3+/-0.6 versus 1.5+/-1.1 U, P<0.05).



This study demonstrates that fibrate therapy improves fasting and postprandial endothelial function in type 2 diabetes. Attenuation of PPL and the associated oxidative stress, with increased HDL cholesterol levels, may be important.
The effect of landiolol on cerebral blood flow in patients undergoing off-pump coronary artery bypass surgery

To examine the effect of landiolol on cerebral blood flow in patients with normal or deteriorated cardiac function. Thirty adult patients who were diagnosed with angina pectoris and who underwent elective off-pump coronary artery bypass surgery were studied. Patients were divided into two groups, one with a preoperative left ventricular ejection fraction (EF) of 50% or higher (normal EF group; n = 15) and the other with an EF of less than 50% (low EF group; n = 15). The mean cerebral blood flow velocity (Vmca) and pulsatility index (PI) in the middle cerebral artery were recorded using transcranial Doppler ultrasonography (TCD). Individual hemodynamic data were obtained using a pulmonary arterial catheter. In both groups, landiolol produced a significant decrease in heart rate (HR), which then returned to baseline 15 min after administration was completed. A significant decrease in mean arterial pressure occurred in the low EF group, but the decrease was within 30% of the baseline. In the normal EF group, there was no decrease in cardiac index (CI), whereas in the low EF group, CI significantly decreased along with the decrease in HR. There were no significant differences in Vmca and PI between the two groups. Continuous administration of landiolol at a dose of 0.04 mg/kg/min after 1 min rapid IV administration at a dose of 0.125 mg/kg/min decreases HR without causing aggravation of CBF during treatment of intraoperative tachycardia in patients with normal and deteriorated cardiac function.
Calcium use during in-hospital pediatric cardiopulmonary resuscitation: a report from the National Registry of Cardiopulmonary Resuscitation.

Specific patterns of calcium use during in-hospital pediatric cardiopulmonary resuscitation have not been reported since publication of pediatric advanced life support guidelines by the American Heart Association in 2000 recommended that calcium use during cardiopulmonary resuscitation be limited to select circumstances. We hypothesized that calcium is used frequently during in-hospital pediatric cardiopulmonary resuscitation and that its use is associated with worse survival to hospital discharge.



We reviewed 1477 consecutive pediatric cardiopulmonary resuscitation index events (for patients younger than 18 years) submitted to the National Registry of Cardiopulmonary Resuscitation from January 2000 through July 2004. The primary outcome was survival to hospital discharge. Secondary outcomes included survival of event and neurologic outcome. Multivariable logistic regression was performed to analyze the association between calcium use and outcomes.



Calcium was used in 659 (45%) of 1477 events. Calcium was more likely to be used during cardiopulmonary resuscitation in the settings of pediatric facilities, ICUs, cardiac surgery, cardiopulmonary resuscitation duration of > or = 15 minutes, asystole, and concurrently with other advanced life support medications: epinephrine, vasopressin, sodium bicarbonate, and magnesium sulfate. The use of calcium during cardiopulmonary resuscitation adjusted for confounding factors was associated with decreased survival to discharge and was not associated with favorable neurologic outcome.



Calcium is used frequently during in-hospital pediatric cardiopulmonary resuscitation. Although epidemiologic associations do not necessarily indicate causality, calcium use during cardiopulmonary resuscitation is associated with decreased survival to hospital discharge and unfavorable neurologic outcome.
A multidisciplinary rehabilitation programme improves disability, kinesiophobia and walking ability in subjects with chronic low back pain: results of a randomised controlled pilot study

To evaluate the effect of a multidisciplinary rehabilitation programme on disability, kinesiophobia, catastrophizing, pain, quality of life and gait disturbances in patients with chronic low back pain (CLBP). This was a parallel-group, randomised, superiority-controlled pilot study in which 20 patients were randomly assigned to a programme consisting of motor training (spinal stabilising exercises plus usual-care) and cognitive–behavioural therapy (experimental group, 10 subjects) or usual-care alone (control group, 10 subjects). Before treatment, 8 weeks later (post-treatment), and 3 months after the end of treatment, the Oswestry Disability Index, the Tampa Scale for Kinesiophobia, the Pain Catastrophizing Scale, a pain numerical rating scale, and the Short-Form Health Survey were assessed. Spatio-temporal gait parameters were also measured by means of an electronic walking mat. A linear mixed model for repeated measures was used for each outcome measure. The programme had significant group (p = 0.027), time (p < 0.001), and time-by-group interaction (p < 0.001) effects on disability, with the experimental group showing an improvement after training of about 61 % (25 % in the control group). The analyses of kinesiophobia, catastrophizing, and the quality of life also revealed significant time, group, and time-by-group interaction effects in favour of the experimental group, and there was a significant effect of time on pain. Both groups showed a general improvement in gait parameters, with the experimental group increasing cadence significantly more. The multidisciplinary rehabilitation programme including cognitive–behavioural therapy was superior to the exercise programme in reducing disability, kinesiophobia, catastrophizing, and enhancing the quality of life and gait cadence of patients with CLBP.
Perioperative management of antithrombotic medication in head and neck reconstruction-a retrospective analysis of 137 patients.

Various protocols exist to prevent thrombosis after free flap surgery in the head and neck. This study reviews the outcome and incidence of perioperative complications in patients undergoing head and neck reconstruction, simply using subcutaneous low-molecular-weight heparin.



A total of 137 free tissue transfers performed between 2007 and 2010 were reviewed. All patients received a general thrombosis prophylaxis with subcutaneous low-molecular-weight enoxaparin. No aspirin, dextran, or additional antithrombotic medication was administered.



Overall flap survival was 97.1%. A total of 3 complete and 1 partial flap loss occurred, all due to venous thrombosis. Five cases of venous congestion were successfully revised.



The free flap survival rate using simple subcutaneous heparin seems to be equivalent to other management regimens. Therefore, we suggest that no additional antithrombotic treatment is needed for patients who undergo head and neck reconstruction with free tissue transfer.
Acute myocardial infarction without thrombolytic therapy: Beneficial effects of magnesium sulfate

Only one third of hospitalized patients with acute myocardial infarction (AMI) receive thrombolytic therapy despite its proven benefits on outcomes. Elderly patients, have a greater risk of death during myocardial infarction; however, thrombolytic therapy appears to be less used in these patients, as compared to the general AMI-patients. In order to evaluate the impact of magnesium supplementation in AMI-patients without thrombolytic therapy, 194 patients participated in a prospective, randomized and placebo-controlled study: 96 patients received a 48-hour intravenous magnesium sulfate and 98 isotonic glucose as placebo. Magnesium infusion reduced the incidence of arrhythmias, congestive heart failure and in-hospital-mortality compared with placebo (27 vs. 40%, p=0.04; 18 vs. 23%, p=0.27; 4 vs. 17%, p<0.01, respectively); in the subgroup of elderly patients (>70 years), the benefit was also obvious (42 vs. 50%; 18 vs. 25%; 9 vs. 23%, p=0.09, respectively). These data suggest that intravenous magnesium supplementation might be justified in order to reduce myocardial damage and mortality rate in subsets of high-risk patients such the elderly and/or patients not suitable for thrombolysis. Additional trials appear to be indicated to evaluate the potential benefit of magnesium in well defined specific subsets of AMT-patients. Nur ein Drittel aller Krankenhauspatienten mit akutem Myokardinfarkt (AMI) wird trotz der erwiesenen Vorteile für die Ergebnisse thrombolytisch behandelt. Bei älteren Patienten besteht eine größere Sterblichkeitsgefahr bei Myokardinfarkten, jedoch scheint bei diesen Patienten im Vergleich zu allgemeinen AMI-Patienten die thrombolytische Therapie weniger angewandt zu werden. Um die Wirkung von Magnesiumsupplementierung bei AMI-Patienten ohne thrombolytische Therapie zu beurteilen, nahmen 194 Patienten an einer prospektiven, randomisierten, placebokontrollierten Untersuchung teil. 96 Patienten wurde im Verlauf von 48 Stunden intravenös Magnesiumsulfat verabreicht und 98 Patienten isotonische Glucose als Placebo. Die Magnesiuminfusionen minderten das Auftreten von Arrhythmien, Stauungsherzinsuffizienz und die Sterblichkeit während des Krankenhausaufenthalts im Vergleich zum Placebo (27 im Vergleich zu 40%, p=0,04; 18 im Vergleich zu 23%, p=0,27 bzw. 4 im Vergleich zu 17%, p<0,01). In der Untergruppe mit älteren Patienten (>70 Jahre) waren die Vorteile ebenfalls offensichtlich (42 im Vergleich zu 50%; 18 im Vergleich zu 25% bzw. 9 im Vergleich zu 23%, p=0,09). Diese Daten lassen vermuten, daß intravenöse Magnesiumsupplementierung gerechtfertigt ist, um Myokardschäden und Sterblichkeit in kleinen Gruppen stark gefährdeter Patienten wie ältere bzw. Patienten, die sich nicht für Thrombolyse eignen, zu mindern. Zusätzliche Versuche scheinen angezeigt zu sein, um die möglichen Vorteile von Magnesium in gut umrissenen spezifischen kleineren AMI-Patientengruppen zu bewerten.
Effective treatment of anal cancer in the elderly with low-dose chemoradiotherapy

Chemoradiotherapy (CRT) is accepted as the standard initial treatment for squamous cell anal cancer. However, frail elderly patients cannot always tolerate full-dose CRT. This paper reports the results of a modified regimen for this group of patients. In all, 16 patients with biopsy-proven squamous cell carcinoma of the anal canal or margin and performance status or co-morbidity precluding the use of full-dose CRT were included in this protocol. The median age was 81 (range 77–91). Patients received a dose of 30 Gy to the gross tumour volume plus 3 cm margin in all directions. Concurrent chemotherapy comprised 5-fluorouracil 600 mg m−2 given over 24 h on days 1–4 of radiotherapy. The treatment was well tolerated. All 16 patients completed treatment as planned. Only one patient experienced any grade 3 toxicity (skin). The local control at a median follow-up of 16 months was 73% (13 out of 16). The overall survival was 69% and disease-specific survival 86%. This is a well-tolerated regimen for elderly/poor performance patients with anal cancer, which can achieve high rates of local control and survival. Longer follow-up will determine whether these encouraging results are maintained.
Yohimbine Enhancement of Exposure Therapy for Social Anxiety Disorder: A Randomized Controlled Trial

Preclinical and clinical trials suggest that yohimbine may augment extinction learning without significant side effects. However, previous clinical trials have only examined adults with specific phobias. Yohimbine has not yet been investigated in the augmentation of exposure therapy for other anxiety disorders.



Adults (n = 40) with a DSM-IV diagnosis of social anxiety disorder were randomized to placebo or yohimbine HCl (10.8 mg) 1 hour before each of four exposure sessions. Outcome measures were collected at baseline, each treatment session, posttreatment, and 1-month follow-up.



Yohimbine was well tolerated. Yohimbine augmentation, relative to placebo augmentation, resulted in faster improvement and better outcomes on self-report measures of social anxiety disorder severity (Liebowitz Social Anxiety Scale, d = .53) and depressed mood severity (Beck Depression Inventory, d = .37) but not on the clinician-rated measures (Clinical Global Impressions-Severity Scale, d = .09; Clinical Global Impressions-Improvement Scale, d = .25). Between-group differences on the Liebowitz Social Anxiety Scale were moderated by the level of fear reported at the end of an exposure exercise (end fear), such that the advantage of yohimbine over placebo was only evident among patients who reported low end fear.



The results provide moderate support for yohimbine as a therapeutic augmentation strategy for exposure therapy in social anxiety disorder, one that may be especially effective when coupled with successful exposure experiences. Beneficial effects for yohimbine were readily evident for self-report measures but not for clinician-rated outcomes of social anxiety severity and improvement.
Temozolomide Plus Thal idomide in Pat ients With Advanced Melanoma : Resul ts of a Dose-Finding Tria l

To establish a safe and tolerated regimen of an oral cytotoxic agent, temozolomide, and a cytostatic agent, thalidomide, in patients with unresectable stage III or IV malignant melanoma.  Patients with unresectable stage III or IV melanoma without brain metastases were entered successively onto four treatment cohorts: level 1, temozolomide 50 mg/m2/d for 6 weeks followed by a 4-week break; levels 2, 3, and 4, temozolomide 75 mg/m2/d for 6 weeks followed, respectively, by breaks of 4, 3, and 2 weeks. Thalidomide was started at 200 mg/d, and escalated to a maximum dose of 400 mg/d. Safety was assessed at weeks 2 and 4 and every 4 weeks thereafter; tumor response was evaluated every 8 to 10 weeks.  Twelve patients were enrolled, three on each cohort. Therapy was generally well tolerated on all of the treatment schedules. Thalidomide at a dose of 400 mg/d was well tolerated in patients younger than 70, and 200 mg/d was well tolerated in older patients. The most common adverse events were grade 2 or 3 constipation and neuropathy, which were attributed to thalidomide. Five major responses (one complete, four partial) were documented, all at dose levels 2 to 4. Three of the five responding patients were in the over-70 age group. The median duration of response was 6 months (range, 4 to 17 months), and the median overall survival was 12.3 months (range, 4 to 19 months).  The combination of temozolomide and thalidomide was well tolerated and had antitumor activity in patients with advanced melanoma, including elderly patients over 70 years old.
Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial.

Gastroesophageal reflux disease (GERD) is a chronic, relapsing disease with symptoms that have negative effects on daily life. Two treatment options are long-term medication or surgery.



To evaluate optimized esomeprazole therapy vs standardized laparoscopic antireflux surgery (LARS) in patients with GERD.



The LOTUS trial, a 5-year exploratory randomized, open, parallel-group trial conducted in academic hospitals in 11 European countries between October 2001 and April 2009 among 554 patients with well-established chronic GERD who initially responded to acid suppression. A total of 372 patients (esomeprazole, n = 192; LARS, n = 180) completed 5-year follow-up.  Two hundred sixty-six patients were randomly assigned to receive esomeprazole, 20 to 40 mg/d, allowing for dose adjustments; 288 were randomly assigned to undergo LARS, of whom 248 actually underwent the operation.



Time to treatment failure (for LARS, defined as need for acid suppressive therapy; for esomeprazole, inadequate symptom control after dose adjustment), expressed as estimated remission rates and analyzed using the Kaplan-Meier method.



Estimated remission rates at 5 years were 92% (95% confidence interval [CI], 89%-96%) in the esomeprazole group and 85% (95% CI, 81%-90%) in the LARS group (log-rank P = .048). The difference between groups was no longer statistically significant following best-case scenario modeling of the effects of study dropout. The prevalence and severity of symptoms at 5 years in the esomeprazole and LARS groups, respectively, were 16% and 8% for heartburn (P = .14), 13% and 2% for acid regurgitation (P < .001), 5% and 11% for dysphagia (P < .001), 28% and 40% for bloating (P < .001), and 40% and 57% for flatulence (P < .001). Mortality during the study was low (4 deaths in the esomeprazole group and 1 death in the LARS group) and not attributed to treatment, and the percentages of patients reporting serious adverse events were similar in the esomeprazole group (24.1%) and in the LARS group (28.6%).



This multicenter clinical trial demonstrated that with contemporary antireflux therapy for GERD, either by drug-induced acid suppression with esomeprazole or by LARS, most patients achieve and remain in remission at 5 years.
Description and validation of a noninvasive placebo acupuncture procedure.

To evaluate a simulated acupuncture technique for use in randomized controlled trials assessing the efficacy of acupuncture for low-back pain.



The clinic of an accredited acupuncture college in Seattle, Washington.



Acupuncture-naïve enrollees of Group Health Cooperative who had visited their primary care provider with a complaint of back pain that persisted for at least 3 months.



In the first experiment, subjects received six insertions of real needles and six pokes with a toothpick in a guidetube in a two-period crossover design. In the second experiment, subjects were randomly assigned to receive either a complete treatment with real acupuncture needles or a simulated treatment using a toothpick in a guidetube.



In the first experiment, we compared subjects' perceptions about which implement was used for each "insertion" while in the second, we compared the perceptions (e.g., acupuncturist's warmth and caring, the reasonableness of acupuncture as a treatment) and pain relief of those who received an acupuncture treatment using needles to those receiving simulated acupuncture.



In the first experiment, the toothpick insertions were perceived as slightly more like real needling than the real needling (mean ratings of 2.8 and 2.1, respectively; p = 0.08). In the second experiment, 52% percent of those receiving the simulated needling versus 65% of those receiving real acupuncture believed they were "definitely" or "probably" receiving real acupuncture (p = 0.33). Perceptions of acupuncture, as measured by a credibility questionnaire, were similar in the two groups. Those receiving real acupuncture were more likely to report immediate pain relief, and this was the factor most predictive of the subject's belief about which treatment they had received (p = 0.02).



The simulated acupuncture procedure evaluated in this study represents a reasonable control treatment for acupuncture-naïve individuals in randomized controlled trials assessing the efficacy of acupuncture for low-back pain.
Can yeast isolation be predicted in complicated secondary non-postoperative intra-abdominal infections?

The aim of this study was to create a predictive score for yeast isolation in patients with complicated non-postoperative intra-abdominal infections (CNPIAI) and to evaluate the impact of yeast isolation on outcome.



All patients with a CNPIAI undergoing emergency surgery over a three-year period were included in the retrospective cohort (RC, n = 290). Patients with a yeast-positive peritoneal fluid culture (YP) were compared with patients with a yeast-negative culture (YN). Multivariate logistic regression was used to identify factors independently associated with yeast isolation and a predictive score was built. The score's performance was then established in the prospective cohort (PC, n = 152) over an 18-month period. Outcome of the whole cohort was evaluated and independent risks factors of mortality searched.



In the RC, 39 patients (13.4%) were YP. Four factors were independently associated with the YP group: length of stay before surgery ≥48 h (odds ratio (OR) (95% confidence interval (CI)) = 3.1 (1.4 to 6.9), P = 0.004, 1 point), per-operative cardiovascular failure (2.4 (1.1 to 5.8), P = 0.04, 1 point), generalized peritonitis (6.8 (2.7 to 16.7), P <0.001, 2 points) and upper gastrointestinal tract perforation (2.5 (1.2 to 5.6), P = 0.02, 1 point). In the PC, the area under the curve (95%CI) of the predictive score's receiver operating characteristic curve was 0.79 (0.72 to 0.86). For predicting an intra-abdominal candidiasis (IAC), a score ≥3 had a sensitivity of 0.60, a specificity of 0.84, a positive predictive value of 0.49 and a negative predictive value of 0.89. Furthermore, yeast isolation was associated with worse outcome and independently associated with mortality in the whole cohort (OR = 2.15; 95%CI (1.03 to 4.46), P = 0.04).



The new predictive score can be used to rule out intra-abdominal candidiasis and thus avoid the initiation of antifungal treatment. It is suited to less severe infections than previously published scores. IAC is associated independently with an increased mortality in this population.