nils-herrmann/clean_scirepeval huggingface dataset:
Effects of suvorexant, an orexin receptor antagonist, on breathing during sleep in patients with chronic obstructive pulmonary disease.

There is a general concern that hypnotic medications in patients with respiratory disorders have the potential to decrease respiratory effort and blunt the arousal response to hypoxemia which may lead to sleep breathing disorders. We investigated whether suvorexant, an orexin receptor antagonist approved for treatment of insomnia at a maximum daily dose of 20 mg in the US, causes sleep breathing disorders in patients with chronic obstructive pulmonary disease (COPD).



This was a randomized, double-blind, placebo-controlled, 2-period, cross-over, study performed in 9 sleep laboratories/clinical research units in the United States. The participants were 25 COPD patients aged 39-72 y with mild-to-moderate airflow limitation based on GOLD spirometry criteria. In each period, patients received suvorexant (40 mg in <65 y-olds; 30 mg in ≥65 y-olds) or placebo for four consecutive nights. Respiratory function during sleep was measured by oxygen saturation using pulse oximetry (SpO2, primary endpoint) and Apnea Hypopnea Index (AHI, secondary endpoint). The study was powered to rule out a difference between treatments of -2 percentage points in SpO2 on Day 4.



There was no treatment effect following single and multiple doses of suvorexant on mean SpO2 during total sleep time (Day 1: suvorexant = 93.14%, placebo = 93.24%, difference = -0.10 [90% CI: -0.50, 0.31]; Day 4: suvorexant = 93.38%, placebo = 92.99%, difference = 0.39 [90% CI: -0.12, 0.91]). There was no clinically meaningful increase in mean AHI by suvorexant compared with placebo on Day 1 (difference = 0.72 [90% CI: -0.60, 2.04]) or Day 4 (difference = 2.05 [90% CI: 0.33, 3.77]).



These data do not suggest an overt respiratory depressant effect with 30-40 mg daily doses of suvorexant, up to twice the maximum recommended dose for treating insomnia in the US, in patients with mild-to-moderate COPD.
Mapping genes for NIDDM. Design of the Finland-United States Investigation of NIDDM Genetics (FUSION) Study.

To map and identify susceptibility genes for NIDDM and for the intermediate quantitative traits associated with NIDDM.



We describe the methodology and sample of the Finland-United States Investigation of NIDDM Genetics (FUSION) study. The whole genome search approach is being applied in studies of several different ethnic groups to locate susceptibility genes for NIDDM. Detailed description of the study materials and designs of such studies are important, particularly when comparing the findings in these studies and when combining different data sets.



Using a careful selection strategy, we have ascertained 495 families with confirmed NIDDM in at least two siblings and no history of IDDM among the first-degree relatives. These families were chosen from more than 22,000 NIDDM patients, representative of patients with NIDDM in the Finnish population. In a subset of families, a spouse and offspring were sampled, and they participated in a frequently sampled intravenous glucose tolerance test (FSIGT) analyzed with the Minimal Model. An FSIGT was completed successfully for at least two nondiabetic offspring in 156 families with a confirmed nondiabetic spouse and no history of IDDM in first-degree relatives.



Our work demonstrates the feasibility of collecting a large number of affected sib-pair families with NIDDM to provide data that will enable a whole genome search approach, including linkage analysis.
Brain chemistry reflects dual states of pain and anxiety in chronic low back pain

The neurobiology of the interaction between pain and anxiety is unknown. The present study examined interrelationships between: regional brain chemistry (as identified by in vivo proton magnetic resonance spectroscopy [1H-MRS] in dorsolateral prefrontal cortex [DLPFC], orbitofrontal cortex [OFC], cingulate and thalamus), pain (as measured by short form of the McGill Pain Questionnaire [SF-MPQ]), and anxiety (measured by the State-Trait Anxiety Inventory) in chronic low back pain (CLBP) patients, and contrasted to the relationship between brain chemistry and anxiety in sex and age-matched normal subjects. The results show that brain chemistry depends on a 3-way interaction of brain regions examined, subject groups (normal vs. CLBP), and anxiety levels (high vs. low). The concentration of N-Acetyl aspartate (the largest peak in 1H-MRS) in OFC could distinguish between anxiety levels and between subject groups. Chemical-perceptual relationships were analyzed by calculating correlations between regional chemicals and perceptual measures of pain and anxiety. To isolate pain from anxiety, these maps were subdivided based on anxiety and, in the CLBP patients along anxiety-more-related vs. anxiety-less-related pain descriptors and along sensory vs. affective pain descriptors. There was a precise relationship between perception and brain chemistry. The chemical-perceptual network best related to pain in CLBP patients was comprised of the DLPFC and OFC; the chemical-anxiety network was best related to the OFC chemistry in normals and to all four regions studied in CLBP patients; and the cingulate was best related to the affective component of pain. We conclude that the chemical-perceptual mapping differentiates between closely related perceptual states of pain and anxiety in chronic pain and provides a brain regional-chemical-perceptual description of the long-term reorganization that occurs with chronic pain.
Effect of statin therapy before Q-wave myocardial infarction on myocardial perfusion.

Recent studies emphasized the non-lipid-lowering effects of hydroxymethylglutaryl coenzyme A reductase inhibitors on endothelial function, inflammation, and platelet activation in patients with stable atherosclerosis. This study sought to evaluate the impact of statin pretreatment in patients with acute myocardial infarction (AMI) on level of systemic inflammation and myocardial perfusion. A total of 253 consecutive patients undergoing primary angioplasty on a native vessel within 12 hours of AMI were divided into a group with statin pretreatment (n = 86) and control patients (n = 167). Angiographic myocardial blush grade (MBG) after revascularization of the infarct-related artery was determined to evaluate myocardial perfusion. Statin pretreatment was associated with a lower frequency of increased C-reactive protein (>or=5 mg/L) on admission compared with the control group (48% vs 64%; p = 0.019). The frequency of normal perfusion (MBG 3) was higher in the statin-pretreatment group than the control group (45% vs 26%, respectively; p <0.001). Statin pretreatment was an independent predictor of normal myocardial perfusion (MBG 3; odds ratio 2.53, 95% confidence interval 1.15 to 9.53, p = 0.022) in addition to age <or=70 years and C-reactive protein <5 mg/L. In conclusion, statin pretreatment in patients with AMI was associated with decreased systemic inflammation and better perfusion after primary angioplasty of the infarct-related artery.
Intermediate stage Hodgkin's disease: preliminary results on 210 patients treated with four ABVD chemotherapy cycles plus extended versus involved field radiotherapy.

To improve long-term survival by reducing toxicity in intermediate stage Hodgkin's disease patients, we compared the effects of involved field (IF) versus extended field (EF) irradiation administered after four cycles of ABVD regimen.



Two hundred and ten Hodgkin's disease patients, at clinical stage II with risk factors and III without risk factors, were enrolled in the randomized study HD94. After four courses of ABVD regimen, patients who achieved complete remission (CR) or partial remission (PR) were randomly assigned to the IF or EF arm. The Kaplan-Meier method was adopted to estimate overall survival (OS) and relapse-free survival (RFS).



After a median follow-up of 78 months (range 13-111 months), OS was 98% and 96%, respectively, in the EF and IF arms; RFS was 94% and 91%, respectively, in the EF and IF arms.



We confirm the efficacy of four cycles of ABVD regimen, with suitable dose intensity, and radiotherapy as consolidation therapy, in intermediate stage Hodgkin's disease patients (CR = 99.5% and OS = 95%). We also found that involved field radiotherapy results were as effective as extended field, without acute toxicity.
Effect of combination therapy with cimetidine and pirenzepine on plasma parathyroid hormone and calcitonin levels in hemodialyzed patients

In this study we evaluated the effects of an oral combination therapy with cimetidine and pirenzepine on plasma parathyroidhormone (PTH) and calcitonin (CT) levels in 24 patients on maintenance hemodialysis (mean age: 50 years; mean duration of dialysis treatment: 23 months). As compared to the pre-treatment plasma levels of PTH and CT, there were no significant changes of their plasma concentrations during a 4-week administration of 800 mg cimetidine or 100 mg pirenzepine daily, and the concentrations also did not change significantly during the following 4 weeks of combination therapy with cimetidine and pirenzepine in the above mentioned dosage. Serum concentrations of calcium and phosphate and the activity of the alkaline phosphatase showed no significant changes either. Therefore, we suggest that this therapeutic approach cannot be considered for the treatment of uremic hyperparathyroidism.
Withdrawal from treatment as an outcome in the ISOLDE study of COPD.

To investigate the determinants of patient withdrawal from our study, and the effect of these withdrawals on the outcome of treatment with inhaled corticosteroids in patients with COPD.



A double-blind, placebo-controlled, randomized trial.



Eighteen outpatient centers in the United Kingdom.



Seven hundred fifty-one patients with stable COPD defined clinically and as baseline postbronchodilator FEV(1) > or = 0.8 L and < 85% predicted, FEV(1)/FVC ratio < 70%, and FEV(1) change after albuterol < 10% of predicted.



Random assignment of either 500 microg bid of inhaled fluticasone propionate (FP) using a spacer device or an identical placebo inhaler. Treatment was continued for 3 years or until patients withdrew from follow-up.



Postbronchodilator FEV(1) was measured on three occasions before randomization and every 3 months thereafter. Health status was assessed by the disease-specific St. George Respiratory Questionnaire (SGRQ) and the modified short-form 36 questionnaire (SF-36) at baseline and every 6 months. Three hundred thirty-nine patients withdrew, of whom 156 patients received FP. Prescription of frequent courses of oral prednisolone was the most common reason for withdrawing as specified in the protocol (69 patients in the FP group withdrew due to respiratory symptoms, compared with 93 patients in the placebo group). This explained the significantly greater dropout of placebo-treated patients that was most evident when FEV(1) was < 50% predicted. Patients withdrawing had a significantly more rapid decline in health status, measured by both the SGRQ and the SF-36 (p < 0.001). Those withdrawing from the placebo group had a more rapid decline in FEV(1) and more exacerbations than the FP-treated groups. Baseline FEV(1) was lower in dropouts than in patients completing the study receiving placebo, but there was no difference between the respective groups receiving FP.



Patients who withdrew from follow-up were those with the most rapidly deteriorating health status and lung function. Losing these patients from the final analysis can reduce the power of a study to achieve its primary end point.
[Immune response of preterm infants to hepatitis B vaccine administered within 24 hours after birth].

To investigate the immune response of preterm infants to hepatitis B vaccination.



Three doses of recombinant hepatitis B vaccine (5 micro g dose) were administered to 35 preterm and 21 full-term infants within 24 hours after birth and at one and six months of postnatal age.



A protective antibody response (anti-HB > 10 mUI/mL) was observed three months after the last dose in 92.6% and 100% of preterm and full-term infants (p > 0.05), respectively. Newborns with gestational age below 34 weeks presented lower antibody responses in all three periods. However, gestational age was not important to determine the antibody response in the three periods analyzed. When antibody response was analyzed in terms of birth weight, it was observed that a protective response was present in 75 and 100% of newborns with birth weight < or = 1,500 g and > 1,500 g, respectively. Birth weight was shown to be a relevant factor in determining a protective antibody response at six months of postnatal age. Nonresponders received a fourth vaccine dose and an adequate antibody response was obtained in 100%.



The antibody response of preterm infants was similar to that of term newborns. Hepatitis B vaccination can be initiated on the first day of life in preterm newborns, following the same scheme recommended for term newborns. However, in preterm infants with birth weight less than or equal to 1,500 g, whose antibody response is lower, anti-HB titers should be monitored at nine months of age, or a four-dose vaccination scheme should be provided, with doses on the first day of postnatal life and one, six and nine months later.
Complications in laparoscopic colorectal surgery: results of a multicentre trial

We present a prospective observational multicentre study of 4834 consecutive cases undergoing laparoscopic colorectal procedures. The study was initiated on 1 August 1995, with centres from Germany, Austria and Switzerland participating. All patients undergoing laparoscopic colorectal surgery were included, and no selection criteria were applied. Between August 1995 and April 2004, the participating centres treated 4834 patients. Three thousand, one hundred and sixty-six operations were performed for benign indications, and 1668 for cancer, with most operations being done for diverticulitis (2019, 41.8%). The conversion rate was 5.6%, and the overall morbidity was 20.1%. Intra-operative complications occurred in 5.9%, postoperative complications in 14.0%, and the overall anastomotic leak rate was 3.1% (colon 2.6%, rectum 11.9%). The 30-day mortality rate was 1.3%. It has been our experience that laparoscopic surgery for colorectal disease is safe. Morbidity and mortality are comparable to those of conventional colorectal surgery.
Seventy-two hours of mild hypothermia after cardiac arrest is associated with a lowered inflammatory response during rewarming in a prospective observational study

Whole-body ischemia and reperfusion trigger a systemic inflammatory response. In this study, we analyzed the effect of temperature on the inflammatory response in patients treated with prolonged mild hypothermia after cardiac arrest.



Ten comatose patients with return of spontaneous circulation after pulseless electrical activity/asystole or prolonged ventricular fibrillation were treated with mild therapeutic hypothermia for 72 hours after admission to a tertiary care university hospital. At admission and at 12, 24, 36, 48, 72, 96 and 114 hours, the patients' temperature was measured and blood samples were taken from the arterial catheter. Proinflammatory interleukin 6 (IL-6) and anti-inflammatory (IL-10) cytokines and chemokines (IL-8 and monocyte chemotactic protein 1), intercellular adhesion molecule 1 and complement activation products (C1r-C1s-C1inhibitor, C4bc, C3bPBb, C3bc and terminal complement complex) were measured. Changes over time were analyzed with the repeated measures test for nonparametric data. Dunn's multiple comparisons test was used for comparison of individual time points.



The median temperature at the start of the study was 34.3°C (33.4°C to 35.2°C) and was maintained between 32°C and 34°C for 72 hours. All patients were passively rewarmed after 72 hours, from (median (IQR)) 33.7°C (33.1°C to 33.9°C) at 72 hours to 38.0°C (37.5°C to 38.1°C) at 114 hours (P <0.001). In general, the cytokines and chemokines remained stable during hypothermia and decreased during rewarming, whereas complement activation was suppressed during the whole hypothermia period and increased modestly during rewarming.



Prolonged hypothermia may blunt the inflammatory response after rewarming in patients after cardiac arrest. Complement activation was low during the whole hypothermia period, indicating that complement activation is also highly temperature-sensitive in vivo. Because inflammation is a strong mediator of secondary brain injury, a blunted proinflammatory response after rewarming may be beneficial.
Modifiers of timing and possible triggers of acute myocardial infarction in the Thrombolysis in Myocardial Infarction Phase II (TIMI II) Study Group.

The aim of this study was to provide insight into the mechanism of acute myocardial infarction by determining the modifiers of timing and possible triggers of onset of infarction.



A higher frequency of onset of acute myocardial infarction has been reported in the morning with a peak in the 1st 3 h after awakening. This observation suggests that the onset of infarction may be triggered by activity in the morning and at other times of the day.



The clinical history of the 3,339 patients entered into the Thrombolysis in Myocardial Infarction phase II study was analyzed to determine characteristics predicting a higher frequency of infarction between 6 AM and noon, and onset of infarction during exertion.



A higher proportion (34.4%) of infarctions began in the morning (6 AM to noon) compared with other times of the day. Characteristics independently predicting a higher frequency between 6 AM to noon were no beta-adrenergic blocking agent use in the 24 h before infarction, no discomfort other than the index pain in the preceding 48 h, occurrence of the infarction on a weekday and no history of current smoking. In 18.7% of patients, infarction occurred during moderate or marked physical activity. Independent predictors of exertion-related infarction included male gender, no history of current smoking, white race, no use of calcium channel blocking agents or nitrates in the preceding 24 h, the absence of either chest pain at rest in the 3 weeks before infarction or any pain in the preceding 48 h, the absence of new onset angina and the presence of exertional pain in the preceding 3 weeks. Compared with patients whose infarction occurred at rest or during mild activity, those with exertion-related infarction had fewer coronary vessels with > or = 60% stenosis (p = 0.002) and were more likely to have an occluded infarct-related vessel after thrombolytic therapy (p = 0.01).



Further study of the timing and activity at onset of infarction may provide insight into the pathophysiologic mechanisms causing acute myocardial infarction and provide clues to preventive measures.
Effects of whole body vibration therapy on main outcome measures for chronic non-specific low back pain: a single-blind randomized controlled trial.

The aim of this study was to determine whether a 12-week course of low-frequency vibrating board therapy is a feasible therapy for non-specific chronic low back pain, and whether it improves the main outcome measures.



Randomized controlled trial.



A total of 50 patients with non-specific low back pain were included. They were randomly assigned to either a vibrating plate via reciprocation therapy group (n = 25) or a control group (n = 25).



The 12-week vibration therapy programme consisted of a total of 24 training sessions (2 times/week, with 1 day of rest between sessions). Assessments of the main outcome measures for non-specific low back pain were performed at baseline and at 12 weeks.



In the vibration therapy group there was a statistically significant improvement, of 20.37% (p = 0.031) in the Postural Stability Index (anterior-posterior); 25.15% (p = 0.013) in the Oswestry Index; 9.31% in the Roland Morris Index (p = 0.001); 8.57% (p = 0.042) in EuroQol 5D-3L; 20.29% (p = 0.002) in the Sens test; 24.13% (p = 0.006) in visual analogue scale back; and 16.58% (p = 0.008) in the Progressive Isoinertial Lifting Evaluation test.



A 12-week course of low-frequency vibrating board therapy is feasible and may represent a novel physical therapy for patients with non-specific low back pain.
Effects of intermittent pneumatic foot compression on blood coagulability and fibrinolysis assessed by a whole blood viscometer Sonoclot

abnormal coagulopathy. They were randomly (by the envelope technique) divided into two groups according to the type of IPC device used: standard or rapid. The subjects were requested to lie in a supine position and to remain calm. Both soles of each subject in one group were compressed for 3 s (130mmHg) at 0.3-Hz intervals during rapid IPC. In the other group, both legs of each subject from the ankles to the thighs were compressed by the standard IPC device, which has a six-chambered cuff that applies compression of 45mmHg for 12s sequentially followed by a 60-s noncompression period. To measure whole blood coagulability using the Sonoclot viscometer, venous blood samples were collected from the left cephalic vein at 10min before compression (control) and at 25 and 60min after compression. The following Sonoclot variables were recorded: sonACT, i.e., Sonoclot-measured activated clotting time (liquid phase or onset of clot formation); clot rate, i.e., slope of the Sonoclot signature (fibrin gel formation stage); and time-to-peak, i.e., duration from the start of measurement to the peak of the Sonoclot signature . Data are expressed as means SD. All data were analyzed by one-way ANOVA, and Fisher’s test was used as a post hoc test. P 0.05 was considered to indicate statistical significance. Typical time courses of the Sonoclot signature before and 25 min after IPC by the use of the AV impulse are shown in Fig. 1. The AV impulse significantly shortened the time-to-peak without changing sonACT or clot rate. Both of the IPC devices significantly shortened the time-to-peak in a time-dependent manner (by more than 40% at 60 min after compression). The other parameters, sonACT and clot rate, were not changed during the study period by the use of either device (Table 1). There were no significant differences in these parameters between the IPC devices tested. The Sonoclot analyzer is used as a blood viscoelastic monitor. One of the benefits of its use is that the Sonoclot signature provides global measurement of