nils-herrmann/clean_scirepeval huggingface dataset:
Daily flaxseed consumption improves glycemic control in obese men and women with pre-diabetes: a randomized study.

The study hypothesis was that fasting glucose, insulin, fructosamine, C-reactive protein, and interleukin-6 decrease and adiponectin increases with daily flaxseed consumption in overweight or obese individuals with pre-diabetes. In this randomized, cross-over study overweight or obese men and postmenopausal women (n = 25) with pre-diabetes consumed 0, 13, or 26 g ground flaxseed for 12 weeks. Glucose, insulin, homeostatic model assessment (HOMA-IR), and normalized percent of α-linolenic fatty acid (ALA) were significantly different by treatment (multiple analysis of variance, P = .036, P = .013, P = .008, P = .024 respectively). Paired t tests showed glucose decreased on the 13 g intervention compared to the 0 g period [13 g = -2.10 ± 1.66 mg/L (mean ± SEM), 0 g = 9.22 ± 4.44 mg/L, P = .036]. Insulin decreased on the 13 g intervention but not the 26 g (P = .021) and 0 g (P = .013) periods (13 g = -2.12 ± 1.00 mU/L, 26 g = 0.67 ± 0.84 mU/L, 0 g = 1.20 ± 1.16 mU/L). HOMA-IR decreased on the 13 g period but not on the 26 g (P = .012) and 0 g (P = .008) periods (13 g = -0.71 ± 0.31, 26 g = 0.27 ± 0.24, 0 g = 0.51 ± 0.35). The α-linolenic fatty acid decrease for the 0 g period was different than the 13 g (P = .024) and 26 g (P = .000) periods (13 g = 0.20 ± 0.04, 26 g = 0.35 ± 0.07, 0 g = -0.01 ± 0.07). Fructosamine, high sensitivity C-reactive protein, adiponectin, and high-sensitivity interleukin-6 had no significant differences. Flaxseed intake decreased glucose and insulin and improved insulin sensitivity as part of a habitual diet in overweight or obese individuals with pre-diabetes.
The association between cholecystectomy and gastroesophageal reflux symptoms: a prospective controlled study.

A large controlled prospective observational study to compare pre- and postsurgery changes in reflux symptoms between cholecystectomy and hernia repair surgery patients.



Six studies have suggested that gastroesophageal reflux worsens after cholecystectomy. However, all these studies had design limitations.



We recruited 302 patients scheduled to undergo elective cholecystectomy (study group) or hernia repair (controls) at 2 hospitals. Both groups filled out the validated Reflux Symptom Score (RSS) and Gastrointestinal Symptom Rating Scale (GSRS) questionnaires 1 to 15 days prior to and 4 to 12 weeks after the operation. Changes in symptom scores between the pre and postsurgery assessments were measured, and compared between the 2 groups.



Baseline RSS and GSRS reflux subscores were higher in the study group than controls (1.44 vs. 1.02 and 1.91 vs. 1.43, respectively; P < 0.05). There were no significant differences in any of the symptom score changes between the 2 groups except for the GSRS pain subscore, which decreased more in the study group than the control group (-0.59 vs. -0.10; P < 0.001). With regard to reflux, the RSS decreased by -0.34 in the study group and -0.14 in controls (P = 0.27), while the GSRS reflux subscore decreased by -0.32 in the study group and -0.05 in controls (P = 0.12). GSRS diarrhea and constipation subscores decreased slightly after surgery, to the same extent in both groups.



This large prospective controlled study, the only one using validated reflux symptom questionnaires, shows that cholecystectomy does not lead to an increase in reflux symptoms. As expected, GSRS pain subscores were decreased in the cholecystectomy group but not the controls.
Intra- and post-operative accuracy assessments of two different patient-specific instrumentation systems for total knee replacement

The aim of this study is to assess and compare the accuracy of two different patient-specific instrumentation (PSI) systems for total knee replacement, both intra-operatively for bone preparation and post-operatively for final component alignment. Twenty-five patients were treated according to a computer tomography (CT)-based PSI system (group A) and 25 to a magnetic resonance imaging (MRI)/X-ray-based system (group B). Alignments on the three anatomical planes and resection thickness at the cutting blocks and at the resulting bone cuts were recorded intra-operatively by a standard surgical navigation system. Alignments of the prosthetic components and mechanical axis were also measured post-operatively on radiographs. These measurements at both the femur and tibia were compared with those of the corresponding pre-operative planning, considering discrepancies larger than 3° as outliers. In both groups, the mean absolute differences between pre-operatively planned alignments and corresponding intra- and post-operative measurements ranged from a minimum of 1.2° to a maximum of 2.9° in all three anatomical planes. In both groups and in both femur and tibia, the plane with the smallest percentage of outliers was the coronal, maximum 17 %. The comparison between two groups was statistically significant (p = 0.02) in the femoral sagittal plane, where group B showed smaller alignment discrepancies at the cutting blocks. Both PSI systems showed good alignments in the coronal plane in all stages. For a few measurements, a better performance was observed in the MRI/X-ray-based system than in the CT-based system.
Prediction of Transfusions After Isolated Coronary Artery Bypass Grafting Surgical Procedures.

Although blood transfusions are common and have been associated with adverse sequelae after cardiac surgical procedures, few contemporaneous models exist to support clinical decision making. This study developed a preoperative clinical decision support tool to predict perioperative red blood cell transfusions in the setting of isolated coronary artery bypass grafting.



We performed a multicenter, observational study of 20,377 patients undergoing isolated coronary artery bypass grafting among patients at 39 hospitals participating in the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative's PERFusion measures and outcomes (PERForm) registry between 2011 and 2015. Candidates' preoperative risk factors were identified based on previous work and clinical input. The study population was randomly divided into a 70% development sample and a 30% validation sample. A generalized linear mixed-effect model was developed to predict perioperative red blood cell transfusion. The model's performance was assessed for calibration and discrimination. Sensitivity analysis was performed to assess the robustness of the model in different clinical subgroups.



Transfusions occurred in 36.8% of patients. The final regression model included 16 preoperative variables. The correlation between the observed and expected transfusions was 1.0. The risk prediction model discriminated well (receiver operator characteristic [ROC]development, 0.81; ROCvalidation, 0.82) and had satisfactory calibration (correlation between observed and expected rates was r = 1.00). The model performance was confirmed across medical centers and clinical subgroups.



Our risk prediction model uses 16 readily obtainable preoperative variables. This model, which provides a patient-specific estimate of the need for transfusion, offers clinicians a guide for decision making and evaluating the effectiveness of blood management strategies.
Skeletal muscle molecular responses to resistance training and dietary supplementation in COPD.

Skeletal muscle dysfunction is a systemic feature of chronic obstructive pulmonary disease (COPD), contributing to morbidity and mortality. Physical training improves muscle mass and function in COPD, but the molecular regulation therein is poorly understood.



Candidate genes and proteins regulating muscle protein breakdown (ubiquitin proteasome pathway), muscle protein synthesis (phosphatidylinositol 3 kinase/Akt/mammalian target of rapamycin pathway), myogenesis (MyoD, myogenin and myostatin) and transcription (FOXO1, FOXO3 and RUNX1) were determined in quadriceps muscle samples taken at four time points over 8 weeks of knee extensor resistance training (RT) in patients with COPD and healthy controls (HCs). Patients with COPD were randomly allocated to receive protein/carbohydrate or placebo supplements during RT.



59 patients with COPD (mean (SD) age 68.0 (9.3) years, forced expiratory volume in 1 s (FEV1) 46.9 (17.8) % predicted) and 21 HCs (66.1 (4.8) years, 105.0 (21.6) % predicted) were enrolled. RT increased lean mass (~5%) and strength (~20%) in all groups. Absolute work done during RT was lower throughout in patients with COPD compared with HCs. RT resulted in increases (from basal) in catabolic, anabolic, myogenic and transcription factor protein expression at 24 h, 4 weeks and 8 weeks of exercise in HCs. This response was blunted in patients with COPD, except for myogenic signalling, which was similar. Nutritional supplementation did not augment functional or molecular responses to RT.



The potential for muscle rehabilitation in response to RT is preserved in COPD. Except for markers of myogenesis, molecular responses to RT are not tightly coupled to lean mass gains but reflect the lower work done during RT, suggesting some caution when identifying molecular targets for intervention. Increasing post-exercise protein and carbohydrate intake is not a prerequisite for a normal training response in COPD.
Effect of testosterone replacement therapy on prostate tissue in men with late-onset hypogonadism: a randomized controlled trial.

Prostate safety is a primary concern when aging men receive testosterone replacement therapy (TRT), but little information is available regarding the effects of TRT on prostate tissue in men.



To determine the effects of TRT on prostate tissue of aging men with low serum testosterone levels.



Randomized, double-blind, placebo-controlled trial of 44 men, aged 44 to 78 years, with screening serum testosterone levels lower than 300 ng/dL (<10.4 nmol/L) and related symptoms, conducted at a US community-based research center between February 2003 and November 2004.



Participants were randomly assigned to receive 150 mg of testosterone enanthate or matching placebo intramuscularly every 2 weeks for 6 months.



The primary outcome measure was the 6-month change in prostate tissue androgen levels (testosterone and dihydrotestosterone). Secondary outcome measures included 6-month changes in prostate-related clinical features, histology, biomarkers, and epithelial cell gene expression.



Of the 44 men randomized, 40 had prostate biopsies performed both at baseline and at 6 months and qualified for per-protocol analysis (TRT, n = 21; placebo, n = 19). Testosterone replacement therapy increased serum testosterone levels to the mid-normal range (median at baseline, 282 ng/dL [9.8 nmol/L]; median at 6 months, 640 ng/dL [22.2 nmol/L]) with no significant change in serum testosterone levels in matched, placebo-treated men. However, median prostate tissue levels of testosterone (0.91 ng/g) and dihydrotestosterone (6.79 ng/g) did not change significantly in the TRT group. No treatment-related change was observed in prostate histology, tissue biomarkers (androgen receptor, Ki-67, CD34), gene expression (including AR, PSA, PAP2A, VEGF, NXK3, CLU [Clusterin]), or cancer incidence or severity. Treatment-related changes in prostate volume, serum prostate-specific antigen, voiding symptoms, and urinary flow were minor.



These preliminary data suggest that in aging men with late-onset hypogonadism, 6 months of TRT normalizes serum androgen levels but appears to have little effect on prostate tissue androgen levels and cellular functions. Establishment of prostate safety for large populations of older men undergoing longer duration of TRT requires further study.
Thiazolidine-4-carboxylic acid, a selective drug against human cancers

Cancer is not one single disease entity but a collective of more than 100 neoplastic disorders, distinguished by the tissues and cell types from which they originate. Hence, it is a priori unlikely tha t chemotherapeutic drugs with comprehensive anticancer spectra can be developed. Drugs with selective toxicity for neoplastic diseases require for their development the recognition of vitally impor tan t biochemical differences between cancer cells and their normal counterparts as points of departure into drug design. The paucity of such informat ion has led to the int roduct ion of some drugs which are generally cytotoxic. Another shortcoming of cancer chemotherapy development is the use of fast growing experimental animal cancers as screening systems of which it is open to doub t tha t they represent valid test systems of neoplastic disease of man. One general characteristic of neoplastic cells is their insensitivity to contact inhibi t ion: growth of normal cells is controlled by contact with other cells while neoplastic cells are not inhibited by such contacts and invade healthy tissues. Gosalvez  has studied a series of compounds for action on the cell-membrane regulatory mechanism and has tested in vitro for the restorat ion of contact inhibi t ion in cultures of tumor cells. He obtained such "reverse transforma t ion" , i.e., a return of tumor cells to normal membrane function in vitro with t hiazolidine-4-car boxylic acid, T4C . The compound is a reaction product of cysteine with formaldehyde and has been known since 1936 .
Early-onset plasmapheresis and LDL-apheresis provide better disease control for pediatric homozygous familial hypercholesterolemia than HMG-CoA reductase inhibitors and ameliorate atherosclerosis.

Plasmapheresis (PA) and low-density lipoprotein apheresis (LDL-A) were assessed in five children with homozygous familial hypercholesterolemia (HFH) previously receiving statins. LDL-A required smaller extracorporeal blood volumes. Mean HDL-cholesterol reduction post-procedure was 32% and 60% with LDL-A and PA, respectively. Non-HDL-C reduction was 64% and 69%, respectively. Pre-procedural LDL-C decreased significantly with weekly versus biweekly LDL-A. Carotid intimal media thickness (IMT) studies demonstrated disappearance of atheromatous lesions and normal ITM in 4/5 patients. Echocardiography revealed normal aortic valves, coronary orifices and supra-valvular area in all patients. Apheresis is effective in pediatric HFH. It may be started in patients weighing 14 kg.
Early Experience in the Treatment of Intra-Cranial Aneurysms by Endovascular Flow Diversion: A Multicentre Prospective Study

Flow diversion is a new approach to the endovascular treatment of intracranial aneurysms which uses a high density mesh stent to induce sac thrombosis. These devices have been designed for the treatment of complex shaped and large size aneurysms. So far published safety and efficacy data on this approach is sparse.



Over 8 months, standardized clinical and angiographic data were collected on 70 patients treated with a flow diverter device (SILK flow diverter (SFD)) in 18 centres worldwide. Treatment and early follow up details were audited centrally. SFDs were deployed alone in 57 (81%) or with endosaccular coils in 10 (14%) aneurysms, which included: 44 (63%) saccular, 26 (37%) fusiform shapes and 18 (26%) small, 37 (53%) large, 15 (21%) giant sizes. Treatment outcome data up to 30 days were reported for all patients, with clinical (50 patients) and imaging (49 patients) follow up (median 119 days) data available.



Difficulties in SFD deployment were reported in 15 (21%) and parent artery thrombosis in 8 (11%) procedures. Procedural complications caused stroke in 1 and serious extracranial bleeding in 3 patients; 2 of whom developed fatal pneumonias. Delayed worsening of symptoms occurred in 5 patients (3 transient, 1 permanent neurological deficit, and 1 death) and fatal aneurysm bleeding in 1 patient. Overall permanent morbidity rates were 2 (4%) and mortality 4 (8%). Statistical analysis revealed no significant association between complications and variables related to treated aneurysm morphology or rupture status.



This series is the largest reporting outcome of the new treatment approach and provides data for future study design. Procedural difficulties in SFD deployment were frequent and anti-thrombosis prophylaxis appears to reduce the resulting clinical sequelae, but at the cost of morbidity due to extracranial bleeding. Delayed morbidity appears to be a consequence of the new approach and warrants care in selecting patients for treatment and future larger studies.
The partners for life program: a couples approach to cardiac risk reduction.

Morbidity and mortality are reliably lower for the married compared with the unmarried across a variety of illnesses. What is less well understood is how a couple uses their relationship for recommended lifestyle changes associated with decreased risk for illness. Partners for Life compared a patient and partner approach to behavior change with a patient only approach on such factors as exercise, nutrition, and medication adherence. Ninety-three patients and their spouses/partners consented to participate (26% of those eligible) and were randomized into either the individual or couples condition. However, only 80 couples, distributed across conditions, contributed data to the analyses, due to missing data and missing data points. For exercise, there was a significant effect of couples treatment on the increase in activity and a significant effect of couples treatment on the acceleration of treatment over time. In addition, there was an interaction between marital satisfaction and treatment condition such that patients who reported higher levels of marital distress in the individuals condition did not maintain their physical activity gains by the end of treatment, while both distressed and nondistressed patients in the couples treatment exhibited accelerating gains throughout treatment. In terms of medication adherence, patients in the couples treatment exhibited virtually no change in medication adherence over time, while patients in the individuals treatment showed a 9% relative decrease across time. There were no condition or time effects for nutritional outcomes. Finally, there was an interaction between baseline marital satisfaction and treatment condition such that patients in the individuals condition who reported lower levels of initial marital satisfaction showed deterioration in marital satisfaction, while non satisfied patients in the couples treatment showed improvement over time.
Incidence, predictors, management, immediate and long-term outcomes following grade III coronary perforation.

The aim of this study was to evaluate the incidence, predictors, management, and clinical outcomes in patients with grade III coronary perforation during percutaneous coronary intervention.



Grade III coronary perforation is a rare but recognized complication associated with high morbidity and mortality.



From 24,465 patients undergoing percutaneous coronary intervention from May 1993 to December 2009, 56 patients had grade III coronary perforation.



Most lesions were complex: 44.6% type B2, 51.8% type C, and 28.6% chronic total occlusions, and within a small vessel (≤ 2.5 mm) in 32.1%. Glycoprotein IIb/IIIa inhibitors were administered in 17.9% of patients. The device causing perforation was intracoronary balloon in 50%: 53.6% compliant, 46.4% noncompliant; intracoronary guidewire in 17.9%; rotablation in 3.6%; and directional atherectomy in 3.6%. Following perforation, immediate treatment and success rates, respectively, were prolonged balloon inflation 58.9%, 54.5%; covered stent implantation 46.4%, 84.6%; coronary artery bypass graft surgery (CABG) and surgical repair 16.0%, 44.4%; and coil embolization 1.8%, 100%. Multiple methods were required in 39.3%. During the procedure (n = 56), 19.6% required cardiopulmonary resuscitation and 3.6% died. In-hospital (n = 54), 3.7% required CABG, 14.8% died. The combined procedural and in-hospital myocardial infarction rate was 42.9%, and major adverse cardiac event rate was 55.4%. At clinical follow-up (n = 46) (median: 38.1 months, range 7.6 to 122.8), 4.3% had a myocardial infarction, 4.3% required CABG, and 15.2% died. The target lesion revascularization rate was 13%, with target vessel revascularization in 19.6%, and major adverse cardiac events in 41.3%.



Grade III coronary perforation is associated with complex lesions and high acute and long-term major adverse cardiac event rates.
Hepatic apoptotic markers are not predictors for the virological response to interferon-based therapy in chronic hepatitis C patients.

Chronic hepatitis C virus (HCV) infection is a major health problem worldwide. The majority of cases involving HCV infection develop into chronic hepatitis because of a failure to develop an effective immune response. Apoptosis of the hepatocytes plays a significant role in the pathogenesis of HCV infection: the interaction between the Fas antigen on hepatocytes and the Fas ligand on T cells corresponds to the main mechanism for hepatocyte damage. Interferon (IFN)-α has antiviral, immunoregulatory, and antiproliferative properties, and apoptosis seems to be a critical event in the action mechanisms of both IFNs. In this study, we aimed to detect any relationship between apoptotic markers in the liver and the response to the treatment.



The study included 180 chronic HCV patients treated with IFN and ribavirin in four centers. Apoptotic markers (Fas, Fas ligand, Fas-associated death domain, caspases 3, 8, and 9, and in-situ apoptosis) were studied in the liver. The age, sex of the patients, response to therapy, ALT level, viral load, and genotype were recorded.



The results of the study showed that the histological activity index and fibrosis correlated with CD95 staining density, caspase-8 intensiveness, and portal and parenchymal Fas ligand scores. The apoptotic parameters of the responsive cases were not significantly different from those of the unresponsive cases.



The apoptotic parameters studied in liver tissue are associated with inflammation and fibrosis; however, these parameters may not predict response to treatment.
Correlates of therapeutic response in panic disorder presenting with palpitations: heart rate variability, sleep, and placebo effect.

To examine the correlates of therapeutic response of patients with panic disorder presenting with palpitations, we hypothesized that therapeutic response would correlate with heart rate variability (HRV) and sleep measures.



After a 1-week placebo washout, 27 patients free of structural heart disease and not on cardioactive drugs were randomized in a double-blinded fashion to 4 weeks of treatment with clonazepam (a known antipanic agent) or placebo. We performed standard sleep measures and recorded HRV from 24-hour Holter acquisitions at baseline and end of study. We defined response to therapy as a 50% improvement in the Hamilton Anxiety Rating Scale (HARS) score, confirmed by questionnaires and reaction to sodium lactate infusion.



There were 12 responders and 15 nonresponders. Normalization of sleep pattern (including less stage 1 and rapid eye movement [REM] sleep) was observed in both drug and placebo responders (P = 0.011 and P = 0.05, respectively) and in placebo responders alone, compared with nonresponders (P = 0.006 and P = 0.013, respectively). Placebo responders were more likely to show less depression, but even after we controlled for depression, main sleep effects remained. None of the HRV measures correlated with response, but compared with placebo, clonazepam led to a decrease in all the time and frequency domain measures of HRV (all P < 0.05).



Central mechanisms are related to the therapeutic response of patients with panic disorder presenting with palpitations, but this does not directly correlate with HRV. Larger and longer studies may allow objective explanations of placebo response in panic disorder.