nils-herrmann/clean_scirepeval huggingface dataset:
Randomized double-blind, double-dummy crossover clinical trial of oral tramadol versus rectal tramadol administration in opioid-naive cancer patients with pain

Tramadol is commonly used as second step drug of the analgesic ladder. In circumstances where the oral route is unavailable, rectal administration of opioids might be a simple alternative. The aim of this study was to compare the analgesic activity and tolerability of tramadol by oral and rectal administration in a double-blind, double-dummy crossover trial. The study included 60 cancer patients with cancer pain no longer responsive to non-opioid drugs. Each patient initially received oral tramadol 50 mg (drops), followed by tramadol sustained release 100 mg orally, and placebo rectally, or tramadol 100 mg rectally and placebo orally, twice a day, in a randomized sequence, on each of 3 days. Patients were allowed to take 50 mg of oral tramadol by drops as needed (four doses per day, to a maximum of 400 mg/day, including the basal dose given by the oral or rectal route). Pain intensity and relief and symptom scores were recorded every day and at the end of each phase of the crossover. The mean age of the patients was 66.1 years (SD 13.5 years); 36 were female, and 44 completed both periods. Patients dropped out due to adverse effects (15 patients) and refusal (1 patient). No differences in the use of rescue dose of oral tramadol were observed between the groups. No differences in pain intensity and relief scores, or in other symptoms between the two treatments were observed. No differences in treatment efficacy as judged by the clinician (P=0.73), in patient compliance (P=0.35), or in patient satisfaction regarding treatment (P<0.35) were found. No differences in adverse effects were found between the two treatments (25.5%, 13 patients, and 20.4%, 11 patients, with oral and rectal treatment, respectively). The proportion of preferences favored oral administration for both physicians (P=0.0002) and patients (P=0.002). Rectal administration of tramadol appears a reliable, noninvasive alternative method of pain control for patients no longer responsive to non-opioid analgesics, unable to take oral tramadol.
In vivo sagittal plane kinematics of the FPV patellofemoral replacement

Isolated symptomatic patellofemoral osteoarthritis has been reported in 2% of men and 8% of women older than the age of 55 years in the community. With the development of improved designs and surgical techniques, interest in the use of patellofemoral replacement has increased. The primary aim of the newer generation of patellofemoral replacement implant designs has been to more closely reproduce normal knee kinematics. This study compares the functional sagittal plane in vivo kinematics of a contemporary patellofemoral prosthesis, the FPV, with normal knee kinematics using the patella tendon angle and patella flexion angle relationships with the knee flexion angle. The in vivo kinematics for a group of 8 patients (15 knees) with patellofemoral replacement and 22 normal subjects was measured for both a step-up and a lunge exercise using an established fluoroscopic method. The patella tendon angle characteristics of the implanted knees were similar to those of the normal knees for the step-up exercise with a significant difference only observed at 50° knee flexion angle. For the lunge exercise, the patella tendon angle for the implanted knee was consistently lower than that measured for the normal knee. Overall the subjects had excellent clinical scores post-patellofemoral replacement showing a significant improvement from their pre-operative scores. The kinematics of the FPV implant was closer to normal than those of total knee implants; however, there were still differences from the normal knees. III.
Identifying Aboriginal-specific AUDIT-C and AUDIT-3 cutoff scores for at-risk, high-risk, and likely dependent drinkers using measures of agreement with the 10-item Alcohol Use Disorders Identification Test

The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item alcohol screener that has been recommended for use in Aboriginal primary health care settings. The time it takes respondents to complete AUDIT, however, has proven to be a barrier to its routine delivery. Two shorter versions, AUDIT-C and AUDIT-3, have been used as screening instruments in primary health care. This paper aims to identify the AUDIT-C and AUDIT-3 cutoff scores that most closely identify individuals classified as being at-risk drinkers, high-risk drinkers, or likely alcohol dependent by the 10-item AUDIT.



Two cross-sectional surveys were conducted from June 2009 to May 2010 and from July 2010 to June 2011. Aboriginal Australian participants (N = 156) were recruited through an Aboriginal Community Controlled Health Service, and a community-based drug and alcohol treatment agency in rural New South Wales (NSW), and through community-based Aboriginal groups in Sydney NSW. Sensitivity, specificity, and positive and negative predictive values of each score on the AUDIT-C and AUDIT-3 were calculated, relative to cutoff scores on the 10-item AUDIT for at-risk, high-risk, and likely dependent drinkers. Receiver operating characteristic (ROC) curve analyses were conducted to measure the detection characteristics of AUDIT-C and AUDIT-3 for the three categories of risk.



The areas under the receiver operating characteristic (AUROC) curves were high for drinkers classified as being at-risk, high-risk, and likely dependent.



Recommended cutoff scores for Aboriginal Australians are as follows: at-risk drinkers AUDIT-C ≥ 5, AUDIT-3 ≥ 1; high-risk drinkers AUDIT-C ≥ 6, AUDIT-3 ≥ 2; and likely dependent drinkers AUDIT-C ≥ 9, AUDIT-3 ≥ 3. Adequate sensitivity and specificity were achieved for recommended cutoff scores. AUROC curves were above 0.90.
Erythrocyte fatty acid composition is associated with the risk of hypertension in middle-aged and older women.

Experimental studies have suggested different effects of various fats on blood pressure. However, epidemiologic evidence of these relations remains limited and inconsistent. We therefore assessed the association of fatty acid (FA) composition in erythrocyte membranes with the risk of hypertension. We selected 516 cases of incident hypertension and 516 matched controls during 12.9 y of follow-up in the Women's Health Study. Erythrocyte FA was measured in baseline bloods using GC. After controlling matching factors and lifestyle factors, erythrocyte SFA showed a positive association, whereas total cis PUFA, cis (n-3) PUFA, and the ratio of PUFA:SFA (PS ratio) showed an inverse association with the risk of hypertension. The multivariable RR of hypertension across the increasing quartiles of erythrocyte FA subtypes were 1.00, 1.19, 1.44, and 1.76 for total SFA; 1.00, 0.84, 0.88, and 0.56 for total cis PUFA; 1.00, 0.87, 0.66, and 0.65 for cis (n-3) PUFA; and 1.00, 0.99, 0.70, and 0.51 for the PS ratio. After further adjusting for obesity-related metabolic factors, these associations were attenuated and remained significant only for the PS ratio. cis MUFA, cis (n-6) PUFA, and trans unsaturated FA in erythrocyte membranes were not associated with the risk of hypertension. Our study showed that FA composition in erythrocyte membranes is associated with the risk of hypertension in middle-aged and older women. However, after controlling for obesity-related metabolic factors, the associations remained significant only for the PS ratio.
Neural correlates of free T3 alteration after catecholamine depletion in subjects with remitted major depressive disorder and in controls

Thyroid hormones and their interactions with catecholamines play a potentially important role in alterations of mood and cognition. This study aimed to examine the neurobiological effects of catecholamine depletion on thyroid hormones by measuring endocrine and cerebral metabolic function in unmedicated subjects with remitted major depressive disorder (RMDD) and in healthy controls. This was a randomized, placebo-controlled, and double-blind crossover trial that included 15 unmedicated RMDD subjects and 13 healthy control subjects. The participants underwent two 3-day-long sessions at 1-week intervals; each participant was randomly administered oral α-methyl-para-tyrosine in one session (catecholamine depletion) and an identical capsule containing hydrous lactose (sham depletion) in the other session prior to a [18F]-fluorodeoxyglucose positron emission tomography scan. Serum concentrations of free T3 (FT3), free T4 (FT4), and TSH were obtained and assessed with respect to their relationship to regional cerebral glucose metabolism. Both serum FT3 (P = 0.002) and FT4 (P = 0.0009) levels were less suppressed after catecholamine depletion compared with placebo treatment in the entire study sample. There was a positive association between both FT3 (P = 0.0005) and FT4 (P = 0.002) and depressive symptoms measured using the Montgomery–Åsberg Depression Rating Scale. The relative elevation in FT3 level was correlated with a decrease in regional glucose metabolism in the right dorsolateral prefrontal cortex (rDLPFC; P < 0.05, corrected). This study provided evidence of an association between a thyroid–catecholamine interaction and mood regulation in the rDLPFC.
Fat malabsorption in cystic fibrosis: comparison of quantitative fat assay and a novel assay using fecal lauric/behenic acid.

The gold standard for the diagnosis of fat malabsorption, the 72-hour fat balance study, requires a 3-day collection to generate a coefficient of fat absorption (CFA). We hypothesized that a new test using behenic acid (behenate test) as a nonabsorbable lipid marker may provide a facile means to assess fat absorption. The study proposed to answer 2 questions: first, whether the behenate test correlated with the gold standard and, second, whether the CFA improved when taking pancreatic enzymes during meals instead of taking them before meals.



The study compared the behenate test with the gold standard in 15 patients with cystic fibrosis during 3 arms that require 3- to 4-day hospitalization: first, taking pancreatic enzymes before meals; second, taking it during meals; and third, without taking it.



The mean CFA was 78.3% when pancreatic enzymes were taken during meals and 80.4% when these enzymes were taken before meals. Correlation between the CFA and the behenate test for collections during all 3 arms was r = 0.219 (P = 0.001).



Timing of ingestion of pancreatic enzymes does not significantly alter the CFA. Although the CFA correlates with the behenate test, the correlation is not robust enough to justify replacement of the gold standard by this test. It is unclear whether the poor correlation between tests relates to intermeal variability in fat excretion or other factors; however, the behenate test may be suitable as a screening test for the detection of fat malabsorption.
Efficacy of nifedipine in the treatment of angina pectoris and chronic airways obstruction.

Twenty patients suffering from angina pectoris with co-existing fixed or labile airways obstruction, were administered fortnightly treatment periods of nifedipine or matching placebo over an 8-week period. Maintenance treatment for their airways obstruction continued throughout this period. Nifedipine was found to be an effective drug in controlling their angina, and did not have an adverse effect on the airways obstruction. Both systolic and diastolic BP was reduced over a 90-min period after administration of a single dose of nifedipine.
Diagnostic value of intraoperative examination of sentinel lymph node in early cervical cancer: a prospective, multicenter study.

Sentinel lymph node (SLN) biopsy is a surgical procedure proposed in early cervical cancer. This technique yields the potential interest to reduce the morbidity of complete lymphadenectomy, which could then be performed only in case of positive SLN. Intraoperative examination has a major per-operative role in predicting nodal involvement and preventing a second step procedure. The aim of this study was to assess the diagnostic value of intraoperative examination with frozen section (FS) or imprint cytology (IC) of SLNs in early cervical cancer.



Prospective study in 7 centers (01/2005-06/2007) including patients with stage IA1 and lymphovascular space involvement to IB1 cervical cancer (squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma). SLNs were detected with a combined method (Tc99m+blue dye) and then removed laparoscopically. Intraoperative examination (FS or IC) was not systematically performed but recommended in case of macroscopical nodal enlargement in 5 centers. Results of intraoperative examination were compared with final histology performed by Hematoxylin-Eosin-Safran staining and immunohistochemistry. The diagnostic value of intraoperative examination was calculated.



One hundred and thirty-nine patients were analyzed in the study. The combined detection rate was 97.8% per patient, with 454 detected SLNs. One hundred and two patients (73.4%) had an intraoperative examination (97 patients with FS and 5 with IC). Among patients with intraoperative examination, 5 SLNs were positive (all with macrometastasis at final histology), as compared with 22 metastatic nodes at final result. The 17 false negative SLNs were: 4 macrometastasis, 4 micrometastasis and 9 isolated tumor cells. Sensitivity of the intraoperative examination per node was 20.7% [95%CI: 7.8%-45.4%] and the negative predictive value 93.0% [95%CI: 89.0%-95.9%].



Intraoperative examination of SLNs by FS and IC has a poor diagnostic value. This is mainly related to micrometastasis and isolated tumor cells, which are not detected by intraoperative techniques. Other techniques, like new molecular assays, should be investigated to improve intraoperative assessment of SLNs.
Oral carcinoma epidemiology in Paraná State, Southern Brazil.

Oral carcinoma is the sixth most frequent type of cancer in the world and the seventh most common in Brazil (the country with the highest incidence in Latin America). Mean five-year survival remains one of the lowest among the main cancers, thus justifying studies that contribute to the development of preventive strategies. The aim of this study was to compare the epidemiological, clinical, and histological characteristics of 91 patients with oral carcinoma. Mean age was 58.62 +/- 10.46 years, and male-to-female ratio was 6.6:1.0 (79 men and 12 women). European descendants predominated with 79 patients (86.8%). Eighty-five individuals (93.4%) smoked and 70 (76.9%) consumed alcohol regularly. Anatomical distribution of tumors was: 27 (29.7%) tongue; 18 (19.8%) floor of mouth; 11 (12.1%) oropharynx; and 11 (12.1%) oral mucosa. Fifty-seven patients (62.6%) presented lymph node involvement and three (3.3%) had distant metastases. Surgery and radiotherapy were used in 43.2% of patients. With the exception of the male/female ratio (which was higher), our data are consistent with previous studies on oral carcinoma patients.
Effective uric acid-lowering treatment for hypertensive patients with hyperuricemia

Uric acid (UA) has been associated with hypertension, renal disease and cardiovascular disease. The aim of the present study was to compare the UA-lowering effects of a standard dose of the UA synthesis inhibitor febuxostat to a standard dose of the uricosuric agent benzbromarone, and to investigate the effects of a low-dose combination of both agents in hypertensive patients with hyperuricemia. Twenty hypertensive patients with inadequate UA control were administered febuxostat 40 mg (Feb), benzbromarone 50 mg (Ben) and febuxostat 20 mg and benzbromarone 25 mg (feb/ben) for 3 months each in a randomized modified crossover manner. UA metabolism, blood pressure (BP) and the indices of organ damage were assessed at baseline and the end of each treatment period. No significant changes were observed in BP or estimated glomerular filtration rate (eGFR) after the treatment with each UA-lowering regimen. The change in UA was significantly greater with feb/ben than with Feb. The excretion of UA and clearance of UA were higher with Ben than with Feb and feb/ben. Urinary 8-hydroxydeoxyguanosine and liver-type fatty-acid-binding protein levels were slightly lower with Ben, whereas flow-mediated dilation was slightly higher with feb/ben and Ben. The UA-lowering effects of the low-dose combination of the UA synthesis inhibitor and uricosuric agent were greater than those of the standard dose of each agent alone. The uricosuric agent may be more effective at improving vascular function than the UA synthesis inhibitor. Thus, the appropriate management of hyperuricemia with uricosuric drugs appears to be useful for hypertensive patients with hyperuricemia.
Postconditioning reduces enzymatic infarct size and improves microvascular reperfusion in patients with ST-segment elevation myocardial infarction.

Postconditioning has been reported to reduce infarct size in ST-segment myocardial infarction (STEMI). However, recently, few other studies did not show any effect of postconditioning and suggested that it may be even harmful. We sought to assess whether postconditioning could reduce infarct size and improve myocardial reperfusion in early presenters with STEMI.



72 STEMI patients treated with primary percutaneous coronary intervention (PCI) were randomly assigned to either the postconditioning (n = 35) or the standard PCI group (control group; n = 37). Blood samples were obtained for creatine kinase (CK) and its MB isoform (CK-MB) within 36 h. The angiographic (myocardial blush grade, MBG) and electrocardiographic (ST-segment resolution, STR) data were evaluated and compared between groups.



The areas under the curve of CK and CK-MB release were significantly reduced in the postconditioning group compared with the control group (38,612.91 ± 25,028.42 vs. 60,547.30 ± 25,264.63 for CK and 5,498.23 ± 3,787.91 vs. 7,443.12 ± 3,561.13 for CK-MB, p < 0.0001). MBG was significantly better in the postconditioning group than in the control group (MBG 3: 82.3 vs. 47.1%, p = 0.0023). In the postconditioning group, STR >70% was more often observed (97.1 vs. 64.1%, p = 0.0007).



In patients with STEMI, postconditioning could significantly reduce enzymatic infarct size and improve myocardial reperfusion.
Early Childhood Risk Factors for Decreased FEV1 at Age Six to Seven Years in Young Children with Cystic Fibrosis.

There are limited objective measures of the severity of lung disease before children are able to routinely perform spirometry, generally at age 6 years. Identifying risk factors for reduced lung function at age 6 provides opportunities to intervene and slow the progression of cystic fibrosis (CF) lung disease.



To evaluate early childhood predictors of lung function at age 6-7 in a large U.S. CF cohort in the current era of widespread early eradication therapy for Pseudomonas aeruginosa (P. aeruginosa).



Participants were children with CF enrolled before age 4 in the Early Pseudomonas Infection Control (EPIC) Observational Study, a multicenter, longitudinal study that enrolled P. aeruginosa-negative children not exceeding 12 years of age. Linear regression was used to estimate the association between potential early childhood risk factors and the best FEV1% predicted at age 6-7 years.



Four hundred and eighty-four children (of 1,797 enrolled in the EPIC Observational Study) met the eligibility criteria for this analysis. Mean (SD) age at enrollment was 2.0 (1.3) years. In a multivariable model adjusted for age at enrollment, the following risk factors were significantly associated with lower mean (95% confidence interval) FEV1% predicted at age 6-7: weight percentile less than 10% during the year of enrollment (-5.3 [-9.1, -1.5]), P. aeruginosa positive during the year of enrollment (-2.8 [-5.7, 0.0]), crackles or wheeze during the year of enrollment (-5.7 [-9.4, -1.9]), mother's education of high school or less (-4.2 [-7.3, -1.2]), and mother smoked during pregnancy (-4.4 [-8.8, 0.1]).



In this large U.S. cohort, we identified several early childhood risk factors for lower FEV1 at age 6-7 years, most of which are modifiable.
Operative complications and differences in outcome after clipping and coiling of ruptured intracranial aneurysms.

OBJECT
Aneurysmal subarachnoid hemorrhage (aSAH) is associated with substantial morbidity and mortality, with better outcomes reported following endovascular coiling compared with neurosurgical clipping of the aneurysm. The authors evaluated the contribution of perioperative complications and neurological decline to patient outcomes after both aneurysm-securing procedures.



A post hoc analysis of perioperative complications from the Clazosentan to Overcome Neurological iSChemia and Infarction Occurring after Subarachnoid hemorrhage (CONSCIOUS-1) study was performed. Glasgow Coma Scale (GCS) scores for patients who underwent neurosurgical clipping and endovascular coiling were analyzed preoperatively and each day following the procedure. Complications associated with a decline in postoperative GCS scores were identified for both cohorts. Because patients were not randomized to the aneurysm-securing procedures, propensity-score matching was performed to balance selected covariates between the 2 cohorts. Using a multivariate logistic regression, the authors evaluated whether a perioperative decline in GCS scores was associated with long-term outcomes on the extended Glasgow Outcome Scale (eGOS).



Among all enrolled subjects, as well as the propensity-matched cohort, patients who underwent clipping had a significantly greater decline in their GCS scores postoperatively than patients who underwent coiling (p = 0.0024). Multivariate analysis revealed that intraoperative hypertension (p = 0.011) and intraoperative induction of hypotension (p = 0.0044) were associated with a decline in GCS scores for patients undergoing clipping. Perioperative thromboembolism was associated with postoperative GCS decline for patients undergoing coiling (p = 0.03). On multivariate logistic regression, postoperative neurological deterioration was strongly associated with a poor eGOS score at 3 months (OR 0.86, 95% CI 0.78-0.95, p = 0.0032).



Neurosurgical clipping following aSAH is associated with a greater perioperative decline in GCS scores than endovascular coiling, which is in turn associated with poorer long-term outcomes. These findings provide novel insight into putative mechanisms of improved outcomes following coiling, highlighting the potential importance of perioperative factors when comparing outcomes between clipping and coiling and the need to mitigate the morbidity of surgical strategies following aSAH.