nils-herrmann/clean_scirepeval huggingface dataset:
The Need for Second-Look Endoscopy to Prevent Delayed Bleeding after Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Randomized Trial

Many authors recommend performing a second-look endoscopy (SLE) to reduce the frequency of delayed bleeding after endoscopic submucosal dissection (ESD) for gastric neoplasms, but these recommendations have been made despite a lack of reliable evidence supporting the effectiveness of SLE.



From January 2012 to May 2013, we investigated 441 gastric neoplasms treated by ESD to assess the risk factors for delayed bleeding. Delayed bleeding occurred in four of these lesions within 1 postoperation day. Therefore, we enrolled the patients with the remaining 437 lesions to determine the utility of SLE performed on the morning of postoperative day 2. All lesions were randomly assigned to SLE (220 lesions) groups or non-SLE (217 lesions) groups.



Delayed bleeding occurred in 18 lesions (4.1%). A large tumor size (>20 mm) was the only independent risk factor for delayed bleeding (p=0.007). The chance of delayed bleeding was not significantly different between the patients receiving a SLE (eight cases) and those patients not receiving a SLE (six cases, p=0.787). Furthermore, SLE for lesions with a large tumor size did not significantly decrease delayed bleeding (p=0.670).



SLE had little or no influence on the prevention of delayed bleeding, irrespective of the risk factors.
Coronary restenosis after sirolimus-eluting stent implantation: morphological description and mechanistic analysis from a consecutive series of cases.

We describe the clinical and morphological patterns of restenosis after sirolimus-eluting stent (SES) implantation.



From 121 patients with coronary angiography obtained >30 days after SES implantation, restenosis (diameter stenosis >50%) was identified in 19 patients and 20 lesions (located at the proximal 5-mm segment in 30% or within the stent in 70%). Residual dissection after the procedure or balloon trauma outside the stent was identified in 83% of the proximal edge lesions. Lesions within the stent were focal, and stent discontinuity was identified in some lesions evaluated by intravascular ultrasound.



Sirolimus-eluting stent edge restenosis is frequently associated with local trauma outside the stent. In-stent restenosis occurs as a localized lesion, commonly associated with a discontinuity in stent coverage. Local conditions instead of intrinsic drug-resistance to sirolimus are likely to play a major role in post-SES restenosis.
Development and validation of the fecal incontinence and constipation quality of life measure in children with spina bifida.

Fecal incontinence and constipation in children with spina bifida are recognized to impact quality of life. Most disease specific quality of life instruments on fecal incontinence target adults and/or children without neuropathic bowel. We developed an instrument to evaluate bowel function and its impact on quality of life in children with spina bifida and their caregivers.



A 51-item questionnaire termed the FIC QOL (Fecal Incontinence and Constipation Quality of Life) survey was developed from expert opinion, patient interviews, and modification of previously published adult and pediatric studies for nonneuropathic bowel dysfunction. The items are divided into 7 quality of life factor groupings, including bowel program, dietary management, symptoms, travel and socialization, family relationships, caregiver emotional impact and financial impact. The questionnaire was given to caregivers of children with and without spina bifida. Discriminant validity was evaluated by comparing the spina bifida and control groups. Test-retest reliability was evaluated by having 41 patients complete 2 surveys within 4 to 6 weeks.



Comparing questionnaires from 92 index patients and 52 controls showed a statistically significant difference for all 7 quality of life factor groupings. The FIC QOL instrument objectively demonstrated the negative impact of fecal incontinence and constipation on quality of life in these families. Comparing 82 questionnaires at 2 time points demonstrated the reliability of all FIC QOL questions.



The FIC QOL instrument provides a valid and reliable measure of the effect of fecal incontinence and constipation on the quality of life of caregivers and their children with spina bifida.
Disparities in the allocation of treatment in advanced ovarian cancer: are there certain patient characteristics associated with nonstandard therapy?

To explore data from the National Cancer Database to identify pretreatment patient characteristics associated with receipt of nonstandard treatment for advanced ovarian cancer.



Between 2003 and 2006, there were 47,390 patients with ovarian cancer registered with the National Cancer Database. Variables included demographics, insurance, Charlson comorbidity score, zip income, and facility characteristics. Multivariable log binomial regression analyses were performed to assess factors associated with nonstandard care.



Among the 47,390 patients, 27,045 (81%) were stage IIIC or IV. After excluding patients with missing treatment information (n=1,129 [2.38%]), 13,789 (53.21%) had received standard treatment. In multivariable analyses, uninsured and Medicaid-insured patients were less likely to receive standard treatment as compared with privately insured patients (relative risk 0.88, 95% confidence interval [CI] 0.83-0.93 and relative risk 0.91, 95% CI 0.86-0.95, respectively). African Americans and Hispanics were also less likely to receive standard treatment (relative risk 0.87, 95% CI 0.83-0.92 and relative risk 0.89, 95% CI 0.84-0.94, respectively). Patients with a Charlson comorbidity score of 2+ were less likely to receive standard care (relative risk 0.74, 95% CI 0.68-0.80). Treatment at a community cancer hospital compared with a teaching hospital was also less likely to be associated with standard treatment (relative risk 0.83, 95% CI 0.80-0.87).



In this large multi-institutional cohort, approximately 47% of patients with stage IIIC and IV ovarian cancer did not receive standard treatment. Pretreatment patient characteristics such as race, insurance status, age, Charlson comorbidity score, and facility type were associated with nonstandard treatment.
Early rheumatoid arthritis: combination therapy with disease-modifying antirheumatic drugs and low-dose glucocorticoids?

Treatment of early rheumatoid arthritis (RA) can ensure greater long-term benefit in terms of preventing irreversible radiographic damage and disability. Low-dose treatment with gluco corticoids in combination with diseasemodify ing antirheumatic drugs (DMARDs) has been shown to be beneficial in the short-term treatment of patients with early RA, but longterm studies are needed to show whether this benefit is sustained.
Reduced acquisition and reactivation of human papillomavirus infections among older women treated with cryotherapy: results from a randomized trial in South Africa

Treatment of women for high-grade cervical cancer precursors frequently results in clearance of the associated high-risk human papillomavirus (hrHPV) infection but the role of treatment among women without hrHPV is unknown. We investigated whether cervical cryotherapy reduces newly detected hrHPV infections among HIV-positive and HIV-negative women who were hrHPV negative when treated.



The impact of cryotherapy on newly detected hrHPV infections was examined among 612 women of known HIV serostatus, aged 35 to 65 years, who were negative for hrHPV DNA, and randomized to either undergo cryotherapy (n = 309) or not (n = 303). All women underwent repeat hrHPV DNA testing 6, 12, 24, and 36 months later.



Among 540 HIV-negative women, cryotherapy was associated with a significant reduction in newly detected hrHPV infections. Women in the cryotherapy group were 55% less likely to have newly detected hrHPV than women in the control group (95% CI 0.28 to 0.71). This association was independent of the influence of changes in sexual behaviors following therapy (adjusted hazards ratio (HR) = 0.49, 95% CI 0.29 to 0.81). Among 72 HIV-positive women, similar reductions were not observed (HR = 1.10, 95% CI 0.53 to 2.29).



Cervical cryotherapy significantly reduced newly detected hrHPV infections among HIV-negative, but not HIV-positive women. These results raise intriguing questions about immunological responses and biological mechanisms underlying the apparent prophylactic benefits of cryotherapy.
Relative inaccuracy of the A1cNow in children with type 1 diabetes.

The Diabetes Control and Complications Trial (DCCT) confirmed the importance of tight glucose control in limiting the development of microvascular complications and established a standard for measuring A1C levels using high-performance liquid chromatography (HPLC) (1). Several studies demonstrated the benefit of rapid A1C testing in the clinic while face-to-face with the patient/family (2–4). The DCA2000 Analyzer (Bayer, Tarrytown, NY) uses an immunoassay method certified by the National Glycohemoglobin Standardization Program (NGSP) (5). It is frequently used to provide a rapid (6 min) A1C result, enhancing the ability to optimize therapy in a timely fashion. We recently reported that the DCA2000 was highly correlated with an HPLC reference (the DCCT standard) (r 0.94, P 0.001), although there was a slight bias with DCA2000 values being, on average, 0.2% higher than laboratory values (6). The A1cNow (Metrika, Sunnyvale, CA) was developed as a single-use, disposable test for measuring A1C at home. It is small, about the size of a pager, requires one drop of blood, and uses an immunoassay. Results are displayed in 8 min. However, there has been only one published study (7) to date assessing the accuracy of the A1cNow, and that study did not compare A1cNow values to the DCA2000. Furthermore, older generation A1cNow devices that were not NGSP certified were used in that study. We therefore designed the current study to compare the accuracy of updated, NGSP-certified A1cNow devices and corresponding DCA2000 levels with the DCCT/Epidemiology of Diabetes Interventions and Complications (EDIC) Study laboratory reference values when used at home and during a clinic visit in children with type 1 diabetes.
Effect of Tang No.1 granule (1) in treating patients with impaired glucose tolerance.

To observe the therapeutic effect of Tang No.1 granule (1, T1G) in treating patients with impaired glucose tolerance (IGT).



One hundred and forty patients with IGT and with Pi-Wei dampness-heat syndrome type were assigned randomly according to their visiting sequence into two equal groups. The control group received only general knowledge about IGT, but to the treated group, based on current knowledge available, T1G was given additionally for 6 months. Changes in related laboratory indexes, including fasting plasma glucose and insulin (FPG and FINS), plasma glucose 2 h after meal (2hPG), glycosylated hemoglobin (HbA1c), serum triglyceride (TG), low density lipoprotein cholesterol (LDL) and insulin resistance index (HOMA-IR), were observed.



The levels of FPG, 2hPG, HbA1c, FINS, TG and HOMA-IR were significantly decreased after treatment in the treated group, showing a significant difference compared to the control group (P<0.01). Among them, HbA1c decreased from 7.08+or-1.41% to 6.56+or-1.29% in the treated group, while in the control group, it decreased from 7.02+or-1.37% to 6.93+or-1.31%. The level of LDL was also reduced in the treated group after treatment (P<0.05). In the treated group, 13 out of 68 patients (19.12%) had their glucose tolerance reversed to normal, while in the control group, only 2/64 (3.1%) got it reverse; a comparison between the two groups in terms of reversion rate showed a significant difference (P<0.01). No severe adverse reaction was found in the therapeutic course.



T1G has good clinical effect as a treatment intervention for IGT, as it could improve glycometabolism, significantly depress the levels of post-prandial blood sugar and blood lipids, alleviate clinical symptoms of patients, and effectively cut-off and reverse the yielding and development of diabetes mellitus.
The effects of risedronate administered in combination with a proton pump inhibitor for the treatment of osteoporosis

This study was performed to investigate the effects of the co-administration of proton pump inhibitor (PPI) on the efficacy of bisphosphonate (BP) treatment for osteoporosis. A total of 180 women with low bone mineral density were randomly divided into four groups, one in which sodium risedronate was administered with sodium rabeprazole and one in which only risedronate was administered (BP + PPI and BP groups, respectively). The biomarkers were measured at the baseline and every 3 months, inlcuding: N-terminal telopeptide of type I collagen corrected for creatinine, bone-specific alkaline phosphatase (BAP), parathyroid hormone, bone mineral density (BMD) of the lumbar spine and physical parameters evaluated according to the SF-36v2™ Health Survey. Statistical comparisons of these parameters were performed after 9 months. Data were available for a total of 137 patients (62 in the BP group and 75 in the BP + PPI group). The Δ % value of increase in BMD and improvement of physical functioning in the BP + PPI group were significantly larger, and its decrease in BAP in the BP + PPI group was significantly smaller than that in the BP group. It is expected that risedronate administration in combination with a PPI may be more effective not only for treating osteoporosis but also improving physical fitness than treatment with risedronate alone.
Altered aiming movements in Parkinson's disease patients and elderly adults as a function of delays in movement onset

This study investigated the effect of lengthening the time the hand remains immobilized on an aiming movement performed by Parkinson's disease (PD) patients and elderly adults, and whether visual information could compensate for the effects of delay. In Experiment One, PD patients and elderly adults kept the limb in a static position for 1, 6, or 10 s prior to movement initiation, both with and without vision of the initial limb position and the movement trajectory. Compared to elderly adults, PD patients had increased movement times and jerk scores, and exhibited shorter primary submovements that erred in initial movement direction. Lengthening the time delay increased movement time, decreased mean acceleration, and decreased the distance covered in the primary submovement for both groups. Parkinsonian patients, however, exhibited reduced length of the primary submovement across delay compared to elderly adults. Occluding vision caused the movements of PD patients to deteriorate on all measures. Although the performance of both groups was enhanced when vision was available, vision was not able to fully counteract the effects of delay in either group. In Experiment Two, participants moved to a previously viewed target to examine movement accuracy. Systematic undershooting of the target as a function of delay was found for both groups. Parkinsonian patients exhibited greater undershooting of the target after the primary submovement both with and without vision. Visual feedback reduced the effects of delay for both the elderly and PD patients. It can be inferred from the results that the decay in position sense as a function of time produces impairments in incorporating the initial limb position in motor planning process.
The effect of n−3 fatty acids on coronary atherosclerosis: Results from SCIMO, an angiographic study, background and implications

According to the model of “response to injury”, the arterial endothelium is occasionally injured in hyperlipidemia, hypertension, diabetes mellitus and in other states known as risk factors. The ensuing inflammatory response is modulated by cytokines and growth factors, among them platelet-derived growth factor (PDGF), and monocyte chemoattractant protein-1 (MCP-1). In two independent studies, we demonstrated that mRNA levels for PDGF-A and-B and for MCP-1 are reduced after ingestion of n−3 fatty acids by human volunteers. This reduction persists after monocyte stimulation/differentiation by adherence. Moreover, the reduction is brought about only by dietary n−3 fatty acids and not by other calsses of unsaturated fatty acids (n−6 or n−9). This appears to be one major mechanism of action of reduced progression/increased regression of establihed coronary artery disease by ingestion of 1.5 g/d n−3 fatty acids, as assessed by coronary angiography in a randomized placebo-controlled double-blind intervention study in 223 patients. The study was conducted according to “Good Clinical Practice”, comprehensive rules regulating investigations with pharmaceutical compounds. Together, our investigations lend support to the importance of PDGF-A, PDGF-B, and MCP-1 in the pathogenesis of atherosclerosis, and the beneficial role of n−3 fatty acids therein.
Auranofin, gold sodium thiomalate, and placebo in the treatment of rheumatoid arthritis Cooperative systematic studies of rheumatic diseases

Two hundred eight patients were studied in a prospective, controlled, double-blind multicenter trial comparing auranofin (AUR), gold sodium thiomalate (GST), and placebo. One hundred sixty-one patients completed at least 20 weeks of therapy. Response to a variety of measures of efficacy was generally modest for both gold treatment groups although improvement was continuing in both groups at the end of the study. There was statistically significant improvement with both gold preparations compared to placebo for the number of tender joints, the joint tenderness score, and physician assessment of disease severity. GST was also significantly better than placebo for the joint swelling score. GST demonstrated more improvement in patients with anemia and thrombocytosis compared to the other treatment groups and both gold preparations were superior to placebo in improvement of an elevated erythrocyte sedimentation rate. Twenty-seven percent of patients on GST were withdrawn from the study for adverse drug reaction with rash and stomatitis being the predominant cause. Only 6% of patients on AUR were withdrawn for untoward drug effect. The time of onset of the adverse reactions is discussed. The two gold preparations were similar in efficacy although AUR was better tolerated.
Does the hypoxic ventilatory response predict the oxygen-induced falls in ventilation in COPD?

The purpose of this study was to determine whether supplemental oxygen-induced decreases in ventilation (VE) and mouth occlusion pressure (P0.1) in patients with COPD are related to the ventilatory or P0.1 responses to hypoxia (delta VE/delta SaO2, delta P0.1/delta SaO2). We measured these responses in 14 patients with a (mean +/- SD) FEV1 of 0.95 +/- .41 L. The VE and P0.1 were also measured while the patients sequentially breathed either room air or supplemental oxygen (1-2 L/min) for 10 min in a randomized single blind fashion. The mean (+/- SEM) SaO2 increased from 90.8 +/- 0.99 percent to 95.2 +/- 0.46 percent and the VE decreased during oxygen breathing from 12.3 +/- 0.46 to 11.6 +/- 0.47 L/min (p < 0.03). However, the individual changes in VE were not significantly related to the corresponding changes in SaO2 (CHG SaO2), (delta VE/delta SaO2), or (delta VE/SaO2) (CHG SaO2). Similarly, the P0.1 decreased from 2.50 +/- 0.27 to 2.26 +/- 0.20 cm H2O (p < 0.05), but the individual changes in P0.1 were not significantly related to (CHG SaO2), (delta P0.1/delta SaO2), or (delta PO.1/delta SaO2) (CHG SaO2).
An Improvement to Martin's Algorithm for Computation of Linear Precedence Functions

References 1. Dixon, W.J. (Ed). BMD Biomedical Computer Programs. U. of California Press, Berkeley, 1973. 2. Dixon, W.J. (Ed). BMD P Biomedical Computer Programs. U. of California Press, Berkeley, 1975. 3. Forsythe, A.B. Adequacy and validity of statistical analysis. In J.W. Franc (Ed.),  Eighth Annual Symposium on the Interface, Health Sciences Computing Facility, U. of California, Los Angeles, 1975, pp. 134-145. 4. Francis, I., and Valliant, R. The novice with a statistical package: performance without competence. In J.W. Frane (Ed.),  Eighth Annual Symposium on the Interface, Health Sciences Computing Fatality, U. of California, Los Angeles, 1975, pp. 110-114. 5. Franc, J.W. and Hill, M.H. Annotated Computer Output for Factor  A Supplement to the Writeup for BMD P4M. Health Sciences Computing Facility, U. of California, Los Angeles, 1975. 6. Larsen, W.A., and McCleary, S.J. The use of partial residual plots in regression analysis.  (1972), 781-790. 7. Lawson, C.L., and Hanson, R.J. Solving Least Squares Problems. Prentice-Hall, Englewood Cliffs, N.J., 1974. 8. Reinsch, C.H. Algorithm 464, eigenvalues of a real, symmetric, tridiagonal matrix.  (July 1973), 689. 9. Velleman, P.F., and Francis, I. Measuring statistical accuracy of regression programs. In J.W. Frane (Ed.),  Eighth Annual Symposium on the Interface, Health Sciences Computing Facility, U. of California, Los Angeles, 1975, pp. 122-127.
Alterations in balance and mobility in people with epilepsy

People with epilepsy (PWE) are burdened by physical disability and side effects of antiepileptic drugs (AED) such as drowsiness and blurred vision. These factors place them at risk for reduced mobility and falls. The purpose of this study was to evaluate mobility and balance in PWE.



This was a cross-sectional study of PWE and age- and sex-matched controls. We evaluated mobility and balance using the Timed Up and Go Test (TUG) and the Tinetti Mobility Test (TMT). Self-reported confidence in balance was assessed using the Activities-Specific Balance Confidence Scale (ABC). Clinical and demographic characteristics and particularly epilepsy-related variables were recorded.



We included 33 PWE and 33 controls. PWE had a mean age of 36.7years, and 61% were male. They had a mean of 1.52 of seizures per month and used a mean of 1.6 anti-epileptic drugs (AEDs). PWE scored significantly worse in all measures (TUG, TMT, ABC) when compared with controls. PWE had poor performance in 60.6% of cases in the TUG and in 48.5% of cases in the TMT, compared to none in the control group. There was good correlation between the three instruments. TUG scores were correlated with epilepsy duration, but not age, seizure control or AED use. On multivariate logistic regression, poor performance TMT was significantly associated with poor confidence in balance, according to the ABC.



PWE have significant alterations in balance and mobility, independently of AED use or seizure control. These alterations are reflected in a poor self-reported confidence in carrying out daily activities.
Role of nifedipine in treatment of hypertension.

The efficacy of nifedipine in the treatment of hypertension was assessed in 15 patients whose hypertension continued while being treated with atenolol 100 mg and bendrofluazide 5 mg daily. Nifedipine was added in doses of 10, 20, and 30 mg three times daily in a placebo controlled, double blind trial. One patient was withdrawn from the trial because of severe postural hypotension with the highest dose. Erect and supine blood pressure in the remaining 14 patients were significantly reduced by all doses of nifedipine. The drug was well tolerated but plasma potassium fell by 0.3 mmol(mEq)/1 during treatment (p less than 0.05). Nifedipine is thus effective in the treatment of hypertension but should probably be used in combination with a potassium sparing diuretic.