nils-herrmann/clean_scirepeval huggingface dataset:
Prospective comparison of computed tomography enterography and magnetic resonance enterography for assessment of disease activity and complications in ileocolonic Crohn's disease.

Studies comparing magnetic resonance enterography (MRE) and computerized tomography enterography (CTE) for Crohn's disease (CD) are scarce.



The aim of this study was to prospectively compare the sensitivity, specificity, and accuracy of abdominal MRE and CTE to assess disease activity and complications (fistulas, strictures) in ileocolonic CD. A total of 44 patients (23 male; 21 female; mean age 44) with ileocolonic CD underwent both MR and CT in a short time interval (mean 5 days). A 16-slice CT with intravenous contrast and an MRI with oral and paramagnetic intravenous contrast were performed. Ileocolonoscopy was used as the reference standard. Sensitivity values of CT and MR for detection of extraenteric signs of disease were compared with the McNemar test, with results of imaging studies, surgery, and physical examination as reference standards.



No significant differences in sensitivity, specificity, and accuracy were observed between MRE and CTE regarding the following parameters at the patient level: localization of CD (P = 1.0), bowel wall thickening (P = 1.0), bowel wall enhancement (P = 1.0), enteroenteric fistulas (P = 0.08), detection of abdominal nodes (P = 1.0), and perivisceral fat enhancement (P = 0.31). MR was significantly superior compared to CT in detecting strictures (P = 0.04). Per segment analysis showed that MRE was significantly superior to CTE in detecting ileal wall enhancement (P = 0.02).



MR and CT are equally accurate to assess disease activity and bowel damage in CD. MR may be superior to CT in detecting intestinal strictures and ileal wall enhancement. MR may represent an alternative technique to CT in assessing ileocolonic CD.
Epilepsy patients treated with vigabatrin exhibit reduced ocular blood flow.

Reduced cerebral blood flow and decreased glucose metabolism have been identified in epilepsy patients receiving vigabatrin. It is likely that such a change may extend to the eye and may be linked to previously reported irreversible visual field defects. The aim of this study was to determine whether patients who have undergone anti-epileptic drug (AED) therapy with vigabatrin have altered ocular haemodynamics.



The study cohort comprised 11 normal subjects (mean age 42.6 (SD 12.7) years and 17 epilepsy patients, of which 10 were either currently or previously treated with vigabatrin (38.6 (11.7) years) and seven were treated with AEDs excluding vigabatrin (46.0 (9.8) years). The three groups were matched at baseline for pulse rate, diastolic and systolic blood pressure, and intraocular pressure (IOP). At a single visit, the ocular blood flow analyser (OBFA; Paradigm Medical Instruments Inc, UT, USA) was used to measure pulsatile ocular blood flow (POBF) and pulse amplitude (PA) in each eye of all subjects. One way ANCOVA (with age as a covariate) was used to identify differences in POBF and PA between the groups. For the vigabatrin group only, Pearson's product moment correlation coefficient was used to explore potential interactions between ocular blood flow parameters and cumulative vigabatrin dose, duration, and maximum dose.



Both the vigabatrin treated epilepsy group and conventionally treated epilepsy group exhibited significantly reduced POBF (p=<0.001, p=0.040) and PA (p=<0.001, p=0.005) compared to normal subjects. Patients treated with vigabatrin exhibited a further reduction in POBF (p=0.046) and PA (p=0.034) compared to conventionally treated epilepsy patients. No significant correlations were found between drug dosage and POBF and PA for the vigabatrin treated epilepsy group.



A significant reduction in POBF and PA is apparent in epilepsy patients treated with AEDs when compared to normal subjects. A further reduction in POBF and PA is apparent between vigabatrin treated and conventionally treated patients. The reduction in ocular perfusion, which is more pronounced in patients previously treated with vigabatrin, may have implications in the impairment of visual function associated with the drug.
Impact of revisions of the JSCCR guidelines on the treatment of T1 colorectal carcinomas in Japan.

In 1977, the Japanese Society for Cancer of the Colon and Rectum (JSCCR) published the first edition of the general guidelines that described how to record clinical and histopathological findings of colorectal carcinomas (CRCs) and how to treat these cancers, and since then, the guidelines were revised several times. The aim of this study was to examine the impact of the revisions of the JSCCR guidelines on the treatment of submucosal CRCs (T1-CRCs) in Japanese clinical settings.



Questionnaires were sent to all 391 member institutions of the JSCCR. The questionnaires consisted of 2 parts: details of the institutions and treatment strategies for T1-CRCs.



73 (19 %) institutions responded to the survey. The number of treated T1-CRCs has increased year by year, and the rate of endoscopic resection for T1-CRCs has significantly increased with revisions of the guidelines (1417 [47 %] of 2985 T1-CRCs in 2003 - 2005, 2110 [50 %] of 4212 in 2006 - 2008, and 2546 [54 %] of 4686 in 2009 - 2011, P<.05).



The revisions of the JSCCR guidelines have influenced the treatment of T1-CRCs in Japanese clinical settings. There is room to revise the criteria for curative endoscopic resection to avoid unnecessary surgeries.
Extended Release Nicotinic Acid – A Novel Oral Agent for Phosphate Control

Hyperphosphatemia is common in hemodialysis patients. Recent animal studies show that nicotinamide inhibits the sodium dependent phosphate co-transport in the small intestine and thereby reduces serum phosphorus levels. Nicotinic acid which is the prodrug of nicotinamide is widely used as antihyperlipidemic agent. We examined in a prospective study whether it reduces serum phosphorus levels in hemodialysis patients.  Patients who were on maintenance hemodialysis were enrolled in to the study if their predialysis serum phosphorus was more than 6 mg/dl. During the pre-trial run in period of 1 week all phosphate binders were stopped. A single dose of extended release nicotinic acid (375 mg) tablet was given with meal. Repeat measurements of serum calcium, phosphorus and alkaline phosphatase were carried out after 8 weeks. Then the drug was stopped in a subgroup of patients and serum phosphorus remeasured after 2 weeks.  There were 34 patients with varied etiological spectrum of end stage renal disease. They were on hemodialysis for a mean period of 8.7 months. Serum phosphorus levels changed significantly from a pre treatment level of 7.7±1.5 mg/dl to post treatment level of 5.6 ±1 mg/dl (p<0.001). There was no significant variance across age groups, sex, disease categories and dialysis duration. The calcium level increased from 8.1±1.0 to 8.5±1.0 mg/dl (p<0.015). The serum alkaline phosphatase level decreased significantly from 107±66 IU/l to 82±46 IU/l (p<0.001 ). There was a significant reduction of calcium phosphate product from 63.1+15.1 mg2 to 48.7±10.9 mg2/dl2 (p<0.001). Oral nicotinic acid was well tolerated. Mild pruritus was encountered in 2 patients.  Oral nicotinic acid may emerge as a safe, low cost yet powerful agent for phosphorus control in dialysis patients.
Cultural adaptation into Spanish of the generalized anxiety disorder-7 (GAD-7) scale as a screening tool

Generalized anxiety disorder (GAD) is a prevalent mental health condition which is underestimated worldwide. This study carried out the cultural adaptation into Spanish of the 7-item self-administered GAD-7 scale, which is used to identify probable patients with GAD.



The adaptation was performed by an expert panel using a conceptual equivalence process, including forward and backward translations in duplicate. Content validity was assessed by interrater agreement. Criteria validity was explored using ROC curve analysis, and sensitivity, specificity, predictive positive value and negative value for different cut-off values were determined. Concurrent validity was also explored using the HAM-A, HADS, and WHO-DAS-II scales.



The study sample consisted of 212 subjects (106 patients with GAD) with a mean age of 50.38 years (SD = 16.76). Average completion time was 2'30''. No items of the scale were left blank. Floor and ceiling effects were negligible. No patients with GAD had to be assisted to fill in the questionnaire. The scale was shown to be one-dimensional through factor analysis (explained variance = 72%). A cut-off point of 10 showed adequate values of sensitivity (86.8%) and specificity (93.4%), with AUC being statistically significant [AUC = 0.957-0.985); p < 0.001]. The scale significantly correlated with HAM-A (0.852, p < 0.001), HADS (anxiety domain, 0.903, p < 0.001), and WHO-DAS II (0.696, p > 0.001).



Elderly people, particularly those very old, may need some help to complete the scale.



After the cultural adaptation process, a Spanish version of the GAD-7 scale was obtained. The validity of its content and the relevance and adequacy of items in the Spanish cultural context were confirmed.
Treatment of acrophobia in virtual reality: the role of immersion and presence.

In this study the effects of virtual reality exposure therapy (VRET) were investigated in patients with acrophobia. Feelings of presence in VRET were systematically varied by using either a head-mounted display (HMD) (low presence) or a computer automatic virtual environment (CAVE) (high presence). VRET in general was found to be more effective than no treatment. No differences were found in effectiveness between VRET using an HMD or CAVE. Results were maintained at 6 months follow-up. Results of VRET were comparable with those of exposure in vivo (Cyberpsychology and Behavior 4 (2001) 335). In treatment completers no relationship was found between presence and anxiety. Early drop-outs experienced less acrophobic complaints and psychopathology in general at pre-test. They also experienced less presence and anxiety in the virtual environment used in session one as compared to patients that completed VRET.
Higher serum creatinine concentrations in black patients with chronic kidney disease: beyond nutritional status and body composition.

Serum creatinine concentrations tend to be higher in black than white individuals and people of other races or ethnicities. These differences have been assumed to be largely related to race-related differences in body composition, especially muscle mass.



In a diverse population of hemodialysis patients, we compared mean serum creatinine concentrations in black versus nonblack patients, adjusting for case mix (age, gender, diabetes, and dialysis vintage), body size (height, weight), laboratory parameters of nutritional status (albumin, predialysis blood urea nitrogen, transferrin, phosphorus, glucose), dialysis dosage (urea reduction ratio), and parameters of bioelectrical impedance (resistance and reactance), proxies for body composition.



Adjusted mean serum creatinine concentrations were significantly higher in black versus nonblack patients (11.7 versus 10.0 mg/dl; P < 0.0001). Black patients were roughly four-fold more likely to have a serum creatinine concentration >10 mg/dl and six-fold more likely to have a serum creatinine concentration >15 mg/dl. Higher serum creatinine concentrations were associated with a lower relative risk for death (0.93; 95% confidence interval 0.88 to 0.98 per mg/dl); the association was slightly more pronounced among nonblack patients.



Serum creatinine concentrations are significantly higher in black compared with nonblack hemodialysis patients; these differences are not readily explained by differences in nutritional status or body composition.
A randomized clinical trial of an individualized home-based exercise programme for women with fibromyalgia.

To determine the efficacy of a 12-week individualized home-based exercise programme on physical functioning, pain severity and psychological distress for women with fibromyalgia (FM).



Seventy-nine women with a primary diagnosis of FM were randomized to a 12-week individualized home-based moderate-intensity exercise programme or to a usual care control group. Outcomes were functional capacity (Fibromyalgia Impact Questionnaire), pain severity and psychological distress. Outcomes were measured at study entry, at the end of the 12-week intervention, and at 3 and 9 months following completion of the intervention.



On the basis of intention-to-treat analyses, a significant improvement in functional capacity at 3 and 9 months following treatment for participants in the exercise group who were more functionally disabled at study entry was observed. At both 3 and 9 months post-treatment, the mean estimated benefit of the intervention was more than 10 points [-12.3 (95% CI, -21.9 to -2.8); -10.8 (95% CI, -21.5 to -0.2)]. Compared with the control group, statistically significant improvements in upper body pain were evident in the exercise group at post-treatment. These between-group differences in upper body pain were maintained at 3 and 9 months post-treatment. No statistically significant group differences on lower body pain and psychological distress were found.



Home-based exercise, a relatively low-cost treatment modality, has the potential to improve important health outcomes in FM.
Randomized Controlled Study Investigating Viral Suppression and Serological Response following PreS 1 / PreS 2 / S Vaccine Therapy Combined with Lamivudine Treatment in HBeAg-Positive Patients with Chronic Hepatitis B

Randomized Controlled Study Investigating Viral Suppression and Serological Response following Pre-S1/Pre-S2/S Vaccine Therapy Combined with Lamivudine Treatment in HBeAg-Positive Patients with Chronic Hepatitis B Pham Thi Le Hoa,* Nguyen Tien Huy, Le The Thu, Cao Ngoc Nga, Kazuhiko Nakao, Katsumi Eguchi, Nguyen Huu Chi, Bui Huu Hoang, and Kenji Hirayama* Department of Infectious Diseases and Department of Internal Medicine, University of Medicine and Pharmacy at Ho Chi Minh City, and The Hospital for Tropical Diseases, Ho Chi Minh City, and University of Medicine at Can Tho City, Can Tho City, Vietnam, and Department of Immunogenetics, Institute of Tropical Medicine (NEKKEN), Department of Internal Medicine, and Center for International Collaborative Research, Nagasaki University, 1-12-4 Sakamoto, Nagasaki 852-8523, and Global COE Program, Nagasaki University, Nagasaki, Japan
Comparison of antianginal actions of verapamil and propranolol.

Verapamil is a slow calcium channel blocker that has been in clinical use for almost 20 years as an antiarrhythmic agent. It also has an antianginal action,' but inconsistent results have been obtained in clinical trials owing to insufficient dosage.2 We found that the drug produced a significant decrease in the number of anginal attacks and the consumption of glyceryl trinitrate with improvement in exercise tolerance and ST changes when used in a dose of 360 mg  We have now compared the potency and mode of action of verapamil with those of propranolol, a standard beta-adrenergicreceptor-blocking drug, using fixed high doses of each.
Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT)

Advanced cancer patients experience considerable symptoms, problems, and needs. Early referral of these patients to specialized palliative care (SPC) could offer improvements. The Danish Palliative Care Trial (DanPaCT) investigates whether patients with metastatic cancer will benefit from being referred to 'early SPC'. DanPaCT is a multicenter, parallel-group, superiority clinical trial with 1:1 randomization. The planned sample size was 300 patients. The primary data collection for DanPaCT is finished. To prevent outcome reporting bias, selective reporting, and data-driven results, we present a detailed statistical analysis plan (SAP) for DanPaCT here.



This SAP provides detailed descriptions of the statistical analyses of the primary and secondary outcomes in DanPaCT. The primary outcome is the change in the patient's 'primary need'. The 'primary need' is a patient-individualised outcome representing the score of the symptom or problem that had the highest intensity out of seven at baseline assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Secondary outcomes are the seven scales that are represented in the primary outcome, but each scale evaluated individually for all patients, and survival. The detailed description includes chosen significance levels, models for multiple imputations, sensitivity analyses and blinding. In addition, we discuss the patient-individualized primary outcome, blinding, missing data, multiplicity and the risk of bias.



Only few trials have investigated the effects of SPC. To our knowledge DanPaCT is the first trial to investigate screening based 'early SPC' for patients with metastatic cancer from a broad spectrum of cancer diagnosis.


May 2011).
Bisphenol A in Chronic Kidney Disease

Phenols are uremic toxins of intestinal origin formed by bacteria during protein metabolism. Of these molecules, p-cresol is the most studied and has been associated with renal function impairment and vascular damage. Bisphenol A (BPA) is a molecule with structural similarity with phenols found in plastic food and beverage containers as well as in some dialyzers. BPA is considered an environmental toxicant based on animal and cell culture studies. Japanese authorities recently banned BPA use in baby bottles based on observational association studies in newborns. BPA is excreted in urine and uremic patients present higher serum levels, but there is insufficient evidence to set cut-off levels or to link BPA to any harmful effect in CKD. However, the renal elimination and potential exposure during dialysis warrant the monitoring of BPA exposure and the design of observational studies in which the potential health risks of BPA for end-stage renal disease patients are evaluated.
Impact of in-stent minimal lumen area at 9 months poststent implantation on 3-year target lesion revascularization-free survival: a serial intravascular ultrasound analysis from the TAXUS IV, V, and VI trials.

Intravascular ultrasound (IVUS) is used to assess intermediate lesions in native coronary arteries; minimum lumen area (MLA) <4.0 mm(2) is accepted as a cutoff for a significant stenosis. We evaluated the IVUS in-stent MLA at 9-month follow-up that best predicted subsequent target lesion revascularization (TLR)-free survival in patients from the TAXUS IV, V, and VI studies.



In the combined TAXUS IV, V, and VI randomized trials, 9-month IVUS was available in 635 patients (331 treated with paclitaxel-eluting stents [PES] and 304 treated with bare-metal stents [BMS]) who did not require TLR in the first 9 months postintervention and who were followed for 3 years. The in-stent MLA that best predicted 3-year TLR-free survival was determined. At 9-months follow-up, IVUS-measured in-stent MLA was 5.7 + or -2.3 mm(2) in the PES group and 4.8 + or - 2.3 mm(2) in the BMS group. Between 9 months and 3 years, TLR was required in 4.9% of patients who were treated with PES and 6.7% of patients who were treated with BMS. Multivariate analysis identified MLA at 9 months as a significant predictor of late TLR (hazard ratio, 0.63 [0.43-0.93]; P = 0.02). The ability of MLA to predict late TLR was further assessed using receiver operating characteristic analysis. MLA was found to be an acceptable discriminator for both PES (c = 0.7448) and BMS (c = 0.7329). Finally, the optimal thresholds of MLA that best predicted subsequent TLR-free survival were determined to be 4.2 mm(2) for PES and 4.0 mm(2) for BMS.



In the combined IVUS analysis of TAXUS IV, V, and VI, patients who did not require TLR within the first 9 months had a high subsequent TLR-free survival rate whether treated with PES or BMS. MLA measured by IVUS at 9 months predicted subsequent TLR with a cutoff similar to intermediate, de novo lesions in native coronary arteries.
Single-ring ablation compared with standard circumferential pulmonary vein isolation using remote magnetic catheter navigation

In ablation of atrial fibrillation, the single-ring method aims for isolation of the posterior wall of the left atrium (LA) including the pulmonary veins (PVs) but avoiding posterior LA lesions. The aim of this randomized prospective study was to evaluate safety and efficacy of remote magnetic navigation (RMN)-guided single-ring ablation strategy as compared to standard RMN-guided circumferential PV ablation (PVA). Eighty consecutive patients undergoing PVA were enrolled prospectively and randomized equally into two study groups. RMN using the Stereotaxis system and open-irrigated 3.5-mm ablation catheters were used with a 3D mapping system in all procedures. Forty patients underwent RMN-guided single-ring ablation, and 40 patients received RMN-guided circumferential PVA. In the circumferential group, 3.3 ± 1.1 PVs were successfully isolated at the end of the procedure as compared to 3.1 ± 1.3 in the single-ring (box) group (p = 0.38). All patients in the box group required additional posterior lesions in order to achieve electrical isolation of the PVs. Single-ring ablation was associated with longer procedure duration (p = 0.01) and ablation time (p = 0.001). After a single procedure, the proportion of patients free of any atrial tachycardia (AT)/atrial fibrillation (AF) episode at 12-month follow-up was 57 % in the box group and 58 % in the circ group. Using RMN, only minor complications have been observed. RMN-guided single-ring PVA provides comparable acute and long-term success rates as compared to RMN-guided circumferential PVA but requires additional posterior lesions to achieve PV isolation and increased procedure and ablation time. Procedural complication rates are low when using RMN.
A prospective cohort study of surgical treatment for back pain with degenerated discs; study protocol

The diagnosis of discogenic back pain often leads to spinal fusion surgery and may partly explain the recent rapid increase in lumbar fusion operations in the United States. Little is known about how patients undergoing lumbar fusion compare in preoperative physical and psychological function to patients who have degenerative discs, but receive only non-surgical care.



Our group is implementing a multi-center prospective cohort study to compare patients with presumed discogenic pain who undergo lumbar fusion with those who have non-surgical care. We identify patients with predominant low back pain lasting at least six months, one or two-level disc degeneration confirmed by imaging, and a normal neurological exam. Patients are classified as surgical or non-surgical based on the treatment they receive during the six months following study enrollment.



Three hundred patients discogenic low back pain will be followed in a prospective cohort study for two years. The primary outcome measure is the Modified Roland-Morris Disability Questionnaire at 24-months. We also evaluate several other dimensions of outcome, including pain, functional status, psychological distress, general well-being, and role disability.



The primary aim of this prospective cohort study is to better define the outcomes of lumbar fusion for discogenic back pain as it is practiced in the United States. We additionally aim to identify characteristics that result in better patient selection for surgery. Potential predictors include demographics, work and disability compensation status, initial symptom severity and duration, imaging results, functional status, and psychological distress.