nils-herrmann/clean_scirepeval huggingface dataset:
99mTc(CO)3(NTA) and 131I-OIH: comparable plasma clearances in patients with chronic kidney disease.

The pharmacokinetics of the tricarbonyl core radiopharmaceutical (99m)Tc(CO)3-nitrilotriacetic acid ((99m)Tc(CO)3(NTA)) in rats and subjects with normal renal function are comparable to those of (131)I-o-iodohippuran ((131)I-OIH), the radiopharmaceutical gold standard for the measurement of effective renal plasma flow. Our objective was to compare the pharmacokinetics of these 2 tracers in subjects with renal failure.



(99m)Tc(CO)3(NTA) was prepared with commercially available NTA and a commercially available labeling kit and isolated by reversed-phase high-performance liquid chromatography. Approximately 74 MBq (2.0 mCi) of (99m)Tc(CO)3(NTA) were coinjected with approximately 11.1 MBq (300 μCi) of (131)I-OIH in 8 subjects with stage 3-4 renal failure; simultaneous images were obtained for 24 min, followed by an anterior image over the gallbladder and abdomen. Plasma clearances were determined from 10 blood samples obtained 3-180 min after injection using the single-injection, 2-compartment model. Plasma protein binding, red cell uptake, and percentage injected dose in the urine at 30 and 180 min were determined.



There was no difference in the plasma clearances of (99m)Tc(CO)3(NTA) and (131)I-OIH (177 ± 63 vs. 171 ± 66 mL/min/1.73 m(2), respectively) (P = 0.41). The plasma protein binding and red cell uptake of (99m)Tc(CO)3(NTA) were 35% ± 7% and 6% ± 3%, respectively; both values were significantly lower than the plasma protein binding (71% ± 5%) and red cell uptake (16% ± 2%) of (131)I-OIH (P < 0.001). There was no significant difference in the percentage injected dose in the urine at 30 min (P = 0.24) and at 3 h (P = 0.82); for comparison, the percentage dose in the urine at 3 h was 77% ± 9% for (99m)Tc(CO)3(NTA) and 78% ± 11% for (131)I-OIH. Image quality with (99m)Tc(CO)3(NTA) was excellent and no activity was identified in the gallbladder or intestine.



Results in patients with renal failure show the clearance and rate of urine excretion of (99m)Tc(CO)3(NTA) to be equivalent to that of (131)I-OIH.
Cost-effectiveness of orlistat for the treatment of overweight and obese patients in Ireland

To assess the cost-effectiveness of orlistat plus a calorie-controlled diet compared with a calorie-controlled diet alone for the treatment of overweight and obese patients in Ireland.Economic modelling techniques using published international efficacy data and Irish cost data were used to estimate the cost-effectiveness of orlistat in obese patients when only responders to treatment (ie achieve 5% weight loss after 3 months of treatment) continue orlistat after 3 months. The model incorporated known relationships between weight loss and quality of life (utility) gain, and weight loss and reduction in risk of type 2 diabetes (T2DM) to predict the impact of weight loss on quality-adjusted-life-years (QALYs) gained and on the onset of T2DM. The costs associated with each treatment arm included the acquisition cost of orlistat, cost of a calorie-controlled dietary programme and monitoring and treatment costs associated with T2DM. An Irish health-care perspective was taken for the analysis, based on 2003 costs.Weight loss data on 1386 patients from five pivotal orlistat clinical trials with at least 12 months duration were pooled (two American and three primarily European studies). All the studies were randomized, placebo-controlled, multicentre trials with a similar design. The inclusion criteria were BMI ≥28 kg / m2, age ≥18 y, no diagnosed T2DM and the ability to lose 2.5 kg in weight during the introductory period.Cost effectiveness was modelled from these data and presented as incremental cost per When orlistat treatment plus a calorie-controlled diet was compared with a calorie-controlled diet alone, the incremental cost per year was [euro ]478. The number needed to treat (NNT) to gain one QALY was estimated to be 35. The incremental cost per QALY gained was within the range considered cost-effective at [euro ]16 954. Sensitivity analysis demonstrated an incremental cost per QALY of [euro ]11 000–35 000 under a variety of assumptions.Our model suggests that orlistat is effective and cost-effective in obese patients, if after 3 months of treatment, only treatment responders continue treatment.
Seasonal variations in glycemic control of type 2 diabetes in Korean women.

Seasonal variations in lifestyle, such as food intake and physical activity, have been reported. Glycemic control in type 2 diabetes mellitus (T2DM) may be affected by such changes. We investigated seasonal variations in glycemic control, food intake, and physical activity in type 2 diabetic patients.



This prospective observational study included 37 Korean female patients who had <8.0 % hemoglobin A1c (HbA1c) and managed diabetes by oral anti-diabetic drugs or lifestyle modification only. Participants underwent four or five assessments, including total physical activity (household, leisure-time, and occupational activity) (metabolic equivalent of test-h/day), food intake (kcal/day), HbA1c, and anthropometry every 3 months (August, November, February, May, and August in the Northern Hemisphere) over 1 year. When anti-diabetic drugs were changed, we analyzed the data just before the changes.



The mean HbA1c levels (%) of August and November in 2008, and February, May, and August in 2009 were 7.0 ± 0.1, 6.9 ± 0.1, 7.2 ± 0.2, 7.4 ± 0.2, and 7.2 ± 0.2, respectively (P = 0.018). The change of HbA1c was nearly 0.5 % for the 1-year period. From August to May of the following year, there were also seasonal variations in food intake (1,872 ± 143, 1,739 ± 97, 1,673 ± 86, 1,561 ± 132, respectively; P = 0.013), and total physical activity [7.7 (3.7-14.6), 6.3 (2.8-10.4), 5.1 (2.7-12.6), and 11.2 (4.7-20.5), respectively; P = 0.048]. However, the seasonal variations of HbA1c and total physical activity became non-significant when farmers were excluded.



These data suggested that glycemic control, total physical activity, and food intake varied seasonally in Korean T2DM patients. These seasonal variations should be considered in education for glycemic control.
Postdiskogram CT features of lidocaine-sensitive and lidocaine-insensitive severely painful disks at provocation lumbar diskography.

At lumbar diskography, intradiskal lidocaine can eliminate or reduce provoked diskogenic pain. The purpose of this study was to evaluate the postdiskogram CT features of lidocaine-sensitive and lidocaine-insensitive severely painful disks.



Intradiskal lidocaine was injected at 182 severely painful levels in 111 patients. Clinical records/imaging studies were reviewed for response to intradiskal lidocaine (complete/substantial, partial, and no pain improvement), evidence of diskographic contrast leakage (fluoroscopic/CT images), and the overall postdiskogram CT appearance in these severely painful disks. The assessed traditional Dallas grade (degeneration/radial tear [RT]) was supplemented by identified postdiskogram CT features of annular derangement (annular gap [AG], RT into peripheral annular tear [PAT], isolated PAT, lamellar annular tear, free/attached annular fragments, bucket-handle tear, and peripheral annular pocket).



Isolated degenerative changes (40%) and radial defects with or without degeneration (60%) subsets were noted. Dallas grade 3 degeneration was most commonly observed (69%) with increased features of annular derangement in disks with a worsening Dallas grade. Complete/substantial versus no pain improvement was significantly associated with disk state (diskographic leakage, contained), radial defect (none, RT, or AG), and "RT-into-PAT" and were statistically significant in univariate models (P < .001). The associations remained significant in multivariate models. Higher Dallas degenerative grade and presence of free annular fragments were associated with a greater chance of no pain relief.



Severely painful disks demonstrated complex annular derangement with both radial defects (RTs and AGs) or degenerative changes present, alone or in combination. Complete/substantial pain improvement after lidocaine administration is associated with disk state, radial defect (RT and AG), and RT-into-PAT.
Asymmetric dimethylarginine predicts survival in the elderly

Asymmetric dimethylarginine (ADMA) is an endogenous inhibitor of nitric oxide synthase implicated in several age-related biological mechanisms such as telomere shortening and cell senescence. We tested the hypothesis that ADMA blood level is an independent predictor of mortality in elderly. This is a longitudinal population-based cohort study. Participants are a representative cohort of 1,025 men and women (age range 65–102 years) living in Chianti area, Tuscany, Italy. The plasma ADMA was measured by liquid chromatography–tandem mass spectrometry. During the follow-up (95 ± 32 months), 384 individuals died, of whom 141 (37 %) died of cardiovascular (CV) causes. In adjusted analyses, the plasma ADMA was the strongest predictor of all-cause mortality (HR (0.1 μMol/L) 1.26, 95 % CI 1.10–1.44, P < 0.001) with a non-significant trend for CV mortality (HR 1.22, P = 0.07). The predictive effect of the ADMA level on mortality was statistically significant among participants with low to low-normal l-arginine levels (≤60 μMol/L), but not in those with l-arginine >60 μMol/L. Notwithstanding the association of ADMA with all-cause mortality was robust, this biomarker failed to add predictive power to a simple model based on the risk factors in the elderly (area under the ROC curve 0.85 ± 0.01 vs. 0.84 ± 0.01). ADMA is a strong independent predictor of mortality in the older population, and l-arginine modifies the effect of ADMA on survival. The mechanisms for this association should be targeted by future studies.
Autologous nonmyeloablative hematopoietic stem cell transplantation in newly diagnosed type 1 diabetes mellitus.

Type 1 diabetes mellitus (DM) results from a cell-mediated autoimmune attack against pancreatic beta cells. Previous animal and clinical studies suggest that moderate immunosuppression in newly diagnosed type 1 DM can prevent further loss of insulin production and can reduce insulin needs.



To determine the safety and metabolic effects of high-dose immunosuppression followed by autologous nonmyeloablative hematopoietic stem cell transplantation (AHST) in newly diagnosed type 1 DM.



A prospective phase 1/2 study of 15 patients with type 1 DM (aged 14-31 years) diagnosed within the previous 6 weeks by clinical findings and hyperglycemia and confirmed with positive antibodies against glutamic acid decarboxylase. Enrollment was November 2003-July 2006 with observation until February 2007 at the Bone Marrow Transplantation Unit of the School of Medicine of Ribeirão Preto, Ribeirão Preto, Brazil. Patients with previous diabetic ketoacidosis were excluded after the first patient with diabetic ketoacidosis failed to benefit from AHST. Hematopoietic stem cells were mobilized with cyclophosphamide (2.0 g/m2) and granulocyte colony-stimulating factor (10 microg/kg per day) and then collected from peripheral blood by leukapheresis and cryopreserved. The cells were injected intravenously after conditioning with cyclophosphamide (200 mg/kg) and rabbit antithymocyte globulin (4.5 mg/kg).



Morbidity and mortality from transplantation and temporal changes in exogenous insulin requirements (daily dose and duration of usage). Secondary end points: serum levels of hemoglobin A1c, C-peptide levels during the mixed-meal tolerance test, and anti-glutamic acid decarboxylase antibody titers measured before and at different times following AHST.



During a 7- to 36-month follow-up (mean 18.8), 14 patients became insulin-free (1 for 35 months, 4 for at least 21 months, 7 for at least 6 months; and 2 with late response were insulin-free for 1 and 5 months, respectively). Among those, 1 patient resumed insulin use 1 year after AHST. At 6 months after AHST, mean total area under the C-peptide response curve was significantly greater than the pretreatment values, and at 12 and 24 months it did not change. Anti-glutamic acid decarboxylase antibody levels decreased after 6 months and stabilized at 12 and 24 months. Serum levels of hemoglobin A(1c) were maintained at less than 7% in 13 of 14 patients. The only acute severe adverse effect was culture-negative bilateral pneumonia in 1 patient and late endocrine dysfunction (hypothyroidism or hypogonadism) in 2 others. There was no mortality.



High-dose immunosuppression and AHST were performed with acceptable toxicity in a small number of patients with newly diagnosed type 1 DM. With AHST, beta cell function was increased in all but 1 patient and induced prolonged insulin independence in the majority of the patients.
Efficacy and toxicities of concurrent chemoradiation for elderly patients with esophageal cancer.

To evaluate the efficacy and toxicity of concurrent chemoradiation in patients with esophageal cancer aged 75 and older.



Twenty-two elderly patients were treated with concurrent chemoradiation. Seventeen received a combination of cisplatin/carboplatin and 5-fluorouracil, 5 received daily 5-fluorouracil. Total doses of radiotherapy ranged from 50 to 65 Gy.



Nineteen out of 22 patients completed the planned chemoradiation. Five in 8 patients (63%) with T1-2 lesion and 1 in 14 patients (7o%) with T3-4 lesion achieved complete response (p=0.011). Only 2 patients experienced grade 3 toxicities. Grade 2 or worse hematological toxicities were less frequently observed in patients who received local-field radiotherapy (p=0.006). There was no isolated lymph node recurrence. The median survival time was 9 months.



This study showed the potential for chemoradiation in elderly patients. A planning target volume of radiotherapy should include only clinically involved lesions in this setting.
Esophageal dysphagia and reflux symptoms before and after oral IQoro(R) training.

To examine whether muscle training with an oral IQoro(R) screen (IQS) improves esophageal dysphagia and reflux symptoms.



A total of 43 adult patients (21 women and 22 men) were consecutively referred to a swallowing center for the treatment and investigation of long-lasting nonstenotic esophageal dysphagia. Hiatal hernia was confirmed by radiologic examination in 21 patients before enrollment in the study (group A; median age 52 years, range: 19-85 years). No hiatal hernia was detected by radiologic examination in the remaining 22 patients (group B; median age 57 years, range: 22-85 years). Before and after training with an oral IQS for 6-8 mo, the patients were evaluated using a symptom questionnaire (esophageal dysphagia and acid chest symptoms; score 0-3), visual analogue scale (ability to swallow food: score 0-100), lip force test (≥ 15 N), velopharyngeal closure test (≥ 10 s), orofacial motor tests, and an oral sensory test. Another twelve patients (median age 53 years, range: 22-68 years) with hiatal hernia were evaluated using oral IQS traction maneuvers with pressure recordings of the upper esophageal sphincter and hiatus canal as assessed by high-resolution manometry.



Esophageal dysphagia was present in all 43 patients at entry, and 98% of patients showed improvement after IQS training [mean score (range): 2.5 (1-3) vs 0.9 (0-2), P < 0.001]. Symptoms of reflux were reported before training in 86% of the patients who showed improvement at follow-up [1.7 (0-3) vs 0.5 (0-2), P < 0.001). The visual analogue scale scores were classified as pathologic in all 43 patients, and 100% showed improvement after IQS training [71 (30-100) vs 22 (0-50), P < 0.001]. No significant difference in symptom frequency was found between groups A and B before or after IQS training. The lip force test [31 N (12-80 N) vs 54 N (27-116), P < 0.001] and velopharyngeal closure test values [28 s (5-74 s) vs 34 s (13-80 s), P < 0.001] were significantly higher after IQS training. The oral IQS traction results showed an increase in mean pressure in the diaphragmatic hiatus region from 0 mmHg at rest (range: 0-0 mmHG) to 65 mmHg (range: 20-100 mmHg).



Oral IQS training can relieve/improve esophageal dysphagia and reflux symptoms in adults, likely due to improved hiatal competence.
Golimumab, a new human anti-tumor necrosis factor alpha antibody, administered intravenously in patients with active rheumatoid arthritis: Forty-eight-week efficacy and safety results of a phase III randomized, double-blind, placebo-controlled study.

To assess the efficacy and safety of intravenous administration of golimumab in patients with rheumatoid arthritis (RA).



Adult patients with RA in whom disease activity was persistent despite treatment with methotrexate (MTX) at a dosage of 15-25 mg/week for > or = 4 weeks were randomized to receive intravenous infusions of placebo plus MTX or intravenous infusions of golimumab at a dose of 2 mg/kg or 4 mg/kg, with or without MTX, every 12 weeks through week 48. Patients with <20% improvement in the swollen and tender joint counts could enter early escape and receive additional active treatment (week 16) or could have their dose regimen adjusted (week 24). The primary end point was the proportion of patients achieving a 50% response according to the American College of Rheumatology improvement criteria (ACR50) at week 14.



The primary study end point was not met (at week 14, an ACR50 response was observed in 21% of the patients treated with golimumab plus MTX compared with 13% of the patients treated with placebo plus MTX [P = 0.051]). By week 24, significantly more patients treated with golimumab plus MTX had achieved an ACR50 response. Differences in the proportion of patients achieving an ACR50 response between the group receiving golimumab monotherapy and the group receiving placebo plus MTX were not significant at either week 14 (16% versus 13%) or week 24 (10% versus 9%). At week 48, the proportions of patients achieving ACR20 and ACR50 responses were highest among those who had received golimumab 4 mg/kg plus MTX (70% and 48%, respectively). Concomitant treatment with MTX was associated with a lower incidence of antibodies to golimumab. The most commonly reported adverse events through week 48 were infections (48% of patients treated with golimumab with or without MTX and 41% of patients receiving placebo plus MTX).



The primary end point was not met. However, intravenously administered golimumab plus MTX appears to have benefit in the longer-term reduction of RA signs/symptoms in MTX-resistant patients, with no unexpected safety concerns.
Sjörgren's syndrome treated with bromhexine: a randomised clinical study.

Existing treatment for Sjögren's syndrome is unsatisfactory, and uncontrolled observations have suggested that bromhexine may be effective. Twenty-nine patients with Sjögren's syndrome were therefore assigned to two randomised double-blind crossover trials with bromhexine and placebo, each comprising two two-week periods. In the first trial bromhexine 24 mg/day was given by mouth; in the second the dose was increased to 48 mg/day. After each treatment period the Schirmer test response, break-up time, Bijsterveld score, and the time taken for the patient to eat a dry biscuit were recorded, as well as the patient's estimate of moistness in the eyes and mouth. In the second (higher-dose) trial values on the Schirmer test were significantly higher after bromhexine than after placebo and the break-up time was also increased after bromhexine, which suggested that the drug has a dose-dependent effect on lacrimal gland secretion in Sjögren's syndrome. It had no effect on salivary gland function. Bromhexine is therefore valuable in the treatment of Sjögren's syndrome.
Fear factors: cross validation of specific phobia domains in a community-based sample of African American adults.

The current study attempted a cross-validation of specific phobia domains in a community-based sample of African American adults based on a previous model of phobia domains in a college student sample of African Americans. Subjects were 100 African American community-dwelling adults who completed the Fear Survey Schedule-Second Edition (FSS-II). Domains of fear were created using a similar procedure as the original, college sample of African American adults. A model including all of the phobia domains from the FSS-II was initially tested and resulted in poor model fit. Cross-validation was subsequently attempted through examining the original factor pattern of specific phobia domains from the college sample (Chapman, Kertz, Zurlage, & Woodruff-Borden, 2008). Data from the current, community based sample of African American adults provided poor fit to this model. The trimmed model for the current sample included the animal and social anxiety factors as in the original model. The natural environment-type specific phobia factor did not provide adequate fit for the community-based sample of African Americans. Results indicated that although different factor loading patterns of fear may exist among community-based African Americans as compared to African American college students, both animal and social fears are nearly identical in both groups, indicating a possible cultural homogeneity for phobias in African Americans. Potential explanations of these findings and future directions are discussed.
Prognostic impact of clinical variables on surgically resected small-cell lung cancer: Results of a retrospective multicenter analysis (FIGHT002A and HOT1301A).

Several American and Japanese guidelines recommend surgery for patients with c-stage I small-cell lung cancer (SCLC), whereas the European Society of Medical Oncology (ESMO) guidelines recommend surgery for patients with not only c-stage I but also c-stage II (T2N1) SCLC. In addition, previous studies identified various factors other than clinical stage that are related to survival in these patients. Thus, further validation and examination of the association of clinical stage and other clinical variables with survival are required for establishing practical management of early-stage SCLC.



We reviewed the clinical courses of 156 SCLC patients who had undergone surgery at 17 institutions between January 2003 and January 2013.



Clinical stages (tumor-node-metastasis [TNM] version 7) of the 156 patients were 98 cases in IA, 14 in IB, 16 in IIA, 7 in IIB, 18 in IIIA, and 3 in IIIB. Median overall survival (OS) was 33.3 months (95% confidence interval: 20.9-45.8). Multivariate analysis revealed that OS was longer in patients either at c-stage II and under, with a maximum tumor diameter of <20mm, with preoperative diagnosis, without a history or presence of other types of cancer, or who underwent prophylactic cranial irradiation (PCI).



These results indicate that a history or presence of other types of cancer might be a major decisive factor for surgery. Patients with c-stages I and II (c-T2N1) can be considered for surgery, and PCI may be useful in patients undergoing surgery in a practical setting, partly supporting the ESMO guidelines.(1).