nils-herrmann/clean_scirepeval huggingface dataset:
Immunogenicity of Iodine 131 chimeric tumor necrosis therapy monoclonal antibody in advanced lung cancer patients

Iodine-131 radiolabeled chimeric tumor necrosis therapy monoclonal antibody (131I-TNT) has been approved for the treatment of advanced lung cancer in China. In the present study, the immunogenicity of TNT was studied in advanced lung cancer patients using BIACORE and enzyme linked immunosorbent assay (ELISA) methods. Serum samples from 78 advanced lung cancer patients were analyzed for antibody development to TNT after systemic or intratumoral administration of two doses of 131I-TNT. Patients’ sera were obtained before, and 2 weeks and 2 months after 131I-TNT radioimmunotherapy. Four of 78 lung cancer patients (4/78 or 5.13%) developed antibodies to TNT as measured by ELISA method, and 7 of 78 patients (8.97%) development anti-TNT antibody as measured by BIACORE biosensor after 2 doses of 131I-TNT administration (P > 0.05). All the 4 ELISA-positive patients were also BIACORE-positive. Among the 7 BIACORE-positive patients, 5 (of 42, 11.9%) patients receiving intravenous TNT injection developed antibodies to TNT, and 2 (of 36, 5.56%) patients, receiving intratumoral therapy developed antibodies to TNT. The route of administration of the radiolabeled TNT antibody was not a statistically significant factor in the incidence of anti-TNT antibody. Detailed BIACORE serological analysis showed that the induced antibodies were mostly of the IgG1 subclass. 131I-TNT was immunogenic in only a small minority of advanced lung cancer patients (8.97%). The route of administration did not statistically influence the incidence of anti-TNT antibody after TNT radioimmunotherapy in lung cancer patients.
Adding saxagliptin to extended-release metformin vs. uptitrating metformin dosage.

To investigate whether patients taking metformin for type 2 diabetes mellitus (T2DM) have improved glycaemic control without compromising tolerability by adding an agent with a complementary mechanism of action vs. uptitrating metformin.



Adults with T2DM and glycated haemoglobin (HbA1c) between 7.0 and 10.5% receiving metformin extended release (XR) 1500 mg/day for ≥8 weeks were randomized to receive saxagliptin 5 mg added to metformin XR 1500 mg (n = 138) or metformin XR uptitrated to 2000 mg/day (n = 144). Endpoints were change from baseline to week 18 in HbA1c (primary), 120-min postprandial glucose (PPG), fasting plasma glucose (FPG) and the proportion of patients achieving HbA1c <7%.



At week 18, the adjusted mean reduction from baseline HbA1c was -0.88% for saxagliptin + metformin XR and -0.35% for uptitrated metformin XR (difference, -0.52%; p < 0.0001). For 120-min PPG and FPG, differences in adjusted mean change from baseline between saxagliptin + metformin XR and uptitrated metformin XR were -1.3 mmol/l (-23.32 mg/dl) (p = 0.0013) and -0.73 mmol/l (-13.18 mg/dl) (p = 0.0030), respectively. More patients achieved HbA1c <7.0% with saxagliptin + metformin XR than with uptitrated metformin XR (37.2 vs. 26.1%; p = 0.0459). The proportions of patients experiencing any adverse events (AEs) were generally similar between groups; neither group showed any notable difference in hypoglycaemia or gastrointestinal AEs.



Adding saxagliptin to metformin XR provided superior glycaemic control compared with uptitrating metformin XR without the emergence of additional safety concerns.
2-year results of paclitaxel-eluting balloons for femoropopliteal artery disease: evidence from a multicenter registry.

This study aimed to appraise 2-year outcomes after percutaneous treatment of femoropopliteal artery disease with paclitaxel-eluting balloons.



Percutaneous transluminal angioplasty with paclitaxel-eluting balloons for femoropopliteal artery disease has provided favorable 1-year results.



Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions ≤15 mm long and with 3- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter registry. Endpoints of interest included primary patency, major adverse events (the composite of death, amputation, or target lesion revascularization), changes in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life after ≥24 months.



A total of 105 patients (114 lesions) treated with paclitaxel-eluting balloons and provisional stenting were enrolled, and final procedural success was obtained in all. Follow-up after 27 ± 3 months was obtained in 98 (93.3%) patients, showing that primary patency was maintained in 71 (72.4%), and major adverse events had occurred in 17 (17.5%), with persistently significant benefits in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life (all p < 0.001). Secondary patency rate was achieved in 89 cases (84.7%).



PEBs are associated with favorable functional and clinical outcomes at 2 years in patients with femoropopliteal artery disease requiring percutaneous revascularization.
Long-Term Follow-Up and Outcome of a Large Cohort of Patients with Common Variable Immunodeficiency

Common Variable Immunodeficiency belongs to the group of rare diseases encompassing antibody deficiency syndromes of highly variable clinical presentation and outcome. The multicenter prospective study on a cohort of 224 patients with Common Variable Immunodeficiency provides an updated view of the spectrum of illnesses which occurred at the clinical onset and over a long period of follow-up (mean time: 11 years) and information on the effects of long-term immunoglobulin treatment. The mean age at the time of diagnosis was 26.6 years. Seventy-five patients were younger than 14 years of age. The mean age at the onset of symptoms was 16.9 years. This implicates with a mean diagnostic delay of 8.9 years. Respiratory tract infections were the most prominent clinical problem observed at diagnosis and during the follow-up. Intravenous immunoglobulin administration induced a significant reduction in the incidence of acute infections, mainly acute pneumonia and acute otitis. However, a progressive increase in the prevalence of patients with chronic diseases, mainly sinusitis and lung disease, was observed in all age groups, including the pediatric population. The morbidity of Common Variable Immunodeficiency due to all associated clinical conditions increased over time despite an adequate replacement with intravenous immunoglobulins. Our data stressed the need to develop international guidelines for the prevention and therapy of chronic lung disease, chronic sinusitis, chronic diarrhoea, and chronic granulomatosis in patients with humoral immunodeficiencies.
Self-help cognitive-behavioral therapy with minimal therapist contact for social phobia: a controlled trial.

Due to treatment accessibility and cost issues, interest in self-help programs (e.g., bibliotherapy, telehealth) for common psychological disorders is growing. Research supporting the efficacy of such a program for social anxiety, however, is limited. The present study examined the efficacy of an 8-week self-directed cognitive behavioral treatment with minimal therapist involvement for social phobia based on a widely available self-help book. Twenty-one adults with social phobia initially received either treatment (i.e. assigned readings in the workbook with limited therapist contact) or were wait-listed. Wait-listed patients eventually received the same self-directed treatment. Results revealed that the self-help/minimal therapist contact treatment was superior to wait-list on most outcome measures. Across the entire sample, reductions in social anxiety, global severity, general anxiety, and depression were observed at posttest and 3-month follow-up. These findings provide preliminary support for using this self-help workbook for individuals with mild to moderate social anxiety in conjunction with infrequent therapist visits to reinforce the treatment principles. Study limitations and future directions are discussed.
The Association of Coloproctology of Great Britain and Ireland study of large bowel obstruction caused by colorectal cancer.

This study was designed to investigate the early outcomes after surgical treatment of malignant large bowel obstruction (MBO) and to identify risk factors affecting operative mortality.



Data were prospectively collected from 1046 patients with MBO by 294 surgeons in 148 UK hospitals during a 12-month period from April 1998. A predictive model of in-hospital mortality was developed using a 3-level Bayesian logistic regression analysis.



The median age of patients was 73 years (interquartile range 64-80). Of the 989 patients having surgery, 91.7% underwent bowel resection with an overall mortality of 15.7%. The multilevel model used the following independent risk factors to predict mortality: age (odds ratio [OR] 1.85 per 10 year increase), American Society of Anesthesiologists grade (OR for American Society of Anesthesiologists grade I versus II,III,IV-V = 3.3,11.7,22.2), Dukes' staging (OR for Dukes' A versus B,C,D = 2.0, 2.1, 6.0), and mode of surgery (OR for scheduled versus urgent, emergency = 1.6, 2.3). A significant interhospital variability in operative mortality was evident with increasing age (variance = 0.004, SE = 0.001, P < 0.001). No detectable caseload effect was demonstrated between specialist colorectal and other general surgeons.



Using prognostic models, it was possible to develop a risk-stratification index that accurately predicted survival in patients presenting with malignant large bowel obstruction. The methodology and model for risk adjusted survival can set the reference point for more accurate and reliable comparative analysis and be used as an adjunct to the process of informed consent.
Anterior talocrural joint laxity: diagnostic accuracy of the anterior drawer test of the ankle.

Prospective, blinded, diagnostic-accuracy study.



To investigate the diagnostic accuracy of the ankle anterior drawer test (ADT) to detect anterior talocrural joint laxity in adults with a history of lateral ankle sprain.



The ADT is used to manually detect anterior talocrural joint laxity following lateral ankle sprain injury; however, the diagnostic accuracy of this test has not been established.



Sixty-six subjects with a history of lateral ankle sprain were examined with the ADT. Anterior talocrural joint laxity was measured digitally from ultrasound images of the talofibular interval during performance of the ADT. In addition, anterior talocrural joint laxity was measured digitally in 20 control subjects to establish a reference standard. ADT results were defined as "positive" or "negative," based on this and a second reference standard established from the literature.



The group with a history of lateral ankle sprain had a mean ± SD anterior talocrural joint laxity of 3.36 ± 3.25 mm, compared with 0.17 ± 1.87 mm in the control group. Thirty-five of 66 (53%) subjects demonstrated anterior talocrural joint laxity at a reference standard of 2.3 mm or greater, and 24 (36%) at a reference standard of 3.7 mm or greater. Sensitivity of the ADT was 0.74 (95% confidence interval [CI]: 0.58, 0.86) and 0.83 (95% CI: 0.64, 0.93) at the 2.3 mm or greater and 3.7 mm or greater reference standards, respectively. Specificity of the test was 0.38 (95% CI: 0.24, 0.56) and 0.40 (95% CI: 0.27, 0.56), respectively. Positive likelihood ratios were 1.2 and 1.4, whereas the negative likelihood ratios were 0.66 and 0.41, respectively.



The ADT provides limited ability to detect excessive anterior talocrural joint laxity; however, it may provide useful information when used in side-to-side ankle comparisons and in conjunction with other physical exam procedures, such as palpation.



Diagnosis, level 3b.
Antiplatelet Efficacy of Fixed-Dose Aspirin-Clopidogrel Combination in Patients with Stable Coronary Artery Disease Treated with Drug-Eluting Stent Implantation.

A fixed-dose combination (FDC) of aspirin and clopidogrel bisulfate may improve medication adherence. However, the absence of data on the relative antiplatelet efficacy of FDC and separate dual pills (SDP) of aspirin and clopidogrel in real-world patients with stable coronary artery disease is a major factor retarding clinical introduction of such an FDC.



This was a single-centre, randomized, open-label, parallel-group, non-inferiority trial. Patients who maintained a regimen of separate aspirin and clopidogrel pills for at least 1 year after drug-eluting stent implantation without adverse events were enrolled. Patients were randomly assigned to either the FDC group or the SDP group. Antiplatelet efficacy and tolerability were assessed at baseline and at 4 weeks.



Of the 93 enrolled patients, 83 (FDC group: n = 42; SDP group: n = 41) completed the study. The difference in the changes in P2Y12 percentage inhibition did not exceed the predetermined value for inferiority [mean difference -1.7; 95 % confidence interval (CI) -6.9 to 4.5, p < 0.001 for non-inferiority]. The changes from baseline to 4 weeks in P2Y12 reaction units (PRU) (mean difference 9.7 PRU, p = 0.46), maximal platelet aggregation (mean difference 2.0 %, p = 0.44) and aspirin reaction units (ARU) (mean difference -2.3 ARU, p = 0.88) did not differ significantly between the treatment groups. The tolerability of the FDC formulation was similar to that of SDP therapy (p = 0.68).



In patients with prior percutaneous coronary intervention, the antiplatelet efficacy of the aspirin/clopidogrel FDC was non-inferior to that of SDP and the tolerability of the two regimens was similar after 4 weeks of treatment.
Diminished insulin clearance during late pregnancy in patients with type I diabetes mellitus.

1. Intensive insulin treatment of patients with Type I diabetes mellitus during pregnancy is associated with a high frequency of serious hypoglycaemic events. A potential change in insulin metabolism during pregnancy may affect both the frequency and the severity of insulin-induced . In 10 patients with Type I diabetes, during the third trimester of pregnancy and 5 to 13 months after delivery, hypoglycaemia was induced by the hyperinsulinaemic hypoglycaemic clamp technique. A constant high-dose intravenous insulin infusion was administered for 150 min and arterial blood glucose was clamped at 2.2 mmol/l by counterregulation with intravenous glucose. During the experiment venous samples were collected for later analysis of free plasma insulin, whereby the metabolic clearance rate of insulin could be calculated.3. The desired blood glucose level was approached after approximately 60 min of insulin infusion. After just 30 min the insulin levels were significantly higher during pregnancy compared with after delivery. In addition, the steady-state insulin level from 90 to 150 min was significantly higher during pregnancy.4. From the steady-state insulin levels at 90 to 150 min, the metabolic clearance rate of insulin was calculated, being 24% higher after delivery.5. We conclude that there is a decreased metabolic clearance rate of insulin during pregnancy. This might be due to altered blood-flow distribution, decreased hepatic insulin extraction and relative increase in body fat during pregnancy. A decreased clearance of insulin will contribute to the risk for serious hypoglycaemic events in patients with Type I diabetes during pregnancy.
A non-interventional study of extended-release methylphenidate in the routine treatment of adolescents with ADHD: effectiveness, safety and adherence to treatment.

This multi-centre, open-label, non-interventional study evaluates effectiveness, safety and adherence to treatment of a specific extended-release methylphenidate with a 50 % immediate and a 50 % extended-release component (Medikinet(®) retard) in the clinical routine treatment of 381 adolescents with ADHD and a mean age of 14.0 ± 1.9 years. ADHD and associated psychiatric symptoms, medication status and dosage frequency, treatment adherence and adverse events were assessed at baseline and after a median treatment length with Medikinet(®) retard of 70 days. Primary outcome criterion was the change of ADHD symptom severity from baseline to endpoint according to the ADHD-KGE (German: ADHS-Klinische Gesamteinschätzung) change score. At baseline, 4.2 % of the patients were treatment naïve, 92.7 % had previously received different methylphenidate formulations and 3.1 % had received atomoxetine or amphetamine. During the study, patients received a mean daily dose of 35.7 ± 15.1 mg Medikinet(®) retard. At endpoint, in 78 % of patients, the total ADHD symptom severity was reduced, in 20.4 %, it remained unchanged and in 1.6 %, it was worsened. The mean ADHD-KGE total ADHD symptom score was reduced from 1.8 ± 0.7 (moderate) at baseline to 0.8 ± 0.5 (mild; p < 0.001) at endpoint; the mean ADHD-KGE total-associated symptom score was reduced from 1.9 ± 0.7 (moderate) at baseline to 1.0 ± 0.6 (mild; p < 0.0001) at endpoint. After the medication switch from previous methylphenidate formulation to Medikinet(®) retard, multiple dosing with ≥3 daily medication intakes was reduced from 12.9 % at baseline to 3.1 % at endpoint (p < 0.001). Adherence to treatment was improved in 37 % of patients. Most frequent adverse events were loss of appetite and gastrointestinal problems. The findings suggest that pharmacologically treated adolescents with ADHD and insufficient symptom reduction and/or treatment adherence benefit from switching to Medikinet(®) retard and that it is well tolerated when given in clinical routine care.
Algorithms for Vertical and Orthogonal L1 Linear Approximation of Points

<italic>This paper presents algorithms for approximating a set of n points by a linear function, or a line, that minimizes the L<subscrpt>1</subscrpt> norm of vertical and orthogonal distances. The algorithms find exact solutions based upon geometric properties of the problems as opposed to approximate solutions based upon existing numerical techniques. The algorithmic complexity of these problems appears not to have been investigated before our work in</italic> [9], <italic>although &Ogr;(n<supscrpt>3</supscrpt>) naive algorithms can be easily obtained based on some simple characteristics of optimal L<subscrpt>1</subscrpt> solutions. In this paper, an &Ogr;(n) optimal time algorithm for the weighted vertical L<subscrpt>1</subscrpt> problem is presented. The algorithm is based upon a modified multi-dimensional search technique which extends the applicability of the basic technique to a wider class of problems. An &Ogr;(n<supscrpt>1.5</supscrpt></italic> log<supscrpt>2</supscrpt> <italic>n) algorithm is presented for the unweighted orthogonal problem, and an &Ogr;(n<supscrpt>2</supscrpt>) algorithm is presented for the weighted problem. An</italic> &OHgr;(<italic>n</italic> log <italic>n) lower bound for the orthogonal L<subscrpt>1</subscrpt> problem is shown under a certain model of computation. Also, the complexity of solving the orthogonal L<subscrpt>1</subscrpt> problem is related to the construction of the k-belt of an arrangement of lines.</italic>
Brazilian Version of the Foot Health Status Questionnaire (FHSQ-Br): Cross-Cultural Adaptation and Evaluation of Measurement Properties

To conduct a cross-cultural adaptation of the Foot Health Status Questionnaire into Brazilian-Portuguese and to assess its measurement properties.



This instrument is an outcome measure with 10 domains with scores ranging from 0-100, worst to best, respectively. The translated instrument will improve the examinations and foot care of rheumatoid arthritis patients.



The questions were translated, back-translated, evaluated by a multidisciplinary committee and pre-tested (n = 40 rheumatoid arthritis subjects). The new version was submitted to a field test (n = 65) to evaluate measurement properties such as test-retest reliability, internal consistency and construct validity. The Health Assessment Questionnaire, Numeric Rating Scale for foot pain and Sharp/van der Heijde scores for foot X-rays were used to test the construct validity.



The cross-cultural adaptation was completed with minor wording adaptations from the original instrument. The evaluation of measurement properties showed high reliability with low variation coefficients between interviews. The alpha-Cronbach coefficients varied from 0.468 to 0.855, while correlation to the Health Assessment Questionnaire and Numeric Rating Scale was statistically significant for five out of eight domains.



Intra- and inter-observer correlations showed high reliability. Internal consistency coefficients were high for all domains, revealing higher values for less subjective domains. As for construct validity, each domain revealed correlations with a specific group of parameters according to what the domains intended to measure.



The FHSQ was cross-culturally adapted, generating a reliable, consistent, and valid instrument that is useful for evaluating foot health in patients with rheumatoid arthritis.
The Canadian National Breast Screening Study: update on breast cancer mortality.

The Canadian National Breast Screening Study (CNBSS), conducted on women age 40-49, was designed to evaluate the efficacy of combined annual mammography and physical examination of the breasts in reducing breast cancer mortality in comparison to usual care (UC) controls. From January 1980 through March 1985, 25,214 women were individually randomized to the mammography/physical exam (MP) arm and 25,216 to the UC. The integrity of the randomization has been reviewed and confirmed to be unbiased. During an average, follow-up of 10.5 years from entry (range: 8.75-13 years), 82 women died from breast cancer in the MP arm and 72 in the UC, for a rate ratio of 1.14 (95% confidence interval: 0.83-1.56). All-cause mortality was almost identical comparing the two groups; the nonsignificant excess of breast cancer deaths in the MP arm was balanced by an excess of other cancer deaths in the UC arm.
A low-fat high-carbohydrate diet supplemented with long-chain n-3 PUFA reduces the risk of the metabolic syndrome.

Dietary changes are major factor in determining cardiovascular risk. We assessed the effects of isoenergetic diets with different fat quantity and quality on the incidence and regression of the metabolic syndrome (MetS) from the LIPGENE project.



Clinical intervention study: the patients (n=337) were randomly assigned to one of four diets for 12 weeks each: two high fat diets, one rich in saturated fat (HSFA) and the other rich in monounsaturated fat (HMUFA), and two low fat diets, one high in complex carbohydrates (LFHCC) supplemented with 1.24g/day of long-chain n-3 polyunsaturated fatty acids (LFHCC n-3) and the other LFHCC diet with placebo (LFHCC).



the effects on MetS risk criteria were recorded before and after the intervention period.



An enlarged waist circumference (≥88cm for women and ≥102cm for men) was present among 95% of the participants, 88% had elevated blood pressure (>130/85mm Hg or antihypertensive drugs), 77% had elevated fasting plasma glucose (≥5.55mmol/L), 51% were hypertriacylglycerolemic (≥1.7mmol/L), and 72% had low HDL cholesterol (<1.0mmol/L for men, and <1.3mmol/L for women). The prevalence of enlarged waist circumference, hypertension and hypertriacylglycerolemia were reduced after the LFHCC n-3 diet (p<0.05). Thus the prevalence of MetS fell by 20.5% after LFHCC n-3 diet compared with the HSFA (10.6%), HMUFA (12%) diet or LFHCC (10.4%) diets (p<0.028).



The consumption of a low-fat high-carbohydrate supplemented with n-3 diet reduced the risk of MetS as compared with isoenergetic high-fat (HSFA and HMUFA) and LFHCC diets.