nils-herrmann/clean_scirepeval huggingface dataset:
Intracutaneous versus intramuscular hepatitis B vaccination in primary non-responding haemodialysis patients.

To determine whether hepatitis B vaccination given intracutaneously (i.c.) is more effective than intramuscularly (i.m.) in primary non-responding haemodialysis patients.



A prospective, randomized study of antibody responses to hepatitis B vaccine given i.c. or i.m., in 25 haemodialysis patients. Outcome measures were rates of seroconversion, mean and geometric mean levels of antibody achieved, and antibody levels 1 year after vaccination.



With a dosing schedule of 10 micrograms vaccine once a week i.c. in the skin overlying the deltoideus muscle of the non-dominant arm during 12 consecutive weeks, antibody levels to hepatitis B surface antigen (anti-HBsAg) of 10 IU/1 or more were achieved in nine of 10 evaluable patients, with a geometric mean of 70 IU/1. Nine months after the end of the vaccination anti-HBsAg levels had dropped to 9 +/- 4 IU/1 (M +/- SE), with a geometric mean of 5 IU/1, in the nine remaining evaluable patients. With a dosing schedule of 40 micrograms vaccine i.m. in the deltoideus muscle of the non-dominant arm at 0, 1, and 3 months, anti-HBsAg levels of at least 10 IU/1 were achieved in eight of 14 evaluable patients, with a geometric mean of 94 IU/1. Nine months after the end of the vaccination anti-HBsAG levels had dropped to 16 +/- 7 IU/1, with a geometric mean of 9 IU/1, in the nine remaining evaluable patients. Anti-HBsAg levels at 8 and 12 weeks were higher in the i.c. than in the group receiving vaccine i.m. (at 8 weeks 134 +/- 76 vs 39 +/- 20 IU/1, P < 0.05, and at 12 weeks 188 +/- 98 vs 47 +/- 18 IU/1 P < 0.01). The half-time of anti-HBsAg is about 13 weeks, both when the averaged absolute and when the geometric mean levels are used for the estimate.



intracutaneous route is a less practical but effective method of vaccination against hepatitis B in primary non-responding haemodialysis patients. The weekly 10 micrograms vaccine i.c. scheme resulted in the fastest development of protective antibody levels, within 8 weeks, which may be useful in previously non-immune persons who may be infected with hepatitis B virus (e.g. needle-stick accidents).
Serum phosphorus levels and pill burden are inversely associated with adherence in patients on hemodialysis

Phosphate binders (PBs) account for about one half of the daily pill burden for US hemodialysis (HD) patients, which may reduce adherence. Adherence can be estimated by the medication possession ratio (MPR), which is defined as the proportion of time a patient had sufficient medication to have taken it as prescribed. Gaps of time between prescription fills lower the patient's MPR. We assessed the association of PB pill burden and adherence (MPR) with phosphorus goal attainment.



Using pharmacy management program data, HD patients on PB monotherapy were tracked from first PB fill during 1 January 2007-30 June 2011 for 1 year, or until PB change or censoring. Data were assessed with generalized linear models.



We analyzed 8616 patients. Higher pill burden was associated with lower adherence. Lower adherence tended to be associated with higher mean phosphorus levels and lower percentage of patients with serum phosphorus ≤5.5 mg/dL (P < 0.001). The association between adherence and these clinical outcomes was most pronounced in the lowest and highest pill burden strata (<3, >3-6, >12-15, >15).



Adherence, as measured by the MPR, was negatively related to higher pill burden and phosphorus levels and positively related to patients in the phosphorus target range. Within pill burden strata, phosphorus increased and patients in the target range generally decreased with decreasing adherence, suggesting that patients prescribed fewer PB pills are less likely to have treatment gaps, and may be more likely to achieve phosphorus targets.
Prevalence and recognition of obstructive sleep apnea in Chinese patients with type 2 diabetes mellitus.

Obstructive sleep apnea (OSA) is associated with disorders of glucose metabolism. Previous studies revealed a high prevalence of OSA among subjects with type 2 diabetes mellitus (DM). The aims of this study were to determine the prevalence of OSA and associated clinical factors in Chinese patients with DM.



All records of the DM clinic at a teaching hospital in Hong Kong were screened between January 2007 and June 2008. Inclusion criteria for patients were Chinese, aged 18 to 75 years, with type 2 DM. Patients with unstable medical illnesses, gestational diabetes, or on renal replacement therapy were excluded.



Of 3,489 records screened, 1,859 subjects were eligible. A random sample of 663 (mean age, 58.2 ± 10.8; mean BMI, 26.0 ± 4.6), except six with known OSA, were invited for polysomnography (PSG). Of 165 subjects on which PSG was performed, OSA was diagnosed (apnea-hypopnea index [AHI] ≥ 5.0/h) in 89 subjects (53.9%, median Epworth Sleepiness Scale, 6 [interquartile range 3, 10]). Fifty-four (32.7%) had moderate/severe OSA (AHI ≥ 15/h). The estimated OSA prevalence in this diabetic cohort was 17.5% (24.7% in men, 10.3% in women). Regression analysis identified that AHI was associated independently with higher BMI, advanced age, male sex, and higher diastolic BP (R(2) = 29.6%). The adjusted OR of requiring three or more antihypertensive drugs in moderate/severe OSA was 2.48 (95% CI, 1.05-5.87). No association between glycemic control (HbA1c) and sleep was identified.



In conclusion, OSA is more prevalent in Chinese adults with DM than in the general population. A high index of suspicion for OSA in patients with DM is warranted, because they may not have overt daytime sleepiness.
Capsule endoscopy versus colonoscopy for the detection of polyps and cancer.

An ingestible capsule consisting of an endoscope equipped with a video camera at both ends was designed to explore the colon. This study compared capsule endoscopy with optical colonoscopy for the detection of colorectal polyps and cancer.



We performed a prospective, multicenter study comparing capsule endoscopy with optical colonoscopy (the standard for comparison) in a cohort of patients with known or suspected colonic disease for the detection of colorectal polyps or cancer. Patients underwent an adapted colon preparation, and colon cleanliness was graded from poor to excellent. We computed the sensitivity and specificity of capsule endoscopy for polyps, advanced adenoma, and cancer.



A total of 328 patients (mean age, 58.6 years) were included in the study. The capsule was excreted within 10 hours after ingestion and before the end of the lifetime of the battery in 92.8% of the patients. The sensitivity and specificity of capsule endoscopy for detecting polyps that were 6 mm in size or bigger were 64% (95% confidence interval [CI], 59 to 72) and 84% (95% CI, 81 to 87), respectively, and for detecting advanced adenoma, the sensitivity and specificity were 73% (95% CI, 61 to 83) and 79% (95% CI, 77 to 81), respectively. Of 19 cancers detected by colonoscopy, 14 were detected by capsule endoscopy (sensitivity, 74%; 95% CI, 52 to 88). For all lesions, the sensitivity of capsule endoscopy was higher in patients with good or excellent colon cleanliness than in those with fair or poor colon cleanliness. Mild-to-moderate adverse events were reported in 26 patients (7.9%) and were mostly related to the colon preparation.



The use of capsule endoscopy of the colon allows visualization of the colonic mucosa in most patients, but its sensitivity for detecting colonic lesions is low as compared with the use of optical colonoscopy.
Repeated adeno-associated virus serotype 2 aerosol-mediated cystic fibrosis transmembrane regulator gene transfer to the lungs of patients with cystic fibrosis: a multicenter, double-blind, placebo-controlled trial.

The primary objective was to determine the safety and tolerability of repeated doses of aerosolized adeno-associated serotype 2 vector containing cystic fibrosis transmembrane conductance regulator (CFTR) complementary DNA (cDNA) , an adeno-associated virus (AAV) vector encoding the complete human CFTR cDNA. Secondary objectives included evaluation of pulmonary function assessed by spirometry, lung abnormalities by high-resolution CT (HRCT), airway cytokines, vector shedding, serum neutralizing antibody to AAV serotype 2 (AAV2), and gene transfer and expression in a subset of subjects undergoing bronchoscopy with bronchial brushings.



Randomized, double-blind, placebo-controlled, phase II trial.



Eight cystic fibrosis (CF) centers in the United States.



CF patients with mild lung disease, defined as FEV(1) > or =60% predicted.



Subjects were randomized to inhale three aerosolized doses of 1 x 10(13) deoxyribonuclease-resistant particles of tgAAVCF or matching placebo at 30-day intervals using the Pari LC Plus nebulizer (PARI; Richmond, VA).



Of 42 subjects randomized, 20 subjects received at least one dose of tgAAVCF and 17 subjects received placebo. No difference in the pattern of adverse events or laboratory abnormalities was noted between the two treatment groups. Improvements in induced-sputum interleukin-8 (p = 0.03) and FEV(1) (p = 0.04) were observed at day 14 and day 30, respectively, in the group receiving tgAAVCF when compared to those receiving placebo. No significant differences in HRCT scans were noted. Vector shedding in sputum was observed at low levels up to 90 days after the third dose of vector. All subjects receiving tgAAVCF exhibited an increase (by at least fourfold) in serum AAV2-neutralizing antibodies and detectable levels in BAL fluid from five of six treated subjects undergoing BAL. Gene transfer but not gene expression was detected in a subset of six tgAAVCF subjects who underwent bronchoscopy.



Repeat doses of aerosolized tgAAVCF were safe and well tolerated, and resulted in encouraging trends in improvement in pulmonary function in patients with CF and mild lung disease.
Electrocardiographic findings in systemic lupus erythematosus: data from an international inception cohort.

To estimate the early prevalence of various electrocardiographic (EKG) abnormalities in patients with systemic lupus erythematosus (SLE) and to evaluate possible associations between repolarization changes (increased corrected QT [QTc] and QT dispersion [QTd]) and clinical and laboratory variables, including the anti-Ro/SSA level and specificity (52 or 60 kd).



We studied adult SLE patients from 19 centers participating in the Systemic Lupus International Collaborating Clinics (SLICC) Inception Registry. Demographics, disease activity (Systemic Lupus Erythematosus Disease Activity Index 2000 [SLEDAI-2K]), disease damage (SLICC/American College of Rheumatology Damage Index [SDI]), and laboratory data from the baseline or first followup visit were assessed. Multivariate logistic and linear regression models were used to asses for any cross-sectional associations between anti-Ro/SSA and EKG repolarization abnormalities.



For the 779 patients included, mean ± SD age was 35.2 ± 13.8 years, 88.4% were women, and mean ± SD disease duration was 10.5 ± 14.5 months. Mean ± SD SLEDAI-2K score was 5.4 ± 5.6 and mean ± SD SDI score was 0.5 ± 1.0. EKG abnormalities were frequent and included nonspecific ST-T changes (30.9%), possible left ventricular hypertrophy (5.4%), and supraventricular arrhythmias (1.3%). A QTc ≥440 msec was found in 15.3%, while a QTc ≥460 msec was found in 5.3%. Mean ± SD QTd was 34.2 ± 14.7 msec and QTd ≥40 msec was frequent (38.1%). Neither the specificity nor the level of anti-Ro/SSA was associated with QTc duration or QTd, although confidence intervals were wide. Total SDI was significantly associated with a QTc interval exceeding 440 msec (odds ratio 1.38 [95% confidence interval 1.06, 1.79]).



A substantial proportion of patients with recent-onset SLE exhibited repolarization abnormalities, although severe abnormalities were rare.
Influence of positioning on ventilation-perfusion relationships in severe adult respiratory distress syndrome.

In 12 patients with severe adult respiratory distress syndrome (ARDS), pulmonary gas exchange and hemodynamics were evaluated before, during, and after a 2-h period of pressure-controlled mechanical ventilation with the patient in the prone position. Ventilation-perfusion relationships (VA/Q) were assessed by a multiple inert gas elimination technique. Pressure-controlled mechanical ventilation in the prone position resulted in an overall increase (p < or = 0.05) of arterial oxygenation after 120 min (98.4 +/- 50.3 to 146.2 +/- 94.9 mm Hg). Whereas eight patients revealed an improvement of PaO2 of more than 10 mm Hg after 30 min in the prone position (responders), four patients reacted to positional changes with a deterioration of arterial oxygenation (nonresponders). Data about the continuous distribution of ventilation-perfusion ratios revealed that in the responder group positioning caused a decrease of shunt perfusion of 11 +/- 5% and a concomitant increase of normal VA/Q by 12 +/- 4% after 30 min. There was no change demonstrable within low VA/Q areas. Returning the patient to the supine position reversed the improvement in gas exchange. The nonresponder group did not show any significant alteration in the distribution of VA/Q during the study. We concluded that improvement of oxygenation during pressure-controlled mechanical ventilation in the prone position is due to a shift of blood flow away from shunt regions, thus increasing areas with normal VA/Q. This redistribution of blood flow is most likely caused by a recruitment of previously ateletatic but nondiseased areas induced by altered gravitational forces.
Validation of the Brazilian-Portuguese Version of the Gesture Behavior Test for Patients with Non-Specific Chronic Low Back Pain

To develop a Brazilian version of the gesture behavior test (GBT) for patients with chronic low back pain.



Translation of GBT into Portuguese was performed by a rheumatologist fluent in the language of origin (French) and skilled in the validation of questionnaires. This translated version was back-translated into French by a native-speaking teacher of the language. The two translators then created a final consensual version in Portuguese. Cultural adaptation was carried out by two rheumatologists, one educated patient and the native-speaking French teacher. Thirty patients with chronic low back pain and fifteen healthcare professionals involved in the education of patients with low back pain through back schools (gold-standard) were evaluated. Reproducibility was initially tested by two observers (inter-observer); the procedures were also videotaped for later evaluation by one of the observers (intra-observer). For construct validation, we compared patients' scores against the scores of the healthcare professionals.



Modifications were made to the GBT for cultural reasons. The Spearman's correlation coefficient and the intra-class coefficient, which was employed to measure reproducibility, ranged between 0.87 and 0.99 and 0.94 to 0.99, respectively (p < 0.01). With regard to validation, the Mann-Whitney test revealed a significant difference (p < 0.01) between the averages for healthcare professionals (26.60; SD 2.79) and patients (16.30; SD 6.39). There was a positive correlation between the GBT score and the score on the Roland Morris Disability Questionnaire (r= 0.47).



The Brazilian version of the GBT proved to be a reproducible and valid instrument. In addition, according to the questionnaire results, more disabled patients exhibited more protective gesture behavior related to low-back.
Glutathione S-transferase polymorphisms and bone tumor risk in China.

We aimed to study the potential role of GSTM1 and GSTT1 in the risk of osteosarcoma in Chinese population.



We collected 110 osteosarcomas by pathologic examination and 226 controls from the First Affiliated Hospital of Harbin Medical University during December 2008 to December 2010. Genotyping was based upon duplex polymerase-chain-reaction with the PCR-CTPP method.



Individuals carrying null GSTM1 and GSTT1 had 1.50 and 2.07 fold risks of osteosarcoma when compared with non-null genotypes, respectively. The increased risk associated with the GSTT1 polymorphism seemed more evident among males (Null GSTT1 genotype vs. non-null genotype, adjusted OR= 2.43, 95% CI: 1.29-3.30) than females (adjusted OR =1.66, 95% CI: 1.02-2.78). The increased risk was also more evident among individuals aged 15 years or less (adjusted OR for null GSTT1 genotype vs. non-null genotype = 2.24, 95% CI: 1.20-3.24) than those aged more than 15 years (adjusted OR = 1.82, 95% CI: 1.07-2.95).



Our study of the association between polymorphisms in GSTM1 and GSTTI and the risk of osteosarcoma in a Chinese population provided evidence that null GSTTI might be a useful marker of susceptibility to osteosarcoma development, especially for male sand young age individuals.
Drawing helps children to talk about their presenting problems during a mental health assessment.

When children require mental health services, clinicians need to conduct assessments that are developmentally sensitive and that include the child's point of view. Drawing is a popular tool that is commonly used in clinical settings. Research on drawing in experimental settings has confirmed that the opportunity to draw while talking increases the amount of verbal information that children report during an interview. The present research examined whether drawing also facilitates children's self reports during a mental health assessment. A total of 33 5-12-year-old children were asked either to draw and tell about their presenting problem or to tell only. Children who drew and told provided twice as much verbal information as children who told only. Further, interviewers in the draw and tell condition used a greater number of minimal responses than did interviewers in the tell only condition. These data have important implications for clinical practice.
Obesity-related derangements of coagulation and fibrinolysis: a study of obesity-discordant monozygotic twin pairs.

Coagulation and fibrinolytic activities are under strong genetic control. We studied the effects of acquired obesity, independent of genetic factors on coagulation and fibrinolysis activities in obesity-discordant healthy monozygotic (MZ) twin pairs. Fourteen obesity-discordant (BMI within-pair difference >3 kg/m(2)) and 10 concordant (BMI difference <2 kg/m(2)) MZ twin pairs were identified from the nationwide FinnTwin16 study. Body composition (dual-energy x-ray absorptiometry), abdominal fat distribution (magnetic resonance imaging), liver fat (magnetic resonance spectroscopy), high sensitivity C-reactive protein, insulin sensitivity (euglycemic hyperinsulinemic clamp), and a panel of different markers of blood coagulation and fibrinolysis in the fasting state were measured. Strong resemblance was observed in most coagulation factors within all twin pairs, with the intraclass correlations ranging from 0.73 to 0.97, P < 0.03. However, the activities of fibrinogen and FIX, FXI, and FXII, and plasminogen activator inhibitor-1 (PAI-1) activities were increased in the obese co-twins (P < 0.05) and strongly correlated with the measures of adiposity, inflammation, and insulin resistance (r = 0.32-0.73, P < 0.05) among the twin individuals. Intrapair differences in fibrinogen and PAI-1 correlated with those in BMI, adiposity, and fasting insulin levels (r = 0.40-0.58, P < 0.05) indicating the independent effect of obesity. Derangements of blood coagulation and fibrinolysis are present already in early adulthood in obese subjects. Acquired obesity, independent of genetic factors, increases the activities of fibrinogen and activities of FIX, FXI, FXII, and PAI-1. This study confirms the mechanisms of simultaneous activities of intrinsic coagulation factors and impaired fibrinolysis predisposing obese subjects to thrombosis.
Randomized phase III study of granulocyte transfusions in neutropenic patients

Despite antibiotics, antifungals and haematopoietic growth factors, infections remain a major threat to neutropenic patients. To determine the role of granulocyte transfusions (GTs) in anti-infective therapy during neutropenia, GT administration was randomized in 74 adults with haematological or malignant diseases, febrile neutropenia and pulmonary or soft-tissue infiltrates after conventional or high-dose chemotherapy, a majority of them after allo-SCT (n=39). Neutrophil reconstitution was equal in the treatment and control arm. GT toxicity was minimal. The probability of 28-day survival after randomization was >80% in both groups, and no effect of GT on survival until day 100 could be detected in patients with fungal (n=55), bacterial or unknown infection (n=17) and various levels of neutropenia (ANC <500 vs >500 × 106/l). These findings can be attributed primarily to procedural obstacles, such as long delay from randomization to first GT, low cell content and slow sequence of GT, difficulties in randomizing a safe and potentially life-saving treatment in severely endangered individuals, and a large proportion of rapidly recovering patients in both arms. The requirement of another trial in a more specific patient population with daily transfusions of sufficient numbers of granulocytes to support or refute the empirically acknowledged benefits of GT is discussed.
A prospective longitudinal clinical trial evaluating quality of life after breast-conserving surgery and high-dose-rate interstitial brachytherapy for early-stage breast cancer.

To prospectively examine quality of life (QOL) of patients with early stage breast cancer treated with accelerated partial breast irradiation (APBI) using high-dose-rate (HDR) interstitial brachytherapy.



Between March 2004 and December 2008, 151 patients with early stage breast cancer were enrolled in a phase 2 prospective clinical trial. Eligible patients included those with Tis-T2 tumors measuring ≤3 cm excised with negative surgical margins and with no nodal involvement. Patients received 3.4 Gy twice daily to a total dose of 34 Gy. QOL was measured using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, version 3.0, and QLQ-BR23 questionnaires. The QLQ-C30 and QLQ-BR23 questionnaires were evaluated during pretreatment and then at 6 to 8 weeks, 3 to 4 months, 6 to 8 months, and 1 and 2 years after treatment.



The median follow-up was 55 months. Breast symptom scores remained stable in the months after treatment, and they significantly improved 6 to 8 months after treatment. Scores for emotional functioning, social functioning, and future perspective showed significant improvement 2 years after treatment. Symptomatic fat necrosis was associated with several changes in QOL, including increased pain, breast symptoms, systemic treatment side effects, dyspnea, and fatigue, as well as decreased role functioning, emotional functioning, and social functioning.



HDR multicatheter interstitial brachytherapy was well tolerated, with no significant detrimental effect on measured QOL scales/items through 2 years of follow-up. Compared to pretreatment scores, there was improvement in breast symptoms, emotional functioning, social functioning, and future perspective 2 years after treatment.