nils-herrmann/clean_scirepeval huggingface dataset:
A novel experience of antiviral therapy for chronic hepatitis B in renal transplant recipients.

Entecavir (ETV) is a potent inhibitor of viral replication in chronic hepatitis B. There is no published data concerning ETV therapy in nucleoside analogue (NUC)-naive hepatitis B surface antigen (HBsAg)-positive renal transplant recipients (RTRs).



We prospectively treated 27 HBsAg-positive RTRs with ETV since 2007. Serial HBV DNA was assessed at baseline and weeks 12, 24, 52 and 104 after treatment. A cohort of 19 patients who received 2-year lamivudine (3TC) therapy during 2004-2007 was used as a historical control.



Of the 27 RTRs, 18 (67%) were NUC-naive patients and 9 (33%) were 3TC-experienced without YMDD mutations. HBV DNA levels became undetectable in 70%, 74%, 96% and 100% of patients after 12, 24, 52 and 104 weeks, respectively, of ETV treatment without viral resistance. There was no change of glomerular filtration rate, and no lactic acidosis or myopathy during treatment. By comparison with the 19 3TC-treated patients, ETV-treated RTRs presented higher rates of undetectable HBV DNA than 3TC-treated RTRs (32%, 37%, 63% and 63% at 12, 24, 52 and 104 weeks; P<0.005). In an analysis excluding 9 patients from the ETV group who were also 3TC-experienced, the remaining 18 ETV-naive RTRs exhibited a better virological response at 52 and 104 weeks than 19 3TC-treated RTRs (P<0.05). Even in the 9 patients who overlapped in two cohorts, ETV exhibited a more rapid virological response than 3TC did, especially at 12 and 24 weeks (P=0.009).



ETV is effective in treating chronic hepatitis B in RTRs. ETV is safe with regards to renal graft function, lactic acidosis, myopathy and virological resistance.
Ticagrelor increases adenosine plasma concentration in patients with an acute coronary syndrome.

This study aimed to investigate the impact of ticagrelor on adenosine plasma concentration (APC) in acute coronary syndrome (ACS) patients.



Ticagrelor is a direct-acting P2Y12-adenosine diphosphate receptor blocker. The clinical benefit of ticagrelor compared with clopidogrel in ACS patients suggests that the drug has non-platelet-directed properties. Animal and in vitro models suggested that the "pleiotropic" properties of ticagrelor may be related to an interaction with adenosine metabolism.



We prospectively randomized 60 ACS patients to receive ticagrelor or clopidogrel. The APC was measured by liquid chromatography. To assess the mechanism of APC variation, we measured adenosine deaminase concentration, adenosine uptake by red blood cells, and cyclic adenosine monophosphate production by cells overexpressing adenosine receptors. The P2Y12-adenosine diphosphate receptor blockade was assessed by the vasodilator-stimulated phosphoprotein index.



Patients receiving ticagrelor had significantly higher APC than patients receiving clopidogrel (1.5 μM [interquartile range: 0.98 to 1.7 μM] vs. 0.68 μM [interquartile range: 0.49 to 0.78 μM]; p < 0.01). The APC was not correlated with vasodilator-stimulated phosphoprotein (p = 0.16). Serum-containing ticagrelor inhibited adenosine uptake by red blood cells compared with clopidogrel or controls (p < 0.01 for both comparisons). Adenosine deaminase activity was similar in serum of patients receiving clopidogrel or ticagrelor (p = 0.1). Ticagrelor and clopidogrel had no direct impact on adenosine receptors (p = not significant).



Ticagrelor increases APC in ACS patients compared with clopidogrel by inhibiting adenosine uptake by red blood cells.
Terlipressin vs. Octreotide in Bleeding Esophageal Varices as an Adjuvant Therapy With Endoscopic Band Ligation: A Randomized Double-Blind Placebo-Controlled Trial

Data are scarce on the head-to-head efficacy of terlipressin and octreotide as an adjuvant therapy to endoscopic management of variceal bleed. The aim of this study was to compare the efficacy and safety of terlipressin with octreotide as an adjuvant therapy to endoscopic variceal band ligation in patients with esophageal variceal bleeding.Cirrhotic patients with esophageal variceal bleed were randomized on admission to receive terlipressin (group A) or octreotide (group B) along with the placebo in the other arm in a double-blind fashion. The two groups were compared for efficacy, safety, overall survival, and length of hospital stay. “Control of variceal bleed” was the measure of efficacy of terlipressin and octreotide. Factors predicting length of stay were also assessed.A total of 324 patients were enrolled; 163 in the terlipressin group (group A) and 161 in the octreotide group (group B). The baseline characteristics of the two groups were comparable for age, gender, etiology of cirrhosis, hemoglobin at presentation, and Child–Pugh class, except that active bleed was seen during upper gastrointestinal endoscopy at the time of enrollment in 26 (16%) and 41 (25.5%) patients in groups A and B, respectively (P=0.034). Overall sixteen patients died (three failure to control bleed and thirteen from causes other than variceal bleed); nine in group A (5.5%) and seven (4.3%) in group B (P=0.626). In the intention to treat analysis, “control of variceal bleed” was noted in 305 patients (94.13%); 151 (92.63%) patients in group A and 154 (95.6%) patients in group B (confidence interval: 0.219–1.492). Packed cell transfusions in group A were 3.7±2.3 units, whereas in group B there were 3.9±2.5 units (P=0.273). Length of hospital stay in groups A and B was 108.40±34.81 and 126.39±47.45 h, respectively (P≤0.001). No cardiovascular side effects were observed in either group. High pulse, low hemoglobin, prothrombin time, blood in nasogastric aspirate, and portosystemic encephalopathy (PSE) were predictors of prolonged hospital stay.The efficacy of terlipressin was not inferior to octreotide as an adjuvant therapy for the control of esophageal variceal bleed and in-hospital survival. The length of hospital stay in the terlipressin group was significantly shorter but not of any clinical importance. The predictors of prolonged hospital stay were low hemoglobin, high pulse, prolonged prothrombin time, blood at nasogastric aspirate, and PSE.
Sustained function of alginate-encapsulated human islet cell implants in the peritoneal cavity of mice leading to a pilot study in a type 1 diabetic patient

Alginate-encapsulated human islet cell grafts have not been able to correct diabetes in humans, whereas free grafts have. This study examined in immunodeficient mice whether alginate-encapsulated graft function was inferior to that of free grafts of the same size and composition. Cultured human islet cells were equally distributed over free and alginate-encapsulated grafts before implantation in, respectively, the kidney capsule and the peritoneal cavity of non-obese diabetic mice with severe combined immunodeficiency and alloxan-induced diabetes. Implants were followed for in vivo function and retrieved for analysis of cellular composition (all) and insulin secretory responsiveness (capsules). Free implants with low beta cell purity (19 ± 1%) were non-functional and underwent 90% beta cell loss. At medium purity (50 ± 1%), they were functional at post-transplant week 1, evolving to normoglycaemia (4/8) or to C-peptide negativity (4/8) depending on the degree of beta cell-specific losses. Encapsulated implants immediately and sustainably corrected diabetes, irrespective of beta cell purity (16/16). Most capsules were retrievable as single units, enriched in endocrine cells that exhibited rapid secretory responses to glucose and glucagon. Single capsules with similar properties were also retrieved from a type 1 diabetic recipient at post-transplant month 3. However, the vast majority were clustered and contained debris, explaining the poor rise in plasma C-peptide. In immunodeficient mice, i.p. implanted alginate-encapsulated human islet cells exhibited a better outcome than free implants under the kidney capsule. They did not show primary non-function at low beta cell purity and avoided beta cell-specific losses by rapidly establishing normoglycaemia. Retrieved capsules presented secretory responses to glucose, which was also observed in a type 1 diabetic recipient.
Comparing strategies for treating emotion perception deficits in traumatic brain injury.

To compare the efficacy of 2 strategies, errorless learning (EL) and self-instruction training (SIT), for remediating emotion perception deficits in individuals with traumatic brain injury (TBI).



Randomized controlled trial comparing groups receiving 25 hours (across 10 weeks) of treatment with either EL or SIT with waitlist control.



Eighteen adult outpatient volunteers with severe TBI who were at least 6 months postinjury.



Photograph-based emotion recognition tasks, The Awareness of Social Inferences Test, and questionnaire measures, for example, the Sydney Psychosocial Reintegration Scale.



Both treatment groups showed modest improvement in emotion perception ability. Limited evidence suggests that SIT may be a favorable approach for this type of remediation.



Although further research is needed, there are reasons for optimism regarding rehabilitation of emotion perception following TBI.
Do positive schizotypal symptoms predict false perceptual experiences in nonclinical populations?

We examined whether positive schizotypy (i.e., reports of hallucinatory and delusional-like experiences) in nonclinical participants could predict false perceptual experiences during detection of fast-moving words beyond a possible response bias. The participants (N = 160) were assigned to one of two conditions: they were asked either to make presence/absence judgments (loose criterion) or to read aloud every detected word (strict criterion). Regression analysis showed that high levels of positive schizotypy predicted false alarms in the loose condition and false perceptions of words in the strict condition. The obtained effects were independent of detection accuracy, task order, impulsivity, and social desirability. We discuss the results in the context of information processing biases linked to the positive symptomatology of schizophrenia. Clinical and theoretical implications are also considered.
N-Acetylcysteine added to volume expansion with sodium bicarbonate does not further prevent contrast-induced nephropathy: results from the cardiac angiography in renally impaired patients study.

We reviewed data from the multicenter CARE (Cardiac Angiography in Renally Impaired Patients) study to see if benefit could be shown for N-acetylcysteine (NAC) in patients undergoing cardiac angiography who all received intravenous bicarbonate fluid expansion. Four hundred fourteen patients with moderate-to-severe chronic kidney disease were randomized to receive intra-arterial administration of iopamidol-370 or iodixanol-320. All patients were prehydrated with isotonic sodium bicarbonate solution. Each site chose whether or not to administer NAC 1,200 mg twice daily to all patients. Serum creatinine (SCr) levels and estimated glomerular filtration rate were assessed at baseline and 2-5 days after receiving contrast. The primary outcome was a postdose SCr increase 0.5 mg/dL (44.2 mumol/L) over baseline. Secondary outcomes were a postdose SCr increase 25% and the mean peak change in SCr. The NAC group received significantly less hydration (892 +/- 236 mL vs. 1016 +/- 328 mL; P < 0.001) and more contrast volume (146 +/- 74 mL vs. 127 +/- 71 mL; P = 0.009) compared with no-NAC group. SCr increases 0.5 mg/dL occurred in 4.2% (7 of 168 patients) in NAC group and 6.5% (16 of 246 patients) in no-NAC group (P = 0.38); rates of SCr increases 25% were 11.9% and 10.6%, respectively (P = 0.75); mean post-SCr increases were 0.07 mg/dL in NAC group versus 0.11 mg/dL in no-NAC group (P = 0.14). In conclusion, addition of NAC to fluid expansion with sodium bicarbonate failed to reduce the rate of contrast-induced nephropathy (CIN) after the intra-arterial administration of iopamidol or iodixanol to high-risk patients with chronic kidney disease.
Psychometric Evaluation of a Treatment Acceptance Measure for Use in Patients Receiving Treatment via Subcutaneous Injection.

Alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, significantly reduces low-density lipoprotein cholesterol, but requires subcutaneous injections rather than oral pills. To measure patients' acceptance of this treatment modality, a new patient-reported outcome, the Injection-Treatment Acceptance Questionnaire (I-TAQ), was developed.



To psychometrically evaluate the I-TAQ with patients at high risk of cardiovascular events receiving alirocumab.



The 22-item, 5-domain I-TAQ was administered cross-sectionally to 151 patients enrolled in alirocumab clinical trials. Item response distributions, factor and multitrait analyses, interitem correlations, correlations with an existing measure of acceptance (convergent validity), and comparison of known-groups were performed to assess the I-TAQ's psychometric properties.



Completion rates were high, with no patients missing more than two items and 91.4% missing no data. All items displayed high ceiling effects (>30%) because of high treatment acceptance. Factor analysis supported the a priori hypothesized item-domain structure with good fit indices (root mean square error approximation = 0.070; comparative fit index = 0.988) and high factor loadings. All items demonstrated item convergent validity (item-scale correlation ≥0.40), except for the side effects domain, which was limited by small numbers (n = 46). Almost all items correlated most highly with the domain to which they were assigned (item discriminant validity). Internal reliability was acceptable for all domains (Cronbach α range 0.72-0.88) and convergent validity was supported by a logical pattern of correlations with the Chronic Treatment Acceptance Questionnaire.



These findings provide initial evidence of validity and reliability for the I-TAQ in patients treated with subcutaneous alirocumab. The I-TAQ could prove to be a valuable patient-reported outcome for therapies requiring subcutaneous injection.
Cognitive and Field Testing of a New Set of Medication Adherence Self-Report Items for HIV Care

We conducted four rounds of cognitive testing of self-report items that included 66 sociodemographically diverse participants, then field tested the three best items from the cognitive testing in a clinic waiting room (N = 351) and in an online social networking site for men who have sex with men (N = 6,485). As part of the online survey we conducted a randomized assessment of two versions of the adherence questionnaire—one which asked about adherence to a specific antiretroviral medication, and a second which asked about adherence to their “HIV medicines” as a group. Participants were better able to respond using adjectival and adverbial scales than visual analogue or percent items. The internal consistency reliability of the three item adherence scale was 0.89. Mean scores for the two different versions of the online survey were similar (91.0 vs. 90.2, p < 0.05), suggesting that it is not necessary, in general, to ask about individual medications in an antiretroviral therapy regimen when attempting to describe overall adherence.
Comparison of transcatheter and surgical aortic valve replacement in severe aortic stenosis: a longitudinal study of echocardiography parameters in cohort A of the PARTNER trial (placement of aortic transcatheter valves).

This study sought to compare echocardiographic findings in patients with critical aortic stenosis following surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).



The PARTNER (Placement of Aortic Transcatheter Valves) trial randomized patients 1:1 to SAVR or TAVR.



Echocardiograms were obtained at baseline, discharge, 30 days, 6 months, 1 year, and 2 years after the procedure and analyzed in a core laboratory. For the analysis of post-implantation variables, the first interpretable study (≤6 months) was used.



Both groups showed a decrease in aortic valve gradients and increase in effective orifice area (EOA) (p < 0.0001), which remained stable over 2 years. Compared with SAVR, TAVR resulted in larger indexed EOA (p = 0.038), less prosthesis-patient mismatch (p = 0.019), and more total and paravalvular aortic regurgitation (p < 0.0001). Baseline echocardiographic univariate predictors of death were lower peak transaortic gradient in TAVR patients, and low left ventricular diastolic volume, low stroke volume, and greater severity of mitral regurgitation in SAVR patients. Post-implantation echocardiographic univariate predictors of death were: larger left ventricular diastolic volume, left ventricular systolic volume and EOA, decreased ejection fraction, and greater aortic regurgitation in TAVR patients; and smaller left ventricular systolic and diastolic volumes, low stroke volume, smaller EOA, and prosthesis-patient mismatch in SAVR patients.



Patients randomized to either SAVR or TAVR experience enduring, significant reductions in transaortic gradients and increase in EOA. Compared with SAVR, TAVR patients had higher indexed EOA, lower prosthesis-patient mismatch, and more aortic regurgitation. Univariate predictors of death for the TAVR and SAVR groups differed and might allow future refinement in patient selection.
Mannose-binding Lectin Mediated Complement Pathway in Autoimmune Neurological Disorders.

Multiple sclerosis (MS) is a complex, demyelinating disease of the central nervous system (CNS) with variable phenotypic presentations, while Guillain-Barre Syndrome (GBS) is the prototypic acute inflammatory disorder that affects the peripheral nervous system. Myasthenia gravis (MG) is a T cell dependent and antibody mediated autoimmune disease. Although it has been shown that complement plays a critical role in the pathogenesis of MS, GBS, and MG, the role of mannose-binding lectin (MBL) as a biomarker of immunopathogensis of these diseases and also its association with the severity of them have been poorly investigated. Therefore, in this study we aimed to measure plasma levels of MBL in patients with MS, GBS, and MG. In a case-control study, plasma was obtained from healthy controls (n=100) and also patients with MS (n=120), GBS (n=30), and MG (n=30). Plasma level measurement of MBL was performed using enzyme-linked immunosorbent assay (ELISA). The mean serum level of MBL was significantly different between groups of patients and healthy controls (p<0.001). We also found a positive correlation between plasma levels of MBL and severity scores of MS, MG, and GBS patients including: expanded disability status scale (EDSS) (r=+0.60 and p=<0.001), quantitative myasthenia gravis score (QMGS) (r=+0.56 and p=0.01), and GBS disability scale (GDS) (r=+0.37 and p=0.04). Taken together, our findings suggest that complement activation mediated by MBL contributes to the pathogenesis and also severity of MS, MG, and GBS. However, because the lectin pathway can be involved in several phases of the immune response, further evidence will be required to elucidate the underlying mechanism.
Study of cytotoxic chemotherapy as an adjuvant to surgery in carcinoma of the bronchus. Report by a Medical Research Council Working Party.

This report gives the findings after two years of a study of long-term oral cytotoxic chemotherapy with busulphan or cyclophoshamide in carcinoma of the bronchus compared with two placebos, identical in appearance to the drug-containing tablets. A total of 753 patients who had had a total resection of the tumour, who had no detectable extrathoracic metastasis, and who were able to attend chest clinics monthly were admitted to the study from January 1965 to January 1968. Twenty-seven patients were excluded from all the analyses.The 217 patients admitted up to December 1965 form the "early" intake, the remaining 509 the "late" intake. There were no significant differences between the series in either intake period in a number of pretreatment factors studied. At 24 months 46% of the busulphan, 44% of the cyclophosphamide, and 49% of the placebo series were alive in the early intake, as were 49%, 50%, and 50% respectively in the late intake. There were no important differences between the series in survival related to pretreatment condition, cause of death, time of detection of metastases, and condition of the survivors at 24 months. Maintenance chemotherapy was interrupted to a greater extent in the busulphan than in the cyclophosphamide series and least in the placebo series.In both intakes clinical toxicity was more frequent in the cyclophosphamide series and similar in frequency in the busulphan and placebo series. Haematological toxicity was particularly frequent and severe in the busulphan series, especially in the early intake, platelet depression being the predominant manifestation.It is concluded that there is no evidence that either of the two cytotoxic drugs in the dosage prescribed improved survival for the two-year period of observation, though a final evaluation of the adjuvant chemotherapy as studied in this investigation will have to await the results at five years.
Epidemiology of RBC Transfusions in Patients With Severe Acute Kidney Injury: Analysis From the Randomized Evaluation of Normal Versus Augmented Level Study.

To assess the epidemiology and outcomes associated with RBC transfusion in patients with severe acute kidney injury requiring continuous renal replacement therapy.



Post hoc analysis of data from a multicenter, randomized, controlled trial.



Thirty-five ICUs in Australia and New Zealand.



Cohort of 1,465 patients enrolled in the Randomized Evaluation of Normal versus Augmented Level replacement therapy study.



Daily information on morning hemoglobin level and amount of RBC transfused were prospectively collected in the Randomized Evaluation of Normal versus Augmented Level study. We analyzed the epidemiology of such transfusions and their association with clinical outcomes.



Overall, 977 patients(66.7%) received a total of 1,192 RBC units. By day 5, 785 of 977 transfused patients (80.4%) had received at least one RBC transfusion. Hemoglobin at randomization was lower in transfused than in nontransfused patients (94 vs 111 g/L; p < 0.001). Mean daily hemoglobin was 88 ± 7 and 99 ± 12 g/L in transfused and nontransfused patients. Among transfused patients, 228 (46.7%) had died by day 90 when compared with 426 (43.6%) of nontransfused patients (p = 0.27). Survivors received on average 316 ± 261 mL of RBC, whereas nonsurvivors received 302 ± 362 mL (p = 0.42). On multivariate Cox regression analysis, RBC transfusion was independently associated with lower 90-day mortality (hazard ratio, 0.55; 95% CI, 0.38-0.79). However, we found no independent association between RBC transfusions and mortality when the analyses were restricted to patients surviving at least 5 days (hazard ratio, 1.29; 95% CI, 0.90-1.85). We found no independent association between RBC transfusion and renal replacement therapy-free days, mechanical ventilator-free days, or length of stay in ICU or hospital.



In patients with severe acute kidney injury treated with continuous renal replacement therapy, we found no association of RBC transfusion with 90-day mortality or other patient-centered outcomes. The optimal hemoglobin threshold for RBC transfusion in such patients needs to be determined in future randomized controlled trials.