nils-herrmann/clean_scirepeval huggingface dataset:
A new insight into the differences among non-cirrhotic and cirrhotic patients using the liver disease quality of life instrument (LDQOL).

Our aims were to validate the Brazilian Portuguese version of the Liver Disease Quality of Life Questionnaire instrument (LDQOL1.0) and evaluate this tool in non-cirrhotic patients.



The LDQOL1.0 consists of the SF-36 generic measure of health-related quality of life (HRQOL) and 12 disease-specific dimensions for patients with liver disease. The Brazilian Portuguese version instrument was administered to 103 patients with liver disease. Reliability was analyzed by studying the internal consistency of the individual disease- specific dimensions of the LDQOL, as well as by studying the test-retest reliability in a sub-group of 74 patients who completed the questionnaire on two occasions 1 to 2 weeks apart. Validity was analyzed by determining the instrument's ability to discriminate between groups of patients according to severity of the liver disease.



Internal consistency in the disease- specific dimensions was good (CACs 0.66-0.94), as well as test-retest reliability in all dimensions (ICCs of 0.64-0.96) p<0.05. We found statistically significant differences in six domains when compensated cirrhotic patients, Child A, were compared with non-cirrhotic patients. We also found statistically significant differences when we compared cirrhotic patients evaluated assessed by Child-Pugh and Meld classifications. Patients with Child C and Meld>or=15 showed worse quality of life. Moderate ceiling and floor effects were found in some disease-specific dimensions.



the Brazilian Portuguese version of the LDQOL 1.0 is very useful for measuring HRQOL in liver diseases.
Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes: a randomized clinical trial.

Insulin detemir is a soluble long-acting basal insulin analog designed to overcome the limitations of conventional basal insulin formulations. Accordingly, insulin detemir has been compared with NPH insulin with respect to glycemic control (HbA1c, prebreakfast glucose levels and variability, and hypoglycemia) and timing of administration.



People with type 1 diabetes (n = 408) were randomized in an open-label, parallel-group trial of 16-week treatment duration using either insulin detemir or NPH insulin. Insulin detemir was administered twice daily using two different regimens, either before breakfast and at bedtime (IDet(morn+bed)) or at a 12-h interval (IDet(12h)). NPH insulin was administered before breakfast and at bedtime. Mealtime insulin was given as the rapid-acting insulin analog insulin aspart.



With both insulin detemir groups, clinic fasting plasma glucose was lower than with NPH insulin (IDet(12h) vs. NPH, -1.5 mmol/l [95% CI -2.51 to -0.48], P = 0.004; IDet(morn+bed) vs. NPH, -2.3 mmol/l (-3.32 to -1.29), P < 0.001), as was self-measured prebreakfast plasma glucose (P = 0.006 and P = 0.004, respectively). The risk of minor hypoglycemia was lower in both insulin detemir groups (25%, P = 0.046; 32%, P = 0.002; respectively) compared with NPH insulin in the last 12 weeks of treatment, this being mainly attributable to a 53% reduction in nocturnal hypoglycemia in the IDet(morn+bed) group (P < 0.001). Although HbA1c for each insulin detemir group was not different from the NPH group, HbA1c for the pooled insulin detemir groups was significantly lower than for the NPH group (mean difference -0.18% [-0.34 to -0.02], P = 0.027). Within-person between-day variation in self-measured prebreakfast plasma glucose was lower for both detemir groups (both P < 0.001). The NPH group gained weight during the study, but there was no change in weight in either of the insulin detemir groups (IDet(12h) vs. NPH, -0.8 kg [-1.44 to -0.24], P = 0.006; IDet(morn+bed) vs. NPH, -0.6 kg [-1.23 to -0.03], P = 0.040).



Overall glycemic control with insulin detemir was improved compared with NPH insulin. The data provide a basis for tailoring the timing of administration of insulin detemir to the individual person's needs.
Dynamics of cytotoxic T cell subsets during immunotherapy predicts outcome in acute myeloid leukemia

Preventing relapse after chemotherapy remains a challenge in acute myeloid leukemia (AML). Eighty-four non-transplanted AML patients in first complete remission received relapse-preventive immunotherapy with histamine dihydrochloride and low-dose interleukin-2 in an international phase IV trial (ClinicalTrials.gov; NCT01347996). Blood samples were drawn during cycles of immunotherapy and analyzed for CD8+ (cytotoxic) T cell phenotypes in blood. During the first cycle of therapy, a re-distribution of cytotoxic T cells was observed comprising a reduction of T effector memory cells and a concomitant increase of T effector cells. The dynamics of T cell subtypes during immunotherapy prognosticated relapse and survival, in particular among older patients and remained significantly predictive of clinical outcome after correction for potential confounders. Presence of CD8+ T cells with specificity for leukemia-associated antigens identified patients with low relapse risk. Our results point to novel aspects of T cell-mediated immunosurveillance in AML and provide conceivable biomarkers in relapse-preventive immunotherapy.
A prospective, randomized, double‐blind, multicentre, parallel‐group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC‐3197) and adalimumab (Humira) in patients with rheumatoid arthritis

In this study, efficacy, tolerability and safety of biosimilar adalimumab (Exemptia; Zydus Cadila) was compared with reference adalimumab (Humira; AbbVie) in patients with moderate to severe rheumatoid arthritis (RA).



In this multicentre, prospective, randomized, double-blind, active controlled parallel arm study, 120 patients with moderate to severe RA were given 40 mg of either test adalimumab (Exemptia) or reference adalimumab (Humira) by subcutaneous route every other week for 12 weeks. The primary endpoint was proportion of responders in two tretament groups by American College of Rheumatology 20 (ACR20) at week 12. The secondary endpoints were change in Disease Activity Score of 28 joints - C-reactive protein (DAS28-CRP) and proportion of patients with an ACR50 and ACR70 response in two treatment groups at week 12. Safety outcomes were also assessed.



After 12 weeks, patients treated every other week with test adalimumab (Zydus Cadila) had statistically similar response rates as compared to reference adalimumab (AbbVie): ACR20 (82% vs. 79.2%; P > 0.7); ACR50 (46%, vs. 43.4%; P > 0.7); ACR70 (14% vs. 15.1%; P > 0.8). The change in DAS28-CRP score was -2.1 ± 1.09 and -2.1 ± 1.21, in test and reference products, respectively. It was statistically significant compared to baseline, but not significantly different between the two products. Three serious adverse events and no death was reported during the study. Both adalimumab preparations were safe and well tolerated in this study.



The results demonstrated biosimilarity with respect to efficacy, tolerability and safety of test adalimumab (Exemptia) and reference adalimumab (Humira) in patients with moderate to severe RA.
The impact of Xpert(®) MTB/RIF in sparsely populated rural settings.

The impact of implementing Xpert(®) MTB/RIF and the choice of instrument placement on patient care in sparsely populated areas with poor access to laboratory and radiology services have not yet been elucidated.



Prospective evaluation of three diagnostic approaches in the Central Karoo, South Africa: smear microscopy as the initial diagnostic, with sputum processing at centralised laboratories, and Xpert as the initial diagnostic with instrument placement at facility level or centralised laboratory.



Of 1449 individuals, 196 were diagnosed with TB. The proportion positive on initial testing was respectively 8%, 20% and 8% during the smear microscopy, decentralised Xpert and centralised Xpert periods. The proportion of bacteriologically confirmed cases was respectively 88%, 99% and 91% during the smear microscopy, decentralised Xpert and centralised Xpert periods. The median time to treatment was respectively 11.5 (interquartile range [IQR] 6-24), 1 (IQR 0-2) and 6 days (IQR 2-9) during the smear microscopy, decentralised Xpert and centralised Xpert periods.



Introducing Xpert as the initial diagnostic in areas with poor access to TB diagnostics increased the proportion of cases with bacteriological confirmation and reduced time to treatment initiation; however, point-of-care placement may have resulted in fewer people being evaluated for TB.
Bare metal stent versus paclitaxel eluting stent for intermediate length femoropopliteal arterial lesions (BATTLE trial): study protocol for a randomized controlled trial

Currently, endovascular treatment is indicated to treat femoropopliteal lesions ≤15 cm. However, the Achilles' heel of femoropopliteal endovascular repair remains restenosis. Paclitaxel eluting stents have shown promising results to prevent restenosis in femoropopliteal lesions compared to percutaneous transluminal angioplasty. A recently released prospective registry using a newer generation of self-expandable nitinol stents (Misago®; Terumo Corp., Tokyo, Japan) supports primary bare metal stenting as a first-line treatment for femoropopliteal lesions. To date, no studies have been designed to compare bare metal stents to paclitaxel eluting stents for the treatment of femoropoliteal lesions. The BATTLE trial was designed to compare paclitaxel eluting stents (Zilver® PTX®) and a last generation bare self-expandable nitinol stents (Misago® RX, Terumo Corp., Tokyo, Japan) in the treatment of intermediate length femoropopliteal lesions (≤14 cm).



A prospective, randomized (1:1), controlled, multicentric and international study has been designed. One hundred and eighty-six patients fulfilling the inclusion criteria will be randomized to one of the two assessments of endovascular repair to treat de novo femoropopliteal lesions ≤14 cm in symptomatic patients (Rutherford 2 to 5): bare stent group and paclitaxel eluting stent group. The primary endpoint is freedom from in-stent restenosis at 1 year defined by a peak systolic velocity index >2.4 (restenosis of >50%) at the target lesion and assessed by duplex scan. Our main objective is to demonstrate the clinical superiority of primary stenting using Zilver® PTX® stent system versus bare metal self-expandable stenting in the treatment of femoropopliteal lesions in patients with symptomatic peripheral arterial disease.



This is the first randomized and controlled study to compare the efficacy of bare metal stents and paclitaxel eluting stents for the treatment of femoropopliteal lesions. It may clarify the indication of stent choice for femoropopliteal lesions of intermediate length.
Atlas vertebra realignment and achievement of arterial pressure goal in hypertensive patients: a pilot study

Anatomical abnormalities of the cervical spine at the level of the Atlas vertebra are associated with relative ischaemia of the brainstem circulation and increased blood pressure (BP). Manual correction of this mal-alignment has been associated with reduced arterial pressure. This pilot study tests the hypothesis that correcting mal-alignment of the Atlas vertebra reduces and maintains a lower BP. Using a double blind, placebo-controlled design at a single center, 50 drug naïve (n=26) or washed out (n=24) patients with Stage 1 hypertension were randomized to receive a National Upper Cervical Chiropractic (NUCCA) procedure or a sham procedure. Patients received no antihypertensive meds during the 8-week study duration. The primary end point was changed in systolic and diastolic BP comparing baseline and week 8, with a 90% power to detect an 8/5 mm Hg difference at week 8 over the placebo group. The study cohort had a mean age 52.7±9.6 years, consisted of 70% males. At week 8, there were differences in systolic BP (−17±9 mm Hg, NUCCA versus −3±11 mm Hg, placebo; P<0.0001) and diastolic BP (−10±11 mm Hg, NUCCA versus −2±7 mm Hg; P=0.002). Lateral displacement of Atlas vertebra (1.0, baseline versus 0.04° week 8, NUCCA versus 0.6, baseline versus 0.5°, placebo; P=0.002). Heart rate was not reduced in the NUCCA group (−0.3 beats per minute, NUCCA, versus 0.5 beats per minute, placebo). No adverse effects were recorded. We conclude that restoration of Atlas alignment is associated with marked and sustained reductions in BP similar to the use of two-drug combination therapy.
Report of a phase 1/2 study of a combination of azacitidine and cytarabine in acute myelogenous leukemia and high-risk myelodysplastic syndromes.

Cytarabine resistance characterizes relapsed and refractory acute myelogenous leukemia (AML). Restoration of cytarabine sensitivity can potentially improve treatment outcome in this setting. Acquired hypermethylation of gene promoters and associated silencing of gene expression has been implicated in chemo resistance, and drug-induced hypomethylation can improve sensitivity to cytarabine in vitro. We conducted an adaptively randomized study of a combination of azacitidine, a hypomethylating agent, and cytarabine in 34 patients with AML. The combination administered in a concomitant fashion is safe at full doses of azacitidine and cytarabine, without unexpected toxicities. However, in this advanced AML population, it was difficult to deliver more than one cycle of therapy, and minimal anti-leukemia activity was seen in patients with relapsed/refractory disease. Complete remission was achieved in 2 of 6 minimally pre-treated patients. We conclude that the combination of azacitidine and cytarabine is feasible but has limited activity in relapsed/refractory AML.
Validation of self-reported diagnosis of diabetes in the 1946 British birth cohort

The aim of this study was to validate self-reported diabetes and age at diagnosis among a sample of the British population, using general practitioners (GPs) as the reference standard. Using data from the Medical Research Council National Survey of Health and Development (NSHD), self-reported diabetes was determined either in response to a direct question at five follow-ups between 1977 and 2010, or from other self-reported medical information. A validation questionnaire was sent to the GP for all participants who reported a diagnosis of diabetes and gave permission to contact their GP (172). The validity of self-reported diabetes was assessed by calculating the percentage of self-reported diabetes cases that were confirmed by their GP, i.e. the positive predictive value (PPV). The difference between self-reported and GP-confirmed age at diagnosis was analysed with a Bland-Altman plot. Completed questionnaires were obtained from 157 GPs (91.2%). Of these, 149 confirmed their patient self-reported diabetes diagnosis (PPV=94.9%). Results were similar when self-reported diabetes was assessed by responses to direct questions only (PPV=95.4%). The average difference between self-reported and GP-reported age at diagnosis was 0.6 years (95% CI 0.2-1.1). We conclude that among the British population questionnaires are a valid method to assess GP-diagnosed diabetes, as measured by responses to a direct question or by patient-reported medical information.
Two-micron thulium laser resection of the distal ureter and bladder cuff during nephroureterectomy for upper urinary tract urothelial carcinoma

The thulium laser (Tm-laser) technique has been used in the management of many urologic conditions. The present study aimed to evaluate the use of this technique for distal ureter and bladder cuff (DUBC) excision during nephroureterectomy for upper urinary tract urothelial carcinoma (UUT-UC). Fifty-eight patients with UUT-UC who underwent radical nephroureterectomy were included in this retrospective study. DUBC was managed by open excision in 24 cases, by transurethral electrosurgery in 17 cases, and by transurethral Tm-laser in 17 cases. Perioperative measures and oncologic outcomes were compared among the three groups. Furthermore, 11 human ureteral segments were collected to measure the burst pressure and show physical pressure tolerance, and six ureteral segments were assessed histologically to investigate the sealing effect. Operative time and hospital stay were significantly longer, and intraoperative blood loss was significantly greater in the open excision group than in the electrosurgery and Tm-laser groups (P < 0.05 for all). There were no significant differences in these parameters between the electrosurgery and Tm-laser groups. In addition, there were no significant differences in the incidences of bladder tumors and retroperitoneal recurrence of urothelial carcinoma among the three groups. The coagulation time and resection time were significantly shorter in the Tm-laser group than in the electrosurgery group. The mean burst pressure did not differ significantly between the tissues sealed by electrosurgery and by Tm-laser. Histopathological analyses showed that distal ureters were completely sealed by both electrosurgery and Tm-laser. The Tm-laser technique is superior to open excision and comparable to transurethral electrosurgery in the management of DUBC during nephroureterectomy for UUT-UC, offering an alternative treatment option for this condition.
Prepulse facilitation and prepulse inhibition in schizophrenia patients and their unaffected siblings

Deficits in schizophrenia patients and their first-degree relatives have been reported in prepulse inhibition (PPI), a phenomenon that measures an early stage of information processing (sensorimotor gating). It is less clear whether these information processing deficits extend to prepulse facilitation (PPF), which measures a later stage of generalized alerting or orienting.



This study examined three separate issues: first, whether schizophrenia patients have deficits in PPI and PPF; second, whether the siblings of patients show deficits in these processes; and third, whether prepulse duration influences the degree of the deficits. These issues were examined in 76 schizophrenia patients, 36 of their siblings, and 41 normal control subjects.



Patients and siblings did not differ from control subjects in PPI, perhaps due to the use of different procedural parameters compared with other laboratories that have consistently found PPI deficits in schizophrenia patients. Patients and their siblings produced significantly less PPF than control subjects. For both PPI and PPF, prepulse duration was not a significant factor.



These results imply that PPF deficits reveal a generalized alerting or orienting deficit that is present in both schizophrenia patients and their siblings, suggesting that this deficit may be tapping an endophenotypic vulnerability factor.
The extent of lymphadenectomy seems to be associated with better survival in patients with nonmetastatic upper-tract urothelial carcinoma: how many lymph nodes should be removed?

The role and extent of lymphadenectomy in patients with upper-tract urothelial carcinoma (UTUC) is debated.



To establish whether the number of lymph nodes (LNs) removed might be associated with better cause-specific survival in patients with UTUC.



The study included 552 consecutive patients who underwent radical nephroureterectomy (RNU) and lymphadenectomy between 1992 and 2006.



Patients were treated with RNU and lymphadenectomy.



Univariable and multivariable Cox proportional hazards regression models addressed the association between the number of LNs removed and cause-specific mortality (CSM). The number of LNs removed was coded as a cubic spline to allow for nonlinear effects. Finally, the most informative cut-off for the number of removed LNs was identified.



In the entire population, the number of LNs removed was not associated with CSM in univariable (hazard ratio [HR]: 0.99; p=0.16) or in multivariable (HR: 0.97; p=0.12) analyses. In contrast, in the subgroup of pN0 patients (n=412), the number of LNs removed achieved the independent predictor status of CSM (HR: 0.93; p=0.02). Eight LNs removed was the most informative cut-off in predicting CSM (HR: 0.42; p=0.004). The inclusion of the variable defining dichotomously the number of removed LNs (< 8 vs > or = 8) in the base model (age, Eastern Cooperative Oncology Group performance status, pathologic stage, grade, architecture, and lymphovascular invasion) significantly increased the accuracy in predicting CSM (+1.7%; p<0.001).



The extension of the lymphadenectomy in pN0 UTUC patients seems to be associated with CSM. Longer survival was observed in patients in whom at least eight LNs had been removed.
FKBP5 as a possible moderator of the psychosis-inducing effects of childhood trauma.

FK506 binding protein 5 (FKBP5) has repeatedly been shown to be a critical determinant of post-traumatic stress disorder (PTSD) and depression following childhood trauma.



To examine the role of FKBP5-trauma interactions in the partly stress-related psychosis phenotype.



In 401 general population twins, four functional polymorphisms were examined in models of psychosis and cortisol, and followed up in models of psychosis in three samples at different familial liability (175 controls, 200 unaffected siblings and 195 patients with a psychotic disorder).



The most consistent finding was an interaction between childhood trauma and rs9296158/rs4713916 on psychotic symptoms and cortisol in the twin sample, combined with a directionally similar interaction in siblings (rs4713916) and patients (rs9296158), A-allele carriers at both polymorphisms being most vulnerable to trauma.



Trauma may increase the risk of psychosis through enduring changes in the cortisol feedback loop, similar to that for PTSD, suggesting comparable biological mechanisms for psychosis across diagnostic boundaries.
No improvement in cardiovascular risk factors in overweight and obese subjects after supplementation with vitamin D3 for 1 year.

Cross-sectional studies indicate vitamin D to be of importance for glucose tolerance, blood pressure and serum lipids, but whether supplementation with vitamin D would improve cardio-vascular risk factors is not known.



The study was a 1 year, double blind placebo-controlled intervention trial performed at the University Hospital of North Norway from November 2005 to October 2007. Subjects. A total of 438 overweight or obese subjects, 21-70 years old, were included and 330 completed the study.



The subjects were randomized to vitamin D (cholecalciferol, vitamin D(3)) 40 000 IU per week (DD group), vitamin D 20 000 IU per week (DP group), or placebo (PP group). All subjects were given 500 mg calcium daily.



Fasting serum lipids and blood pressure were measured and an oral glucose tolerance test performed at start and end of the study.



At baseline the mean serum 25(OH)D levels were 58 nmol L(-1) (all subjects) and increased to 140 and 101 nmol L(-1) in the DD and DP groups, respectively. No significant differences were found between the three groups regarding change in measures of glucose metabolism or serum lipids. In the DP group, there was a slight but significant increase in systolic blood pressure compared with the placebo group.



Our results do not support a positive effect of vitamin D on glucose tolerance, blood pressure or serum lipids. Further studies in subjects with low serum 25(OH)D levels combined with impaired glucose tolerance, hypertension or dyslipidaemia are needed.