nils-herrmann/clean_scirepeval huggingface dataset:
Atypical manifestations in Brazilian patients with neuro-Behçet’s disease

Type and frequency of systemic and neurologic manifestations of Behçet’s disease (BD) vary with ethnicity. In Brazil, BD occurs as sporadic cases. We describe clinical and radiological features of 36 Brazilian patients of mixed ethnicity with neuro-Behçet’s disease (NBD). Medical records of 178 BD patients were reviewed and 36 (20%) NBD patients were identified. Twenty-one NBD patients (58.3%) were female and 27 (75%) presented with parenchymal manifestations. Brainstem involvement was the most common neurologic syndrome (41.7%). Seizures (27.8%), isolated aseptic meningitis (16.7%), optic neuropathy (ON) (16.7%), cerebral venous thrombosis (CVT) (8.3%), peripheral neuropathy (2.8%), and spinal cord involvement (5.6%) were other neurologic manifestations observed among Brazilian NBD patients. Eighteen (50%) had at least one relapse, and isolated aseptic meningitis was the most common relapsing manifestation. No significant differences concerning the number of relapses between parenchymal and non-parenchymal groups were found. A multivariate model including disease duration, cell count in spinal fluid, cyclosporine use, immunosuppressive use at disease onset, age at NBD onset, and ON did not reveal any significant associations with NBD relapse. There was a low frequency of CVT and an unexpected higher number of isolated aseptic meningitis. Brazilian NBD patients present more parenchymal and atypical manifestations, and relapse more often than NBD patients from other populations.
Feasibility, Acceptability, and Preliminary Efficacy of an Online HIV Prevention Program for Diverse Young Men who have Sex with Men: The Keep It Up! Intervention

Young men who have sex with men (YMSM) are disproportionately infected with HIV/AIDS and there are few prevention programs with published efficacy for this population. This study evaluated the feasibility, acceptability, and preliminary efficacy of an online, interactive, and highly engaging HIV prevention program called Keep It Up! The intervention was designed to be delivered to diverse YMSM upon receiving an HIV negative text result, with the goal for them to “Keep It Up” and stay negative. In a randomized clinical trial, the intervention was compared to an online didactic HIV knowledge condition. The study sample included 102 sexually active YMSM. Participants reported completing online modules in settings that were private and not distracting. Mixed methods data showed intervention participants felt the program was valuable and acceptable. Compared to the control condition, participants in the intervention arm had a 44 % lower rate of unprotected anal sex acts at the 12-week follow-up (p < 0.05). Los hombres jóvenes que tienen relaciones sexuales con hombres (HJSH) están desproporcionadamente infectados con el VIH/SIDA y son pocos los programas de prevención con eficacia publicada para esta población. Este estudio evaluó la viabilidad, aceptabilidad y eficacia preliminar de un programa de prevención del VIH llamado Manténgalo! (Keep It Up! en ingles) que se ofrece por internet y que es interactivo y atrayente. La intervención se diseñó para ser entregada a diversos HJSH al recibir estos un resultado negativo de VIH. El objetivo es que se “mantengan” negativos. En una prueba clínica aleatoria se comparó la intervención con una condición didáctica de conocimiento del VIH ofrecida por internet. La muestra de estudio incluyó 102 HJSH sexualmente activos. Los participantes informaron haber completado módulos por internet en entornos privados y sin distracciones. Los datos obtenidos mediante diferentes métodos muestran que quienes participaron en la intervención sintieron que el programa era valioso y aceptable. Comparado con la condición de control, los participantes en el grupo de intervención presentaron una reducción del 44 % en los actos de sexo anal sin protección en su seguimiento 12 semanas después (p < 0.05).
Effect of nerve-sparing radical hysterectomy on bladder function recovery and quality of life in patients with cervical carcinoma.

To investigate the bladder function recovery and quality of life (QOL) using nerve-sparing radical hysterectomy (NSRH) in treating early invasive cervical carcinoma.



Subjects included patients who underwent radical hysterectomy by laparotomy for early-stage cervical carcinoma. Thirty-one patients were randomly assigned to 2 groups: group A, 15 patients who underwent NSRH; and group B, 16 patients who underwent classical radical hysterectomy. We observed the patients' general clinical information, surgical characteristics, postoperative vital signs, pathological findings, adjuvant therapies, and adverse effects. A urodynamic study was used to assess the bladder function. The patients' QOL was evaluated by Functional Assessment of Cervical Cancer Therapy (FACT-Cx).



Twenty-nine patients completed the study. No significant differences were found in age, body mass index, surgery characteristics, pathological findings, adjuvant therapies, and main adverse effects between the 2 groups (P > 0.05). The postoperative time of bladder function recovery in group A was obviously earlier than that in group B (P < 0.05). The urodynamic study showed that the extent of bladder function recovery in group A was better than that in group B (P < 0.05). The QOL in group A evaluated 1 year after operation was improved compared with that in group B (P < 0.05). The QOL analysis showed that group A did much better than group B in social and family life, emotional well-being, working status, and the symptom correlated with the operation (P < 0.05). No significant differences were found in basic bodily functions (P > 0.05).



Nerve-sparing radical hysterectomy is a safe and reliable technique for early invasive cervical carcinoma. The postoperative bladder function recovery and the patients' QOL were improved after NSRH compared with the control group. Therefore, NSRH could be an alternative management to modify the classical surgery for cervical carcinoma with International Federation of Gynecology and Obstetrics stages IB1 to IIA.
Ankylosing neurogenic myositis ossificans of the hip. An enhanced volumetric CT study.

Neurogenic myositis ossificans is a disabling condition affecting the large joints of patients with severe post-traumatic impairment of the central nervous system. It can result in ankylosis of the joint and vascular or neural compression. Surgery may be hazardous with potential haemorrhage, neurovascular injury, iatrogenic fracture and osteochondral injury. We undertook pre-operative volumetric CT assessment of 45 ankylosed hips with neurogenic myositis ossificans which required surgery. Helical CT with intravenous contrast, combined with two- and three-dimensional surface reconstructions, was the only pre-operative imaging procedure. This gave good differentiation of the heterotopic bone from the adjacent vessels. We established that early surgery, within 24 months of injury, was neither complicated by peri-operative fracture nor by the early recurrence of neurogenic myositis ossificans. Surgical delay was associated with a loss of joint space and a greater degree of bone demineralisation. Enhanced volumetric CT is an excellent method for the pre-operative assessment of neurogenic myositis ossificans and correlates well with the operative findings.
A randomized placebo-controlled phase III trial of oral laquinimod for multiple sclerosis

The phase III placebo-controlled BRAVO study assessed laquinimod effects in patients with relapsing-remitting MS (RRMS), and descriptively compared laquinimod with interferon beta (IFNβ)-1a (Avonex® reference arm). RRMS patients age 18–55 years with Expanded Disability Status Scale (EDSS) scores of 0–5.5 and documented pre-study relapse (≥ 1 in previous year, 2 in previous 2 years, or 1 in previous 1–2 years and ≥ 1 GdE lesion in the previous year) were randomized (1:1:1) to laquinimod 0.6 mg once-daily, matching oral placebo, or IFNβ-1a IM 30 μg once-weekly (rater-blinded design), for 24 months. The primary endpoint was annualized relapse rate (ARR); secondary endpoints included percent brain volume change (PBVC) and 3-month confirmed disability worsening. In all, 1,331 patients were randomized: laquinimod (n = 434), placebo (n = 450), and IFNβ-1a (n = 447). ARR was not significantly reduced with laquinimod [−18 %, risk ratio (RR) = 0.82, 95 % CI 0.66–1.02; p = 0.075] vs. placebo. Laquinimod significantly reduced PBVC (28 %, p < 0.001). Confirmed disability worsening was infrequent (10 % laquinimod, 13 % placebo). The change in confirmed disability worsening with laquinimod measured using EDSS was −31 % [hazard ratio (HR) 0.69, p = 0.063], and using Multiple Sclerosis Functional Composite (MSFC) z-score was −77 % (p = 0.150), vs. placebo. IFNβ-1a reduced ARR 26 % (RR = 0.74, 95 % CI 0.60–0.92, p = 0.007), showed no effect on PBVC loss (+11 %, p = 0.14), and changes in disability worsening were −26 and −66 % as measured using the EDSS (HR 0.742, p = 0.13) and MSFC (p = 0.208), respectively. Adverse events occurred in 75, 82, and 70 % of laquinimod, IFNβ-1a, and placebo patients, respectively. Once-daily oral laquinimod 0.6 mg resulted in statistically nonsignificant reductions in ARR and disability progression, but significant reductions in brain atrophy vs. placebo. Laquinimod was well-tolerated.
Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin.

The interferon-free combination of the protease inhibitor ABT-450 with ritonavir (ABT-450/r) and the NS5A inhibitor ombitasvir (also known as ABT-267) plus the nonnucleoside polymerase inhibitor dasabuvir (also known as ABT-333) and ribavirin has shown efficacy against the hepatitis C virus (HCV) in patients with HCV genotype 1 infection. In this phase 3 trial, we evaluated this regimen in previously untreated patients with HCV genotype 1 infection and no cirrhosis.



In this multicenter, randomized, double-blind, placebo-controlled trial, we assigned previously untreated patients with HCV genotype 1 infection, in a 3:1 ratio, to an active regimen consisting of a single-tablet coformulation of ABT-450/r-ombitasvir (at a once-daily dose of 150 mg of ABT-450, 100 mg of ritonavir, and 25 mg of ombitasvir), and dasabuvir (250 mg twice daily) with ribavirin (in doses determined according to body weight) (group A) or matching placebos (group B). The patients received the study treatment during a 12-week double-blind period. The primary end point was sustained virologic response at 12 weeks after the end of treatment. The primary analysis compared the response rate in group A with the response rate (78%) in a historical control group of previously untreated patients without cirrhosis who received telaprevir with peginterferon and ribavirin. Adverse events occurring during the double-blind period were compared between group A and group B.



A total of 631 patients received at least one dose of the study drugs. The rate of sustained virologic response in group A was 96.2% (95% confidence interval, 94.5 to 97.9), which was superior to the historical control rate. Virologic failure during treatment and relapse after treatment occurred in 0.2% and 1.5%, respectively, of the patients in group A. The response rates in group A were 95.3% among patients with HCV genotype 1a infection and 98.0% among those with HCV genotype 1b infection. The rate of discontinuation due to adverse events was 0.6% in each study group. Nausea, pruritus, insomnia, diarrhea, and asthenia occurred in significantly more patients in group A than in group B (P<0.05 for all comparisons). Reductions in the hemoglobin level were all of grade 1 or 2; reductions of grade 1 and 2 occurred in 47.5% and 5.8%, respectively, of the patients in group A, whereas grade 1 reductions occurred in 2.5% of the patients in group B.



In previously untreated patients with HCV genotype 1 infection and no cirrhosis, a 12-week multitargeted regimen of ABT-450/r-ombitasvir and dasabuvir with ribavirin was highly effective and was associated with a low rate of treatment discontinuation.
Capecitabine and bevacizumab for non-resectable metastatic colorectal cancer patients: final results from phase II AIO KRK 0105 trial

Current guidelines recommend treatment with capecitabine and bevacizumab for patients (pts) with non-resectable metastatic colorectal cancer (mCRC), although clinical data in this particular patient group are lacking. Previously untreated patients with non-resectable mCRC were to receive capecitabine (1,250 mg/sqm bid d1-14 oral) and bevacizumab (7.5 mg/kg i.v.) every 3 weeks. Progression-free survival (PFS) was the primary endpoint. Secondary endpoints include overall survival (OS), objective response rate (ORR) and toxicity. 82 pts were included: 40 female, median age 70 (range 50–86). ECOG PS 0/1/2 was 38/52/10%, respectively. Synchronous metastases were present in 58 pts. 16 pts had primary tumor in situ. Median treatment duration was 4.1 months (6 cycles). Toxicity was generally mild. ORR was 38%, with 5 complete and 23 partial responses. Median PFS was 7.0 months [95% CI (5.0-9.1)] and OS 17.9 months [95% CI (14.6-21.6)]. Second- and third-line systemic therapy was given to 57% and 33% of pts, respectively. Besides the favourable tolerability, PFS and OS were shorter than reported by other trials. Careful patient selection for upfront capecitabine and bevacizumab is essential.
Examining five- and ten-year survival in older women with breast cancer using cancer-specific geriatric assessment.

To examine five- and ten-year survival based on cancer-specific geriatric assessment (C-SGA) in older women with early stage breast cancer.



We evaluated 660 women ≥65-years old diagnosed with stage I-IIIA primary breast cancer and attending physician permission to contact in four geographic regions in the United States of America (USA). Data were collected over ten-years of follow-up from consenting women's medical records, telephone interviews, National Death Index and Social Security Death Index. C-SGA was described by four domains using six measures: socio-demographic (financial resources); clinical (comorbidity, obesity); function (physical function limitations); and psychosocial (general mental health, social support). Survival from all-cause and breast-cancer-specific mortality and receipt of guideline-recommended therapy was assessed for different groups of subjects with C-SGA domain deficits (cut-off ≥3 deficits).



The proportion of women with ≥3 C-SGA deficits surviving ten-years was consistently statistically significantly lower (all-cause 26% versus 46% and breast-cancer-specific 76% versus 89%, p≤0.04). The proportion significantly decreased as number of C-SGA deficits increased (linear trend p<0.0001). Receipt of guideline-recommended therapy decreased with age but not consistently by number of C-SGA deficits. The all-cause and breast-cancer-specific death rate at five- and ten-years was consistently approximately two times higher in women with ≥3 C-SGA deficits even when fully adjusted for confounding factors (HR(5-yrAllCauseFullyAdjusted)=1.87 [1.36-2.57], HR(10-yrAllCauseFullyAdjusted)=1.74 [1.35-2.15], HR(5-yrBreastCancerFullyAdjusted)=1.95 [1.18-3.20], HR(10-yrBreastCancerFullyAdjusted)=1.99 [1.21-3.28]).



Regardless of age and stage of disease, C-SGA predicts five- and ten-year all-cause and breast-cancer-specific survival in older women. Hence, C-SGA may provide an effective strategy to guide treatment decision-making and to identify risk factors for intervention.
Comparison of effects of rosuvastatin (10 mg) versus atorvastatin (40 mg) on rho kinase activity in caucasian men with a previous atherosclerotic event.

In addition to inhibiting cholesterol biosynthesis, statins also inhibit the formation of isoprenoid intermediates, which are required for the activation of the Rho/Rho kinase (ROCK) pathway. Increased ROCK activity has been implicated in causing endothelial dysfunction and atherosclerosis. However, it is not known whether statins, at doses used to lower cholesterol levels, inhibit ROCK activity in humans with atherosclerosis. Furthermore, it is not known whether lipophilic and hydrophilic statins differ in their ability to inhibit ROCK activity. Accordingly, we enrolled 30 men with stable atherosclerosis (low-density lipoprotein [LDL] > or =100 mg/dL) in a randomized, double-blind study comparing equivalent LDL-lowering doses of a hydrophilic statin (rosuvastatin 10 mg once a day) with a lipophilic statin (atorvastatin 40 mg once a day) for 28 days. We assessed the change in lipids, ROCK activity, and flow-mediated dilation (FMD) of the brachial artery before and after statin therapy. Both treatment groups exhibited comparable 30% to 32% and 42% to 45% reductions in total and LDL cholesterol, respectively. Only atorvastatin reduced triglycerides, and neither statin altered high-density lipoprotein cholesterol. Whereas both statins inhibited ROCK activity (p <0.0001), the extent of inhibition was greater with rosuvastatin (18 +/- 2% vs 8 +/- 2%, p = 0.0006). Statins also improved FMD from 7.4 +/- 0.6 to 9.3 +/- 0.4 (p = 0.003) with rosuvastatin being slightly better than atorvastatin. The inhibition of ROCK activity by statins did not correlate with reductions in LDL (p = 0.57) but was associated with improvement in FMD. In conclusion, these findings provide direct clinical evidence that statins, at clinically relevant doses, could differentially inhibit ROCK activity and improve endothelial function by cholesterol-independent mechanism.
Effect of egg ingestion on trimethylamine-N-oxide production in humans: a randomized, controlled, dose-response study.

It is important to understand whether eating eggs, which are a major source of dietary choline, results in increased exposure to trimethylamine-N-oxide (TMAO), which is purported to be a risk factor for developing heart disease.



We determined whether humans eating eggs generate TMAO and, if so, whether there is an associated increase in a marker for inflammation [ie, high-sensitivity C-reactive protein (hsCRP)] or increased oxidation of low-density lipoprotein (LDL).



In a longitudinal, double-blind, randomized dietary intervention, 6 volunteers were fed breakfast doses of 0, 1, 2, 4, or 6 egg yolks. Diets were otherwise controlled on the day before and day of each egg dose with a standardized low-choline menu. Plasma TMAO at timed intervals (immediately before and 1, 2, 4, 8, and 24 h after each dose), 24-h urine TMAO, predose and 24-h postdose serum hsCRP, and plasma oxidized LDL were measured. Volunteers received all 5 doses with each dose separated by >2-wk washout periods.



The consumption of eggs was associated with increased plasma and urine TMAO concentrations (P < 0.01), with ∼14% of the total choline in eggs having been converted to TMAO. There was considerable variation between individuals in the TMAO response. There was no difference in hsCRP or oxidized LDL concentrations after egg doses.



The consumption of ≥2 eggs results in an increased formation of TMAO. Choline is an essential nutrient that is required for normal human liver and muscle functions and important for normal fetal development. Additional study is needed to both confirm the association between TMAO and atherosclerosis and identify factors, microbiota and genetic, that influence the generation of TMAO before policy and medical recommendations are made that suggest reduced dietary choline intake.
Levels of 5-hydroxymethyl-2'-deoxyuridine in DNA from blood of women scheduled for breast biopsy.

Systemic oxidative stress is thought to contribute to risk of various cancers, including breast cancer. DNA repair ability also has been associated with breast cancer risk. In this work, we examined levels of oxidative DNA damage as an indication of breast cancer risk in women because oxidative DNA damage levels should reflect the net balance of oxidative stress and DNA repair ability. Levels of 5-hydroxymethyl-2'-deoxyuridine, one form of oxidative DNA damage, were measured in DNA from blood of women scheduled for breast biopsy. The blood samples analyzed included women whose biopsy results indicated invasive breast cancer, high-risk lesions (atypical hyperplasia or carcinoma in situ), or benign lesions. Mean levels of 5-hydroxymethyl-2'-deoxyuridine were significantly higher in blood of women who had high risk or invasive breast lesions versus women with benign lesions. If atypical hyperplasia or carcinoma in situ are precursor lesions for breast cancer, then these results suggest that oxidative DNA damage may be involved in the cancer process before invasive cancer develops.
Effect of common single-nucleotide polymorphisms in acetylsalicylic acid metabolic pathway genes on platelet reactivity in patients with diabetes

Platelet reactivity in patients on acetylsalicylic acid (ASA) therapy can be influenced by physiological or pathological conditions affecting ASA pharmacokinetics or pharmacodynamics. The mechanism of such variability in the therapeutic response to ASA, particularly in diabetic patients, is poorly understood. The rate of elimination of ASA and its metabolite, salicylic acid (SA), is likely a major factor determining drug efficacy. The objective of this study was to investigate the effect of genetic polymorphisms in the selected candidate genes within the ASA metabolic pathway on the platelet reactivity and concentration of ASA and thromboxane A(2) (TxA(2)) metabolites in a population of patients with type 2 diabetes mellitus (T2DM).



The study cohort consisted of 287 Caucasians with T2DM who had been taking ASA tablets at the dose of 75 mg per day for at least 3 months. Platelet reactivity analyses were performed using VerifyNow Aspirin and PFA-100 assays. The measured ASA metabolite included salicylic acid (ASA), and TxA(2) metabolites included serum TxB(2) and urinary 11-dh-TxB(2). Genotyping for the selected 18 single-nucleotide polymorphisms (SNPs) within 5 genes of the ASA metabolic pathway was performed using a Sequenom iPLEX platform.



No statistically significant association was observed between the investigated SNPs genotypes, platelet reactivity, and measured metabolites in the investigated cohort of patients.



The results of our study failed to confirm that the selected variants in the genes within the ASA metabolic pathway might contribute to platelet reactivity in a diabetic population treated with ASA.
Clinical outcomes of laparo-endoscopic single-site surgery radical nephrectomy

The conventional laparoscopic surgery is now paving way to the new technologies including robotic and laparoscopic single-site surgery (LESS). We present our updated experience on LESS radical nephrectomy (LESS–RN). The data from patients undergoing LESS–RN in our two institutions were reviewed along with various clinical and pathological parameters. Between 2008 and 2011, 42 LESS–RN were performed (right = 22, left = 20) with mean (range) age and BMI of 63.7 (33–86) years and 25.1 (18–38.6) kg/m2, respectively. In addition to the instruments in the single port, one extra 3-mm needlescopic instrument was required in 19 patients (right = 17, left = 2). In three patients, two additional 5-mm trocars and instruments were required. None required open conversion. The recorded adverse events include one bowel injury (intraoperative closure without the need for stoma), one postoperative bleeding requiring blood transfusion, one prolonged ileus, and one deep venous thrombosis. The resected specimens revealed pT1a (n = 3), pT1b (n = 33), pT2a (n = 4), and pT3b (n = 2) tumors. The finding of pT3b was incidental rather than planned procedure. None of the patients had positive margins. LESS–RN has proven to be feasible and safe. Beyond cosmesis, further advantages of this approach need to be addressed by randomized trials.