nils-herrmann/clean_scirepeval huggingface dataset:
Isolated ductus arteriosus aneurysm in the fetus and infant: a multi-institutional experience.

The purpose of this study was to describe the clinical characteristics and outcome and to elucidate the pathogenesis of ductus arteriosus aneurysm (DAA).



Ductus arteriosus aneurysm is a rare lesion that can be associated with severe complications including thromboembolism, rupture and death.



We reviewed the clinical records, diagnostic imaging studies and available histology of 24 cases of DAA, diagnosed postnatally (PD) in 15 and antenatally (AD) in 9 encountered in five institutions.



Of PD cases, 13 presented at <2 months, and all AD cases were detected incidentally after 33 weeks of gestation during a late trimester fetal ultrasound study. Of the 24, only 4 had DAA-related symptoms and 6 had associated syndromes: Marfan, Smith-Lemli-Opitz, trisomies 21 and 13 and one possible Ehlers-Danlos. Three had complications related to the DAA: thrombus extension into the pulmonary artery, spontaneous rupture, and asymptomatic cerebral infarction. Six underwent uncomplicated DAA resection for ductal patency, DAA size or extension of thrombus. In the four examined, there was histologic evidence of reduced intimal cushions in two and abnormal elastin expression in two. Five of the 24 died, with only one death due to DAA. Of 19 survivors, all but one remain clinically asymptomatic at a median follow-up of 35 months; however, two have developed other cardiac lesions that suggest Marfan syndrome. A review of 200 consecutive third trimester fetal ultrasounds suggests an incidence of DAA of 1.5%.



Ductus arteriosus aneurysm likely develops in the third trimester perhaps due to abnormal intimal cushion formation or elastin expression. Although it can be associated with syndromes and severe complications, many affected infants have a benign course. Given the potential for development of other cardiac lesions associated with connective tissue disease, follow-up is warranted.
The expression of CYP2W1: a prognostic marker in colon cancer.

The enzyme Cytochrome P450 2W1 (CYP2W1) is found in fetal colon tissue and is also detected in colorectal cancer but not in non-transformed tissue. In a pilot study, we reported that the immunohistochemically-detected expression of CYP2W1 might be of prognostic value since high expression of CYP2W1 was indicative of a worse prognosis. The aim of this study was to validate the pilot study's results using a larger, independent group of patients with colon cancer.



Immunohistochemical detection of CYP2W1 in 235 malignant colon tumors of stage II and III, was carried out using a polyclonal antibody. Grading of staining was carried out by two independent readers. The highest grade that involved more than 5% of the tumor area on each slide was used for the classification of CYP2W1 expression.



CYP2W1 was expressed at high levels in 30% of the tumors. In the entire colon cancer group it was an independent prognostic factor in multivariate analysis (p=0.04), where high expression (grade 3) correlated with worse outcome. CYP2W1 expression was an independent prognostic factor in the subgroup of patients with colon cancer stage III (p=0.003), but not for those with stage II. In 107 cases, two slices from different areas of the same tumor were available, and no significant difference in CYP2W1 expression between the slices was observed (r=0.53, p<0.001).



The results of the current study were in agreement with those of the previous pilot study and show that higher expression of CYP2W1 seems to be of prognostic value in colon cancer. Furthermore, we found equal expression in slices from two different areas of the same tumor. Since the CYP2W1 enzyme has been shown to catalytically activate compounds to cytotoxic products, the enzyme might be used as a novel drug target for the treatment of colon cancer.
Fish oil supplementation decreases serum soluble receptor activator of nuclear factor-kappa B ligand/osteoprotegerin ratio in female patients with rheumatoid arthritis.

Soluble receptor activator of nuclear factor-kappa B ligand (sRANKL) to osteoprotegerin ratio is designated as a bone metabolism equation in many rheumatologic disorders and would be modified with fish oil (FO) supplementation.



Eighty-three females with rheumatoid arthritis were divided randomly to 40 and 43 patients treated with (1 g/day) or without FO for 3 months accompanied with conventional drugs, respectively. Osteoprotegerin, sRANKL, tumor necrosis factor alpha (TNFalpha) serum levels were measured before and after treatment.



Serum levels of osteoprotegerin increased, although sRANKL, TNFalpha and sRANKL/osteoprotegerin ratio decreased with FO therapy. A significant positive correlation was observed between sRANKL/osteoprotegerin ratio and TNFalpha levels (r=0.327, p=0.040) in the FO-treated group.



FO could decrease the inflammatory response by lowering of serum TNFalpha levels and sRANKL/osteoprotegerin ratio.
Immature platelet fraction and high-on treatment platelet reactivity with ticagrelor in patients with acute coronary syndromes

Residual high-on treatment platelet reactivity (HRPR) has been associated with a 2–9 fold increased risk of acute ischemic events in patients with acute coronary syndromes or coronary stenting. However, the mechanism of suboptimal platelet inhibition are still poorly understood. Aim of present study was to evaluate the role of the percentage of reticulated platelets on HRPR with ticagrelor. In patients treated with ASA (100–160 mg) and ticagrelor (90 mg twice a day) platelet reactivity and the reticulated platelets fraction (immature platelets fraction, IPF) were assessed at 30–90 days after acute coronary syndrome. Aggregation was assessed by multiple-electrode aggregometry. HRPR was defined as ADP test >417 AU*min. Our population is represented by 190 patients, divided according to tertiles values of IPF (<2.5; 2.5–3.99; ≥4 %). Higher IPF was associated to a larger platelet volume and lower platelets count (p < 0.001), and inversely related with a history of previous coronary revascularization (p = 0.03). Twenty-one out of 190 (11.0 %) patients displayed HRPR. No difference in the levels of circulating IPF was found in patients with or without HRPR (p = 0.25), with no correlation between the rate of reticulated platelets and platelet reactivity at ADP test (r = −0.084, p = 0.26). In fact no association was observed between high levels of IPF and the occurrence of HRPR (adjusted OR[95 % CI] = 0.69[0.34–1,37], p = 0.28), even after correction for baseline differences. In patients treated with ticagrelor, the levels of circulating reticulated platelets assessed at 30–90 days post-ACS are not associated with platelet reactivity or the occurrence of HRPR.
A phase II trial of chemoradiation therapy with weekly oxaliplatin and protracted infusion of 5-fluorouracil for esophageal cancer

Chemoradiation therapy using regimens containing cisplatin and 5-fluorouracil are most commonly used for inoperable cancer of the esophagus. Cisplatin is relatively toxic and is not suitable for many patients. Little data exists using platinum analogues together with protracted infusion 5-fluorouracil and radiation therapy in the curative setting.  Fourteen patients with localised oesophageal cancer suitable for curative chemoradiation therapy registered on the study. Chemotherapy consisted of 5-fluorouracil 225 mg/m2 daily throughout radiation therapy, with oxaliplatin 60 mg/m2 weekly. The radiation dose was 56 to 60 Gy in 28 to 30 fractions.  The median age of the patients was 70.5 years. Therapy was associated with excessive grade 3 and 4 non-hematologic toxicity. There was one treatment related death. The median progression-free survival was 31.5 months and median overall survival 32.6 months. Six patients achieved a prolonged complete endoscopic and radiological response.  Although weekly oxaliplatin in combination with infusional 5 fluorouracil produces durable remissions in esophageal cancer, the regimen used in this trial was not acceptable for routine use. Future protocols should incorporate lower chemotherapy doses.
Hyaluronic acid in the treatment of osteoarthritis of the knee.

We examined the efficacy, safety and patient satisfaction of intra-articular hyaluronic acid (HA) in patients with osteoarthritis of the knee.



One hundred patients with mild to moderate osteoarthritis of the knee entered a randomized blind-observer trial of 6 months HA vs placebo. Primary efficacy criteria were pain on walking, measured with a visual analogue scale, and the Lequesne Index.



For pain on walking, a significant difference in favour of HA was found for completed patients at week 5, the end of the course of injections, and at month 6, the end of the study (P = 0.0087 and P = 0.0049, respectively). Further analysis using the Last Observation Carried Forward (LOCF) also showed a significant benefit favouring HA at month 6 (P = 0.0010). For the Lequesne Index, a significant difference in favour of HA was found at week 5 (P = 0.030) and at month 2 (P = 0.0431), but this was only of borderline significance at month 4 (P = 0.0528). Patients' global assessment of efficacy favoured HA at month 6 (P = 0.012). Improvement in other secondary criteria was generally superior in the HA group compared to placebo both at week 5 and month 6. Adverse events, mainly local injection site reactions, occurred in both groups with equal frequency.



The study demonstrated that five weekly intra-articular injections of sodium hyaluronate (Hyalgan) were superior to placebo and well tolerated in patients with osteoarthritis of the knee with a symptomatic benefit which persisted for 6 months.
Reliability and validity of childhood asthma control test in a population of Chinese asthmatic children

No quick and easy assessment tool is presently available to measure asthma control and outcome in Chinese children. We translated an established seven-item questionnaire into the Chinese Childhood Asthma Control Test (C-CACT) to measure asthma symptoms and their effect on daily function in 247 children aged 4–11 years enrolled from specialty clinics around Tainan. Subjects were classed as having either intermittent or persistent asthma and were evaluated at two outpatient visits 4–8 weeks apart (baseline and follow-up). C-CACT at baseline correlated significantly with physician evaluation scores (PES) except in predicted peak expiratory flow rate. There were significant differences for mean C-CACT score and mean PES between the intermittent group and persistent group. Internal consistency reliability of the survey was 0.741 at baseline and 0.759 at the follow-up visit. Test–retest reliability among 209 patients with the same specialist rating of asthma control at baseline and follow-up was r = 0.546 (P < 0.001). C-CACT scores of patients whose therapy needed to be stepped up was significantly lower than in those with unchanged or stepped-down therapy (F = 39.61, P < 0.001). C-CACT provides a reliable, valid, and responsive measure of asthma control in Chinese children.
Paclitaxel-coated balloon angioplasty versus drug-eluting stenting for the treatment of infrapopliteal long-segment arterial occlusive disease: the IDEAS randomized controlled trial.

This study sought to report the results of a prospective randomized controlled trial comparing paclitaxel-coated balloons (PCB) versus drug-eluting stents (DES) in long infrapopliteal lesions.



DES have an established role in the treatment of short infrapopliteal lesions, whereas there is increasing evidence for the use of PCB in longer below-the-knee lesions.



Inclusion criteria were patients with Rutherford classes 3 to 6 and angiographically documented infrapopliteal disease with a minimum lesion length of 70 mm. The primary endpoint was target lesion restenosis >50% assessed by digital angiography at 6 months. Secondary endpoints included immediate post-procedure stenosis and target lesion revascularization.



Fifty patients were randomized to undergo infrapopliteal PCB angioplasty (25 arteries in 25 limbs; PCB group) or primary DES placement (30 arteries in 27 limbs; DES group). Immediate residual post-procedure stenosis was significantly lower in DES (9.6 ± 2.2% vs. 24.8 ± 3.5% in PCB; p < 0.0001). At 6 months, 5 patients died (2 in PCB vs. 3 in DES; p = 1.00) and 3 suffered a major amputation (1 in PCB vs. 2 in DES; p = 1.00). In total, 44 angiograms were evaluable with quantitative vessel analysis. Binary (>50%) angiographic restenosis rate was significantly lower in DES (7 of 25 [28%] vs. 11 of 19 [57.9%] in PCB; p = 0.0457). There were no significant differences with regard to target lesion revascularization (2 of 26 [7.7%] in DES vs. 3 of 22 [13.6%] in PCB; p = 0.65). Positive vessel wall remodeling was observed in 3 cases in the PCB arm (3 of 19 [(15.8%)] vs. 0 of 19 [0%] in DES; p = 0.07).



Compared with PCB in long infrapopliteal lesions, DES are related with significantly lower residual immediate post-procedure stenosis and have shown significantly reduced vessel restenosis at 6 months. PCB may produce positive vessel remodeling.
Co-occurrence of Trichomonas vaginalis and bacterial vaginosis and vaginal shedding of HIV-1 RNA.

Trichomonas vaginalis (TV) and bacterial vaginosis (BV) are independently associated with increased risk of vaginal shedding in HIV-positive women. Because these 2 conditions commonly co-occur, this study was undertaken to examine the association between TV/BV co-occurrence and vaginal shedding of HIV-1 RNA.



HIV-positive women attending outpatient HIV clinics in 3 urban US cities underwent a clinical examination; were screened for TV, BV, Neisseria gonorrhoeae, Chlamydia trachomatis, and vulvovaginal candidiasis; and completed a behavioral survey. Women shedding HIV-1 RNA vaginally (≥50 copies/mL) were compared with women who had an undetectable (<50 copies/mL) vaginal viral load to determine if women who were TV positive and BV positive or had co-occurrence of TV/BV had higher odds of shedding vaginally when compared with women who did not have these conditions.



In this sample of 373 HIV-positive women, 43.1% (n = 161) had co-occurrence of TV/BV and 33.2% (n = 124) were shedding HIV-1 RNA vaginally. The odds of shedding HIV vaginally in the presence of TV alone or BV alone and when TV/BV co-occurred were 4.07 (95% confidence interval [CI], 1.78-9.37), 5.65 (95% CI, 2.64-12.01), and 18.63 (95% CI, 6.71-51.72), respectively, when compared with women with no diagnosis of TV or BV, and after adjusting for age, antiretroviral therapy status, and plasma viral load.



T. vaginalis and BV were independently and synergistically related to vaginal shedding of HIV-1 RNA. Screening and prompt treatment of these 2 conditions among HIV-positive women are important not only clinically but for HIV prevention, as well.
Association between Val66Met brain-derived neurotrophic factor (BDNF) gene polymorphism and post-treatment relapse in alcohol dependence.

The purpose of this study was to examine relationships between genetic markers of central serotonin (5-HT) and dopamine function, and risk for post-treatment relapse, in a sample of alcohol-dependent patients.



The study included 154 patients from addiction treatment programs in Poland, who met DSM-IV criteria for alcohol dependence. After assessing demographics, severity of alcohol use, suicidality, impulsivity, depression, hopelessness, and severity of alcohol use at baseline, patients were followed for approximately 1 year to evaluate treatment outcomes. Genetic polymorphisms in several genes (TPH2, SLC6A4, HTR1A, HTR2A, COMT, and BDNF) were tested as predictors of relapse (defined as any drinking during follow-up) while controlling for baseline measures.



Of 154 eligible patients, 123 (80%) completed follow-up and 48% (n = 59) of these individuals relapsed. Patients with the Val allele in the Val66Met BDNF polymorphism and the Met allele in the Val158Met COMT polymorphism were more likely to relapse. Only the BDNF Val/Val genotype predicted post-treatment relapse [odds ratio (OR) = 2.62; p = 0.019], and time to relapse (OR = 2.57; p = 0.002), after adjusting for baseline measures and other significant genetic markers. When the analysis was restricted to patients with a family history of alcohol dependence (n = 73), the associations between the BDNF Val/Val genotype and relapse (OR = 5.76, p = 0.0045) and time to relapse (hazard ratio = 4.93, p = 0.001) were even stronger.



The Val66Met BDNF gene polymorphism was associated with a higher risk and earlier occurrence of relapse among patients treated for alcohol dependence. The study suggests a relationship between genetic markers and treatment outcomes in alcohol dependence. Because a large number of statistical tests were conducted for this study and the literature on genetics and relapse is so novel, the results should be considered as hypothesis generating and need to be replicated in independent studies.
Nortriptyline for treating enuresis in ADHD—a randomized double-blind controlled clinical trial

Treating enuresis in children with attention deficit hyperactivity disorder (ADHD) has not been previously reported. This study aims to investigate the efficacy, tolerability, and adverse effects of nortriptyline for treating enuresis in children with ADHD. Forty-three children aged from 5 to 14 years old were randomized into two groups. The treatment group received methylphenidate plus nortriptyline, while the placebo group received methylphenidate plus placebo. Nortriptyline and placebo were administered for 30 days and methylphenidate was administered for 45 days. The major outcome measure was parent-reported frequency of enuresis for 2 weeks prior to the intervention, during the intervention, and for 2 weeks after stopping the adjuvant therapy. Adverse effects were also checked. While nortriptyline statistically decreased the incidence of nocturnal enuresis during the intervention, the number of enuresis events did not significantly change in the placebo group. In addition, enuresis was not different from the baseline frequency of enuresis after stopping nortriptyline or placebo administration. Both nortriptyline and placebo were tolerated well. Administration of nortriptyline for treating enuresis in ADHD has not been investigated before. Nortriptyline is statistically superior to placebo. However, enuresis will relapse after stopping nortriptyline in children with ADHD who continue taking methylphenidate.
The hemorheological safety of pulsed electromagnetic fields in postmenopausal women with osteoporosis in southwest China: a randomized, placebo controlled clinical trial.

Apart from medications, pulsed electromagnetic fields (PEMFs) are used to treat osteoporosis nowadays. However studies on hemorheological safety of PEMFs were scarce. This randomized, placebo controlled clinical trial assessed whether PEMFs could lead to significant hemorheological changes. Fifty-five postmenopausal women were randomly assigned to receive placebo or PEMFs. Venous blood samples were collected at baseline and after treatment to measure 14 hemorheological determinants. Independent samples t-test, paired samples t-test and chi-squared tests were performed respectively. Relationships between variables were determined by Pearson correlation analysis. Multiple linear stepwise regression analysis was used to explore predictors of selected determinants. No significant differences existed between the placebo and PEMFs groups for any of the 14 hemorheological determinants (P>0.05) or the percentage of patients with hemorheological determinant within reference range (P>0.05). Hematocrit was found to be correlated with BMI (P=0.007). The most significant predictor of blood reduced viscosity at low shear rate was blood viscosity at low shear rate. And blood reduced viscosity at high shear rate was the most important predictor of plasma viscosity. These results showed, compared with placebo, PEMFs treatment of postmenopausal osteoporosis was not associated with adverse changes in hemorheological determinants, which may contribute to venous thromboembolism.
Is structured group psychoeducation for bipolar patients effective in ordinary mental health services? A controlled trial in Italy.

Recent reviews of evidence-based guidelines for the clinical management of Bipolar Disorders (BD) have recommended that "all patients with BD be offered group or individual psychoeducation" to prevent relapse, improve treatment adherence, quality of life, and functioning. The present study evaluated the effectiveness of psychoeducation in routine mental health services in reducing number of hospitalisations and number of days spent in hospital, at a 1-year follow-up.



A total of 102 outpatients were recruited from two Italian Departments of Mental Health. Inclusion criteria were a lifetime BD type I or II diagnosis, assessed with SCID, and ≥ 3 months of euthymia. Exclusion criteria were DSM-IV Axis I comorbidity, mental retardation (IQ<70), organic brain damage, or deafness. All participants received standard psychiatric care, including standard pharmacological treatment; the experimental group also received 21 group psychoeducation sessions, weekly held and conducted according to Colom and Vieta's model.



The number of patients hospitalised during the 1-year follow-up, the mean number of hospitalisations per patient, and the mean number of hospitalisation days were significantly lower for psychoeducated patients.



Our findings support the view that group psychoeducation is an effective way to prevent hospitalisation and decrease hospital days in pharmacologically treated patients with bipolar disorder also in routine clinical settings. The results confirm that psychoeducation promotes improvement in illness course by preventing acute phases and enhancing mood stability, and consequently, improvement in the quality of life for people with BD.
Long-term outcomes of a multidisciplinary cognitive behavioural programme for coping with chronic neuropathic spinal cord injury pain.

To explore the long-term outcomes of CONECSI (COping with NEuropathiC Spinal cord Injury pain), a multidisciplinary cognitive behavioural treatment programme in persons with spinal cord injury.



Long-term follow-up pre-post-intervention design.



A total of 29 subjects with a spinal cord injury and chronic neuropathic pain from 4 Dutch rehabilitation centres.



Primary outcomes were pain intensity and pain-related disability (Chronic Pain Grade questionnaire). Secondary outcomes were mood (Hospital Anxiety and Depression Scale), participation in activities (Utrecht Activities List), and life satisfaction (Life Satisfaction Questionnaire). Random coefficient analysis was used for the analyses of measurements before (t1), immediate post-intervention (t2), and 6 (t3), 9 (t4), and 12 (t5) months follow-up.



The analyses showed significant improvements on pain intensity (t1-t2 and t1-t5) and pain-related disability (t1-t2, t1-t4, and t1-t5), anxiety and participation in activities (t1-t2, t1-t3, and t1-t5).



This exploratory study suggests that a multidisciplinary cognitive behavioural programme might have lasting improvements on pain intensity, pain-related disability, anxiety, and participation in activities in people with chronic neuropathic spinal cord injury pain and highlights the potential of such programmes.