nils-herrmann/clean_scirepeval huggingface dataset:
Prospective Association Between the Dietary Inflammatory Index and Cardiovascular Diseases in the SUpplémentation en VItamines et Minéraux AntioXydants (SU.VI.MAX) Cohort

Cardiovascular diseases (CVD) are the leading cause of death in the world, and diet plays a major role in CVD incidence, especially through lipid oxidation mechanisms. This, in turn, leads to tissue inflammation and formation of atheromatous plaques.



Our objective was to evaluate the association between the inflammatory potential of the diet and the incidence of overall CVD or its subclasses. We included 7743 participants from the Supplémentation en Vitamines et Minéraux AntioXydants (SU.VI.MAX) cohort. All cardiovascular events were recorded using self-reported information or clinical visits, and were validated. The dietary inflammatory index (DII) was computed using repeated 24-hour dietary records (mean=9.5±3.4 records/subject). Hazard ratio and 95% CI for outcomes (CVD and subclasses) were estimated across sex-specific quartiles of the DII using Cox proportional hazard models. A total of 292 cardiovascular events were recorded and validated during an average of 11.4 years of follow-up: 93 myocardial infarctions, 58 strokes, 128 angina pectoris and revascularization interventions, and 13 sudden deaths. When considering CVD subclasses, a diet with pro-inflammatory properties, as expressed by higher DII scores, was significantly associated with a higher risk of myocardial infarction (hazard ratioQuartile 4 versus Quartile 1=2.24, 95% CI: 1.08-4.67). No significant association was observed between the DII score and stroke or both angina pectoris and revascularization intervention.



A pro-inflammatory diet, as measured by a higher DII score, was prospectively associated with a higher risk of myocardial infarction. Promotion of a diet exhibiting anti-inflammatory properties may help prevent myocardial infarctions.
Depression and functional outcome after stroke: the effect of antidepressant therapy on functional recovery.

The optimal strategy to prevent post-stroke depression is an important but still-unresolved issue. This study examined the differences in functional recovery among post-stroke depressed patients (DP) compared to post-stroke non-depressed patients (NDP) over the course of six months after stroke.



On the basis of a semistructured psychiatric examination, DSM-IV diagnostic criteria and the Hamilton Depression score, a consecutive series of ischemic or hemorrhagic stroke patients were included in this study. They had suffered from first-time stroke, and did not have depression diagnosis before. During follow-up, treatment with 20 mg/day citalopram per os was initiated whenever a diagnosis of depression was established. Their functional recoveries were assessed using the Scandinavian Stroke Scale, the modified Rankin scale and the Barthel index during acute hospitalization, at the time of depression diagnosis and at the third and sixth month follow-up visits.



Forty patients met the diagnostic criteria and 11 patients suffered from depression during the follow-up period. There were no differences in demographic variables, lesion characteristics and neurological symptoms between DP and NDP. Functional recovery in DP was impaired in comparison to NDP (P<0.05). All DP, whose mood improved after administration of citalopram, and improved daily functions living functions during the follow-up.



This study's findings suggest that remission of post-stroke depression is associated with improvement in functional recovery. Early diagnosis and effective treatment of depression will help the rehabilitation outcome of stroke patients.
Acipimox in the treatment of patients with hyperlipidaemia: A double blind trial

Fifty-two patients with Fredrickson Type IIb or Type IV hyperlipidaemia, in whom diet had not achieved satisfactory lipid levels, completed a double blind randomised study of acipimox versus placebo. The patients were given acipimox, 250 mg three times daily or placebo for a three month period, and plasma lipids and glucose were monitored. The patients receiving acipimox showed a fall in the mean concentration of plasma triglyceride compared to placebo (0.74 mmol/l) and this was most marked in patients whose initial plasma triglyceride levels were greater than 3 mmol/l (1.0 mmol/l, confidence limits 0.18, 1.82). Acipimox was well tolerated, and could be a useful addition to the drugs available for the treatment of patients with hypertriglyceridaemia.
Effects of probiotics in patients with diabetes mellitus type 2: study protocol for a randomized, double-blind, placebo-controlled trial

Low grade chronic inflammation is observed in patients with type 2 diabetes mellitus (T2DM). Endotoxin derived from gut bacteria may act as a potent inflammatory stimulant. Probiotics, which are believed to contain health promoting live microorganisms, may influence circulating endotoxin levels. Ingestion of live probiotic cultures may alter gut microbiota in a beneficial manner to reduce inflammation; no information is available whether or not they do so in patients with T2DM. Therefore, the aim of this study is to characterize the beneficial effects of probiotics on circulating endotoxin levels and other biomarkers related to systemic low-grade inflammation in patients with T2DM.



One hundred and twenty consenting adult Saudi T2DM patients (naïve or newly diagnosed and without co-morbidities) will be enrolled in this clinical trial and randomized to receive daily placebo or probiotics (Ecologic®Barrier) for 26 weeks in a double-blind manner. Inflammatory and metabolic markers will be measured and fecal samples analyzed. Measurements/samples will be obtained at baseline and after 4, 8, 12/13 and 26 weeks of treatment.



It is expected that the probiotic product will induce beneficial changes in gut microbiota, reduce the systemic inflammatory state through altering systemic endotoxin levels and, as such, reduce the systemic inflammatory response observed in T2DM subjects.
No Evidence of an Association Between Efavirenz Exposure and Suicidality Among HIV Patients Initiating Antiretroviral Therapy in a Retrospective Cohort Study of Real World Data

Recently, published studies have reported conflicting results regarding the association between efavirenz exposure and the risk of suicidality among patients with human immunodeficiency virus. The objective of this analysis was to compare the rate of suicidality among patients initiating efavirenz-containing versus efavirenz-free antiretroviral (ARV) regimens.This retrospective cohort study used US administrative claims data for commercially and Medicaid-insured individuals for the years 2006 to 2013. ARV-naive patients aged ≥12 years initiating an efavirenz-containing or efavirenz-free ARV regimen with ≥6 months of continuous insurance enrollment prior to ARV initiation were selected. The primary outcome was suicidality, defined as the occurrence of any medical claim with a diagnosis code for suicidal ideation or an inpatient or emergency department medical claim for suicide attempt. Unadjusted incidence rates were calculated and propensity score-adjusted hazard ratios were estimated to account for differences in patient characteristics.There were 19,983 patients (efavirenz-containing, n = 11,187; efavirenz-free, n = 8796) in the commercial database and 5154 patients (efavirenz-containing, n = 2224; efavirenz-free, n = 2930) in the Medicaid database. Unadjusted incidence rates (95% confidence interval [CI]) of suicidality per 1000 person-years were: commercial, efavirenz-containing (3.3 [2.4-4.4]), efavirenz-free (4.0 [2.7-5.8]); Medicaid, efavirenz-containing (25.7 [18.8-34.4]), efavirenz-free (40.6 [31.9-50.9]). In propensity score-adjusted analyses, efavirenz use was not associated with suicidality: adjusted hazard ratio (95% CI) of suicidality compared with efavirenz-free regimen, commercial, 1.029 (0.636-1.665); Medicaid, 0.902 (0.617-1.319).This analysis found no conclusive evidence of an increased risk of suicidality among patients initiating an efavirenz-containing ARV regimen. However, channeling bias may exist even after adjusting for measured patient characteristics.
The Role of HLA-Class Ib Molecules in Immune-Related Diseases, Tumors, and Infections 2016

1 Laboratory of Oncology, Istituto Giannina Gaslini, Via Gerolamo Gaslini, No. 5, 16147 Genova, Italy 2 Neuroradiology Unit, Department of Neurosciences and Rehabilitation, Azienda Ospedaliera-Universitaria, Arcispedale S. Anna, Via Aldo Moro, No. 8, Cona, 44124 Ferrara, Italy 3 Department of Experimental and Diagnostic Medicine, Section of Microbiology, University of Ferrara, Via Savonarola, No. 9, 44121 Ferrara, Italy 4CEA, Institut des Maladies Émergentes et des Thérapies Innovantes (iMETI), Service de Recherche en Hémato-Immunologie (SRHI), Hôpital Saint-Louis, Avenue Claude Vellefaux 1, 75010 Paris, France
Effects of raloxifene on sex steroid hormones and C-telopeptide in postmenopausal women with primary breast cancer

Within a multicentric, double-blind, placebo-controlled phase II trial, postmenopausal women with primary breast cancer were randomized to either 60 or 600 mg daily of raloxifene or placebo administered for 2 weeks prior to surgery. Circulating levels of sex-hormone binding globulin (SHBG), dehydroepiandrosterone-sulfate (DHEA-S), estrone (E1), estrone-sulfate (E1-S), estradiol (E2), and C-terminal telopeptide (CTX), were determined at baseline and the day before surgery in 37 women enrolled at the European Institute of Oncology in Milan. Raloxifene had a statistically significant different effect compared with placebo on SHBG (p<0.001) and E2 (p=0.03), without any dose–response relationship. Women on raloxifene (n=26) showed an increase from baseline of 10.7% (inter-quartile range: 5.9; 24.2) in SHBG and of 1.3% (inter-quartile range: −8.0; 24.5) in E2, whereas women on placebo (n=11) showed a decrease by 15.5% (inter-quartile range: 7.9; 18.1) and 17.3% (inter-quartile range: 6.5; 40.0), respectively. No significant differences were found on the other variables. A positive correlation was observed between DHEA-S and E1-S (p=0.001) or E2 (p<0.001), while SHBG correlated negatively with E1-S (p=0.024) and E2 (p=0.01), and positively with DHEA-S (p=0.016) and CTX (p=0.040). Our results provide evidence for an early endocrine effect of raloxifene which further suggests a favorable impact on breast cancer prevention.
Reduced-intensity chemotherapy and PET-guided radiotherapy in patients with advanced stage Hodgkin's lymphoma (HD15 trial): a randomised, open-label, phase 3 non-inferiority trial

The intensity of chemotherapy and need for additional radiotherapy in patients with advanced stage Hodgkin's lymphoma has been unclear. We did a prospective randomised clinical trial comparing two reduced-intensity chemotherapy variants with our previous standard regimen. Chemotherapy was followed by PET-guided radiotherapy.



In this parallel group, open-label, multicentre, non-inferiority trial (HD15), 2182 patients with newly diagnosed advanced stage Hodgkin's lymphoma aged 18-60 years were randomly assigned to receive either eight cycles of BEACOPP(escalated) (8×B(esc) group), six cycles of BEACOPP(escalated) (6×B(esc) group), or eight cycles of BEACOPP(14) (8×B(14) group). Randomisation (1:1:1) was done centrally by stratified minimisation. Non-inferiority of the primary endpoint, freedom from treatment failure, was assessed using repeated CIs for the hazard ratio (HR) according to the intention-to-treat principle. Patients with a persistent mass after chemotherapy measuring 2·5 cm or larger and positive on PET scan received additional radiotherapy with 30 Gy; the negative predictive value for tumour recurrence of PET at 12 months was an independent endpoint. 
Of the 2182 patients enrolled in the study, 2126 patients were included in the intention-to-treat analysis set, 705 in the 8×B(esc) group, 711 in the 6×B(esc) group, and 710 in the 8×B(14) group. Freedom from treatment failure was sequentially non-inferior for the 6×B(esc) and 8×B(14) groups as compared with 8×B(esc). 5-year freedom from treatment failure rates were 84·4% (97·5% CI 81·0-87·7) for the 8×B(esc) group, 89·3% (86·5-92·1) for 6×B(esc) group, and 85·4% (82·1-88·7) for the 8×B(14) group (97·5% CI for difference between 6×B(esc) and 8×B(esc) was 0·5-9·3). Overall survival in the three groups was 91·9%, 95·3%, and 94·5% respectively, and was significantly better with 6×B(esc) than with 8×B(esc) (97·5% CI 0·2-6·5). The 8×B(esc) group showed a higher mortality (7·5%) than the 6×B(esc) (4·6%) and 8×B(14) (5·2%) groups, mainly due to differences in treatment-related events (2·1%, 0·8%, and 0·8%, respectively) and secondary malignancies (1·8%, 0·7%, and 1·1%, respectively). The negative predictive value for PET at 12 months was 94·1% (95% CI 92·1-96·1); and 225 (11%) of 2126 patients received additional radiotherapy.



Treatment with six cycles of BEACOPP(escalated) followed by PET-guided radiotherapy was more effective in terms of freedom from treatment failure and less toxic than eight cycles of the same chemotherapy regimen. Thus, six cycles of BEACOPP(escalated) should be the treatment of choice for advanced stage Hodgkin's lymphoma. PET done after chemotherapy can guide the need for additional radiotherapy in this setting.



Deutsche Krebshilfe and the Swiss Federal Government.
Nebivolol Effects on Nitric Oxide Levels, Blood Pressure, and Renal Function in Kidney Transplant Patients.

In hypertensive kidney transplant recipients, the effects of nebivolol vs metoprolol on nitric oxide (NO) blood level, estimated glomerular filtration rate (eGFR), and blood pressure (BP) have not been previously reported. In a 12-month prospective, randomized, open-label, active-comparator trial, hypertensive kidney transplant recipients were treated with nebivolol (n=15) or metoprolol (n=15). Twenty-nine patients (nebivolol [n=14], metoprolol [n=15]) completed the trial. The primary endpoint was change in blood NO level after 12 months of treatment. Secondary endpoints were changes in eGFR, BP, and number of antihypertensive drug classes used. After 12 months of treatment, least squares mean change in plasma NO level in the nebivolol kidney transplant recipient group younger than 50 years was higher by 68.19% (99.17% confidence interval [CI], 13.02-123.36), 69.54% (99.17% CI, 12.71-126.37), and 66.80% (99.17% CI, 12.95-120.64) compared with the metoprolol group younger than 50 years, the metoprolol group 50 years and older, and the nebivolol group 50 years and older, respectively. The baseline to month 12 change in mean arterial BP, eGFR, and number of antihypertensive drug classes used was not significantly different between the treatment groups. In hypertensive kidney transplant recipients, nebivolol use in patients younger than 50 years increased blood NO.
The Patient's Anastrozole Compliance to Therapy (PACT) Program: a randomized, in-practice study on the impact of a standardized information program on persistence and compliance to adjuvant endocrine therapy in postmenopausal women with early breast cancer.

Compliance and persistence are often overlooked in adjuvant breast cancer treatment.



PACT was a prospective, multicenter, randomized, open, parallel-group study assessing whether educational materials (EMs) enhanced compliance with aromatase inhibitor (AI) therapy in postmenopausal women with early, hormone-receptor-positive (HR+) breast cancer. The primary end points were compliance (proportion taking ≥ 80% anastrozole) at 12 months and persistence (proportion reporting anastrozole intake during the study period).



Four thousand eight hundred and forty-four patients were randomly assigned 1:1 to receive standard therapy or standard therapy with EMs. There was no difference between arms in compliance (N = 2740; 88.5%/88.8%, respectively, P = 0.81) or persistence rates (N = 2740; 40.5%/43.0%, respectively, P = 0.18). Modified end point analyses found no differences in compliance between arms based on the classification of: (i) patients with missing documentation or follow-up visit <9 months as non-compliant (N = 4397, P = 0.15); (ii) patients with early (≤ 292 days) 12-month follow-up documentation excluded (N = 4091, P = 0.19); (iii) patients reaching ≥ 80% compliance during individual follow-up as compliant (N = 4397, P = 0.26). Modified persistence analyses found no difference between arms (N = 4397, P = 0.37).



Addition of EMs to standard therapy did not significantly affect compliance and persistence with adjuvant anastrozole.
Cerebral palsy and intrauterine growth in single births: European collaborative study

Cerebral palsy seems to be more common in term babies whose birthweight is low for their gestational age at delivery, but past analyses have been hampered by small datasets and Z-score calculation methods.



We compared data from ten European registers for 4503 singleton children with cerebral palsy born between 1976 and 1990 with the number of births in each study population. Weight and gestation of these children were compared with reference standards for the normal spread of gestation and weight-for-gestational age at birth.



Babies of 32-42 weeks' gestation with a birthweight for gestational age below the 10th percentile (using fetal growth standards) were 4-6 times more likely to have cerebral palsy than were children in a reference band between the 25th and 75th percentiles. In children with a weight above the 97th percentile, the increased risk was smaller (from 1.6 to 3.1), but still significant. Those with a birthweight about 1 SD above average always had the lowest risk of cerebral palsy. A similar pattern was seen in those with unilateral or bilateral spasticity, as in those with a dyskinetic or ataxic disability. In babies of less than 32 weeks' gestation, the relation between weight and risk was less clear.



The risk of cerebral palsy, like the risk of perinatal death, is lowest in babies who are of above average weight-for-gestation at birth, but risk rises when weight is well above normal as well as when it is well below normal. Whether deviant growth is the cause or a consequence of the disability remains to be determined.
Rosiglitazone decreases fasting plasma peptide YY3–36 in type 2 diabetic women: a possible role in weight gain?

Rosiglitazone often results in weight gain. We hypothesized that rosiglitazone may modulate circulating levels of ghrelin and peptide YY3–36 and this modulation may be related to weight-gaining effect of this agent. This study was designed as an open-label, randomized, controlled trial of 3-month duration. Women with newly diagnosed type 2 diabetes were studied. Twenty-eight of the 55 eligible participants were randomly assigned to receive rosiglitazone (4 mg/d). Twenty-seven patients with diabetes matched for age and body mass index served as controls on diet alone. We evaluated the effects of 3 months of rosiglitazone treatment on fasting peptide YY3–36 and ghrelin levels, and anthropometric measurements. The 3-month administration of rosiglitazone reduced fasting plasma peptide YY3–36 levels by 25%, the between-group difference was statistically significant. No effect of this thiazolidinedione compound on fasting ghrelin concentrations was observed at the end of study. The ghrelin/body mass index ratio also did not change significantly after treatment. Seventy-five percent of the women with diabetes complained of increased hunger at the end of study. Nevertheless, all subjects exhibited a decrease in fasting PYY levels after 3 months of rosiglitazone therapy, irrespective of the levels of hunger. There was no significant correlation between changes in peptide YY3–36 and those in anthropometric parameters and insulin sensitivity at the end of the study. Rosiglitazone-induced decrease in fasting peptide YY3–36 levels may in part contribute to orexigenic and weight-gaining effect of this thiazolidinedione derivative.
Sleep apnoea related hypoxia is associated with cognitive disturbances in patients with tetraplegia

Sleep disordered breathing is common in patients with tetraplegia. Nocturnal arterial hypoxemia and sleep fragmentation due to sleep apnoea may be associated with cognitive dysfunction. We therefore studied the influence of sleep disordered breathing on neuropsychological function in 37 representative tetraplegic patients (mean age 34±9.7 years). Thirty percent (11 of 37 patients) had clinically significant sleep disordered breathing, defined as apnoea plus hypopnoea index (AHI) greater than 15 per hour of sleep. Most apnoeas were obstructive in type. Seven patients (19%) desaturated to <80% during the night. Neuropsychological variables were significantly correlated with measures of sleep hypoxia, but not with the AHI and the frequency of sleep arousals. The neuropsychological functions most affected by nocturnal desaturation were: verbal attention and concentration, immediate and short-term memory, cognitive flexibility, internal scanning and working memory. There appeared to be a weak association between the presence of severe sleep hypoxia and visual perception, attention and concentration but no association was found between sleep variables and depression scores. We concluded that sleep disordered breathing is common in patients with tetraplegia and may be accompanied with significant oxygen desaturation. The latter impairs daytime cognitive function in these patients, particularly attention, concentration, memory and learning skills. Cognitive disturbances resulting from sleep apnoea might adversely affect rehabilitation in patients with tetraplegia.
Effect of a school-based sun-protection intervention on the development of melanocytic nevi in children.

"Kidskin" was a 5-year (1995-1999), school-based intervention trial among first-grade children in Perth, Western Australia. It aimed to assess whether a sun-protection intervention could protect against nevus development on the trunk, face, and arms. Included were a control group, a "moderate intervention" group, and a "high intervention" group. Control schools taught the standard health curriculum, while intervention schools received a specially designed sun-protection curriculum over 4 years. The high intervention group also received program materials over summer vacations when sun exposure was likely to be highest and were offered low-cost sun-protective swimwear. After adjustment for baseline nevus counts and potential confounding, nevus counts on all body sites were slightly lower in both intervention groups relative to the control group at follow-up, although the differences were not statistically significant and the high intervention was no more protective. Children in the moderate and high intervention groups, respectively, had fewer nevi on the back (6%, 95% confidence interval (CI): 0, 12; 4%, 95% CI: -3, 11), chest (boys) (5%, 95% CI: -4, 13; 3%, 95% CI: -8, 14), face (11%, 95% CI: 0, 21; 9%, 95% CI: -6, 21), and arms (8%, 95% CI: -1, 17; 3%, 95% CI: -10, 14).