nils-herrmann/clean_scirepeval huggingface dataset:
One year maintenance of carboplatin in patients with epithelial ovarian cancer--a phase II study.

The 5 year survival rate in patients with advanced epithelial ovarian cancer is 25-40% and treatment is mainly palliative once the disease recurs.



To determine the time to progression, overall survival and toxicity of 1 year maintenance treatment with carboplatin in women with advanced EOC after achieving complete remission with platinum-based combination chemotherapy.



Twenty-two women with epithelial ovarian cancer stage III-IV previously treated with platinum-based combinations who had achieved complete remission evidenced by symptoms, pelvic examination, computerized tomography and serum CA-125, were assigned to the study protocol consisting of: carboplatin of AUC=6, three cycles every 2 months, followed by two cycles once every 3 months for a total of five courses over 1 year.



Median follow-up in the 22 patients was 83 months (range 18-133 months), median disease-free survival was 36 months (range 2.5-126.4, 95% confidence interval 16.39-56.34). The 5 year survival was 59.7% with a mean overall survival of 83 months (range 18-133, 95% CI 39.11-127.29). Eleven patients have relapsed and died, 11 are alive, 6 are still in complete remission, and 5 are alive with recurrent disease. Grade III-IV toxicity was shown in some of the patients, anemia in 9%, thrombocytopenia in 9%, fatigue in 4.5%, and hypersensitivity in 4.5%.



A 1 year extension of treatment with a single-agent carboplatin, administered to women with advanced EOC who had achieved complete recovery on platinum-based chemotherapy as their first-line therapy, has an acceptable toxicity. The disease-free survival and overall survival values noted in this study are encouraging and warrant further investigation.
A pilot study of the effect of inhaled buffered reduced glutathione on the clinical status of patients with cystic fibrosis.

To assess the impact of inhaled, buffered reduced glutathione (GSH) on clinical indicators of cystic fibrosis (CF) pathophysiology.



A randomized, double-blind, placebo-controlled pilot study was conducted over an 8-week period. Nineteen subjects, age 6 to 19 years, with CF status documented by positive sweat chloride test results (> 60 mEq/L) were recruited for the trial. After matching on age and sex, 10 patients were randomly assigned to the treatment group and 9 patients to the placebo group. Primary outcomes were FEV1, FVC, forced expiratory flow at 25 to 75% of vital capacity, and peak flow; secondary outcomes were body mass index, 6-min walk distance, and self-reported cough frequency, mucus production/viscosity/color, wellness, improvement, and stamina.  Treatment was buffered GSH, and placebo was sodium chloride with a hint of quinine. The total daily dose of buffered GSH was approximately 66 mg/kg of body weight, and the total daily dose of placebo was approximately 15 mg/kg of body weight (quinine, 25 to 30 microg/kg). Doses were distributed across four inhalation sessions per day and spaced 3- to 4-h apart. General linear mixed models were used to analyze the data. The final sample size was nine subjects in the treatment group and seven subjects in the placebo group.



Mean change for peak flow was -6.5 L/min for the placebo group and +33.7 L/min for the GSH group (p = 0.04), and self-reported average improvement on a scale from 1 to 5 (1 being much worse and 5 being much better) was 2.8 for placebo and 4.7 for GSH (p = 0.004). Of the 13 primary and secondary outcomes examined, 11 outcomes favored the treatment group over the placebo group (p = 0.002), indicating a general tendency of improvement in the GSH group. No adverse events in the treatment group were noted.



This pilot study indicates the promise of nebulized buffered GSH to ameliorate CF disease, and longer, larger, and improved studies of inhaled GSH are warranted.
Overexpression of MutSα Complex Proteins Predicts Poor Prognosis in Oral Squamous Cell Carcinoma

The DNA mismatch repair (MMR) system is responsible for the detection and correction of errors created during DNA replication, thereby avoiding the incorporation of mutations in dividing cells. The prognostic value of alterations in MMR system has not previously been analyzed in oral squamous cell carcinoma (OSCC).The study comprised 115 cases of OSCC diagnosed between 1996 and 2010. The specimens collected were constructed into tissue microarray blocks. Immunohistochemical staining for MutSα complex proteins hMSH2 and hMSH6 was performed. The slides were subsequently scanned into high-resolution images, and nuclear staining of hMSH2 and hMSH6 was analyzed using the Nuclear V9 algorithm. Univariable and multivariable Cox proportional hazard regression models were performed to evaluate the prognostic value of hMSH2 and hMSH6 in OSCC.All cases in the present cohort were positive for hMSH2 and hMSH6 and a direct correlation was found between the expression of the proteins (P < 0.05). The mean number of positive cells for hMSH2 and hMSH6 was 64.44 ± 15.21 and 31.46 ± 22.38, respectively. These values were used as cutoff points to determine high protein expression. Cases with high expression of both proteins simultaneously were classified as having high MutSα complex expression. In the multivariable analysis, high expression of the MutSα complex was an independent prognostic factor for poor overall survival (hazard ratio: 2.75, P = 0.02).This study provides a first insight of the prognostic value of alterations in MMR system in OSCC. We found that MutSα complex may constitute a molecular marker for the poor prognosis of OSCC.
Extended duration therapy with pegylated interferon and ribavirin for patients with genotype 3 hepatitis C and advanced fibrosis: final results from the STEPS trial.

Patients with genotype 3 hepatitis C virus (HCV) infection and cirrhosis have poor response rates after 24 weeks treatment with pegylated interferon and ribavirin. Treatment for 48 weeks is therefore recommended, although the benefits of this are untested. We examined extended therapy in patients with genotype 3 HCV and advanced fibrosis.



Multicentre, open labelled randomized trial comparing therapy with 24 weeks pegylated interferon and ribavirin to 48 weeks of the same therapy.



136 patients completed the study. 67 received 24 weeks therapy and the SVR rate (48%) did not differ from that seen in the 69 patients who received 48 weeks therapy (42%). The response rates in patients with biopsy proven cirrhosis (13 patients treated for 24 weeks, 18 patients treated for 48 weeks) or cirrhosis proven on imaging (28 patients treated for 24 weeks and 25 patients treated for 48 weeks) were 46% in those treated for 24 weeks and 40% in those treated for 48 weeks. The differences were not significantly different. Treatment failure was due to relapse in the majority of patients.



Patients with genotype 3 HCV and advanced fibrosis do not benefit from extended therapy with pegylated interferon and ribavirin.
Immune responses to stress after stress management training in patients with rheumatoid arthritis

Psychological stress may alter immune function by activating physiological stress pathways. Building on our previous study, in which we report that stress management training led to an altered self-reported and cortisol response to psychological stress in patients with rheumatoid arthritis (RA), we explored the effects of this stress management intervention on the immune response to a psychological stress task in patients with RA.



In this study, 74 patients with RA, who were randomly assigned to either a control group or a group that received short stress management training, performed the Trier Social Stress Test (TSST) 1 week after the intervention and at a 9-week follow-up. Stress-induced changes in levels of key cytokines involved in stress and inflammatory processes (for example, interleukin (IL)-6 and IL-8) were assessed.



Basal and stress-induced cytokine levels were not significantly different in patients in the intervention and control groups one week after treatment, but stress-induced IL-8 levels were lower in patients in the intervention group than in the control group at the follow-up assessment.



In line with our previous findings of lower stress-induced cortisol levels at the follow-up of stress management intervention, this is the first study to show that relatively short stress management training might also alter stress-induced IL-8 levels in patients with RA. These results might help to determine the role of immunological mediators in stress and disease.
A new rating scale for the assessment of the alcohol-withdrawal syndrome (AWS scale).

A new rating scale for the quantitative assessment of the alcohol-withdrawal syndrome (AWS) was developed from the CIWA-A scale by item analysis based on the data from 132 alcoholic patients. The clinical evaluation of this AWS scale in a second sample of 256 alcoholic patients showed that it adequately assessed the course and severity of the AWS. The AWS scale provides data for a rational strategy of therapy for the AWS by rating mental and somatic symptoms on different scales. In particular, the mental subscale allows prediction of a complicated AWS. Subjects with an AWS score > or = 10 at admission have a higher risk of becoming delirious than those with a lower score (46.6% vs 2.8%; P < 0.001). In order to minimize the prescription of drugs with abuse potential, such as diazepam and clomethiazole, a structured treatment programme of in-patient alcohol detoxification based on the AWS score was also developed. The comparison revealed that, in the second sample, which was treated following this protocol, the number of cases given medication was lower and the amount of clomethiazole prescribed per patient was less.
Validation of an Informant-Reported Web-Based Data Collection to Assess Dementia Symptoms

The Web offers unprecedented access to the experience of people with dementia and their care partners, but data gathered online need to be validated to be useful.



To test the construct validity of an informant Web-based data collection to assess dementia symptoms in relation to the 15-point Dependence Scale (DS).



In an online survey posted on the DementiaGuide website, care partners of people with dementia built individualized profiles from the 60-item SymptomGuide and completed a questionnaire, which included the DS and a staging tool.



In the 250 profilees (155, 62% women, mean age 77 years), increasing dependence was associated with a greater chance of institutionalization. For example, no one at the lowest levels of dependence (DS score < 5, n = 33) was in long-term care, compared with half (13/25) of the profilees at the highest levels of dependence (DS score > 12) being in institutions (χ(2)(4) = 27.9, P < .001). The Web-based DS was correlated with the number of symptoms: higher DS scores were associated with a higher stage of dementia (F > 50, P < .001).



In an online survey, the Web-based DS showed good construct validity, potentially demonstrating how the Web can be used to learn more about dementia progression and how it relates to symptoms experienced by patients across the course of dementing illnesses. Even so, caution is needed to assure the validity of data collected online.
Genetic markers of suicidal ideation emerging during citalopram treatment of major depression.

Suicidal ideation is an uncommon symptom than can emerge during antidepressant treatment. The biological basis of treatment-emergent suicidal ideation is unknown. Genetic markers may shed light on the causes of treatment-emergent suicidal ideation and help identify individuals at high risk who may benefit from closer monitoring, alternative treatments, or specialty care.



A clinically representative cohort of outpatients with major depressive disorder who enrolled in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial were treated with citalopram under a standard protocol for up to 14 weeks. DNA samples from 1,915 participants were genotyped for 768 single-nucleotide polymorphisms in 68 candidate genes. Allele and genotype frequencies were compared between the 120 participants who developed treatment-emergent suicidal ideation and those who did not.



Two markers were significantly associated with treatment-emergent suicidal ideation in this sample (marker rs4825476, p=0.0000784, odds ratio=1.94; permutation p=0.01; marker rs2518224, p=0.0000243, odds ratio=8.23; permutation p=0.003). These markers reside within the genes GRIA3 and GRIK2, respectively, both of which encode ionotropic glutamate receptors.



Markers within GRIK2 and GRIA3 were associated with treatment-emergent suicidal ideation during citalopram therapy. If replicated, these findings may shed light on the biological basis of this potentially dangerous adverse event and help identify patients at increased risk.
Outcome of pregnancy in type 1 diabetic patients treated with insulin lispro or regular insulin: an Italian experience

Some studies have shown that fetal outcome observed in patients using insulin lispro is much the same as in pregnant women using regular insulin. This study aims to analyze the Italian data emerging from a multinational, multicenter, retrospective study on mothers with type 1 diabetes mellitus before pregnancy, comparing those treated with insulin lispro for at least 3 months before and 3 months after conception with those treated with regular insulin. The data collected on pregnant women with diabetes attending 15 Italian centers from 1998 to 2001 included: HbA1c at conception and during the first and third trimesters, frequency of severe hypoglycemic episodes, spontaneous abortions, mode and time of delivery, fetal malformations and mortality. Seventy-two diabetic pregnancies treated with lispro and 298 treated with regular insulin were analyzed, revealing a trend towards fewer hypoglycemic episodes in the former, who also had a significantly greater reduction in HbA1c during the first trimester. The rate of congenital malformations was similar in the offspring of the two groups of women treated with insulin lispro or regular insulin. These findings suggest that insulin lispro could be useful for the treatment of hyperglycemia in type 1 diabetic pregnant women.
Prevalence of the Metabolic Syndrome Among a Racially/Ethnically Diverse Group of U.S. Eighth-Grade Adolescents and Associations With Fasting Insulin and Homeostasis Model Assessment of Insulin Resistance Levels   

The purpose of this study was to report the prevalence of the International Diabetes Federation (IDF)-defined metabolic syndrome and its components among a cross-sectional sample of racially/ethnically diverse eighth grade youths and examine the association between the presence of the syndrome and participant fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR) levels.



Data were from a cross-sectional study with 1,453 racially/ethnically diverse eighth grade students from 12 middle schools in three U.S. states (Texas, North Carolina, and California). Height, weight, waist circumference, and blood pressure were recorded. Fasting blood samples were analyzed for triglycerides, HDL cholesterol, glucose, and insulin; HOMA-IR was calculated. Sex, race/ethnicity, and pubertal stage were self-reported. IDF criteria were used to determine the prevalence of the metabolic syndrome. The odds ratio for being classified with the syndrome was calculated by quintiles of fasting insulin and HOMA-IR.



Of the sample, 138 students (9.5%) were classified with metabolic syndrome. Hispanics were more likely to have high abdominal adiposity and high triglycerides. Male adolescents were more likely to have high triglycerides, low HDL cholesterol, high blood pressure, and high fasting glucose. Participants in the highest insulin quintile were almost 200 times more likely to be classified with the syndrome than participants in the lowest quintile with comparable associations for HOMA-IR quintiles.



In a racially/ethnically diverse sample of U.S. adolescents, 9.5% of participants were identified with the metabolic syndrome using the IDF criteria. The likelihood of metabolic syndrome classification significantly increased with higher insulin and HOMA-IR values.
One-year mortality among unselected outpatients with heart failure.

To estimate 1-year mortality and prognostic factors in unselected outpatients with heart failure, and to compare the observed mortality with the estimates of the primary care physicians.



Four hundred and eleven consecutive patients with heart failure New York Heart Association (NYHA) class II-IV (mean population age 75 years, 56% males) were enrolled in 71 primary care offices throughout Switzerland. During a mean follow-up period of 1.4 years, 68 patients had died. One-year total mortality was 12.6% compared to 4.3% in the underlying Swiss population (standardized mortality ratio 3.0). Among patients with heart failure NYHA II, III and IV, mortality was 7.1%, 15.0% and 28.0%, respectively. In multivariate Cox regression, statistically significant (P<0.05) predictors of mortality were NYHA class (NYHA III: risk ratio [RR]=1.6; NYHA IV: RR=2.2), recent hospital stay for heart disease (RR=2.3), creatinine>120 micromol.l(-1) (RR=1.8) systolic blood pressure<100 mmHg (RR=2.4), heart rate>100 min(-1) (RR=2.7), age (per 10 years, RR=1.6) and female gender (RR=0.49). Among patients with reduced left ventricular ejection fraction, 1-year mortality was 14.3%, and predictors were similar except that female gender was no longer associated with reduced mortality. Primary care physicians significantly overestimated 1-year mortality (estimated mortality 25.9% vs observed mortality 12.6%,P =0.001).



Unselected outpatients with heart failure have a poor prognosis, particularly those with advanced heart failure and a recent hospital stay for heart disease. Primary care physicians are aware of the high mortality of this growing patient population.
The F-MACHOP regimen in the treatment of aggressive non-Hodgkin's lymphomas: a single center experience in 72 patients.

Since July 1991 we have employed the F-MACHOP regimen for the treatment of aggressive non-Hodgkin's lymphomas (NHL). The aim of the present study was to evaluate the response rate and the toxicity of this chemotherapy program.



Seventy-two consecutive patients entered the study and were treated with the F-MACHOP regimen for 6 planned courses, given every 21 days. G- or GM-CSF were administered whenever required.



Sixty-six patients (92%) obtained a response: 38 (53%) a complete remission (CR) and 28 (39%) a partial remission (PR); 4 (6%) proved to be resistant and 2 (3%) died of chemotherapy-related toxicity. Fifty-seven patients with a good performance status were subsequently selected to undergo autologous stem cell transplantation (ASCT). During chemotherapy, grade III-IV neutropenia was observed in 59% of the patients; a significant drop in hemoglobin levels was detected, with blood transfusions being required in 21% of the cases; platelet counts were unaffected. The main extrahematological toxic events were: alopecia (100% of the patients), osteoarthromyalgias (58%), grade I-II neuropathy (53%) and grade I-II hepatic toxicity (43%).



Our study confirms the efficacy of the F-MACHOP regimen in obtaining a high rate of response (CR + PR) in most aggressive NHL cases, with an acceptable toxicity and a low rate of toxic deaths. This regimen enables the majority of patients to be selected for ASCT as consolidation therapy without significant toxicity.
EEG alpha power during maintenance of information in working memory in adults with ADHD and its plasticity due to working memory training: A randomized controlled trial

The present study examined whether neural indices of working memory maintenance differ between young adults with ADHD and their healthy peers (Study 1), and whether this neural index would change after working memory training (Study 2).



Study 1 involved 136 college students with ADHD and 41 healthy peers (aged 18-35 years) and measured their posterior alpha activity during a visual delayed-match-to-sample task using electroencephalography (EEG). Study 2 involved 99 of the participants with ADHD who were randomized into a standard-length or shortened-length Cogmed working memory training program or a waitlist control group.



The ADHD group tended to be less accurate than the peers. Similarly, the ADHD group exhibited lower posterior alpha power at a trend level compared to their healthy peers. There were no training effects on participants' performance and only marginal increases in posterior alpha power in training groups compared to the waitlist group.



Considering that the training effects were small and there was no load and dose effect, we conclude that the current study provides no convincing evidence for specific effects of Cogmed.



These findings provide unique insights into neuroplasticity, or lack thereof, with near-transfer tasks in individuals with ADHD.
Radiographic changes in rheumatoid arthritis patients attaining different disease activity states with methotrexate monotherapy and infliximab plus methotrexate: the impacts of remission and tumour necrosis factor blockade.

To examine the association of radiographic progression and disease activity states in patients with rheumatoid arthritis (RA) treated with methotrexate with or without infliximab.



Patients (n = 1049) with active RA for 3 years or less and no previous methotrexate treatment were randomly assigned (4 : 5 : 5) to receive methotrexate plus placebo or methotrexate plus infliximab 3 or 6 mg/kg at weeks 0, 2 and 6, and every 8 weeks thereafter to week 46. Disease activity was classified by the simplified disease activity index as remission (< or =3.3), low (>3.3 to < or =11), moderate (>11 to < or =26), high (>26). Radiographic progression was measured as a change from baseline to week 54 in total Sharp score.



At weeks 14 and 54, more patients receiving methotrexate plus infliximab than methotrexate plus placebo were in remission (10.7% versus 2.8% week 14; 21.3% versus 12.3% week 54; p<0.001 for both). Methotrexate plus placebo halted radiographic progression only if patients achieved remission within 3 months, whereas methotrexate plus infliximab also halted or minimised progression in patients with low or moderate activity, respectively. Patients with persistently high disease activity levels had much less progression of joint damage if treated with methotrexate plus infliximab versus methotrexate monotherapy. Even with infliximab plus methotrexate there was a direct relationship between disease activity and radiographic changes, although the slope was deflected when compared with methotrexate monotherapy.



With methotrexate, joint damage progresses even at low and moderate disease activity levels, whereas methotrexate plus infliximab inhibits radiographic progression across all disease activity states.