nils-herrmann/clean_scirepeval huggingface dataset:
Comparison of therapeutic effects of omega-3 fatty acid eicosapentaenoic acid and fluoxetine, separately and in combination, in major depressive disorder.

To compare therapeutic effects of eicosapentaenoic acid (EPA), fluoxetine and a combination of them in major depression.



Sixty outpatients with a diagnosis of major depressive disorder based on DSM-IV criteria and a score >or=15 in the 17-item Hamilton Depression Rating Scale (HDRS) were randomly allocated to receive daily either 1000 mg EPA or 20 mg fluoxetine, or their combination for 8 weeks. Double dummy technique was used to double blind the study. Patients were assessed at 2 week intervals. Change in HDRS was the primary outcome measure.



Analysis of covariance for HDRS at week 8 across treatment groups was performed in 48 patients who completed at least 4 weeks of the study, with the last observation carried forward. Treatment, age of onset and baseline HDRS had a significant effect on HDRS at week 8. EPA + fluoxetine combination was significantly better than fluoxetine or EPA alone from the fourth week of treatment. Fluoxetine and EPA appear to be equally effective in controlling depressive symptoms. Response rates (>or=50% decrease in baseline HDRS) were 50%, 56% and 81% in the fluoxetine, EPA and combination groups, respectively.



In the present 8 week trial EPA and fluoxetine had equal therapeutic effects in major depressive disorder. EPA + fluoxetine combination was superior to either of them alone.
Cytidine deaminase single-nucleotide polymorphism is predictive of toxicity from gemcitabine in patients with pancreatic cancer: RTOG 9704

The aim of this study is to validate the prognostic and predictive value of the non-synonymous cytidine deaminase (CDA) Lys27Gln polymorphism for hematological toxicity and survival using a randomized phase III adjuvant trial (Radiation Therapy Oncology Group (RTOG) 9704) in pancreatic cancer in which one treatment arm received gemcitabine. CDA is involved in gemcitabine inactivation, and there is conflicting data on the role of the non-synonymous CDA Lys27Gln polymorphism in predicting toxicity and survival in cancer patients treated with gemcitabine. RTOG 9704 randomized 538 patients after pancreatic resection to receive radiotherapy with either 5-fluorouracil (5-FU) or gemcitabine. CDA Lys27Gln polymorphism genotype was analyzed. We tested an association between CDA single-nucleotide polymorphism genotype and the survival outcome by the Cox proportional hazard model adjusting for other covariates, as well as toxicity by the logistic regression model. There is statistically significant more severe hematological toxicity in patients treated with gemcitabine with either the homozygote wild-type genotype (Lys/Lys) alone (odds ratio (OR)=0.06, P=0.01), or in combination with the heterozygote (Lys/Gln; OR=0.14, P=0.03) when compared with homozygote variant genotype (Gln/Gln) when adjusted for other covariates. This was not seen in the non-gemcitabine treated arm. There are no genotype differences with respect to survival outcome. In conclusion, in this prospective randomized adjuvant study of patients with pancreatic cancer, the CDA Lys27Gln polymorphism is validated as a predictive marker of gemcitabine hematological toxicity, but not with treatment response or survival.
Prognosis for the recovery of surgeons from chemical dependency: a 5-year outcome study.

Rates of relapse, monitoring contract completion, and return to medical practice may differ between surgeons and nonsurgeons being monitored for diagnosed substance use disorders.



Retrospective 5-year longitudinal cohort study.



A sample of 16 state physician health programs in the United States.



Nine hundred four physicians who underwent treatment for a substance use disorder and were consecutively admitted to 1 of 16 state physician health programs between September 1, 1995, and September 1, 2001. The study analyzed a subset of data comparing 144 surgeons with 636 nonsurgeons.



Rates of continued drug and alcohol misuse (relapse), monitoring contract completion, and return to medical practice at 5 years.



Surgeons were significantly more likely than nonsurgeons to enroll in a physician health program because of alcohol-related problems (odds ratio, 1.9; 95% CI, 1.3-2.7; P = .001) and were less likely to enroll because of opioid use (odds ratio, 0.5; 95% CI, 0.3-0.8, P = .002). Surgeons were neither more nor less likely than nonsurgeons to have a positive drug test result, complete or fail to complete the monitoring contract, or extend the monitoring period beyond the original 5 years specified in their agreements. Fewer surgeons than nonsurgeons were licensed and practicing medicine at the conclusion of the monitoring period, although this difference was not statistically significant.



Surgeons in this study had positive outcomes similar to those of nonsurgeons. However, further research is necessary to conclude whether surgeons are less likely than their nonsurgeon peers to successfully return to medical practice following chemical dependency treatment.
Mirror therapy improves hand function in subacute stroke: a randomized controlled trial.

To evaluate the effects of mirror therapy on upper-extremity motor recovery, spasticity, and hand-related functioning of inpatients with subacute stroke.



Randomized, controlled, assessor-blinded, 4-week trial, with follow-up at 6 months.



Rehabilitation education and research hospital.



A total of 40 inpatients with stroke (mean age, 63.2y), all within 12 months poststroke.



Thirty minutes of mirror therapy program a day consisting of wrist and finger flexion and extension movements or sham therapy in addition to conventional stroke rehabilitation program, 5 days a week, 2 to 5 hours a day, for 4 weeks.



The Brunnstrom stages of motor recovery, spasticity assessed by the Modified Ashworth Scale (MAS), and hand-related functioning (self-care items of the FIM instrument).



The scores of the Brunnstrom stages for the hand and upper extremity and the FIM self-care score improved more in the mirror group than in the control group after 4 weeks of treatment (by 0.83, 0.89, and 4.10, respectively; all P<.01) and at the 6-month follow-up (by 0.16, 0.43, and 2.34, respectively; all P<.05). No significant differences were found between the groups for the MAS.



In our group of subacute stroke patients, hand functioning improved more after mirror therapy in addition to a conventional rehabilitation program compared with a control treatment immediately after 4 weeks of treatment and at the 6-month follow-up, whereas mirror therapy did not affect spasticity.
GAD65 vaccination: 5 years of follow-up in a randomised dose-escalating study in adult-onset autoimmune diabetes

The aim of this study was to ascertain whether treatment of GAD65 autoantibody (GADA)-positive diabetic patients with alum-formulated recombinant GAD65 (GAD-alum) is safe and does not compromise beta cell function. This Phase 2, placebo-controlled, dose-escalation clinical trial, which was randomized through a central office, was performed in 47 GADA-positive type 2 diabetic patients, who received subcutaneous injections of GAD-alum (4 [n = 9], 20 [n = 8], 100 [n = 9] or 500 [n = 8] μg) or placebo (n = 13) at weeks 1 and 4 of the trial. Participants and caregivers were blinded to group assignments. The primary outcome was safety as assessed by neurological tests, medications and beta cell function evaluated over 5 years, representing the end of the trial. No severe study-related adverse events occurred during the 5 year follow-up. None of the dose groups was associated with an increased risk of starting insulin treatment compared with the placebo group. The use of oral hypoglycaemic agents did not differ between the dose groups. After 5 years, fasting C-peptide levels declined in the placebo group (−0.24; 95% CI −0.41 to −0.07 log10 nmol/l; p = 0.01) and the 500 µg dose group (−0.37; 95% CI −0.57 to −0.17 log10 nmol/l; p = 0.003), but not in the 4 µg (−0.10; 95% CI −0.28 to 0.07 log10 nmol/l; p = 0.20), 20 µg (0.04; 95% CI −0.12 to 0.19 log10 nmol/l; p = 0.58) and 100 µg (0.00; 95% CI −0.20 to −0.20 log10 nmol/l; p = 0.98) dose groups. The primary outcome of safety was achieved, since no severe study-related adverse events occurred. Because the study was initiated before 1 July 2005, the protocol was not registered in a registry. This trial was funded by the National Institutes of Health (grant numbers DK26190 and DK53004), the Swedish Research Council (grant number 72X-14064) and Diamyd Therapeutics (Stockholm, Sweden).
Clinical and genetic outcome determinants of Internet- and group-based cognitive behavior therapy for social anxiety disorder.

No study has investigated clinical or genetic predictors and moderators of Internet-based cognitive behavior therapy (ICBT) compared with cognitive behavioral group therapy for (CBGT) for SAD. Identification of predictors and moderators is essential to the clinician in deciding which treatment to recommend for whom. We aimed to identify clinical and genetic (5-HTTLPR, COMTval158met, and BDNFval66met) predictors and moderators of ICBT and CBGT.



We performed three types of analyses on data from a sample comprising participants (N = 126) who had undergone ICBT or CBGT in a randomized controlled trial. Outcomes were i) end state symptom severity, ii) SAD diagnosis, and iii) clinically significant improvement.



The most stable predictors of better treatment response were working full time, having children, less depressive symptoms, higher expectancy of treatment effectiveness, and adhering to treatment. None of the tested gene polymorphisms were associated with treatment outcome. Comorbid general anxiety and depression were moderators meaning that lower levels were associated with a better treatment response in ICBT but not in CBGT.



We conclude that demographic factors, symptom burden, adherence, and expectations may play an important role as predictors of treatment outcome. The investigated gene polymorphisms do not appear to make a difference.
Prognostic Value of Classifying Parapharyngeal Extension in Nasopharyngeal Carcinoma Based on Magnetic Resonance Imaging

To subclassify parapharyngeal extension in nasopharyngeal carcinoma (NPC) and investigate its prognostic value and staging categories based on magnetic resonance imaging (MRI).



Data from 1504 consecutive NPC patients treated with definitive-intent radiotherapy were analyzed retrospectively. Sites of parapharyngeal extension were defined by MRI. Overall survival (OS), local relapse-free survival (LRFS), and distant metastasis-free survival (DMFS) were calculated by the Kaplan-Meier method and compared with the log-rank test. Hazard consistency and hazard discrimination were determined by multivariate analysis with Cox proportional hazards models.



1104 patients (73.4%) had parapharyngeal extension; 1.7-63.8% had involvement of various anatomic sites. The hazard ratio for death was significantly higher with extensive parapharyngeal extension (lateral pterygoid muscle of masticator space and beyond or parotid space) than with mild extension (medial pterygoid muscle of masticator space, or carotid, prestyloid, and prevertebral or retropharyngeal space). OS, LRFS, and DMFS with extensive parapharyngeal extension were similar to those in T4 disease; OS, LRFS, and DMFS with mild parapharyngeal extension were significantly higher than in those T3 disease (all P ≤ 0.015).



Parapharyngeal extension in NPC should be subclassified as mild or extensive, which should be regarded as stages T2 and T4 diseases, respectively.
Online-haemodiafiltration vs. conventional haemodialysis: a cross-over study

The main short-term advantages of haemodiafiltration (HDF) are supposedly better removal of Beta2-microglobulin (ß2-m) and phosphate, and better haemodynamic stability. The main disadvantage is higher costs. The aim of the study was to compare the clinical and biological parameters associated with HDF and high-flux haemodialysis (HD), using a cross-over design, while maintaining the same dialysis parameters.



All patients on a 3 × 4 hours schedule were observed during 3 identical 6-months periods: HDF1 - HD - HDF2. The mean values for the 2 last months of each period were compared.



A total of 51 patients (76 % males, 45 % diabetic) with a mean age of 74 ± 15 years, and who had been on dialysis for 49 ± 60 months were included. The mean blood flow (329 ± 27 ml/min), dialysate flow (500 ml/min), and convection volumes (21.6 ± 3.2 L) were recorded. Patient medications were not changed. Predialysis blood pressure, phosphataemia, calcaemia, iPTH, Kt/V, nPNA and intradialytic events were similar throughout the 3 periods. Only serum albumin (34. 4 ± 3.6, 35.9 ± 3.4, 34.1 ± 4 g/L, p < 0. 0001) and ß2-m serum levels (26.1 ± 5.4, 28 ± 6, 26.5 ± 5 mg/L, p < 0.001, values shown for HDF1, HD, HDF2, respectively) were significantly lower during the HDF periods. Factor associated with higher delta serum albumin levels between HD and HDF periods was mainly a lower convection volume.



Comparing HDF and HD, we did not observe any differences in haemodynamic stability or in serum phosphate levels. Only serum ß2-m (-6% vs. HD) and albumin (-5% vs. HD) levels changed. The long-term clinical consequences of these biochemical differences should be prospectively assessed.
Re-evaluation and modification of the Stuivenberg Hospital Acute Renal Failure (SHARF) scoring system for the prognosis of acute renal failure: an independent multicentre, prospective study.

A prognostic scoring system for hospital mortality in acute renal failure (Stuivenberg Hospital Acute Renal Failure, SHARF score) was developed in a single-centre study. The scoring system consists of two scores, for the time of diagnosis of acute renal failure (ARF) and for 48 h later, each originally based on four parameters (age, serum albumin, prothrombin time and heart failure). The scoring system was now tested and adapted in a prospective study.



The study involved eight intensive care units. We studied 293 consecutive patients with ARF in 6 months. Their mortality was 50.5%. The causes of ARF were medical in 184 (63%) patients and surgical in 108 (37%). In the latter group, 74 (69%) patients underwent cardiac and 19 (18%) vascular surgery.



As the performance of the original SHARF scores was much lower in the multicentre study than in the original single-centre study, we re-analysed the multicentre data to customize the original model for the population studied. The independent variables were the score developed in the original study plus all additonal parameters that were significant on univariate analysis. The new multivariate analysis revealed an additional subset of three parameters for inclusion in the model (serum bilirubin, sepsis and hypotension). For the modified SHARF II score, r(2) was 0.27 at 0 and 0.33 at 48 h, respectively, the receiver operating characteristic (ROC) values were 0.82 and 0.83, and the Hosmer-Lemeshow goodness-of-fit P values were 0.19 and 0.05.



After customizing and by using two scoring moments, this prediction model for hospital mortality in ARF is useful in different settings for comparing groups of patients and centres, quality assessment and clinical trials. We do not recommend its use for individual patient prognosis.
Worse health-related quality of life and hip function in female patients with elevated chromium levels

Blood metal ion levels can be an indicator for detecting implant failure in metal-on-metal (MoM) hip arthroplasties. Little is known about the effect of bilateral MoM implants on metal ion levels and patient-reported outcomes. We compared unilateral patients and bilateral patients with either an ASR hip resurfacing (HR) or an ASR XL total hip replacement (THR) and investigated whether cobalt or chromium was associated with a broad spectrum of patient outcomes.  From a registry of 1,328 patients enrolled in a multicenter prospective follow-up of the ASR Hip System, which was recalled in 2010, we analyzed data from 659 patients (311 HR, 348 THR) who met our inclusion criteria. Cobalt and chromium blood metal ion levels were measured and a 21-item patient-reported outcome measures (PROMs) questionnaire was used mean 6 years after index surgery.  Using a minimal threshold of ≥7 ppb, elevated chromium ion levels were found to be associated with worse health-related quality of life (HRQoL) (p < 0.05) and hip function (p < 0.05) in women. These associations were not observed in men. Patients with a unilateral ASR HR had lower levels of cobalt ions than bilateral ASR HR patients (p < 0.001) but similar levels of chromium ions (p = 0.09). Unilateral ASR XL THR patients had lower chromium and cobalt ion levels (p < 0.005) than bilateral ASR XL THR patients.  Chromium ion levels of ≥7 ppb were associated with reduced functional outcomes in female MoM patients.
Changes in risk perception following a smoking cessation intervention: the role of acculturation in a sample of Latino caregivers

The present exploratory study examined the role of acculturation in the perception of the risks of smoking following a smoking cessation induction intervention among Latino caregivers of children with asthma. The sample consisted of 131 Latino smokers (72.9 % female; 18.3 % born in the U.S.) who were caregivers of a child with asthma. Caregivers were randomized to one of two smoking cessation interventions that were part of a home-based asthma program. Self-report measures of risk-perception were assessed at baseline, end of treatment (2 months after baseline), and 2- and 3-months post-treatment. At baseline, caregivers, regardless of level of acculturation, reported moderate to high levels of concern about the effects of secondhand smoke on their child’s health as well as perceived risk regarding the effect of smoking on their own health. However, caregivers who were low in acculturation had a greater increase in concern about the effects of smoking on their child from pre-to post treatment compared to those who were high in acculturation (p = .001). Lastly, level of acculturation moderated the association between caregivers’ concern about smoking on their child’s health and their motivation to quit smoking (p < .05), but not cessation rates or reduced secondhand smoke exposure (p > .05). Specifically, motivation to quit at 3 months was greater for those with low acculturation. Though exploratory, these findings suggest that risk perception may be more easily influenced in low versus high acculturated populations and this should be considered in the design of clinical interventions and potentially mass media campaigns seeking to influence risk of caregiver behavior on child health with ethnic and racial minorities.
Effects of a mushroom mycelium extract on the treatment of prostate cancer.

To determine whether supplemental amounts of a polysaccharide/oligosaccharide complex obtained from a shiitake mushroom extract (SME) would lower the prostate-specific antigen (PSA) level in patients with prostate cancer.



A total of 62 men (mean age 73.2 years, range 53.6 to 85.5) with histologically proven prostate cancer who had two consecutive elevated PSA readings were accrued to the study during a 3-month period. This was an open-label study in which the patients received oral administration of capsules containing SME given three times daily for 6 months. The endpoint for the trial was the lowering of the PSA levels.



Of the 62 men enrolled in the study, 61 were assessable. At 4 months, 1 patient withdrew because of unrelated surgery and 7 withdrew because of disease progression; none had responded with a decrease of greater than 50% in the PSA level. By 6 months, a total of 23 patients had progression and none had responded. Thirty-eight patients had stable PSA levels after 6 months. Although not the primary endpoint of the study, in other studies these patients could have been included as responders. When the patients' rates of PSA rise before study entry were analyzed, 4 (7%) had stabilized disease while taking SME. Thus, the final results for our study patients were 0 with a complete response, 0 with a partial response, 4 (7%) with stable disease, and 23 of 61 with progression while taking SME.



SME alone is ineffective in the treatment of clinical prostate cancer.
Step-up therapy for children with uncontrolled asthma receiving inhaled corticosteroids.

For children who have uncontrolled asthma despite the use of low-dose inhaled corticosteroids (ICS), evidence to guide step-up therapy is lacking.



We randomly assigned 182 children (6 to 17 years of age), who had uncontrolled asthma while receiving 100 microg of fluticasone twice daily, to receive each of three blinded step-up therapies in random order for 16 weeks: 250 microg of fluticasone twice daily (ICS step-up), 100 microg of fluticasone plus 50 microg of a long-acting beta-agonist twice daily (LABA step-up), or 100 microg of fluticasone twice daily plus 5 or 10 mg of a leukotriene-receptor antagonist daily (LTRA step-up). We used a triple-crossover design and a composite of three outcomes (exacerbations, asthma-control days, and the forced expiratory volume in 1 second) to determine whether the frequency of a differential response to the step-up regimens was more than 25%.



A differential response occurred in 161 of 165 patients who were evaluated (P<0.001). The response to LABA step-up therapy was most likely to be the best response, as compared with responses to LTRA step-up (relative probability, 1.6; 95% confidence interval [CI], 1.1 to 2.3; P=0.004) and ICS step-up (relative probability, 1.7; 95% CI, 1.2 to 2.4; P=0.002). Higher scores on the Asthma Control Test before randomization (indicating better control at baseline) predicted a better response to LABA step-up (P=0.009). White race predicted a better response to LABA step-up, whereas black patients were least likely to have a best response to LTRA step-up (P=0.005).



Nearly all the children had a differential response to each step-up therapy. LABA step-up was significantly more likely to provide the best response than either ICS or LTRA step-up. However, many children had a best response to ICS or LTRA step-up therapy, highlighting the need to regularly monitor and appropriately adjust each child's asthma therapy.
A placebo-controlled study of liposome-mediated gene transfer to the nasal epithelium of patients with cystic fibrosis

Cystic fibrosis (CF) is a common, serious, inherited disease. The major cause of mortality in CF is lung disease, due to the failure of airway epithelial cells to express a functional product of the cystic fibrosis transmembrane conductance regulator (CFTR) gene. A potential treatment for CF lung disease is the expression of CFTR in the airways following gene transfer. We have undertaken a double-blinded, placebo-controlled, clinical study of the transfer of the CFTR cDNA to the nasal epithelium of 12 CF patients. Cationic liposomes complexed with plasmid containing the human CFTR cDNA were administered to eight patients, whilst four patients received placebo. Biopsies of the nasal epithelium taken 7 days after dosing were normal. No significant changes in clinical parameters were observed. Functional expression of CFTR assessed by in vivo nasal potential difference measurements showed transient correction of the CF chloride transport abnormality in two patients (15 days after dosing in one patient). Fluorescence microscopy demonstrated CFTR function ex vivo in cells from nasal brushings. In total, evidence of functional CFTR gene transfer was obtained in six out of the eight treated patients. These results provide proof of concept for liposome-mediated CF gene transfer.