nils-herrmann/clean_scirepeval huggingface dataset:
Frequency of Perceived Poststress Symptoms in Inpatients, Outpatients and Healthy Controls: The Role of Perceived Exhaustion and Stress.

Poststress symptoms occur as a consequence of stress, most commonly during leisure periods such as weekends and vacations. However, the prevalence and the pathological mechanisms of poststress symptoms are poorly understood.



Here, we compared the frequency of poststress symptoms in healthy controls (n = 984), outpatients (n = 420), and inpatients (n = 101). In outpatients, demographic factors, psychosocial stress, and perceived exhaustion were tested as predictors of poststress symptoms with multivariate regression analysis. Poststress symptoms and perceived exhaustion were assessed using 2 Neuropattern Questionnaires (the NPQ - Patient Questionnaire and the NPQ - Symptom List), and psychosocial stress was evaluated using the Patient Health Questionnaire (PHQ).



Poststress symptoms appeared in 2.9% of healthy controls, 20.0% of outpatients, and 34.7% of inpatients. Predictors were educational level, psychosocial stress, and perceived exhaustion. Poststress symptoms differed primarily between exhausted (75.0%) and nonexhausted patients (25.0%).



Poststress symptoms are rather common in clinical populations, and they are primarily associated with the degree of perceived exhaustion. Preliminary evidence suggests that poststress symptoms are possibly related to depletion of norepinephrine stores, which may facilitate a stratified preventive and therapeutic treatment of these subjects.
Felodipine, a New Calcium Antagonist, as Monotherapy in Mild or Moderate Hypertension

The role of felodipine, a new calcium antagonist, as monotherapy in mild and moderate hypertension (supine diastolic blood pressure between 95 and 100mm Hg: phase V) was investigated in a placebo-controlled, double-blind study of 109 patients from 13 centres using 3 different doses. After a 2-week placebo run-in phase the patients were randomised in a double-blind fashion to receive felodipine 2.5mg bid (32 patients), 5mg bid (30 patients), 10mg bid (24 patients) or placebo (25 patients). Clinical and laboratory measurements were performed after 1, 3 and 8 weeks. 94 patients completed the study. Felodipine reduced supine systolic blood pressure by 22mm Hg from baseline after 8 weeks’ treatment on 2.5mg bid, 24mm Hg on 5mg bid and 24mm Hg on 10mg bid at 2 hours after dosage. The corresponding reduction in the placebo group was 6mm Hg. There was a reduction in supine diastolic blood pressure from baseline of 13mm Hg on felodipine 2.5mg bid, 14mm Hg on felodipine 5mg bid and 20mm Hg on felodipine 10mg bid, with no reduction in patients receiving placebo. The percentage of patients completing the study who achieved a supine diastolic blood pressure of 90mm Hg or less after 8 weeks’ treatment at 2 hours after dosage was 9% on placebo, 67% on felodipine 2.5mg bid, 57% on felodipine 5mg bid and 92% on felodipine 10mg bid; and at 12 hours after dosage those achieving target supine diastolic blood pressure was 17% on placebo, 37% on felodipine 2 5mg bid, 25% on felodipine 5mg bid and 62% on felodipine 10mg bid. Felodipine was generally well tolerated, although 10 patients on felodipine 10mg bid (42%), 1 on felodipine 5mg bid (3%) and 2 on felodipine 2.5mg bid (6%) withdrew from the study because of adverse effects. One serious adverse event, a myocardial infarction, occurred during the study in a patient with a history of postprandial non-exertional chest pain. In conclusion, felodipine monotherapy appreciably reduces blood pressure in mild and moderate hypertension without significant tachycardia in the short term. Doses of felodipine 2.5mg bid and 5mg bid are better tolerated than 10mg bid and can be recommended for initial treatment in this category of patients.
Prospective Assessment of Frailty Using the Fried Criteria in Patients Undergoing Left Ventricular Assist Device Therapy.

Frail patients are more prone to adverse events after cardiac surgery, particularly after implantation of left ventricular assist devices. Thus, frailty assessment may help identify patients unlikely to benefit from left ventricular assist device therapy. The purpose was to establish a suitable measure of frailty in adults with end-stage heart failure. In a prospective cohort of 75 patients (age 58 ± 12 years) with end-stage heart failure, we assessed the association between frailty (5-component Fried criteria) and the composite primary outcome of inpatient mortality or prolonged length of stay, as well as extubation status, time on ventilator, discharge status, and long-term mortality. Fried frailty criteria were met in 44 (59%) patients, but there was no association with the primary outcome (p = 0.10). However, an abridged set of 3 criteria (exhaustion, inactivity, and grip strength) was predictive of the primary outcome (odds ratio 2.9, 95% confidence interval 1.1 to 7.4), and of time to extubation and time to discharge. In patients with advanced heart failure, the 5-component Fried criteria may not be optimally sensitive to clinical differences. In conclusion, an abridged set of 3 frailty criteria was predictive of the primary outcome and several secondary outcomes, and may therefore be a clinically useful tool in this population.
Safety of long-term biologic therapy in rheumatologic patients with a previously resolved hepatitis B viral infection.

European and Asian studies report conflicting data on the risk of hepatitis B virus (HBV) reactivation in rheumatologic patients with a previously resolved HBV (prHBV) infection undergoing long-term biologic therapies. In this patient category, the safety of different immunosuppressive biologic therapies, including rituximab, was assessed. A total of 1218 Caucasian rheumatologic patients, admitted consecutively as outpatients between 2001 and 2012 and taking biologic therapies, underwent evaluation of anti-HCV and HBV markers as well as liver amino transferases every 3 months. Starting from January 2009, HBV DNA monitoring was performed in patients with a prHBV infection who had started immunosuppressive biologic therapy both before and after 2009. Patients were considered to have elevated aminotransferase levels if values were >1× upper normal limit at least once during follow-up. We found 179 patients with a prHBV infection (14 treated with rituximab, 146 with anti-tumor necrosis factor-alpha, and 19 with other biologic therapies) and 959 patients without a prHBV infection or other liver disease (controls). The mean age in the former group was significantly higher than the controls. Patients with a prHBV infection never showed detectable HBV DNA serum levels or antibody to hepatitis B surface antigen/hepatitis B surface antigen seroreversion. However, when the prevalence of elevated amino transferases in patients with prHBV infection was compared to controls, it was significantly higher in the former group only for aminotransferase levels >1× upper normal limit but not when aminotransferase levels >2× upper normal limit were considered.



Among patients with a prHBV infection and rheumatologic indications for long-term biologic therapies, HBV reactivation was not seen; this suggests that universal prophylaxis is not justified and is not cost-effective in this clinical setting.
Relapse of hepatitis B in HBeAg-negative chronic hepatitis B patients who discontinued successful entecavir treatment: the case for continuous antiviral therapy.

To evaluate the off-treatment durability of response in HBeAg-negative chronic hepatitis B patients who achieved a protocol-defined 'Response' (HBV-DNA<0.7MEq/mL and ALT<1.25xULN) with entecavir at 48 weeks and the efficacy of entecavir in patients treated beyond one year.



Entecavir-treated and lamivudine-treated patients who achieved a protocol-defined 'Response' were evaluated off-treatment for HBV-DNA<300copies/mL and ALT normalisation. Entecavir- and lamivudine-treated patients who achieved a protocol-defined 'Virological Response' (HBV-DNA<0.7MEq/mL but ALT1.25xULN) at 48 weeks, continued blinded treatment until they achieved Response or 96 weeks, whichever came first.



Among 'Responders' who discontinued treatment after 48 weeks, 7/257 (3%) entecavir-treated and 10/201 (5%) lamivudine-treated patients sustained HBV-DNA below 300copies/mL at 24-weeks off-treatment. Among the 54 patients who continued blinded treatment in the second year, 7/26 (27%) entecavir-treated and 6/28 (21%) lamivudine-treated patients normalised ALT and 22/26 (85%) entecavir-treated and 16/28 (57%) lamivudine-treated patients maintained HBV-DNA<300copies/mL at end-of-dosing. The safety profiles of both drugs remained comparable through a second year of treatment.



The majority of protocol-defined Responders relapsed after 1 year when treatment was discontinued. Treatment with entecavir beyond 1 year provided continued virological and biochemical benefit.
Open-label, multicenter, phase 3 extension study of the safety and efficacy of donepezil in patients with Alzheimer disease.

Donepezil hydrochloride is a selective acetylcholinesterase inhibitor approved for the symptomatic treatment of mild to moderately severe Alzheimer disease (AD). Controlled clinical trials of up to 24 weeks have demonstrated that donepezil treatment (5 and 10 mg/d) significantly improves cognition and global function.



To investigate the long-term benefits of donepezil treatment in patients with AD.



Multicenter, open-label, 144-week extension of 2 US phase 3, double-blind, placebo-controlled clinical trials: a 15-week study (12 weeks of treatment followed by a 3-week placebo washout) and a 30-week study (24 weeks of treatment followed by a 6-week placebo washout).



All patients (N = 763) initially received donepezil, 5 mg/d, for 6 weeks, after which an increase to 10 mg/d was encouraged.



Primary efficacy measures were the Alzheimer's Disease Assessment Scale-cognitive subscale and the Clinical Dementia Rating-Sum of the Boxes.



After the shorter 3-week placebo washout, donepezil-associated benefits remained above original baseline values for an additional 24 weeks of open-label treatment. Benefits on Alzheimer's Disease Assessment Scale-cognitive subscale scores for patients who received 10 mg/d in the double-blind study were evident compared with the other groups for 108 weeks of open-label treatment. In contrast, donepezil-associated benefits were lost after the 6-week placebo washout, and scores decreased below original baseline values for all patient groups. Although scores improved relative to the new open-label study baseline scores after drug use was restarted, patients remained below original baseline values. The most common adverse events were associated with the nervous and digestive systems and were generally mild and transient; 17% of patient discontinuations were associated with adverse events.



Donepezil is an effective and safe drug for the long-term symptomatic treatment of mild to moderately severe AD for up to 144 weeks (2.8 years), and sustained treatment may confer some advantages.
Reduction of biofilm formation with trisodium citrate in haemodialysis catheters: a randomized controlled trial.

Formation of an intraluminal microbial biofilm is noted to play a significant role in the development of catheter-related infections (CRIs). Recently, it has been demonstrated that trisodium citrate (TSC) has superior antimicrobial effects over heparin for catheter locking. In this randomized controlled trial, we compared the influence of catheter locking with heparin and TSC on the in vivo intraluminal biofilm formation in haemodialysis catheters.



Six patients were studied from the time of catheter insertion for haemodialysis treatment. They were randomly assigned to TSC 30% or heparin 5000 U/ml for catheter locking for the duration of 1 month. After elective guidewire exchange of the catheter, the locking solution was also changed. After removal, catheters were dissected in three segments and examined by standardized scanning electron microscopy (SEM) to assess quantitative biofilm formation. Furthermore, standardized cultures of all segments were performed to identify any microorganisms.



In catheters filled with TSC, the average coverage by biofilm was 16% versus 63% in the heparin group (P < 0.001). A total of eight subsegments were associated with local catheter infection in the patients who were randomized to heparin locking versus three subsegments who were assigned to TSC (P < 0.05).



Our study demonstrates that using TSC 30% for catheter locking reduces the formation of microbial biofilm in haemodialysis catheters and culture-positive colonization. It is likely that this is the explanation for the observed prevention of CRIs by TSC locking.
The effect of short-term, high-dose oral N-acetylcysteine treatment on oxidative stress markers in cystic fibrosis patients with chronic P. aeruginosa infection -- a pilot study.

Patients with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa lung infection have increased oxidative stress as a result of an imbalance between the production of reactive oxygen species caused by inflammation and their inactivation by the impaired antioxidant systems. Supplementation with anti-oxidants is potentially beneficial for CF patients.



The effect of 4 weeks of oral N-acetylcysteine (NAC) treatment (2400 mg/day divided into two doses) on biochemical parameters of oxidative stress was investigated in an open-label, controlled, randomized trial on 21 patients; 11 patients in the NAC group and 10 in the control group. Biochemical parameters of oxidative burden and plasma levels of antioxidants were assessed at the end of the study and compared to the baseline values in the two groups.



A significant increase in the plasma levels of the antioxidant ascorbic acid (p=0.037) and a significant decrease in the levels of the oxidized form of ascorbic acid (dehydroascorbate) (p=0.004) compared to baseline were achieved after NAC treatment. No significant differences were observed in the control group. The parameters of oxidative burden did not change significantly compared to baseline in either of the groups. A better lung function was observed in the NAC treated group with a mean (SD) change compared to baseline of FEV1% predicted of 2.11 (4.6), while a decrease was observed in the control group (change -1.4 (4.6)), though not statistically significant.



Treatment with N-acetylcysteine 1200 mg×2/day for 30 days significantly decreased the level of oxidized vitamin C and increased the level of vitamin C (primary end-points) and a not statistically significant improvement of lung function was observed in this group of patients.
Candidacy for kidney transplantation of older adults.

To develop a prediction model for kidney transplantation (KT) outcomes specific to older adults with end-stage renal disease (ESRD) and to use this model to estimate the number of excellent older KT candidates who lack access to KT.



Secondary analysis of data collected by the United Network for Organ Sharing and U.S. Renal Disease System.



Retrospective analysis of national registry data.



Model development: Medicare-primary older recipients (aged ≥ 65) of a first KT between 1999 and 2006 (N = 6,988). Model application: incident Medicare-primary older adults with ESRD between 1999 and 2006 without an absolute or relative contraindication to transplantation (N = 128,850).



Comorbid conditions were extracted from U.S. Renal Disease System Form 2728 data and Medicare claims.



The prediction model used 19 variables to estimate post-KT outcome and showed good calibration (Hosmer-Lemeshow P = .44) and better prediction than previous population-average models (P < .001). Application of the model to the population with incident ESRD identified 11,756 excellent older transplant candidates (defined as >87% predicted 3-year post-KT survival, corresponding to the top 20% of transplanted older adults used in model development), of whom 76.3% (n = 8,966) lacked access. It was estimated that 11% of these candidates would have identified a suitable live donor had they been referred for KT.



A risk-prediction model specific to older adults can identify excellent KT candidates. Appropriate referral could result in significantly greater rates of KT in older adults.
Precision Medicine in Patients With Resistant Hypertension and Obstructive Sleep Apnea: Blood Pressure Response to Continuous Positive Airway Pressure Treatment.

In patients with resistant hypertension (RH) and obstructive sleep apnea (OSA), the blood pressure response to continuous positive airway pressure (CPAP) treatment is highly variable and could be associated with differential micro-ribonucleic acid (miRNA) profiles. Currently, no available methods exist to identify patients who will respond favorably to CPAP treatment.



The aim of this study was to identify plasma miRNA profiles that predict blood pressure responses to CPAP treatment.



Cardiovascular system-focused circulating miRNA expression was evaluated in plasma samples using an 84-miRNA array among patients with RH and OSA at baseline and after 3 months of adherent CPAP use. Pathway analysis and miRNA target gene enrichment were performed in silico. Plasma levels of peptides and hormones related to cardiovascular function were also measured.



The OSA responder group exhibited blood pressure decreases exceeding the observed median (>4.5 mm Hg) after CPAP, which were not present in the nonresponder group (≤4.5 mm Hg) (p < 0.01). Three miRNAs provided a discriminatory predictive model for such a favorable blood pressure response to CPAP (area under the curve: 0.92; p = 0.01). Additionally, CPAP treatment significantly altered a total of 47 plasma miRNAs and decreased aldosterone-to-renin ratios in the responder group (p = 0.016) but not in the nonresponder group.



A singular pre-CPAP treatment cluster of 3 plasma miRNAs predicts blood pressure responses to CPAP treatment in patients with RH and OSA. CPAP treatment is accompanied by changes in cardiovascular system-related miRNAs that may potentially influence the risk for cardiovascular disease among patients with OSA and RH.
Functional status and quality of life after emergency revascularization for cardiogenic shock complicating acute myocardial infarction.

Our goal was to describe the functional status of cardiogenic shock survivors, identify the correlates of cardiogenic shock, and compare global quality of life and functional status of patients randomly assigned to treatment with emergency revascularization (ERV) versus initial medical stabilization (IMS).



Historically, the hospital survival rate of patients with cardiogenic shock complicating acute myocardial infarction (MI) has been very low. Shock survivors are salvaged from a critically ill state, and their later functional status is not well documented. The SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK (SHOCK) trial showed significantly improved one-year survival after ERV compared with IMS.



The SHOCK trial survivors completed interviews at 2 weeks after discharge and at 6 and 12 months after MI. Functional status assessment included the Multidimensional Index of Life Quality and New York Heart Association (NYHA) congestive heart failure functional class.



Eighty-seven percent of one-year survivors of the SHOCK trial were in NYHA functional class I or II. Between two weeks after discharge and one year after MI, improvement was similar in the two treatment groups (18% overall), but fewer patients remained stable (44% vs. 71%), and more patients worsened or died (34% vs. 15%) in the IMS group compared with those assigned to ERV. Assignment to ERV was the only independent predictor of outcome at one year.



Although one-year mortality after ERV is still high (54%), most survivors have good functional status. The ERV patients have a lower rate of deterioration than IMS patients. The level of recovery for shock patients undergoing ERV is similar to that of historical controls not in cardiogenic shock undergoing elective revascularization.
Probucol for treatment of hyperlipidemia in persistent childhood nephrotic syndrome

In a prospective, uncontrolled multicenter study, we have evaluated the effects of probucol on hyperlipidemia, proteinuria, and glomerular filtration rate (GFR) in hyperlipidemic children with persistent nephrotic syndrome. Probucol was started for a total of 12 weeks in 8 children and for 24 weeks in 14 children. Lipoprotein profiles, serum malondialdehyde (MDA) levels, proteinuria, renal function, and electrocardiogram were monitored every 4 weeks. Side effects were recorded by questionnaire. Treatment was completed by 7 of 8 patients for 12 weeks and by 7 of 14 children for 24 weeks. After 12 weeks, the mean serum concentrations of triglycerides (−15%), total cholesterol (−25%), very low-density lipoprotein-cholesterol (−27%), low-density lipoprotein-cholesterol (−23%), and high-density lipoprotein-cholesterol (−24%), as well as apolipoprotein (apo) A-I (−19%), apo B (−21%), and MDA (−32%) were reduced. The positive effects of probucol on the lipoprotein profile persisted over 24 weeks; however, there was no significant effect on either proteinuria or GFR. In conclusion, probucol had beneficial effects on lipoproteins and lipid peroxidation, but improved neither proteinuria nor GFR. The drug was generally tolerated well, but had to be discontinued because of a prolonged QT interval in 4 of 22 patients.
Effects of 3,4-Methylenedioxymethamphetamine on Patient Utterances in a Psychotherapeutic Setting.

3,4-Methylenedioxymethamphetamine (MDMA) administered as an adjunct to talk therapy influences patient speech content and increases improvement in treatment-resistant posttraumatic stress disorder (PTSD). Data came from the recordings of Mithoefer et al. (2011). In the third therapeutic session studied, patients were assigned, double blind, to an MDMA or a placebo group. Condition-blind scorers listened to therapy recordings and scored utterances where patients initiated topics that were empathic (regarding others' emotions), entactic (requesting or appreciating physical touch), or ensuic (describing a change in their sense of themselves). Patients who received MDMA produced high levels of ensuic, empathic, and entactic utterances compared with those who received the placebo. Interrater discourse scoring was reliable. The relationship between the number of scored utterances and the Clinician Administered PTSD Scale scores measuring PTSD severity after the treatment was significant, and reanalysis grouped bimodally into "many" or "few" such utterances remained significant. MDMA assisted these patients in having meaningful and disorder-resolving thoughts and discourse in talk therapy.
Impacts of dietary fat changes on pregnant women with gestational diabetes mellitus: a randomized controlled study.

This study aims to determine the impact of increasing polyunsaturated fatty acid intake on blood glucose, lipid metabolism, and pregnancy outcomes of pregnant women with gestational diabetes mellitus.



Under constant total energy and protein intake, 84 pregnant women with gestational diabetes mellitus were randomly divided into the experimental and control groups, which were given oil-rich and conventional low-oil meals, respectively.



After the dietary intervention, the intake and energy supply of fat and the three fatty acids were significantly higher in the experimental group than the control group (p<0.001). The intake and energy supply of polyunsaturated fatty acids increased significantly post-intervention in the experimental group but did not change in the control group. In both the intervention and the control group, fasting blood glucose, 2 h postprandial plasma glucose, and the insulin resistance index decreased significantly post-intervention (p<0.05); the lipid changes were consistent between groups. Pregnancy outcomes did not differ significantly between the two groups (p>0.05).



An appropriate increase in polyunsaturated fatty acid intake benefits pregnant women with gestational diabetes mellitus as well as fetuses, as long as the diet therapy follows basic recommendations and total energy intake is strictly controlled.