nils-herrmann/clean_scirepeval huggingface dataset:
FEC versus sequential docetaxel followed by epirubicin/cyclophosphamide as adjuvant chemotherapy in women with axillary node-positive early breast cancer: a randomized study of the Hellenic Oncology Research Group (HORG)

A randomized multicenter phase III study was conducted to compare the sequential docetaxel followed by epirubicin/cyclophosphamide combination with that of FEC regimen as adjuvant chemotherapy in women with axillary node-positive early breast cancer. Seven hundred and fifty-six women with axillary lymph node-positive breast cancer were randomized to receive either 4 cycles of docetaxel (100 mg/m2) followed by 4 cycles of epirubicin (75 mg/m2) plus cyclophosphamide (700 mg/m2) (experimental arm) or 6 cycles of FEC (epirubicin 75 mg/m2, cyclophosphamide 700 mg/m2, and 5-fluorouracil 700 mg/m2; control arm). All regimes were administered every 3 weeks. The primary end point was five-year disease-free survival (DFS). After a median follow-up period of 5 years, 233 (30.8%) relapses had occurred (108 and 125 in the experimental and control arms, respectively; P = 0.181). The five-year DFS was 72.6% (95% CI 63.8–81.3%) and 67.2% (95% CI 58.0–76.4%) for women randomized in the experimental and control arms, respectively (P = 0.041; log rank test). There was no difference in the overall survival between the two arms (83.8 and 81.4% in the experimental and control arms, respectively; P = 0.533). The experimental arm was associated with increased neutropenia requiring administration of granulocyte colony-stimulating factor in 90.5% of the patients as compared with 74.1% in the control arm (P = 0.0001). The sequential docetaxel followed by epirubicin/cyclophosphamide adjuvant chemotherapy regimen resulted in improved five-year DFS in women with axillary node-positive early breast cancer at the expense of increased but manageable myelotoxicity.
Tobacco withdrawal symptoms: an experimental analysis

This study was a prospective examination of tobacco withdrawal symptoms in a controlled environment. Smokers (N= 27) were hospitalized for a 7-day period during which a battery of tests was administered. Smokers were assigned to either an experimental group (N = 20) or a control group (N = 7). Subjects in the experimental group smoked ad libitum for a 3-day baseline period and then underwent 4 days of tobacco deprivation. Subjects in the control group continued to smoke ad libitum throughout the study. Of the 37 measures of tobacco withdrawal employed in this study, nine showed significant changes following tobacco deprivation. These changes include decreased heart rate and increased caloric intake, weight, craving for tobacco, confusion, depression-dejection, number of awakenings, duration of awakenings, and increased poor concentrations as observed by others.
Outcome of late-life depression after 3 years of sequential treatment.

To study the outcome of a sequential treatment protocol in elderly, severely depressed in-patients.



All 81 patients from a 12-week double-blind randomized controlled trial (RCT) comparing venlafaxine with nortriptyline were asked to participate in a 3 year follow-up study. Thirty-two patients who did not achieve remission during the RCT, entered an open sequential treatment protocol and were treated with augmentation with lithium, switch to a monoamine oxidase inhibitor or ECT.



Seventy-eight of the 81 patients (96.3%) achieved a response [> or = 50% reduction in Montgomery Asberg Depression Rating Scale score) and 68 patients (84%) a complete remission (final MADRS score < or = 10) within 3 years of treatment. Greater severity and longer duration of the depressive episode at baseline predicted poor recovery. Augmentation with lithium may be the best treatment option in treatment resistant depressed elderly. Only few patients dropped-out due to side-effects.



Our study demonstrates the importance of persisting with antidepressant treatment in elderly patients who do not respond to the first or second treatment.
Frontal and rostral anterior cingulate (rACC) theta EEG in depression: Implications for treatment outcome?

In major depressive disorder (MDD), elevated theta current density in the rostral anterior cingulate (rACC), as estimated by source localization of scalp-recorded electroencenphalogram (EEG), has been associated with response to antidepressant treatments, whereas elevated frontal theta has been linked to non-response. This study used source localization to attempt to integrate these apparently opposite results and test, whether antidepressant response is associated with elevated rACC theta and non-response with elevated frontal theta and whether theta activity is a differential predictor of response to different types of commonly used antidepressants. In the international Study to Predict Optimized Treatment in Depression (iSPOT-D), a multi-center, international, randomized, prospective practical trial, 1008 MDD participants were randomized to escitalopram, sertraline or venlafaxine-XR. The study also recruited 336 healthy controls. Treatment response and remission were established after eight weeks using the 17-item Hamilton Rating Scale for Depression (HRSD17). The resting-state EEG was assessed at baseline with eyes closed and source localization (eLORETA) was employed to extract theta from the rACC and frontal cortex. Patients with MDD had elevated theta in both frontal cortex and rACC, with small effect sizes. High frontal and rACC theta were associated with treatment non-response, but not with non-remission, and this effect was most pronounced in a subgroup with previous treatment failures. Low theta in frontal cortex and rACC are found in responders to antidepressant treatments with a small effect size. Future studies should investigate in more detail the role of previous treatment (failure) in the association between theta and treatment outcome.
Gene-environment interactions in the development of combined type ADHD: evidence for a synapse-based model.

To determine the mechanism of interaction of prenatal smoking exposure and child genotype in the development of attention deficit/hyperactivity disorder (ADHD), polymorphisms in the CHRNA4 gene were tested for interactions with prenatal smoking exposure on risk for ADHD subtypes using multiple logistic regression. An exon 5 polymorphism demonstrated a significant interaction with history of maternal smoking during pregnancy for increasing risk for severe combined type ADHD (OR = 3.0, 95% CI 1.1-8.4 for population-defined severe combined type, OR = 3.9 95% CI 1.2-13.1 for DSM-IV defined combined subtype ADHD). This interaction increased the effects of previously reported interactions for the DRD4 and DAT1 genes with prenatal smoking exposure. Given the known functions and the known areas of expression of these three genes at the dopaminergic synapse in the pre-frontal cortex, the results are compatible with a synapse-based model of the development of this form of ADHD. The subtype specificity of these findings supports the concept that ADHD is composed of a group of distinct disorders.
Effects of initiating carvedilol in patients with severe chronic heart failure: results from the COPERNICUS Study.

Beta-blockers remain underused despite their established utility for improving outcome in heart failure. Concerns that initiation of treatment produces few immediate benefits and may have important risks may be deterring widespread use.



To evaluate the early effects of the beta-blocker carvedilol in patients with severe heart failure.



Randomized, double-blind, placebo-controlled trial conducted from October 28, 1997, to March 20, 2000, at 334 hospital centers in 21 countries among 2289 patients with symptoms of heart failure at rest or with minimal exertion who were clinically euvolemic and had a left ventricular ejection fraction of less than 25%.



Patients were randomly assigned to receive carvedilol, with start dosage of at 3.125 mg twice daily with uptitration to a target dosage of 25 mg twice daily (n = 1156), or placebo (n = 1133), in addition to their usual medications for heart failure.



Death, hospitalization, or permanent withdrawal from study drug, as well as adverse events during the first 8 weeks of treatment.



The carvedilol group experienced no increase in cardiovascular risk but instead had fewer patients who died (19 vs 25; hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.41-1.35); who died or were hospitalized (134 vs 153; HR, 0.85; 95% CI, 0.67-1.07); or who died, were hospitalized, or were permanently withdrawn from treatment (162 vs 188; HR, 0.83; 95% CI, 0.68-1.03). These effects were similar in direction and magnitude to those observed during the entire study, and were apparent particularly in the 624 patients with recent or recurrent decompensation or a very depressed left ventricular ejection fraction. Differences in favor of carvedilol became apparent as early as 14 to 21 days following initiation of treatment. Worsening heart failure was the only serious adverse event with a frequency greater than 2% and was reported with similar frequency in the placebo and carvedilol groups (6.4% vs 5.1%).



These data suggest that, in clinically euvolemic patients, the relation of benefit to risk during initiation of treatment with carvedilol is similar to that seen during long-term therapy with the drug. Our findings should provide the reassurance needed to encourage the high levels of use that are warranted by the results of long-term clinical trials.
Performance adaptive training control strategy for recovering wrist movements in stroke patients: a preliminary, feasibility study

In the last two decades robot training in neuromotor rehabilitation was mainly focused on shoulder-elbow movements. Few devices were designed and clinically tested for training coordinated movements of the wrist, which are crucial for achieving even the basic level of motor competence that is necessary for carrying out ADLs (activities of daily life). Moreover, most systems of robot therapy use point-to-point reaching movements which tend to emphasize the pathological tendency of stroke patients to break down goal-directed movements into a number of jerky sub-movements. For this reason we designed a wrist robot with a range of motion comparable to that of normal subjects and implemented a self-adapting training protocol for tracking smoothly moving targets in order to facilitate the emergence of smoothness in the motor control patterns and maximize the recovery of the normal RoM (range of motion) of the different DoFs (degrees of Freedom). The IIT-wrist robot is a 3 DoFs light exoskeleton device, with direct-drive of each DoF and a human-like range of motion for Flexion/Extension (FE), Abduction/Adduction (AA) and Pronation/Supination (PS). Subjects were asked to track a variable-frequency oscillating target using only one wrist DoF at time, in such a way to carry out a progressive splinting therapy. The RoM of each DoF was angularly scanned in a staircase-like fashion, from the "easier" to the "more difficult" angular position. An Adaptive Controller evaluated online performance parameters and modulated both the assistance and the difficulty of the task in order to facilitate smoother and more precise motor command patterns. Three stroke subjects volunteered to participate in a preliminary test session aimed at verify the acceptability of the device and the feasibility of the designed protocol. All of them were able to perform the required task. The wrist active RoM of motion was evaluated for each patient at the beginning and at the end of the test therapy session and the results suggest a positive trend. The positive outcomes of the preliminary tests motivate the planning of a clinical trial and provide experimental evidence for defining appropriate inclusion/exclusion criteria.
Efficacy of the "body movement and perception" method in the treatment of fibromyalgia syndrome: an open pilot study.

Group exercises may be useful in fibromyalgia syndrome (FMS). The 'Body movement and perception' (BMP) method is based on low impact exercises, awareness of body perception and relaxation, aimed at treating small groups of patients following the Resseguier method (RM) and integrating RM with exercises derived from soft gymnastics. We assessed the effects of BMP method on FMS.



40 women with FMS (age and disease duration: 51.7±7.2 and 4.9±3.8 years) participated in an open pilot study. BMP sessions were performer twice a week (50 minutes each) for 8 weeks. Patients were assessed at enrolment (T0) and at the end of the study (T1) by a self-administered questionnaire (temporal characteristics of pain, pain interference in working and recreational activities and in night-time rest, awareness of pain, fatigue, irritability, well-being, quality of movement, ability to focus on perception and to perceive whole body, postural selfcontrol, ability to relax) and a clinical evaluation (tender points, assumption of analgesics/NSAIDs, distribution of pain, pain in sitting and standing position, pain during postural passages and gait, postural body alignment, muscular contractures).



At T1, FMS patients significantly improved with respect to T0 in pain, fatigue, irritability, well-being, quality of movement, postural self-control, ability to relax mind and body, movement perception, tender point scores, assumption of analgesic/NSAIDs, body alignment and muscle contractures (p<0.05 for all the comparisons T1 versus T0).



In FMS patients, rehabilitation with BMP improves pain and well being, reduces the number of tender points and muscle contractures, thus it is useful in FMS management.
Near-infrared spectroscopy-mediated neurofeedback enhances efficacy of motor imagery-based training in poststroke victims: a pilot study.

Despite the findings that motor imagery and execution are supposed to share common neural networks, previous studies using imagery-based rehabilitation have revealed inconsistent results. In the present study, we investigated whether feedback of cortical activities (neurofeedback) using near-infrared spectroscopy could enhance the efficacy of imagery-based rehabilitation in stroke patients.



Twenty hemiplegic patients with subcortical stroke received 6 sessions of mental practice with motor imagery of the distal upper limb in addition to standard rehabilitation. Subjects were randomly allocated to REAL and SHAM groups. In the REAL group, cortical hemoglobin signals detected by near-infrared spectroscopy were fed back during imagery. In the SHAM group, irrelevant randomized signals were fed back. Upper limb function was assessed using the finger and arm subscales of the Fugl-Meyer assessment and the Action Research Arm Test.



The hand/finger subscale of the Fugl-Meyer assessment showed greater functional gain in the REAL group, with a significant interaction between time and group (F(2,36)=15.5; P<0.001). A significant effect of neurofeedback was revealed even in severely impaired subjects. Imagery-related cortical activation in the premotor area was significantly greater in the REAL group than in the SHAM group (T(58)=2.4; P<0.05).



Our results suggest that near-infrared spectroscopy-mediated neurofeedback may enhance the efficacy of mental practice with motor imagery and augment motor recovery in poststroke patients with severe hemiparesis.
Wheelchair skills performance between discharge and one year after inpatient rehabilitation in hand-rim wheelchair users with spinal cord injury.

To study possible changes in wheelchair skills in participants with spinal cord injury between discharge and 1 year after rehabilitation, and to determine whether changes in wheelchair skills performance are related to lesion and personal characteristics, self-efficacy, and wheelchair satisfaction.



Prospective cohort study.



Eight rehabilitation centres with spinal cord injury units in the Netherlands.



A total of 111 participants performed the Wheelchair Circuit twice: at discharge (t1) and 1 year after discharge (t2). Personal/lesion characteristics, self-efficacy, and wheelchair satisfaction were measured. Normalized ability score and performance time score were analysed with a linear multilevel regression analysis for possible associations with wheelchair skills.



No statistically significant changes were found in the ability and performance time scores of the Wheelchair Circuit over the first year after discharge. Younger persons, those with paraplegia, and those with a better self-efficacy score showed higher ability scores and faster performance time scores on both test occasions.



Wheelchair skills performance, measured with the Wheelchair Circuit, did not change during the first year after discharge from inpatient rehabilitation. Wheelchair skills performance was associated with age, lesion level and self-efficacy perceptions.
B-type natriuretic peptide and high sensitive C-reactive protein predict 2-year all cause mortality in chest pain patients: a prospective observational study from Salta, Argentina

Several mechanisms are involved in the pathophysiology of the Acute Coronary Syndrome (ACS). We have addressed whether B-type natriuretic peptide (BNP) and high-sensitive C-reactive protein (hsCRP) in admission samples may improve risk stratification in chest pain patients with suspected ACS.



We included 982 patients consecutively admitted with chest pain and suspected ACS at nine hospitals in Salta, Northern Argentina. Total and cardiac mortality were recorded during a 2-year follow up period. Patients were divided into quartiles according to BNP and hsCRP levels, respectively, and inter quartile differences in mortality were statistically evaluated applying univariate and multivariate analyses.



119 patients died, and the BNP and hsCRP levels were significantly higher among these patients than in survivors. In a multivariable Cox regression model for total death and cardiac death in all patients, the hazard ratio (HR) in the highest quartile (Q4) as compared to the lowest quartile (Q1) of BNP was 2.32 (95% confidence interval (CI), 1.24-4.35), p = 0.009 and 3.34 (95% CI, 1.26-8.85), p = 0.015, respectively. In the TnT positive patients (TnT > 0.01 ng/mL), the HR for total death and cardiac death in Q4 as compared to Q1 was 2.12 (95% CI, 1.07-4.18), p = 0.031 and 3.42 (95% CI, 1.13-10.32), p = 0.029, respectively.The HR for total death for hsCRP in Q4 as compared to Q1 was 1.97 (95% CI, 1.17-3.32), p = 0.011, but this biomarker did not predict cardiac death (p = 0.21). No prognostic impact of these two biomarkers was found in the TnT negative patients.



BNP and hsCRP may act as clinically useful biomarkers when obtained at admission in a population with suspected ACS.
The interactive effect of improvement of vitamin D status and VDR FokI variants on oxidative stress in type 2 diabetic subjects: a randomized controlled trial

The objectives were to evaluate the effects of improvement of vitamin D status on biomarkers of oxidative stress (OS) in type 2 diabetic (T2D) subjects and whether vitamin D receptor (VDR)-FokI polymorphisms could modulate the response to vitamin D3 intake.Subjects with T2D were allocated to one of the two groups to receive either plain doogh (PD; containing 150 mg calcium and no vitamin D/250 ml, n1=50) or vitamin D3-fortified doogh (FD; containing 500 IU/250 ml, n1=50) twice a day for 12 weeks. Outcomes were changes in serum 25-hydroxyvitamin D (25(OH)D), superoxide dismutase, glutathione (GSH), total antioxidant capacity (TAC) and malondialdehyde (MDA). VDR genotypes in 140 T2D subjects in FD were determined by FokI restriction enzyme.After 12 weeks, serum 25(OH)D increased significantly in FD (from 38.5±202.2 to 72.0±23.5, P<0.001) as compared with PD (from 38.8±22.8 to 33.4±22.8, P=0.28). Comparisons between FD and PD revealed significant differences in changes of serum MDA (−0.54±0.82 μmol/l vs +0.17±1 μmol/l, P<0.001), GSH (+8.4±40.1 ng/l vs −13.1±29.4 ng/l, P=0.002) and TAC (+0.14±0.43 mmol/l  vs +0.02±0.45 mmol/l bovine serum albumin equivalent, P=0.03). Although there was no significant association between FokI genotypes and OS biomarkers, ff variant subgroup showed the weakest response to vitamin D.Conclusions:Improvement of vitamin D status via daily intake of FD ameliorates OS biomarkers in T2D subjects and the interactive effect of FokI genotypes cannot be ruled out.
Human papillomavirus testing and liquid-based cytology: results at recruitment from the new technologies for cervical cancer randomized controlled trial.

Although testing for human papillomavirus (HPV) has higher sensitivity and lower specificity than cytology alone for detecting cervical intraepithelial neoplasia (CIN), studies comparing conventional and liquid-based cytology have had conflicting results.



In the first phase of a two-phase multicenter randomized controlled trial, women aged 35-60 years in the conventional arm (n = 16,658) were screened using conventional cytology, and women in the experimental arm (n = 16,706) had liquid-based cytology and were tested for high-risk HPV types using the Hybrid Capture 2 assay. Women in the conventional arm were referred to colposcopy with atypical cells of undetermined significance (ASCUS) or higher and those in the experimental arm were referred with ASCUS or higher cytology or with a positive (> or = 1 pg/mL) HPV test. Sensitivity and positive predictive value (PPV) for detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) were calculated.



The screening methods and referral criterion applied in the experimental arm had higher sensitivity than that in the conventional arm (relative sensitivity = 1.47; 95% confidence interval [CI] = 1.03 to 2.09) but a lower PPV (relative PPV = 0.40; 95% CI = 0.23 to 0.66). With HPV testing alone at > or = 1 pg/mL and at > or = 2 pg/mL, the gain in sensitivity compared with the conventional arm remained similar (relative sensitivity = 1.43, 95% CI = 1.00 to 2.04 and relative sensitivity = 1.41, 95% CI = 0.98 to 2.01, respectively) but PPV progressively improved (relative PPV = 0.58, 95% CI = 0.33 to 0.98 and relative PPV = 0.75, 95% CI = 0.45 and 1.27, respectively). Referral based on liquid-based cytology alone did not increase sensitivity compared with conventional cytology (relative sensitivity = 1.06; 95% CI = 0.72 to 1.55) but reduced PPV (relative PPV = 0.57; 95% CI = 0.39 to 0.82).



HPV testing alone was more sensitive than conventional cytology among women 35-60 years old. Adding liquid-based cytology improved sensitivity only marginally but increased false-positives. HPV testing using Hybrid Capture 2 with a 2 pg/mL cutoff may be more appropriate than a 1 pg/mL cutoff for primary cervical cancer screening.
Improving Maternal Mental Health Following Preterm Birth Using an Expressive Writing Intervention: A Randomized Controlled Trial.

Evaluations of evidence-based, easily accessible, psychological interventions to improve maternal mental health following very preterm birth are scarce. This study investigated the efficacy and acceptability of the expressive writing paradigm for mothers of very preterm infants. The level of maternal posttraumatic stress and depressive symptoms was the primary outcome. Participants were 67 mothers of very preterm babies who were randomly allocated into the intervention (expressive writing; n = 33) or control group (treatment-as-usual; n = 32) when their infant was aged 3 months (corrected age, CA). Measurements were taken at 3 months (pre-intervention), 4 months (post-intervention), and 6 months CA (follow-up). Results showed reduced maternal posttraumatic stress (d = 0.42), depressive symptoms (d = 0.67), and an improved mental health status (d = 1.20) in the intervention group, which were maintained at follow-up. Expressive writing is a brief, cost-effective, and acceptable therapeutic approach that could be offered as part of the NICU care.