nils-herrmann/clean_scirepeval huggingface dataset:
The effects of forest therapy on depression and anxiety in patients with chronic stroke.

To assess whether forest therapy is effective for treating depression and anxiety in patients with chronic stroke by using several psychological tests. We measured reactive oxygen metabolite (d-ROM) levels and biological antioxidant potentials (BAPs) associated with psychological stress.



Fifty-nine patients with chronic stroke were randomly assigned to either a forest group (staying at a recreational forest site) or to an urban group (staying in an urban hotel); the duration and activities performed by both groups were the same. Scores on the Beck Depression Inventory (BDI), Hamilton Depression Rating Scale (HAM-D17), Spielberger State-Trait Anxiety Inventory (STAI), d-ROMs and BAPs were evaluated both before and after the treatment programs.



In the forest group, BDI, HAM-D17 and STAI scores were significantly lower following treatment, and BAPs were significantly higher than baseline. In the urban group, STAI scores were significantly higher following treatment. Moreover, BDI, HAM-D17 and STAI scores of the forest group were significantly lower, and BAPs were significantly higher following treatment (ANCOVA, p <0.05).



Forest therapy is beneficial for treating depression and anxiety symptoms in patients with chronic stroke, and may be particularly useful in patients who cannot be treated with standard pharmacological or electroconvulsive therapies.
Metastatic seminoma treated with either single agent carboplatin or cisplatin-based combination chemotherapy: a pooled analysis of two randomised trials

To study the role of single agent carboplatin chemotherapy in patients with metastatic seminoma based on the data from two randomised trials. In subgroup analyses in patients with different disease characteristics, the outcome treated with either single agent carboplatin or cisplatin-based combination chemotherapy was compared. Individual patient data from two randomised European trials involving patients with metastatic seminoma were gathered. The primary endpoint for all analyses was progression-free survival. The source data of 361 patients, 184 treated with cisplatin-based combinations and 177 treated with carboplatin single agent therapy, were entered into the analysis. Patient characteristics were comparable among the cisplatin-based and the carboplatin single agent treated patient groups with lymph nodes and lungs being the most frequent metastatic sites in 92 and 8% of patients, respectively. Overall, patients treated with single agent carboplatin had an inferior 5-year overall (89 and 94%; P=0.09) and progression-free survival rate (72 and 92%; P< 0.0001) compared with patients receiving cisplatin-based combinations. For all investigated subgroups (based on age, prior radiation therapy, metastatic sites), carboplatin single agent therapy was found to be inferior to cisplatin-based combination chemotherapy. In conclusion, carboplatin single agent therapy cannot be recommended as standard treatment for any patient subgroup with advanced metastatic seminoma and cisplatin-based combination regimens remain the standard of care.
The Effect of 17β-Estradiol at Doses of 0.5, 1 and 2 mg Compared with Placebo on Early Postmenopausal Bone Loss in Hysterectomized Women

In a randomized double-masked placebo-controlled parallel-group trial 166 hysterectomized (± oophorectomy) perimenopausal and postmenopausal women aged 45–55 years with a follicle stimulating hormone level above 20 IU/l were treated with one daily dose of either 0.5 mg 17β-estradiol (E2), 1 mg E2, 2 mg E2 or placebo for 2 years. Bone mineral density (BMD) and biochemical bone markers were determined. All three doses of E2 were significantly better than placebo with respect to change in BMD at the lumbar spine (L1–L4) (p<0.0001 for all pairwise comparisons) and hip (femoral neck, trochanter, Ward’s triangle). The mean percentage change from baseline at the lumbar spine was −0.2%, 0.8% and 1.8% in the 0.5, 1 and 2 mg E2 groups respectively compared with −3.5% in the placebo group. Both 1 and 2 mg E2 were significantly better than placebo in increasing the BMD at the femoral neck (p<0.001), trochanter (p<0.01) and Ward’s triangle (p<0.0001), while 0.5 mg E2 was significantly better than placebo at the femoral neck (p<0.001) and Ward’s triangle (p<0.0001). The overall difference in mean percentage change in BMD at the femoral neck versus placebo (−0.2%) was 3.8% for 0.5 mg, 4.0% for 1 mg and 3.9% for 2 mg E2; the corresponding numbers for trochanter were −0.3%, 1.3%, 3.3% and 3.2%, respectively, and −2.2%, 2.9%, 2.9% and 4.0%, respectively, for Ward’s triangle. More than half the women who received placebo presented with a decrease in BMD at the hip. The percentage of women in the 0.5 mg E2 group who maintained or increased BMD at the femoral neck, trochanter and Ward’s triangle was 69%, 56% and 44%, respectively. For 1 mg E2 the numbers were 69%, 78% and 61% respectively, and for 2 mg E2 were 59%, 68% and 59% respectively. Osteocalcin, serum pyridinium crosslinks, urinary pyridinium crosslinks and urinary hydroxyproline/creatinine decreased significantly (p<0.0001, p<0.05) in the 0.5, 1 and 2 mg E2 groups compared with the placebo group after 6 and 24 months of treatment.
Gemcitabine plus doxorubicin as first-line treatment in advanced or metastatic breast cancer (MBC), a phase II study.

Doxorubicin and Gemcitabine have promising antineoplastic activity and manageable toxicity as a single agent in the treatment of patients (pts) with advanced breast cancer.



This study evaluated the efficacy and toxicity of the combination of gemcitabine plus doxorubicin as first-line treatment of advanced or MBC patients.



Patients with advanced or MBC received gemcitabine 1250mg/m2 IV on days 1 and 8 plus doxorubicin 60mg/m2 IV on day 1 every 21 days for a maximum of 6 cycles.



Thirty-five patients were included, and all are evaluable for safety and efficacy. Median age was 47 years (range, 33 to 60 years). Fourteen patients (40%) were post-and 21 (60%) were premenopausal. Prior treatment included mastectomy (23pts); adjuvant nonanthracycline containing combination chemotherapy (18pts); adjuvant hormonal therapy (3pts) and 2 pts did not receive any adjuvant therapy. Twelve patients had metastatic disease at presentation. Seventeen pts were chemonaive. Hormonal receptors were positive in 6, negative in 21, and unknown in 8 pts. Site of metastasis included one site in 15 pts, two sites in 14, and three sites in 6 pts. Complete remission was observed in 6/35 (17.1%) and partial remission in 14/35 (40%) pts, for an overall response rate of 57.1%. Stable disease was observed in 8 (22.9%) and progressive disease in 7 (20%) pts. The median time to tumor progression was 7 months (range, 5-23 months; 95% CI, 6-8 months) and the median survival time was 16 months (range, 6-43 months; 95% CI, 13-19 months). The overall survival at 1 and 2 years was 74.2% and 34.2%; respectively; with 4/35 (11.4%) patients alive at 40 months. A total of 186 cycles of treatment were administered (range2-6 cycles, median 6 cycles). The doses of both doxorubicin and gemcitabine were modified after interim analysis of toxicity following the first 22 cycles administered to the first 10 patients [Mucositis grade 3-4 occurred in 6/10 (60%), grade 3-4 neutropenia in 3/10 (30%), and febrile neutropenia grade 3 in 2/10 (20%) patients] to doxorubicin 50mg/m2 on day 1 and gemcitabine to 1000 mg/m2 on days 1 and 8 in the remaining cycles. After doses reduction, the toxicity was generally tolerable.



The combination of gemcitabine plus doxorubicin after doses modification can be safely administered every 21 days with promising response as first-line therapy for MBC. The response rate, time to disease progression and overall survival rates of this regimen are comparable to other standard therapies for MBC, as well as other gemcitabine combinations.
Anticoagulation after subcutaneous enoxaparin is time sensitive in STEMI patients treated with tenecteplase

The adequacy of anticoagulation with enoxaparin as an adjuvant to fibrinolytic therapy for STEMI is unclear and has implications for both efficacy and safety; especially in patients undergoing a pharmacoinvasive reperfusion strategy. A subset of fibrinolytic-treated patients in the WEST study was enrolled in a systematic anti-Xa substudy. All received ASA and subcutaneous (SQ) enoxaparin 1 mg/kg followed by TNK-tPA. Incremental IV dosing of enoxaparin (0.3–0.5 mg/kg) was allowed prior to percutaneous coronary intervention (PCI). Anti-Xa blood samples were drawn prior and after angiography. Data are presented as percentages, medians and IQRs. Forty-five patients underwent angiography 2.8 h (2.5–14.6) after fibrinolytic. The pre-angiography median anti-Xa acquired 179 min (153–875) after SQ enoxaparin was 0.48 U/ml (0.42–0.65); a relationship between anti-Xa activity and time from administration was evident (r = 0.418, p < 0.007). Without supplemental IV enoxaparin the 2nd anti-Xa acquired 218 min (195–930) after SQ enoxaparin was 0.48 U/ml (0.41–0.80, n = 29). After supplemental IV enoxaparin, the 2nd anti-Xa was 0.92 U/ml (0.72–1.10, n = 16). An incremental IV enoxaparin dose and anti-Xa relationship was demonstrated (r = 0.59, p = 0.001) i.e. no IV 0.48 U/ml (0.41–0.80, n = 29), 0.3 mg/kg IV 0.81 U/ml (0.63–1.00, n = 12), and 0.5 mg/kg IV 1.34 U/ml (1.16–1.54, n = 4). Most fibrinolytic treated STEMI patients receiving weight-adjusted SQ enoxaparin (1 mg/kg) had subtherapeutic anti-Xa levels (<0.5 U/ml) after ~3 h. A strategy of supplemental 0.3 mg/kg IV enoxaparin at time of PCI reliably achieved anti-Xa ≥ 0.5 U/ml. Our findings provide a rational novel strategy for anti-thrombotic management in STEMI patients undergoing a pharmacoinvasive reperfusion strategy.
Planning for Action: The Impact of an Asthma Action Plan Decision Support Tool Integrated into an Electronic Health Record (EHR) at a Large Health Care System.

Asthma is a chronic airway disease that can be difficult to manage, resulting in poor outcomes and high costs. Asthma action plans assist patients with self-management, but provider compliance with this recommendation is limited in part because of guideline complexity. This project aimed to embed an electronic asthma action plan decision support tool (eAAP) into the medical record to streamline evidence-based guidelines for providers at the point of care, create individualized patient handouts, and evaluate effects on disease outcomes.



eAAP development occurred in 4 phases: web-based prototype creation, multidisciplinary team engagement, pilot, and system-wide dissemination. Medical record and hospital billing data compared frequencies of asthma exacerbations before and after eAAP receipt with matched controls.



Between December 2012 and September 2014, 5174 patients with asthma (∼10%) received eAAPs. Results showed an association between eAAP receipt and significant reductions in pediatric asthma exacerbations, including 33% lower odds of requiring oral steroids (P < .001), compared with controls. Equivalent adult measures were not statistically significant.



This study supports existing evidence that patient self-management plays an important role in reducing asthma exacerbations. We show the feasibility of leveraging technology to provide guideline-based decision support through an eAAP, addressing known challenges of implementation into routine practice.
Clopidogrel Resistance is Associated with Long-Term Thrombotic Events in Patients Implanted with Drug-Eluting Stents

There are limited prospective data on clopidogrel resistance and clinical outcome of patients with selective coronary drug-eluting stent (DES) implantation.



To investigate whether clopidogrel resistance is associated with long-term thrombotic events in patients with selective coronary DES implantation.



A total of 154 patients who underwent selective percutaneous coronary intervention (PCI) with DES were enrolled in this study. Platelet aggregation was measured using light transmittance aggregometry (LTA) before clopidogrel administration (baseline) and 24 hours after loading with clopidogrel 300 mg. Clopidogrel resistance was defined as ≤10% absolute difference between baseline aggregation and post-administration aggregation. All patients who received the same anti-platelet treatment were followed up for 1 year after discharge for the incidence of a composite endpoint consisting of cardiovascular death, myocardial infarction (MI) and revascularization, and secondly for the incidence of stent thrombosis.



The incidence of clopidogrel resistance is 20.28% in our study population. Patients who are complicated by diabetes mellitus, smoke, or have a higher body mass index (BMI) tend to have clopidogrel resistance. Patients in the clopidogrel-resistant group have significantly higher incidences of composite endpoints (21.88% vs 4.92%; p = 0.006) and stent thrombosis (12.5% vs 1.64%; p = 0.017) than patients in the clopidogrel-response group during 1-year follow-up.



Diabetes, smoking, and high BMI are associated with clopidogrel resistance, and clopidogrel resistance indicates an increased risk of long-term thrombotic events in patients implanted with DES.
After vs. priming effects of anodal transcranial direct current stimulation on upper extremity motor recovery in patients with subacute stroke.

Transcranial direct current stimulation (tDCS) of the motor cortex seems to be effective in improving motor performance in patients with chronic stroke, while some recent findings have reported conflicting results for the subacute phase. We aimed to verify whether upper extremity motor rehabilitation could be enhanced by treatment with tDCS administered before a rehabilitative session.



Hand dexterity and force in 16 individuals with subacute stroke were assessed before (T0) and after anodal stimulation (T1) and after a successive session of motor rehabilitation (T2) in a double-blind, randomized, sham-controlled, crossover trial. To confirm the value of the device as a specific effector, behavioral tests were also administered.



Anodal and sham stimulation plus rehabilitation significantly improved manual dexterity (repeated-measure Anova: A-tDCS: p = 0.005; S-tDCS: p = 0.042). Post hoc analysis revealed a significant stimulation effect only for A-tDCS (p = 0.013 between T0 and T1) and not for S-tDCS, whereas the rehabilitation effect (between T1 and T2) was not significant in either group. Hand force and behavioral features were unchanged.



Anodal brain stimulation improves hand dexterity but does not increase the effectiveness of the rehabilitation directly. These results suggest the presence of aftereffects, not priming effects, of A-tDCS superimposed onto motor learning phenomena.
Proton pump inhibitors for prophylaxis of nosocomial upper gastrointestinal tract bleeding: effect of standardized guidelines on prescribing practice.

Proton pump inhibitors (PPIs) are frequently prescribed for prophylaxis of nosocomial upper gastrointestinal tract bleeding. Some inpatients receiving PPIs may have no risk factors for nosocomial upper gastrointestinal tract bleeding, and PPIs may be continued unnecessarily at hospital discharge. We aimed to assess the effect of standardized guidelines on PPI prescribing practices.



Guidelines for PPI use were implemented on the medical service at a tertiary center. We reviewed PPI use among inpatient admissions during the month before implementation of guidelines and then prospectively evaluated PPI use among admissions during the month after implementation of guidelines.



Among an overall cohort of 942 patients, 48% were prescribed PPIs while inpatients, and 41% were prescribed PPIs at hospital discharge. Univariate predictors of inpatient PPI use included age, length of hospital stay, history of gastroesophageal reflux disease or upper gastrointestinal tract bleeding, and outpatient PPI, aspirin, or glucocorticoid use. Among patients not on an outpatient regimen of PPIs at admission, implementation of guidelines resulted in lower rates of inpatient PPI use (27% before vs 16% after, P = .001) and PPI prescription at discharge (16% before vs 10% after, P = .03).



Introduction of standardized guidelines resulted in lower rates of PPI use among a subset of inpatients and reduced the rate of PPI prescriptions at discharge.
A double-blind randomized study assessing safety and efficacy following one-year adjunctive treatment with bitopertin, a glycine reuptake inhibitor, in Japanese patients with schizophrenia

Bitopertin, a glycine reuptake inhibitor, was investigated as a novel treatment for schizophrenia. We report all the results of a double-blind randomized study assessing safety and efficacy following 52-week adjunctive treatment with bitopertin in Japanese patients with schizophrenia.



This study enrolled Japanese outpatients with schizophrenia who met criteria for either "negative symptoms", i.e., patients with persistent, predominant negative symptoms of schizophrenia even after long-term treatment with antipsychotics or "sub-optimally controlled symptoms", i.e., patients with insufficiently improved symptoms of schizophrenia even after long-term treatment with antipsychotics, respectively. One hundred sixty-one patients were randomly assigned to receive 52-week treatments with bitopertin doses of 5, 10, or 20 mg/day at ratio of 1:5:5, where existing antipsychotics were concomitantly administered. Efficacy endpoints included Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI), and Personal and Social Performance (PSP). The purpose of the present study is primarily to evaluate the safety, and secondarily to investigate the clinical efficacy of bitopertin.



One hundred fourteen patients (71 %) completed 52-week treatment with bitopertin. Most of the adverse events were mild or moderate in their severity. The patients in the 20-mg group experienced more adverse events than the patients in the other two groups. Common dose-dependent adverse events were somnolence and insomnia associated with worsening schizophrenia. The blood hemoglobin levels gradually decreased from baseline in a dose-dependent manner, but there were no patients with the decrease below 10 g/dL that would have led to their discontinuation. All the efficacy endpoints gradually improved in all the treatment groups for both of the two symptoms, while there were no clear differences among the three dose groups.



Altogether, bitopertin was found to be generally safe and well-tolerated for the treatment of patients with schizophrenia. All three bitopertin treated groups showed improvements in all the efficacy endpoints for both of the two symptoms, i.e., "negative symptoms" and "sub-optimally controlled symptoms", throughout the duration of the study.


 2011).
Effect of Group vs Individual Cognitive Processing Therapy in Active-Duty Military Seeking Treatment for Posttraumatic Stress Disorder: A Randomized Clinical Trial.

Cognitive processing therapy (CPT), an evidence-based treatment for posttraumatic stress disorder (PTSD), has not been tested as an individual treatment among active-duty military. Group CPT may be an efficient way to deliver treatment.



To determine the effects of CPT on PTSD and co-occurring symptoms and whether they differ when administered in an individual or a group format.



In this randomized clinical trial, 268 active-duty servicemembers consented to assessment at an army medical center from March 8, 2012, to September 23, 2014, and were randomized to group or individual CPT. Inclusion criteria were PTSD after military deployment and stable medication therapy. Exclusion criteria consisted of suicidal or homicidal intent or psychosis. Data collection was completed on June 15, 2015. Analysis was based on intention to treat.



Participants received CPT (the version excluding written accounts) in 90-minute group sessions of 8 to 10 participants (15 cohorts total; 133 participants) or 60-minute individual sessions (135 participants) twice weekly for 6 weeks. The 12 group and individual sessions were conducted concurrently.



Primary measures were scores on the Posttraumatic Symptom Scale-Interview Version (PSS-I) and the stressor-specific Posttraumatic Stress Disorder Checklist (PCL-S); secondary measures were scores on the Beck Depression Inventory-II (BDI-II) and the Beck Scale for Suicidal Ideation (BSSI). Assessments were completed by independent evaluators masked to treatment condition at baseline and 2 weeks and 6 months after treatment.



Among the 268 participants (244 men [91.0%]; 24 women [9.0%]; mean [SD] age, 33.2 [7.4] years), improvement in PTSD severity at posttreatment was greater when CPT was administered individually compared with the group format (mean [SE] difference on the PSS-I, -3.7 [1.4]; Cohen d = 0.6; P = .006). Significant improvements were maintained with the individual (mean [SE] PSS-I, -7.8 [1.0]; Cohen d = 1.3; mean [SE] PCL-S, -12.6 [1.4]; Cohen d = 1.2) and group (mean [SE] PSS-I, -4.0 [0.97]; Cohen d = 0.7; mean [SE] PCL-S, -6.3 [1.4]; Cohen d = 0.6) formats, with no differences in remission or severity of PTSD at the 6-month follow-up. Symptoms of depression and suicidal ideation did not differ significantly between formats.



Individual treatment resulted in greater improvement in PTSD severity than group treatment. Depression and suicidal ideation improved equally with both formats. However, even among those receiving individual CPT, approximately 50% still had PTSD and clinically significant symptoms. In the military population, improving existing treatments such as CPT or developing new treatments is needed.
Evolving approach to aortic valve replacement in children and adolescents--a preliminary report.

Surgical treatment methods are still controversial in children with congenital or acquired aortic valve dysfunction.



To evaluate treatment results in children after mechanical or biological valve implantation.



We analysed a group of 55 children after mechanical valve implantation (group A) and a group of 8 children after Freestyle biological valve implantation (group B). We evaluated in both groups: patient's age, type of valve dysfunctions, severity of heart failure symptoms, and quality of life. The parameters of physiological left ventricular (LV) remodelling were examined on the basis of echocardiographical signs of LV contractibility (%SF) and anatomical changes: LV diastolic diameter (LVDd), LV posterior wall thickness (LVPW), thickness of intra-ventricle septum (IVS) and pressure gradient between LV and aorta (LV-Ao).



There were no hospital deaths in either group. There were two late deaths in children from group A. Thromboembolic (2), nonspecific bleeding complications (2), and infections (2) occurred in group A. There were two re-operations in children after mechanical valve implantation. The early postoperative period was good in groups A and B. Furthermore, late postoperative period was good in group B. Physiological LV remodelling occurred in children in groups A and B. Quality of life was good in both groups.



Good clinical results, simplicity, repeatability and safety of surgical technique mean that mechanical valve implantation in the aortic position is still an attractive option for treatment in children and adults. However, absence of bleeding, thromboembolic and infection complications and improvement of durability mean that the Freestyle biological new generation valve could be a good option for future in children and adolescents who need aortic valve replacement.