nils-herrmann/clean_scirepeval huggingface dataset:
Predictive Value of Upper Limb Muscles and Grasp Patterns on Functional Outcome in Cervical Spinal Cord Injury.

To determine which single or combined upper limb muscles as defined by the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI); upper extremity motor score (UEMS) and the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP), best predict upper limb function and independence in activities of daily living (ADLs) and to assess the predictive value of qualitative grasp movements (QlG) on upper limb function in individuals with acute tetraplegia.



As part of a Europe-wide, prospective, longitudinal, multicenter study ISNCSCI, GRASSP, and Spinal Cord Independence Measure (SCIM III) scores were recorded at 1 and 6 months after SCI. For prediction of upper limb function and ADLs, a logistic regression model and unbiased recursive partitioning conditional inference tree (URP-CTREE) were used.  Logistic regression and URP-CTREE revealed that a combination of ISNCSCI and GRASSP muscles (to a maximum of 4) demonstrated the best prediction (specificity and sensitivity ranged from 81.8% to 96.0%) of upper limb function and identified homogenous outcome cohorts at 6 months. The URP-CTREE model with the QlG predictors for upper limb function showed similar results.



Prediction of upper limb function can be achieved through a combination of defined, specific upper limb muscles assessed in the ISNCSCI and GRASSP. A combination of a limited number of proximal and distal muscles along with an assessment of grasping movements can be applied for clinical decision making for rehabilitation interventions and clinical trials.
The impact of right ventricular involvement on the postdischarge long-term mortality in patients with acute inferior ST-segment elevation myocardial infarction.

To investigate the long-term impact of right ventricular myocardial involvement (RVI) after acute inferior ST-segment elevation myocardial infarction (STEMI).



A total of 1208 consecutive patients, who survived to discharge after hospitalization for acute inferior STEMI, were studied. Patients were divided into those with (n = 459) or without (n = 749) of RVI involvement, defined as ST-segment elevation > or =1 mm in V4R. Cardiac death by 3 years was the primary study end point.



By the end of follow-up, 207 (17.1%) patients had died. Patients with RVI were at similar risk for death at 3 years than those without (17.6% vs 16.8%, hazard ratio 1.1, 95% confidence interval 0.8-1.4, P = .79). By multivariate Cox analysis, several variables, but not RVI, were associated with the incidence of 3 years cardiac death.



Right ventricular myocardial involvement does not portend any increased risk for long-term mortality, in patients who survived to discharge after hospitalization for acute inferior STEMI.
Venous thromboembolism prophylaxis in acutely ill hospitalized medical patients. A retrospective multicenter study.

To analyze the incidence of VTE in hospitalized medical patients and prophylaxis applied in accordance with the 8th ACCP guidelines and the National PRETEMED guide for thromboprophylaxis.



Discharge lists were reviewed to select the first consecutive 20 patients, aged ≥ 40 years and admitted ≥ 4 days to the Internal Medicine Departments of 79 Spanish hospitals. Exclusion criteria were: admission for diagnostic procedures, VTE or surgical illness, or care during hospitalization provided by the local investigator.



From September 2011 to July 2012, 2845 discharge reports were evaluated and 1623 were considered eligible for the study. Overall 930 (57.3%) patients of this group were at risk of VTE according to the ACCP guidelines, 759 (81.6%) received VTE prophylaxis (mechanical or pharmacological) and 159 (17.1%) had at least one risk factor that might contraindicate anticoagulant use. The proportion of patients at VTE risk according to the ACCP and National PRETEMED guidelines with no risk factors of bleeding that did not receive prophylaxis was 16.3% and 17.2%, respectively. During hospitalization, there were 14 (0.9%) episodes of symptomatic VTE, 12 (86%) of which occurred in patients receiving prophylaxis. VTE rate was 1.3% among patients with VTE risk that received prophylaxis and 3.5% in patients that also had one risk factor that might contraindicate anticoagulant use.



In a setting characterized by high thromboprophylaxis compliance most of the episodes occurred in patients receiving pharmacological prophylaxis. Patients with combined VTE and bleeding risk factors showed the highest rate of both symptomatic VTE and prophylaxis failure.
Efficacy of exercise as an adjunct treatment for clinically depressed inpatients during the initial stages of antidepressant pharmacotherapy: An open randomized controlled trial.

Physical exercise as adjunctive treatment for hospitalized patients with major depressive disorder (MDD) has been of increasing interest in the past few years. While preliminary findings are promising, these prior studies have been plagued by inclusion of participants at different stages of medication use at study entry. The present study evaluates the effects of a short (10-days) add-on endurance-training intervention in hospitalized MDD patients on antidepressant medication for less than two weeks.



Thirty-five participants were randomly assigned to one of three study groups: aerobic exercise (n=14), placebo (stretching) exercise (n=11), or no intervention (control; n=10). The study outcome was the change in the Beck Depression Inventory (BDI-II) total score from baseline to the end of the study period.



The intent-to-treat analysis showed significant improvements in BDI-II scores for both the aerobic and the stretching groups. However, comparing pre- to post-study depression changes in these two groups, we found a large effect size in favor of aerobic exercise (Cohen's d=-1.06). No significant change in depressive symptoms was found in the control group.



The nature of the intervention (i.e., exercise) meant blinding participants to treatments was not possible. Precise information on medication dosage was not available, and the short duration of interventions and lack of follow-up assessment were all limitations.



Endurance-training can be a helpful adjunct treatment for hospitalized patients with severe affective disorders in the initial stages of pharmacotherapy.
METFORMIN: an efficacy, safety and pharmacokinetic study on the short-term and long-term use in obese children and adolescents – study protocol of a randomized controlled study

The prevalence of childhood obesity and insulin resistance is rising, increasing the risk of diabetes mellitus type 2. To prevent these complications, lifestyle intervention is the corner stone in treatment. However, long-term efficacy of lifestyle intervention is questionable. In addition to lifestyle intervention, pharmacological treatments have been explored. Metformin has been shown to be moderately effective to reduce BMI in obese adolescents with hyperinsulinemia. However, data on pharmacokinetics and long-term efficacy and safety are lacking as well as an evidence-based dosing regimen for this age group. The primary objective of the METFORMIN study is to determine the effect of adding metformin treatment to lifestyle intervention in reducing BMI in obese adolescents with insulin resistance. In addition, the pharmacokinetics of metformin in obese adolescents will be studied.



The METFORMIN study is a multi-centre prospective study that consists of two 18-month phases: a double-blind randomized placebo-controlled trial (part 1) and an open-label follow-up study (part 2). During part 1, the participants will be given metformin 1,000 mg or placebo twice daily and will be offered a lifestyle intervention programme; 144 participants will be included, 72 in each arm. Primary endpoints are reduction in body mass index, insulin resistance, and percentage body fat.



This study will provide data on short- and long-term efficacy and safety of metformin and on the pharmacokinetics of metformin in obese adolescents.
Influence of wrap length on the effectiveness of Nissen and Toupet fundoplication: a prospective randomized study

Incontinence or hypercontinence of the fundic wrap depends primarily on the length of the valve or the type of procedure. Much less attention has been paid to the fundic wrap length. This study aimed to compare the effectiveness of two different wrap lengths among the patients undergoing partial or total fundoplication. For this study, 153 patients were randomized to either Nissen (1.5- or 3-cm wrap) or Toupet (1.5- or 3-cm wrap) laparoscopic fundoplication. The groups were compared according to intensity of dysphagia, esophageal manometry data, ambulatory 24-h pH monitoring data, postoperative esophagitis rate, and overall treatment failure rate. In all the groups, the tone of the lower esophageal sphincter was significantly increased and the DeMeester score significantly decreased, reaching normal levels. At 6 months after surgery, the Toupet 1.5-cm group had significantly more cases of esophagitis than the 3-cm wrap group (24.2% vs 3.3%; p < 0.05). At 12 months after surgery, only one patient in the Nissen 3-cm group had moderate to severe dysphagia. In all cases, failures were associated with persistent erosive esophagitis. At the 12-month follow-up assessment, treatment failures were significantly more common in Toupet 1.5-cm group than in the Toupet 3-cm group (17.5% vs 2.7%; p < 0.05). However, such differences were not observed in the Nissen groups (7.8% for 1.5 cm and 15.6% for 3 cm; p > 0.05). Evaluation of the treatment results suggests that the wrap length is important in partial Toupet fundoplication to avoid treatment failures. The 3-cm wrap is superior to the 1.5-cm wrap in cases of partial posterior Toupet fundoplication. The influence of wrap length on treatment failure remains unconfirmed for the Nissen procedure.
Electrical stimulation therapy of the lower esophageal sphincter is successful in treating GERD: final results of open-label prospective trial

Electrical stimulation of the lower esophageal sphincter (LES) improves LES pressure without interfering with LES relaxation. The aim of this open-label pilot trial was to evaluate the safety and efficacy of long-term LES stimulation using a permanently implanted LES stimulator in patients with gastroesophageal reflux disease (GERD). GERD patients who were at least partially responsive to proton pump inhibitors (PPI) with abnormal esophageal pH, hiatal hernia ≤3 cm, and esophagitis ≤LA grade C were included. Bipolar stitch electrodes were placed in the LES and an IPG was placed in a subcutaneous pocket. Electrical stimulation was delivered at 20 Hz, 215 μs, 3–8 mA in 30 min sessions. The number and timing of sessions was tailored to each patient’s GERD profile. Patients were evaluated using GERD-HRQL, daily symptom and medication diaries, SF-12, esophageal pH, and high-resolution manometry. 24 patients (mean age = 53 years, SD = 12 years; 14 men) were implanted; 23 completed their 6-month evaluation. Median GERD-HRQL scores at 6 months was 2.0 (IQR = 0–5.5) and was significantly better than both baseline on-PPI [9.0 (range = 6.0–10.0); p < 0.001] and off-PPI [23 (21–25); p < 0.001] GERD-HRQL. Median%  24-h esophageal pH < 4.0 at baseline was 10.1 and improved to 5.1 at 6 months (p < 0.001). At their 6-month follow-up, 91 % (21/23) of the patients were off PPI and had significantly better median GERD-HRQL on LES stimulation compared to their on-PPI GERD-HRQL at baseline (9.0 vs. 2.0; p < 0.001). There were no unanticipated implantation- or stimulation-related adverse events or untoward sensation due to stimulation. There were no reports of treatment-related dysphagia, and manometric swallow was also unaffected. Electrical stimulation of the LES is safe and effective for treating GERD. There is a significant and sustained improvement in GERD symptoms, esophageal pH, and reduction in PPI usage without any side effects with the therapy. Furthermore, the therapy can be optimized to address an individual patient’s disease.
Effects of safflower seed extract supplementation on oxidation and cardiovascular risk markers in healthy human volunteers.

We previously demonstrated that safflower seed extract (SSE) and its major antioxidant constituents, serotonin hydroxycinnamic acid amides, suppressed LDL oxidation in vitro, decreased plasma autoantibody titres to oxidized LDL and attenuated atherosclerotic lesion formation in apoE-deficient mice. In this report, we examined whether SSE, rich in serotonin derivatives, could affect markers of oxidative stress, inflammation and aortic stiffness in healthy human subjects. Twenty Japanese male volunteers were studied at baseline, after 2.1 g SSE supplementation daily (providing 290 mg serotonin derivatives/d) for 4 weeks, and after a 4-week washout period. Significant reductions in circulating oxidized LDL, autoantibody titres to malondialdehyde-modified LDL, the soluble form of vascular cell adhesion molecule-1 (sVCAM-1), and urinary 8-isoprostane were observed after a 4-week intervention. Although there were no statistically significant differences in blood pressure or brachial-ankle pulse wave velocity (baPWV), an index of arterial stiffness, baPWV was lower than baseline in eleven of twenty subjects and was accompanied by a reduction in blood pressure. Statistically significant negative correlations were observed between the extent of initial cardiovascular risk markers (autoantibody titres, 8-isoprostane, sVCAM-1 and baPWV) and the effect of intervention. This suggested that individuals with elevated oxidative stress, inflammation, and/or arterial stiffness may receive more benefit from SSE supplementation.
High school automated external defibrillator programs as markers of emergency preparedness for sudden cardiac arrest.

School-based automated external defibrillator (AED) programs have demonstrated a high survival rate for individuals suffering sudden cardiac arrest (SCA) in US high schools.



To examine the relationship between high schools having an AED on campus and other measures of emergency preparedness for SCA.



Cross-sectional study.



United States high schools, December 2006 to September 2009.



Principals, athletic directors, school nurses, and certified athletic trainers represented 3371 high schools.



Comprehensive surveys on emergency planning for SCA submitted by high school representatives to the National Registry for AED Use in Sports from December 2006 to September 2009. Schools with and without AEDs were compared to assess other elements of emergency preparedness for SCA.



A total of 2784 schools (82.6%) reported having 1 or more AEDs on campus, with an average of 2.8 AEDs per school; 587 schools (17.4%) had no AEDs. Schools with an enrollment of more than 500 students were more likely to have an AED (relative risk [RR] = 1.12, 95% confidence interval [CI] = 1.08, 1.16, P < .01). Suburban schools were more likely to have an AED than were rural (RR = 1.08, 95% CI = 1.04, 1.11, P < .01), urban (RR = 1.13, 95% CI = 1.04, 1.16, P < .01), or inner-city schools (RR = 1.10, 95% CI = 1.04, 1.23, P < .01). Schools with 1 or more AEDs were more likely to ensure access to early defibrillation (RR = 3.45, 95% CI = 2.97, 3.99, P < .01), establish an emergency action plan for SCA (RR = 1.83, 95% CI = 1.67, 2.00, P < .01), review the emergency action plan at least annually (RR = 1.99, 95% CI = 1.58, 2.50, P < .01), consult emergency medical services to develop the emergency action plan (RR = 1.18, 95% CI = 1.05, 1.32, P < .01), and establish a communication system to activate emergency responders (RR = 1.06, 95% CI = 1.01, 1.08, P < .01).



High schools with AED programs were more likely to establish a comprehensive emergency response plan for SCA. Implementing school-based AED programs is a key step associated with emergency planning for young athletes with SCA.
Antimicrobial prophylaxis for major head and neck surgery in cancer patients: sulbactam-ampicillin versus clindamycin-amikacin.

A total of 99 patients with head and neck cancer who were to undergo surgery were randomized in a prospective comparative study of sulbactam-ampicillin (1:2 ratio; four doses of 3 g of ampicillin and 1.5 g of sulbactam intravenously [i.v.] every 6 h) versus clindamycin (four doses of 600 mg i.v. every 6 h)-amikacin (two doses of 500 mg i.v. every 12 h) as prophylaxis starting at the induction of anesthesia. The two groups of evaluable patients (43 in the clindamycin-amikacin treatment group and 42 in the sulbactam-ampicillin treatment group) were comparable as far as age (mean, 57 years; range, 21 to 84 years), sex ratio (71 males, 28 females), weight (mean, 66 kg; range, 40 to 69 kg), indication for surgery (first surgery, 48 patients; recurrence, 37 patients), previous anticancer treatment (surgery, radiation therapy, chemotherapy), type of surgery, and stage of cancer. The overall infection rate (wound, bacteremia, and bronchopneumonia) within 20 days after surgery was 20 patients in each group. Wound infections occurred in 14 (33%) sulbactam-ampicillin-treated patients and 9 (21%) clindamycin-amikacin-treated patients (P = 0.19; not significant). The rates of bacteremia were 2 and 4%, respectively. The rates of bronchopneumonia were 14.3 and 23.2%, respectively (P was not significant). Most infections were polymicrobial, but strict anaerobes were recovered only from patients who received sulbactam-ampicillin. Antimicrobial treatment was required within 20 days after surgery for 42% of the sulbactam-ampicillin-treated patients and 44% of the clindamycin-amikacin-treated patients. By comparison with previous studies, we observed a decreased efficacy of antimicrobial prophylaxis in patients with head and neck cancer undergoing surgery because of the increased proportion of patients who were at very high risk for infection (extensive excision and plastic reconstruction in patients with recurrent stage III and IV cancers) and because of the longer duration of surgery.
Successful Delivery of Twin Pregnancy in Class U3b/C2/V1 Uterus by Bilateral Caesarean Section after Spontaneous Conception

A case of a 19-year-old female with class U3b/C2/V1 uterus conceived a twin pregnancy with a fetus in each horn after spontaneous conception. She referred to our department with presentation of premature rupture of membranes, with a history of cesarean delivery of a single full term living fetus a year and a half before this delivery. Examination revealed two completely separate uterine horns with a fetus in each horn, two distinct externally rounded cervices, and a single vagina with a short nonobstructing vaginal septum in the upper part of the vagina. And as the appropriate mode of delivery is still unclear, each case should be managed as the condition requires, and in our case urgent bilateral caesarean sections were performed.
A multicenter pilot study of subcallosal cingulate area deep brain stimulation for treatment-resistant depression.

OBJECT
Deep brain stimulation (DBS) has been recently investigated as a treatment for major depression. One of the proposed targets for this application is the subcallosal cingulate gyrus (SCG). To date, promising results after SCG DBS have been reported by a single center. In the present study the authors investigated whether these findings may be replicated at different institutions. They conducted a 3-center prospective open-label trial of SCG DBS for 12 months in patients with treatment-resistant depression.



Twenty-one patients underwent implantation of bilateral SCG electrodes. The authors examined the reduction in Hamilton Rating Scale for Depression (HRSD-17) score from baseline (RESP50).



Patients treated with SCG DBS had an RESP50 of 57% at 1 month, 48% at 6 months, and 29% at 12 months. The response rate after 12 months of DBS, however, increased to 62% when defined as a reduction in the baseline HRSD-17 of 40% or more. Reductions in depressive symptomatology were associated with amelioration in disease severity in patients who responded to surgery.



Overall, findings from this study corroborate the results of previous reports showing that outcome of SCG DBS may be replicated across centers.
Extremely low frequency electromagnetic fields prevent chemotherapy induced myelotoxicity.

Side effects of chemo-radiotherapy reduce the quality and also the survivability of patients. The consequent fatigue and infections, related to myelodepression, act to reduce the dose-intensity of the protocol. Late side effects of chemo-radiotherapy include secondary tumours, acute myeloid leukemias and cardiotoxicity. Side effects of chemotherapy are related to oxidative stress produced by the treatment. Oxidative stress also reduces the efficacy of the treatment. Antioxidative treatment with natural (dietetic) or chemical agents has been reported to reduce the toxicity of chemo-radiotherapy and improve the efficacy of treatment. We here report our experience with SEQEX, an electromedical device that generates Extremely Low Frequency ElectroMagnetic Fields (ELF-EMF) to produce endogenic cyclotronic ionic resonance, to reduce myelotoxicity consequent to ABVD protocol in patients with Hodgkin's lymphoma.
Primary chemotherapy with gemcitabine as prolonged infusion, non-pegylated liposomal doxorubicin and docetaxel in patients with early breast cancer: final results of a phase II trial.

Combinations of anthracyclines, taxanes and gemcitabine have shown high activity in breast cancer. This trial was designed to evaluate a modified combination regimen as primary chemotherapy. Non-pegylated liposomal doxorubicin (NPLD) was used instead of conventional doxorubicin to improve cardiac safety. Gemcitabine was given 72 h after NPLD and docetaxel as a prolonged infusion over 4 h in order to optimize synergistic effects and accumulation of active metabolites.



Forty-four patients with histologically confirmed stage II or III breast cancer were treated with NPLD (60 mg/m(2)) and docetaxel (75 mg/m(2)) on day 1 and gemcitabine as 4-h infusion (350 mg/m(2)) on day 4. Treatment was repeated every 3 weeks for a maximum of six cycles. All patients received prophylactically recombinant granulocyte colony-stimulating factor. Patients with axillary lymph node involvement after primary chemotherapy received adjuvant treatment with cyclophosphamide, methotrexate and fluorouracil.



The clinical response rate was 80%, and complete remissions of the primary tumor occurred in 10 patients (25%). Breast conservation surgery was performed in 19 out of 20 patients (95%) with an initial tumor size of less than 3 cm and in 14 patients (70%) with a tumor size <or=3 cm. Seven patients had histologically confirmed complete responses accounting for a pCR rate of 17.5%. Expression of Ki--67 was the most important predictive parameter for response with high 38.9% breast pCR rate in patients with elevated Ki--67 expression. Although the predominant toxicity was myelosuppression with grade 3/4 neutropenia in 61% of patients few neutropenic complications resulted. Non-hematological toxicity was generally moderate with grade 3 or 4 toxicity in 10.0% of cycles. Most common non-hematologic toxicities were nausea, vomiting, alopecia, mucositis, asthenia and elevation of liver enzymes.



The evaluated schedule provides a safe and highly effective combination treatment for patients with early breast cancer, which is suitable for phase III studies.