nils-herrmann/clean_scirepeval huggingface dataset:
Prognostic impact of systemic inflammatory diseases in elderly patients with congestive heart failure.

Inflammation is part of the pathophysiology of congestive heart failure (CHF). However, little is known about the impact of the presence of systemic inflammatory disease (SID), defined as inflammatory syndrome with constitutional symptoms and involvement of at least two organs as co-morbidity on the clinical course and prognosis of patients with CHF.



This is an analysis of all 622 patients included in TIME-CHF. After an 18 months follow-up, outcomes of patients with and without SID were compared. Primary endpoint was all-cause hospitalization free survival. Secondary endpoints were overall survival and CHF hospitalization free survival. At baseline, 38 patients had history of SID (6.1%). These patients had higher N-terminal pro brain natriuretic peptide and worse renal function than patients without SID. SID was a risk factor for adverse outcome [primary endpoint: hazard ratio (HR) = 1.73 (95% confidence interval: 1.18-2.55, P = 0.005); survival: HR = 2.60 (1.49-4.55, P = 0.001); CHF hospitalization free survival: HR = 2.3 (1.45-3.65, P < 0.001)]. In multivariate models, SID remained the strongest independent risk factor for survival and CHF hospitalization free survival.



In elderly patients with CHF, SID is independently accompanied with adverse outcome. Given the increasing prevalence of SID in the elderly population, these findings are clinically important for both risk stratification and patient management.
Screening for the metabolic side effects of antipsychotic medication: findings of a 6-year quality improvement programme in the UK

To increase the frequency and quality of screening for the metabolic syndrome in people prescribed continuing antipsychotic medication.



An audit-based, quality improvement programme (QIP) with customised feedback to participating mental health services after each audit, including benchmarked data on their relative and absolute performance against an evidence-based practice standard and the provision of bespoke change interventions.



Adult, assertive outreach, community psychiatric services in the UK.



6 audits were conducted between 2006 and 2012. 21 mental health Trusts participated in the baseline audit in 2006, submitting data on screening for 1966 patients, while 32 Trusts participated in the 2012 audit, submitting data on 1591 patients.



Over the 6 years of the programme, there was a statistically significant increase in the proportion of patients for whom measures for all 4 aspects of the metabolic syndrome had been documented in the clinical records in the previous year, from just over 1 in 10 patients in 2006 to just over 1 in 3 by 2012. The proportion of patients with no evidence of any screening fell from almost ½ to 1 in 7 patients over the same period.



The findings suggest that audit-based QIPs can help improve clinical practice in relation to physical healthcare screening. Nevertheless, they also reveal that only a minority of community psychiatric patients prescribed antipsychotic medication is screened for the metabolic syndrome in accordance with best practice recommendations, and therefore potentially remediable causes of poor physical health remain undetected and untreated.
A phase I, dose-escalation study of the Eg5-inhibitor EMD 534085 in patients with advanced solid tumors or lymphoma

The kinesin spindle protein Eg5 is involved in mitosis, and its inhibition promotes mitotic arrest. EMD 534085, a potent, reversible Eg5 inhibitor, demonstrated significant preclinical antitumor activity.  This first-in-man, single-center, open-label, phase I dose-escalation study (3 + 3 design) investigated EMD 534085 safety, pharmacokinetics and antitumor activity in refractory solid tumors, Hodgkin’s lymphoma, or non-Hodgkin’s lymphoma. EMD 534085 (starting dose 2 mg/m2/day) was administered intravenously every 3 weeks. Doses were escalated in 100 % steps in successive cohorts of 3 patients until grade 2 toxicity occurred, followed by 50 % until the first dose-limiting toxicity (DLT) arose. If <2 of 6 patients experienced a DLT, doses were further increased by 25 %. Dose-escalation was stopped if a DLT occurred in ≥2 of 6 patients.  Forty-four patients received EMD 534085. Median treatment duration was 43 days (range, 21–337). Thirty-eight patients (86 %) received ≥2 cycles. DLTs were grade 4 neutropenia (1 patient each at 108 and 135 mg/m2/day), and grade 3 acute coronary syndrome with troponin I elevation (1 patient at 135 mg/m2/day). The maximum tolerated dose (MTD) was 108 mg/m2/day. The most common treatment-related adverse events were asthenia (50 %) and neutropenia (32 %). EMD 534085 appeared to have linear pharmacokinetics. Increase in phospho-histone H3 positive cells in paired pre- and on-treatment biopsies showed evidence of target modulation. No complete or partial responses were observed. Best response was stable disease in 23 patients (52 %).  EMD 534085 appeared to be well tolerated; MTD was 108 mg/m2/day. Preliminary antitumor results suggested limited activity in monotherapy.
Serum adiponectin multimer complexes and liver cancer risk in a large cohort study in Japan.

Evidence suggests a link between adiponectin, an adipocytokine, and liver tumorigenesis. Different multimer complexes of adiponectin, with low-molecular weight (LMW), middle-molecular weight (MMW) and high-molecular weight (HMW), may have different roles. Therefore the present study was performed with the aim of assessing associations between these multimers and liver cancer development. A nested case-control study (59 liver cancer cases [mean age=63.5 years] and 334 controls [62.7 years]) was conducted as a part of the Japan Collaborative Cohort (JACC) Study recruiting healthy participants, aged 40-79 years, for the follow-up period from 1988-1990 to 1999. The end point was liver cancer occurrence/death. Serum levels of HMW, MMW and LMW adiponectin were determined at baseline using an ELISA assay. Multivariate-adjusted logistic regression analyses comparing the tertile levels of adiponectin multimers showed that the groups stratified with the highest percentage of LMW tended to have lower odds ratios (ORs) than the lowest group (OR adjusted for sex, age and area=0.54 [95%CI: 0.26-1.11] and adjusted for sex, age, area, body mass index, smoking, alcohol, coffee consumption, diabetes history and HCV-antibody positivity =0.50 [95%CI: 0.22-1.15]), albeit without statistical significance (set at p<0.05). Higher percentages of circulating LMW adiponectin may lead to a reduction of liver cancer risk and relationships with multimer composition may merit further study.
Concurrent chemoradiation with capecitabine and weekly irinotecan as preoperative treatment for rectal cancer: results from a phase I/II study

The aim of this study was to investigate the efficacy and safety of chemoradiation using capecitabine and irinotecan as neoadjuvant therapy for patients with rectal cancer. Conventional radiation was given at daily fractions of 1.8 Gy on 5 days a week for a total dose of 55.8 (50.4+5.4) Gy. Concurrently, irinotecan 40 mg m−2 once weekly and capecitabine continuously at dose levels of 500, 650, 750 and 825 mg m−2 twice daily were administered. Surgery was performed 4–6 weeks following completion of chemoradiation. A total of 28 patients (3 UICC II, 25 UICC III) were enrolled and all received treatment. Dose-limiting toxicity was diarrhoea grade IV and hand–foot syndrome at the 825 mg m−2 dose level. The maximum tolerated dose of capecitabine was 750 mg m−2. Diarrhoea was the most common toxicity: grade III in nine patients. Two patients died, one due to pneumonia and one due to sudden cardiac death. A complete response and only microfocal residual tumour disease was achieved in four and three patients (27%). In all, 25 of 28 patients undergoing surgery, 24 (96%) had R0 resection. Preoperative chemoradiation based on continuous daily capecitabine and weekly irinotecan appears to tolerated and effective in patients with rectal cancer.
Cisplatin and etoposide in oesophageal cancer: a phase II study. Rotterdam Oesophageal Tumour Study Group.

In the search for effective chemotherapy regimens which can be used in multimodality treatment programmes for patients with cancer of the oesophagus, we conducted a phase II trial to determine the activity and toxicity of the combination of cisplatin and etoposide in patients with advanced squamous cell carcinoma of the oesophagus. Seventy-three consecutive patients with unresectable or metastatic squamous cell carcinoma of the thoracic oesophagus were treated with cisplatin 80 mg m-2 by 4 h infusion on day 1, etoposide 100 mg (fixed dose) by 2 h infusion on day 1 and 2, and etoposide 200 mg m-2 orally on day 3 and 5. Courses were repeated every 4 weeks, for a maximum of six courses. The oral dosages of etoposide were modified individually until a significant degree of myelosuppression was reached. Of 65 evaluable patients, five complete responses (CRs) and 26 partial responses (PRs) were seen, for an overall response rate of 48% (95% confidence interval 35-60%). Median time to progression was 7 months (range 3-72 + months). There were two toxic deaths (neutropenic sepsis). The response rate equals that of other cisplatin-based regimens. Its toxicity profile allows addition of a third active drug such as 5-fluorouracil.
Focal hepatic lesion ultrasound-guided biopsies.

To compare the results of pathologic and cytologic reports of specimens acquired from focal liver lesions using ultrasound-guided biopsy and to evaluate the necessity of performing both techniques in the same patient.



21 patients were eligible for enrollment in the study. Specimens for both pathologic and cytologic examination were obtained from 16 lesions using a 17G needle guide in a single puncture attempt. In 2 cases the diagnosis was based on cytologic smears. In 3 cases only histologic sections were acquired. The needle was introduced under continuous ultrasonographic control using a freehand technique. A cytologist was present at all times.



The diagnostic sensitivity of cytologic examination was 83.33% and that of histologic examination was 94.74%. Histology diagnosed all cases of benign lesions and was proved inconclusive in 1 patient. The diagnostic sensitivity and accuracy of both methods combined reached 100%. In 94.4% malignancy was immediately diagnosed by cytology.



Combination of both methods should increase the sensitivity and accuracy in diagnosing focal liver lesions performing a safe minimally invasive technique.
Metabolic effects of dialyzate glucose in chronic hemodialysis: results from a prospective, randomized crossover trial.

There is no agreement concerning dialyzate glucose concentration in hemodialysis (HD) and 100 and 200 mg/dL (G100 and G200) are frequently used. G200 may result in diffusive glucose flux into the patient, with consequent hyperglycemia and hyperinsulinism, and electrolyte alterations, in particular potassium (K) and phosphorus (P). This trial compared metabolic effects of G100 versus G200.



Chronic HD patients participated in this randomized, single masked, controlled crossover trial (www.clinicaltrials.gov: #NCT00618033) consisting of two consecutive 3-week segments with G100 and G200, respectively. Intradialytic serum glucose (SG) and insulin concentrations (SI) were measured at 0, 30, 60, 120, 180, 240 min and immediately post-HD; P and K were measured at 0, 120, 180 min and post-HD. Hypoglycemia was defined as an SG<70 mg/dL. Mean SG and SI were computed as area under the curve divided by treatment time.



Fourteen diabetic and 15 non-diabetic subjects were studied. SG was significantly higher with G200 as compared to G100, both in diabetic {G200: 192.8±48.1 mg/dL; G100: 154.0±27.3 mg/dL; difference 38.8 [95% confidence interval (CI): 21.2-56.4] mg/dL; P<0.001} and non-diabetic subjects [G200: 127.0±11.2 mg/dL; G100 106.5±10.8 mg/dL; difference 20.6 (95% CI: 15.3-25.9) mg/dL; P<0.001]. SI was significantly higher with G200 in non-diabetic subjects. Frequency of hypoglycemia, P and K serum levels, interdialytic weight gain and adverse intradialytic events did not differ significantly between G100 and G200.



G200 may exert unfavorable metabolic effects in chronic HD patients, in particular hyperglycemia and hyperinsulinism, the latter in non-diabetic subjects.
Impact of a selenium chemoprevention clinical trial on hospital admissions of HIV-infected participants.

To evaluate the impact of selenium chemoprevention (200 microg/day) on hospitalizations in HIV-positive individuals.



Data were obtained from 186 HIV+ men and women participating in a randomized, double-blind, placebo-controlled selenium clinical trial (1998-2000). Supplements were dispensed monthly, and clinical evaluations were conducted every 6 months. Inpatient hospitalizations, hospitalization costs, and rates of hospitalization were determined 2 years before and during the trial.



At enrollment, no significant differences in CD4 cell counts or viral burden were observed between the two study arms. Fewer placebo-treated participants were using antiretrovirals (p <.05). The total number of hospitalizations declined from 157 before the trial to 103 during the 2 year study. A marked decrease in total admission rates (RR = 0.38; p =.002) and percent of hospitalizations due to infection/100 patients for those receiving selenium was observed (p =.01). As a result, the cost for hospitalization decreased 58% in the selenium group, compared to a 30% decrease in the placebo group (p =.001). In the final analyses, selenium therapy continued to be a significant independent factor associated with lower risk of hospitalization (p =.001).



Selenium supplementation appears to be a beneficial adjuvant treatment to decrease hospitalizations as well as the cost of caring for HIV-1-infected patients.
A versatile mechanical ventilator (DIGIT) with high flow stability and a programmable inspiratory phase flow pattern

Describes the general characteristics of a newly developed nonconstant-flow generator for automatic ventilation of the lungs. It is known that the application of very high pressure to high internal resistance leads to a very stable flow, in that the flow itself is unaffected by external load (patient) variations. The stability of the flow means that the inspiratory process can be controlled by means of the ventilated volume, thus extending DIGIT utilization to high resistance patients. The modulation of the flow is implemented via a digital electromechanical system, which allows the ventilator functions to be accurately programmed. The desired flow waveform is obtained by means of a series of pneumatic valves, the apertures of which are digitally controlled. The design is innovative in that it allows the flow waveform in each of the ten digitalized time steps into which each inspiratory phase is divided to be both programmed and controlled. Other ventilators commercially available and currently in use do not have this functional capability, as they are all designed to model the integral flow of the inspiratory waveform without being able to modify the subunit time steps of a single inspiratory phase. The authors also discuss the results of fundamental tests concerning the performance characteristics of the ventilator.
Comparison of EXIT-25 and the Frontal Assessment Battery for evaluation of executive dysfunction in patients attending a memory clinic.

The Frontal Assessment Battery (FAB) and the EXIT-25 have emerged as 2 widely used screening instruments for executive dysfunction, but their screening properties have not been evaluated in a head-to-head comparison.



Prospective cohort study of 92 individuals presenting for cognitive assessment at a community hospital.



The EXIT-25 took longer than the FAB to complete (mean difference = 9.27 min, 95% CI: 9.86-8.68). EXIT-25 and FAB scores showed significant correlation (Spearman's r = -0.79, p < 0.001) with one another, and each showed acceptable convergent validity and divergent validity.



The 2 tests provide similar information about the presence of executive dysfunction. The FAB takes less time to complete, and appears to be less frustrating for patients, making it more feasible as a screening test for executive dysfunction in a memory clinic setting.
Dexamethasone for the prophylaxis of radiation-induced pain flare after palliative radiotherapy for symptomatic bone metastases: a phase II study.

Pain flare occurs in over one-third of patients receiving palliative radiotherapy for bone metastases. A single dose of dexamethasone can decrease the incidence of pain flare during the first 2 days immediately after radiotherapy. We conducted a phase II prospective study to investigate the prophylactic role of prolonged dexamethasone.



Patients with bone metastases treated with a single 8Gy were prescribed 8mg dexamethasone just before palliative radiotherapy and for 3 consecutive days after treatment. Worst pain score and analgesic consumption data were collected at baseline and daily for 10 days after treatment. Analgesic consumption was converted into a total daily oral morphine equivalent dose in the analysis. Pain flare was defined (a priori) as a two-point increase in worst pain on an 11-point numeric rating scale compared with baseline with no decrease in analgesic intake, or a 25% increase in analgesic intake with no decrease in worst pain score. To distinguish pain flare from progressive disease, we required that the worst pain score and analgesic intake returned to baseline levels after the increase/flare.



Forty-one patients were evaluable (32 men, nine women). Their median age was 67 years. The overall incidence of pain flare was 9/41 (22%) within 10 days after the completion of radiotherapy. Most (55%) of these pain flares occurred on day 5. Absence of pain flare was 34/41(83%) and 39/41 (95%) for days 1-5 and 6-10 after the completion of radiotherapy, respectively.



Dexamethasone is effective in the prophylaxis of radiotherapy-induced pain flare after palliative radiotherapy for bone metastases. Randomised studies are needed to confirm this finding.
Comparative Trial of Trimipramine versus Doxepin in Depressed Hospitalised Patients

This paper summarises the results of a randomised, double-blind study, in which trimipramine was compared with doxepin , with respect to antidepressant , anxiolytic and cardio vascular effects in hospital ised patients with major depression and anxiety". Previous comparati ve studies have shown trimipramine to possess similar efficacy to imipramine but fewer side effects (Rifkin et al. 1980), and efficacy similar to or less than that of amitriptyline but greater tolerance and superior anxiolytic effect (Pecknold et al. 1979; Rickels et al. 1970). Doxepin has a more rapid onset of action than amitriptyline but more side effects and stronger sedative action (Castrogiovanni et al. 1971 ; Grof et al. 1974; Mendels & Secunda 1980; Richelson 1974).
Randomized, multicenter trial to assess the efficacy, safety and tolerability of a single dose of a novel AMPA receptor antagonist BGG492 for the treatment of acute migraine attacks.

Glutamate is implicated in migraine pathophysiology; amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) receptor antagonists represent a potential therapeutic approach because of their anti-excitatory actions.



This randomized, double-blind, proof-of-concept study assessed the efficacy of the AMPA receptor antagonist, BGG492 (250 mg), vs placebo and sumatriptan (100 mg), in 75 subjects with acute migraine attacks. Efficacy was measured using the Patient Migraine Diary. Pharmacokinetic and safety data were collected.



Improvement from severe/moderate to mild/no headache pain (primary response) was reported in 58%, 58%, and 54% of BGG492-treated subjects at 2, 3, and 4 hours post-dose ( P = 0.2, 0.5, and 0.5 vs placebo), respectively, compared with 68%, 84%, and 92% sumatriptan-treated subjects, and 40%, 48%, and 44% in the placebo group. Percentages of subjects with ≥ 2-point improvement in pain score from baseline at 2 hours were 29%, 40%, and 16% for BGG492, sumatriptan, and placebo, respectively. Pain-free response at 2 hours was reported for 25%, 24%, and 16% of BGG492, sumatriptan, and placebo subjects, respectively. Adverse events were reported by 80%, 56%, and 60% of BGG492, sumatriptan, and placebo subjects, respectively.



Proof-of-concept criterion was not met (≥ 25% BGG492 subjects with a primary response vs placebo at two timepoints). BGG492 was comparable to sumatriptan in terms of pain-free response.
Recreational Sports Activities After Calcaneal Fractures and Subsequent Subtalar Joint Arthrodesis.

Subtalar joint arthrodesis is a common treatment for the management of hindfoot pathologic entities. Despite pain reduction, hindfoot stiffness is a common concern of active patients, who wish to continue or start exercising for fitness. The purpose of the present retrospective observational clinical study was to assess the rate and type of recreational sports activities in patients before and after subtalar joint arthrodesis and to correlate the clinical outcome and the level of sports activities. In 33 patients (22 males, 11 females) treated with subtalar joint arthrodesis, the pre- and postoperative participation in sports and recreational activities was evaluated. The American Orthopaedic Foot and Ankle Society hindfoot scale score, 36-item Short Form Health Survey, and a visual analog scale for pain were used as clinical outcome measures. The weekly session number, session time, and interval to activity recovery after surgery were registered. Patients with a subtalar joint arthrodesis returned to a satisfactory level of activity postoperatively. The sports participation almost reached levels similar to those preoperatively but with a shift from high- to low-impact activities.
Estimating minimal clinically important differences of upper-extremity measures early after stroke.

To estimate minimal clinically important difference (MCID) values of several upper-extremity measures early after stroke.



Data in this report were collected during the Very Early Constraint-induced Therapy for Recovery of Stroke trial, an acute, single-blind randomized controlled trial of constraint-induced movement therapy. Subjects were tested at the prerandomization baseline assessment (average days poststroke, 9.5d) and the first posttreatment assessment (average days poststroke, 25.9d). At each time point, the affected upper extremity was evaluated with a battery of 6 tests. At the second assessment, subjects were also asked to provide a global rating of perceived changes in their affected upper extremity. Anchor-based MCID values were calculated separately for the affected dominant upper extremities and the affected nondominant upper extremities for each of the 6 tests.



Inpatient rehabilitation hospital.



Fifty-two people with hemiparesis poststroke.



Not applicable.



Estimated MCID values for grip strength, composite upper-extremity strength, Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), Motor Activity Log (MAL), and duration of upper-extremity use as measured with accelerometry.



MCID values for grip strength were 5.0 and 6.2 kg for the affected dominant and nondominant sides, respectively. MCID values for the ARAT were 12 and 17 points, for the WMFT function score were 1.0 and 1.2 points, and for the MAL quality of movement score were 1.0 and 1.1 points for the 2 sides, respectively. MCID values were indeterminate for the dominant (composite strength), the nondominant (WMFT time score), and both affected sides (duration of use) for the other measures.



Our data provide some of the first estimates of MCID values for upper-extremity standardized measures early after stroke. Future studies with larger sample sizes are needed to refine these estimates and to determine whether MCID values are modified by time poststroke.