nils-herrmann/clean_scirepeval huggingface dataset:
Rizatriptan in migraineurs with unilateral cranial autonomic symptoms: a double-blind trial

The objective and background is to confirm in a double-blind, placebo-controlled study the high triptan response rates we had previously reported in an open study in migraine patients with unilateral cranial autonomic symptoms. In this randomized, double-blind, placebo-controlled study 80 migraineurs with unilateral cranial autonomic symptoms were assigned to receive rizatriptan 10 mg wafer or placebo (ratio 1:1) and treated for a single moderate or severe migraine attack. The primary endpoints were pain freedom at 2 h and total migraine freedom at 2 h. Secondary endpoints included pain relief, no associated symptoms and sustained pain freedom or relief. Significantly more patients reported pain freedom at 2 h after taking rizatriptan (54 %) than after placebo (8 %) (therapeutic gain 46 % [28 %; 64 %]; P < 0.001). Similarly, significantly more patients reported total migraine freedom at 2 h after rizatriptan (51 %) than after placebo (8 %) (therapeutic gain 43 % [26 %; 61 %]; P < 0.001). Rizatriptan was also more effective than placebo on most secondary endpoints. We confirm in a placebo-controlled study our previous data suggesting that the presence of unilateral cranial autonomic symptoms in migraineurs predicts a positive response to triptans, probably owing to intense trigeminal peripheral afferent activation which strongly recruits peripheral neurovascular 5-HT1B/1D receptors. Acute and preventive pharmacological trials in migraine should focus also on this subset of migraine patients.
Do patients perceive a link between a fragility fracture and osteoporosis?

To evaluate factors associated with whether patients associate their fracture with future fracture risk.



Fragility fracture patients participated in a telephone interview. Unadjusted odds ratios (OR, [95% CI]) were calculated to identify factors associated with whether patients associate their fracture with increased fracture risk or osteoporosis. Predictors identified in univariate analysis were entered into multivariable logistic regression models.



127 fragility fracture patients (82% female) participated in the study, mean (SD) age 67.5 (12.7) years. An osteoporosis diagnosis was reported in 56 (44%) participants, but only 17% thought their fracture was related to osteoporosis. Less than 50% perceived themselves at increased risk of fracture. The odds of an individual perceiving themselves at increased risk for fracture were higher for those that reported a diagnosis of osteoporosis (OR 22.91 [95%CI 7.45;70.44], p < 0.001), but the odds decreased with increasing age (0.95 [0.91;0.99], p<0.009). The only variable significantly associated with the perception that the fracture was related to osteoporosis was self-reported osteoporosis diagnosis (39.83 [8.15;194.71], p<0.001).



Many fragility fracture patients do not associate their fracture with osteoporosis. It is crucial for physicians to communicate to patients that an osteoporosis diagnosis, increasing age or a fragility fracture increases the risk for future fracture.
The Fagerström Test for Nicotine Dependence-Smokeless Tobacco (FTND-ST).

Few nicotine dependence measures have been developed for smokeless tobacco (ST) users. Existing measures are limited by the requirement to rate the nicotine content of ST brands for which data is scarce or non-existent. We modified the Fagerström Test for Nicotine Dependence (FTND) for ST users, referred to this scale as the FTND-ST, and evaluated its characteristics in a population of 42 ST users. The correlation between the FTND-ST total score and the serum cotinine concentrations was 0.53 (p<0.001). Internal consistency reliability assessed using the coefficient alpha was 0.47. Correlations and the coefficient alpha are similar to those reported for commonly used nicotine dependence measures. Development and refinement of nicotine dependence measures for ST users are essential steps in order to advance the field of ST research.
Response to upper-limb robotics and functional neuromuscular stimulation following stroke.

Twelve moderately to severely involved chronic stroke survivors (>12 mo) were randomized to one of two treatments: robotics and motor learning (ROB-ML) or functional neuromuscular stimulation and motor learning (FNS-ML). Treatment was 5 h/d, 5 d/wk for 12 wk. ROB-ML group had 1.5 h per session devoted to robotics shoulder and elbow (S/E) training. FNS-ML had 1.5 h per session devoted to functional neuromuscular stimulation (surface electrodes) for wrist and hand (W/H) flexors/extensors. The primary outcome measure was the functional measure Arm Motor Ability Test (AMAT). Secondary measures were AMAT-S/E and AMAT-W/H, Fugl-Meyer (FM) upper-limb coordination, and the motor control measures of target accuracy (TA) and smoothness of movement (SM). ROB-ML produced significant gains in AMAT, AMAT-S/E, FM upper-limb coordination, TA, and SM. FNS-ML produced significant gains in AMAT-W/H and FM upper-limb coordination.
Database Privacy

The emphasis in database privacy should fall on a balance between confidentiality, integrity and availability of personal data, rather than on confidentiality alone. This balance should not necessarily be a trade-off, but should take into account the sensitive nature of the data being stored and attempt to increase all three dimensions to the highest level possible.To achieve such a balance, technological means should be developed.The paper illustrates some of the inherent problems in database privacy that should be addressed by technical solutions. It next demonstrates that the notion of privacy is complex; this complexity is likely to impede development of technical solutions.Finally, the paper finally uses the notion of informed consent to illustrate how the privacy problem can be viewed from multiple angles to flesh out the underlying problems that may be addressed by technical solutions.
Phase I studies of AVE9633, an anti-CD33 antibody-maytansinoid conjugate, in adult patients with relapsed/refractory acute myeloid leukemia

The efficacy of anti-CD33 immunoconjugates had been previously demonstrated for gemtuzumab-ozogamicin. AVE9633 is an anti-CD33-maytansine conjugate created by ImmunoGen Inc. Phase I trials of AVE9633 were performed in patients with AML to evaluate tolerability, pharmacokinetics and pharmacodynamics. Three phase I studies of AVE9633 were performed in 54 patients with refractory/relapsed AML, evaluating drug infusion on day 1 of a 21-day cycle (Day 1 study), day 1 and 8 (Day 1/8 study) and day 1, 4 and 7 (Day 1/4/7 study) of a 28-day cycle. Toxicity was mainly allergic reaction during infusion (3 grade 3 bronchospasms). DLT was reached for the D1–D7 schedule at 150 mg/sqm (1 keratitis, 1 liver toxicity), and the MTD was set at 130 mg/sqm for this schedule. In the two other phases I, the DLT was not reached. In the Day 1/8 study, CD33 on peripheral blasts was saturated and down-modulated for doses of 75 mg/m2 × 2 or higher, which was correlated with WBC kinetics and plasma levels of AVE9633. Decrease of DM4/CD33 ratio on the blasts surface between day 1 and 8 was the rational for evaluating day 1/4/7 schedule. This induced relatively constant DM4/CD33 levels over the first 8 days, however no activity was noted. One CRp, one PR and biological activity in five other patients were observed in this study. The Day 1 and Day 1/4/7 studies were early discontinued because of drug inactivity at doses significantly higher than CD33 -saturating doses. No myelossuppression was observed at any trial of AVE9633. The pharmacokinetics/pharmacodynamics data obtained in these studies will provide very useful information for the design of the next generation of immunoconjugates.
Major depression diagnoses among patients with systemic sclerosis: baseline and one-month followup.

Depression is common in many rheumatic diseases and is associated with poor prognosis. No studies of patients with any rheumatic diseases, however, have assessed the stability of major depressive disorder (MDD) diagnoses over time. The objective of the present study was to assess the stability of MDD diagnoses among patients with systemic sclerosis (SSc; scleroderma), a rare autoimmune rheumatic disease, across 2 assessments approximately 1 month apart.



SSc patients were recruited from 7 Canadian Scleroderma Research Group Registry sites (April 2009 to June 2012). Current (30-day) MDD was assessed with the Composite International Diagnostic Interview at baseline and approximately 1 month later.



Among 309 patients with baseline assessments who received followup assessments an average of 34 days later, prevalence of 30-day MDD was 4% (95% confidence interval [95% CI] 2%-7%; n = 12) at baseline and 5% (95% CI 3%-8%; n = 16) at followup. Only 3 of 12 patients (25% [95% CI 9%-53%]) with MDD at baseline had MDD 1 month later.



Most patients with SSc who meet criteria for MDD appear to experience mild, time-limited episodes of low mood that often resolve on their own without specific treatment. Consistent with international guidelines on depression management in nonpsychiatric settings, "watchful waiting" or "active monitoring" is a good strategy for SSc patients with mild depression to avoid unnecessary treatment among those whose symptoms may be transient and may resolve without medical intervention.
Nateglinide and glibenclamide metabolic effects in naïve type 2 diabetic patients treated with metformin.

Most antidiabetic agents target only one of several underlying causes of diabetes. The complementary actions of the glinides and the biguanides may give optimal glycemic control in patients with type 2 diabetes mellitus. The aim of the present study was to compare the effects of nateglinide plus metformin with glibenclamide plus metformin on glucose and lipid metabolism, and haemodynamic parameters in patients with type 2 diabetes mellitus.



We enrolled 248 type 2 diabetic patients. Patients were randomly assigned to receive nateglinide (n = 124) or glibenclamide (n = 124), after 6 months of run-in, in which we titrated nateglinide (starting dose 180 mg/day), glibenclamide (starting dose 7.5 mg/day), and metformin (starting dose 1500 mg/day). The final doses were (mean +/- standard deviation), 300 +/- 60, 12.5 +/- 2.5, and 2500 +/- 500 mg/day, respectively. We followed these patients for 1 year after titration. We assessed body mass index (BMI), fasting (FPG) and post-prandial (PPG) plasma glucose, glycosylated haemoglobin (HbA(1c)), fasting (FPI) and post-prandial (PPI) plasma insulin, homeostasis model assessment (HOMA) index, and lipid profile [total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), triglycerides (Tg), apolipoprotein A-I (Apo A-I), and apolipoprotein B (Apo B)], systolic blood pressure (SBP), and diastolic blood pressure (DBP). All variables were evaluated at baseline and after 3 and 6 months in the run-in period, and at baseline, and after 3, 6, 9 and 12 months for both treatment groups.



Body mass index did not show any significant change during the study. We observed a significant improvement from baseline to 1 year on HbA(1c) (P < 0.01 vs. baseline and vs. glibenclamide group, respectively), FPG (P < 0.01 vs. baseline), PPG (P < 0.01 vs. baseline), and on HOMA index (P < 0.05 vs. baseline) in the nateglinide group. In the glibenclamide group, we found significant changes in HbA(1c) (P < 0.05 vs. baseline), FPG (P < 0.01 vs. baseline), PPG (P < 0.05 vs. baseline), and HOMA index (P < 0.05 vs. baseline). No significant change was observed in TC, LDL-C, HDL-C, Tg, Apo A-I, Apo B, SBP, DBP and HR in either group after 3, 6, 9 and 12 months. These effects of nateglinide and glibenclamide on insulin-resistance parameters are in agreement with previous reports. Contrarily to previous reports, we did not observe any significant BP change in patients treated with glibenclamide. Although both nateglinide and glibenclamide attenuated PPG and HOMA index, they did not have significant effects on lipid metabolism, as already shown in subjects with type 2 diabetes and good glycemic control.



Nateglinide improved glycemic control better than glibenclamide in combination with metformin.
Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis.

Hydroxyethyl starch (HES) [corrected] is widely used for fluid resuscitation in intensive care units (ICUs), but its safety and efficacy have not been established in patients with severe sepsis.



In this multicenter, parallel-group, blinded trial, we randomly assigned patients with severe sepsis to fluid resuscitation in the ICU with either 6% HES 130/0.42 (Tetraspan) or Ringer's acetate at a dose of up to 33 ml per kilogram of ideal body weight per day. The primary outcome measure was either death or end-stage kidney failure (dependence on dialysis) at 90 days after randomization.



Of the 804 patients who underwent randomization, 798 were included in the modified intention-to-treat population. The two intervention groups had similar baseline characteristics. At 90 days after randomization, 201 of 398 patients (51%) assigned to HES 130/0.42 had died, as compared with 172 of 400 patients (43%) assigned to Ringer's acetate (relative risk, 1.17; 95% confidence interval [CI], 1.01 to 1.36; P=0.03); 1 patient in each group had end-stage kidney failure. In the 90-day period, 87 patients (22%) assigned to HES 130/0.42 were treated with renal-replacement therapy versus 65 patients (16%) assigned to Ringer's acetate (relative risk, 1.35; 95% CI, 1.01 to 1.80; P=0.04), and 38 patients (10%) and 25 patients (6%), respectively, had severe bleeding (relative risk, 1.52; 95% CI, 0.94 to 2.48; P=0.09). The results were supported by multivariate analyses, with adjustment for known risk factors for death or acute kidney injury at baseline.



Patients with severe sepsis assigned to fluid resuscitation with HES 130/0.42 had an increased risk of death at day 90 and were more likely to require renal-replacement therapy, as compared with those receiving Ringer's acetate. (Funded by the Danish Research Council and others; 6S ClinicalTrials.gov number, NCT00962156.).
Renal function at the time of a myocardial infarction maintains prognostic value for more than 10 years

Renal function is an important predictor of mortality in patients with myocardial infarction (MI), but changes in the impact over time have not been well described.We examined the importance of renal function by estimated GFR (eGFR) and se-creatinine as an independent long-term prognostic factor.



Prospective follow-up of 6653 consecutive MI patients screened for entry in the Trandolapril Cardiac Evaluation (TRACE) study. The patients were analysed by Kaplan-Meier survival analysis, landmark analysis and Cox proportional hazard models. Outcome measure was all-cause mortality.



An eGFR below 60 ml per minute per 1.73 m2, consistent with chronic renal disease, was present in 42% of the patients. We divided the patients into 4 groups according to eGFR. Overall, Cox proportional-hazards models showed that eGFR was a significant prognostic factor in the two groups with the lowest eGFR, hazard ratio 1,72 (confidence interval (CI) 1,56-1,91) in the group with the lowest eGFR. Using the eGFR group with normal renal function as reference, we observed an incremental rise in hazard ratio. We divided the follow-up period in 2-year intervals. Landmark analysis showed that eGFR at the time of screening continued to show prognostic effect until 16 years of follow-up. By multivariable Cox regression analysis, the prognostic effect of eGFR persisted for 12 years and of se-creatinine for 10 years. When comparing the lowest group of eGFR with the group with normal eGFR, prognostic significance was present in the entire period of follow-up with a hazard ratio between 1,97 (CI 1,65-2,35) and 1,35 (CI 0,99-1,84) in the 2-year periods.



One estimate of renal function is a strong and independent long-term prognostic factor for 10-12 years following a MI.
Concurrent chemo- and radiotherapy in patients with locally advanced carcinoma of the cervix.

The feasibility of concurrent chemotherapy and radiotherapy for advanced primary carcinoma of the cervix was evaluated and the results were compared to historical controls.



In a single institution study, patients (n = 74) with primary cervical carcinoma received 3 cycles carboplatin/5-fluorouracil concurrent with radiotherapy followed by salvage hysterectomy (group I). Treatment results were compared with those of a historical control group (n = 39) (group II), treated similarly but without chemotherapy.



In group I median follow-up is 28 months (12-68+) and in group II 23 months (14-90+ months). The 5-year overall survival, progression-free survival and local recurrence free survival for group I and II are, respectively, 69% versus 38% (P < 0.003), 67% versus 38% (P < 0.005) and 84% versus 43% (P < 0.0001). Two patients in each group developed posttreatment enteritis.



Radiotherapy with concurrent carboplatin and 5-fluorouracil resulted in a better overall survival, disease free survival and local disease free survival compared to historical controls. The toxicity of this schedule did not exceed that of radiation alone in historical controls.
The Changes in Mean Platelet Volume after Using of Antiplatelet Drugs in Acute Ischemic Stroke: A Randomized Controlled Trial.

To measure the changes of mean platelet volume (MPV) after using four antiplatelet drugs in acute non-cardioembolic ischemic stroke patients and assess the association of antiplatelets and MPV and stroke outcome.



Ischemic stroke survivors with National Institute of Health Stroke Scale (NIHSS) 8 were randomly allocated intofour groups, receiving aspirin, clopidogrel, combined aspirin and dipyridamole, and cilostazol. The change of MPV NIHSS, and modified Rankin Scale (mRS) were recorded at baseline and week 4 in all studied groups. MPV was measured using the standard automated blood test for complete blood count.



Twenty-one subjects were included in this study. They comprised of five cases in each antiplatelet group, except for aspirin, which had six subjects. Male was 57%, and hypertension was the most common risk factor (61.9%). Most of participants (76%) had small vessel disease. At 4-week, MPVwas reduced and NIHSS, mRS were improved in every studied group. Clopidogrel sign ficantly reduced NIHSS score (p = 0.003), and it produced the greatest reduction in MPV compared to others.



Every type of antiplatelets included in this study reduced MPV NIHSS, and mRS in acute non-cardioembolic stroke patients. Clopidogrel improved NIHSS the most.
Bortezomib-induced peripheral neuropathy in multiple myeloma: a comparison between previously treated and untreated patients.

Peripheral neuropathy (PN), with neuropathic pain as main symptom, represents the dose-limiting toxicity of the proteasome inhibitor bortezomib. Aim of this study was to compare the incidence, risk factors, severity and outcome of PN and neuropathic pain in patient treated with bortezomib up-front or at relapse. We studied 55 patients with multiple myeloma (MM) who received bortezomib as first line therapy and 70 pre-treated patients who received bortezomib in relapse or progression. Regarding PN, no differences were found among untreated and pre-treated patients in the incidence (55% vs 52%, p=0.43), severity (NCI grade 3-4 9% vs 14%, p=0.27), and outcome (improved/resolved 90% vs 91%, p=0.58). Concerning neuropathic pain, the incidence was lower (50% vs 81%, p=0.008) and solved earlier (35 days vs 91 days, p=0.02) in untreated compared with pre-treated patients. Untreated patients needed dose modification less frequently (36% vs 73%, p=0.012). No correlation was found between development of PN and prior exposure to potentially neurotoxic drugs such as thalidomide, vincristine, and cysplatin. Age represented the main risk factor for PN (p=0.036) with an increase in risk of PN amounting to 6% per year of age. In conclusion, incidence, severity and outcome of bortezomib-related PN are similar in untreated and pre-treated MM patients except for neuropathic pain which has lower incidence and shorter duration in untreated patients with less frequent need for bortezomib discontinuation. Age emerges as the most relevant risk factor for peripheral neuropathy, with a risk increase for PN of 6% per year of age.
Radiation dose to procedural personnel and patients from an X-ray volume imaging system

To evaluate the radiation dose received by procedural personnel and patients from an X-ray volume imaging (XVI) system during interventional procedures. Forty patients were examined using catheter angiography (group A), digital subtraction angiography (group B) and cone-beam CT (CBCT, group C). Doses to procedural personnel (using thermo-luminescent dosimeters, TLDs) and patients were estimated. Image quality and lesion delineation were assessed using objective and subjective methods. Shapiro–Wilk, two-sided Student’s t and Wilcoxon matched-pairs tests were used to test statistical significance. Doses (milligrays) measured in the hands and left knee of the interventionist were higher than those in an assistant physician (P < 0.05). Doses (dose–area product and skin entry dose) were lower in group A and higher in C compared with other groups; moreover, comparison among the groups were significant (all P = 0.0001). Subjective and objective lesion delineation showed significant results (all P < 0.05) among the tumour types considered. Image quality estimation showed the opposite results for objective and subjective analysis. More doses were obtained for hands of the procedural personnel compared to other anatomical regions measured. Catheter angiography showed lower dose compared with other imaging groups examined. Lesion delineation was clearly possible using CBCT. Objective and subjective analysis showed the opposite results regarding image quality because of higher noise levels and artefacts. • Interventional radiological procedures inevitably impart relatively high radiation doses • Little is known about the doses imparted by cone-beam CT (CBCT)-guided procedures.  During interventional radiological procedures the hands of personnel receive high doses. • Catheter angiography delivered lower doses compared with CBCT and digital subtraction angiography (DSA). • Nevertheless the use of CBCT to delineate lesions is advantageous for patients.