nils-herrmann/clean_scirepeval huggingface dataset:
Simultaneous ring voice-over-Internet phone system enables rapid physician elicitation of explicit informed consent in prehospital stroke treatment trials.

Cellular phone conversations between on-scene patients or their legally authorized representatives (LARs) and off-scene enrolling physician-investigators require immediate and reliable connection systems to obtain explicit informed research consent in prehospital treatment trials.



The NIH Field Administration of Stroke Therapy-Magnesium (FAST-MAG) Trial implemented a voice-over-internet protocol (VOIP) simultaneous ring system (multiple investigator cell phones called simultaneously and first responder connected to call) to enable physician-investigators to elicit consent immediately from competent patients or LARs encountered by 228 ambulances enrolling patients in a multicenter prehospital stroke trial. For 1 month, the number, origin, duration, and yield of enrolling line calls were monitored prospectively.



Six investigators were connected to 106 enrolling line calls, with no identified unanswered calls. Thirty-five percent of new patient calls yielded an enrollment. The most common reasons for non-enrollment were last known well >2 h (n = 7) and unconsentable patient without LAR available (n = 7). No non-enrollments were directly attributable to the VOIP system. In enrollments, consent was provided by the patient in 67% and a LAR in 33%. The duration of enrollment calls (mean +/- SD: 8.4 +/- 2.5 min, range 6-14) was longer than non-enrollment calls (5.5 +/- 3.5, range 2-13; p < 0.001). The median interval from last known well to study agent start was 46 min, and 70% were enrolled within 60 min of onset.



The simultaneous ring system was reliable and effective, permitting enrollment of a substantial number of patients within the first hour after stroke onset. VOIP cellular networks with simultaneous ring are a preferred means of facilitating consent in prehospital treatment trials.
Antihypertensive effect of various doses of hydrochlorothiazide and its relation to the plasma level of the drug

Nine previously untreated hypertensive patients (WHO Stage I and II) were given hydrochlorothiazide (hct) 12.5, 25, 50 and 75 mg for two weeks after an initial four week period of placebo treatment. Blood pressure recordings were made casually and after 30 min rest in lying, sitting and standing positions. Plasma concentrations of the drug were measured by GLC. A significant decrease in BP was seen during treatment with hct 12.5 mg except in the casual standing position. Doubling of the dose twice produced very little further decrease in BP. The mean steady state concentration was 111 ng · ml−1 during treatment with hct 75 mg. A linear relationship was found between the plasma concentration of hct at 0 and 5 h and the various dose levels of hct. No relation was found between plasma concentration and reduction in blood pressure.
Compliance with drug therapy for postmenopausal osteoporosis

Patient compliance with pharmacotherapy for osteoporosis is typically poor in clinical practice; less frequent dosing with bisphosphonates may improve compliance. Using data from 49 US health plans, we identified all women aged ≥45 years with osteoporosis who initiated therapy with a bisphosphonate, calcitonin, estrogen, or raloxifene. Compliance was examined alternatively in terms of incidence of adherence failure (medication days <80% of possible) and persistence failure (gap in therapy ≥90 days), and was compared across treatment groups using Kaplan-Meier methods and Cox proportional hazards models. The study population included 18,822 women, 48% of whom initiated weekly bisphosphonate therapy. Overall risk of adherence failure was 47% at 3  months, 70% at 1  year, and 84% at 3  years. Risk of persistence failure was 47% at 1  year, and 77% at 3  years. In multivariate analyses, risk of adherence failure was higher for calcitonin (hazard ratio=2.7 vs weekly bisphosphonate therapy, p<0.01), but comparable for all other therapies. Relative risks of persistence failure were generally similar. Approximately three-quarters of women who initiate osteoporosis drug therapy are non-adherent with treatment within 12  months, and almost 50% have discontinued such therapy by this time. Compliance with weekly bisphosphonate therapy is generally no better than that with osteoporosis medications requiring more frequent dosing.
Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device: analysis of the PUFS trial results.

OBJECT
Neuroophthalmological morbidity is commonly associated with large and giant cavernous and supraclinoid internal carotid artery (ICA) aneurysms. The authors sought to evaluate the neuroophthalmological outcomes after treatment of these aneurysms with the Pipeline Embolization Device (PED).



The Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial was an international, multicenter prospective trial evaluating the safety and efficacy of the PED. All patients underwent complete neuroophthalmological examinations both before the PED procedure and at a 6-month follow-up. All examinations were performed for the purpose of this study and according to study criteria.



In total, 108 patients were treated in the PUFS trial, 98 of whom had complete neuroophthalmological follow-up. Of the patients with complete follow-up, 39 (40%) presented with a neuroophthalmological baseline deficit that was presumed to be attributable to the aneurysm, and patients with these baseline deficits had significantly larger aneurysms. In 25 of these patients (64%), the baseline deficit showed at least some improvement 6 months after PED treatment, whereas in 1 patient (2.6%), the deficits only worsened. In 5 patients (5%), new deficits had developed at the 6-month follow-up, while in another 6 patients (6%), deficits that were not originally assumed to be related to the aneurysm had improved by that time. A history of diabetes was associated with failure of the baseline deficits to improve after the treatment. The aneurysm maximum diameter was significantly larger in patients with a new deficit or a worse baseline deficit at 6 months postprocedure.



Patients treated with the PED for large and giant ICA aneurysms had excellent neuroophthalmological outcomes 6 months after the procedure, with deficits improving in most of the patients, very few deficits worsening, and few new deficits developing.
Temporally constrained ICA: an application to artifact rejection in electromagnetic brain signal analysis

Independent component analysis (ICA) is a technique which extracts statistically independent components from a set of measured signals. The technique enjoys numerous applications in biomedical signal analysis in the literature, especially in the analysis of electromagnetic (EM) brain signals. Standard implementations of ICA are restrictive mainly due to the square mixing assumption-for signal recordings which have large numbers of channels, the large number of resulting extracted sources makes the subsequent analysis laborious and highly subjective. There are many instances in neurophysiological analysis where there is strong a priori information about the signals being sought; temporally constrained ICA (cICA) can extract signals that are statistically independent, yet which are constrained to be similar to some reference signal which can incorporate such a priori information. We demonstrate this method on a synthetic dataset and on a number of artifactual waveforms identified in multichannel recordings of EEG and MEG. cICA repeatedly converges to the desired component within a few iterations and subjective analysis shows the waveforms to be of the expected morphologies and with realistic spatial distributions. This paper shows that cICA can be applied with great success to EM brain signal analysis, with an initial application in automating artifact extraction in EEG and MEG.
Screening Flexible Sigmoidoscopy Using an Upper Endoscope is Better Tolerated by Women

Flexible sigmoidoscopy (FS) is a commonly used method for colorectal cancer screening. Women are more likely than men to have a FS with a limited depth of insertion, in part due to differences of anatomy and perception of pain.The objective of this prospective single-blinded randomized clinical study is to assess satisfaction in women undergoing screening FS using an upper endoscope (E, diameter 9.8 mm) versus a standard sigmoidoscope (S, diameter 13.3 mm) as measured by pain and discomfort and overall satisfaction using a validated survey instrument. Secondary endpoints of FS efficacy included the depth of insertion of the instrument, frequency of polyp detection, and complication rate.A total of 160 asymptomatic women undergoing screening FS were entered over a 4-month period (July through November 2002). All procedures were performed by two experienced physician assistants. The two groups were of similar age (E = 57.5, S = 58.2, p= 0.579) and had a similar rate of previous abdominal surgery (E = 51.2%, S = 45.0%, p= 0.428) or hysterectomy (E = 34.2%, S = 26.3%, p= 0.274). Depth of insertion of the scope was 54.5 cm (±9.2 cm) with the E and 51.6 cm (± 10.3 cm) with the S (p= 0.058). Polyps were found more frequently in the study group (18.3%) compared with the control group (p= 10.2%) though this did not reach statistical significance (p= 0.131). Overall satisfaction with FS was similar in both groups (p= 0.694) but pain and discomfort were less in the patients undergoing FS using the E (p= 0.006). Controlling for age and previous surgery the differences in pain scores remained significant (p= 0.035). Endoscopist assessment of procedure difficulty (p= 0.726) and complication rates (p= 0.614) was equivalent. Controlling for the presence of polyps, the total duration for the procedure was 7.2 min in the E group and 5.7 min in the S group (p= 0.008). There were no significant differences between women with and without hysterectomy on either overall satisfaction or pain and discomfort.Screening FS in women using an upper endoscope is a feasible approach to colorectal cancer screening. Patients screened with an upper endoscope reported less pain and discomfort compared to standard sigmoidoscope while overall satisfaction did not differ. The trend toward increased polyp detection in patients undergoing FS with an upper endoscope may be related to a more thorough examination due to less patient discomfort and/or an increased depth of insertion of the upper endoscope. Thinner, more flexible endoscopes should be considered when performing screening FS in women.
Assessment of the long-term reproducibility of baseline and dobutamine-induced myocardial blood flow in patients with stable coronary artery disease.

Although physical exercise is the preferred stimulus for cardiac stress testing, pharmacologic agents are useful in patients who are unable to exercise. Previous studies have demonstrated short-term repeatability of exercise and adenosine stress, but little data exist regarding dobutamine (Dob) stress or the long-term reproducibility of pharmacologic stressors in coronary artery disease (CAD) patients. PET allows accurate, noninvasive quantification of myocardial blood flow (MBF) and coronary flow reserve (CFR). The aim of the study was to investigate the long-term reproducibility of Dob stress on MBF and CFR in CAD patients using PET.



Fifteen patients with chronic stable angina and angiographically proven CAD (>70% stenosis in at least 1 major coronary artery) underwent PET with (15)O-labeled water and Dob stress at baseline (time [t] = 0) and after 24 wk (t = 24). MBF at rest and MBF during Dob stress were calculated for the whole left ventricle, the region subtended by the most severe coronary artery stenosis (Isc), and remote myocardium subtended by arteries with minimal or no disease (Rem). Reproducibility was assessed using the Bland-Altman (BA) repeatability coefficient and was also expressed as a percentage of the mean value of the 2 measurements (%BA).



Dob dose (30 +/- 11 vs. 031 +/- 11 microg/kg/min; P = not significant [ns]) and peak Dob rate.pressure product (20,738 +/- 3,947 vs. 20,047 +/- 3,455 mm Hg x beats/min; P = ns) were comparable at t = 0 and t = 24. There was no significant difference in resting or Dob MBF (mL/min/g) between t = 0 and t = 24 for the whole left ventricle (1.03 +/- 0.19 vs. 1.10 +/- 0.20 and 2.02 +/- 0.44 vs. 2.09 +/- 0.57; P = ns for both), Isc (1.05 +/- 0.24 vs. 1.10 +/- 0.26 and 1.79 +/- 0.53 vs. 1.84 +/- 0.62; P = ns for both), or Rem (1.03 +/- 0.23 vs. 1.10 +/- 0.26 and 2.27 +/- 0.63 vs. 2.26 +/- 0.63; P = ns for both) territories. Global (1.98 +/- 0.40 vs. 1.90 +/- 0.46; P = ns) and regional CFR (Isc: 1.65 +/- 0.40 vs. 1.67 +/- 0.47, and Rem: 2.25 +/- 0.57 vs. 2.06 +/- 0.51; P = ns) were reproducible. The BA repeatability coefficients (and %BA) for MBF in ischemic and remote territories were 0.3 (28%) and 0.26 (24%) at rest and 0.49 (27%) and 0.58 (26%) during Dob stress.



In patients with clinically stable CAD, Dob induces reproducible changes in both global and regional MBF and CFR over a time interval of 24 wk. The reproducibility of MBF and CFR with Dob was comparable with the short-term repeatability reported for adenosine and physical exercise in healthy subjects.
Prior human polyomavirus and papillomavirus infection and incident lung cancer: a nested case–control study

To test whether infection with select human polyomaviruses (HPyV) and human papillomaviruses (HPV) is associated with incident lung cancer. We performed a nested case–control study, testing serum from the carotene and retinol efficacy trial, conducted 1985–2005, for antibodies to Merkel cell (MCV), KI (KIV), and WU (WUV) HPyVs as well as to six high-risk and two low-risk HPV types. Incident lung cancer cases (n = 200) were frequency-matched with controls (n = 200) on age, enrollment and blood draw dates, intervention arm assignment, and the number of serum freeze/thaw cycles. Sera were tested using multiplex liquid bead microarray antibody assays. We used logistic regression to assess the association between HPyV and HPV antibodies and lung cancer. There was no evidence of a positive association between levels of MCV, KIV, or WUV antibodies and incident lung cancer (p corrected >0.10 for all trend tests; odds ratio (OR) range 0.72–1.09, p corrected >0.10 for all). There was also no evidence for a positive association between HPV 16 or 18 infection and incident lung cancer (p corrected ≥0.10 for all trend tests; OR range 0.25–2.54, p > 0.05 for all OR > 1), but the number of persons with serologic evidence of these infections was small. Prior infection with any of several types of HPyV or HPV was not associated with subsequent diagnosis of lung cancer. Infection with these viruses likely does not influence a person’s risk of lung cancer in Western smoking populations.
A Placebo-Controlled Trial of Dextromethorphan as an Adjunct in Opioid-Dependent Patients Undergoing Methadone Maintenance Treatment

Low-dose dextromethorphan (DM) might have anti-inflammatory and neurotrophic effects mechanistically remote from an NMDA receptor. In a randomized, double-blind, controlled 12 week study, we investigated whether add-on dextromethorphan reduced cytokine levels and benefitted opioid-dependent patients undergoing methadone maintenance therapy (MMT).



Patients were randomly assigned to a group: DM60 (60mg/day dextromethorphan; n = 65), DM120 (120mg/day dextromethorphan; n = 65), or placebo (n = 66). Primary outcomes were the methadone dose required, plasma morphine level, and retention in treatment. Plasma tumor necrosis factor (TNF)-α, C-reactive protein, interleukin (IL)-6, IL-8, transforming growth factor-β1, and brain-derived neurotrophic factor (BDNF) levels were examined during weeks 0, 1, 4, 8, and 12. Multiple linear regressions with generalized estimating equation methods were used to examine the therapeutic effect.



After 12 weeks, the DM60 group had significantly longer treatment retention and lower plasma morphine levels than did the placebo group. Plasma TNF-α was significantly decreased in the DM60 group compared to the placebo group. However, changes in plasma cytokine levels, BDNF levels, and the methadone dose required in the three groups were not significantly different.



We provide evidence-decreased concomitant heroin use-of low-dose add-on DM's efficacy for treating opioid-dependent patients undergoing MMT.
A decade of HIV care in rural Tanzania: Trends in clinical outcomes and impact of clinic optimisation in an open, prospective cohort

Our objectives were to describe trends in enrolment and clinical outcomes in the open, prospective Kilombero and Ulanga Antiretroviral Cohort (KIULARCO) in the Morogoro region of southern Tanzania, and identify strengths and areas for improvement in the care of HIV-positive individuals in rural Tanzania.



We included adults (≥15 years) and children (<15 years) enrolled in the cohort in 2005-2014. The cohort underwent significant changes from autumn 2012 to optimise care. We evaluated mortality and loss to follow-up (LTFU) using competing risks methods, ART usage, opportunistic infections (OI), co-infections and laboratory abnormalities.



Overall, 7010 adults and 680 children were enrolled; enrolment peaked in 2008 but has increased steadily since 2011. Among adults (65% female; median age 37 [interquartile range 31-45] years), the proportion referred from hospital wards quadrupled in 2013-14 versus earlier years. 653 (9%) adults died and 2648 (38%) were LTFU; the five-year cumulative probabilities of death and LTFU were 10.3% and 44.0%, respectively. Among children, 69 (10%) died and 225 (33%) were LTFU. The corresponding five-year probabilities were 12.1% and 39.6%. Adult ART use (regardless of eligibility) increased from 5% in 2005 to 89% in 2014 (similarly among children), with 9% on second-line therapy in 2014 (17% of children). OI diagnoses increased over time; tuberculosis prevalence at enrolment quadrupled from 6% in 2011 to 26% in 2014. The proportion of newly-enrolled participants assessed for laboratory abnormalities peaked at nearly 100% in 2014 (from a minimum of 24%), yet abnormality prevalences remained fairly constant.



In this cohort, ART usage improved dramatically and is approaching targets of 90%. Improved screening led to increases in detection of OIs and laboratory abnormalities, suggesting that a large number of these co-morbidities previously went undetected and untreated. Further work will address the high LTFU rates and implications for mortality estimates, and the management and outcomes of co-morbidities.
Factors Associated With Daily Consumption of Sugar-Sweetened Beverages Among Adult Patients at Four Federally Qualified Health Centers, Bronx, New York, 2013

Consumption of sugar-sweetened beverages (SSBs) is associated with cardiovascular disease risk factors. This study examined the relationships between SSB consumption and demographic, health behavior, health service, and health condition characteristics of adult patients of a network of federally qualified health centers (FQHCs) in a low-income, urban setting.



Validated, standardized self-reported health behavior questions were incorporated into the electronic health record (EHR) and asked of patients yearly, at 4 FQHCs. We conducted cross-sectional analysis of EHR data collected in 2013 from 12,214 adult patients by using logistic regression.



Forty percent of adult patients consumed 1 or more SSBs daily. The adjusted odds ratios indicated that patients who consumed more than 1 SSB daily were more likely to be aged 18 to 29 years versus age 70 or older, current smokers versus never smoking, eating no servings of fruits and/or vegetables daily or 1 to 4 servings daily versus 5 or more servings daily, and not walking or biking more than 10 blocks in the past 30 days. Patients consuming 1 or more servings of SSBs daily were less likely to speak Spanish than English, be women than men, be diagnosed with type 2 diabetes versus no diabetes, and be diagnosed with hypertension versus no hypertension.



SSB consumption differed by certain demographic characteristics, health behaviors, and health conditions. Recording SSB intake and other health behaviors data in the EHR could help clinicians in identifying and counseling patients to promote health behavior changes. Future studies should investigate how EHR data on patient health behavior can be used to improve the health of patients and communities.
Is craniosacral therapy effective for migraine? Tested with HIT-6 Questionnaire.

To determine whether or not craniosacral therapy alleviates migraine symptoms.



A cross-over experimental design was used with twenty participants, aged between 20 and 50 years, who suffered from at least two migraine attacks per month. Participants were randomly assigned to two equal-sized groups, A and B. All received six craniosacral treatments over four weeks and the groups answered the "HIT-6" Questionnaire four times; every four weeks (Times 1, 2, 3 and 4). Group A, received treatment after answering the questionnaire the first time, but Group B, answered the questionnaire twice before receiving treatment.



Immediately after treatments and one month afterwards there was significant lowering in HIT-6 scorings compared with prior to treatment. There was also significant difference in HIT-6 scorings between Times 1 and 4 (p = 0.004). The effect size was 0.43-0.55.



The results indicate that craniosacral treatment can alleviate migraine symptoms. Further research is suggested.
Pharmacokinetics of platinum after oral or intravenous cisplatin: a phase 1 study in 32 adult patients

To develop a population pharmacokinetic model for simultaneous analysis of oral/intravenous cisplatin data in order to estimate the mean population pharmacokinetic parameters, mainly the bioavailability, of cisplatin and to evaluate the influence of covariates on the pharmacokinetic variability. Pharmacokinetic and demographic data were collected from 32 adult patients (20 males/12 females, age range 47–76 years) receiving 30-min infusions or an oral formulation of cisplatin, 10–30 mg/m2, for various malignancies. Both total plasma and ultrafilterable or unbound platinum concentrations were determined. Unbound and total platinum concentrations were ascribed to a two-compartment model, with first-order absorption and elimination. The oral bioavailability (F) population estimates were, respectively, 0.39 and 0.30 with associated intersubject variabilities (ISV) of 24% and 26%. Peak concentrations following oral dosing occurred at 1.0 h and 1.6 h for unbound and total platinum, respectively. Clearance (CL) and central distribution volume (V 1) of unbound platinum were significantly related to body surface area (BSA). The CL and V 1 mean estimates were, respectively, 37 l/h and 23 l with an associated ISV of 15%. The final pharmacokinetic models were validated using 1000 bootstrap samples of the original datasets. Both unbound and total platinum data allowed a fair evaluation of oral cisplatin disposition, with close estimations for both absorption rates and oral bioavailability. These results also support the conventional dose adjustment of cisplatin based on BSA.