nils-herrmann/clean_scirepeval huggingface dataset:
Evaluation of an ELISA for p16INK4a as a screening test for cervical cancer.

The low sensitivity of cytology and low specificity of human papillomavirus testing prompts searching for more accurate cervical cancer screening strategies. Our goal was to evaluate an ELISA-based test for p16(INK4a).



1,781 women undergoing routine screening provided cervical specimens for p16(INK4a) ELISA (original and enhanced versions of a prototype), liquid-based cytology, and Hybrid Capture II (hc2) testing. All women with a positive result and a random sample of those with negative results on all tests were referred for histologic diagnosis. Cervical intraepithelial neoplasia grade >or=3 (>or=CIN3) was the main outcome. The original analysis included all >or=CIN3 outcomes (n = 28). The a posteriori analysis was used to represent clinically relevant results with >or=CIN3 as outcomes only when detected after a positive screening test (n = 27).



Participants had a median age of 23 years. The prevalence of high-risk human papillomavirus DNA was 30.6%. In a posteriori analyses, the sensitivity and specificity for p16(INK4a) ELISA (>or=8 pg/mL cut-point), cytology, and hc2 were 50.9%, 58.1%, and 100.0%, respectively, and 90.4%, 89.3%, and 69.2%, respectively. Referral to colposcopy of women with positive results for hc2 and p16(INK4a) (enhanced ELISA, >or=6 pg/mL cut-point) had a sensitivity of 91.8% (95% confidence interval, 79.1-100.0%) and specificity of 86.0% (95% confidence interval, 82.0-89.0%). Results of the original analyses had similar specificity but substantially lower sensitivity due to the strong influence of the single CIN3 case with completely negative screening results.



An enhanced version of this prototypic p16(INK4a) ELISA showed promise in screening, particularly when combined with hc2.
Docosahexaenoic acid supplementation decreases liver fat content in children with non-alcoholic fatty liver disease: double-blind randomised controlled clinical trial.

To investigate whether dietary supplementation with docosahexaenoic acid (DHA) decreases liver fat content in children with non-alcoholic fatty liver disease (NAFLD).



We performed a randomised controlled trial of DHA supplementation (250 and 500 mg/day) versus placebo in 60 children with biopsy-proven NAFLD (20 children per group).



The main outcome was the change in liver fat content as detected by ultrasonography after 6 months of treatment. Secondary outcomes were the changes in insulin sensitivity index, alanine transaminase, triglycerides and body mass index after 6 months of treatment.



Blood DHA increased in children supplemented with DHA (0.65%, 95% CI 0.30% to 1.10% for the DHA 250 mg group and 1.15%, 0.87% to 1.43% for the DHA 500 mg group). The odds of more severe versus less severe liver steatosis after treatment was lower in children treated with DHA 250 mg/day (OR = 0.01, 0.002 to 0.11, p <0.001) and DHA 500 mg/day (OR = 0.04, 0.002 to 0.46, p = 0.01) as compared to placebo but there was no difference between the DHA groups (p = 0.4). Insulin sensitivity index increased and triglycerides decreased to a similar degree in both DHA groups as compared to placebo but there was no effect on alanine transaminase and body mass index.



DHA supplementation improves liver steatosis and insulin sensitivity in children with NAFLD.
Effect of antiviral treatment in patients with chronic HCV infection and t(14;18) translocation.

Hepatitis C virus (HCV) may be associated with the mixed cryoglobulinemia syndrome and other B-cell lymphoproliferative disorders (LPDs). The t(14;18) translocation may play a pathogenetic role. Limited data are available regarding the effects of antiviral therapy on rearranged B-cell clones. We evaluated the effects of interferon and ribavirin on serum, B-lymphocyte HCV RNA, and t(14; 18) in 30 HCV+, t(14;18)+ patients without either mixed cryoglobulinemia syndrome or other LPDs. The t(14;18) translocation was analyzed by both bcl-2/JH polymerase chain reaction and bcl-2/JH junction sequencing in peripheral blood mononuclear cells in all patients. Fifteen untreated patients with comparable characteristics served as controls. Throughout the study, the presence or absence of both t(14;18) and HCV RNA sequences were, in most cases, associated in the same cell samples. At the end of treatment, t(14;18) was no longer detected in 15 patients (50%) with complete or partial virologic response, whereas it was persistently detected in nonresponders (P <.05), as well as in 14 of 15 control patients. In 4 responder patients, t(14;18) and HCV RNA sequences were no longer detected in blood cells after treatment, but were again detected after viral relapse; the same B-cell clones were involved in the pretreatment and posttreatment periods. In conclusion, this study suggests that antiviral therapy may induce regression of t(14;18)-bearing B-cell clones in HCV+ patients and that this phenomenon may be related, at least in part, to the antiviral effect of therapy. This in turn suggests that antiviral treatment may help prevent or treat HCV-related LPDs.
Pioglitazone treatment enlarges subcutaneous adipocytes in insulin-resistant patients.

Obesity-related insulin resistance is associated with an increase in adipocyte size. In rodent models, treatment with the insulin-sensitizers thiazolidinediones (TZDs) leads to the appearance of small, insulin-sensitive adipocytes. Whether such TZD-dependent morphological changes occur in adipose tissue of insulin-resistant patients is unclear.



The objective of the study was to study the effects of treatment with the TZD pioglitazone on sc adipose tissue morphology and function in insulin-resistant subjects.



This was a placebo-controlled, randomized crossover study.



The study was conducted at a university medical center.



Twelve adult patients with congenital adrenal hyperplasia (CAH) characterized by insulin resistance were included in this study.



After a 4-wk run-in phase, patients were treated with pioglitazone (45 mg/d) followed by placebo, each for 16 wk or vice versa.



After both placebo and pioglitazone treatment, insulin sensitivity was determined by hyperinsulinemic euglycemic clamp and abdominal sc adipose tissue was obtained to measure adipocyte cell surface and expression of genes involved in glucose uptake and inflammation.



Pioglitazone treatment significantly improved the insulin sensitivity index (placebo: 0.35 +/- 0.16 micromol/kg . min per milliunit per liter; pioglitazone 0.53 +/- 0.16 micromol/kg . min per milliunit per liter, P < 0.001) and increased mRNA expression levels of adiponectin and glucose transporter-4 in adipose tissue. The increase in insulin sensitivity was accompanied by a significant enlargement of the sc adipocyte cell surface (placebo: 2323 +/- 725 microm(2); pioglitazone 2821 +/- 885 microm(2), P = 0.03).



In the human situation, treatment of insulin-resistant subjects with pioglitazone improves insulin sensitivity, whereas at the same time, sc adipocyte cell surface increases.
Relationship between disability and health-related quality of life and caregiver burden in patients with upper limb poststroke spasticity.

To evaluate the relationship between disability and both health-related quality of life (HRQoL) and caregiver burden in patients with upper limb poststroke spasticity.



Multicenter open-label study.



Thirty-five sites in North America.



Patients (N = 279) with upper limb poststroke spasticity.



Post hoc analyses of data from an open-label study were performed to estimate HRQoL and caregiver burden at study baseline across levels of disability in 4 problem domains: hygiene, dressing, limb posture, and pain. Disability severity in these areas was determined by using the 4-point Disability Assessment Scale rated by the physicians.



HRQoL measured by the patient-reported EuroQol 5 Dimensions questionnaire and the Stroke-Adapted Sickness Impact Profile and caregiver burden.



At study baseline, increasing disability in the hygiene, dressing, and pain domains of the Disability Assessment Scale was associated with diminishing HRQoL scores (P < .002) measured by the EuroQol 5 Dimensions. By using the Stroke-Adapted Sickness Impact Profile, greater disability scores in all problem domains were significantly associated with higher overall dysfunction scores (P ≤ .05). Within the physical dimension of the Stroke-Adapted Sickness Impact Profile, significant associations also were observed in all domains. At baseline, caregiver burden was significantly related to increasing levels of hygiene and dressing domain severity (P ≤ .05). Caregiver assistance requirement increased from approximately 9.0-28.2 hours per week in the hygiene domain and 3.3-32.1 hours per week in the dressing domain as disability increased from "none" to "severe."



In patients with upper limb poststroke spasticity, increasing disability in the hygiene, dressing, and pain domains of the Disability Assessment Scale were associated with diminishing HRQoL. Furthermore, these patients required caregiver assistance proportionally related to the severity of their disability in the hygiene and dressing domains.
Hand-assisted laparoscopic versus total laparoscopic right colectomy: a randomized controlled trial.

Laparoscopic colectomy for colorectal cancer is associated with definite short-term benefits, and is increasingly practised worldwide. The limitations of a pure laparoscopic approach include a relative lack of tactile feedback and long procedural time. Hand-assisted laparoscopic surgery was introduced in an attempt to facilitate operation by improving the tactile sensation. To date, there is no consensus as to which approach is better. Herein we conducted a randomized controlled trial comparing hand-assisted laparoscopic colectomy (HALC) with total laparoscopic colectomy (TLC) in the management of right-sided colonic cancer.



Adult patients with carcinoma of the caecum and ascending colon were recruited and randomized to undergo either HALC or TLC. Measured outcomes included operative time, blood loss, conversion rate, postoperative morbidities, postoperative pain, length of hospital stay, disease recurrence and patient survival.



Sixty patients (HALC=30, TLC=30) were recruited. The two groups were comparable with regard to age, gender distribution, body mass index and final histopathological staging. No difference was observed between the groups in terms of operating time, conversion rate, operative blood loss, pain score and length of hospital stay. With a median follow-up of 27 to 33 months, no difference was observed in terms of disease recurrence, and the 5-year survival rates remained similar (83%vs 80%, P=0.923).



HALC is safe and feasible, but it does not show any significant benefits over TLC in terms of operating time and conversion rate. Routine use of the hand-assisted laparoscopic technique in right hemicolectomy is therefore not recommended.
Development of a radiopharmaceutical activity schedule for technetium-99m dimercaptosuccinic acid in children based on image quality criteria

The aim of this study was to determine an activity schedule (amount of administered activity in relation to body weight) for technetium-99m dimercaptosuccinic acid examinations in children, from information present in renal scintigraphic images. Scans from 48 children (5 weeks to 14.8 years old) were graded for image quality according to the clarity of both kidney outline and internal structure. Numerical image data (kidney and background counts, signal-to-noise ratio) were associated with these subjective gradings to formulate three criteria, specifying the required values of the above-measured parameters to yield optimum grades of image quality. When applied to derived functions, a kidney uptake of 20% was required to satisfy the criterion based on the signal-to-noise ratio. Using this value with the other two criteria predicts the form of the weight-dependent activity schedule as a function of imaging time. Examples of schedules for imaging times of 300 and 600 s are compared with a schedule based on surface area.
Impact of hospital admission during nonworking hours on patient outcomes after thrombolysis for stroke.

Whether the time of hospital admission is relevant for short-term outcome after stroke is under debate and may depend on care facilities.



We retrospectively analyzed medical records from patients who received thrombolytic therapy within 4.5 hours of stroke onset in a stroke unit of the Charité-University Hospital Berlin (Charité; n=291) or within the stroke telemedicine (TEMPiS) network, comprising 12 community hospitals with telestroke units in Bavaria (n=616).



Thrombolytic therapy was administered during nonworking hours in 59.5% (Charité) and 55.0% (TEMPiS) of patients. A trend toward a lower rate of symptomatic intracranial hemorrhage (3.4% versus 9.2%; P=0.053), clinical worsening (11.9% versus 19.7%; P=0.079), and 7-day mortality (3.4% versus 8.7%; P=0.073) after admission during working hours was seen at Charité. However, multivariable analysis did not show a significant impact of the time of admission on clinical worsening, symptomatic intracranial hemorrhage, or 7-day mortality in both cohorts. Thrombolysis based on brain computed tomography instead of magnetic resonance imaging (odds ratio=4.98, 95% CI, 1.09 to 22.7) and more severe National Institutes of Health Stroke Scale score on admission (odds ratio=1.15 per point; 95% CI, 1.07 to 1.24) were associated with 7-day mortality at Charité. National Institutes of Health Stroke Scale score on admission (odds ratio=1.13 per point; 95% CI, 1.06 to 1.19) and older age (odds ratio=1.05 per year; 95% CI, 1.004 to 1.09) were correlated with 7-day mortality in TEMPiS. National Institutes of Health Stroke Scale on admission was the only independent predictor of symptomatic intracranial hemorrhage or clinical worsening in both cohorts.



The majority of stroke patients received thrombolysis during nonworking hours. The time of hospital admission did not significantly influence the short-term outcome after thrombolysis.
Treatment of duodenal ulcer with pirenzepine and cimetidine.

The purpose of this single blind controlled multicentre trial was to compare the relative effectiveness of pirenzepine and cimetidine in healing endoscopically proven duodenal ulcers. One hundred and twenty six patients with duodenal ulcer were treated with a daily dose of 100 mg pirenzepine (50 mg each before breakfast and before the evening meal), and 128 patients were treated with 1000 mg cimetidine (200 mg with breakfast, lunch, and evening meal and 400 mg at bedtime). Endoscopy was repeated after four weeks by an endoscopist who had not been informed about the treatment. Pirenzepine showed a healing rate of 64.3%, cimetidine one of 73.4%. This difference is not statistically significant (one-sided test: chi 1(2) = 2.48). After four weeks a higher proportion of first ulcers than of recurrent lesions was healed. Pain relief was rapidly achieved with both drugs. A significant trend in favour of cimetidine may, however, not be clinically relevant considering the small difference in the absolute numbers of pain free days and nights. Adverse effects were rare and reversible. We conclude that the efficacy of pirenzepine is similar to that of cimetidine in healing duodenal ulcers.
Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases.

A phase 3 trial was conducted to evaluate the efficacy of a prophylactic quadrivalent vaccine in preventing anogenital diseases associated with human papillomavirus (HPV) types 6, 11, 16, and 18.



In this randomized, placebo-controlled, double-blind trial involving 5455 women between the ages of 16 and 24 years, we assigned 2723 women to receive vaccine and 2732 to receive placebo at day 1, month 2, and month 6. The coprimary composite end points were the incidence of genital warts, vulvar or vaginal intraepithelial neoplasia, or cancer and the incidence of cervical intraepithelial neoplasia, adenocarcinoma in situ, or cancer associated with HPV type 6, 11, 16, or 18. Data for the primary analysis were collected for a per-protocol susceptible population of women who had no virologic evidence of HPV type 6, 11, 16, or 18 through 1 month after administration of the third dose.



The women were followed for an average of 3 years after administration of the first dose. In the per-protocol population, those followed for vulvar, vaginal, or perianal disease included 2261 women (83%) in the vaccine group and 2279 (83%) in the placebo group. Those followed for cervical disease included 2241 women (82%) in the vaccine group and 2258 (83%) in the placebo group. Vaccine efficacy was 100% for each of the coprimary end points. In an intention-to-treat analysis, including those with prevalent infection or disease caused by vaccine-type and non-vaccine-type HPV, vaccination reduced the rate of any vulvar or vaginal perianal lesions regardless of the causal HPV type by 34% (95% confidence interval [CI], 15 to 49), and the rate of cervical lesions regardless of the causal HPV type by 20% (95% CI, 8 to 31).



The quadrivalent vaccine significantly reduced the incidence of HPV-associated anogenital diseases in young women.
A browser for a public-domain SpeechWeb

A SpeechWeb is a collection of hyperlinked applications, which are accessed remotely by speech browsers running on end-user devices. Links are activated through spoken commands. Despite the fact that protocols and technologies for creating and deploying speech applications have been readily available for several years, we have not seen the development of a Public-Domain SpeechWeb. In this paper, we show how freely available software and commonly used communication protocols can be used to change this situation.
Validity of the hospital discharge diagnosis in epidemiologic studies of biliopancreatic pathology

The aim was to analyse the magnitude, direction and predictors of change in the main hospital discharge diagnosis (HDD) after a clinical expert review, among patients included in a multicentre molecular epidemiologic study of biliopancreatic diseases.  A total of 602 patients with a suspicion diagnosis of pancreas cancer (PC), cancer of the extrahepatic biliary system (CEBS) or benign biliopancreatic pathologies (BPP) were prospectively recruited at five general hospitals. A structured form was used to collect information from medical records. A panel of experts revised all diagnostic information and established the main clinico-pathological diagnosis (CPD) by consensus.  Of the 204 cases with a HDD of PC, 176 (86%) were deemed to have a CPD of PC, eight of CEBS, twelve a neoplasm of different origin, four BPP and four syndromic diagnoses. Thus, 28 cases (14%) were false positives. Of the 129 patients with a HDD of CEBS, 15 (12%) were false positives. Nine of the 396 cases with a HDD of non-PC (2%) had a CPD of PC (false negatives), whilst 14 of 471 patients with a HDD of non-CEBS (3%) were deemed to have CEBS. Overall, sensitivity and specificity of HDD for PC were, respectively, 95 and 93%, and for CEBS, 89 and 97%. Cytohistological confirmation and laparotomy were independent predictors of diagnostic change.  Validity of the HDD was high, but its association with some clinical variables suggests that sole reliance on HDD can significantly bias results, and highlights the need to review all HDDs. Alternatively, only patients at high risk of misdiagnosis could be reviewed: primarily, those lacking a cytohistological diagnosis or a laparotomy. No exclusions appear warranted solely on the basis of age, gender or tumour spread.
Analgesic effect of transcranial direct current stimulation on central post-stroke pain.

Pain that occurs after a stroke lowers the quality of life. Such post-stroke pain is caused in part by the brain lesion itself, called central post-stroke pain. We investigated the analgesic effects of transcranial direct current stimulation (tDCS) in stroke patients through quantitative sensory testing. Fourteen participants with central post-stroke pain (7 female and 7 male subjects) were recruited and were allocated to either tDCS (n = 7) or sham-tDCS (n = 7) group. Their ages ranged from 45 to 55 years. tDCS was administered for 20 min at a 2-mA current intensity, with anodal stimulations were performed at primary motor cortex. The sham-tDCS group was stimulated 30-second current carrying time. Both group interventions were given for 3 days per week, for a period of 3 weeks. Subjective pain was measured using the visual analogue scale (VAS) of 0 to 10. Sensations of cold and warmth, and pain from cold and heat were quantified to examine analgesic effects. The sham-tDCS group showed no statistically significant differences in time. In contrast, tDCS group showed decreased VAS scores and skin temperature (p < 0.05). The threshold temperatures for the sense of cold and pain from cold increased (p < 0.05), and those for the sense of warmth and pain from heat decreased (p < 0.05). Our findings indicate that tDCS improved sensory identification and exerted analgesic effects in the stroke patients with central post-stroke pain.
The treatment of diabetic gastroparesis with botulinum toxin

Gastroparesis is a disorder of delayed gastric emptying that is often chronic in nature. Up to 50% of type 1 diabetic subjects have symptoms of gastroparesis, which include nausea, vomiting, and early satiety. Elevated pyloric pressures may be responsible for delayed gastric emptying in diabetic subjects. Botulinum toxin inhibits the release of acetylcholine and produces transient paralysis when injected into smooth muscle. The aim of this study was to determine whether injection of the pylorus with botulinum toxin in patients with diabetic gastroparesis improves symptoms of gastroparesis, alters gastric emptying scan time, and/or changes weight and insulin use.



 Eight type 1 diabetic subjects (six women and two men; mean age 41 years; mean years with diabetes 25.3) who had failed standard therapy were enrolled. Intervention consisted of injection of the pylorus with 200 units of botulinum toxin during upper endoscopy. Symptoms, antropyloric manometry, gastric emptying scan times, weight, and insulin use were all recorded before intervention and during a 12-week follow-up period.



Seven of the eight patients completed the full 12-week follow-up period. No complications were noted. Mean symptom scores declined from 27 to 12.1 (P < 0.01), whereas the SF-36 physical functioning domain also improved (P < 0.05). Four patients noted an increase in insulin use of >5 units/day. Six of the seven patients gained weight (P = 0.05). Gastric emptying scan time improved in four patients.



Botulinum toxin injection of the pylorus is safe and improves symptoms in patients with diabetic gastroparesis. These results warrant further investigation with a large, double-blind, placebo-controlled trial.