nils-herrmann/clean_scirepeval huggingface dataset:
Long-term course of chronic hepatitis C in children: from viral clearance to end-stage liver disease.

The natural course of chronic hepatitis C (CHC) in children is not well understood. The aim of this study was to assess the long-term course of CHC in a large sample of otherwise healthy children.



From 1990 to 2005, 504 consecutive antihepatitis C virus (HCV)-positive children were enrolled at 12 centers of a national observatory and were followed up retrospectively/prospectively.



Putative exposure was perinatal in 283 (56.2%) cases, parenteral in 158 (31.3%), and unknown in 63 (12.5%). At baseline, 477 (94.6%) cases were HCV RNA seropositive, 118 (24.7%) of which were treated with standard interferon alpha. Ten years after putative exposure, the outcome in 359 HCV RNA-positive, untreated patients was (1) undetectable viremia in 27 (7.5%) (by Cox regression analysis, spontaneous viral clearance was independently predicted by genotype 3 [hazard ratio 6.44; 95% confidence interval: 2.7-15.5]) and (2) persistent viremia in 332 (92%) cases. Six of these 332 cases (1.8%) progressed to decompensated cirrhosis (mean age, 9.6 years). This latter group included 5 Italian children perinatally infected with genotype 1a (4 of the mothers were drug users). Thirty-three (27.9%) treated patients achieved a sustained virologic response.



Over the course of a decade, few children with chronic HCV infection cleared viremia spontaneously, and those who did were more likely to have genotype 3. Persistent viral replication led to end-stage liver disease in a small subgroup characterized by perinatal exposure, maternal drug use, and infection with HCV genotype 1a. Children with such features should be considered for early treatment.
Safety of gadoversetamide in patients with acute and chronic myocardial infarction.

To assess the safety data from two large, multicenter, phase 2 trials on the use of gadoversetamide (OptiMARK, Tyco Healthcare/Mallinckrodt, St. Louis, MO) as a contrast agent in delayed hyperenhancement magnetic resonance imaging (DE-MRI) in patients with acute and chronic myocardial infarction (MI).



The study population from both trials comprised 577 patients who were randomly assigned to one of four dose groups (0.05, 0.1, 0.2, or 0.3 mmol/kg) before undergoing DE-MRI. Safety evaluations included physical and electrocardiographic (ECG) examinations. Vital signs, laboratory values, adverse events (AE), and serious adverse events (SAE) were monitored before and after contrast administration.



Of the 577 patients who received gadoversetamide, 124 (21.5%) reported a total of 164 AEs; most were mild (139 AEs; 84.8%) or moderate (25 AEs; 15.2%). ECG-related changes were the most frequent AE. Site investigators judged only eight AEs as likely related to gadoversetamide and only two of the eight as clinically relevant. Further evaluation suggested neither AE was related to gadoversetamide. Two SAEs were reported, but none was judged related to gadoversetamide by the site investigators.



Gadoversetamide is safe for use in patients with acute or chronic MI up to a dose of 0.3 mmol/kg.
Validity of the Functional Gait Assessment in patients with Parkinson disease: construct, concurrent, and predictive validity.

The Functional Gait Assessment (FGA) is a validated measurement of gait-related activities in certain populations and may be potentially useful to assess balance and gait disorders in patients with Parkinson disease (PD).



The purpose of this study was to determine the construct, concurrent, and predictive validity of the FGA in inpatients with PD.



This was a prospective cohort study.



One hundred twenty-one inpatients with PD were prospectively enrolled. The FGA and other relevant appraisals of gait, balance, disease severity, and activities of daily living were performed. Six months later, the patients were interviewed by telephone to have their fall information collected. Principal component analysis was used to determine construct validity. Spearman correlation coefficients were used to determine concurrent validity between the FGA and other measures. Cutoff point, sensitivity, specificity, and positive likelihood ratio were calculated for predictive validity based on the receiver operating characteristic curve.



One common factor was extracted for construct validity, which cumulatively explained 64.0% of the total variance. Correlation coefficients for the FGA compared with other measures ranged from .57 to .85. The cutoff point for predicting falls was 18, with sensitivity of 80.6%, specificity of 80.0%, and positive likelihood ratio of 4.03.



This study was limited by the length of time of follow-up and self-reports of falls without the requirement of a fall diary. Medication adjustment after the FGA evaluation may have led to a different cutoff score for identifying those patients who were at risk of falling.



The FGA demonstrated good construct validity in patients with PD. It had moderate to strong correlations with other balance and gait appraisals. The FGA can be used to predict falls within the subsequent 6 months.
Validation of the Brazilian version of the Clinical Gait and Balance Scale and comparison with the Berg Balance Scale.

To validate the Clinical Gait and Balance Scale (GABS) for a Brazilian population of patients with Parkinson's disease (PD) and to compare it to the Berg Balance Scale (BBS).



One hundred and seven PD patients were evaluated by shortened UPDRS motor scale (sUPDRSm), Hoehn and Yahr (HY), Schwab and England scale (SE), Falls Efficacy Scale International (FES-I), Freezing of Gait Questionnaire (FOG-Q), BBS and GABS.



The internal consistency of the GABS was 0.94, the intra-rater and inter-rater reliability were 0.94 and 0.98 respectively. The area under the receiver operating characteristic (ROC) curve was 0.72, with a sensitivity of 0.75 and specificity of 0.6, to discriminate patients with a history of falls in the last twelve months, for a cut-off score of 13 points.



Our study shows that the Brazilian version of the GABS is a reliable and valid instrument to assess gait and balance in PD.
CYP2D6 Genotyping with Oligonucleotide Microarrays and Nortriptyline Concentrations in Geriatric Depression

Recent advances in oligonucleotide microarray technology (“gene chips”) permit rapid screening for DNA sequence variation. The CYP2D6 gene encodes debrisoquine hydroxylase, which metabolizes the antidepressant nortriptyline and other psychotropic medications. Nortriptyline plasma concentrations were obtained after at least three weeks of treatment in 36 geriatric patients with major depression who were taking a mean of 8.6 other medications besides nortriptyline. Oligonucleotide microarrays were used to detect 16 CYP2D6 alleles that affect debrisoquine hydroxylase activity. Subjects carrying alleles encoding impaired debrisoquine hydroxylase activity had significantly greater nortriptyline concentrations and lower nortriptyline doses than did other subjects. Significant correlations were found between the numbers of alleles encoding decreased metabolism and nortriptyline plasma concentration, nortriptyline dose, and nortriptyline plasma concentration standardized for dose, indicating a gene dosage effect. These results demonstrate that CYP2D6 genotyping on a microarray platform can be used to predict plasma antidepressant concentrations despite advanced patient age and numerous concurrent medications.
Multicenter evaluation of the NucliSens EasyQ HIV-1 v1.1 assay for the quantitative detection of HIV-1 RNA in plasma.

The Nuclisens EasyQ HIV-1 v1.1 assay (Biomerieux) is a real-time detection method combined with NASBA technology designed to measure plasma HIV-RNA. Its performance was assessed in 1008 clinical specimens collected from individuals infected with clade B (774) and non-B (234) HIV-1 variants at four European laboratories. The results were compared with those obtained using three other commercial viral load assays: Cobas Amplicor Monitor HIV-1 v1.5 (Roche), Versant HIV-1 RNA assay (Bayer) and Nuclisens HIV-1 QT (Biomerieux). Overall, the linearity, specificity and reproducibility of the EasyQ assay was comparable with that from the other tests. The correlation coefficient (R) between methodologies was 0.85 for Amplicor; 0.87 for Versant; and 0.91 for Nuclisens. The specificity of the assay was 99.4%. Of note, Versant missed 17% of specimens with non-B subtypes which could be detected by EasyQ, while Amplicor provided similar results than EasyQ. HIV-1 group O specimens were only detected by the EasyQ assay. In conclusion, the performance of the EasyQ assay seems to be similar to that of other HIV-1 viral load tests currently on the market, but it is more sensitive than Versant for HIV-1 non-B subtypes and shows a wider dynamic range than Amplicor. Moreover, as it incorporates the advantage of real-time detection procedures, it facilitates high throughput and short turnaround time.
Ayahuasca-assisted therapy for addiction: results from a preliminary observational study in Canada.

This paper reports results from a preliminary observational study of ayahuasca-assisted treatment for problematic substance use and stress delivered in a rural First Nations community in British Columbia, Canada.



The "Working with Addiction and Stress" retreats combined four days of group counselling with two expert-led ayahuasca ceremonies. This study collected pre-treatment and six months follow-up data from 12 participants on several psychological and behavioral factors related to problematic substance use, and qualitative data assessing the personal experiences of the participants six months after the retreat.



Statistically significant (p < 0.05) improvements were demonstrated for scales assessing hopefulness, empowerment, mindfulness, and quality of life meaning and outlook subscales. Self-reported alcohol, tobacco and cocaine use declined, although cannabis and opiate use did not; reported reductions in problematic cocaine use were statistically significant. All study participants reported positive and lasting changes from participating in the retreats.



This form of ayahuasca-assisted therapy appears to be associated with statistically significant improvements in several factors related to problematic substance use among a rural aboriginal population. These findings suggest participants may have experienced positive psychological and behavioral changes in response to this therapeutic approach, and that more rigorous research of ayahuasca-assisted therapy for problematic substance use is warranted.
Poor symptomatic relief and quality of life in patients treated for “solitary rectal ulcer syndrome without external rectal prolapse”

Solitary rectal ulcer syndrome (SRUS) is a chronic disabling condition. Several therapeutic options have been advocated including conservative approaches and surgery, bringing into question their functional outcomes. This study aimed to assess treatment procedures on both anorectal complaints and quality of life (QoL) using standardised self-administered questionnaires. Forty-one patients who underwent treatments for SRUS in two referral centres were reviewed. A standardised self-administered questionnaire including incontinence (Cleveland Clinic), constipation (Knowles–Eccersley–Scott symptom, KESS) and gastrointestinal quality of life index validated scoring systems was mailed to each patient (median follow-up, 36 months). Correlation between treatment options, functional results and quality of life was analysed. The mean Cleveland Clinic and KESS scores were respectively 5.3 ± 5.8 (normal 0) and 19.1 ± 8 (normal <9). The mean QoL score reached 89 ± 28.8 (normal 125). A linear correlation between the QoL score and functional results was observed. There was no influence of treatment options on QoL results. A multivariate analysis identified five parameters predictive of a better QoL: presence of paradoxical puborectalis contraction, absence of descending perineum, absence of procidentia, age <40 and treatment exclusively based on laxatives. Despite several therapeutic options including surgery, patients with SRUS still frequently complain of disturbed anorectal function and significant alteration of their QoL.
Volume delineation by fusion of fuzzy sets obtained from multiplanar tomographic images

Techniques of three-dimensional (3-D) volume delineation from tomographic medical imaging are usually based on 2-D contour definition. For a given structure, several different contours can be obtained depending on the segmentation method used or the user's choice. The goal of this work is to develop a new method that reduces the inaccuracies generally observed. A minimum volume that is certain to be included in the volume concerned (membership degree /spl mu/=1), and a maximum volume outside which no part of the volume is expected to be found (membership degree /spl mu/=0), are defined semi-automatically. The intermediate fuzziness region (0</spl mu/<1) is processed using the theory of possibility. The resulting fuzzy volume is obtained after data fusion from multiplanar slices. The influence of the contrast-to-noise ratio was tested on simulated images. The influence of slice thickness as well as the accuracy of the method were studied on phantoms. The absolute volume error was less than 2% for phantom volumes of 2-8 cm/sup 3/, whereas the values obtained with conventional methods were much larger than the actual volumes. Clinical experiments were conducted, and the fuzzy logic method gave a volume lower than that obtained with the conventional method. Our fuzzy logic method allows volumes to be determined with better accuracy and reproducibility.
Predictors for symptom re-exacerbation after targeted stepwise drug discontinuation in first-episode schizophrenia: Results of the first-episode study within the German research network on schizophrenia

After a first episode in schizophrenia guidelines recommend antipsychotic maintenance treatment (MT) for at least 1year. Recent RCTs on subsequent targeted intermittent treatment (IT) after stepwise drug discontinuation yielded noticeably higher relapse rates than during MT also in first-episode patients. Nevertheless, about 50% of patients remain stable under IT. Given the potential adverse effects of antipsychotics and the preference of many patients to discontinue drugs, valid predictors for the feasibility of IT are urgently needed to support decision making.



Based on a one-year RCT phase comparing MT with IT in first-episode patients after 1year of MT, conducted within the German Research Network on Schizophrenia (GRNS), predictors for deterioration under IT in 19 feasible patients were identified by logistic regression analysis.



Deterioration occurred in 10 patients (52.6%). Univariate analyses indicated a lower PANSS positive score after acute treatment as well as after one year of MT as significant predictors; in multivariate logistic regression, in addition to the lower PANSS positive score after acute treatment, reaching enduring remission and having had a deterioration both during MT evolved as significant predictors and indicate a higher risk for deterioration.



Although limited by the small sample size, our findings suggest that patients who show a favorable response and full and enduring symptom remission during antipsychotic treatment, as well as those with marked deterioration despite MT should rather be recommended to remain on treatment because they are at higher risk for symptom re-exacerbation after (stepwise) drug discontinuation.
Weight change after smoking cessation using variable doses of transdermal nicotine replacement

Examine weight change in subjects receiving variable doses of transdermal nicotine replacement for smoking cessation.  Randomized, double-blind clinical trial.  One-week inpatient treatment with outpatient follow-up through 1 year.  This report examines weight change after smoking cessation for 70 subjects randomized to placebo or to 11, 22, or 44 mg/d doses of transdermal nicotine. The study included 1 week of intensive inpatient treatment for nicotine dependence with active patch therapy continuing for another 7 weeks. Counseling sessions were provided weekly for the 8 weeks of patch therapy and with long-term follow-up visits at 3, 6, 9, and 12 months.  Forty-two subjects were confirmed biochemically (i.e., by expired carbon monoxide) to be nonsmokers at all weekly visits during patch therapy. Their 8-week weight change from baseline was 3.0±2.0 kg. For these subjects, 8-week weight change was found to be negatively correlated with percentage of cotinine replacement (r=−.38, p=.012) and positively correlated with baseline weight (r=0 .48, p=.001), and age (r=.35, p=.025). Men had higher (p=.003) 8-week weight gain (4.0±1.8 kg) than women (2.1±1.7 kg). Of the 21 subjects who abstained continuously for the entire year, 20 had their weight measured at 1-year follow-up. Among these 20 subjects, 1-year weight change was not found to be associated with gender, baseline weight, baseline smoking rate, total dose of transdermal nicotine, or average percentage of cotinine replacement during the 8 weeks of patch therapy.  This study suggests that higher replacement levels of nicotine may delay postcessation weight gain. This effect is consistent for both men and women. We could not identify any factors that predict weight change with long-term abstinence from smoking.
Hypotensive effects of solitary addition of conventional nonfat dairy products to the routine diet: a randomized controlled trial.

The high consumption of low-fat and nonfat dairy products is associated with reduced risk of high blood pressure.



We aimed to investigate whether the solitary addition of nonfat dairy products to the normal routine diet was capable of lowering blood pressure in middle-aged and older adults with elevated blood pressure.



With the use of a randomized, crossover intervention-study design, 49 adults (56% women) with elevated blood pressure (mean ± SEM age: 53 ± 2 y; systolic blood pressure: 135 ± 1; diastolic blood pressure: 80 ± 1 mm Hg) underwent a high-dairy condition (+4 servings conventional nonfat dairy products/d) and isocaloric no-dairy condition (+4 servings fruit products/d) in which all dairy products were removed. Both dietary conditions lasted 4 wk with a 2-wk washout before crossing over into the alternate condition.



The high-dairy condition produced reductions in systolic blood pressure (135 ± 1 to 127 ± 1 mm Hg) and pulse pressure (54 ± 1 to 48 ± 1 mm Hg) (both P < 0.05). The hypotensive effects were observed within 3 wk after the initiation of the dietary intervention and in both casual seated and ambulatory (24-h) measurements (P < 0.05). Pulse pressure was increased after the removal of all dairy products in the no-dairy condition (54 ± 1 to 56 ± 1 mm Hg; P < 0.05). There were no changes in diastolic blood pressure after either dietary condition.



We concluded that the solitary manipulation of conventional dairy products in the normal routine diet would modulate blood pressure in middle-aged and older adults with prehypertension and hypertension.
Target lobe volume reduction and COPD outcome measures after endobronchial valve therapy.

Endobronchial valve (EBV) therapy may be associated with improvements in chronic obstructive pulmonary disease-related outcomes and may therefore be linked to improvements in the body mass index, airflow obstruction, dyspnoea, exercise capacity (BODE) index. Data from 416 patients with advanced emphysema and hyperinflation across Europe and USA, who were randomised to EBV (n=284) or conservative therapy (n=132) were analysed. Quantitative image analysis was used to compare the volume of the targeted lobe at baseline and at 6 months to determine target lobe volume reduction (TLVR). 44% of patients receiving EBV therapy (versus 24.7% of controls) had clinically significant improvements in the BODE index (p<0.001). BODE index was significantly reduced by mean ± sd 1.4 ± 1.8, 0.2 ± 1.3 and 0.1 ± 1.3 points in patients with TLVR >50%, 20%-50% and <20%, respectively (intergroup differences p<0.001), but increased by 0.3 ± 1.2 points in controls. Changes in BODE were predicted by baseline BODE and correlated significantly with lobar exclusion and lung volumes at 6 months. A greater proportion of patients in the treatment group than in the control group achieved a clinically meaningful improvement in BODE index; however, the likelihood of benefit was less than half in both groups. Patients in whom TLVR was obtained had greater improvements in clinical outcomes.
Efavirenz pharmacokinetics during the third trimester of pregnancy and postpartum.

The impact of pregnancy on efavirenz (EFV) pharmacokinetics is unknown.



International Maternal Pediatric Adolescent AIDS Clinical Trials P1026s is an on-going, prospective, nonblinded study of antiretroviral pharmacokinetics in HIV-infected pregnant women that included a cohort receiving 600 mg EFV once daily as part of combination antiretroviral therapy. Intensive steady-state 24-hour blood sampling was performed during the third trimester and at 6-12 weeks postpartum. Maternal and umbilical cord blood samples were drawn at delivery. Pharmacokinetics targets were the estimated 10th percentile EFV area under the curve (AUC) in nonpregnant historical controls (40.0 mcg·hr(-1)·mL(-1)) and a trough concentration of 1 mcg/mL.



Twenty-five women were enrolled during the third trimester: median (range) age was 29.3 (18.9-42.9) years, weight 69.0 (40-130) kg, and gestational age 32.9 (30.1-38.7) weeks. Median (range) EFV AUC(0-24), C(max), and C(24 hours) were 55.4 mcg·hr(-1)·mL(-1) (13.5-220.3), 5.4 mcg/mL (1.9-12.2), and 1.6 mcg/mL (0.23-8.13), respectively. EFV AUC and C(max) did not differ during pregnancy and postpartum but C(24 hours) was lower during the third trimester (1.6 vs. 2.1 mcg/mL, P = 0.01). During the third trimester, 5 of 25 (20%) women had an EFV AUC below the target and 3 of 25 (12%) had a trough concentration below 1 mcg/mL. EFV cord blood/maternal concentration ratio was 0.49 (0.37-0.74). All women had a HIV-1 RNA viral load less than 400 copies per milliliter at delivery and 19 (76%) had a viral load below 50 copies per milliliter. One child was perinatally HIV infected. Three women were exposed to EFV throughout the first 6 weeks of pregnancy. EFV was well tolerated, and among the 25 infants, no congenital anomalies or newborn complications were reported.



Changes in EFV pharmacokinetics during pregnancy compared with postpartum are not sufficiently large enough to warrant a dose adjustment during pregnancy.
Low-dose topiramate in alcohol dependence: a single-blind, placebo-controlled study.

Topiramate (TOP) and anticonvulsants in general are considered safe and effective drugs for the treatment of alcohol dependence, even though TOP-induced adverse events are quite common, especially for high initial doses or if titration to 300 mg/d is too rapid. The aim of the present study was to assess the efficacy and tolerability profile of low-dose TOP for relapse prevention.



After detoxification, 52 patients were randomized into 2 groups as follows: 26 patients received 100 mg of TOP (oral, twice daily), titrated over 2 weeks, and 26 patients received placebo (PLA). Both groups underwent rehabilitation twice a week.



After 6 weeks of treatment, compared with the PLA group, patients receiving TOP showed the following: (1) fewer drinking days (P < 0.05); (2) less daily alcohol consumption (P < 0.05); (3) more days of treatment (P < 0.05); (4) reduced levels of craving (Obsessive-Compulsive Drinking Scale) and withdrawal symptoms (Clinical Institute Withdrawal Assessment for Alcohol-Revised); and (5) improvement of anxiety, depression, and obsessive-compulsive symptom severity (Symptom Check List 90 Revised).



Despite the small sample size and the short follow-up period, the present PLA-controlled study demonstrated the potential usefulness of TOP, even when administered at a dosage of 100 mg/d, for the treatment of detoxified alcohol-dependent subjects, confirming results from previous studies testing higher doses of TOP.