nils-herrmann/clean_scirepeval huggingface dataset:
Persistent high risk HPV infection associated with development of cervical neoplasia in a prospective population study.

To monitor the association between the course of high risk human papillomavirus (HR-HPV) infection and the development of cervical neoplasia over time, from a baseline of normal cervical cytology.



This paper presents the follow up data from a previous cross sectional analysis. Women from a screening population who had normal cytology and who were HR-HPV positive were recalled after two to three years for cytology and HPV genotyping. The development of cervical neoplasia at follow up was related to the course of HPV infection (clearance, persistence, or sequential infection) and the presence of single or multiple HPV infections at baseline. A comparator control group of women who were HPV and cytologically negative at baseline were selected from the same population.



Twelve cases of dyskaryosis were found in women who were HPV positive at baseline; four were high grade. Only three cases of low grade dyskaryosis were found in the control group. Women with type specific persistent infections were significantly more likely to develop cervical neoplasia than women who cleared the infection (p = 0.0001) or were sequentially infected with different types (p = 0.001). Women with multiple HPV infections at baseline were no more likely to develop cervical dyskaryosis than those with a single infection.



Type specific persistent HR-HPV infection as monitored by genotyping can identify women at increased risk of cervical neoplasia more accurately than a single or repeated presence/absence HPV test. The cost effectiveness of such an approach should be investigated by an appropriate, large scale cost-benefit analysis.
Patterns of care study of radiation therapy for cervix cancer in Japan: the influence of the stratification of institution on the process.

To improve the quality of radiation oncology in Japan, Patterns of Care Study (PCS), a widely known quality assurance (QA) program in the USA, was introduced. The feasibility was tested by collecting nationwide data by extramural audit for cervix cancer.



From July 1996 through February 1997, PCS audits were performed for 29 institutions nationwide. On the basis of the facility survey by Tsunemoto, 13 institutions were classified as A1 (university hospital/cancer center), 10 as B1 (other institutions treating >120 patients/year) and six as B2 (other institutions treating <120 patients/year). Medical charts for the patients treated for cervix cancer between 1992 and 1994 were reviewed based on the data format of the US PCS. The total number of patients surveyed was 432.



Simulation was used for >90% of the patients in both A1 and B1-2 institutions. However, in B1-2, planning for 5% of the patients was performed with only a clinical set-up (p = 0.0287). A daily fraction with a size of 200 cGy was given to >65% of patients in A1 and to <47% in B1-2. On the other hand, >50% of those in B1-2 were treated with daily fractions of 180 cGy and less compared with 25% in A1 institutions (p < 0.0001). Brachytherapy was utilized more frequently for patients in Stages II (p = 0.0365), III (p = 0.0015) and IV (p = 0.0483) in A1 than in B1-2. As for external beam equipment, linear accelerators with 10 MV or more were used for 83% of the patients in A1. However, in B1-2 institutions, machines with lower energy were used for 38% of the patients (p < 0.0001). The median number of full-time-equivalent (FTE) radiation oncologists was 2.7 in A1, 0.65 in B1 and 0.2 in B2.



Institutional stratification, including equipment and personnel, was found to affect significantly the patterns of care for cervix cancer. Therefore, to improve the quality of radiation therapy nationwide, improvements in equipment and in supply of FTE personnel are extremely important. PCS was found to have great potential for a practical evaluation of how much improvement will be required in Japan.
Transient viral load increases in HIV-infected children in the U.K. and Ireland: what do they mean?

To investigate transient increases in viral load during sustained suppression in children in the UK and Ireland Collaborative HIV Paediatric Study (CHIPS).



Cohort of HIV-infected children from 39 centres.



Transient viraemia was defined as > or =1 detectable viral loads (> or =50 copies/ml) between two undetectable values (<50 copies/ml) <280 days apart, during a period of sustained viral suppression (from a confirmed level of <50 copies/ml until the last undetectectable measurement before antiretroviral therapy change or until a confirmed level of >50 copies/ml).



Of 595 children initiating HAART without previous treatment, 347 (58%) achieved sustained suppression. Of these, 78 (23%) experienced 109 episodes of transient viraemia (median 134 copies/ml); 92 (84%) had levels of <1000 copies/ml (maximum 39,839). Transient viraemia was more common during second-line therapy (25/100 child-years [CY]) and following a previous episode (19/100 CY) compared with first-line therapy without a previous episode (11/100 CY). Rates decreased with age at HAART initiation (incidence rate ratio [IRR] 0.95 per year older; P = 0.05), but were higher in those suppressed for longer (IRR 1.63 in those suppressed for 21 year versus <1 year; P = 0.03). CD4+ and CD8+ T-cell counts were similar before and after transient viraemia. Of detectable viral loads during periods of suppression 44% were transient increases rather than virological failure: experiencing transient viraemia did not increase subsequent virological failure (P = 0.20).



Transient viraemia is relatively common among children on HAART, occurring more frequently in those starting HAART at younger ages, on second-line therapy and after longer suppression. It does not appear to affect CD4+ or CD8+ T-cell counts or the risk of subsequent virological failure. Natural variation, assay effects and adherence might all have a role.
Ovarian ablation or suppression in premenopausal early breast cancer: results from the international adjuvant breast cancer ovarian ablation or suppression randomized trial.

Substantial survival benefits exist for patients with early-stage breast cancer who undergo treatment with single-modality tamoxifen, ovarian ablation or suppression, or chemotherapy. To determine whether additional benefits exist with combined treatment, the Adjuvant Breast Cancer (ABC) Trials were undertaken.



The ABC Ovarian Ablation or Suppression Trial randomly assigned pre- and perimenopausal patients with early-stage breast cancer who were receiving prolonged (5 years) tamoxifen treatment with or without chemotherapy to ovarian ablation or suppression (by oophorectomy, ovarian irradiation, or treatment with luteinizing hormone-releasing hormone agonist) versus no ovarian ablation or suppression. Trial endpoints included relapse-free and overall survival. Hazard ratios (HRs) were derived from Cox models, and all statistical tests were two-sided.



Between 1993 and 2000, 2144 (1063 ovarian ablation or suppression, 1081 no ovarian ablation or suppression) patients were randomly assigned. A total of 942 (89%) received ovarian ablation or suppression as allocated. Overall, no evidence of a benefit for ovarian ablation or suppression was observed for relapse-free survival (relapse in the ovarian ablation/suppression versus no ovarian ablation/suppression group, 290 events versus 306 events, HR = 0.95, 95% confidence interval [CI] = 0.81 to 1.12; P = .56) or overall survival (death from any cause in the ovarian ablation or suppression versus no ovarian ablation/suppression group, 215 events versus 230 events, HR = 0.94, 95% CI = 0.78 to 1.13; P = .44), nor were differences seen after adjustment for age, nodal status, or estrogen receptor (ER) status.



Overall, no added effect of ovarian ablation or suppression was seen on relapse-free survival or overall survival of premenopausal women who were treated for early-stage breast cancer. However, the role of ovarian ablation or suppression in young (<40 years) women with ER-positive tumors, especially those not receiving chemotherapy, requires further study.
The association of serum potassium level with left ventricular mass in patients with primary aldosteronism.

Primary aldosteronism (PA) is associated a worse cardiovascular outcome than essential hypertension. Hypokalemia, which is one major characteristic of PA, can affect both cardiac structure and function. The goal of this study is to evaluate the influence of serum potassium level on left ventricular (LV) mass and function in PA patients.



We prospectively analysed 85 PA patients from October 2006 to September 2008 and 27 essential hypertension patients as the control group (group 1). Thirty-two patients with serum potassium < 3·5 mmol L(-1) were defined as hypokalemia (group 2), and 53 patients with serum potassium ≥ 3·5 mmol L(-1) were defined as normokalemia (group 3). Echocardiography including tissue Doppler image (TDI) recordings was performed in all patients.



Group 2 patients had significant higher systolic and diastolic blood pressure (DBP), log-transformed plasma aldosterone concentration, log-transformed aldosterone-to-renin ratio and lower serum potassium level than groups 1 and 3. In echocardiographic measurement, group 2 patients had higher LV mass index (LVMI) than groups 1 and 3. In multivariate analysis for factors affecting LVMI in PA patients, only serum potassium level (P = 0·001), use of spironolactone (P = 0·004) and DBP (P = 0·005) were independent factors. In the TDI study, both groups 2 and 3 had lower e' and E/e' values than group 1.



Serum potassium level is significantly associated with LVMI in PA patients. Compared with essential hypertensive patients, PA patients had a greater impairment of cardiac diastolic function.
Changes in body mass index and hemoglobin concentration in breastfeeding women living with HIV with a CD4 count over 350: Results from 4 African countries (The ANRS 12174 trial)

Breastfeeding is recommended for infants born to HIV-infected women in low-income settings. Both breastfeeding and HIV-infection are energy demanding. Our objective was to explore how exclusive and predominant breastfeeding changes body mass index (BMI) among breastfeeding HIV1-positive women participating in the ANRS12174 trial (clinical trial no NCT0064026).



HIV-positive women (n = 1 267) with CD4 count >350, intending to breastfeed HIV-negative infants were enrolled from Burkina Faso, South Africa, Uganda and Zambia and counselled on breastfeeding. N = 1 216 were included in the analysis. The trial compared Lamivudine and Lopinavir/Ritonavir as a peri-exposure prophylaxis. We ran a linear mixed-effect model with BMI as the dependent variable and exclusive or predominant breastfeeding duration as the key explanatory variable.



Any breastfeeding or exclusive/predominant) breastfeeding was initiated by 99.6% and 98.6% of the mothers respectively in the first week after birth. The median (interquartile range: IQR) duration of the group that did any breastfeeding or the group that did exclusive /predominant breastfeeding were 9.5 (7.5; 10.6) and 5.8 (5.6; 5.9)) months, respectively. The median (IQR) age, BMI, CD4 count, and HIV viral load at baseline (day 7) were 27 (23.3; 31) years, 23.7 (21.3; 27.0) kg/m2, 530 (432.5; 668.5) cells/μl and 0.1 (0.8; 13.7)1000 copies/mL, respectively. No major change in mean BMI was seen in this cohort over a 50-week period during lactation. The mean change between 26 and 50 weeks after birth was 0.7 kg/m2. Baseline mean BMI (measured on day 7 postpartum) and CD4 count were positively associated with maternal BMI change, with a mean increase of 1.0 kg/m2 (0.9; 1.0) per each additional baseline-BMI kilogram and 0.3 kg/m2 (0.2; 0.5) for each additional CD4 cell/μl, respectively.



Breastfeeding was not negatively correlated with the BMI of HIV-1 infected Sub-Saharan African mothers. However, a higher baseline BMI and a CD4 count >500 cells/μl were associated with maternal BMI during the exclusive/ predominant breastfeeding period. Considering the benefits of breast milk for the infants and the recurrent results from different studies that breastfeeding is not harmful to the HIV-1-infected mothers, this study also supports the WHO 2016 guidelines on infant feeding that mothers living with HIV should breastfeed where formula is not safe for at least 12 months and up to 24 months, given that the right treatment or prophylaxis for the infection is administered. These findings and conclusions cannot be extrapolated to women who are immune-compromised or have AIDS.
Online movement control in multiple sclerosis patients with tremor: effects of tendon vibration.

Patients with intention tremor due to multiple sclerosis (MS) exhibit an increased reliance on visual feedback in the sensorimotor control of slow goal-directed movements. In the present study, the use of proprioceptive information was investigated in MS patients with intention tremor compared to MS patients without tremor and healthy controls. Tendon vibration was applied to the wrist extensor muscles during a memory-guided slow wrist step-tracking task to investigate the use of muscle spindle afferent information in online movement control. A significant reduction of movement amplitude was induced by tendon vibration in all three groups, but the effect was found to be smaller in MS patients with tremor (28%) than in subjects without tremor (50%). Vibration also induced an increase of overall tremor amplitude in the MS tremor group; however, its effect on movement amplitude was not directly related to (changes in) tremor severity. The results suggest that the decreased online use of proprioceptive information in MS patients with tremor reflects an adaptation over time to cope with a tremor-related noisy background. Abnormalities in proprioceptive processing may explain why MS patients with tremor show an increased reliance on visual feedback for online motor control.
Genotyping on ALDH2: Comparison of Four Different Technologies

This study aimed to compare the accuracy and performance of four genotyping methods for detecting single nucleotide polymorphisms (SNPs) in aldehyde dehydrogenase-2 (ALDH2), which is the principal enzyme involved in alcohol metabolism.



We genotyped rs671 of ALDH2 in 96 coronary heart disease (CHD) patients with four methods including high resolution melting analysis (HRM), TaqMan allelic discrimination assay (TaqMan), allele-specific PCR (AS-PCR) and pyrosequencing. Meanwhile, we compared the accuracy and performance of these methods.



All selected patients were successfully genotyped with referred methods. The results of these four assays showed 100% concordant results and had 100% accuracy as verified by Sanger sequencing.



All of the referred methods can be used for genotyping ALDH2 rs671 with the same accuracy compared to Sanger sequencing. In small size of clinical samples, HRM and AS-PCR outperform over others due to their lower cost and less hands-on operation, which are suitable for clinical application.
A double blind community-based randomized trial of amoxicillin versus placebo for fast breathing pneumonia in children aged 2-59 months in Karachi, Pakistan (RETAPP)

Fast breathing pneumonia is characterized by tachypnoea in the absence of danger signs and is mostly viral in etiology. Current guidelines recommend antibiotic therapy for all children with fast breathing pneumonia in resource limited settings, presuming that most pneumonia is bacterial. High quality clinical trial evidence to challenge or support the continued use of antibiotics, as recommended by the World Health Organization is lacking.



This is a randomized double blinded placebo-controlled non-inferiority trial using parallel assignment with 1:1 allocation ratio, to be conducted in low income squatter settlements of urban Karachi, Pakistan. Children 2-59 months old with fast breathing, without any WHO-defined danger signs and seeking care at the primary health care center are randomized to receive either three days of placebo or amoxicillin. From prior studies, a sample size of 2430 children is required over a period of 28 months. Primary outcome is the difference in cumulative treatment failure between the two groups, defined as a new clinical sign based on preset definitions indicating illness progression or mortality and confirmed by two independent primary health care physicians on day 0, 1, 2 or 3 of therapy. Secondary outcomes include relapse measured between days 5-14. Modified per protocol analysis comparing hazards of treatment failure with 95% confidence intervals in the placebo arm with hazards in the amoxicillin arm will be done.



This study will provide evidence to support or refute the use of antibiotics for fast breathing pneumonia paving a way for guideline change.
Clinical features of colorectal cancer in Iran: a 15-year review.

The increasing frequency of colorectal cancer in Asian countries, which have traditionally had a lower incidence than populations in developed countries, and a lower age of onset in Iran led us to perform a study on patients with colorectal cancer to investigate the clinical features of colorectal cancer in Iranians.



We studied 977 consecutive cases of colorectal cancer in terms of age, gender, and anatomic location during a 15-year period (1989-2004). The patients were hospitalized in three referral hospitals affiliated to Shahid Beheshti Medical University in Tehran, Iran. Related data were extracted from the patients' medical records and processed using SPSS ver. 12. Most of our patients (251 cases or 25.6%) were between 60 and 69 years of age. We recorded 534 men (54.3%) and 443 women (45.7%). A total of 36% of patients were between 40 and 59 years and 306 patients (31.32%) had rectal cancer.



The highest frequency of colorectal cancer in our study belonged to an age group a decade younger than the range mentioned in the literature for populations in developed societies.



Regarding similar studies, it seems reasonable to adopt screening a decade earlier for Iranian patients.
A mouse radiation-induced liver disease model for stereotactic body radiation therapy validated in patients with hepatocellular carcinoma.

Lower radiation tolerance of the whole liver hinders dose escalations of stereotactic body radiation therapy (SBRT) in hepatocellular carcinoma (HCC) treatment. This study was conducted to define the exact doses that result in radiation-induced liver disease (RILD) as well as to determine dose constraints for the critical organs at risk (OARs) in mice; these parameters are still undefined in HCC SBRT.



This study consisted of two phases. In the primary phase, mice treated with helical tomotherapy-based SBRT were stratified according to escalating radiation doses to the livers. The pathological differences, signs [such as mouse performance status (MPS)], and serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/albumin levels were observed. Radiation-induced disease severities of the OARs were scored using systematic evaluation standards. In the validation phase in humans, 13 patients with HCC who had undergone radiotherapy before hepatectomy were enrolled to validate RILD pathological changes in a mouse study.



The evaluation criteria of the mouse liver radiotherapy-related signs were as follows: MPS ≥ 2.0 ± 0.52, AST/ALT ≥ 589.2 ± 118.5/137.4 ± 15.3 U/L, serum albumin ≤ 16.8 ± 2.29 g/L. The preliminary dose constraints of the OARs were also obtained, such as those for the liver (average dose ≤ 26.36 ± 1.71 Gy) and gastrointestinal tract (maximum dose ≤ 22.63 Gy). Mouse RILD models were able to be developed when the livers were irradiated with average doses of ≥31.76 ± 1.94 Gy (single fraction). RILD pathological changes in mice have also been validated in HCC patients.



Mouse RILD models could be developed with SBRT based on the dose constraints for the OARs and evaluation criteria of mouse liver radiotherapy-related signs, and the authors' results favor the study of further approaches to treat HCC with SBRT.
Feasibility and Efficacy of Sodium Reduction in the Trials of Hypertension Prevention , Phase I

Phase I of the Trials of Hypertension Prevention was a multicenter, randomized trial of the feasibility and efficacy of seven nonpharmacologic interventions, including sodium reduction, in lowering blood pressure in 30to 54 -year-old individuals with a diastolic blood pressure of 80 to 89 mm Hg. Six centers tested an intervention designed to reduce dietary sodium to 80 mmol (1800 mg)/24 h with a total of 327 active intervention and 417 control subjects. The intervention consisted of eight group and two one-to-one meetings during the first 3 months, followed by less-intensive counseling and support for the duration of the study. The mean net decrease in sodium excretion was 43.9 mmol/24 h at 18 months. Women had lower sodium intake at baseline and were therefore more likely to decrease to less than 80 mmol/24 h. Black subjects were less likely to decrease to less than 80 mmol/d, independent of sex or baseline sodium excretion. The mean (95% confidence interval) net decrease associated with treatment was —2.1 (—33, —0.8) mm Hg for systolic blood pressure and —1.2 (—2.0, —03) mm Hg for diastolic blood pressure at 18 months (both P<.01). Multivariate analyses indicated a larger systolic blood pressure effect in women (—4.44 versus —1.23 mm Hg in men), adjusted for age, race, baseline blood pressure, and baseline 24-hour urinary sodium excretion (P=.O2). Dose-response analyses indicated an adjusted decrease of —1.4 mm Hg for systolic blood pressure and —0.9 mm Hg for diastolic blood pressure for a decrease of 100 mmol/24 h in 18-month sodium excretion. These results support the utility of sodium reduction as a population strategy for hypertension prevention and raise questions about possible differences in dose response associated with gender and initial level of sodium intake.
Safety, Tolerability, and Immunogenicity of the Novel Antituberculous Vaccine RUTI: Randomized, Placebo-Controlled Phase II Clinical Trial in Patients with Latent Tuberculosis Infection

To evaluate the safety, tolerability and immunogenicity of three different doses (5, 25 and 50 µg) of the novel antituberculous vaccine RUTI compared to placebo in subjects with latent tuberculosis infection.



Double-blind, randomized, placebo-controlled Phase II Clinical Trial (95 patients randomized). Three different RUTI doses and placebo were tested, randomized both in HIV-positive (n = 47) and HIV-negative subjects (n = 48), after completion of one month isoniazid (INH) pre-vaccination. Each subject received two vaccine administrations, 28 Days apart. Five patients withdrew and 90 patients completed the study. Assessment of safety showed no deaths during study. Two subjects had serious adverse events one had a retinal detachment while taking INH and was not randomized and the other had a severe local injection site abscess on each arm and was hospitalized; causality was assessed as very likely and by the end of the study the outcome had resolved. All the patients except 5 (21%) patients of the placebo group (3 HIV+ and 2 HIV-) reported at least one adverse event (AE) during the study. The most frequently occurring AEs among RUTI recipients were (% in HIV+/-): injection site reactions [erythema (91/92), induration (94/92), local nodules (46/25), local pain (66/75), sterile abscess (6/6), swelling (74/83), ulcer (20/11), headache (17/22) and nasopharyngitis (20/5)]. These events were mostly mild and well tolerated. Overall, a polyantigenic response was observed, which differed by HIV- status. The best polyantigenic response was obtained when administrating 25 µg RUTI, especially in HIV-positive subjects which was not increased after the second inoculation.



This Phase II clinical trial demonstrates reasonable tolerability of RUTI. The immunogenicity profile of RUTI vaccine in LTBI subjects, even being variable among groups, allows us considering one single injection of one of the highest doses in future trials, preceded by an extended safety clinical phase.