nils-herrmann/clean_scirepeval huggingface dataset:
HPV vaccine protein L1 predicts disease outcome of high-risk HPV+ early squamous dysplastic lesions.

Prediction of the clinical outcome of nonadvanced, early dysplastic lesions is one of the unresolved problems of cervical cancer screening programs. We examined the influence of human papillomavirus (HPV) L1 capsid protein detection in a randomized, prospective study of 187 high-risk HPV+ early dysplastic lesions during 36 to 46 months. The difference in the clinical outcome of the HPV L1- cases and the HPV L1+ cases was highly statistically significant (P < .0001) and independent of the classification of low-grade squamous intraepithelial lesion (mild dysplasia) and high-grade squamous intraepithelial lesion of the moderate dysplastic type. L1+ mild and moderate dysplasias, reflecting productive HPV infection, showed low malignant potential, justifying a wait-and-watch strategy to prevent overtreatment, especially in young women. L1- early dysplastic lesions, as nonproductive infections or precancerous lesions, have a high malignancy potential and close follow-up with colposcopy and histologic evaluation should be advised.
Experience of CyberKnife Robotic Radiosurgery in treating intra and extra-cranial tumours: A review of outcomes.

To determine the success rate and complication of CyberKnife Robotic Radiosurgery for treating intracranial and extra cranial tumours.



The cross-sectional observational study was carried out at the Department of CyberKnife Robotic Radiosurgery at the Jinnah Postgraduate Medical Centre, Karachi, and reviewed data related to a year from December 2012 to December 2013. Patients referred from different hospitals within and outside Pakistan for stereotactic radiosurgery were included. The patients had benign tumours less than 7cm size, post-operative residual tumour and recurrent tumour with post-radiotherapy. Patients were followed up every three months with contrast magnetic resonance imaging. Radiosurgery was considered successful if patients improved clinically with radiologically stable disease or if there was interval reduction in the size of tumour. SPSS 17 was used for data analysis.



Initially, 260 patients were selected, but 9(3.5%) were lost, and the final sample size was 251(96.5%). Clinically successful outcome results were seen in 225(90%) patients, while 8(3%) showed no change in symptoms and 18(7%) patients' follow-up is awaited. Radiological improvement was noted in 218(87%); stable disease in 138(55%) and 80(32%) cases showed more than 30% reduction in size after 6-12 months of follow-up. Only 5(2%) cases showed subtle increase in size within 3-month interval due to post-radiation oedema. Acute transient post-radiation changes were seen in 25(10%) patients, sub-acute changes in 4(1.59%) and 1(0.3%) patient showed radionecrosis after 9-month interval.



Cyberknife was an effective, safe and successful treatment alternative to surgery in benign and malignant tumours with low risk of post-radiotherapy complication compared to conventional radiation.
HIV Incidence Remains High in KwaZulu-Natal, South Africa: Evidence from Three Districts

HIV prevalence and incidence among sexually active women in peri-urban areas of Ladysmith, Edendale, and Pinetown, KwaZulu-Natal, South Africa, were assessed between October 2007 and February 2010 in preparation for vaginal microbicide trials.



Sexually active women 18-35 years, not known to be HIV-positive or pregnant were tested cross-sectionally to determine HIV and pregnancy prevalence (798 in Ladysmith, 1,084 in Edendale, and 891 in Pinetown). Out of these, approximately 300 confirmed non-pregnant, HIV-negative women were subsequently enrolled at each clinical research center (CRC) in a 12-month cohort study with quarterly study visits. Women in the cohort studies were required to use a condom plus a hormonal contraceptive method. HIV prevalence rates in the baseline cross-sectional surveys were high: 42% in Ladysmith, 46% in Edendale and 41% in Pinetown. Around 90% of study participants at each CRC reported one sex partner in the last 3 months, but only 14-30% stated that they were sure that none of their sex partners were HIV-positive. HIV incidence rates based on seroconversions over 12 months were 14.8/100 person-years (PY) (95% CI 9.7, 19.8) in Ladysmith, 6.3/100 PY (95% CI 3.2, 9.4) in Edendale, and 7.2/100 PY (95% CI 3.7, 10.7) in Pinetown. The 12-month pregnancy incidence rates (in the context of high reported contraceptive use) were: 5.7/100 PY (95% CI 2.6, 8.7) in Ladysmith, 3.1/100 PY (95% CI 0.9, 5.2) in Edendale and 6.3/100 PY (95% CI 3.0, 9.6) in Pinetown.



HIV prevalence and incidence remain high in peri-urban areas of KwaZulu-Natal.
Phase I trial examining addition of gemcitabine to CHOP in intermediate grade NHL

Gemcitabine induces a 20% response as single-agent therapy in patients with relapsed or refractory NHL. We report phase I findings of gemcitabine in combination with standard CHOP chemotherapy with G-CSF support for intermediate grade NHL. The protocol was modified during enrollment to include rituximab in CD 20+ lymphomas. Patients received CHOP plus gemcitabine at 500 mg/m2 (Cohort 1) or 750 mg/m2 (Cohort 2) on days 1 and 4 of each 21-day cycle. Accrual was suspended once each cohort was filled. Dose escalation occurred after all patients in the cohort were determined to not have a dose-limiting toxicity. Between April 2002 and May 2004, 10 patients were enrolled and completed the study treatment (6 in Cohort 1, 4 in Cohort 2). In Cohort 1, grade 3 toxicities included neutropenia, anemia, neuropathy, and constipation. Grade 4 toxicities were febrile neutropenia and thrombocytopenia. In Cohort 2, grade 3 toxicities included neutropenia, thrombocytopenia, mucositis, anemia, and intestinal obstruction. Grade 4 toxicities included febrile neutropenia, neutropenia, and thrombocytopenia. One patient developed MDS 36 months after chemotherapy. Three of four patients in Cohort 2 developed dose-limiting toxicities (mucositis and thrombocytopenia) requiring dose reduction in gemcitabine after cycle 1. Overall, the survival rate at 2.5 years was 71%. This Phase I trial concludes that gemcitabine 500 mg/m2 on days 1 and 4 of each 21-day cycle is the maximum tolerated dose when combined with standard CHOP chemotherapy with G-CSF support for intermediate grade NHL.
Improving asthma care for the elderly: a randomized controlled trial using a simple telephone intervention.

Several studies suggest that asthma is undertreated in the elderly population.



To determine if the use of a simple telephone intervention can improve asthma care in the elderly.



Fifty-two elderly subjects with asthma who required their rescue inhalers more than twice a week and had at least one emergency department or urgent care visit in the previous year were randomized to an intervention or control group. All subjects received two telephone calls over a 12-month period. The intervention group received an asthma-specific questionnaire and the control group received a general health questionnaire. Medication use and health care utilization were evaluated at the beginning and end of a 12-month period.



The study was completed by 23 control and 25 intervention subjects. Baseline data were similar in both groups. After 12 months, 72% (n = 18) of the intervention group were on an inhaled corticosteroid compared with 40% (n = 10) of the control group (p = 0.08). The intervention group had fewer emergency department visits when compared with the control group (p = 0.21). Sixty-four percent (n = 16) of the intervention group had an asthma action plan compared with 26% (n = 6) in the control group (p = 0.01).



This study suggests that asthma care in the elderly can be improved using a simple telephone intervention.



Clinicians need to recognize that under treatment of asthma in the elderly still exists and to use alternative methods such as a simple telephone questionnaire to improve care in this population.
Breakfast cereal fortified with folic acid, vitamin B-6, and vitamin B-12 increases vitamin concentrations and reduces homocysteine concentrations: a randomized trial.

High homocysteine and low B vitamin concentrations have been linked to the risk of vascular disease, stroke, and dementia and are relatively common in older adults.



We assessed the effect of breakfast cereal fortified with folic acid, vitamin B-6, and vitamin B-12 on vitamin and homocysteine status.



A randomized, double-blind trial was conducted in 189 volunteers aged 50-85 y. The subjects had no history of hypertension, anemia, asthma, cancer, or cardiovascular or digestive disease and did not regularly consume multiple or B vitamin supplements or highly fortified breakfast cereal. Subjects were randomly assigned to consume 1 cup (0.24 L) breakfast cereal fortified with 440 microg folic acid, 1.8 mg vitamin B-6, and 4.8 microg vitamin B-12 or placebo cereal for 12 wk. Blood was drawn at 0, 2, 12, and 14 wk. Methionine-loading tests were conducted at baseline and week 14.



Final baseline-adjusted plasma homocysteine concentrations were significantly lower and B vitamin concentrations were significantly higher in the treatment group than in the placebo group (P < 0.001). The percentage of subjects with plasma folate concentrations < 11 nmol/L decreased from 2% to 0%, with vitamin B-12 concentrations < 185 pmol/L from 9% to 3%, with vitamin B-6 concentrations < 20 nmol/L from 6% to 2%, and with homocysteine concentrations > 10.4 micromol/L (women) or > 11.4 micromol/L (men) from 6.4% to 1.6%. The percentage of control subjects with values beyond these cutoff points remained nearly constant or increased.



In this relatively healthy group of volunteers, consumption of 1 cup fortified breakfast cereal daily significantly increased B vitamin and decreased homocysteine concentrations, including post-methionine-load homocysteine concentrations.
The incidence of rheumatoid arthritis in Spain: results from a nationwide primary care registry.

To estimate the incidence of early arthritis (EA) and of RA in adults (>16 yrs) in Spain.



Primary care physicians were instructed in the detection of new cases using a checklist. All cases were evaluated at EA units (EAUs) within 15 days of detection. ACR criteria for the classification of RA were assessed every 6 months thereafter.



In an area covering 4,342,378 inhabitants over the age of 16 yrs, 2467 patients were referred to the EAU, of whom 1063 fulfilled EA criteria (43.1%). After 6 months, 362 patients fulfilled RA criteria. The estimated annual incidence of EA was 25/100,000 population (95% CI: 23, 26). The annual incidence of RA was 8.3 cases/100,000 (95% CI: 7.5, 9.2): 11.3/100,000 in women (95% CI: 10.0, 12.8), and 5.2/100,000 in men (95% CI: 4.3, 6.3). The incidence of RA increased with age in both sexes. At the 6 months' assessment, 187 (51.7%) of the patients with RA were RF positive. The presentation of RA was mainly polyarticular (n = 268; 74.0%). There were 701/1063 patients with EA who did not fulfil RA criteria by 6 months after the first rheumatologist visit. If all cases of undifferentiated arthritis (n = 118; 17%) became RA, the incidence would be in the range of 10 cases/100,000 population.



RA incidence in Spain is in the lower range of published data. The incidence of EA is about three times that of RA.
Prevalence of infective endocarditis in patients with systemic lupus erythematosus.

Compared with the general population, patients with systemic lupus erythematosus, or SLE, have an increased prevalence of functionally impaired cardiac valves due to the presence of Libman-Sacks lesions. These lesions may place patients with SLE at risk of developing infective endocarditis, or IE.



The authors performed a retrospective chart review to determine the association between SLE with valvulopathy and IE. They reviewed the records of 361 patients from two health care facilities who had the diagnostic code of SLE.



Of the 275 records that met the 1982 revised American Rheumatism Association criteria for SLE, 51 (18.5 percent) were for patients who had a clinically detectable heart murmur that resulted in echocardiography being performed. Nine (3.3 percent) of the 275 patients had a clinically significant valvular abnormality, three (1.1 percent) had a potentially significant valvular abnormality, and one (0.4 percent) had a history of IE that was diagnosed two years before her diagnosis of SLE was made.



The findings suggest that 18.5 percent of this cohort of patients with SLE had a clinically detectable heart murmur that would require further investigation to determine its significance. Furthermore, between 3.3 and 4.4 percent of the study population had cardiac valve abnormalities that potentially required antibiotic prophylaxis before certain dental procedures. However, the authors identified no cases that demonstrated an association between IE and diagnosed SLE.



Dentists should query their patients with SLE about their cardiac status and consult with the patient's physician if the cardiac status is unknown. Patients with confirmed valvular abnormalities should receive antibiotic prophylaxis for designated bacteremia-producing dental procedures.
Factors predicting survival after diagnosis of laryngeal cancer.

Survival in patients with laryngeal cancer has not increased remarkably within the last years. It is presumed that a variety of factors act jointly in predicting survival after diagnosis: tumour stage, tumour site, treatment approaches, age and comorbidities. The aim of this German clinical multi-centre study is to present results from multivariate analysis. A retrospective cohort study was conducted in four hospitals in South-West Germany. Incident cases with laryngeal squamous cell carcinoma were included for the years 1998 to 2004, resulting in a population sample of 594 patients. Multivariate regression analysis was performed using the Cox proportional hazards model. Patients were followed up for 64.1months on average. Overall 5-year survival was 66% (95% confidence interval (CI): 62-70%). The strongest risk factors in multivariate analysis were age at first diagnosis (hazard ratio (HR): 1.5; 95% CI: 1.5-1.7 per each additional 10years), tumour stage, and the development of recurrences (HR 3.1; 95% CI: 2.3-4.2) or second primary carcinomas (HR 2.1; 95% CI: 1.4-3.1). A somewhat weaker effect was shown for patients with comorbidities (using Charlson's comorbidity index). The choice of treatment did not strongly affect survival when adjusting for other factors, possibly because the optimal treatment approach was applied for the specific constitution and requirements of each patient. For future research it would be desirable to study the effect of treatment on quality of life in multivariate analysis as well as other modifiable risk factors as smoking and drinking reduction or cessation after diagnosis.
Antipsychotic response in first-episode schizophrenia: efficacy of high doses and switching

Clinicians treating schizophrenia routinely employ high doses and/or antipsychotic switching to achieve response. However, little is actually known regarding the value of these interventions in early schizophrenia. Data were gathered from a treatment algorithm implemented in patients with first-episode schizophrenia that employs two antipsychotic trials at increasing doses before clozapine. Patients were initially treated with either olanzapine or risperidone across three dose ranges, (low, full, high), and in the case of suboptimal response were switched to the alternate antipsychotic. We were interested in the value of (a) high dose treatment and (b) antipsychotic switching. A total of 244 patients were evaluated, with 74.5% (184/244) responsive to Trial 1, and only 16.7% (10/60) responsive to Trial 2. Percentage of response for subjects switched from olanzapine to risperidone was 4.0% (1/25) vs. 25.7% (9/35) for those switched from risperidone to olanzapine. High doses yielded a 15.5% response (14.6% for risperidone vs. 16.7% for olanzapine).The present findings concur with other research indicating that response rate to the initial antipsychotic trial in first-episode schizophrenia is robust; thereafter it declines notably. In general, the proportion of responders to antipsychotic switching and high dose interventions was low. For both strategies olanzapine proved superior to risperidone, particularly in the case of antipsychotic switching (i.e. risperidone to olanzapine vs. vice versa). It remains to be established whether further antipsychotic trials are associated with even greater decrements in rate of response. Findings underscore the importance of moving to clozapine when treatment resistance has been established.
Nicotine tartrate liquid enemas for mildly to moderately active left-sided ulcerative colitis unresponsive to first-line therapy: a pilot study.

Ulcerative colitis is predominantly a disease of non-smokers, and transdermal nicotine is therapeutic but often results in side-effects. Administration of nicotine as a liquid rectal enema results in less systemic nicotine absorption.



To determine the safety and clinical response of nicotine tartrate liquid enemas for active left-side ulcerative colitis in a pilot study.



Ten non-smoking patients with mildly to moderately active left-sided ulcerative colitis unresponsive to first-line therapy were treated in an open protocol with nightly nicotine tartrate liquid enemas at a dose of 3 mg nicotine base for 1 week then 6 mg for 3 weeks. Clinical assessments were determined at baseline and 4 weeks by endoscopy, physician assessment and a patient diary of daily symptoms. Peak and trough serum nicotine and trough plasma cotinine were determined by gas chromatography/mass spectrometry and high performance liquid chromatography, respectively.



After 4 weeks of treatment, 5/7 patients (71%) showed clinical and sigmoidoscopic improvement (per protocol analysis). The other three patients discontinued therapy within 7 days because of inability to retain the liquid enemas. No patients showed histologic improvement. Six of the patients who completed the 4-week study had peak and trough serum nicotine concentration determined, only 1 of 6 patients had a detectable peak nicotine concentration (value 2.3 ng/mL), and all six patients had undetectable trough nicotine concentrations. The mean trough plasma cotinine concentration was 13 +/- 10 ng/mL. Transient and mild adverse events occurred in 4/10 patients (nausea, lightheadedness, tremor, sleep disturbance). Given the low or undetectable serum nicotine concentrations, these adverse events are not likely to be related to the nicotine enemas.



Nicotine tartrate liquid enemas administrated at a dose of 3 mg nicotine base/day for 1 week and then 6 mg/day for 3 weeks are safe and appear to result in clinical improvement in some patients with mildly to moderately active, left-sided ulcerative colitis unresponsive to first-line therapy. Placebo-controlled trials are warranted to confirm these preliminary findings.
Blockade of Interferon‐γ Normalizes Interferon‐Regulated Gene Expression and Serum CXCL10 Levels in Patients With Systemic Lupus Erythematosus

To assess the safety and immunologic impact of inhibiting interferon-γ (IFNγ) with AMG 811, a human IgG1 monoclonal antibody against IFNγ, in patients with systemic lupus erythematosus (SLE).



Twenty-six patients with mild-to-moderate, stable SLE were administered placebo or a single dose of AMG 811, ranging from 2 mg to 180 mg subcutaneously or 60 mg intravenously.



Similar to results previously reported following inhibition of type I IFNs, treatment of SLE patients with AMG 811 led to a dose-dependent modulation of the expression of genes associated with IFN signaling, as assessed by microarray analysis of the whole blood. The list of impacted genes overlapped with that identified by stimulating human whole blood with IFNγ and with those gene sets reported in the literature to be differentially expressed in SLE patients. Serum levels of IFNγ-induced chemokines, including IFNγ-inducible protein 10 (IP-10), were found to be elevated at baseline in SLE patients as compared to healthy volunteers. In contrast to previously reported results from studies using type I IFN-blocking agents, treatment with AMG 811 led to dose-related reductions in the serum levels of CXCL10 (IP-10).



The scope and nature of the biomarkers impacted by AMG 811 support targeting of IFNγ as a therapeutic strategy for SLE.
Short- and long-term efficacy of a community-based COPD management programme in less advanced COPD: a randomised controlled trial.

The effectiveness of pulmonary rehabilitation in advanced COPD is well established, but few data are available in less advanced disease.



In a 2 year randomised controlled trial, 199 patients with an average moderate airflow obstruction but impaired exercise capacity (mean (SD) forced expiratory volume in 1 s (FEV(1)) 60 (16)%, peak work load (Wmax) <70%) were randomised to the INTERdisciplinary COMmunity-based COPD management programme (INTERCOM) or usual care. Intervention consisted of 4 months multidisciplinary rehabilitation followed by a 20-month maintenance phase. Outcomes (4, 12, 24 months): health-related quality of life (St George's Respiratory Questionnaire (SGRQ)), exacerbation frequency, MRC dyspnoea score, cycle endurance time (CET), 6-minute walking distance (6MWD), skeletal muscle strength and patients' and caregivers' perceived effectiveness.



Between-group comparison after 4 months revealed the following mean (SE) significant differences in favour of INTERCOM: SGRQ total score 4.06 (1.39), p = 0.004; activity and impact subscores, p<0.01; MRC score 0.33 (0.13), p = 0.01; Wmax 6.0 (2.3) Watt, p = 0.02; CET 221 (104) s, p = 0.04; 6MWD 13 (6) m, p = 0.02; hand grip force 4.3 (1.5) lb, p<0.01; and fat-free mass index 0.34 (0.13) kg/m(2), p = 0.01. Between-group differences over 2 years were as follows: SGRQ 2.60 (1.3), p = 0.04; MRC score 0.21 (0.10), p = 0.048; CET 253 (104) s, p = 0.0156; 6MWD 18 (8) m, p = 0.0155. Exacerbation frequency was not different (RR 1.29 (95% CI 0.89 to 1.87)). Patients' and caregivers' perceived effectiveness significantly favoured the INTERCOM programme (p<0.01).



This study shows that a multidisciplinary community-based disease management programme is also effective in patients with COPD with exercise impairment but less advanced airflow obstruction.
Serum vitamin D and the metabolic syndrome among osteoporotic postmenopausal female patients of a family practice clinic in Jordan.

Vitamin D deficiency and insufficiency and the metabolic syndrome are two common health issues worldwide. The association between these two health problems is subject to debate.



This study aims to investigate the association between vitamin D deficiency or insufficiency and the metabolic syndrome in a sample of osteoporotic postmenopausal women attending a family practice clinic in Amman-Jordan.



This was an observational cross sectional study. It was carried out in the family practice clinic in Jordan University Hospital. The study included all postmenopausal osteoporotic women attending the clinic between June 2011 and May 2012, yielding a total of 326 subjects. The association between metabolic syndrome and serum vitamin D levels was investigated.



Waist circumference, body mass index, triglycerides and fasting blood sugar were significantly higher among postmenopausal women with metabolic syndrome, but HDL cholesterol was significantly lower (p<0.05). The prevalence of metabolic syndrome among all study participants was 42.9%. Triglycerides and LDL cholesterol were significantly higher among women deficiency or insufficiency (p<0.05). The prevalence of vitamin D deficiency or insufficiency was 45.7%. Among patients with metabolic syndrome, the prevalence of vitamin D deficiency or insufficiency was 50.7%.



Findings of the current study suggest a lack of relationship between serum vitamin D and metabolic syndrome. However, a significant inverse relationship was found between serum vitamin D levels and both serum triglycerides and LDL levels.