nils-herrmann/clean_scirepeval huggingface dataset:
Induction and maintenance therapy with infliximab for children with moderate to severe ulcerative colitis.

We evaluated the efficacy and safety of infliximab for inducing and maintaining benefit in children with moderately to severely active ulcerative colitis (UC).



Patients (6-17 years old) who had active UC (Mayo scores of 6-12; endoscopic subscores ≥ 2) and had not responded to or tolerated conventional treatment were given 5 mg/kg infliximab at weeks 0, 2, and 6. The primary end point was response at week 8 (decreases in Mayo scores ≥ 30% and ≥ 3 points and decreases in rectal bleeding subscores of ≥ 1 or an absolute subscore of ≤ 1). At week 8, only responders were randomly assigned to groups given infliximab every 8 or 12 weeks (q8w or q12w) and followed through week 54. Maintenance end points included pediatric UC activity index scores <10 points, defined as remission.



At week 8, infliximab induced a response in 73.3% of patients (44 of 60) (95% confidence interval, 62.1%-84.5%; a positive result was defined by 95% confidence interval lower limit >40%). Among responders, twice as many were in remission at week 54 after q8w (8 of 21, 38.1%) than q12w (4 of 22, 18.2%; P = .146) therapy. Assuming the q8w remission rate for responders, the overall remission rate at week 54 would be 28.6%. Serious adverse events and infusion reactions occurred in similar proportions in the q8w and q12w groups. No deaths, malignancies, opportunistic infections, tuberculosis, or delayed hypersensitivity reactions were reported.



Infliximab was safe and effective, inducing a response at week 8 in 73.3% of pediatric patients with moderate to severely active UC who did not respond to conventional therapy. The overall remission rate at week 54 for all enrolled patients was 28.6%, assuming the more effective q8w remission rate.
Development of a preliminary diabetes dietary satisfaction and outcomes measure for patients with type 2 diabetes

Adopting dietary lifestyle changes for diabetes management is often difficult for patients; yet the health-related quality of life (HRQOL) outcomes of dietary management for the patient are not extensively developed in the HRQOL assessments now widely used in diabetes research. This study developed a preliminary instrument, the diabetes dietary satisfaction and outcomes measure, to assess outcomes of individuals' experiences in following a meal plan for the treatment of type 2 diabetes. A theoretical framework and preliminary focus group data guided the design of a 47-item questionnaire, administered to 239 patients with type 2 diabetes. Medical file data was obtained on 180 of these patients. Fifty-four percent of respondents were women, with mean age of 64 ± 12 years and diabetes duration of 10 ± 8 years. Scores for the satisfaction and other outcome measures discriminated between patient groups by age, gender, medication use, depression diagnosis, meal plan status, and employment status. Significant correlations also occurred with diet adherence, number of co-morbidities, and glycemic control as measured by glycolated hemoglobin (HbA1c). Future research with additional patient samples is needed to refine the measure for use in diabetes education programs.
The acute cardioprotective effect of glucocorticoid in myocardial ischemia–reperfusion injury occurring during cardiopulmonary bypass

The purpose of this study was to evaluate the acute cardioprotective effect of high-dose methylprednisolone (25 mg/kg) in the controlled in vivo model of myocardial ischemia–reperfusion injury occurring during cardiopulmonary bypass. Forty nondiabetic male patients with three-vessel disease undergoing first-time bypass surgery were enrolled for this double-blind prospective study. Patients were randomized to be given 25 mg/kg methylprednisolone (Group I) and saline (Group II) 1 h before cardiopulmonary bypass. The levels of cardiac troponin-I (cTnI) were used as a marker of myocardial tissue damage in myocardial ischemia–reperfusion injury. The cTnI levels were measured before surgery, at the second hour after cardiopulmonary bypass, at the 6th and 24th hours, and 5th day postoperatively. There was no significant difference between the two groups in respect to the duration of ischemia and reperfusion. The preoperative cTnI levels were 0.22 ± 0.29 ng/ml in Group I and 0.23 ± 0.28 ng/ml in Group II. cTnI levels increased to 2.40 ± 1.0 ng/ml in Group I and 3.19 ± 0.88 ng/ml in Group II at the 2nd hour after cardiopulmonary bypass. When the differences between T1 and T0 level that showed the amount of troponin release occurring due to ischemia–repefusion injury was calculated and then compared, there was a significant difference between Groups I and II (P = 0.024). The cTnI levels measured at 6 h after CPB were 1.98 ± 0.63 ng/ml in Group I and 2.75 ± 1.15 ng/ml in Group II (P = 0.049). cTnI levels decreased to 0.22 ± 0.10 ng/ml in Group I and 0.49 ± 0.25 ng/ml in Group II on the postoperative day 5 (P = 0.0001). Univalent regression analysis showed that preoperative high-dose corticosteroid usage decreased the troponin release in about 12% and this effect was statistically significant (R2 = 0.12, P < 0.05). A single dose of intravenous methylpredisolone (25 mg/kg) given 1 h before ischemia reduced myocardial ischemia–reperfusion injury. These results demonstrated that the acute cardioprotective effect of corticosteroids has much potential in the future for reducing ischemia–reperfusion injury occurring during cardiopulmonary bypass when it is inevitable.
Use of personal digital assistants for data collection in a multi-site AIDS stigma study in rural south Nyanza, Kenya.

To describe the development, cost effectiveness and implementation of a PDA based electronic system to collect, verify and manage data from a multi-site study on HIV/AIDS stigma and pregnancy in a rural, resource-poor area.



We worked within a large prevention of mother-to-child-transmission (PMTCT) program in nine rural health facilities to implement a PDA-based data collection system and to study the feasibility of its use in a multisite HIV research study in rural Kenya. The PDAs were programmed for collecting screening and eligibility data, and responses to structured interviews on HIV/AIDS stigma and violence in three local languages.



Between November 2007 and December 2008, nine PDAs were used by Clinic and Community Health Assistants to enrol 1,270 participants on to the PMTCT program. Successes included: capacity-building of interviewers, low cost of implementation, quick turnaround time of data entry with good data quality, and convenience.



Our study demonstrated the feasibility of utilizing PDAs for data collection in a multi-site observational study on HIV/AIDS stigma conducted in remote rural health facilities in Kenya. However, appropriate and frequent data backup protocols need to be established and paper forms are still needed as backup tools in resource-poor settings.
Translating a heart disease lifestyle intervention into the community: the South Asian Heart Lifestyle Intervention (SAHELI) study; a randomized control trial

South Asians (Asian Indians and Pakistanis) are the second fastest growing ethnic group in the United States (U.S.) and have an increased risk of atherosclerotic cardiovascular disease (ASCVD). This pilot study evaluated a culturally-salient, community-based healthy lifestyle intervention to reduce ASCVD risk among South Asians.



Through an academic-community partnership, medically underserved South Asian immigrants at risk for ASCVD were randomized into the South Asian Heart Lifestyle Intervention (SAHELI) study. The intervention group attended 6 interactive group classes focused on increasing physical activity, healthful diet, weight, and stress management. They also received follow-up telephone support calls. The control group received translated print education materials about ASCVD and healthy behaviors. Primary outcomes were feasibility and initial efficacy, measured as change in moderate/vigorous physical activity and dietary saturated fat intake at 3- and 6-months. Secondary clinical and psychosocial outcomes were also measured.



Participants' (n = 63) average age was 50 (SD = 8) years, 63 % were female, 27 % had less than or equal to a high school education, one-third were limited English proficient, and mean BMI was 30 kg/m2 (SD ± 5). There were no significant differences in change in physical activity or saturated fat intake between the intervention and control group. Compared to the control group, the intervention group showed significant weight loss (-1.5 kg, p-value = 0.04) and had a greater sex-adjusted decrease in hemoglobin A1C (-0.43 %, p-value <0.01) at 6 months. Study retention was 100 %.



This pilot study suggests that a culturally-salient, community-based lifestyle intervention was feasible for engaging medically underserved South Asian immigrants and more effective at addressing ASCVD risk factors than print health education materials.
Method of invitation and geographical proximity as predictors of NHS Health Check uptake

Uptake of NHS Health Checks remains below the national target. Better understanding of predictors of uptake can inform targeting and delivery. We explored invitation method and geographical proximity as predictors of uptake in deprived urban communities.



This observational cohort study used data from all 4855 individuals invited for an NHS Health Check (September 2010-February 2014) at five general practices in Stoke-on-Trent, UK. Attendance/non-attendance was the binary outcome variable. Predictor variables included the method of invitation, general practice, demographics, deprivation and distance to Health Check location.



Mean attendance (61.6%) was above the city and national average, but varied by practice (47.5-83.3%; P < 0.001). Telephone/verbal invitations were associated with higher uptake than postal invitations (OR = 2.87, 95% CI = 2.26-3.64), yet significant practice-level variation remained. Distance to Health Check was not associated with attendance. Increasing age (OR = 1.04, 95% CI = 1.03-1.04), female gender (OR = 1.48, 95% CI = 1.30-1.68) and living in the least deprived areas (OR = 1.59, 95% CI = 1.23-2.05) were all independent positive predictors of attendance.



Using verbal or telephone invitations should be considered to improve Health Check uptake. Other differences in recruitment and delivery that might explain remaining practice-level variation in uptake warrant further exploration. Geographical proximity may not be an important predictor of uptake in urban populations.
Improving evidence-based primary care for chronic kidney disease: study protocol for a cluster randomized control trial for translating evidence into practice (TRANSLATE CKD)

Chronic kidney disease (CKD) and end stage renal disease (ESRD) are steadily increasing in prevalence in the United States. While there is reasonable evidence that specific activities can be implemented by primary care physicians (PCPs) to delay CKD progression and reduce mortality, CKD is under-recognized and undertreated in primary care offices, and PCPs are generally not familiar with treatment guidelines. The current study addresses the question of whether the facilitated TRANSLATE model compared to computer decision support (CDS) alone will lead to improved evidence-based care for CKD in primary care offices.



This protocol consists of a cluster randomized controlled trial (CRCT) followed by a process and cost analysis. Only practices providing ambulatory primary care as their principal function, located in non-hospital settings, employing at least one primary care physician, with a minimum of 2,000 patients seen in the prior year, are eligible. The intervention will occur at the cluster level and consists of providing CKD-specific CDS versus CKD-specific CDS plus practice facilitation for all elements of the TRANSLATE model. Patient-level data will be collected from each participating practice to examine adherence to guideline-concordant care, progression of CKD and all-cause mortality. Patients are considered to meet stage three CKD criteria if at least two consecutive estimated glomerular filtration rate (eGFR) measurements at least three months apart fall below 60 ml/min. The process evaluation (cluster level) will determine through qualitative methods the fidelity of the facilitated TRANSLATE program and find the challenges and enablers of the implementation process. The cost-effectiveness analysis will compare the benefit of the intervention of CDS alone against the intervention of CDS plus TRANSLATE (practice facilitation) in relationship to overall cost per quality adjusted years of life.



This study has three major innovations. First, this study adapts the TRANSLATE method, proven effective in diabetes care, to CKD. Second, we are creating a generalizable CDS specific to the Kidney Disease Outcome Quality Initiative (KDOQI) guidelines for CKD. Additionally, this study will evaluate the effects of CDS versus CDS with facilitation and answer key questions regarding the cost-effectiveness of a facilitated model for improving CKD outcomes. The study is testing virtual facilitation and Academic detailing making the findings generalizable to any area of the country.
Static magnetic field therapy for symptomatic diabetic neuropathy: a randomized, double-blind, placebo-controlled trial.

To determine if constant wearing of multipolar, static magnetic (450G) shoe insoles can reduce neuropathic pain and quality of life (QOL) scores in symptomatic diabetic peripheral neuropathy (DPN).



Randomized, placebo-control, parallel study.



Forty-eight centers in 27 states.



Three hundred seventy-five subjects with DPN stage II or III were randomly assigned to wear constantly magnetized insoles for 4 months; the placebo group wore similar, unmagnetized device.



Nerve conduction and/or quantified sensory testing were performed serially.



Daily visual analog scale scores for numbness or tingling and burning and QOL issues were tabulated over 4 months. Secondary measures included nerve conduction changes, role of placebo, and safety issues. Analysis of variance (ANOVA), analysis of covariance (ANCOVA), and chi-square analysis were performed.



There were statistically significant reductions during the third and fourth months in burning (mean change for magnet treatment, -12%; for sham, -3%; P<.05, ANCOVA), numbness and tingling (magnet, -10%; sham, +1%; P<.05, ANCOVA), and exercise-induced foot pain (magnet, -12%; sham, -4%; P<.05, ANCOVA). For a subset of patients with baseline severe pain, statistically significant reductions occurred from baseline through the fourth month in numbness and tingling (magnet, -32%; sham, -14%; P<.01, ANOVA) and foot pain (magnet, -41%; sham, -21%; P<.01, ANOVA).



Static magnetic fields can penetrate up to 20mm and appear to target the ectopic firing nociceptors in the epidermis and dermis. Analgesic benefits were achieved over time.
Arousal in patients with gastro-oesophageal reflux and sleep apnoea.

Nocturnal gastro-oesophageal reflux has been observed in patients with obstructive sleep apnoea (OSA). Negative intrathoracic pressure during apnoeas and arousal have been suggested as the underlying mechanisms. In order to evaluate this hypothesis, the coincidence and sequence in time of arousal, apnoea and reflux events were analysed. Fifteen patients with OSA or heavy snoring were studied by means of standard polysomnograpy with parallel recording of 24-h oesophageal pH. Reflux events during the day were present in all patients, five of whom had symptoms of reflux. In three of these and in five other patients, a total of 69 nocturnal reflux events were found. In 68 events, arousal was found with the reflux event. Only one reflux without arousal was found (sleep stage 2). Seventeen events occurred during wakefulness after sleep onset. The percentage of time with a pH of <4 during wakefulness after sleep onset was significantly higher than the percentage of time with a pH of <4 during total sleep time (p<0.05). In 37 of the 52 reflux events which occurred during sleep, either an apnoea or a hypopnoea was found prior to the event. The investigation of sequence in time did not prove a causal relation between respiratory events and reflux events. The results indicate that gastro-oesophageal reflux and obstructive sleep apnoea are two separate disorders, which both have a high prevalence in obese patients.
Lichen planopilaris-like eruption during treatment with tyrosine
kinase inhibitor nilotinib*

Tyrosine kinase inhibitors are effective as a target therapy for malignant neoplasms. Imatinib was the first tyrosine kinase inhibitor used. After its introduction, several other drugs have appeared with a similar mechanism of action, but less prone to causing resistance. Even though these drugs are selective, their toxicity does not exclusively target cancer cells, and skin toxicity is the most common non-hematologic adverse effect. We report an eruption similar to lichen planopilaris that developed during therapy with nilotinib, a second generation tyrosine kinase inhibitor, in a patient with chronic myeloid leukemia resistant to imatinib. In a literature review, we found only one report of non-scarring alopecia due to the use of nilotinib.
Olive oil, other dietary fats, and the risk of breast cancer (Italy)

Data from a multicenter case-control study on breast cancer conducted in Italy have been used to analyze the relationship of olive oil and other dietary fats to breast cancer risk. Cases were 2,564 women hospitalized with histologically confirmed, incident breast cancer. Controls were 2,588 women admitted to the same network of hospitals for acute, non-neoplastic, non-hormone related, on-digestive tract disorders. Cases and controls were interviewed between 1991 and 1994 using a validated food-frequency questionnaire. The data were modelled through multiple logistic regression controlling for demographic and reproductive breast-cancer risk factors, energy intake and, mutually, for types of dietary fat. For olive oil, compared with the lowest quintile, the odds ratios (OR) were 1.05, 0.99, 0.93, and 0.87 for increasing quintiles of intake; in a model postulating linear logit increase, the OR per unit (30g) was 0.89 (95 percent confidence interval [CI]=0.81–0.99, P=0.03). Among other oils or fats considered, the OR for the highest level of intake was 0.72 (CI=0.6–0.9) for a group of specific seed oils (including safflower, maize, peanut, and soya) compared with nonusers. The ORs for the highest cf lowest level of intake were 0.80 for mixed or unspecified seed oils, 0.95 for butter, and 0.96 for margarine. The study, based on a large dataset from various Italian regions, shows an inverse relationship of breast cancer risk with intake of olive oil and other vegetable oils, but not with butter or margarine.
Effect of switching hepatic enzyme-inducer antiepileptic drug to levetiracetam on bone mineral density, 25 hydroxyvitamin D, and parathyroid hormone in young adult patients with epilepsy.

We sought to determine the effect of changing phenytoin therapy on bone mineral density (BMD) and 25-hydroxyvitamin D in patients with epilepsy. Of the 90 patients, 54 patients had switched to levetiracetam, 19 patients had stopped, and 17 patients continued taking phenytoin. We proposed a 2-year period to examine 25-hydroxyvitamin D, parathyroid hormone, and BMD. The patients who switched or stopped phenytoin showed a significant increase in BMD of the lumbar spine and left femur, and in 25-hydroxyvitamin D. In contrast, those who continued phenytoin had a significant decrease in BMD at both sites and in 25-hydroxyvitamin D. Patients who were taken off phenytoin and those switching to levetiracetam did not show a significant difference in BMD, 25-hydroxyvitamin D, parathyroid, or calcium at follow-up. Compared with those who continued phenytoin, the BMD was significantly higher in patients switching to levetiracetam and those who stopped using phenytoin. Switching medications may be necessary in some cases to avoid low BMD.
Prevention of relapse using granulocyte CSF-primed PBPCs following HLA-mismatched/haploidentical, T-cell-replete hematopoietic SCT in patients with advanced-stage acute leukemia: a retrospective risk-factor analysis

The role of donor lymphocyte infusion (DLI) in the prophylaxis of relapse has not been defined. We retrospectively analyzed the data from 88 patients with advanced-stage acute leukemia after HLA-mismatched/haploidentical hematopoietic SCT (HSCT) whose treatment did (n=61) or did not (n=27) include granulocyte CSF (GCSF)-primed PBPCs infusion (GPBPCI). The two groups were compared with respect to relapse and OS. Further, a detailed analysis of risk factors was performed. The 2-year cumulative incidence of relapse in patients receiving prophylactic GPBPCI and not receiving prophylactic GPBPCI were 36% and 55% (P=0.017), respectively. Estimated survival at 3 years was 31% for patients receiving prophylactic GPBPCI and 11% for patients not receiving prophylactic GPBPCI (P=0.001). The three-year probability of leukemia-free survival was also higher in patients who received prophylactic GPBPCI (22%) compared with patients who did not (11%) (P=0.003). Multivariate analysis for relapse showed that use of prophylactic GPBPCI after transplantation was an independent prognostic factor (P=0.025). Higher OS was associated with use of prophylactic GPBPCI (P=0.002), AML (P=0.027) and female sex (P=0.023). Our results suggest that use of prophylactic GPBPCI may increase survival of patients with advanced-stage acute leukemia who receive HLA-mismatched/haploidentical HSCT.
The predictive value of asthma medications to identify individuals with asthma--a study in German general practices.

The assessment of prescribing performance by aggregated measures mainly developed from automated databases is often helpful for general practitioners. For asthma treatment, the frequently applied ratio of anti-inflammatory to bronchodilator drugs may, however, be misleading if the specificity of a drug for the treatment of asthma, compared with other diseases, is unknown.



To test the association of specific drugs with the diagnosis of asthma compared with other diagnoses.



Cross-sectional study analysing prescription data from a retrospective chart review.



Eight general practices and one community respiratory practice in a town in Northern Germany.



All patients in the participating practices who received at least one of the 50 asthma drugs most frequently prescribed in Germany within the past 12 weeks were identified. Odds ratios (ORs) with 95% confidence intervals (ClI) were calculated to reveal any association between a specific drug and the diagnosis of asthma. The unit of analysis was the item prescribed.



Topical betamimetics (e.g salbutamol, fenoterol) were the most often prescribed asthma drugs in the general practices (52.1 ) and in the respiratory practice (57.6%). Inhaled steroids accounted for 15% and 13%; systemic steroids accounted for 10% and 13%, respectively. In the general practices, inhaled betamimetics had a moderate marker function for asthma (OR = 2.0; 95% CI = 1.14-3.58). A fixed oral combination drug of clenbuterol plus ambroxol was a marker drug against asthma (OR = 0.35; 95% CI = 0.20-0.61). In the respiratory practice, the diagnosis of asthma was strongly marked by fixed combinations of cromoglycate plus betamimetics (OR = 29.0; 95% CI = 6.86-122.24) and moderately by inhaled betamimetics (OR = 2.6; 95% CI = 1.28-5.14). In contrast, systemic steroids (OR = 0.24; 95% CI 0.10-0.57) and even inhaled steroids (OR = 0.46; 95% ClI= 0.22-0.96) proved to contradict the diagnosis of asthma.



Only betamimetics were markers for asthma patients in both types of practices; inhaled steroids, however, were not. Combinations of cromoglycate were markers in the respiratory practice only. Limited specificity of drugs for a disease (e.g asthma) should be taken into account when analysing prescribing data that are not diagnosis linked.