nils-herrmann/clean_scirepeval huggingface dataset:
Experience with independent radiological review during a topotecan trial in ovarian cancer.

The results of phase II clinical trials are usually based on response of tumours to new oncolytic agents as evidenced by radiological imaging techniques. In this trial, all claimed responders were reviewed at a specially convened meeting by the peer group of study investigators and a radiologist, independent of the study institutions.



One hundred eleven patients with advanced epithelial ovarian cancer who had previously been treated with a platinum based regimen and had subsequently relapsed and who had measurable disease were treated with topotecan at a dose of 1.5 mg/m2/day i.v. on five consecutive days repeated every 21 days to assess efficacy and tolerability. Ninety-three were considered eligible for the study per protocol and lesions were assessed by either computerised tomography (CT) or ultrasound (US). At the meeting, scans from all 24 (25.8%) claimed responders were reviewed, lesions remeasured by the radiologist and a group discussion led to a final response classification.



Ninety-two patients were found to be eligible for the study and 14 (15.2%) were confirmed as responders. Ten were rejected as responders, mainly because the lesion did not decrease in size by < or = 50%, but one patient failed to meet the entry criteria. Remeasurement of CT scans was more objective than US scans. Difficulties were encountered during review of some CT scan sequences because of non-uniform imaging parameters.



Independent radiological review in conjunction with the peer review group in this trial enabled rigorous and consistent application of response criteria. This decreased the response rate from 25.8% to 15.2%, but this represents a more objective assessment. CT scanning is an objective technique for assessing response rates in phase II studies whereas US is subjective and dose not necessarily allow accurate lesion assessment on subsequent examinations, nor allows independent review at a later date. For these reasons it should not be used in such studies for accurate lesion assessment. Cross-sectional imaging techniques such as CT and magnetic resonance imaging (MRI) do allow accurate lesion assessment and independent review at a later date, but standard protocols need to be instituted, to allow consistency and a comparison to be made with subsequent studies using the same agent and a broad comparison to be made with other agents.
Electronic alerts versus on-demand decision support to improve dyslipidemia treatment: a cluster randomized controlled trial.

Indirect evidence shows that alerting users with clinical decision support systems seems to change behavior more than requiring users to actively initiate the system. However, randomized trials comparing these methods in a clinical setting are lacking. We studied the effect of both alerting and on-demand decision support with respect to screening and treatment of dyslipidemia based on the guidelines of the Dutch College of General Practitioners.



In a clustered randomized trial design, 38 Dutch general practices (77 physicians) and 87,886 of their patients (39,433 men 18 to 70 years of age and 48,453 women 18 to 75 years of age) who used the ELIAS electronic health record participated. Each practice was assigned to receive alerts, on-demand support, or no intervention. We measured the percentage of patients screened and treated after 12 months of follow-up. In the alerting group, 65% of the patients requiring screening were screened (relative risk versus control=1.76; 95% confidence interval, 1.41 to 2.20) compared with 35% of patients in the on-demand group (relative risk versus control=1.28; 95% confidence interval, 0.98 to 1.68) and 25% of patients in the control group. In the alerting group, 66% of patients requiring treatment were treated (relative risk versus control=1.40; 95% confidence interval, 1.15 to 1.70) compared with 40% of patients (relative risk versus control=1.19; 95% confidence interval, 0.94 to 1.50) in the on-demand group and 36% of patients in the control group.



The alerting version of the clinical decision support systems significantly improved screening and treatment performance for dyslipidemia by general practitioners.
Prostate cancer detection by prostate-specific antigen-related parameters.

Total serum prostate-specific antigen (PSA) levels, free-to-total PSA ratio (F/T ratio) and PSA density (PSAD) were compared to clarify the clinical significance of these parameters in the diagnosis of prostate cancer (CaP) with intermediate PSA concentrations (4-10 ng/ml). PSAD and F/T ratio were obtained during the period from May 1999 to April 2001 from 43 patients with serum PSA concentrations of 4-10 ng/ml who underwent ultrasound-guided systematic sextant biopsies. PSAD was compared with total serum PSA and F/T ratio via receiver operating characteristic (ROC) curves for diagnosis of CaP. Diagnosis of CaP and non-CaP was made in 12 (27.9%) and 31 (72.1%) of the 43 patients, respectively. Mean serum PSA, PSA density and F/T ratio were 7.308 +/- 0.636 ng/ml, 0.271 +/- 0.039 ng/ml/cm3 and 16.225 +/- 4.911% in patients with CaP and 6.300 +/- 0.289 ng/ml, 0.178 +/- 0.020 ng/ml/cm3 and 15.213 +/- 0.980% in those with non-CaP, respectively. The ROC curve analysis demonstrated that PSAD predicted the biopsy outcome significantly better than F/T ratio and total PSA in all 43 patients (p < 0.05). In distinguishing CaP patients, the cutoff value of 0.16 ng/ml/cm3 for PSAD yielded a specificity level of 71.0% at a sensitivity level of 83.3%. Our study revealed that PSAD is a significant predictor in distinguishing CaP from non-CaP in Japanese men.
Non-prescription treatment of NSAID induced GORD by Australian pharmacies: a national simulated patient study

Patients regularly present to community pharmacies for advice about and treatment for reflux symptoms and NSAIDs are a common cause of these symptoms. There is no published literature detailing the approach that pharmacies take to these enquiries, the pharmacotherapy they recommend or whether they contribute to the safe and effective use of reflux medicines.  To assess in an observational study design the clinical history gathering, recommendations for GORD management and counselling provided by community pharmacies in a simulated patient scenario involving suspected NSAID induced reflux symptoms.  Australian community pharmacies.  Simulated patients visited 223 community pharmacies to request treatment for reflux symptoms. The interaction was audiotaped and assessed against guidelines for the treatment of reflux symptoms. Main outcome measures Alignment of community pharmacies with international expert gastroenterologist guidance and national professional practice guidelines for the treatment of reflux symptoms by pharmacists including: consultation with a pharmacist; confirmation of reflux diagnosis based on symptoms; recommendation of short courses proton pump inhibitor (PPI) therapy; advice on the safe and effective use of reflux medicines and referral to a doctor for further assessment.  Pharmacists consulted with the simulated patient in 77 % of cases. Symptoms were enquired about in 95 % of cases and a medicines history taken in 69 % of cases. Recommendations for treatment included: PPIs (18 %), histamine H2 antagonists (57 %) and antacids (19 %). Advice on product use was given in 83 % of cases. Referral to a doctor to discuss reflux symptoms was made in 63 % of cases.  When assessing patients for the symptoms of GORD, Australian pharmacists and non-pharmacist support staff take a comprehensive history including symptomatology, duration of symptoms, concomitant medicines and medical conditions and any GORD treatments previously trialled. They provide comprehensive counselling on the use of antisecretory and antacid medicines. Counselling could involve more comprehensive information on lifestyle approaches for GORD management and side effects of antisecretory and antacid medicines. Further alignment with guidelines for the management of GORD would result in greater referral to a doctor for assessment of recurrent GORD and greater recommendation of PPIs for symptoms. However alignment with guidelines by all pharmacists is unrealistic if the guidelines are not universally available to them.
Evaluation of left ventricular functions in patients with pseudoexfoliation syndrome using tissue Doppler echocardiography and its association with plasma BNP levels.

Pseudoexfoliation syndrome (PES) is a systemic disorder that involves various visceral organs. In this observational cross-sectional study we aimed to investigate the left ventricular functions in patients with PES by using tissue Doppler imaging and correlations between B-type natriuretic peptide (BNP) levels and cardiac functions.



The study enrolled 22 patients with PES (9 male, 41%), aged 57.0 ± 8.8 years, and 23 control subjects (9 male, 39%), aged 52.8 ± 4.9 years. Patients with any cardiovascular disease were excluded. Fasting blood samples were taken and tissue Doppler imaging was performed at the mitral annulus with echocardiographic examination. The independent t and Mann-Whitney U tests were used.



The Em velocities at the basal septum and lateral annulus were significantly lower in patients with PES showing decreased diastolic functions (7.6 ± 2.0 versus 9.1 ± 1.6 cm/s, p=0.01 and 9.3 ± 3.5 versus 11.5 ± 3.1 cm/s, p=0.04 respectively). While global left ventricular systolic function assessed by ejection fraction was not significantly different between patients with PES and controls, the septum S-wave velocities of PES patients were lower (7.6 ± 1.3 versus 8.5 ± 1.2 cm/s, p=0.03). Total plasma BNP levels were significantly higher in PES patients (129.04 ± 99.38 pg/mL versus 59.64 ± 53.69 pg/mL; p=0.005) and there was a negative correlation between plasma BNP concentration and mitral annulus average Em velocities (r=-0.554, p=0.009). E/Em ratio was also significantly higher in PES patients (7.85 ± 2.01 versus 6.64 ± 1.48, p=0.03).



In this study we showed decreased left ventricular diastolic functions correlated with plasma BNP levels in PES patients. Although further studies needed, evaluation and follow-up of PES patients in terms of left ventricular functions will be useful.
Relation of Obesity to Survival After In-Hospital Cardiac Arrest.

Previous studies have shown that obesity is paradoxically associated with improved outcomes in many cardiovascular (CV) disease states; however, whether obesity affects survival after in-hospital cardiac arrest (IHCA) has not been well examined. We queried the 2003 to 2011 Nationwide Inpatient Sample databases to identify all patients aged ≥18 years who underwent cardiopulmonary resuscitation for IHCA. Obese patients were identified using the co-morbidity variable for obesity, as defined in Nationwide Inpatient Sample databases. Survival to hospital discharge was compared between obese and nonobese patients using multivariate regression models. Of 836,289 patients with IHCA, 67,216 (8.0%) were obese. Obese patients were younger and more likely to be women compared with nonobese patients. Despite being younger, obese patients had significantly higher prevalence of most CV co-morbidities such as dyslipidemia, coronary artery disease, previous myocardial infarction, heart failure, diabetes mellitus, hypertension, peripheral vascular disease, and chronic renal failure (p <0.001 for all). Obese patients were more likely to have ventricular tachycardia or ventricular fibrillation as the initial cardiac arrest rhythm (22.3% vs 20.9%; p <0.001). After multivariate risk adjustment, obese patients had improved survival to hospital discharge compared with nonobese patients (31.4% vs 24.1%; unadjusted odds ratio 1.44, 95% CI 1.42 to 1.47, p <0.001; adjusted odds ratio 1.15, 95% CI 1.13 to 1.17, p <0.001). Similar results were seen in patients with CV or non-CV conditions as the primary diagnosis and in those with ventricular tachycardia/ventricular fibrillation or pulseless electrical activity/asystole as the cardiac arrest rhythm. In conclusion, this large retrospective analysis of a nationwide cohort of patients with IHCA demonstrated higher risk-adjusted odds of survival in obese patients, consistent with an "obesity paradox."
Subjective and functional results after total gastrectomy: prospective study for longterm comparison of reconstruction procedures

Many reconstruction procedures have been developed in efforts to resolve patients' complaints after total gastrectomy. However, there have been few reports of longterm comparisons between reconstruction procedures, especially with regard to the prevention of duodenal food passage. This study was undertaken to compare the longterm subjective and functional results among Roux-en-Y esophagojejunostomy (R-Y), R-Y with pouch (P-Y), and jejunal interposition with pouch (P-I) after total gastrectomy.  Consecutive patients requiring curative total gastrectomy were enrolled in this prospective study by the envelope method.  Hospital stay was longer following a P-I than an R-Y or a P-Y. Over 50% of R-Y patients complained of heartburn, and 20% of R-Y patients showed dumping syndrome throughout the postoperative period, with this rate being significantly different from rates in the other two groups. P-Y patients complained of early satiety in the late postoperative period, while P-I patients complained of early satiety in the early postoperative period. The nutritional index in P-I patients was higher than those in patients with the other two procedures. Gastrointestinal and hepatobiliary dual scintigraphy (GHDS) showed that the rate of bile reflux with an R-Y was relatively high after surgery. Food reflux with a P-Y was increased (9.4% to 11.1%), but with a P-I food reflux was decreased at 3 years after surgery (13.3% to 9.9%). Patients with a P-Y had a faster recovery of body, weight in the early postoperative period; however, at 5 years after operation, body weight recovery with a P-I was greatest.  Reconstruction should be performed with pouch formation after total gastrectomy with curative intent.
Trajectories of Risk for Early Sexual Activity and Early Substance Use in the Fast Track Prevention Program

Children who exhibit early-starting conduct problems are more likely than their peers to initiate sexual activity and substance use at an early age, experience pregnancy, and contract a sexually-transmitted disease [STD], placing them at risk for HIV/AIDS. Hence, understanding the development of multi-problem profiles among youth with early-starting conduct problems may benefit the design of prevention programs. In this study, 1,199 kindergarten children (51 % African American; 47 % European American; 69 % boys) over-sampled for high rates of aggressive-disruptive behavior problems were followed through age 18. Latent class analyses (LCA) were used to define developmental profiles associated with the timing of initiation of sexual activity, tobacco and alcohol/drug use and indicators of risky adolescent sex (e.g. pregnancy and STD). Half of the high-risk children were randomized to a multi-component preventive intervention (Fast Track). The intervention did not significantly reduce membership in the classes characterized by risky sex practices. However, additional analyses examined predictors of poor outcomes, which may inform future prevention efforts.
Gene expression microarray-based assay to determine tumor site of origin in a series of metastatic tumors to the ovary and peritoneal carcinomatosis of suspected gynecologic origin.

The origin of the primary tumor is sometimes difficult to determine in peritoneal and ovarian metastases. A series of 25 metastatic tumors to the ovary and 7 cases of peritoneal carcinomatosis of suspected gynecologic origin were collected. Total RNA was extracted from frozen tumor tissue and studied by the Tissue of Origin-Frozen test, a microarray-based gene expression test from Pathwork Diagnostics (Redwood City, CA). Independently, formalin-fixed, paraffin-embedded tumor tissue was subjected to pathologic analysis. Immunohistochemical stains included keratins 7 and 20, estrogen and progesterone receptors, CDX2, villin, CEA, WT-1, TTF-1, mammoglobin, GCDF-15, and CD31. Clinical data were considered as gold standard, and after clinicopathologic evaluation, the tissue of origin was found in 29 cases. The Tissue of Origin-Frozen test correctly identified the ovary as site of origin in 7 of 7 peritoneal carcinomatosis cases, whereas immunohistochemical stains only allowed appropriate recognition in 5. In addition, the Tissue of Origin-Frozen test identified correctly the site of origin in 18 of the 22 metastatic tumors to the ovary with known origin. In the remaining 4 tumors, the correct origin was the second option in 2 cases and was not determined in the other 2. Immunohistochemistry correctly identified the site of origin in 17 of these 22 ovarian metastases. A combination of Tissue of Origin-Frozen and immunohistochemistry correctly identified the site of origin in 19 of 22 ovarian metastases of known origin. Although conventional pathologic examination and immunohistochemistry are commonly used for assessing the tumor site of origin, Tissue of Origin testing can be useful in difficult cases.
Prognostic influence of tumor-infiltrating mast cells in patients with follicular lymphoma treated with rituximab and CHOP.

Gene expression profiling and immunohistochemical studies have demonstrated that nonmalignant tumor infiltrating inflammatory cells contribute to clinical outcome in patients with follicular lymphoma (FL). Particularly, tumor-associated macrophage (TAM) content correlates with longer survival rates after immunochemotherapy. Here we investigated the prognostic importance of tumor-associated mast cells (MCs) and their relation to TAMs in patients with FL treated with a combination of rituximab (R) and cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy. Of the 98 patients, 70 received R-CHOP at diagnosis and 28 at relapse. According to Kaplan-Meier estimates, the patients with high MC content had a worse 4-year progression-free survival (PFS) than the ones with low MC content after R-CHOP therapy (34% vs 74%, P = .002). The adverse prognostic value of MCs was seen both for the patients treated at diagnosis and at relapse, whereas no such impact on PFS was observed for the control patients treated with chemotherapy only (P = .4). When the TAM-related PFS was analyzed separately in patients with high and low MC contents, the positive prognostic effect of TAM was seen only in patients with few MCs. Taken together, the data demonstrate that a high MC score is associated with unfavorable prognosis and it eliminates the positive prognostic value of TAMs in patients with FL treated with immunochemotherapy.
Delta-9-tetrahydrocannabinol may palliate altered chemosensory perception in cancer patients: results of a randomized, double-blind, placebo-controlled pilot trial.

A pilot study (NCT00316563) to determine if delta-9-tetrahydrocannabinol (THC) can improve taste and smell (chemosensory) perception as well as appetite, caloric intake, and quality of life (QOL) for cancer patients with chemosensory alterations.



Adult advanced cancer patients, with poor appetite and chemosensory alterations, were recruited from two sites and randomized in a double-blinded manner to receive either THC (2.5 mg, Marinol(®); Solvay Pharma Inc., n = 24) or placebo oral capsules (n = 22) twice daily for 18 days. Twenty-one patients completed the trial. At baseline and posttreatment, patients completed a panel of patient-reported outcomes: Taste and Smell Survey, 3-day food record, appetite and macronutrient preference assessments, QOL questionnaire, and an interview.



THC and placebo groups were comparable at baseline. Compared with placebo, THC-treated patients reported improved (P = 0.026) and enhanced (P < 0.001) chemosensory perception and food 'tasted better' (P = 0.04). Premeal appetite (P = 0.05) and proportion of calories consumed as protein increased compared with placebo (P = 0.008). THC-treated patients reported increased quality of sleep (P = 0.025) and relaxation (P = 0.045). QOL scores and total caloric intake were improved in both THC and placebo groups.



THC may be useful in the palliation of chemosensory alterations and to improve food enjoyment for cancer patients.
Antihypertensive effect of Nigella sativa seed extract in patients with mild hypertension.

Hypertension (HT) is a lifestyle-related disease and dietary modifications are effective for its management and prevention. We conducted a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of treatment with an oral Nigella sativa (NS) seed extract supplement in patients with mild HT. Subjects were randomized into three groups: a placebo and two test groups that received 100 and 200 mg of NS extract twice a day. After 8 weeks, systolic blood pressure (SBP) values in both case groups were found to be significantly reduced when compared with the baseline values for each group. In addition, the decrease in SBP in the two case groups was statistically significant relative to the placebo group (P < 0.05-0.01). Meanwhile, diastolic blood pressure (DBP) values in the case groups were found to be significantly reduced from the baseline and a significant reduction was also observed in these groups (P < 0.01) when compared with the placebo group. In addition, extract administration reduced both SBP and DBP in a dose-dependent manner. Meanwhile, NS extract caused a significant decline in the level of total and low-density-lipoprotein (LDL)-cholesterol relative to baseline data. No complications caused by NS were observed. The results suggest that the daily use of NS seed extract for 2 months may have a blood pressure-lowering effect in patients with mild HT.
Immediate unprepared hydroflush colonoscopy for severe lower GI bleeding: a feasibility study.

Urgent colonoscopy is not always the preferred initial intervention in severe lower GI bleeding because of the need for a large volume of oral bowel preparation, the time required for administering the preparation, and concern regarding adequate visualization.



To evaluate the feasibility, safety, and outcomes of immediate unprepared hydroflush colonoscopy for severe lower GI bleeding.



Prospective feasibility study of immediate colonoscopy after tap-water enema without oral bowel preparation, aided by water-jet pumps and mechanical suction devices in patients admitted to the intensive care unit with a primary diagnosis of severe lower GI bleeding.



Tertiary referral center.



Primary outcome measurement was the percentage of colonoscopies in which the preparation permitted satisfactory evaluation of the entire length of the colon suspected to contain the source of bleeding. Secondary outcome measurements were visualization of a definite source of bleeding, length of hospital and intensive care unit (ICU) stays, rebleeding rates, and transfusion requirements.



Thirteen procedures were performed in 12 patients. Complete colonoscopy to the cecum was performed in 9 of 13 patients (69.2%). However, endoscopic visualization was thought to be adequate for definitive or presumptive identification of the source of bleeding in all procedures, with no colonoscopy repeated because of inadequate preparation. A definite source of bleeding was identified in 5 of 13 procedures (38.5%). The median length of ICU stay was 1.5 days; of hospital stay, 4.3 days. Recurrent bleeding during the same hospitalization, requiring repeated endoscopy, surgery, or angiotherapy, was seen in 3 of 12 patients (25%).



Uncontrolled feasibility study of selected patients.



Immediate unprepared hydroflush colonoscopy in patients with severe lower GI bleeding is feasible with the hydroflush technique.