nils-herrmann/clean_scirepeval huggingface dataset:
Effect of Nigella sativa seeds on the glycemic control of patients with type 2 diabetes mellitus.

Diabetes mellitus is a common chronic disease affecting millions of people world wide. Standard treatment is failing to achieve required correction of blood glucose in many patients. Therefore, there is a need for investigating potential hypoglycemic drugs or herbs to improve glycemic control in diabetic patients. Nigella sativa seeds were used as an adjuvant therapy in patients with diabetes mellitus type 2 added to their anti-diabetic medications. A total of 94 patient were recruited and divided randomly into three dose groups. Capsules containing Nigella sativa were administered orally in a dose of 1, 2 and 3 gm/day for three months. The effect of Nigella sativa on the glycemic control was assessed through measurement of fasting blood glucose (FBG), blood glucose level 2 hours postprandially (2 hPG), and glycosylated hemoglobin (HbA1c). Serum C-peptide and changes in body weight were also measured. Insulin resistance and beta-cell function were calculated usin the homeostatic model assessment (HOMA2). Nigella sativa at a dose of 2 gm/day caused significant reductions in FBG, 2hPG, and HbA1 without significant change in body weight. Fasting blood glucose was reduced by an average of 45, 62 and 56 mg/dl at 4, 8 and 12 weeks respectively. HbAlC was reduced by 1.52% at the end of the 12 weeks of treatment (P<0.0001). Insulin resistance calculated by HOMA2 was reduced significantly (P<0.01), while B-cell function was increased (P<0.02) at 12 weeks of treatment. The use of Nigella sativa in a dose of 1 gm/day also showed trends in improvement in all the measured parameters but it was not statistically significant from the baseline. However, no further increment in the beneficial response was observed with the 3 gm/day dose. The three doses of Nigella sativa used in the study did not adversely affect either renal functions or hepatic functions of the diabetic patients throughout the study period.



the results of this study indicate that a dose of 2 gm/ day of Nigella sativa might be a beneficial adjuvant to oral hypoglycemic agents in type 2 diabetic patients.
Phase II multicentre randomised study of docetaxel plus epirubicin vs 5-fluorouracil plus epirubicin and cyclophosphamide in metastatic breast cancer

The purpose of the study was to evaluate the efficacy and safety of docetaxel plus epirubicin (ET) and of 5-fluorouracil plus epirubicin and cyclophosphamide (FEC) as first-line chemotherapy for metastatic breast cancer. A total of 142 patients (intent-to-treat (ITT)) with at least one measurable lesion were randomised to receive docetaxel 75 mg m−2 plus epirubicin 75 mg m−2 or 5-fluorouracil 500 mg m−2 plus epirubicin 75 mg m−2 and cyclophosphamide 500 mg m−2 intravenously once every 3 weeks for up to eight cycles. Prophylactic granulocyte-colony-stimulating factor was only permitted after the first cycle, if required. Per-protocol analysis (n=132) gave an overall response rate for ET of 63.1% (95% confidence interval (CI), 50–78%) and for FEC 34.3% (95% CI, 23–47%) after a median seven and six cycles, respectively. Intent-to-treat population (n=142) gave an overall response rate for ET of 59% (95% CI, 47–70%) and for FEC 32% (95% CI, 21–43%) after a median seven and six cycles, respectively. The median response duration for ET was 8.6 months (95% CI, 7.2–9.6 months) and for FEC 7.8 months (95% CI, 6.5–10.4 months). The median time to progression (ITT) for ET was 7.8 months (95% CI, 5.8–9.6 months) and for FEC 5.9 months (95% CI, 4.6–7.8 months). After a median follow-up of 23.8 months, median survival (ITT) for ET and FEC were 34 and 28 months, respectively. Nonhaematologic grade 3–4 toxicities were infrequent in both arms. Haematologic toxicity was more common with ET and febrile neutropenia was reported in 13 patients (18.6%) in the ET group. Two deaths in the ET group were possibly related to study treatment. In conclusion, both ET and FEC were associated with acceptable toxicity. ET is a highly active first-line therapy for metastatic breast cancer.
Rationale of the BREAst cancer e-healTH [BREATH] multicentre randomised controlled trial: An Internet-based self-management intervention to foster adjustment after curative breast cancer by decreasing distress and increasing empowerment

After completion of curative breast cancer treatment, patients go through a transition from patient to survivor. During this re-entry phase, patients are faced with a broad range of re-entry topics, concerning physical and emotional recovery, returning to work and fear of recurrence. Standard and easy-accessible care to facilitate this transition is lacking. In order to facilitate adjustment for all breast cancer patients after primary treatment, the BREATH intervention is aimed at 1) decreasing psychological distress, and 2) increasing empowerment, defined as patients’ intra- and interpersonal strengths. The non-guided Internet-based self-management intervention is based on cognitive behavioural therapy techniques and covers four phases of recovery after breast cancer (Looking back; Emotional processing; Strengthening; Looking ahead). Each phase of the fully automated intervention has a fixed structure that targets consecutively psychoeducation, problems in everyday life, social environment, and empowerment. Working ingredients include Information (25 scripts), Assignment (48 tasks), Assessment (10 tests) and Video (39 clips extracted from recorded interviews). A non-blinded, multicentre randomised controlled, parallel-group, superiority trial will be conducted to evaluate the effectiveness of the BREATH intervention. In six hospitals in the Netherlands, a consecutive sample of 170 will be recruited of women who completed primary curative treatment for breast cancer within 4 months. Participants will be randomly allocated to receive either usual care or usual care plus access to the online BREATH intervention (1:1). Changes in self-report questionnaires from baseline to 4 (post-intervention), 6 and 10 months will be measured. The BREATH intervention provides a psychological self-management approach to the disease management of breast cancer survivors. Innovative is the use of patients’ own strengths as an explicit intervention target, which is hypothesized to serve as a buffer to prevent psychological distress in long-term survivorship. In case of proven (cost) effectiveness, the BREATH intervention can serve as a low-cost and easy-accessible intervention to facilitate emotional, physical and social recovery of all breast cancer survivors.
A phase II study of neoadjuvant bevacizumab plus capecitabine and concomitant radiotherapy in patients with locally advanced rectal cancer

To assess safety and activity of neoadjuvant bevacizumab, capecitabine and standard radiotherapy in locally advanced rectal cancer as well as potential predictive biomarkers. The multicentric phase II study enrolled 43 patients who received bevacizumab infusion (5 mg/kg) every 2 weeks for 4 cycles; oral capecitabine at 825 mg/m2 twice a day for 5.5 weeks with external–beam irradiation (50.4 Gy in 28 fractions over 5.5 weeks). We determined certain biomarkers before and after therapy for correlation with response. Post-operative histologic examination revealed no residual cancer cells in 6 of the 43 patients (14%; 95% confidence limits 3.60–24.31%). In another 22 patients (51.2%) a varying percentage of cancer cells in residual areas of fibrosis/ necrosis was found, corresponding to Mandard TRG 2 or 3 classification. Tumor resection with negative circumferential margin was achieved in 38/40 (95%) operated patients. Sphincter–sparing surgery was obtained in 31 (72.1%) patients. Primary tumor and lymph nodes downstaging was observed in 15 (34.9%) and 16 (37.2%) cases, respectively. Neoadjuvant therapy was safe and well tolerated. The most frequent side effects were G1-2 diarrhea, proctitis, rectal bleeding and hypertension. No biomarker tested was significantly predictive of both pathological complete response and disease-free survival. Pre-treatment CD-34 vessel density, post-treatment Ki-67 labeling index and VEGFR-2 cancer cells expression significantly correlated with residual tumor area. The schedule of neoadjuvant therapy tested was safe and active. Pre-treatment vessel density by the panendothelial marker anti CD-34 antibody, post-treatment Ki-67 labeling index and VEGFR-2 expression were significantly associated to residual tumor area. The biomarkers correlations warrant further evaluation in prospective clinical trials.
Slow release theophylline in preschool asthmatics.

A double blind crossover trial with active or placebo slow release theophylline (Slo-phyllin) in children with asthma aged up to 4 years is described. Although no difference in symptom scores was shown, other differences in favour of active treatment were noted. We conclude that this preparation is of benefit in the management of the wheezing preschool child. The value of symptom scores as an index of clinical improvement is discussed.
Navigation-guided Ommaya reservoir placement: implications for the treatment of leptomeningeal metastases.

Ommaya reservoirs are commonly used in the diagnosis and management of leptomeningeal metastases (LM) from malignant tumors. The present study investigates the utility of an intraoperative navigation-guided technique for Ommaya reservoir placement. Between March 2004 and December 2005, 85 navigation-guided Ommaya reservoir placements were performed in 77 patients with intracranial malignancies at the Komagome Metropolitan Hospital. Anterior horn puncture and posterior horn puncture were used for 59 and 26 procedures, respectively. A slit ventricle was present in 6 cases. All procedures were performed under assistance from the Medtronic STEALTH STATION TRIA navigation system. Computed tomographic (CT) scans were routinely obtained just after completion of the procedure. Patients diagnosed with LM received subsequent treatment. An Ommaya catheter was applied to the ventricular puncture needle registered in the navigation system and was inserted into the lateral ventricle. Using the real-time "Guidance View", the surgeon was able to verify the catheter position continuously during the procedure. Postoperative CT scan revealed an appropriate catheter position in all except for one case. Complications (catheter malposition) occurred in only one case (complication rate, 1.2%). None of the patients experienced hemorrhage or infection. In conclusion, navigation-guided Ommaya reservoir placement was associated with a very low incidence of complications. This method appears to be safe and effective when employed in patients with intracranial malignancy.
The in vivo cell kinetics in breast carcinogenesis

CD95 ligand expression has been observed in various malignancies. Studying the CD95 ligand (CD95L) and receptor (CD95) system in eight non-malignant mammary tissues and 40 breast cancer tissues, mRNA and protein expression was determined by quantitative reverse transcriptase-polymerase chain reaction (RT-PCR) and immunofluorescence. mRNA levels of CD95L correlated positively (r=0.90; p< 0.01) and transmembrane CD95 inversely (r=-0.88; p< 0.01) with histopathological grading of the breast tumours: CD95L mRNA levels were low in adenomas, but increased by 20-fold in grade I, 120-fold in grade II, and 310-fold in grade III breast cancer. In contrast, CD95 mRNA levels were low in high-grade carcinomas, but high in benign mammary tissues. Since CD95L acts as an efficient inducer of apoptosis in CD95(+) cells, apoptotic cells were identified on the tissue sections. Tumour-infiltrating lymphocytes and stromal cells in close proximity to CD95L-expressing breast cancer underwent apoptosis. As a functional test, CD95(+) target cells were cultured on breast cancer tissue sections. The target cells underwent apoptosis when cultured on breast cancer sections, but could be rescued when CD95L was specifically blocked by a CD95-Fc fusion molecule. The data suggest an inverse regulation of CD95 ligand and receptor expression during dedifferentiation of breast cancer. Killing of bystander cells by the CD95L-expressing breast tumour could be involved in tissue invasion.
Effect of a nutrition education programme on clinical status and dietary behaviours of adults with type 2 diabetes in a resource-limited setting in South Africa: a randomised controlled trial.

To evaluate the effect of a participant-customised nutrition education programme on glycated Hb (HbA(1c)), blood lipids, blood pressure, BMI and dietary behaviours in patients with type 2 diabetes mellitus.



A randomised controlled trial. The control group (n 41) received education materials. The intervention group (n 41) received the same education materials and participated in eight weekly (2-2·5 h) group nutrition education sessions and follow-up sessions. Outcomes were assessed at 6 and 12 months. An intention-to-treat analysis was conducted. ANCOVA compared the groups (adjustments for baseline values, age, sex and clinic).



Two community health centres, Moretele sub-district (North West Province), South Africa.



Adults (aged 40-70 years) with type 2 diabetes, HbA(1c) ≥8 %.



Differences in HbA(1c) (primary outcome) were -0·64 % (P=0·15) at 6 months and -0·63 % (P=0·16) at 12 months in favour of the intervention group. Starchy-food intake was significantly lower in the intervention group, 9·3 v. 10·8 servings/d (P=0·005) at 6 months and 9·9 v. 11·9 servings/d (P=0·017) at 12 months. Median energy intake was significantly lower in the intervention group at 12 months (5988 v. 6946 kJ/d, P=0·017). No significant group differences in BMI, lipid profile, blood pressure and intakes of macronutrients, vegetables and fruits were observed.



Nutrition education was not efficacious on HbA(1c); however, it improved specific dietary behaviours. Group education and hands-on activities appeared to contribute to the improvement. Optimal goal setting and self-efficacy training/assessment could benefit future nutrition education programmes for people with type 2 diabetes mellitus in resource-limited settings.
Response to letter regarding article, "postprocedural aortic regurgitation in balloon-expandable and self-expandable transcatheter aortic valve replacement procedures: analysis of predictors and impact on long-term mortality: insights from the FRANCE2 registry".

T ranscatheter aortic valve replacement (TAVR) is a technique to treat patients with symptomatic aortic steno-sis and contraindications or at high risk for conventional surgical valve replacement. 1 Two revalving devices based on different technical concepts, self-expandable (SE) or balloon-expandable (BE), have been developed and are currently available. Significant postprocedural aortic regurgitation (AR) is observed in 10% to 20% of cases after transcatheter aortic valve replacement (TAVR). The prognostic value and the predictors of such a complication in balloon-expandable (BE) and self-expandable (SE) TAVR remain unclear. TAVR was performed in 3195 consecutive patients at 34 hospitals. Postprocedural transthoracic echocardiography was performed in 2769 (92%) patients of the eligible population, and these patients constituted the study group. Median follow-up was 306 days (Q1–Q3=178–490). BE and SE devices were implanted in 67.6% (n=1872) and 32.4% (n=897). Delivery was femoral (75.3%) or nonfemoral (24.7%). A postprocedural AR≥grade 2 was observed in 15.8% and was more frequent in SE (21.5%) than in BE-TAVR (13.0%, P=0.0001). Extensive multivariable analysis confirmed that the use of a SE device was one of the most powerful independent predictors of postprocedural AR≥grade 2. For BE-TAVR, 8 independent predictors of postprocedural AR≥grade 2 were identified including femoral delivery (P=0.04), larger aortic annulus (P=0.0004), and smaller prosthesis diameter (P=0.0001). For SE-TAVR, 2 independent predictors were identified including femoral delivery(P=0.0001). Aortic annulus and prosthesis diameter were not predictors of postprocedural AR for SE-TAVR. A postprocedural AR≥grade 2, but not a postprocedural AR=grade 1, was a strong independent predictor of 1-year mortality for BE (hazard ratio=2.50; P=0.0001) and SE-TAVR (hazard ratio=2.11; P=0.0001). Although postprocedural AR≥grade 2 was well tolerated in patients with AR≥grade 2 at baseline (1-year mortality=7%), it was associated with a very high mortality in other subgroups: renal failure (43%), AR<grade 2 at baseline (31%), low transaortic gradient (35%), or nonfemoral delivery (45%). Postprocedural AR≥grade 2 was observed in 15.8% of successful TAVR and was the strongest independent predictor of 1-year mortality. The use of the SE device was a powerful independent predictor of postprocedural AR≥grade 2.
Preserved b-Cell Function in Type 1 Diabetes by Mesenchymal Stromal Cells

The retention of endogenous insulin secretion in type 1 diabetes is an attractive clinical goal, which opens possibilities for long-term restoration of glucose metabolism. Mesenchymal stromal cells (MSCs) constitute, based on animal studies, a promising interventional strategy for the disease. This prospective clinical study describes the translation of this cellular intervention strategy to patients with recent-onset type 1 diabetes. Twenty adult patients with newly diagnosed type 1 diabetes were enrolled and randomized to MSC treatment or to the control group. Residual b-cell function was analyzed as C-peptide concentrations in blood in response to a mixed-meal tolerance test (MMTT) at 1-year follow-up. In contrast to the patients in the control arm, who showed loss in both C-peptide peak values and C-peptide when calculated as area under the curve during the 1st year, these responses were preserved or even increased in the MSC-treated patients. Importantly, no side effects of MSC treatment were observed. We conclude that autologous MSC treatment in new-onset type 1 diabetes constitutes a safe and promising strategy to intervene in disease progression and preserve b-cell function.
Salivary phosphate-binding chewing gum reduces hyperphosphatemia in dialysis patients.

In uremic patients, hyperphosphatemia is associated with cardiovascular calcification and increased cardiovascular mortality. Despite the use of phosphate binders, only half of hemodialysis (HD) patients achieve recommended serum phosphate levels. A hyperphosphoric salivary content, which correlates linearly with serum phosphate, has been reported in HD patients. We hypothesized that binding salivary phosphate during periods of fasting in addition to using phosphate binders with meals could improve the treatment of hyperphosphatemia. We assessed the phosphate-binding capacity of the natural polymer chitosan by (31)P nuclear magnetic resonance and established that 10 and 20% (wt/vol) middle viscosity chitosan solutions bind 30 and 50% of the phosphate contained in PBS, respectively. Thirteen HD patients with serum phosphate levels >6.0 mg/dl despite treatment with sevelamer hydrochloride chewed 20 mg of chitosan-loaded chewing gum twice daily for 2 wk at fast in addition to their prescribed phosphate-binding regimen. Salivary phosphate and serum phosphate significantly decreased during the first week of chewing; by the end of 2 wk, salivary phosphate decreased 55% from baseline (73.21 +/- 19.19 to 33.19 +/- 6.53; P < 0.00001), and serum phosphate decreased 31% from baseline (7.60 +/- 0.91 to 5.25 +/- 0.89 mg/dl; P < 0.00001). Salivary phosphate returned to baseline by day 15 after discontinuing the chewing gum, whereas serum phosphate levels took 30 d to return to baseline. Parathyroid hormone and serum calcium concentrations were not affected by the gum. In conclusion, adding salivary phosphate binding to traditional phosphate binders could be a useful approach for improving treatment of hyperphosphatemia in HD patients.
Effect of nicotinamide treatment on the residual insulin secretion in Type 1 (insulin-dependent) diabetic patients

In vivo and in vitro experiments have shown that nicotinamide enhances the regeneration of rat B cells. Nicotinamide has been administered to human subjects at a dose of 3 g/day for more than one year without any serious side effects. A trial was conducted to study if nicotinamide could protect B cells in Type I (insulin-dependent) diabetic patients with established diabetes, but still with residual insulin secretion, the latter being evaluated throughout the study period. A randomized double-blind study was carried out on 26 Type I diabetic patients aged 15 to 40 years who had been treated with insulin for 1 to 5 years but who had a residual insulin secretion characterized by a glucagon stimulated C-peptide level higher than 0.1 nmol/l. They were given either 3 g/day of nicotinamide or a placebo for nine months. At baseline the treated and control groups did not differ according to age, diabetes duration, insulin dose, HbA1c or C-peptide levels. Three patients dropped out of the study. At 9 months there were no significant changes in the insulin doses required. However, HbA1c rose in the control group (8.1±0.4 vs 9.8±0.5%, p<0.05) but not in the nicotinamide treated group (7.5±0.5 vs 6.9±0.4%). Insulin secretion deteriorated in the control patients (fasting C-peptide: 0.28±0.05 vs 0.12±0.03 nmol/l, p<0.05; post glucagon C-peptide: 0.34±0.07vs 0.14±0.02, p<0.05) but not in the treated patients (fasting C-peptide: 0.22±0.04 vs 0.24±0.05 nmol/l; post glucagon C-peptide: 0.30±0.04 vs 0.33±0.07). At six and nine months, fasting and stimulated C-peptide were higher in the treated than in the non-treated group. The C-peptide response to a meal test gradually declined in the placebo group, whereas it was stable in the nicotinamide treated group. No serious side effects were noted; in particular, hepatic function and plasma lipid content remained unchanged. These results suggest that nicotinamide treatment may protect residual B-cell function in Type 1 diabetes; but further studies are needed to assess the clinical implications of such treatment.
Fibrinolytic capacity in peritoneal fluid after laparoscopic and conventional colorectal resection: data from a randomized controlled trial

A reduced peritoneal fibrinolytic capacity after surgery is currently accepted to be the main cause for postoperative adhesions. The aim of this prospective randomized trial was to determine the fibrinolytic activity in peritoneal fluid after laparoscopic as compared to conventional colorectal resection. A randomized controlled trial in parallel with the multicenter trial Lapkon II was conducted. Peritoneal fluid was sampled via drain at 2, 8, and 24 h after elective laparoscopic (n=14; LAP) and conventional (n=16; CON) colorectal resections. Activities and concentrations of tissue plasminogen activator (t-PA), plasminogen activator inhibitor type-1 (PAI-1) and t-PA/PAI complex were determined in all specimen by ELISA kits. There was no difference in age, sex or body mass index between both groups. Postoperatively, t-PA activity decreased in both groups and was lower 2 h after closing the abdomen in the laparoscopic group (p<0.05). PAI-1 activity and concentration increased in both groups. Difference between the groups was measured for PAI-1 concentration after 24 h (p<0.05). There were no differences between the groups regarding t-PA concentrations, PAI-1 activity and t-PA/PAI complex. After closing the abdominal cavity, postoperative changes in fibrinolytic capacity of peritoneal fluid can be determined in samples collected by a drain. However, there were no major differences in the postoperative course of fibrinolytic capacity in peritoneal fluid after laparoscopic and conventional colorectal resections.