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OBJECTIVES: Visual cognitive performance (VCP) is an important factor in high-speed interactions with the environment such as sports or driving, however, the testing, training and determination of factors that influence this ability are scarce. The purpose of the Nutrition, Vision and Cognition in Sport Studies (IONSport) is to determine the nutritional factors that explain large variance in VCP and training responses. The objective of this study is to determine if daily beef or vegetable protein consumption affect VCP training responses. METHODS: Thirty-seven women (age 18–35 years) were randomized to either one serving of beef (90% lean ground sirloin, 3 oz) or one serving of vegetable protein (Morningstar prime veggie burgers, 3 oz) per day for 30 days. These foods were equivalent in serving size, calories, protein and fat but distinct in micronutrients. At the end of the dietary intervention, they performed 15 visual cognitive training sessions (Neurotracker) in 10 visits to the laboratory. On the days of training, all food intake was documented for 18 days (Three prior to starting, five from day zero to 15 and 10 from day 15–30). Mean nutritional intakes were calculated for the 15 days of food records during the intervention. RESULTS: Both groups significantly (P

Green leafy vegetables (GLV) may reduce the risk of red meat (RM)-induced colonic DNA damage and colorectal cancer (CRC). We previously reported the primary outcomes (feasibility) of a 12-week randomized controlled crossover trial in adults with habitual high RM and low GLV intake with body mass index (BMI) &gt, 30 kg/m2 (NCT03582306). Herein, our objective was to report a priori secondary outcomes. Participants were recruited and enrolled in 2018, stratified by gender, and randomized to two arms: immediate intervention group (IG, n = 26) or delayed intervention group (DG, n = 24). During the 4 week intervention period, participants were provided with frozen GLV and counseled to consume 1 cooked cup equivalent daily. Participants consumed their normal diet for the remaining 8 weeks. At each of four study visits, anthropometrics, stool, and blood were taken. Overall, plasma Vitamin K1 (0.50 ± 1.18 ng/mL, p &lt, 0.001) increased, while circulating 8OHdG (−8.52 ± 19.05 ng/mL, p &lt, 0.001), fecal 8OHdG (−6.78 ± 34.86 ng/mL, p &lt, 0.001), and TNFα (−16.95 ± 60.82 pg/mL, p &lt, 0.001) decreased during the GLV intervention compared to control periods. Alpha diversity of fecal microbiota and relative abundance of major taxa did not differ systematically across study periods. Further investigation of the effects of increased GLV intake on CRC risk is warranted.

Preclinical and observational research suggests green leafy vegetables (GLVs) may reduce the risk of red meat (RM)-induced colonic DNA damage and colon cancer (CC). We sought to determine the feasibility of a high GLV dietary intervention in adults with an increased risk of CC (NCT03582306) via a 12-week randomized controlled crossover trial. Participants were randomized to immediate or delayed (post-4-week washout) intervention groups. During the 4-week intervention period, participants were given frozen GLVs and counseled to consume one cooked cup equivalent daily. The primary outcomes were: accrual&mdash, recruiting 50 adults in 9 months, retention&mdash, retaining 80% of participants at completion, and adherence&mdash, meeting GLV intake goals on 90% of days. Adherence data were collected twice weekly and 24-h dietary recalls at each time point provided nutrient and food group measures. The Food Acceptability Questionnaire (FAQ) was completed to determine acceptability. On each of the four study visits, anthropometrics, stool, saliva, and blood were obtained. Fifty adults were recruited in 44 days. Participants were 48 &plusmn, 13 years of age, 62% female, and 80% Caucasian, with an average BMI at screening of 35.9 &plusmn, 5.1. Forty-eight (96%) participants were retained and completed the study. During the intervention phase, participants consumed GLVs on 88.8% of days, the adherence goal of one cup was met on 73.2% of days. Dietary recall-derived Vitamin K and GLVs significantly increased for all participants during the intervention periods. Overall satisfaction did not differ between intervention and control periods (p = 0.214). This feasibility trial achieved accrual, retention and acceptability goals, but fell slightly short of the benchmark for adherence. The analysis of biological specimens will determine the effects of GLVs on gut microbiota, oxidative DNA damage, and inflammatory cytokines.

Background: Vildagliptin is a selective inhibitor of dipeptidyl peptidase IV (DPP-4) that improves glycemic control and pancreatic β-cell function in patients with Type 2 diabetes. Vildagliptin may be an appropriate agent to combine with other antihyperglycemic agents in patients requiring combination therapy to achieve optimal glycemic control. Two studies were performed to determine the potential for pharmacokinetic and pharmacodynamic interactions between vildagliptin and the sulfonylurea, glyburide, or pioglitazone in patients with Type 2 diabetes. Methods: Two open-label, multiple-dose, 3-period, randomized, crossover studies in patients with Type 2 diabetes were carried out. Steady state drug pharmacokinetics and postprandial plasma glucose and insulin responses were assessed during treatment with vildagliptin 100 mg b.i.d. alone and in combination with glyburide 10 mg q.d. (n = 17) or with vildagliptin 100 mg q.d. alone or in combination with pioglitazone 45 mg q.d. (n = 15). Results: Coadministration of vildagliptin with either glyburide or pioglitazone had no clinically significant effect on the pharmacokinetics of any of the 3 drugs. Changes in AUC and C max during combination treatment were small (≤ 15%), and 90% confidence intervals for the geometric mean ratios (drug coadministration/monotherapy) were generally contained within the acceptance range for bioequivalence (0.80 - 1.25). Vildagliptin/glyburide coadministration significantly reduced the area under the plasma glucose-time curve compared with glyburide alone (AUE 0-5h reduced by 12% (p = 0.005) and AUE 0-15h by 13% (p = 0.003)), and increased the area under the plasma insulin-time curve (AUE 0-15h increased by 12% (p = 0.041)). Vildagliptin/pioglitazone coadministration also significantly reduced postprandial glucose exposure compared with pioglitazone alone (AUE 0.5-5.5h reduced by 11% (p - 0.029) and AUE 0-15.5h by 10% (p = 0.019)). Vildagliptin was generally well tolerated whether administered alone or in combination with glyburide or pioglitazone, and was not associated with hypoglycemia. Conclusions: Coadministration of vildagliptin with either glyburide or pioglitazone in patients with Type 2 diabetes improves postprandial glycemic control without notable effects on drug pharmacokinetics.

Imatinib at 400 mg daily is standard treatment for chronic myeloid leukemia in chronic phase. We here describe the correlation of imatinib trough plasma concentrations (Cmins) with clinical responses, event-free survival (EFS), and adverse events (AEs). Trough level plasma samples were obtained on day 29 (steady state, n = 351). Plasma concentrations of imatinib and its metabolite CGP74588 were determined by liquid chromatography/mass spectrometry. The overall mean (± SD, CV%) steady-state Cmin for imatinib and CGP74588 were 979 ng/mL (± 530 ng/mL, 54.1%) and 242 ng/mL (± 106 ng/mL, 43.6%), respectively. Cumulative estimated complete cytogenetic response (CCyR) and major molecular response (MMR) rates differed among the quartiles of imatinib trough levels (P = .01 for CCyR, P = .02 for MMR). Cmin of imatinib was significantly higher in patients who achieved CCyR (1009 ± 544 ng/mL vs 812 ± 409 ng/mL, P = .01). Patients with high imatinib exposure had better rates of CCyR and MMR and EFS. An exploratory analysis demonstrated that imatinib trough levels were predictive of higher CCyR independently of Sokal risk group. AE rates were similar among the imatinib quartile categories except fluid retention, rash, myalgia, and anemia, which were more common at higher imatinib concentrations. These results suggest that an adequate plasma concentration of imatinib is important for a good clinical response. This study is registered at http://clinicaltrials.gov as NCT00333840.

Data on abortions, stillbirths and kid mortality from an experimental herd, used for the development of the Yaez, were analyzed. Total number of embryos was 960. Mortality was divided according to kids' age, to early mortality (during first 48 h), mortality before weaning at 70 d (BWA) and after weaning up to 180 d (AWA). There were more abortions among primiparous does (11 %) than among older ones (5.3%). More triplets were aborted (13.4% vs. 6.2%) and/or born dead (15.5% vs. 5.3%) than kids in smaller litters. Season affected mortality of kids before, as well as after, weaning. Rates were 7%, 25.3% and 12.8% BWA for winter, spring and summer born kids, respectively. After weaning 8%, 22.6% and 9.5% died out of winter, spring and summer kids, respectively. Day of birth in season was a significant factor of mortality of kids before and after weaning. Of the kids born during the first 10 d of season, 7.7% died BWA and 8.9% AWA; out of kids that were born from 11 to 20 days, 17.5% died BWA and 16.5% AWA, while 27.2% of the kids that were born after 20 d died BWA and 20.7% died AWA. Mortality rate before and after weaning increased corresponding to the percentage of ibex genes in the dam, the sire and the kid. Combination of low birth weight with hybridization of goat and ibex resulted in increased mortality in all three ages. During the first 48 h of their life average mortality was 4.5%; of kids born up to 1.5 kg with 10–30% ibex genes, 17.6% died; and from the group with more than 30% ibex genes, 33.3% died.

The difficult insertion of a right subclavian catheter in a 63-year-old patient resulted in a pseudoaneurysm of the brachiocephalic artery requiring a resection-suture. The preventive measures of that complication are reminded.

e15130 Background: A first set of US-guided biopsy does not exclude prostate cancer in men with elevated PSA. Repeated biopsy detection rate is only 10 to 30% and increases risks of complications. Localization of suspected targets on MRI with subsequent sonography may be difficult. Therefore, we addressed the ability of contrast-enhanced US-guided biopsies in detecting prostate cancer after MRI localization. Methods: 79 patients (mean age 62y) with elevated PSA value (mean = 12.9 ng/ml) and prior negative biopsy (1-5, mean 2.3) were included in a prospective study. They underwent prostate MRI examination: T1-weighted, T2-weighted, diffusion-weighted and dynamic contrast-enhanced sequences. A single physician performed a first set of targeted biopsies (TB) on MRI-suspected lesion and identified on contrast-enhanced US as well, and subsequently performed a set of sextant randomized “non targeted biopsies” (NTB). Diagnostic efficacy of each biopsy approach – TB or NTB- was evaluated regards to pathological r...

A total of 551 pts with newly diagnosed CML-CP received imatinib (IM) 400 mg orally once daily as part of the IRIS study (O’Brien et al, NEJM 2003). We now summarize the correlation of clinical responses with the steady-state trough plasma concentrations (Cmin) of IM and its major active metabolite CGP74588. Cmin is a reflection of IM clearance and metabolism in CML pts. Trough PK samples (24 hrs post dose) were obtained in IM pts at Day 1 and steady state (Day 29). The plasma concentrations of IM and CGP74588 were determined by liquid chromatography/mass spectrometry. Estimated rates of complete cytogenetic response (CCyR - 0% Ph+) and major molecular response (MMR - ≥ 3 log reduction in BCR-ABL/BCR ratio from a standardized baseline value for untreated pts) were given for the lower and upper quartiles (below Q1=25th percentile, above Q3=75th percentile) and the inter-quartile range of PK trough levels. After 4 weeks of IM at 400 mg, the overall mean (±SD, CV%) steady-state trough levels (Cmin) for IM and CGP74588 (n=351 pts) were 979 (±530, 54.1%) and 242 (±106, 43.6%) ng/mL, respectively. Median (Q1–Q3, min-max) values (in ng/mL) were 879 (647–1170, 153–3910) for IM and 223 (169–291, 50–841) for CGP74588. Times to CCyR and MMR within CCyR pts were significantly different between the three groups of IM plasma exposure (low/intermediate/high; p CCyR and MMR rates [95% CI] within 1, 2, and 4 yrs by categories of IM trough plasma concentrations measured on Day 29 IM trough level < 647 ng/mL (Q1) N = 87 647–1170 ng/mL N = 178 > 1170 ng/mL (Q3) N = 86 CCyR (%) − 1 yr 59 [48, 70] 71 [64, 78] 73 [63, 83] − 2 yrs 73 [63, 83] 80 [73, 86] 84 [75, 92] − 4 yrs 81 [71, 91] 87 [81, 93] 89 [82, 96] MMR (%) in pts with CCyR − 1 yr 43 [28, 59] 56 [47, 66] 55 [41, 68] − 2 yrs 63 [49, 78] 78 [69, 86] 86 [76, 96] − 4 yrs 65 [50, 80] 83 [75, 91] 90 [81, 100] The trough plasma level following the 1st dose also showed a correlation with CCyR and MMR responses, but appeared to be less predictive than the trough level at steady state. Although all CML-CP pts had received 400 mg qd IM, CCyR and MMR rates at 1 to 4 yrs were depending on their IM trough level (24 hrs after the last dose) after 4 weeks of IM. Similar results were observed for the major active metabolite of IM. These results suggest that achieving and maintaining an adequate plasma concentration of IM is important for a good clinical response, and that therapeutic drug monitoring could be done by measuring trough levels at steady state conditions.

Clomiphene citrate, 50 mg/day, was administered to 105 patients with idiopathic azoospermia or oligoasthenospermia. Plasma FSH, LH, testosterone, and in a few cases estradiol were evaluated on day 0 and day 15 of therapy. Twelve other patients with no treatment were assayed in the same way. Statistical analysis demonstrated that, as a group, the infertile male population responds normally to clomiphene administration. On the other hand, three types of individual responses were recorded: complete positive response, dissociated positive response, and negative response. Sixty-nine patients were randomly selected for clomiphene therapy, 50 mg/day for 100 days; however, of 54 who completed the treatment schedule, only 11 showed elevated sperm counts. A study of correlations between hormonal and semen responses to clomiphene indicates that a complete or dissociated endocrine response is not an accurate predictor of possible semen amelioration on long-term therapy; on the other hand, sperm characteristics did not improve in those patients who did not demonstrate a positive hormonal response, mainly testosterone, on the 15th day of therapy.