Results of a survey of biological drug and device industries inspected by FDA under the Team Biologics Program.

The Product Quality Research Institute, in conjunction with the Food and Drug Administration, conducted an anonymous, electronic survey of the biological products manufacturing industry inspected by Team Biologics, with emphasis in obtaining industry input on inspection and compliance aspects of program operations. Representatives from all of the product-specific manufacturing industries inspected under the Team Biologics Program responded to this survey (vaccines; fractionated plasma proteins and recombinant analogs; allergenics; therapeutics and in-vivo diagnostics; and in-vitro diagnostics, including blood grouping reagents). Data and written feedback was obtained regarding each firm's interactions and experiences of Team Biologics inspections at its facilities over the past three years.

Tako-tsubo syndrome on the rise: a review of the current literature.

Tako-tsubo syndrome (TTS) or stress-related acute reversible ventricular apical dysfunction is an emerging but seemingly under-recognised cardiomyopathy mimicking acute ST elevation myocardial infarction (STEMI) without concomitant epicardial coronary artery disease. Severe emotional stress is the most common trigger for this syndrome in the published series, but it can also be precipitated by severe intercurrent medical illness. Precise epidemiological data are not yet available, although TTS most commonly affects elderly women.

Physical activity and physical fitness counseling patterns of adult nurse practitioners.

Purpose: This descriptive exploratory study examined factors related to physical activity counseling practices of adult nurse practitioners (ANPs) nationwide. The purposes of this study were to (a) examine physical activity assessment and counseling practices, (b) identify barriers to physical activity counseling, (c) describe knowledge and confidence in physical activity assessment and counseling, (d) identify personal physical activity practices, and (e) describe use of objective physical fitness measures in the primary care setting.

Data Sources: Participants were a randomly selected group of ANPs who are members of the American Academy of Nurse Practitioners.

Potentiation of mammary cancer inhibition by combination of antagonists of growth hormone-releasing hormone with docetaxel.

Antagonists of growth hormone-releasing hormone (GHRH) are being developed for the treatment of various cancers. In this study, we investigated the effectiveness of treatment with GHRH antagonist JMR-132 alone and in combination with docetaxel chemotherapy in nude mice bearing MX-1 human breast cancers. Specific high-affinity binding sites for GHRH were found on MX-1 tumor membranes using ligand competition assays with (125)I-labeled GHRH antagonist JV-1-42.

Synergistic inhibition of growth of lung carcinomas by antagonists of growth hormone-releasing hormone in combination with docetaxel.

We investigated the effect of antagonists of growth hormone-releasing hormone (GHRH) MZ-J-7-138 and JV-1-92 on H460 human non-small cell lung carcinoma (NSCLC) xenografted orthotopically into nude mice. Treatment with MZ-J-7-138 or JV-1-92 inhibited orthotopic growth of H460 NSCLC by 52-65% (P < 0.001) and was associated with a significant decrease in protein expression of K-Ras, cyclooxygenase-2 (Cox-2) and phospho-Akt (pAkt).

Therapy of ovarian cancers with targeted cytotoxic analogs of bombesin, somatostatin, and luteinizing hormone-releasing hormone and their combinations.

The aim of this study was to investigate the effect of treatment of experimental ovarian cancers with targeted cytotoxic analogs as single compounds and in combination. Targeted cytotoxic analogs of bombesin (AN-215), somatostatin (AN-238), and luteinizing hormone-releasing hormone (AN-207) consisted of 2-pyrrolinodoxorubicin (AN-201) linked to the respective peptide carrier. AN-238 at 200 nmol/kg significantly inhibited growth of UCI-107, ES-2 and OV-1063 ovarian cancers.

Counting the cost: markers of endothelial damage in hematopoietic stem cell transplantation.

During hematopoietic stem cell transplantation (HSCT), endothelial damage is the pathological hallmark of veno-occlusive disease of the liver, thrombotic microangiopathy, capillary leak syndrome and graft-versus-host disease. Events prior to conditioning, the conditioning regimen itself as well as calcineurin inhibitors may all induce endothelial damage. Unfortunately, the relative importance of these factors and their interactions, the time frame of endothelial damage and individual susceptibility remain unknown.

The first aminoacylase-catalyzed enantioselective synthesis of aromatic beta-amino acids.

The first aminoacylase-catalyzed enantioselective synthesis of aromatic beta-amino acids is reported. The presence of an N-chloroacetyl group as acyl group in the substrate as well as the use of porcine kidney acylase I as a suitable enzyme component are prerequisites for this resolution process whereby optically active beta-amino acids are formed with high enantioselectivities of >98% ee.

Circulating endothelial cells as a marker of endothelial damage in allogeneic hematopoietic stem cell transplantation.

Damage to endothelial cells is the common feature of vascular disorders associated with hematopoietic stem cell transplantation (HSCT). Elevated numbers of circulating endothelial cells reflect the extent of endothelial damage in a variety of disorders but their use in HSCT has not been investigated so far. We studied 39 patients undergoing allogeneic HSCT with different conditioning regimens and 22 healthy controls.

Characteristics of patients with abnormal stress technetium Tc 99m sestamibi SPECT studies without significant coronary artery diameter stenoses.

Background: Single-photon emission computed tomography (SPECT) sestamibi (MIBI) is an excellent tool for detection of coronary artery disease (CAD), preoperative risk assessment, and follow-up management after coronary revascularization. While the sensitivity of MIBI SPECT for detecting CAD has been reported to exceed 90%, the specificity ranges between 53-100%.

Hypothesis: The study was undertaken to assess characteristics of patients with abnormal stress technetium Tc99m sestamibi SPECT (MIBI) studies without significant coronary artery diameter stenoses (< 50%).

Practical asymmetric enzymatic reduction through discovery of a dehydrogenase-compatible biphasic reaction media.

[reaction: see text] An enzyme-compatible biphasic reaction media for the asymmetric biocatalytic reduction of ketones with in situ cofactor regeneration has been developed. In this biphasic reaction media, which is advantageous for reactions at higher substrate concentrations, both enzymes (alcohol dehydrogenase and FDH from Candida boidinii) remain stable. The reductions with poorly water-soluble ketones were carried out at substrate concentrations of 10-200 mM, and the optically active (S)-alcohols were formed with moderate to good conversions and with up to >99% ee.

Hypertension outcomes in an urban nurse-managed center.

Purpose: To assess the quality of hypertension (HTN) care in an urban nurse-managed center (NMC) by chart audits of insured and uninsured (N = 52) African Americans who were managed by nurse practitioners.

Data Sources: A chart audit form was developed by the authors that merged Health Plan Employer Data and Information Set (HEDIS) criteria with the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI) criteria.

Conclusions: There was near comparable hypertension control among the two groups.

Doppler echocardiographic findings in 2 identical variants of a rare cardiac anomaly, "subtotal" cor triatriatum: a critical review of the literature.

Improved diagnostic procedures of echocardiography and better awareness of the anomaly and its possible variants lead the examiner to the right diagnosis of the rare cor triatriatum sinister. We describe two cases of a variant of "subtotal" cor triatriatum sinister. A uniform classification system is desirable to compare cases, treatment, and outcome.

Experiences of Lesbian couples during childbirth.

An increasing number of Lesbians are choosing to have children. Do nurses interact with the couples differently during the childbirth experience?

Ebstein's anomaly in adults: Doppler-echocardiographic evaluation.

A systematic approach and segmental analysis are required for comprehensive assessment including both morphologic and functional abnormalities associated with Ebstein's anomaly. The essence of the disease is an apical displacement of both the septal and the posterior tricuspid leaflets, exceeding 20 mm or 8 mm/m2 in adults. As a consequence, the right heart consists of three components including the true right atrium, the functional right ventricle (RV) and an intervening zone that is anatomically ventricular but functionally right atrial (atrialized RV).

[Tubercular psoas abscess].

History And Admission Findings: A 43-year-old patient suffered from fatigue, nocturnal sweating, rigor and a weight loss of 5 kg over the last 4 weeks. A year before he had been anaemic and he was treated with omeprazole and iron. On admission physical examination was unremarkable, except for the known swelling in the right flank.