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Biomedical subjects

E Frenkel

Publications and source records attributed to E Frenkel.

At least 19 recordsLinked to original sources

Balloon cervical ripening with extra-amniotic infusion of saline or prostaglandin E2: a double-blind, randomized controlled study.

OBJECTIVE: To compare extra-amniotic infusion of diluted prostaglandin (PG) E2 solution with saline infusion in balloon cervical ripening and labor induction. METHODS: Women with pregnancy complications and Bishop scores of 3 or lower (n = 116) were assigned randomly to receive extra-amniotic infusion (1 mL/minute) of normal saline or PGE2 in saline (0.5 microg/mL) through a Foley catheter with a 30-mL inflated balloon. We induced labor using intravenous oxytocin only when labor had not developed by 6 hours after balloon expulsion. Analysis was by intent-to-treat. We assessed ripening efficiency and course of labor in women who had spontaneous balloon expulsion (n = 110) and trial of labor (n = 107), respectively. RESULTS: Ripening with PGE2 was associated with significantly shorter mean (+/- standard error of the mean [SEM]) time for balloon expulsion (4.7 +/- 0.4 versus 6.5 +/- 0.6 hours) and with significantly higher Bishop scores (P <.002), compared with ripening with saline. In the PGE2 group, rates of labor induction (15%) and oxytocin use (37%) were significantly lower than in the saline group (51% and 72%, respectively). The groups did not differ significantly in other labor abnormalities, labor duration, mode of delivery, birth weight, Apgar scores, and puerperal morbidity. CONCLUSION: Cervical ripening by extra-amniotic balloon and PGE2 infusion is faster and more effective than by balloon and saline infusion, resulting in a higher rate of spontaneous labor and a lower rate of oxytocin use.

Adult↗

Laboratory assessment of the status of Her-2/neu protein and oncogene in breast cancer specimens: comparison of immunohistochemistry assay with fluorescence in situ hybridisation assays.

AIM: To evaluate the clinical usefulness of three commercially available assays for Her-2/neu oncogene and protein measurements. The Her-2/neu protein is overexpressed, mostly as a result of gene amplification, in 20-30% of human breast cancers, and has been shown to have prognostic and predictive value for treatment with chemotherapy or the new monoclonal antibody, Herceptin. METHODS: An immunohistochemistry (IHC) assay using the Dako polyclonal antibody A0485, which measures the Her-2/neu protein, was compared with two new Food and Drug Administration (FDA) approved fluorescence in situ hybridisation (FISH) assays--INFORM and PathVysion, in a cohort of 52 formalin fixed, paraffin wax embedded breast tissues. These tissues were selected randomly from 84 consecutive infiltrating breast cancer specimens, which were first stratified according to the Her-2/neu protein levels as measured by IHC. RESULTS: The two FISH assays achieved a 98% concordance rate: 14 specimens (27%) showed Her-2/neu gene amplification and 37 specimens (71%) showed no Her-2/neu gene amplification. The PathVysion assay had certain advantages over the INFORM assay. In contrast, the IHC assay detected Her-2/neu overexpression in a high percentage of cases, including 13 high positive specimens (25%) and 13 medium positive specimens (25%). Although 10 of these 13 IHC high positive specimens showed gene amplification by FISH, nine of 13 IHC medium positive specimens showed no gene amplification. Statistical analyses showed that the differences between IHC and FISH assays were primarily in the specimens with medium positive IHC, but negative FISH results. CONCLUSIONS: Because of the increasing importance of the Her-2/neu oncogene and oncoprotein in the clinical management of patients with breast cancer, the accurate and consistent evaluation of Her-2/neu status is crucial. This study suggests that the best approach is to combine both IHC and FISH assays; that is, to use the IHC assay as a triage step, followed by the PathVysion FISH assay to analyse the IHC medium and high positive cases.

Biomarkers, Tumor↗

Characteristics of normal lochia.

The objective of this paper is to determine the characteristics of each phase of lochia and how these may be influenced by a number of obstetric variables. Thirty-nine healthy women who had spontaneous vaginal delivery following uncomplicated pregnancy volunteered to complete a diary sheet immediately postpartum. The women were instructed to assess the color of their lochia by a color slide with differential gradation from dark red to white. The color was labeled as rubra (red, red-brown), serosa (brown-pink, brown), or alba (yellow, white). The overall duration of lochia was 36.0 +/- 7.5 days (range 17 to 51 days, median 37 days). Three types of lochia color patterns were identified: type 1--rubra-->serosa-->alba sequence (n = 20); type 2-rubra-->serosa-->alba sequence with prolonged rubra phase and short serosa and alba phases (n = 11); and type 3-with two rubra phases (rubra-->serosa/alba-->rubra-->serosa/alba sequence with near-equal duration of each phase) (n = 8). The rubra phase lasts 12.1 +/- 6.7 days in type 1, 24.8 +/- 5.0 days in type 2, and 5.5 +/- 2.5 days (the first rubra) in type 3 pattern (p < 0.05). There was a higher proportion of lactating women among women with type 1 pattern as compared with type 2 (11/20 and 2/11, p < 0.05, respectively). Women with type 2 pattern were of higher parity (2.8 +/- 1.3) as compared with those with type 1 (1.8 +/- 0.8) (p < 0.05). There were no significant differences in infants' birth weight between the various color types (3,276.0 +/- 379.8 g, 3,564.4 +/- 737.9 g, and 3,080.0 +/- 180.0 g for type 1, type 2, and type 3, respectively. There were no significant differences in overall duration of lochia or gestational age at delivery between the various color types. The results confirm the clinical impression that lochia persists longer than classically reported and is of diverse patterns. Three unique types of color patterns were identified. Type 1 is the most prevalent and is associated with prolonged breast feeding and thus can be considered as the classic type. Type 2 is associated with short or no breast feeding and higher parity. Type 3 may be a variant of type 2. We suggest that traditional teaching on lochia characteristics needs reappraisal.

Adult↗

Comparison of the differential distribution of leukocytes in preeclampsia versus uncomplicated pregnancy.

OBJECTIVE: To describe leukocyte count and differential distribution in preeclampsia and uncomplicated pregnancy. STUDY DESIGN: Blood samples were obtained from 46 consecutive preeclamptic patients and 46 controls with uncomplicated pregnancy. Thirty met the criteria for mild preeclampsia and 16 for severe. The blood was tested within 1 h of venepuncture. An aliquot of the blood was tested in the Cell-Dyn 2000 for complete blood cell count. MAIN RESULTS: The absolute neutrophil count was significantly elevated in preeclamptic patients as compared with that of controls with uncomplicated pregnancy (9,410.1+/-3,066.9 vs. 7,498.6+/-2,354.0 x 10(6)/l, p < 0.05). In neutrophils, the elevation was more prominent in severe preeclamptic patients as compared with mild preeclamptic patients (10,658.8+/-3520.4 vs. 8,694.4+/-2,561.9 x 10(6)/l, p < 0.05). The absolute lymphocyte and eosinophil counts declined in patients with preeclampsia as compared with uncomplicated pregnancy, whereas monocyte and basophil counts did not differ. CONCLUSION: Our results suggest that preeclampsia is associated with an increase in the absolute neutrophil count.

Adult↗

Ripening of the unfavorable cervix with extraamniotic catheter balloon: clinical experience and review.

The use of an extraamniotic catheter balloon, inflated above the internal cervical os, has been advocated as a nonpharmacological, mechanical method of cervical ripening before induction of labor. Additional measures may include applying traction on the catheter, or the infusion of normal saline (1 ml/min) via the catheter's port into the extraamniotic space. The results of catheter balloon cervical ripening are reviewed from 13 published reports and a departmental series of 190 pregnancies with unfavorable cervix, encompassing nearly 1000 patients. A mean change in cervical score of at least 3 points, was noted in most studies after balloon expulsion or removal. The present series and other studies suggest that oxytocin use for induction and/or augmentation of labor is increased after balloon ripening, compared with its use in spontaneous labor or after cervical ripening by prostaglandins. In 11 studies, catheter balloon ripening was compared with cervical ripening by other mechanical, or pharmacological (i.e., oxytocin or prostaglandins) methods. Of these, eight were prospective and randomized-controlled and three were case-controlled studies. It is suggested that ripening efficacy by catheter balloon is similar, or better, than other methods; but there is no significant difference in the mode of delivery or perinatal outcome. This review also suggests that cervical ripening with extraamniotic catheter balloon has the advantages of simplicity, low cost, reversibility, and lack of systemic or serious side effects.

Adult↗

Twenty-five-year followup of the Israeli High-Risk Study: current and lifetime psychopathology.

Current and lifetime psychopathology was assessed in 50 Israeli children of parents with schizophrenia who were either of kibbutz families and raised collectively with the help of child care workers, or of urban families and raised by their parents. Index subjects were compared with 50 matched control children of healthy parents by means of the Schedule for Affective Disorders and Schizophrenia-Israel. Subjects were evaluated in adulthood at a mean age of 31 years; schizophrenia was found exclusively among children of ill parents, and no effect of town or kibbutz rearing on risk for schizophrenia was observed. Major affective illness was more common among kibbutz index subjects. Affective symptomatology observed in some index parents was evenly distributed among town and kibbutz parents and was not related to the diagnosis of affective disorders in at-risk children. Current adult functioning was similar between town-and kibbutz-raised subjects (and in general reflected good adjustment); an excess of personality disorders was found among index subjects. The present findings support the concept that both familial and environmental factors operate in the expression of psychopathology.

Activities of Daily Living↗

Reanalysis of SCOR and anxiety measures in the Israeli High-Risk Study.

In an earlier study, skin conductance orienting response (SCOR) and anxiety measures obtained when the subjects of the Israeli High-Risk Study were 11 years old were analyzed, using adult diagnostic information, when the subjects were 26 years old. The present study considers similar data obtained from most of this sample when the subjects were 16 years old. As in the earlier analysis, those subjects who would receive a schizophrenia spectrum diagnosis at 26 had higher anxiety ratings at age 16. Nondiagnosed index subjects also had significantly higher anxiety ratings than the nondiagnosed controls. The subjects who would receive affective spectrum diagnoses at age 26 had the most hyporesponsive SCORs, as predicted, while the subjects who would later be diagnosed in the schizophrenia spectrum had an unexpected hyperresponsive SCOR to the dishabituation tone in a habituation series. Further consideration of the long-term stability of SCORs seems necessary; they may be related to the developing psychopathological processes.

Adolescent↗

Locus of control and mental health in adolescence and adulthood.

Eighty-nine subjects of the original sample of the National Institute of Mental Health joint study by the United States and Israel, known as the Israeli High-Risk Study, were given a clinical interview and a questionnaire measuring locus of control (LOC) during the second phase of the study, when the subjects were adolescents. During phases 3 and 4, approximately 8 and 15 years later, the subjects were psychiatrically assessed and 56 of them repeated the LOC questionnaire. The two measures of LOC were correlated, as were general assessments of mental health (MH). Adolescent LOC was related to lifetime MH, although LOC and MH were not related to each other concurrently in either adolescence or adulthood. The best predictive model for lifetime MH outcomes was a combination of adolescent MH and LOC variables; background variables, including parental schizophrenia, were superfluous. The data suggest that whereas adolescent MH is the best predictor of general MH, adolescent LOC is the better predictor of schizophrenia and major affective disorders.

Adolescent↗

Overview and summary: twenty-five-year followup of high-risk children.

We report a 25-year followup of a group of 50 children at genetic risk for schizophrenia (by virtue of having a parent with the disorder) and 50 matched controls. The children who eventually developed schizophrenia spectrum disorders, including schizophrenia, were identifiable by cognitive-psychophysiological, neurointegrative, and social/personality traits in the preteenage period. The children at risk were also more likely to develop other Axis I disorders, chiefly affective. Moreover, the risk of Axis I disorders was significantly greater among children raised in the group atmosphere of a kibbutz than among those raised in their own nuclear families in cities and towns in Israel. The study is a unique contribution to knowledge of factors underlying the development of psychopathology.

Adolescent↗

Testicular tumors in men with human immunodeficiency virus.

During a 2-year period 5 men positive for the human immunodeficiency virus (HIV) presented with 6 testis tumors among a total of 3,015 men seen at our hospital acquired immunodeficiency syndrome (AIDS) clinic. This testis tumor incidence of 0.2% is 57 times that of the United States average of 3.5 cases per 100,000 men. Two patients were only HIV positive and 3 others already had AIDS-related complex for 2 to 15 months at the time of tumor diagnosis. Tumor histology was mixed germ cell tumor in 4 patients, pure seminoma in 1 and Burkitt's lymphoma in 1. Patients underwent routine staging evaluations. Three patients had low stage mixed germ cell tumor (clinical stage 1 or 2A) and underwent retroperitoneal lymphadenectomy, which revealed pathological stage 1 or 2A disease in 1 and 2, respectively. These patients did not receive adjuvant chemotherapy. Two patients had advanced mixed germ cell tumor (clinical stage 2C) or Burkitt's lymphoma (clinical stage 4) and received combination chemotherapy from the onset. Outcome was evaluated with regard to progression of HIV disease and tumor status. The 2 patients who were only HIV positive remained so for 9 and 48 months. The 3 patients with AIDS-related complex had progression to AIDS within 1 to 9 months and 2 of these patients died 1 1/2 and 7 months after tumor diagnosis. All 3 patients with resected low stage disease had tumor recurrence within 1 to 9 months and were begun on platinum-based combination chemotherapy. The risk of false low clinical staging and early tumor progression may be higher in HIV positive men than in other testis tumor patients. Patient ability to tolerate chemotherapy and to obtain a satisfactory tumor response appeared to be primarily related to lack of progression of HIV disease to frank AIDS.

AIDS-Related Complex↗

Osmotic blood-brain barrier opening to IgM monoclonal antibody in the rat.

Pharmacokinetic parameters of iodinated monoclonal antibody (MAb) delivery to normal rat brain were examined. The mean cerebrovascular permeability-surface area (PA; permeability X capillary surface area) to immunoglobulin M (IgM) MAb (mol wt 1,000,000) 10 min after infusion was 0.40 X 10(-6) S-1. When osmotic blood-brain barrier (BBB) disruption is utilized, the PA increased to 8.36 X 10(-6) S-1. Neither intravenous nor intracarotid MAb administration significantly affected delivery to brain. However, osmotic BBB opening significantly (P less than 0.0005) increased MAb uptake independent of the route of administration. After BBB opening and intracarotid MAb the maximum concentration in brain at 1 h was 0.72% per gram of the total administered dose. For 6 h postdisruption, ipsilateral brain levels were 25- to 100-fold greater than in the contralateral hemisphere or nonbarrier-disrupted controls. MAb concentration in brain slightly decreased over 72 h (P less than 0.05). Antibody recovered from disrupted brain retained 90% of its immunological reactivity for at least 24 h. MAb delivery to ipsilateral brain after BBB disruption was linear over a dose of 0.5-5.0 micrograms IgM, whereas the percentage of the total administered dose remained unchanged. After osmotic treatment, barrier opening was maximal to MAb delivery for 1 min with delivery declining rapidly thereafter. The type of anesthesia used and the administration of a thyroid-blocking agent were found to affect brain MAb levels after BBB disruption.

Animals↗

Medical oncology manpower training: a position statement of the American Society of Clinical Oncology.

The evolution of Medical Oncology is facing its first major crisis, that of oversupply of trained oncologists. The tabulated number of certified medical oncologists does not constitute all of the physicians practicing Medical Oncology in the United States. Because of the adequate supply of medical oncologists in clinical practice, but a deficiency of academic oncologists dedicated to research careers, a reduction in training programs should emphasize those programs that lack research opportunities. These recommendations are in keeping with the report of the Long-Range Planning Committee of the American Society of Clinical Oncology of March 21, 1984. Plans to expedite these goals are being established.

Medical Oncology↗

Is there a "gold standard" for human serum vitamin B12 assay?

In a study from four laboratories using two commercial vitamin B12 radioassays (impure hog intrinsic factor concentrate containing both intrinsic factor and R binders (IF + R) to measure total corrinoids and the same concentrate presaturated with cobinamide (Cbi) to block B12 binding sites on R binder (IF + R + Cbi) to measure only cobalamins), the rank order of results was generally the same. The concordance between the two tests for classifying sera as normal or deficient was 91% in 311 serum samples. Three percent of sera below the "true B12" (B12 binding to IF + R + Cbi) normal cut-off point were not below the cut-off point for normal "total B12" (B12 binding to IF + R); 6% of sera below the total B12 normal cut-off point were not below true B12 cut-off point. The correlations between Euglena gracilis and the radioassays were 0.80 and 0.83 in the 50 serum samples that also had E. gracilis serum vitamin B12 levels. Lactobacillus leichmannii serum vitamin B12 levels were determined in 49 of the 311 serum samples and results were comparable with results obtained by four radioassay binder systems: IF + R, IF + R + Cbi, highly purified hog IF, and saliva R binder. The closest correlate with L. leichmannii was radioassay using IF + R as binder (r = 0.93), then IF + R + Cbi (r = 0.92), pure IF (r = 0.80), and pure R (r = 0.73). The key to reliable results appears not to reside in a particular assay but rather in determining for each assay its own range of results in participants determined clinically and morphologically normal vs. participants with deficient vitamin B12 (with B12 deficiency defined independently of a serum B12 assay). When laboratory assay results differ from clinical judgment, further evaluation is the appropriate course. There is no "gold standard" for human serum vitamin B12 assay.

Biological Assay↗