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Biomedical subjects

S L Feigenbaum

Publications and source records attributed to S L Feigenbaum.

15 recordsLinked to original sources
PubMed1996

Quality assurance in clinical trials.

Quality assurance is important in the development and conduct of a successful single-site clinical trial. The successful principal investigator (PI) is one who aligns him/ herself with a knowledgeable team with demonstrated capabilities in all aspects of clinical trial design and execution including professionals with expertise in biostatistics and experimental design, research administration including budget preparation and proposal submission, patient recruitment and contact, data collection, data analysis, and computers. The effective PI will become an effective coordinator of these functions by assembling this team, establishing a realistic schedule, and demonstrating enthusiasm, integrity, and leadership. The team, as it is being assembled, and which typically includes nonphysicians, will find helpful an explicitly enlarged, detailed statement of the proposed hypothesis. This statement may include the type of patients to be studied, duration of the proposed observation period, and the methods of evaluation. Careful planning is the best assurance that a successful and worthwhile study will be accomplished.

Clinical Trials as Topic↗
PubMed1996

Transsphenoidal pituitary resection for preoperative diagnosis of prolactin-secreting pituitary adenoma in women: long term follow-up.

The long term efficacy and safety of transsphenoidal resection for preoperative diagnosis of PRL-secreting pituitary adenomas in a large series of women have not been described. Four hundred and nine consecutive women at this university tertiary referral center undergoing transsphenoidal resection for preoperative diagnosis of PRL-secreting pituitary adenoma were followed for a minimum of 4 yr. The objective was to determine the efficacy and morbidity of this procedure and to identify features correlating with the resolution of hyperprolactinemia. Outcome measures included referral, preoperative, surgical, postoperative hospitalization, and long-term follow-up information, including recent PRL concentration. Follow-up was ascertained in 83% of patients who were followed for a mean of 9.2 yr. Recurrence of hyperprolactinemia occurred in 47% of total patients, but in only 16% with a single surgical procedure, histological diagnosis of prolactinoma, and postoperative PRL concentration of 5 ng/mL or less. The best single predictor of cure was postoperative day 1 PRL concentration of 5 ng/mL or less. Eighty-eight percent of women desiring conception conceived within 1 yr. Glucocorticoid-dependent hypopituitarism occurred in 23% of patients undergoing postoperative radiotherapy. There was no operative mortality. Operative morbidity was low. Our experience demonstrates that women undergoing transsphenoidal surgery for diagnosis of PRL-secreting adenoma form a heterogeneous patient population. The best long term results are achieved in the pure prolactinoma group, for whom transsphenoidal resection is generally safe and effective.

Adolescent↗
PubMed1995

Hormonal and pregnancy relationships to rheumatoid arthritis: convergent effects with immunologic and microvascular systems.

OBJECTIVE: To review sex hormones and rheumatoid arthritis (RA) and the interrelationships between hormonal, immunological, and vascular systems. DATA SOURCES: Publications detailing serum sex hormone levels and their HLA interactions, steroidogenesis, pregnancy, and therapeutic uses of sex hormones in RA. STUDY SELECTION: Controlled studies of sex hormone levels in RA patients not previously treated with glucocorticoids. DATA EXTRACTION: Mean (+/- SD) serum levels of dehydroepiandrosterone sulfate (DHEAS), testosterone (T), and estradiol (E2). DATA SYNTHESIS: Mean (+/- SD) levels were collated into tables for women with pre-versus postmenopausal onsets of disease and men. Data were also ordered across all study groups by increasing mean levels of the control subjects. Pooled data were summarized statistically, and major sources of variation between the studies were identified. CONCLUSIONS: Serum DHEAS, an adrenal androgen, was impressively decreased among women with premenopausal onset of RA. One study showed such deficiency years before disease onset. Serum T was somewhat decreased in the premenopausal onset group, but could be explained by decreased peripheral conversion of the lower levels of adrenal androgens. Women with postmenopausal onset of RA had modestly decreased serum DHEAS levels overall, but no difference in serum T, compared with controls. Male RA cases had consistently decreased serum levels of T, but not of DHEAS. Serum E2 was comparable in all RA versus control groups. The complex biology of pregnancy was interpreted as an example of vital interactions between hormonal, immunological, and vascular systems, as they may relate to the physiopathology of RA. The major age, sex, and hereditable determinants of RA were compared within a composite table of estimated relative risks. Elucidation of the interacting risk factors offers promising avenues of research in this complex disease.

Adrenal Cortex Hormones↗
PubMed1994

Interleukin-1 beta regulates human cytotrophoblast metalloproteinase activity and invasion in vitro.

During early human pregnancy, fetal cytotrophoblasts rapidly invade the uterus. This process has many similarities to tumor invasion, except that the extent and the timing of cytotrophoblast invasion are carefully regulated. Therefore, this system is particularly useful for studying mechanisms that regulate invasive processes. Previously, we showed that production and activation of the 92-kDa type IV collagenase (matrix metalloproteinase(MMP)-9) is necessary for cytotrophoblast invasion in vitro. In other systems, interleukin (IL)-1 beta is an important regulator of matrix-degrading metalloproteinases. Therefore, we investigated trophoblast production of IL-1 beta and its receptors, as well as the effects of this cytokine on cytotrophoblast metalloproteinase activity and invasion. The results showed that release of IL-1 beta parallels the invasive potential of the cytotrophoblasts; the highest levels are produced by first trimester cells and the lowest levels by term cells. Immunoprecipitation showed that cytotrophoblasts express the 80-kDa type I IL-1 receptor, suggesting that autocrine effects are possible. IL-1 beta stimulated trophoblast MMP-9 secretion (by a mechanism that required nascent mRNA and protein synthesis) as well as metalloproteinase activity and invasion of Matrigel. Increasing (by lipopolysaccharide treatment) or decreasing (by glucocorticoid treatment) IL-1 beta production had parallel effects on MMP-9 secretion, metalloproteinase activity, and invasion. Because IL-1 beta and corticosteroids are present in high concentrations at the maternal-fetal interface, normal trophoblast invasion may be regulated, in part, by their opposing actions. In contrast, stimulation of cytotrophoblast IL-1 beta secretion by lipopolysaccharide may play a role in the sequela of infected fetal membranes.

Collagenases↗
PubMed1991

Lymphocytic adenohypophysitis: a pituitary mass lesion occurring in pregnancy. Proposal for medical treatment.

Lymphocytic adenohypophysitis is a nonneoplastic, autoimmune cause of pituitary enlargement and insufficiency. Forty-eight of the 50 reported cases have occurred in women, nearly all in association with pregnancy. Left undiagnosed and untreated, it can progress to pituitary insufficiency and death. Histologic studies show characteristic changes of autoimmune disease with lymphocytic infiltration and destruction of anterior pituitary tissue with fibrotic replacement. Lymphocytic adenohypophysitis is currently diagnosed after other pituitary mass lesions are excluded and has been treated with a combination of neurosurgery and end-organ hormone replacement. However, with improved knowledge of the pathophysiologic characteristics and natural history of the disease and with the ability to make a prospective diagnosis, we believe glucocorticoids may suppress the inflammatory response and protect remaining pituitary tissue. Two previously unreported pregnancy-associated cases are described, including one prospectively diagnosed and treated without neurosurgery during pregnancy. Obstetrician-gynecologists must place lymphocytic adenohypophysitis in the differential diagnosis of pituitary enlargement associated with pregnancy, since treatment is available and the sequelae may be life-threatening.

Adult↗
PubMed1991

Screening assays for immunologic infertility: a comparison study.

Because the immunobead antisperm antibody test (IBT) is difficult to learn and results are heavily operator-dependent, we compared findings on IBT with those of SpermMAR and SpermCheck in 58 patients to determine whether the latter two tests could demonstrate improved screening ability. Assays performed on both sperm and serum (i.e., direct and indirect) yielded 100% positive predictive values when IBT was used as the standard. Both SpermCheck and SpermMAR are easier to perform, and, as the former has a slightly greater sensitivity, we recommend SpermCheck for the detection of immunologic infertility.

Autoantibodies↗
PubMed1988

Differing fetal growth patterns in pregnancies complicated by preterm labor.

Previous studies have demonstrated diminished ultrasonic fetal growth parameters in women delivering preterm. In this study, we tested the following hypothesis: In pregnancies complicated by spontaneous preterm labor, 1) unsuccessful tocolysis is likely to be associated with diminished fetal growth, and 2) successful tocolysis is likely to occur when fetal growth is normal. Ultrasound examinations were performed in 78 pregnancies complicated by preterm labor before 35 weeks' gestation. Tocolysis was attempted unless contraindicated or unless cervical dilatation was advanced (4 cm or greater). Pregnancies delivering before 36 weeks' gestation were compared with those delivering after this gestational age. Among the 48 pregnancies delivered before 36 weeks' gestation, a significantly greater proportion had ultrasonic growth parameters lower than normal values at corresponding gestational ages. In contrast, those pregnancies that had successful tocolysis and delivered near term demonstrated a normal distribution of ultrasound growth parameters. In pregnancies complicated by preterm labor, ultrasonic documentation of diminished fetal growth may identify the subgroup at increased risk for preterm delivery.

Adult↗
PubMed1987

Ultrasonic prediction of birth weight in preterm fetuses: which formula is best?

Data from previous studies have suggested that birth weight prediction was enhanced by using formulas specifically derived from preterm fetuses. However, no prospective comparison of different formulas was performed. We obtained ultrasonic data on 61 pregnancies at risk for preterm delivery with a gestational age of 29.0 +/- 3.0 weeks (mean +/- SD). In all women birth weight was predicted within 7 days of delivery. Of the 61 pregnancies, 49 (80%), 41 (67%), 30 (49%), and 17 (28%) weighed less than 1750, 1500, 1250, and 1000 gm, respectively; 14 published formulas were compared for accuracy in predicting birth weight in these four categories. The formulas with the smallest absolute mean percent errors incorporated head and abdominal circumferences and femur length. The formula of Weiner et al., derived from low birth weight infants, produced the smallest absolute mean percent error and SD, 10.9% +/- 7.9%; this error was further reduced to 7.7% +/- 6.5% in infants weighing less than 750 gm. These findings suggest that birth weight in the preterm fetus is best predicted by a formula targeted to such a population.

Birth Weight↗
PubMed1983

Seronegative rheumatoid arthritis. Fact or fiction?

Patients with clinical features of rheumatoid arthritis (RA) but negative rheumatoid factor (RF) present a diagnostic challenge. The seronegative spondyloarthropathy (SNSA) syndromes, previously believed to be "rheumatoid arthritis variants," eg, Reiter's syndrome and psoriatic arthritis, are now considered to be genetically separate from RA and have been shown to be closely associated with HLA-B27. This syndromic discrimination has raised question as to the validity of RF negative RA (ie, seronegative RA). Demographic, clinical, and roentgenologic features of seronegative RA and SNSA are compared. Also, more common diagnoses that may stimulate seronegative RA are outlined according to onset age of arthritis. Recent concepts of RF positivity and HLA-DR4 correlations are reviewed. Multiple unknown factors contribute to the currently recognized syndrome of RA. Its diagnosis continues to rest on an aggregate of host, clinical, immunologic, and radiologic features.

Arthritis, Rheumatoid↗
PubMed1981

Primary fibromyalgia (fibrositis): clinical study of 50 patients with matched normal controls.

Detailed clinical study of 50 patients with primary fibromyalgia and 50 normal matched controls has shown a characteristic syndrome. Primary fibromyalgia patients are usually females, aged 25-40 yr, who complain of diffuse musculoskeletal aches, pains or stiffness associated with tiredness, anxiety, poor sleep, headaches, irritable bowel syndrome, subjective swelling in the articular and periarticular areas and numbness. Physical examination is characterized by presence of multiple tender points at specific sites and absence of joint swelling. Symptoms are influenced by weather and activities, as well as by time of day(worse in the morning and the evening). In contrast, symptoms of psychogenic rheumatism patients have little fluctuation, if any, and are modulated by emotional rather than physical factors. In psychogenic rheumatism, there is diffuse tenderness rather than tender points at specific sites. Laboratory tests and roentgenologic findings in primary fibromyalgia are normal or negative. Primary fibromyalgia should be suspected by the presence of its own characteristic features, and not diagnosed just by the absence of other recognizable conditions. This study has also shown that primary fibromyalgia is a poorly recognized condition. Patients were usually seen by many physicians who failed to provide a definite diagnosis despite frequent unnecessary investigations. A guideline for diagnosis of primary fibromyalgia, based upon our observations, is suggested. Management is usually gratifying in these frustrated patients. The most important aspects are a definite diagnosis, explanation of the various possible mechanisms responsible for the symptoms, and reassurance regarding the benign nature of this condition. A combination of reassurance, nonsteroidal antiinflammatory drugs, good sleep, local tender point injections, and various modes of physical therapy is successful in most cases.

Adolescent↗
PubMed1979

Prognosis in rheumatoid arthritis. A longitudinal study of newly diagnosed younger adult patients.

The course of rheumatoid arthritis was analyzed in 50 newly-diagnosed adults followed prospectively for an average of over five years. Eighteen patients had no swelling and no erosion (outcome 1), 22 patients had swelling without erosion (outcome 2) and 10 patients had erosion (outcome 3). Computer-assisted data screening and multivariate analytic technics were employed to derive a simple index from entry data which correlated closely with the patients' subsequent articular course. The index included six entry items: positive rhematoid factor; two or more swollen upper extremity joints on examination (2 points each); history of Raynaud's-like symptoms; malaise or weakness at the onset of arthritis; white race and female sex (1 point each). This index was 80 per cent accurate over-all in classifying patients into the three mutually exclusive articular outcome categories. Zero to 2 points on entry predicted no swelling, 3 to 5 points swelling without erosion and 6 to 8 points the development of bony erosion. Although results must be qualified to this patient population in the early stages of disease, the analytic approaches developed promise to assist with a broad range of clinical research and medical care delivery problems.

Adolescent↗
PubMed1976

Prospective study of the early course of rheumatoid arthritis in young adults: comparison of patients with and without rheumatoid factor positivity at entry and identification of variables correlating with outcome.

The early course of newly diagnosed RA among young adult patients (16-44 yr) is described from results of an ongoing study with a mean follow-up of 3.4 yr. Study diagnosis was based on the judgement of experienced rheumatologists, and data on several hundred variables were obtained on entry and annually for the purpose of defining patterns of onset and course of disease. Race and sex factors, as well as certain entry manifestations, e.g., RF, were found to correlate with onset and course patterns. Females, and especially white females, had significantly greater numbers of swollen upper extremity joints than males at entry and at last observation, with increased likelihood of developing bone erosions. At entry, RF positive patients differed only on few articular manifestations from RF negative patients, but had a higher frequency of positive ANA at entry and more subcutaneous nodules and bone erosions during follow-up. Seropositive white females at entry had significantly more swollen upper joints than their seronegative counterparts, but with no difference found at last follow-up. White females of each serogroup had more joint involvement at last examination than patients of other race-sex groups. Males had more acute onset, especially under age 30, with significantly greater improvement in arthritis and in ESR than did females. The majority (55%) of patients entered as seropositive, converted to seronegative during follow-up, and no correlation of either joint swelling or erosions was noted with this phenomenon. At last visit, RF positively did not correlate with bone erosions, but patients developing bone erosions had higher frequency of ANA and higher mean serum complement levels at last examination. The following entry factors were found to correlate significantly with a better outcome: maleness, acute onset under age 30, less swollen upper joints, and negative RF. Type of drug therapy tended to reflect severity of arthritis, rather than vice versa, and functional capacity improved significantly from entry to last evaluation in both males and females, even though the latter had stable or progressive arthritis. Further study is necessary over long intervals and in wider age range to more adequately interpret the biologic implications of findings of this ongoing study. A better understanding of the pathogenesis of RA may be derived from critical studies of the contribution of host factors, e.g., sex, and other variables predisposing to the development of RF positivity (and ANA), subcutaneous nodules, and bone erosions, particularly in systematic ongoing studies of patients with early diagnosed disease.

Adolescent↗
PubMedDate not supplied

Integrated hormonal-immunological-vascular (H-I-V triad) systems interactions in the rheumatic diseases.

An expanded paradigm for the diffuse rheumatic diseases is presented which focuses upon the integrated interactions of hormonal, immunological and vascular systems, i.e. the "H-I-V" triad. The reciprocal interactions between the (neuro)hormonal and immunological systems are increasingly recognized in experimental models and human examples of these diseases. Other important two-way interactions, e.g. between the hormonal and vascular systems, are also believed to be operating, but are relatively unexplored at present. An overview of the triad interactions between these vital regulatory systems of the body is offered. These interactions are further influenced by their relationships to broader genetic controls, physiological modulators, and environmental influences. Earlier, physiopathogenic stages of these evolving rheumatic disorders need to be understood, if prevention and optimal healing are to be achieved in the future.

Autoimmunity↗