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Biomedical subjects

S Bauer

Publications and source records attributed to S Bauer.

At least 145 records · Page 8Linked to original sources
PubMed1994

Regulatory review of cellular and gene therapies: an overview of the process.

Cell and gene therapies, using several different approaches, have been proposed for a variety of genetic diseases, cancer and AIDS. The major regulatory review process in the US consists of an institutional review board, the recombinant DNA advisory committee (RAC) and the Food and Drug Administration (FDA). Within the Center for Biologics Evaluation and Research, the Division of Cellular and Gene Therapies has been formed to primarily review investigational new drug applications (INDs) for cellular and gene therapies. Several appropriate "points to consider" documents have been prepared and the RAC has approved over 40 clinical protocols. Advances in biotechnology and the scientific basis for these advances are changing rapidly. Although a flexible, case-by-case approach is necessitated by these rapid changes, regulatory concerns common to all biologicals administered to human subjects remain unchanged. These include safety, efficacy, purity, potency, quality control and assessment, and reproducibility of individual lots. The goal of the review process is a prompt, complete and meticulous review. The emphasis of a pre-IND meeting is toward a working relationship between the sponsor and the FDA prior to the phase I, II and III clinical trials. A timely and ongoing evaluation of pre-clinical testing cannot be overemphasized in this rapidly growing and changing field. The development of a working relationship at this stage will ensure a seamless integration of the IND process with the product and establishment license applications. Because replication-competent retrovirus (RCR) represents a potential for pathogenicity, the FDA is recommending a conservative approach to RCR testing.

Animals↗
PubMed1994

Sports and nutrition--an out-patient program for adipose children (long-term experience).

Sports activity (3 times per week), nutritional changes and modification of behavior are the basic tenets of an outpatient program run for 9- to 12-year-old adipose children since 1987. The following goals are to be attained: increase in physical performance capacity and body awareness, long-lasting change in eating habits, weight loss to under 20% overweight compared to the age-normal (height/normal weight), and understanding of the permanence of body weight problems. Individual nutritional consultation is offered in addition to the initial examination consisting of physical examination, skin fat-fold measurement, blood chemical parameters, spiroergometry and a detailed consultation with parents and children. The eating habits of the children are recorded in a dietary history (3-day dietary protocol, questionnaire) and discussed in individual meetings with the parents and children. Moreover, the nutritional program includes regular nutritional consultations and parents' meetings every month. Cooking instructions for children and parents provide practical knowledge of food preparation to preserve nutrients in an energy-reduced, tasty diet, as well as theoretical basics of nutrition. The control examinations show individual weight loss or stability and improvement in blood lipid parameters. Awareness and controlled nutritional habits were learned especially by the children of parents who, for their part, tried to tailor their nutrition to be better balanced, more nutritional and more need-oriented. Children who maintain the learned nutritional habits after completion of the outpatient program, and who remain active in sports, show long-lasting constant weight. Prevention must begin in childhood. Intensive nutritional support combined with an appropriate sports program should be offered as a preventive measure.

Ambulatory Care↗
PubMed1994

Fibrin-targeted recombinant hirudin inhibits fibrin deposition on experimental clots more efficiently than recombinant hirudin.

BACKGROUND: Although the indirect thrombin inhibitor heparin and the more potent direct inhibitor hirudin are useful in preventing thrombosis, a substantial opportunity remains for improving the thrombus selectivity of thrombin inhibitors. METHODS AND RESULTS: To explore the effect of targeting an antithrombin to the surface of a clot, we covalently linked recombinant hirudin to the Fab' (or IgG) of a monoclonal antibody (59D8) that selectively binds to an epitope on fibrin that becomes exposed only after thrombin cleaves fibrinopeptide B. Antibody-coupled hirudin bound to an immobilized peptide of the fibrin beta-chain amino-terminal sequence and inhibited the peptidolytic activity of thrombin more efficiently than free hirudin. Thrombin inhibition dependent on binding to immobilized fibrin monomer was enhanced 1100-fold (P < .0001). Hirudin-59D8 Fab' was 10 times more effective than hirudin in inhibiting fibrin deposition on experimental clot surfaces in fibrinogen solution (P < .0001) and human plasma (P < .0001). The more effective inhibition of thrombin by the conjugate was supported by significantly diminished concentrations of fibrinopeptide A in the plasma supernatant of the clot (P = .0001). Inhibition of clotting by an uncoupled mixture of hirudin and 59D8 Fab' was indistinguishable from that by hirudin alone, indicating that the conjugate's greater inhibitory activity was due to the covalent linkage between antibody and hirudin. CONCLUSIONS: Fibrin-targeted hirudin (in comparison with unmodified hirudin) significantly reduces fibrin deposition on the surface of experimental clots.

Antibodies, Monoclonal↗
PubMed1994

Descriptions of wellness by individuals with schizophrenia.

A major challenge in the rehabilitation of individuals with schizophrenia is to establish a system of monitoring disease status so interventions can be instituted to prevent disease exacerbation and to promote healthier functioning. Monitoring illness status has primarily focused on indicators of illness. The aim of the present study was to determine what individuals with schizophrenia described as evidence of wellness to generate descriptors for a wellness questionnaire. Twenty participants diagnosed with schizophrenia and living in a community setting were interviewed about their descriptors of wellness. Coding of transcriptions of the interviews yielded two major categories of wellness: Statements related to the reduction or absence of troublesome (illness) indicators and statements related to the presence of helpful or positive (wellness) indicators. Three subcategories, thoughts, feelings, and actions or behaviors emerged under both major categories. The majority of wellness descriptions focused on the presence of wellness and were actions or behaviors.

Adult↗
PubMed1994

[Energy and nutritional intake in young weight lifters before and after nutritional counseling].

A well-balanced diet is an essential component for the development and maintenance of physical performance. Several studies on the dietary status of power athletes have shown, that there are still problems to realize the nutritional recommendations. The purpose of the present study was to analyse the energy- and nutrient intake of 11 young weight lifters aged 14 to 17 years before and after an intensive nutritional counselling (NC). Dietary status was evaluated by 7-day-protocols filled out by the young athletes 4 weeks before and 4 weeks after the NC. Before the NC the athletes (x: age 15, height 174 cm, weight 69.5 kg, BMI 22.2 kg/m2) had a mean energy intake of 179.7 kJ/kg body weight (11.2 MJ/day). The energy percentage of carbohydrate:fat:protein was 48:37:15. The protein consumption was 1.6 g/kg of body weight and the fluid intake was 1.7 l/day. The athletes did not meet the recommendation for niacin, folic acid, vitamin E, magnesium, calcium, iodine and zinc. After the NC the athletes had a significant higher energy percentage of carbohydrate and lower energy percentage of fat. In addition a significantly higher intake of fluid, dietary fiber, vitamins and minerals was observed. This study revealed that the young weight lifters without NC fall short of nutritional recommendations. With the intensive nutritional counselling an improvement of the nutrient intake could be reached. Additional nutritional counselling for the athletes and an intensive teamwork with the coach and parents of the athletes seem necessary to develop and stabilize a good nutritional behavior.

Adolescent↗
PubMed1994

[Physical activity and eating behavior: strategies for improving the serum lipid profile of children and adolescents].

Coronary risk factors such as obesity, dyslipoproteinaemia and low physical fitness are often prevalent in childhood. In contrast, regular physical activity and healthy nutrition have been shown to be effective in primary and secondary prevention of coronary artery disease. An increment in physical activity with concomitant weight loss has a profound influence on peripheral lipoprotein metabolism and has shown to improve the atherogenic lipoprotein profile. As risk factors often track from childhood into adulthood it seems inevitable to prevent or diminish risk factors as early as possible. Therefore, intervention programmes for prevention of coronary artery disease have to be conducted in childhood. Experience from an own intervention programme of obese children has shown that the combination of intensive dietary and physical education improves physical fitness, body composition as well as lipid metabolism. Whether short-term benefits will continue into adulthood and reduce coronary artery disease in midlife will have to be shown. Nonetheless, it seems out of question that children showing risk factors such as obesity or hypercholesterolaemia will benefit from early intervention programmes when changing dietary and exercise behaviours.

Adolescent↗
PubMed1994

Increased cytosolic free sodium in platelets from patients with early-stage chronic renal failure.

Cytosolic free sodium concentration ([Na+]i) and sodium transport systems were measured in intact platelets from 19 patients with early-stage chronic renal failure and 33 healthy control subjects using the novel fluorescent dye sodium-binding-benzofuran-isophthalate. Resting [Na+]i was significantly greater in patients with chronic renal failure compared to control subjects (40.8 +/- 3.1 mmol/l versus 32.2 +/- 2.0 mmol/l, mean +/- SEM, P < 0.05). After inhibition of Na-K-ATPase by 1 mmol/l ouabain a higher net sodium influx was observed in platelets from patients with chronic renal failure compared to control subjects (49.8 +/- 8.7 mmol/l versus 28.5 +/- 5.2 mmol/l, P < 0.05). The platelet Na-H exchanger was similar in the two groups. Cytosolic free calcium concentration ([Ca2+]i) was measured using fura2 and did not show significant differences between the two groups. To evaluate whether a circulating factor may be associated with elevated [Na+]i, a linked-enzyme Na-K-ATPase assay was included. Compared to control subjects plasma from patients with chronic renal failure produced a significant inhibition of steady-state Na-K-ATPase activity by 11.2 +/- 3.0% (P < 0.01). It is concluded that early-stage renal failure is associated with significant impairment of platelet sodium metabolism.

Adult↗
PubMed1993

[Abdominal pain, fresh blood in the anus].

A 60-year-old lady with type II diabetes, arterial hypertension and 'melancholia' was treated with Lithium, a neuroleptic (Leponex) and an ACE inhibitor (Reniten). She was referred to our hospital because of abdominal pain, subfebrile temperatures, diarrhea and hematochezia. The radiological and sonographic examinations showed a thickened wall of the left hemicolon. Colonoscopy revealed a sharply delineated segment with pronounced inflammation in the descending colon and the proximal sigmoid colon, suggestive for an ischemic colitis. Histology of the inflamed colon was compatible with this diagnosis. Under suspended enteral feeding and antibiotic therapy the symptoms disappeared within two weeks, and a control colonoscopy six weeks later was completely normal. 1 1/2 years later the patient suffered from a second episode of ischemic colitis exactly a the same site. Again, complete cure was achieved by conservative treatment.

Anti-Bacterial Agents↗
PubMed1993

The surrogate light chain in B-cell development.

The proteins encoded by the VpreB and lambda 5 genes associate with each other to form a light (L) chain-like structure, the surrogate L chain. It can form Ig-like complexes with three partners-the classical heavy (H) chain, the DHJHC mu-protein, or the newly discovered p55 chain; these are expressed on the surface of pre-B cells at different stages of development. Here, Fritz Melchers and colleagues review the structures of the VpreB and lambda 5 genes in mouse and their relatives in humans, describe their pattern of expression, and speculate on their possible evolution and functions.

Amino Acid Sequence↗
PubMed1993

Silent renal damage in symptom-free siblings of children with vesicoureteral reflux: assessment with technetium Tc 99m dimercaptosuccinic acid scintigraphy.

Sixteen symptom-free siblings of children with vesicoureteral reflux were found to have the condition and underwent renal scintigraphy with technetium 99m dimercaptosuccinic acid. Of these 16 children, 6 had scintigraphic evidence of renal damage. Screening for vesicoureteral reflux in siblings of children known to have the condition should therefore be carried out early in life; when reflux is present, an immediate assessment of the renal parenchyma should be made.

Child↗
PubMed1993

Influence of 6-week, 6 days per week, training on pituitary function in recreational athletes.

The influence on pituitary function of 6 weeks of training on 6 days a week was examined in six recreational athletes. Endurance training on a bicycle ergometer for 31-33 min was performed on 4 days each week at 90-96% (weeks 1-3) and 89-92% (weeks 4-6) of the 4 mmol lactate thresholds determined on day 0 and day 21, respectively, with interval training of 3-5 x 3-5 min in addition on 2 days a week at 117-127% and 115-110%, respectively. Determination of the serum hormone levels and a combined pituitary function test (200 micrograms thyrotropin releasing hormone (TRH), 100 micrograms gonadotrophin-releasing hormone (GnRH), 100 micrograms corticotrophin releasing hormone (CRH), 50 micrograms growth hormone releasing hormone (GHRH)) were made before training, after 6 weeks of training and after another 3 weeks of recovery. Training increased performance at 2 mmol lactate by 25%, at 4 mmol by 12%, and maximum performance by approximately 12%. The releasing hormone-stimulable prolactin, thyroid stimulating hormone (TSH) and somatotrophic hormone (STH) synthesis-secretion capacity remained unchanged, the adrenocorticotrophic hormone (ACTH) was increased after training. Cortisol release was reduced, follicle-stimulating hormone (FSH)-synthesis-secretion capacity was increased after training, and the luteinizing hormone (LH)-synthesis-secretion capacity reduced. This had no influence on base or exercise-induced serum hormone levels (cortisol, aldosterone, insulin, prolactin, FSH, LH, TSH, ACTH, ADH and STH), which showed no dependence on training, except for free testosterone which showed a decreasing trend (P < 0.10) of 19-25% and post-exercise ACTH which showed an increasing trend of 33% (P < 0.10). Conditioning (cortisol sensitivity and ACTH response) or adaptation (FSH and LH responses) to changed testosterone serum levels and altered spermatogenesis is discussed.

Adrenocorticotropic Hormone↗
PubMed1993

Effect of temperature, duration of storage and sampling procedure on ammonia concentration in equine blood plasma.

The effect of storage duration at different storage temperatures on the plasma ammonia concentration of equine EDTA whole blood, EDTA plasma and heparin plasma samples was investigated. Further, the effect of jugular vein compression before and during blood sampling on the plasma ammonia values was evaluated. In EDTA whole blood kept at 4 degrees C there was no significant increase of ammonia content after 6 hours of storage, whereas the increase was already significant 3 hours after collection if the EDTA whole blood was kept at 20-22 degrees C. EDTA plasma samples stored at 20-22 degrees C, 4 degrees C and -20 degrees C showed mean ammonia formation rates of 26.8 mumol/l, 6.6 mumol/l and 0.03 mumol/l per day, respectively. There were no differences between ammonia values of EDTA and heparin plasma samples immediately after sampling and following 3 days of storage at 4 degrees C and 3 and 90 days of storage at -20 degrees C. Although significant, the absolute differences between the mean plasma ammonia contents of EDTA blood sampled with and without compression of the jugular vein were small (20.2 +/- 4.1 mumol/l and 23.4 +/- 4.3 mumol/l resp.).

Ammonia↗
PubMed1993

Increased cytosolic free sodium concentrations in platelets from type 2 (non-insulin-dependent) diabetic patients is associated with hypertension.

Cytosolic free sodium concentrations ([Na+]i) in intact platelets from 32 type 2 (non-insulin-dependent) diabetic patients and from 27 age- and sex-matched non-diabetic control subjects were measured with the novel sodium-sensitive fluorescent dye sodium-binding-benzofuran-isophthalate. [Na+]i was significantly higher in platelets from type 2 diabetic patients compared with control subjects (40.6 +/- 2.4 vs 32.0 +/- 2.0 mmol/l, means +/- S.E.M., P < 0.03). Both systolic and diastolic blood pressure were significantly elevated in diabetic patients compared with control subjects. Analysis of diabetic patients showed a significant association between [Na+]i and diastolic blood pressure (P = 0.026). Stimulation of Na/H exchange by thrombin increased [Na+]i in both groups. After inhibition of Na/K/ATPase by ouabain (1 mmol/l), [Na+]i was significantly increased both in diabetic patients and non-diabetic subjects in a similar way (by 40.2 +/- 7.3 and 31.7 +/- 5.3 mmol/l respectively). It is concluded that increased [Na+]i in cells from type 2 diabetic patients may be related to hypertension.

Adult↗
PubMed1993

Community clinic offers access to care. A system and a city collaborate to care for an immigrant population.

The Southwest Community Health Clinic (SCHC) has been providing free preventive healthcare to the poor residents of its Houston neighborhood since June 1991. Sponsored by the Sisters of Charity of the Incarnate Word Health Care System and the city of Houston, the clinic invites healing through hospitality, unlike many free clinics. The family-focused clinic takes a multidisciplinary team approach to preventive healthcare. The staff of approximately 30 healthcare professionals provides prenatal and pediatric care; immunizations; tuberculosis screenings; and a variety of social services for patients' physical, emotional, and spiritual needs. SCHC's well-child program screens children from birth through age five for physical and developmental problems. Clinic staff teach and guide parents on their children's health. The program stresses early identification of developmental delays and disabilities, with referral to appropriate services. SCHC has also implemented a tuberculosis testing program to prevent spread of the disease. Persons who test positive are referred to the City of Houston Department of Health and Human Service's chest clinics for follow-up and treatment. Community outreach is a major ingredient of SCHC's preventive healthcare program. A community health advocate, who is familiar with the cultures, traditions, and languages of the population being served, identifies families needing care and supports their access and use of healthcare services.

Adult↗