IMMUNOCHEMICAL EFFECTS OF INJECTION THERAPY WITH ALLERGENS BY CUSTOMARY AND INTENSIVE DOSAGE REGIMENS IN CHILDREN

PEDIATRICS ◽  
1972 ◽  
Vol 49 (4) ◽  
pp. 536-546
Author(s):  
C. D. May ◽  
M. Lyman ◽  
R. Alberto ◽  
N. Aduna
Keyword(s):  
Clinical Trials ◽  
Injection Therapy ◽  
Skin Tests ◽  
Protein Nitrogen ◽  
Blocking Antibody ◽  
Dosage Regimens ◽  
Neutralizing Capacity ◽  
Allergen Extracts ◽  
Frequent Measurement

Evaluation of dosage regimens for injection therapy with allergen extracts was undertaken by determination of immunochemical responses. Antigenic release of histamine was used as a means of measuring leukocyte sensitivity to allergens and antigen-neutralizing capacity of serum or "blocking" antibody. Customary dosage regimens providing 190,000 to 265,000 Protein Nitrogen Units of allergen in 2 years, and intensive dosage regimens providing these amounts or more in a few weeks were evaluated in 46 allergic children by frequent measurement of luekocyte sensitivity and antigen-neutralizing capacity of serum. Uninjected subjects were studied simultaneously. With 32 children receiving customary dosage regimens for injection of an allergen extract (Alternaria, ragweed, house dust), increases and decreases in leukocyte sensitivity in those children receiving injections did not differ significantly from others without injections. Modest increases in antigen-neutralizing capacity of serum occurred with injections. With 14 children receiving intensive dosage regimens for injection of the same allergens, much higher titers of antigen-neutralizing capacity in the serum could be achieved, but little net change in leukocyte sensitivity was observed, except for one case in which leukocytes became desensitized. In no case did intradermal skin tests with the allergens become negative, meaning the children were not desensitized. The dosage regimens used for injection of the allergens tested did not evoke immunochemical responses which encourage one to undertake extensive clinical trials.

scholarly journals THE DETERMINATION OF SMALL AMOUNTS OF PROTEIN NITROGEN

1925 ◽  
Vol 64 (1) ◽  
pp. 75-80
Author(s):  
Edna Ruth Main ◽  
Arthur P. Locke
Keyword(s):  
Protein Nitrogen

Systemic Lupus Erythematosus Disease Activity Index 2000 Responder Index-50 Enhances the Ability of SLE Responder Index to Identify Responders in Clinical Trials

2011 ◽  
Vol 38 (11) ◽  
pp. 2395-2399 ◽  
Author(s):  
ZAHI TOUMA ◽  
DAFNA D. GLADMAN ◽  
DOMINIQUE IBAÑEZ ◽  
SHAHRZAD TAGHAVI-ZADEH ◽  
MURRAY B. UROWITZ
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trials ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Activity Index ◽  
Disease Activity Index ◽  
Systemic Lupus ◽  
Original Definition ◽  
Definition Of

Objective.To evaluate the performance of the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) when the SLE Disease Activity Index 2000 (SLEDAI-2K) is substituted with SLEDAI-2K Responder Index-50 (SRI-50), a valid and reliable index of disease activity improvement. Also, to determine whether the SRI-50 will enhance the ability of SRI in detecting responders.Methods.Our study was conducted on patients who attended the Lupus Clinic from September 2009 to September 2010. SLEDAI-2K, SRI-50, the British Isles Lupus Assessment Group measure, and the Physician’s Global Assessment were determined initially and at followup. SRI was determined at the followup visit according to its original definition using the SLEDAI-2K score and by substituting SLEDAI-2K with SRI-50.Results.A total of 117 patients with SLEDAI-2K ≥ 4 at baseline were studied. Patients had 1 followup visit over a 3-month period. Twenty-nine percent of patients met the original definition of SRI and 35% of patients met the definition of SRI when SLEDAI-2K was substituted with SRI-50. The use of SRI-50 allowed determination of significant improvement in 7 additional patients. This improvement could not be discerned with the use of SLEDAI-2K as a component of SRI. At followup visits that showed improvement, SRI-50 scores decreased to a greater extent than SLEDAI-2K scores (p < 0.0001).Conclusion.SRI-50 enhances the ability of SRI to identify patients with clinically important improvement in disease activity. SRI-50 was superior to SLEDAI-2K in detecting partial clinical improvement, ≥ 50%, between visits. These properties of the SRI-50 enable it to be used as an independent outcome measure of improvement or as a component of SRI in clinical trials.

scholarly journals An Empirical Biomarker-based Calculator for Autosomal Recessive Polycystic Kidney Disease The Nieto-Narayan Formula

2016 ◽  
Author(s):  
Jake A Nieto ◽  
Michael A Yamin ◽  
Itzhak D. Goldberg ◽  
Prakash Narayan
Keyword(s):  
Clinical Trials ◽  
Kidney Disease ◽  
Polycystic Kidney Disease ◽  
Imaging Modality ◽  
Pediatric Population ◽  
Polycystic Kidney ◽  
Drug Candidates ◽  
Serial Determination ◽  
Stage Renal Disease

Autosomal polycystic kidney disease (ARPKD) is associated with progressive enlargement of the kidneys fuelled by the formation and expansion of fluid-filled cysts. The disease is congenital and children that do not succumb to it during the neonatal period will, by age 10 years, more often than not, require nephrectomy+renal replacement therapy for management of both pain and renal insufficiency. Since increasing cystic index (CI; percent of kidney occupied by cysts) drives both renal expansion and organ dysfunction, management of these patients, including decisions such as elective nephrectomy and prioritization on the transplant waitlist, could clearly benefit from serial determination of CI. So also, clinical trials in ARPKD evaluating efficacy of novel drug candidates could benefit from serial determination of CI. Although ultrasound is currently the imaging modality of choice for diagnosis of ARPKD, its utilization for assessing disease progression is highly limited. Magnetic resonance imaging or computed tomography, although more reliable for determination of CI, are expensive, time-consuming and somewhat impractical in the pediatric population. Using a well-established mammalian model of ARPKD, we undertook a big data-like analysis of minimally- or non-invasive serum and urine biomarkers of renal injury/dysfunction to derive a family of equations for estimating CI. We then applied a signal averaging protocol to distil these equations to a single empirical formula for calculation of CI. Such a formula will eventually find use in identifying and monitoring patients at high risk for progressing to end-stage renal disease and aid in the conduct of clinical trials.

scholarly journals STUDY OF ANTI-VIRUS ACTIONS OF METABOLITES OF LACTOBACTERIA

2020 ◽  
Vol 73 (7) ◽  
pp. 1484-1488
Author(s):  
Svetlana V. Kalinichenko ◽  
Kristina V. Melentyevа ◽  
Hans Manee ◽  
Natalia V. Dubinina ◽  
Natalia V. Zvereva ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Antiviral Activity ◽  
Cell Cultures ◽  
Lactobacillus Rhamnosus ◽  
Culture Fluid ◽  
Probiotic Strain ◽  
Maximum Tolerated Dose ◽  
Clinical Strains ◽  
Coxsackie B

The aim: of the work was to study the antiviral activity of the metabolites of the probiotic strain Lactobacillus rhamnosus GG (LGG or ATCC 53103) regarding clinical strains of enteroviruses (Coxsackie B-5, ECNO21) isolated from the feces of intestinal infections. Materials and methods: The object of the study was substrate-dependent cell cultures of HeLa, Vero, Hep-2 lines. The titer of the virus was determined by the presence of a clear cytopathic action (CPA) in the monolayer infected cells of the virus. Results: Determination of the enteric virus infections activity in the culture fluid showed that in samples with the LGG metabolites, the infections activity of the clinical strains of enteroviruses decreased after 24 hours, at 1.5-1.7 (p <0.05) times, and after 96 hours in 3, 6 – 5,7 times (p <0,01). the processing of cell cultures by metabolites in the amount of 0.3 mg / ml contributed to a decrease in the titer of viruses by 2.77 ± 0.11 lg TCDD50 / cm3, 2.83 ± 0.11 lg TCD50 / cm3 and 2.94 ± 0.13 lg TCD50 / cm3 for Vero, HeLa and Hep-2 line cells in 24 hours. Conclusions: It has been experimentally determined that the maximum tolerated dose (MTD) of L. rhamnosus GG metabolites was 0.3 μg / ml for all cultures of cell lines. Determination of the antiviral activity of L. rhamnosus GG metabolites in clinical viruses of enteroviruses (Coxsackie B-5 and ECNO-21) showed a decrease in infection activity in 1.5-1.7 times, (p <0.05) of clinical trials in clinical trials enteroviruses.

scholarly journals THE PLACENTAL TRANSMISSION OF ANTIBODIES IN THE SKIN SENSITIVE TYPE OF HUMAN ALLERGY

1940 ◽  
Vol 72 (5) ◽  
pp. 611-621 ◽  
Author(s):  
William B. Sherman ◽  
Stanley F. Hampton ◽  
Robert A. Cooke
Keyword(s):  
Human Placenta ◽  
Passive Transfer ◽  
Skin Tests ◽  
Pollen Extract ◽  
Human Beings ◽  
Typhoid Vaccine ◽  
Blocking Antibody ◽  
Quantitative Studies ◽  
Blocking Antibodies ◽  
Immune Antibody

1. Quantitative studies of the skin-sensitizing antibodies, blocking antibodies, and hemagglutinins in sera of allergic human beings have been made. 2. A comparison of 12 maternal and the 12 corresponding cord sera by the method of passive transfer showed the human placenta to be impermeable to skin-sensitizing antibodies. 3. Direct skin tests and passive transfer studies of 6 infants at the ages of 3 to 6 months showed negative reactions to the antigens to which their mothers were sensitive. 4. The blocking antibody present in the sera of hay fever patients after treatment with pollen extract injections was also demonstrated in the cord sera. The apparent placental transmission of this antibody gave further evidence that it was distinct from the skin-sensitizing antibody. Infant sera obtained at the ages of 3 to 6 months showed no evidence of this immune antibody. 5. The cord sera from 4 of these cases were shown to contain the same isoagglutinins as the maternal sera, showing that the placentas were permeable to these antibodies. The mothers and their offspring reacted alike to Schick testing. 6. Typhoid agglutinins were demonstrated in maternal and cord sera of an adult who previously received injections of triple typhoid vaccine, whereas the serum of the corresponding infant at the age of 3 months failed to show agglutinins.

scholarly journals Pseudomonas Exotoxin Immunotoxins and Anti-Tumor Immunity: From Observations at the Patient’s Bedside to Evaluation in Preclinical Models

Toxins ◽  
2019 ◽  
Vol 11 (1) ◽  
pp. 20 ◽  
Author(s):  
Yasmin Leshem ◽  
Ira Pastan
Keyword(s):  
Clinical Trials ◽  
Tumor Immunity ◽  
Murine Models ◽  
Preclinical Models ◽  
Pseudomonas Exotoxin ◽  
Blocking Antibody ◽  
Pseudomonas Exotoxin A ◽  
Protein Toxin ◽  
Clinical Responses ◽  
Anti Tumor Activity

Immunotoxins are protein drugs composed of a targeting domain genetically fused to a protein toxin. One killing domain being explored is a truncated Pseudomonas exotoxin A (PE). PE based immunotoxins are designed to kill cells directly by inhibiting their ability to synthesize proteins. However, observations from clinical trials suggest that this alone cannot explain their anti-tumor activity. Here we discuss patterns of clinical responses suggesting that PE immunotoxins can provoke anti-tumor immunity, and review murine models that further support this ability. In addition, we describe our preclinical effort to develop a combination therapy of local PE immunotoxins with a systemic anti-CTLA-4 immune check point blocking antibody. The combination eradicated murine tumors and prolonged the survival of mice. Clinical trials that test the ability of immunotoxins to augment immunotherapy have been recently opened.

A Bayesian cost–benefit approach to the determination of sample size in clinical trials

2007 ◽  
Vol 27 (1) ◽  
pp. 68-82 ◽  
Author(s):  
Takashi Kikuchi ◽  
Hamid Pezeshk ◽  
John Gittins
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Cost Benefit

Selenium as a Catalyst in Determination of Non-protein Nitrogen in Blood

1937 ◽  
Vol 7 (ts1_1) ◽  
pp. 18-19
Author(s):  
Frederick Reis ◽  
Harry H. Powers
Keyword(s):  
Protein Nitrogen
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