(Complimentary Newsletter from Target Health Inc.)
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2 October 2006
I.
WHAT'S NEW?
Data Management at Target Health
II.
QUIZ - (Fill In The Blanks)
Hyperthermia
In Cancer Treatment
III.
HISTORY OF MEDICINE
Intravenous Injections
IV. INFECTIOUS DISEASE
"SAFE" Treatment of Trachoma May Worsen Patient Outcome
V. METABOLIC DISEASE
Islet Transplantation For Type 1 Diabetes
VI. IMMUNOLOGY
Bird Flu Vaccine Looks Promising
VII. PUBLIC HEALTH
Socioeconomic Status and Obstructive Sleep Apnea
VIII. FDA
Vectibix, Amgen's Drug For
IX.
Data
Management at Target Health
Data management is taking on a new perspective at Target Health. Target e*CRF®
now addresses 85% of data managment tasks. We now review monitored CRF forms
online and can electronically lock forms remotely. We can run batch edit checks
via the Internet and we are using Target Encoder™ to code MedDRA and WHODRUG
terms. We are finalizing a pharmacovigilance module for Target e*CRF® to
provide "one-top shopping" central SAE management. Soon Target
Document® will allow users all over the world to manage and electronically sign
documents. Our goal is to run a "paperless" operation. A current international
program is being finalized which will utilize 100% of our data mangement
program.
For more information about
Target Document®, please contact Dr.
Jules T. Mitchel.
Hyperthermia In Cancer Treatment
Hyperthermia is a type of cancer
treatment in which body tissue is exposed to high temperatures, up to 113°F. It
has shown that high 1) ___ can damage and kill cancer cells, usually with
minimal injury to normal tissues By killing cancer
cells and damaging 2) ___ and structures within cells, hyperthermia may shrink
3) ___. Hyperthermia is under study in 4) ___ trials and is not
widely available. Hyperthermia is almost always used with other forms of cancer
therapy, such as radiation therapy and 5) ___. Hyperthermia may make some
cancer cells more sensitive to radiation or harm other cancer cells that
radiation cannot damage. Hyperthermia can also enhance the effects of certain
anticancer 6) ___. In local hyperthermia, different types of energy may be used
to apply heat, including microwave, radio frequency, and 7) ___. In regional
hyperthermia, perfusion techniques can be used to treat cancers in the arms and
legs, such as melanoma, or cancer in some organs, such as the liver or lung.
Some of the patient’s blood is removed, heated, and then 8) ___ back into the
limb or organ. Whole-body hyperthermia is used to treat metastatic cancer.
Here, thermal chambers are used, similar to large incubators, or hot water
blankets. The effectiveness of hyperthermia treatment is related to temperature
achieved during the treatment, as well as length of treatment and cell and
tissue characteristics. Temperature of the tumor and surrounding 9) __ is
monitored throughout treatment. Using local 10) ___, small needles or tubes
with tiny thermometers are inserted into the treatment area to monitor the
temperature. Imaging techniques, such as CT may be used to make sure the probes
are properly positioned within the tumor.
ANSWERS: 1) temperatures; 2) proteins; 3) tumors;
4) clinical; 5) chemotherapy; 6) drugs; 7) ultrasound; 8) pumped; 9) tissue;
10) anesthesia
III. HISTORY OF MEDICINE
Intravenous Injections
While forms of intravenous
injection and infusion began as early as 1670, in 1853, Charles Gabriel Pravaz
and Alexander Wood were the first to develop a syringe with a needle fine
enough to pierce the skin. Many of the technical difficulties which had faced
those experimenting with blood transfusion were removed after 1853 by the
invention of the hypodermic syringe, with its hollow pointed needle. Credit for
the evolution of this universally useful appliance is usually given to Doctor
Alexander Wood (born 1817), who was appointed Secretary of the Royal College of
Physicians of
"SAFE" Treatment
of Trachoma May Worsen Patient Outcome
Trachoma is one
of the most common causes of blindness in the developing world. It is linked to
extreme poverty and poor sanitation. Trachoma is triggered by bacteria that
cause repeated conjunctivitis, irritating the eyes and creating a mucous
discharge. Although the conjunctivitis clears up after a month or so, it is
easily spread. This is particularly the case in places where there is little
water for people to wash their hands and faces regularly. Each infection of
trachoma leads to a small amount of scarring on the cornea and
conjunctiva. This scarring builds up over years of repeated infection until
trichiasis sets in. The
World Health Organization developed the SAFE strategy (Surgery for trichiasis;
Antibiotics for Chlamydia trachomatis infection; Facial cleanliness; and
Environmental improvement) to eliminate blinding trachoma globally by the year 2020. Despite
a number of studies using various intervals of treatment for different
prevalence rates, there has been a lack of sufficient follow-up beyond the
final treatment point to determine rates of recurrence of disease and infection
and the risk factors that may contribute to each. As a result, a study
published in the Journal of the American Medical Association
(2006;296:1488-1497), was performed to evaluate the impact of 2 annual targeted
azithromycin treatments on active trachoma and Camydia trachomatis
infection rates over 3 years in Vietnam. For the study, three communes were
randomly selected for a longitudinal study in
Islet Transplantation For Type 1 Diabetes
Islet
transplantation offers the potential to improve glycemic control in a subgroup
of patients with type 1 diabetes mellitus who are disabled by refractory
hypoglycemia. According to an article published I n the New England Journal of
Medicine (2006;355:1318-1330), an international,
multicenter clinical trial was performed to explore the feasibility and
reproducibility of islet transplantation with the use of a single common
protocol (the
Bird Flu Vaccine Looks
Promising
In 1999, two children in
Socioeconomic
Status and Obstructive Sleep Apnea
Low socioeconomic status
(SES) is associated with a range of health outcomes. As a result, a study
published in the Journal of Pediatrics (2006;149:342-347)
was performed to study the relationship between residence in a neighborhood of
severe socioeconomic disadvantage and childhood obstructive sleep apnea (OSA).
The study involved a cross-sectional analysis of 843 (49% female, 36%
African-American) children 8 to 11 years of age from a community-based cohort.
Data on neighborhood conditions were obtained from the 2000 US Census. The main
outcome measure was OSA, defined as an obstructive apnea hypopnea index >5
events per hour or an obstructive apnea index >1 event per hour. Results
showed that residence in a neighborhood of severe socioeconomic disadvantage
was significantly associated with OSA after adjusting for effects of previously
established risk factors: premature birth, obesity, and African-American
ethnicity (OR = 3.4). Secondary analyses showed that neighborhood disadvantage
remained significantly associated with OSA: (1) in the African-American
subgroup, after controlling for effects of prematurity and obesity; and (2)
after controlling for indicators of household-level SES or other health characteristics.
According to the authors, childhood OSA is associated with low SES as measured
by an index describing severe neighborhood disadvantage, emphasizing the
potential importance of environmental factors, particularly those associated
with neighborhood distress, as risk factors for OSA.
TARGET HEALTH excels in
Regulatory Affairs and works closely with many of its clients performing all
FDA submissions. TARGET HEALTH receives daily updates of new developments at
FDA. Each week, highlights of what is going on at FDA are shared to assure that
new information is expeditiously made available.
Vectibix, Amgen's Drug For
In the
For more information about our
expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.
TARGET HEALTH INC. (www.targethealth.com)
is a full service e*CRO with full-time staff dedicated to all aspects of drug
and device development. Areas of expertise include Regulatory Affairs,
comprising, but not limited to, IND, IDE, NDA, PMA and 510(k) submissions,
execution of Clinical Trials, Project Management, Biostatistics and Data
Management, Web Trials, utilizing Target e*CRF®, our proprietary Internet-based
Clinical Trial System, and Medical Writing. TARGET HEALTH's Pharmaceutical
Advisory Dream Team (PADT) assists companies in strategic planning from
Discovery to Market Launch. Let us help you on your next project.
TARGET HEALTH INC.
24th Floor
Phone: (212) 681-2100; Fax (212) 681-2105
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www.targethealth.com
Dr. Jules T. Mitchel, President
Ms Joyce Hays, CEO
©2006 Target Health Inc. All rights reserved