Evaluation and Long-Term Follow-up of Patients With Inflammatory Disorders
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Infectious Disease, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 2 - Any |
| Updated: | 3/24/2019 |
| Start Date: | February 5, 1993 |
Evaluation and Long Term Follow Up of Patients With Acute or Chronic Inflammatory Disorders
This study will investigate inflammatory diseases and disorders. Inflammation is the body s
immune response to many things, including infections and other acute or chronic irritants. It
may also be a sign of abnormal immune function. This study will allow evaluation and
long-term follow-up of such disorders to:
- Establish and maintain a group of patients that may be eligible for other NIAID
protocols.
- Provide clinical training and experience for NIAID fellows.
- Provide a mechanism for NIAID staff to maintain their clinical skills.
- Serve as a starting point for new investigations of syndromes not currently under study.
Patients between 1 and 80 years of age with acute or chronic inflammation, including but not
limited to viral, fungal or bacterial infections, or abnormal immune responses may be
eligible for this study. Immediate family members of patients may also be enrolled for
preliminary examination to see if they are affected in any way that may warrant further
investigation.
All patients and family members will have a history, physical examination and laboratory
tests. Depending on the results, family members may require additional tests. Patients will
have additional diagnostic tests indicated for their specific disease, according to accepted
medical standards. These may include routine blood and urine tests, X-rays or other imaging
studies, body fluid or tissue cultures, skin tests for allergic or immune responses, and
others as needed.
Treatments will include only medications approved by the Food and Drug Administration
according to accepted dose schedules and delivery methods.
Patients may be requested to donate extra blood for research studies. No more than 450 cc (30
tablespoons) will be drawn from adults within a 6-week period, and no more that 7 cc (1/2
tablespoon) from children under 18 years of age in the same time period.
immune response to many things, including infections and other acute or chronic irritants. It
may also be a sign of abnormal immune function. This study will allow evaluation and
long-term follow-up of such disorders to:
- Establish and maintain a group of patients that may be eligible for other NIAID
protocols.
- Provide clinical training and experience for NIAID fellows.
- Provide a mechanism for NIAID staff to maintain their clinical skills.
- Serve as a starting point for new investigations of syndromes not currently under study.
Patients between 1 and 80 years of age with acute or chronic inflammation, including but not
limited to viral, fungal or bacterial infections, or abnormal immune responses may be
eligible for this study. Immediate family members of patients may also be enrolled for
preliminary examination to see if they are affected in any way that may warrant further
investigation.
All patients and family members will have a history, physical examination and laboratory
tests. Depending on the results, family members may require additional tests. Patients will
have additional diagnostic tests indicated for their specific disease, according to accepted
medical standards. These may include routine blood and urine tests, X-rays or other imaging
studies, body fluid or tissue cultures, skin tests for allergic or immune responses, and
others as needed.
Treatments will include only medications approved by the Food and Drug Administration
according to accepted dose schedules and delivery methods.
Patients may be requested to donate extra blood for research studies. No more than 450 cc (30
tablespoons) will be drawn from adults within a 6-week period, and no more that 7 cc (1/2
tablespoon) from children under 18 years of age in the same time period.
Inflammatory disorders, including but not limited to those caused by viral, bacterial,
fungal, and parasitic infections, and those associated with aberrant immunologic responses
are exceedingly common acute and chronic disorders affecting humans. The pathogenesis of
these various disorders are being investigated under a number of NIAID clinical research
protocols. This protocol is an evaluation and long-term follow protocol of such disorders for
the purposes of maintaining a group of patients on which LCID investigators draw for our
other various protocols. The patients admitted under this protocol also provide training and
experience for members of the NIAID infectious diseases and allergy and immunology fellowship
training programs as well as to provide a mechanism for the members of the Laboratory of
Clinical Infectious Diseases to maintain their clinical skills. It is anticipated that the
patients will receive a degree of clinical evaluation, care and monitoring more extensive
than that generally available and that specimens collected from them can sometimes be used
for laboratory studies related to inflammatory conditions. Also, this protocol may serve as a
start point to studies of syndromes or diseases not being addressed by specific protocols,
and therefore, can be used to evaluate family members of patients with inflammatory
conditions when appropriate in order to try to understand further the disease before
embarking in a specific protocol.
fungal, and parasitic infections, and those associated with aberrant immunologic responses
are exceedingly common acute and chronic disorders affecting humans. The pathogenesis of
these various disorders are being investigated under a number of NIAID clinical research
protocols. This protocol is an evaluation and long-term follow protocol of such disorders for
the purposes of maintaining a group of patients on which LCID investigators draw for our
other various protocols. The patients admitted under this protocol also provide training and
experience for members of the NIAID infectious diseases and allergy and immunology fellowship
training programs as well as to provide a mechanism for the members of the Laboratory of
Clinical Infectious Diseases to maintain their clinical skills. It is anticipated that the
patients will receive a degree of clinical evaluation, care and monitoring more extensive
than that generally available and that specimens collected from them can sometimes be used
for laboratory studies related to inflammatory conditions. Also, this protocol may serve as a
start point to studies of syndromes or diseases not being addressed by specific protocols,
and therefore, can be used to evaluate family members of patients with inflammatory
conditions when appropriate in order to try to understand further the disease before
embarking in a specific protocol.
- INCLUSION CRITIERIA:
Males and females ages 1 year to 80 years are eligible.
Inflammatory conditions associated with, but not limited, to acute and chronic infections
or presumed infections, and congenital or acquired immunologic disorders.
If appropriate, immediate family members of patients with inflammatory conditions may be
evaluated under this protocol, as a preamble to see if further investigation is warranted,
what would be done under a specific protocol.
Willingness to participate in clinical protocols when appropriate.
Subjects must maintain a private physician for non-protocol related medical complaints and
for emergency medical treatment required for these or other of their disorders.
Willingness to provide tissue samples for studying immune dyregulation and for genetic
analysis.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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