Dataset Viewer (First 5GB)
filename
stringlengths 27
27
| xml
stringlengths 1.59k
4.62M
| text
stringlengths 286
192k
|
|---|---|---|
NCT0000xxxx/NCT00000102.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000102</url>
</required_header>
<id_info>
<org_study_id>NCRR-M01RR01070-0506</org_study_id>
<secondary_id>M01RR001070</secondary_id>
<nct_id>NCT00000102</nct_id>
</id_info>
<brief_title>Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Center for Research Resources (NCRR)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Center for Research Resources (NCRR)</source>
<brief_summary>
<textblock>
This study will test the ability of extended release nifedipine (Procardia XL), a blood
pressure medication, to permit a decrease in the dose of glucocorticoid medication children
take to treat congenital adrenal hyperplasia (CAH).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This protocol is designed to assess both acute and chronic effects of the calcium channel
antagonist, nifedipine, on the hypothalamic-pituitary-adrenal axis in patients with
congenital adrenal hyperplasia. The multicenter trial is composed of two phases and will
involve a double-blind, placebo-controlled parallel design. The goal of Phase I is to examine
the ability of nifedipine vs. placebo to decrease adrenocorticotropic hormone (ACTH) levels,
as well as to begin to assess the dose-dependency of nifedipine effects. The goal of Phase II
is to evaluate the long-term effects of nifedipine; that is, can attenuation of ACTH release
by nifedipine permit a decrease in the dosage of glucocorticoid needed to suppress the HPA
axis? Such a decrease would, in turn, reduce the deleterious effects of glucocorticoid
treatment in CAH.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<phase>Phase 1/Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Congenital Adrenal Hyperplasia</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Nifedipine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- diagnosed with Congenital Adrenal Hyperplasia (CAH)

- normal ECG during baseline evaluation

Exclusion Criteria:

- history of liver disease, or elevated liver function tests

- history of cardiovascular disease
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>14 Years</minimum_age>
<maximum_age>35 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Medical University of South Carolina</name>
<address>
<city>Charleston</city>
<state>South Carolina</state>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>January 2004</verification_date>
<study_first_submitted>November 3, 1999</study_first_submitted>
<study_first_submitted_qc>November 3, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">November 4, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Adrenal Hyperplasia, Congenital</mesh_term>
<mesh_term>Adrenogenital Syndrome</mesh_term>
<mesh_term>Adrenocortical Hyperfunction</mesh_term>
<mesh_term>Hyperplasia</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Nifedipine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000102
org study id: NCRR-M01RR01070-0506
secondary id: M01RR001070
nct id: NCT00000102
lead sponsor:
This study will test the ability of extended release nifedipine (Procardia XL), a blood
pressure medication, to permit a decrease in the dose of glucocorticoid medication children
take to treat congenital adrenal hyperplasia (CAH).
This protocol is designed to assess both acute and chronic effects of the calcium channel
antagonist, nifedipine, on the hypothalamic-pituitary-adrenal axis in patients with
congenital adrenal hyperplasia. The multicenter trial is composed of two phases and will
involve a double-blind, placebo-controlled parallel design. The goal of Phase I is to examine
the ability of nifedipine vs. placebo to decrease adrenocorticotropic hormone (ACTH) levels,
as well as to begin to assess the dose-dependency of nifedipine effects. The goal of Phase II
is to evaluate the long-term effects of nifedipine; that is, can attenuation of ACTH release
by nifedipine permit a decrease in the dosage of glucocorticoid needed to suppress the HPA
axis? Such a decrease would, in turn, reduce the deleterious effects of glucocorticoid
treatment in CAH.
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Nifedipine
criteria:
gender: All
minimum age: 14 Years
maximum age: 35 Years
healthy volunteers: No
facility:
country: United States
mesh term: Adrenal Hyperplasia, Congenital
mesh term: Adrenogenital Syndrome
mesh term: Adrenocortical Hyperfunction
mesh term: Hyperplasia
mesh term: Nifedipine |
NCT0000xxxx/NCT00000104.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000104</url>
</required_header>
<id_info>
<org_study_id>NCRR-M01RR00400-0587</org_study_id>
<secondary_id>M01RR000400</secondary_id>
<nct_id>NCT00000104</nct_id>
</id_info>
<brief_title>Does Lead Burden Alter Neuropsychological Development?</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Center for Research Resources (NCRR)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
<collaborator>
<agency>HRSA/Maternal and Child Health Bureau</agency>
<agency_class>U.S. Fed</agency_class>
</collaborator>
</sponsors>
<source>National Center for Research Resources (NCRR)</source>
<brief_summary>
<textblock>
Inner city children are at an increased risk for lead overburden. This in turn affects
cognitive functioning. However, the underlying neuropsychological effects of lead overburden
and its age-specific effects have not been well delineated. This study is part of a larger
study on the effects of lead overburden on the development of attention and memory. The
larger study is using a multi-model approach to study the effects of lead overburden on these
effects including the event-related potential (ERP), electrophysiologic measures of attention
and memory are studied. Every eight months, for a total of three sessions the subjects will
complete ERP measures of attention and memory which require them to watch various computer
images while wearing scalp electrodes recording from 11 sites. It is this test that we are
going to be doing on CRC. There will be 30 lead overburdened children recruited from the
larger study for participation in the ERP studies on CRC. These 30 children will be matched
with 30 children without lead overburden. This portion of the study is important in providing
an index of physiological functioning to be used along with behaviorally based measures of
attention and memory, and for providing information about the different measures.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Defined Population</observational_model>
<time_perspective>Other</time_perspective>
</study_design_info>
<condition>Lead Poisoning</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>ERP measures of attention and memory</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Pregnant mothers of the Phillips neighborhood in Minneapolis, Minnesota. Subject
recruitment will take place in local clinics which serve pregnant women and offspring
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>0 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Department of Neurology 420 Delaware St. SE, Box 486 Mayo</name>
<address>
<city>Minneapolis</city>
<state>Minnesota</state>
<zip>55455</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>December 2003</verification_date>
<study_first_submitted>November 3, 1999</study_first_submitted>
<study_first_submitted_qc>November 3, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">November 4, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>lead overburden</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Poisoning</mesh_term>
<mesh_term>Lead Poisoning</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000104
org study id: NCRR-M01RR00400-0587
secondary id: M01RR000400
nct id: NCT00000104
lead sponsor:
collaborator:
Inner city children are at an increased risk for lead overburden. This in turn affects
cognitive functioning. However, the underlying neuropsychological effects of lead overburden
and its age-specific effects have not been well delineated. This study is part of a larger
study on the effects of lead overburden on the development of attention and memory. The
larger study is using a multi-model approach to study the effects of lead overburden on these
effects including the event-related potential (ERP), electrophysiologic measures of attention
and memory are studied. Every eight months, for a total of three sessions the subjects will
complete ERP measures of attention and memory which require them to watch various computer
images while wearing scalp electrodes recording from 11 sites. It is this test that we are
going to be doing on CRC. There will be 30 lead overburdened children recruited from the
larger study for participation in the ERP studies on CRC. These 30 children will be matched
with 30 children without lead overburden. This portion of the study is important in providing
an index of physiological functioning to be used along with behaviorally based measures of
attention and memory, and for providing information about the different measures.
observational model: Defined Population
time perspective: Other
intervention type: Procedure
intervention name: ERP measures of attention and memory
criteria:
gender: Female
minimum age: 0 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility:
country: United States
mesh term: Poisoning
mesh term: Lead Poisoning |
NCT0000xxxx/NCT00000105.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000105</url>
</required_header>
<id_info>
<org_study_id>2002LS032</org_study_id>
<secondary_id>MT1999-06</secondary_id>
<nct_id>NCT00000105</nct_id>
</id_info>
<brief_title>Vaccination With Tetanus and KLH to Assess Immune Responses.</brief_title>
<official_title>Vaccination With Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune Responses</official_title>
<sponsors>
<lead_sponsor>
<agency>Masonic Cancer Center, University of Minnesota</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Masonic Cancer Center, University of Minnesota</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this study is to learn how the immune system works in response to vaccines. We
will give the vaccines to subjects who have cancer but have not had treatment, and to
patients who have had chemotherapy or stem cell transplant. Some patients will get vaccines
while they are on treatments which boost the immune system (like the immune stimulating drug
interleukin-2 or IL-2). Although we have safely treated many patients with immune boosting
drugs, we do not yet know if they improve the body's immune system to respond better to a
vaccine. Some healthy volunteers will also be given the vaccines in order to serve as control
subjects to get a good measure of the normal immune response. We will compare the patients
and the healthy volunteers to study how their immune systems respond to the vaccines.

There are several different types of white cells in the blood. We are interested in immune
cells in the blood called T-cells. These T-cells detect foreign substances in the body (like
viruses and cancer cells). We are trying to learn more about how the body fights these
foreign substances. Our goal is to develop cancer vaccines which would teach T-cells to
detect and kill cancer cells better. We know that in healthy people the immune system
effectively protects against recurrent virus infection. For example, that is why people only
get "mono" (mononucleosis) once under normal circumstances. When the body is infected with
the "mono" virus, the immune system remembers and prevents further infection. We are trying
to use the immune system to prevent cancer relapse. To test this, we will give two vaccines
which have been used to measure these immune responses. Blood samples will be studied from
cancer patients and will be compared to similar samples from normal subjects.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Patients will receive each vaccine once only consisting of:

Arm A: Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml
intramuscularly (this arm closed 1/2/02).

Arm B: Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml
intramuscularly (this arm closed 3/18/03).

Arm C: Biosyn KLH 1000 mcg (1 mg) with Montanide ISA51 (now replaced with vegetable (VG)
source after 8/31/06 to increase product safety) subcutaneous Tetanus toxoid 0.5 ml
intramuscularly (this arm open 3/18/03).

Subjects ineligible for tetanus may still receive KLH on this protocol. This is especially
true given the national shortage of tetanus vaccines. Subjects will be eligible for tetanus
when it becomes available if there has been no significant change in treatment interventions
or overall health status and it is within 3 months of the KLH vaccine.
</textblock>
</detailed_description>
<overall_status>Terminated</overall_status>
<why_stopped>
Replaced by another study.
</why_stopped>
<start_date>July 2002</start_date>
<completion_date type="Actual">March 2012</completion_date>
<primary_completion_date type="Actual">March 2012</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>To assess whether patients can mediate an appropriate immune response KLH</measure>
<time_frame>Week 4 post vaccination</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>Tetanus Response</measure>
<time_frame>Throughout study</time_frame>
</secondary_outcome>
<number_of_groups>3</number_of_groups>
<enrollment type="Actual">112</enrollment>
<condition>Cancer</condition>
<arm_group>
<arm_group_label>Arm A: Intracel KLH</arm_group_label>
<description>Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly (this arm closed 1/2/02).</description>
</arm_group>
<arm_group>
<arm_group_label>Arm B: Biosyn KLH</arm_group_label>
<description>Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly (this arm closed 3/18/03).</description>
</arm_group>
<arm_group>
<arm_group_label>Arm C: Biosyn KLH with Montanide ISA51</arm_group_label>
<description>Biosyn KLH 1000 mcg (1 mg) with Montanide ISA51 (replaced with vegetable (VG) source after 8/31/06) and subcutaneous Tetanus toxoid 0.5 ml intramuscularly.</description>
</arm_group>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>Intracel KLH Vaccine</intervention_name>
<description>Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly.</description>
<arm_group_label>Arm A: Intracel KLH</arm_group_label>
<other_name>KLH BCI-ImmuneActivator(TM)</other_name>
<other_name>IntraCel</other_name>
</intervention>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>Biosyn KLH</intervention_name>
<description>Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly.</description>
<arm_group_label>Arm B: Biosyn KLH</arm_group_label>
<arm_group_label>Arm C: Biosyn KLH with Montanide ISA51</arm_group_label>
<other_name>Immunocyanin</other_name>
<other_name>IMMUCOTHEL®</other_name>
<other_name>VACMUNE®</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Montanide ISA51</intervention_name>
<description>Emulsify the KLH with Montanide ISA-51. The KLH 1 mg vial will be reconstituted in 0.5 mL sterile water. Once solubilized, add 0.6 mL of Montanide ISA to the vial and administered contents subcutaneously.</description>
<arm_group_label>Arm C: Biosyn KLH with Montanide ISA51</arm_group_label>
<other_name>Montanide ISA 51 VG</other_name>
</intervention>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>Tetanus toxoid</intervention_name>
<description>Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only.</description>
<arm_group_label>Arm A: Intracel KLH</arm_group_label>
<arm_group_label>Arm B: Biosyn KLH</arm_group_label>
<arm_group_label>Arm C: Biosyn KLH with Montanide ISA51</arm_group_label>
<other_name>PUROGENATED®</other_name>
</intervention>
<biospec_retention>Samples With DNA</biospec_retention>
<biospec_descr>
<textblock>
analysis of blood samples before and 4 weeks postvaccination
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
- Normal volunteers

- Patients with Cancer (breast, melanoma, hematologic)

- Transplant patients (umbilical cord blood transplant, autologous transplant)

- Patients receiving other cancer vaccines
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Patients must have a diagnosis of cancer of any histologic type.

- Patients must have a Karnofsky performance status great or equal to 70%.

- Patients must have an expected survival for at least four months.

- Normal healthy volunteers to serve as control for this study.

- All patients must sign informed consent approved by the Committee on the Use of Human
Subjects at the University of Minnesota

Exclusion Criteria:

- Pregnant or lactating women. Females of child-bearing potential will be asked to take
a pregnancy test before receiving vaccines.

- Serious intercurrent medical illnesses which would interfere with the ability of the
patient to carry out the follow-up monitoring program.

- Immunization should not be administered during the course of any febrile illness or
acute infection.

- Hypersensitivity to any component of the vaccine, including Thimerosal, a mercury
derivative.

- The occurrence of any type of neurologic symptoms to tetanus vaccine in th past.

- Patients with a history of seafood allergy are excluded from receiving KLH.

- Subjects who have had tetanus toxoid within the last 7 years are not eligible for
tetanus vaccine component of this protocol.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Jeffrey Miller, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Masonic Cancer Center, University of Minnesota</affiliation>
</overall_official>
<location>
<facility>
<name>Division of Hematology, Oncology, and Transplantation 420 Delaware St., SE, Box 806 Mayo</name>
<address>
<city>Minneapolis</city>
<state>Minnesota</state>
<zip>55455</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>November 2017</verification_date>
<study_first_submitted>November 3, 1999</study_first_submitted>
<study_first_submitted_qc>November 3, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">November 4, 1999</study_first_posted>
<last_update_submitted>November 27, 2017</last_update_submitted>
<last_update_submitted_qc>November 27, 2017</last_update_submitted_qc>
<last_update_posted type="Actual">November 29, 2017</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Tetanus</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Monatide (IMS 3015)</mesh_term>
<mesh_term>Freund's Adjuvant</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000105
org study id: 2002LS032
secondary id: MT1999-06
nct id: NCT00000105
lead sponsor:
has dmc: Yes
The purpose of this study is to learn how the immune system works in response to vaccines. We
will give the vaccines to subjects who have cancer but have not had treatment, and to
patients who have had chemotherapy or stem cell transplant. Some patients will get vaccines
while they are on treatments which boost the immune system (like the immune stimulating drug
interleukin-2 or IL-2). Although we have safely treated many patients with immune boosting
drugs, we do not yet know if they improve the body's immune system to respond better to a
vaccine. Some healthy volunteers will also be given the vaccines in order to serve as control
subjects to get a good measure of the normal immune response. We will compare the patients
and the healthy volunteers to study how their immune systems respond to the vaccines.
There are several different types of white cells in the blood. We are interested in immune
cells in the blood called T-cells. These T-cells detect foreign substances in the body (like
viruses and cancer cells). We are trying to learn more about how the body fights these
foreign substances. Our goal is to develop cancer vaccines which would teach T-cells to
detect and kill cancer cells better. We know that in healthy people the immune system
effectively protects against recurrent virus infection. For example, that is why people only
get "mono" (mononucleosis) once under normal circumstances. When the body is infected with
the "mono" virus, the immune system remembers and prevents further infection. We are trying
to use the immune system to prevent cancer relapse. To test this, we will give two vaccines
which have been used to measure these immune responses. Blood samples will be studied from
cancer patients and will be compared to similar samples from normal subjects.
Patients will receive each vaccine once only consisting of:
Arm A: Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml
intramuscularly (this arm closed 1/2/02).
Arm B: Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml
intramuscularly (this arm closed 3/18/03).
Arm C: Biosyn KLH 1000 mcg (1 mg) with Montanide ISA51 (now replaced with vegetable (VG)
source after 8/31/06 to increase product safety) subcutaneous Tetanus toxoid 0.5 ml
intramuscularly (this arm open 3/18/03).
Subjects ineligible for tetanus may still receive KLH on this protocol. This is especially
true given the national shortage of tetanus vaccines. Subjects will be eligible for tetanus
when it becomes available if there has been no significant change in treatment interventions
or overall health status and it is within 3 months of the KLH vaccine.
observational model: Case-Control
time perspective: Prospective
measure: To assess whether patients can mediate an appropriate immune response KLH
time frame: Week 4 post vaccination
measure: Tetanus Response
time frame: Throughout study
arm group label: Arm A: Intracel KLH
description: Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly (this arm closed 1/2/02).
arm group label: Arm B: Biosyn KLH
description: Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly (this arm closed 3/18/03).
arm group label: Arm C: Biosyn KLH with Montanide ISA51
description: Biosyn KLH 1000 mcg (1 mg) with Montanide ISA51 (replaced with vegetable (VG) source after 8/31/06) and subcutaneous Tetanus toxoid 0.5 ml intramuscularly.
intervention type: Biological
intervention name: Intracel KLH Vaccine
description: Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly.
arm group label: Arm A: Intracel KLH
other name: KLH BCI-ImmuneActivator(TM)
other name: IntraCel
intervention type: Biological
intervention name: Biosyn KLH
description: Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly.
arm group label: Arm B: Biosyn KLH
arm group label: Arm C: Biosyn KLH with Montanide ISA51
other name: Immunocyanin
other name: IMMUCOTHEL®
other name: VACMUNE®
intervention type: Drug
intervention name: Montanide ISA51
description: Emulsify the KLH with Montanide ISA-51. The KLH 1 mg vial will be reconstituted in 0.5 mL sterile water. Once solubilized, add 0.6 mL of Montanide ISA to the vial and administered contents subcutaneously.
arm group label: Arm C: Biosyn KLH with Montanide ISA51
other name: Montanide ISA 51 VG
intervention type: Biological
intervention name: Tetanus toxoid
description: Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only.
arm group label: Arm A: Intracel KLH
arm group label: Arm B: Biosyn KLH
arm group label: Arm C: Biosyn KLH with Montanide ISA51
other name: PUROGENATED®
analysis of blood samples before and 4 weeks postvaccination
study pop:
sampling method: Probability Sample
criteria:
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffrey Miller, MD
role: Principal Investigator
affiliation: Masonic Cancer Center, University of Minnesota
facility:
country: United States
responsible party type: Sponsor
mesh term: Tetanus
mesh term: Monatide (IMS 3015)
mesh term: Freund's Adjuvant |
NCT0000xxxx/NCT00000106.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000106</url>
</required_header>
<id_info>
<org_study_id>NCRR-M01RR03186-9943</org_study_id>
<secondary_id>M01RR003186</secondary_id>
<nct_id>NCT00000106</nct_id>
</id_info>
<brief_title>41.8 Degree Centigrade Whole Body Hyperthermia for the Treatment of Rheumatoid Diseases</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Center for Research Resources (NCRR)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Center for Research Resources (NCRR)</source>
<brief_summary>
<textblock>
Recently a non-toxic system for whole body hyperthermia (WBH) used at the University of
Wisconsin has been shown to induce soluble tumor necrosis factor-receptor (sTNF-R) I and II
when patients are heated systemically to 41.8C for 60 minutes. This observation might provide
a biological basis for the therapeutic application of WBH to rheumatoid diseases, for which
there is a positive anecdotal clinical experience. Inherent in the hypothesis which is the
basis for this protocol is the concept that the induction of TNF receptors by WBH may induce
a remission in patients with active rheumatoid arthritis. Beyond clinical response the
biological endpoint for this investigation includes cytokine levels, TNF levels, sTNF-R
levels and changes in cellular TNF receptors.
</textblock>
</brief_summary>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Rheumatic Diseases</condition>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Whole body hyperthermia unit</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Patients are required to meet the criteria of the American College of Rheumatology
(ACR)for rheumatoid arthritis.

- Patients should be in functional class II, or III according to the criteria of the
ACR.

- All candidates must be unsuccessfully treated (lack of efficacy) with at least two of
the following disease-modifying antirheumatic drugs: hydroxychloroquinine, oral or
injectable gold, methotrexate, azathioprine, penicillamine, and sulfasalazine.

- Patients receiving nonsteroidal antiinflammatory drugs (NSAIDs), corticosteroids (<=
10 mg per day), or both are eligible if the dosage has been stable for at least four
weeks before treatment and remained so throughout the study and follow-up period (the
use of narcotics for pain flares is allowed).

- The necessary degree of disease activity at enrollment should be confirmed by a
finding of 10 or more swollen joints, 12 or more tender joints, and one of the
following two criteria: a Westergren erythrocyte sedimentation rate of at least 28 mm
per hour or a serum C-reactive protein level of more than 2.0 mg per deciliter; or
morning stiffness for at least 60 minutes.

- Patients must have adequate bone marrow function, adequate liver function, adequate
renal function, calcium and electrolytes.

- Patients must have a dobutamine stress ECHO, or exercise cardiac MUGA, or exercise
ECHO scan prior to entry and must fulfill certain criteria to be eligible. The spirit
of the criteria are to rule out organic heart disease.

- Respiratory status: Patients who have FEV1 of >= 60% of predicted, as well as a
maximum voluntary volume (MVV) of >= 60% of predicted, and blood gases with a PO2 of
>= 60 or oxygen saturation of >= 90% are eligible.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>K4/666 CSC 600 Highland Av</name>
<address>
<city>Madison</city>
<state>Wisconsin</state>
<zip>53792</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>November 2000</verification_date>
<study_first_submitted>January 18, 2000</study_first_submitted>
<study_first_submitted_qc>January 18, 2000</study_first_submitted_qc>
<study_first_posted type="Estimate">January 19, 2000</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>Rheumatoid Diseases</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Rheumatic Diseases</mesh_term>
<mesh_term>Collagen Diseases</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000106
org study id: NCRR-M01RR03186-9943
secondary id: M01RR003186
nct id: NCT00000106
lead sponsor:
Recently a non-toxic system for whole body hyperthermia (WBH) used at the University of
Wisconsin has been shown to induce soluble tumor necrosis factor-receptor (sTNF-R) I and II
when patients are heated systemically to 41.8C for 60 minutes. This observation might provide
a biological basis for the therapeutic application of WBH to rheumatoid diseases, for which
there is a positive anecdotal clinical experience. Inherent in the hypothesis which is the
basis for this protocol is the concept that the induction of TNF receptors by WBH may induce
a remission in patients with active rheumatoid arthritis. Beyond clinical response the
biological endpoint for this investigation includes cytokine levels, TNF levels, sTNF-R
levels and changes in cellular TNF receptors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
intervention type: Device
intervention name: Whole body hyperthermia unit
criteria:
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility:
country: United States
mesh term: Rheumatic Diseases
mesh term: Collagen Diseases |
NCT0000xxxx/NCT00000107.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000107</url>
</required_header>
<id_info>
<org_study_id>NCRR-M01RR00109-0737</org_study_id>
<secondary_id>M01RR000109</secondary_id>
<nct_id>NCT00000107</nct_id>
</id_info>
<brief_title>Body Water Content in Cyanotic Congenital Heart Disease</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Center for Research Resources (NCRR)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Center for Research Resources (NCRR)</source>
<brief_summary>
<textblock>
Adults with cyanotic congenital heart disease have elevated levels of plasma proatrial
natruretic peptide (proANP) which most likely results in chronic dehydration, leading to
reduced oxygen transport to tissues and shortness of breath with activity. The purpose of
this study is to characterize adults with cyanotic congenital heart defects with respect to
their body composition (water and fat-free mass) and resting metabolic rates. The study
consists of several measures of how much body water, fat and lean tissue a subject has, and
measures the number of calories the subject's body uses at rest. Adult subjects with cyanotic
congenital heart disease will be recruited along with healthy noncyanotic control subjects
matched for age, gender, and body weight.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
</study_design_info>
<condition>Heart Defects, Congenital</condition>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Resting blood pressure below 140/90
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>17 Years</minimum_age>
<maximum_age>60 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>University of Vermont</name>
<address>
<city>Burlington</city>
<state>Vermont</state>
<zip>05401</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>December 2003</verification_date>
<study_first_submitted>January 18, 2000</study_first_submitted>
<study_first_submitted_qc>January 18, 2000</study_first_submitted_qc>
<study_first_posted type="Estimate">January 19, 2000</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>Cyanotic Congenital Heart Disease</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Heart Defects, Congenital</mesh_term>
<mesh_term>Congenital Abnormalities</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000107
org study id: NCRR-M01RR00109-0737
secondary id: M01RR000109
nct id: NCT00000107
lead sponsor:
Adults with cyanotic congenital heart disease have elevated levels of plasma proatrial
natruretic peptide (proANP) which most likely results in chronic dehydration, leading to
reduced oxygen transport to tissues and shortness of breath with activity. The purpose of
this study is to characterize adults with cyanotic congenital heart defects with respect to
their body composition (water and fat-free mass) and resting metabolic rates. The study
consists of several measures of how much body water, fat and lean tissue a subject has, and
measures the number of calories the subject's body uses at rest. Adult subjects with cyanotic
congenital heart disease will be recruited along with healthy noncyanotic control subjects
matched for age, gender, and body weight.
observational model: Case-Control
criteria:
gender: All
minimum age: 17 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility:
country: United States
mesh term: Heart Defects, Congenital
mesh term: Congenital Abnormalities |
NCT0000xxxx/NCT00000108.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000108</url>
</required_header>
<id_info>
<org_study_id>NCRR-M01RR00042-1647</org_study_id>
<secondary_id>M01RR000042</secondary_id>
<nct_id>NCT00000108</nct_id>
</id_info>
<brief_title>Effects of Training Intensity on the CHD Risk Factors in Postmenopausal Women</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Center for Research Resources (NCRR)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Center for Research Resources (NCRR)</source>
<brief_summary>
<textblock>
The purpose of this research is to find out whether training at different exercise
intensities reduces the risk of developing cardiovascular disease (CVD) to a different
extent. Heart attacks and stroke are the leading cause of death in older women. Reduced
variability of the heart rate and increased dips and swings in blood pressure are risks
factors that predict the chance of developing CVD as are increased levels of clotting protein
fibrinogen and plasminogen activator inhibitor 1, and high levels of LDL-cholesterol
(>160mg/dl). We will be measuring all of these risk factors and any changes in your body fat
level before you start training and after 15 and 30 weeks of training in the form of walking.
At the present time the effects of exercise intensity on these factors are not well
understood. This study will add to the basic understanding of these issues and allow us to
recommend to postmenopausal women optimal exercise intensities to lose body fat and reduce
the risk of developing CVD.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Prevention</primary_purpose>
</study_design_info>
<condition>Cardiovascular Diseases</condition>
<condition>Coronary Disease</condition>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Exercise</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Postmenopausal and preferably on hormone replacement therapy

- In good general health

- Have a body mass index (BMI, weight in kg/height in m2) of between 25 and 40

- Exercise less than 20 min/day two days a week
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>50 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>3060G Central Campus Recreation Bldg 401 Washtenaw Ave.</name>
<address>
<city>Ann Arbor</city>
<state>Michigan</state>
<zip>48109-2214</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>December 2003</verification_date>
<study_first_submitted>January 18, 2000</study_first_submitted>
<study_first_submitted_qc>January 18, 2000</study_first_submitted_qc>
<study_first_posted type="Estimate">January 19, 2000</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>exercise</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cardiovascular Diseases</mesh_term>
<mesh_term>Coronary Disease</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000108
org study id: NCRR-M01RR00042-1647
secondary id: M01RR000042
nct id: NCT00000108
lead sponsor:
The purpose of this research is to find out whether training at different exercise
intensities reduces the risk of developing cardiovascular disease (CVD) to a different
extent. Heart attacks and stroke are the leading cause of death in older women. Reduced
variability of the heart rate and increased dips and swings in blood pressure are risks
factors that predict the chance of developing CVD as are increased levels of clotting protein
fibrinogen and plasminogen activator inhibitor 1, and high levels of LDL-cholesterol
(>160mg/dl). We will be measuring all of these risk factors and any changes in your body fat
level before you start training and after 15 and 30 weeks of training in the form of walking.
At the present time the effects of exercise intensity on these factors are not well
understood. This study will add to the basic understanding of these issues and allow us to
recommend to postmenopausal women optimal exercise intensities to lose body fat and reduce
the risk of developing CVD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
intervention type: Behavioral
intervention name: Exercise
criteria:
gender: Female
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility:
country: United States
mesh term: Cardiovascular Diseases
mesh term: Coronary Disease |
NCT0000xxxx/NCT00000110.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000110</url>
</required_header>
<id_info>
<org_study_id>NCRR-M01RR00032-0855</org_study_id>
<secondary_id>M01RR000032</secondary_id>
<nct_id>NCT00000110</nct_id>
</id_info>
<brief_title>Influence of Diet and Endurance Running on Intramuscular Lipids Measured at 4.1 TESLA</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Center for Research Resources (NCRR)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Center for Research Resources (NCRR)</source>
<brief_summary>
<textblock>
The purpose of this pilot investigation is to use 1 H Magnetic Resonance Spectroscopy (MRS)
to 1) document the change in intra-muscular lipid stores (IML) before and after a prolonged
bout of endurance running and, 2) determine the pattern (time course) of IML replenishment
following an extremely low-fat diet (10% of energy from fat) and a moderate-fat diet (35% of
energy from fat). Specifically, the study will evaluate the change in IML following a 2-hour
training run and the recovery of IML in response to the post-exercise low-fat or moderate-fat
diet in 10 endurance trained athletes who will consume both diets in a randomly assigned
cross-over fashion. We hypothesize that IML will be depleted with prolonged endurance
exercise, and that replenishment of IML will be impaired by an extremely low-fat diet
compared to a moderate-fat diet. Results of this pilot study will be used to apply for
extramural grant support from NIH or the US Armed Forces to investigate the effect of dietary
fat on the health and performance of individuals performing heavy physical training. It is
anticipated that this methodology could also be employed in obesity research to delineate,
longitudinally, the reported cross-sectional relationships among IML stores, insulin
resistance and obesity.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
<masking>Single</masking>
</study_design_info>
<condition>Obesity</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>magnetic resonance spectroscopy</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>dietary fat</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Healthy volunteers (developmental phase)

- Healthy endurance-trained subjects

- Maximum age for males is 39

- Maximum age for females is 49
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>49 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>The University of Alabama at Birmingham Nutrition Sciences Department</name>
<address>
<city>Birmingham</city>
<state>Alabama</state>
<zip>35294</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>December 2003</verification_date>
<study_first_submitted>January 18, 2000</study_first_submitted>
<study_first_submitted_qc>January 18, 2000</study_first_submitted_qc>
<study_first_posted type="Estimate">January 19, 2000</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>exercise</keyword>
<keyword>exertion</keyword>
<keyword>physical fitness</keyword>
<keyword>lipids</keyword>
<keyword>nutrition</keyword>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000110
org study id: NCRR-M01RR00032-0855
secondary id: M01RR000032
nct id: NCT00000110
lead sponsor:
The purpose of this pilot investigation is to use 1 H Magnetic Resonance Spectroscopy (MRS)
to 1) document the change in intra-muscular lipid stores (IML) before and after a prolonged
bout of endurance running and, 2) determine the pattern (time course) of IML replenishment
following an extremely low-fat diet (10% of energy from fat) and a moderate-fat diet (35% of
energy from fat). Specifically, the study will evaluate the change in IML following a 2-hour
training run and the recovery of IML in response to the post-exercise low-fat or moderate-fat
diet in 10 endurance trained athletes who will consume both diets in a randomly assigned
cross-over fashion. We hypothesize that IML will be depleted with prolonged endurance
exercise, and that replenishment of IML will be impaired by an extremely low-fat diet
compared to a moderate-fat diet. Results of this pilot study will be used to apply for
extramural grant support from NIH or the US Armed Forces to investigate the effect of dietary
fat on the health and performance of individuals performing heavy physical training. It is
anticipated that this methodology could also be employed in obesity research to delineate,
longitudinally, the reported cross-sectional relationships among IML stores, insulin
resistance and obesity.
primary purpose: Treatment
masking: Single
intervention type: Procedure
intervention name: magnetic resonance spectroscopy
intervention type: Drug
intervention name: dietary fat
criteria:
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
facility:
country: United States |
NCT0000xxxx/NCT00000111.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000111</url>
</required_header>
<id_info>
<org_study_id>NCRR-M01RR00042-1620</org_study_id>
<secondary_id>M01RR000042</secondary_id>
<nct_id>NCT00000111</nct_id>
</id_info>
<brief_title>Intraoral Grafting of Ex Vivo Produced Oral Mucosal Composites</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Center for Research Resources (NCRR)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Center for Research Resources (NCRR)</source>
<brief_summary>
<textblock>
The purpose of this study is to see if we can develop a good graft for oral mucosal tissue
that is like the top of the mouth in a "test tube" that could be used successfully in humans.
We have already done this successfully mice. The next step is to take a small piece of tissue
from a human volunteer and see if we can grow a larger piece of tissue from it outside the
human body and graft it back into the same person successfully. We expect that this technique
will work. It has already been tried in patients with burns of the skin who have had similar
procedures where the skin is grafted back to them. The significance of this research is that
oral tissue taken from the top of the mouth or palate is in limited supply and leaves the
patient with a painful and uncomfortable post surgery experience. If we are successful with
our technique the patient will experience less pain and discomfort from the site that we are
using to grow our tissue outside the body than if we had taken it from the top of the mouth
or palate. In addition, by waiting longer periods to grow the patient's cells we can make
larger pieces of oral tissue than we could have gotten directly from the patient's mouth.
Patients who will participate in this study will need to require a soft tissue graft from the
mouth to an area that needs additional attached or keratinized mucosa. This will most likely
be either in preparation for patients who have or will have dental implants placed. Another
subset of patients are those who need scar tissue released or the vestibule of their mouth
(area that turns from the gums to the lip) released.
</textblock>
</brief_summary>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<condition>Mouth Diseases</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Oral mucosal graft</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Lack sufficient attached keratinized tissue at recipient surgical site in question
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<verification_date>September 2000</verification_date>
<study_first_submitted>January 18, 2000</study_first_submitted>
<study_first_submitted_qc>January 18, 2000</study_first_submitted_qc>
<study_first_posted type="Estimate">January 19, 2000</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>mouth mucosa</keyword>
<keyword>transplants</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Mouth Diseases</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000111
org study id: NCRR-M01RR00042-1620
secondary id: M01RR000042
nct id: NCT00000111
lead sponsor:
The purpose of this study is to see if we can develop a good graft for oral mucosal tissue
that is like the top of the mouth in a "test tube" that could be used successfully in humans.
We have already done this successfully mice. The next step is to take a small piece of tissue
from a human volunteer and see if we can grow a larger piece of tissue from it outside the
human body and graft it back into the same person successfully. We expect that this technique
will work. It has already been tried in patients with burns of the skin who have had similar
procedures where the skin is grafted back to them. The significance of this research is that
oral tissue taken from the top of the mouth or palate is in limited supply and leaves the
patient with a painful and uncomfortable post surgery experience. If we are successful with
our technique the patient will experience less pain and discomfort from the site that we are
using to grow our tissue outside the body than if we had taken it from the top of the mouth
or palate. In addition, by waiting longer periods to grow the patient's cells we can make
larger pieces of oral tissue than we could have gotten directly from the patient's mouth.
Patients who will participate in this study will need to require a soft tissue graft from the
mouth to an area that needs additional attached or keratinized mucosa. This will most likely
be either in preparation for patients who have or will have dental implants placed. Another
subset of patients are those who need scar tissue released or the vestibule of their mouth
(area that turns from the gums to the lip) released.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
intervention type: Procedure
intervention name: Oral mucosal graft
criteria:
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
mesh term: Mouth Diseases |
NCT0000xxxx/NCT00000112.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000112</url>
</required_header>
<id_info>
<org_study_id>NCRR-M01RR06022-0029</org_study_id>
<secondary_id>M01RR006022</secondary_id>
<nct_id>NCT00000112</nct_id>
</id_info>
<brief_title>Prevalence of Carbohydrate Intolerance in Lean and Obese Children</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Center for Research Resources (NCRR)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Center for Research Resources (NCRR)</source>
<brief_summary>
<textblock>
The prevalence of obesity in children is reaching epidemic proportions. Excess adiposity is
more than just a cosmetic problem, having substantial metabolic consequences. Insulin
resistance, hyperinsulinemia, impaired glucose tolerance, and frank diabetes are often seen
in obese children. In this study the prevalence of impaired glucose (carbohydrate) tolerance
in lean children with a family history of diabetes and obese children with acanthosis
nigricans with or without a family history of diabetes mellitus will be studied.
</textblock>
</brief_summary>
<overall_status>Unknown status</overall_status>
<last_known_status>Recruiting</last_known_status>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Defined Population</observational_model>
<time_perspective>Other</time_perspective>
</study_design_info>
<condition>Obesity</condition>
<condition>Glucose Intolerance</condition>
<condition>Diabetes</condition>
<condition>Acanthosis Nigricans</condition>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Obesity: BM +/- 95% for age general good health
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>8 Years</minimum_age>
<maximum_age>18 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Sonia Caprio, M.D.</last_name>
<phone>1-203-764-5692</phone>
<email>[email protected]</email>
</overall_contact>
<location>
<facility>
<name>Yale University School of Medicine, Pediatric Endocrinology</name>
<address>
<city>New Haven</city>
<state>Connecticut</state>
<zip>06520-8064</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>December 2003</verification_date>
<study_first_submitted>January 18, 2000</study_first_submitted>
<study_first_submitted_qc>January 18, 2000</study_first_submitted_qc>
<study_first_posted type="Estimate">January 19, 2000</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Acanthosis Nigricans</mesh_term>
<mesh_term>Glucose Intolerance</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000112
org study id: NCRR-M01RR06022-0029
secondary id: M01RR006022
nct id: NCT00000112
lead sponsor:
The prevalence of obesity in children is reaching epidemic proportions. Excess adiposity is
more than just a cosmetic problem, having substantial metabolic consequences. Insulin
resistance, hyperinsulinemia, impaired glucose tolerance, and frank diabetes are often seen
in obese children. In this study the prevalence of impaired glucose (carbohydrate) tolerance
in lean children with a family history of diabetes and obese children with acanthosis
nigricans with or without a family history of diabetes mellitus will be studied.
observational model: Defined Population
time perspective: Other
criteria:
gender: All
minimum age: 8 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sonia Caprio, M.D.
phone: 1-203-764-5692
email: [email protected]
facility:
status: Recruiting
country: United States
mesh term: Acanthosis Nigricans
mesh term: Glucose Intolerance |
NCT0000xxxx/NCT00000113.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000113</url>
</required_header>
<id_info>
<org_study_id>NEI-9</org_study_id>
<secondary_id>U10EY011756</secondary_id>
<nct_id>NCT00000113</nct_id>
</id_info>
<brief_title>Correction of Myopia Evaluation Trial (COMET)</brief_title>
<official_title>Correction of Myopia Evaluation Trial (COMET)</official_title>
<sponsors>
<lead_sponsor>
<agency>Stony Brook University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>Stony Brook University</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
To evaluate whether progressive addition lenses (PALs) slow the rate of progression of
juvenile-onset myopia (nearsightedness) when compared with single vision lenses, as measured
by cycloplegic autorefraction. An additional outcome measure is axial length, as measured by
A-scan ultrasonography.

To describe the natural history of juvenile-onset myopia in a group of children receiving
conventional treatment (single vision lenses).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Myopia (nearsightedness) is an important public health problem, which entails substantial
societal and personal costs. It is highly prevalent in our society and even more frequent in
Asian countries; furthermore, its prevalence may be increasing over time. High myopia
contributes to significant loss of vision and blindness. At present, the mechanisms involved
in the etiology of myopia are unclear, and there is no way to prevent the condition. Current
methods of correction require lifelong use of lenses or surgical treatment, which is
expensive and may lead to complications. The rationale for this trial, the Correction of
Myopia Evaluation Trial (COMET), arises from the convergence of research involving (1) the
link between accommodation and myopia in children and (2) animal models of myopia showing the
important role of the visual environment in eye growth. A contribution of this research is
that blur is a critical component in the development of myopia. The primary aim of COMET, to
evaluate the efficacy of progressive addition lenses, a noninvasive intervention, in slowing
the progression of myopia, follows from this line of reasoning. These lenses should provide
clear visual input over a range of viewing distances without focusing effort by the child.
The comparison of myopia progression in children treated with PALs versus single vision
lenses will allow the quantification of the effect of PALs on myopia progression during the
followup period.

The COMET is a multicenter, randomized, double-masked clinical trial to evaluate whether PALs
slow the progression of juvenile-onset myopia as compared with single vision lenses. The
study is a collaborative effort that involves a Study Chair at the New England College of
Optometry; four clinical centers at colleges of optometry in Boston, Birmingham,
Philadelphia, and Houston; and a Coordinating Center at the State University of New York at
Stony Brook.

The sample size goal, 450 children with myopia in both eyes who met specific inclusion and
exclusion criteria, was attained with the enrollment of 469 children in one year. Children
were identified from school screenings, clinic records, and referrals from local
practitioners. Eligible children were randomly assigned to receive progressive addition or
single vision lenses. Participating children are being examined at 6-month intervals
following baseline, for at least 3 years, to measure changes in refractive error and to
update prescriptions, according to a specified protocol. A dilated examination to evaluate
the study outcome measures is performed at the annual study visits. A standardized, common
protocol is used at all centers.

The primary outcome of the study is progression of myopia, defined as the magnitude of the
change relative to baseline in spherical equivalent refraction, determined by cycloplegic
autorefraction. The secondary outcome of the study is axial length measured by A-scan
ultrasonography.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>September 1997</start_date>
<completion_date type="Actual">September 2013</completion_date>
<primary_completion_date type="Actual">October 2001</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Progression of myopia, determined by cycloplegic autorefraction</measure>
</primary_outcome>
<secondary_outcome>
<measure>Axial length measured by A-scan ultrasonography</measure>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">469</enrollment>
<condition>Myopia</condition>
<arm_group>
<arm_group_label>Progressive Addition Lenses (PALs)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Single Vision Lenses</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Progressive Addition Lenses</intervention_name>
<description>Varilux comfort with +2.00 addition</description>
<arm_group_label>Progressive Addition Lenses (PALs)</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>single vision lenses</intervention_name>
<arm_group_label>Single Vision Lenses</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Children between the ages of 6 and 12 years with myopia in both eyes (defined as spherical
equivalent between -1.25 D and -4.50 D in each eye as measured by cycloplegic
autorefraction), astigmatism less than or equal to 1.50 D, and no anisometropia (defined as
a difference in spherical equivalent between the two eyes greater than 1.0 D) are eligible
for inclusion. Exclusion criteria include visual acuity greater than 20/25, strabismus, use
of contact lenses, birth weight less than 1,250 grams, use of bifocal or progressive
addition lenses, or any conditions precluding adherence to the protocol.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>6 Years</minimum_age>
<maximum_age>12 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Jane Gwiazda, PhD</last_name>
<role>Study Chair</role>
<affiliation>New England College of Optometry</affiliation>
</overall_official>
<overall_official>
<last_name>Leslie Hyman, PhD</last_name>
<role>Study Director</role>
<affiliation>Stony Brook Medicine</affiliation>
</overall_official>
<location>
<facility>
<name>University of Alabama-Birmingham, School of Optometry</name>
<address>
<city>Birmingham</city>
<state>Alabama</state>
<zip>35294-0010</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>New England College of Optometry</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02115</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Pennsylvania College of Optometry</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19141-3399</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Houston, College of Optometry</name>
<address>
<city>Houston</city>
<state>Texas</state>
<zip>77204-6052</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>http://www.nei.nih.gov/health/clinicalstudies/</url>
<description>NEI Clinical Studies Database</description>
</link>
<results_reference>
<citation>Gwiazda J, Hyman L, Hussein M, Everett D, Norton TT, Kurtz D, Leske MC, Manny R, Marsh-Tootle W, Scheiman M. A randomized clinical trial of progressive addition lenses versus single vision lenses on the progression of myopia in children. Invest Ophthalmol Vis Sci. 2003 Apr;44(4):1492-500. doi: 10.1167/iovs.02-0816.</citation>
<PMID>12657584</PMID>
</results_reference>
<results_reference>
<citation>Gwiazda JE, Hyman L, Norton TT, Hussein ME, Marsh-Tootle W, Manny R, Wang Y, Everett D; COMET Grouup. Accommodation and related risk factors associated with myopia progression and their interaction with treatment in COMET children. Invest Ophthalmol Vis Sci. 2004 Jul;45(7):2143-51. doi: 10.1167/iovs.03-1306.</citation>
<PMID>15223788</PMID>
</results_reference>
<results_reference>
<citation>Hyman L, Gwiazda J, Hussein M, Norton TT, Wang Y, Marsh-Tootle W, Everett D. Relationship of age, sex, and ethnicity with myopia progression and axial elongation in the correction of myopia evaluation trial. Arch Ophthalmol. 2005 Jul;123(7):977-87. doi: 10.1001/archopht.123.7.977.</citation>
<PMID>16009841</PMID>
</results_reference>
<verification_date>April 2016</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>April 14, 2016</last_update_submitted>
<last_update_submitted_qc>April 14, 2016</last_update_submitted_qc>
<last_update_posted type="Estimate">April 15, 2016</last_update_posted>
<keyword>myopia</keyword>
<keyword>nearsightedness</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Myopia</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000113
org study id: NEI-9
secondary id: U10EY011756
nct id: NCT00000113
lead sponsor:
collaborator:
has dmc: Yes
To evaluate whether progressive addition lenses (PALs) slow the rate of progression of
juvenile-onset myopia (nearsightedness) when compared with single vision lenses, as measured
by cycloplegic autorefraction. An additional outcome measure is axial length, as measured by
A-scan ultrasonography.
To describe the natural history of juvenile-onset myopia in a group of children receiving
conventional treatment (single vision lenses).
Myopia (nearsightedness) is an important public health problem, which entails substantial
societal and personal costs. It is highly prevalent in our society and even more frequent in
Asian countries; furthermore, its prevalence may be increasing over time. High myopia
contributes to significant loss of vision and blindness. At present, the mechanisms involved
in the etiology of myopia are unclear, and there is no way to prevent the condition. Current
methods of correction require lifelong use of lenses or surgical treatment, which is
expensive and may lead to complications. The rationale for this trial, the Correction of
Myopia Evaluation Trial (COMET), arises from the convergence of research involving (1) the
link between accommodation and myopia in children and (2) animal models of myopia showing the
important role of the visual environment in eye growth. A contribution of this research is
that blur is a critical component in the development of myopia. The primary aim of COMET, to
evaluate the efficacy of progressive addition lenses, a noninvasive intervention, in slowing
the progression of myopia, follows from this line of reasoning. These lenses should provide
clear visual input over a range of viewing distances without focusing effort by the child.
The comparison of myopia progression in children treated with PALs versus single vision
lenses will allow the quantification of the effect of PALs on myopia progression during the
followup period.
The COMET is a multicenter, randomized, double-masked clinical trial to evaluate whether PALs
slow the progression of juvenile-onset myopia as compared with single vision lenses. The
study is a collaborative effort that involves a Study Chair at the New England College of
Optometry; four clinical centers at colleges of optometry in Boston, Birmingham,
Philadelphia, and Houston; and a Coordinating Center at the State University of New York at
Stony Brook.
The sample size goal, 450 children with myopia in both eyes who met specific inclusion and
exclusion criteria, was attained with the enrollment of 469 children in one year. Children
were identified from school screenings, clinic records, and referrals from local
practitioners. Eligible children were randomly assigned to receive progressive addition or
single vision lenses. Participating children are being examined at 6-month intervals
following baseline, for at least 3 years, to measure changes in refractive error and to
update prescriptions, according to a specified protocol. A dilated examination to evaluate
the study outcome measures is performed at the annual study visits. A standardized, common
protocol is used at all centers.
The primary outcome of the study is progression of myopia, defined as the magnitude of the
change relative to baseline in spherical equivalent refraction, determined by cycloplegic
autorefraction. The secondary outcome of the study is axial length measured by A-scan
ultrasonography.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Progression of myopia, determined by cycloplegic autorefraction
measure: Axial length measured by A-scan ultrasonography
arm group label: Progressive Addition Lenses (PALs)
arm group type: Experimental
arm group label: Single Vision Lenses
arm group type: Active Comparator
intervention type: Other
intervention name: Progressive Addition Lenses
description: Varilux comfort with +2.00 addition
arm group label: Progressive Addition Lenses (PALs)
intervention type: Other
intervention name: single vision lenses
arm group label: Single Vision Lenses
criteria:
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: Jane Gwiazda, PhD
role: Study Chair
affiliation: New England College of Optometry
last name: Leslie Hyman, PhD
role: Study Director
affiliation: Stony Brook Medicine
facility:
facility:
facility:
facility:
country: United States
url: http://www.nei.nih.gov/health/clinicalstudies/
description: NEI Clinical Studies Database
citation: Gwiazda J, Hyman L, Hussein M, Everett D, Norton TT, Kurtz D, Leske MC, Manny R, Marsh-Tootle W, Scheiman M. A randomized clinical trial of progressive addition lenses versus single vision lenses on the progression of myopia in children. Invest Ophthalmol Vis Sci. 2003 Apr;44(4):1492-500. doi: 10.1167/iovs.02-0816.
PMID: 12657584
citation: Gwiazda JE, Hyman L, Norton TT, Hussein ME, Marsh-Tootle W, Manny R, Wang Y, Everett D; COMET Grouup. Accommodation and related risk factors associated with myopia progression and their interaction with treatment in COMET children. Invest Ophthalmol Vis Sci. 2004 Jul;45(7):2143-51. doi: 10.1167/iovs.03-1306.
PMID: 15223788
citation: Hyman L, Gwiazda J, Hussein M, Norton TT, Wang Y, Marsh-Tootle W, Everett D. Relationship of age, sex, and ethnicity with myopia progression and axial elongation in the correction of myopia evaluation trial. Arch Ophthalmol. 2005 Jul;123(7):977-87. doi: 10.1001/archopht.123.7.977.
PMID: 16009841
mesh term: Myopia |
NCT0000xxxx/NCT00000114.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000114</url>
</required_header>
<id_info>
<org_study_id>NEI-10</org_study_id>
<nct_id>NCT00000114</nct_id>
</id_info>
<brief_title>Randomized Trial of Vitamin A and Vitamin E Supplementation for Retinitis Pigmentosa</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine whether supplements of vitamin A or vitamin E alone or in combination affect the
course of retinitis pigmentosa.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide
prevalence of about 1 in 4,000. Patients typically report night blindness in adolescence and
lose vision in the midperipheral followed by far-peripheral visual field in adulthood due to
progressive loss of both rod and cone function. Most patients have reductions in central
vision by age 50 to 80 years. Modern-day electroretinograms (ERGs) make it possible to record
retinal responses from most patients with remaining vision and thereby monitor objectively
the course of their disease.

While the natural course of retinal degeneration in the common forms of RP was being studied,
it was noted that a subgroup of patients aged 18 through 49 who were treating themselves with
both vitamin A and vitamin E and other nutritional supplements exhibited less decline in ERG
amplitude over a 2-year period. These preliminary findings, as well as the known roles of
vitamins A and E in maintaining normal photoreceptor function and structure, prompted this
randomized, controlled trial to determine whether these vitamins alone or in combination
would halt or slow the progression of the common forms of RP.

This study was a randomized, controlled double-masked trial with 2 x 2 factorial design and
duration of 4 to 6 years. Patients were assigned to one of four treatment groups:

15,000 IU/day vitamin A

15,000 IU/day vitamin A + 400 IU/day vitamin E

trace amounts of both vitamins A and E

400 IU/day of vitamin E

The main outcome measure was the 30-Hz cone ERG amplitude. In addition, visual field and
visual acuity were measured annually.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>May 1984</start_date>
<completion_date type="Actual">June 1987</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Factorial Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Retinitis Pigmentosa</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Vitamin E</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Vitamin A</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Men and nonpregnant women between ages 18 and 49 years with common forms of RP were
included. All eligible patients had retinal arteriolar attenuation, elevated dark
adaptation thresholds, and reduced ERGs. Patients had best corrected Snellen visual acuity
of 20/100 or better, central visual field diameter on the Goldman perimeter with V4 e white
test light of 8 degrees or greater, and ERG amplitude of 2.5 or greater in response to
0.5-Hz white light or of 0.12 ultraviolet light or greater in response to 30-Hz white
flickering light in at least one eye. In addition, patients had normal fasting serum
retinol and serum liver function profile and weight above the lower fifth percentile for
age, sex, and height. All patients had a total estimated pre-trial intake of vitamins A and
E from diet plus pills not greater than 11,500 IU/day and 40 IU/day, respectively.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>49 Years</maximum_age>
</eligibility>
<link>
<url>http://www.nei.nih.gov/news/clinicalalerts/alert-rp.asp</url>
<description>Clinical Alert-Information for Doctors Who Follow Patients with Retinitis Pigmentosa</description>
</link>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/rppressrelease.asp</url>
<description>NEI Press Release-Treatment for Retinitis Pigmentosa Reported</description>
</link>
<reference>
<citation>Berson EL, Rosner B, Sandberg MA, Hayes KC, Nicholson BW, Weigel-DiFranco C, Willett W. A randomized trial of vitamin A and vitamin E supplementation for retinitis pigmentosa. Arch Ophthalmol. 1993 Jun;111(6):761-72. doi: 10.1001/archopht.1993.01090060049022.</citation>
<PMID>8512476</PMID>
</reference>
<reference>
<citation>Sandberg MA, Weigel-DiFranco C, Rosner B, Berson EL. The relationship between visual field size and electroretinogram amplitude in retinitis pigmentosa. Invest Ophthalmol Vis Sci. 1996 Jul;37(8):1693-8.</citation>
<PMID>8675413</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<keyword>retinitis pigmentosa</keyword>
<keyword>vitamin supplements</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Retinitis</mesh_term>
<mesh_term>Retinitis Pigmentosa</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Vitamins</mesh_term>
<mesh_term>Vitamin E</mesh_term>
<mesh_term>Vitamin A</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000114
org study id: NEI-10
nct id: NCT00000114
lead sponsor:
To determine whether supplements of vitamin A or vitamin E alone or in combination affect the
course of retinitis pigmentosa.
Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide
prevalence of about 1 in 4,000. Patients typically report night blindness in adolescence and
lose vision in the midperipheral followed by far-peripheral visual field in adulthood due to
progressive loss of both rod and cone function. Most patients have reductions in central
vision by age 50 to 80 years. Modern-day electroretinograms (ERGs) make it possible to record
retinal responses from most patients with remaining vision and thereby monitor objectively
the course of their disease.
While the natural course of retinal degeneration in the common forms of RP was being studied,
it was noted that a subgroup of patients aged 18 through 49 who were treating themselves with
both vitamin A and vitamin E and other nutritional supplements exhibited less decline in ERG
amplitude over a 2-year period. These preliminary findings, as well as the known roles of
vitamins A and E in maintaining normal photoreceptor function and structure, prompted this
randomized, controlled trial to determine whether these vitamins alone or in combination
would halt or slow the progression of the common forms of RP.
This study was a randomized, controlled double-masked trial with 2 x 2 factorial design and
duration of 4 to 6 years. Patients were assigned to one of four treatment groups:
15,000 IU/day vitamin A
15,000 IU/day vitamin A + 400 IU/day vitamin E
trace amounts of both vitamins A and E
400 IU/day of vitamin E
The main outcome measure was the 30-Hz cone ERG amplitude. In addition, visual field and
visual acuity were measured annually.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Vitamin E
intervention type: Drug
intervention name: Vitamin A
criteria:
gender: All
minimum age: 18 Years
maximum age: 49 Years
url: http://www.nei.nih.gov/news/clinicalalerts/alert-rp.asp
description: Clinical Alert-Information for Doctors Who Follow Patients with Retinitis Pigmentosa
url: http://www.nei.nih.gov/news/pressreleases/rppressrelease.asp
description: NEI Press Release-Treatment for Retinitis Pigmentosa Reported
citation: Berson EL, Rosner B, Sandberg MA, Hayes KC, Nicholson BW, Weigel-DiFranco C, Willett W. A randomized trial of vitamin A and vitamin E supplementation for retinitis pigmentosa. Arch Ophthalmol. 1993 Jun;111(6):761-72. doi: 10.1001/archopht.1993.01090060049022.
PMID: 8512476
citation: Sandberg MA, Weigel-DiFranco C, Rosner B, Berson EL. The relationship between visual field size and electroretinogram amplitude in retinitis pigmentosa. Invest Ophthalmol Vis Sci. 1996 Jul;37(8):1693-8.
PMID: 8675413
mesh term: Retinitis
mesh term: Retinitis Pigmentosa
mesh term: Vitamins
mesh term: Vitamin E
mesh term: Vitamin A |
NCT0000xxxx/NCT00000115.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000115</url>
</required_header>
<id_info>
<org_study_id>NEI-11</org_study_id>
<nct_id>NCT00000115</nct_id>
</id_info>
<brief_title>Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular
edema.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Uveitis, an intraocular inflammatory disease, is the cause of about 10 percent of visual
impairment in the United States. Uveitis may lead to many sight-threatening conditions,
including cataract, vitreal opacities, glaucoma, and, most commonly, cystoid macular edema.
Reduction of swelling or edema within the retina depends on the movement of fluid from the
retina through the choroid. A number of studies indicate that this process requires active
transport of fluid ions by the retinal pigment epithelium and may involve the carbonic
anhydrase system. Current treatment of uveitis-associated cystoid macular edema requires the
use of immunosuppressive or anti-inflammatory agents. However, many patients are either
resistant or intolerant to this therapy. Recent reports suggested that acetazolamide, a
carbonic anhydrase inhibitor that is used to lower intraocular pressure in some glaucoma
patients, might be safe and effective in reducing uveitis-associated cystoid macular edema.

Because the course of ocular inflammatory disease can be variable, a double-masked,
randomized, crossover trial was designed to test the efficacy of acetazolamide compared with
a placebo for the treatment of uveitis-associated cystoid macular edema. Randomized adult
patients received either oral acetazolamide sodium 500 mg or a matched placebo every 12 hours
for the first 4 weeks of the study. Children 8 years of age or older received a lesser dose
based on body weight. Following a 4-week period, during which no medication was given,
patients then received a 4-week course of the opposite medication. Primary end points
included reduction in cystoid macular edema (graded on fluorescein angiography) and
improvement in visual acuity (measured on standardized Early Treatment Diabetic Retinopathy
Study [ETDRS] charts). Laser acuity was also assessed as a secondary outcome variable.
Adverse effects of the acetazolamide therapy were monitored by clinical and laboratory
examinations.

A total of 40 patients were recruited for the study. Patients were seen at the beginning of
the study for baseline measurements and at 4, 8, and 12 weeks after enrollment into the
study.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>December 1990</start_date>
<completion_date type="Actual">June 1994</completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Macular Edema, Cystoid</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Acetazolamide</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Males and females 8 years of age or older and weighing at least 35 kg (77 lb) were eligible
for the study. Patients had to have a best corrected visual acuity of 20/40 or worse in at
least one eye with cystoid macular edema demonstrable on fluorescein angiography.

Patients were allowed to receive systemic therapy for their uveitis. Exclusion criteria
included current use of acetazolamide as part of a therapeutic regimen; a history of
hypersensitivity reactions to acetazolamide, sulfonamides, or angiography dye; unclear
ocular media that would obscure fluorescein angiography; macular subretinal
neovascularization or a macular hole; or inability to take acetazolamide for medical
reasons.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>8 Years</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<reference>
<citation>Whitcup SM, Csaky KG, Podgor MJ, Chew EY, Perry CH, Nussenblatt RB. A randomized, masked, cross-over trial of acetazolamide for cystoid macular edema in patients with uveitis. Ophthalmology. 1996 Jul;103(7):1054-62; discussion 1062-3. doi: 10.1016/s0161-6420(96)30567-8.</citation>
<PMID>8684794</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Macular Edema</mesh_term>
<mesh_term>Edema</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Acetazolamide</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000115
org study id: NEI-11
nct id: NCT00000115
lead sponsor:
To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular
edema.
Uveitis, an intraocular inflammatory disease, is the cause of about 10 percent of visual
impairment in the United States. Uveitis may lead to many sight-threatening conditions,
including cataract, vitreal opacities, glaucoma, and, most commonly, cystoid macular edema.
Reduction of swelling or edema within the retina depends on the movement of fluid from the
retina through the choroid. A number of studies indicate that this process requires active
transport of fluid ions by the retinal pigment epithelium and may involve the carbonic
anhydrase system. Current treatment of uveitis-associated cystoid macular edema requires the
use of immunosuppressive or anti-inflammatory agents. However, many patients are either
resistant or intolerant to this therapy. Recent reports suggested that acetazolamide, a
carbonic anhydrase inhibitor that is used to lower intraocular pressure in some glaucoma
patients, might be safe and effective in reducing uveitis-associated cystoid macular edema.
Because the course of ocular inflammatory disease can be variable, a double-masked,
randomized, crossover trial was designed to test the efficacy of acetazolamide compared with
a placebo for the treatment of uveitis-associated cystoid macular edema. Randomized adult
patients received either oral acetazolamide sodium 500 mg or a matched placebo every 12 hours
for the first 4 weeks of the study. Children 8 years of age or older received a lesser dose
based on body weight. Following a 4-week period, during which no medication was given,
patients then received a 4-week course of the opposite medication. Primary end points
included reduction in cystoid macular edema (graded on fluorescein angiography) and
improvement in visual acuity (measured on standardized Early Treatment Diabetic Retinopathy
Study [ETDRS] charts). Laser acuity was also assessed as a secondary outcome variable.
Adverse effects of the acetazolamide therapy were monitored by clinical and laboratory
examinations.
A total of 40 patients were recruited for the study. Patients were seen at the beginning of
the study for baseline measurements and at 4, 8, and 12 weeks after enrollment into the
study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Acetazolamide
criteria:
gender: All
minimum age: 8 Years
maximum age: N/A
citation: Whitcup SM, Csaky KG, Podgor MJ, Chew EY, Perry CH, Nussenblatt RB. A randomized, masked, cross-over trial of acetazolamide for cystoid macular edema in patients with uveitis. Ophthalmology. 1996 Jul;103(7):1054-62; discussion 1062-3. doi: 10.1016/s0161-6420(96)30567-8.
PMID: 8684794
mesh term: Macular Edema
mesh term: Edema
mesh term: Acetazolamide |
NCT0000xxxx/NCT00000116.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000116</url>
</required_header>
<id_info>
<org_study_id>NEI-12</org_study_id>
<nct_id>NCT00000116</nct_id>
</id_info>
<brief_title>Randomized Trial of DHA for Retinitis Pigmentosa Patients Receiving Vitamin A</brief_title>
<official_title>Clinical Trial of Docosahexaenoic Acid (DHA) in Patients With Retinitis Pigmentosa Receiving Vitamin A Treatment</official_title>
<sponsors>
<lead_sponsor>
<agency>Carol Weigel DiFranco</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this trial is to determine whether a nutritional supplement in addition to
vitamin A will slow the course of retinitis pigmentosa.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide
prevalence of approximately 1 in 4,000. Patients typically report night blindness and
difficulty with midperipheral visual field in adolescence. As the condition progresses, they
lose far peripheral visual field. Most patients have reductions in central vision by age 50
to 80 years. Based on electroretinograms (ERGs), the course of the disease can be slowed on
average among adults on 15,000 IU/day of vitamin A palmitate. While conducting the trial on
the effects of vitamin A on RP, it became apparent that another substance in the diet could
be affecting the course of the disease. This prompted the present randomized, controlled
trial.

This study is a randomized, controlled, double-masked trial with a planned duration of 5
years. Patients with the common forms of RP are assigned to either a test or a control group.
All receive 15,000 IU/day of vitamin A palmitate in addition to either 1200 mg/d of
docosahexaenoic acid or control capsules. Participants will not know the contents of the
supplement or the group to which they have been assigned until the end of the trial. The main
outcome measurement is the total point score on the Humphrey Field Analyzer (HFA). In
addition, computer-averaged 30-Hz cone ERG amplitudes and visual acuity are measured
annually.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">May 1996</start_date>
<completion_date type="Actual">September 2002</completion_date>
<primary_completion_date type="Actual">September 2002</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
<masking_description>In this trial neither the participants, nor the clinicians, nor the investigators were aware of treatment group assignment.</masking_description>
</study_design_info>
<primary_outcome>
<measure>Change in Humphrey Field Analyzer (HFA) total point score 30-2 program</measure>
<time_frame>Annual percent change per year at each of 4 years of followup</time_frame>
<description>Sum of points in Decibels of total points seen in 30-2 program. Higher scores = better vision/larger visual field</description>
</primary_outcome>
<secondary_outcome>
<measure>Change in Humphrey Field Analyzer (HFA) total point score 30 -2 plus 30/60-2 programs combined</measure>
<time_frame>Annual percent change per year at each of four years of followup</time_frame>
<description>Sum of points in decibels of total points seen in 30-2 and 30/60-2 programs combined- Higher scores = better vision/ larger visual field</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in 30Hz Electroretinogram ( ERG) amplitude</measure>
<time_frame>Annual percent change per year at each of four years of followup</time_frame>
<description>Value in microvolts of response to 30hz ERG. Higher values = greater visual function</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in Early Treatment of Diabetic Retinopathy(EDTRS) Visual Acuity</measure>
<time_frame>Change in number of letters read per year at each of four years of followup.</time_frame>
<description>Number of letters read per year. More letters read = better visual acuity</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">221</enrollment>
<condition>Retinitis Pigmentosa</condition>
<arm_group>
<arm_group_label>Docosahexaenoic acid + Vitamin A</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants randomized to this arm received 1200 mg/d docosahexaenoic acid and 15000 IU/d Vitamin A as retinyl palmitate</description>
</arm_group>
<arm_group>
<arm_group_label>Control fatty acid + Vitamin A</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>Patients randomized to this arm received 500 mg/d of fatty acid with no docosahexaenoic acid and 15000 IU/ Vitamin A as retinyl palmitate</description>
</arm_group>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Vitamin A</intervention_name>
<description>15000 IU/d as retinyl palmitate</description>
<arm_group_label>Control fatty acid + Vitamin A</arm_group_label>
<arm_group_label>Docosahexaenoic acid + Vitamin A</arm_group_label>
</intervention>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Docosahexaenoic acid</intervention_name>
<description>1200 mg/d</description>
<arm_group_label>Docosahexaenoic acid + Vitamin A</arm_group_label>
</intervention>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Control fatty acid</intervention_name>
<arm_group_label>Control fatty acid + Vitamin A</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

Ocular Criteria:

Retinitis Pigmentosa, typical (non-syndromic) forms Best corrected visual acuity Greater
than or equal to (GE )20/100 HFA 30-2 total point score GE 250 dB (decibels) 30 (Hertz) Hz
ERG cone amplitude GE 0.68 microvolts

Dietary Criteria:

Dark fish intake Less than or equal to (LE) five servings per week Dietary omega-3 fatty
acid intake LE 0.41 g/d Preformed Vitamin A intake in diet and supplements LE 10,000 IU/d
Supplement intake LE 5000 IU/d of Vitamin A and LE 30 IU/d Vitamin E Consumption LE 3
alcoholic beverages per day

Medical and other criteria:

Body Mass Index Less than (LT )40 and weight GE 5th percentile for age, sex, and height
Serum retinol level LE 100 mg/dl and serum retinyl ester levels LE 380 nm/L Serum
cholesterol level LT 300 mg/dL and serum triglyceride levels LT 400 mg/dL Agree not to know
study capsule content

Exclusion criteria:

Ocular criteria:

No confounding ocular disease

Dietary criteria:

No intake of cod liver oil or omega-3 capsules

Medical and other criteria:

Not pregnant or planning to become pregnant No clinically significant abnormal result on
Complete Blood Count or serum liver function profile No other disease which might affect
absorption or metabolism of DHA or Vitamin A
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>55 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Eliot Berson (Deceased), MD</last_name>
<role>Principal Investigator</role>
<affiliation>Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School</affiliation>
</overall_official>
<location>
<facility>
<name>Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School, Massachusetts Eye and Ear Infirmary</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02114</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Berson EL, Rosner B, Sandberg MA, Hayes KC, Nicholson BW, Weigel-DiFranco C, Willett W. A randomized trial of vitamin A and vitamin E supplementation for retinitis pigmentosa. Arch Ophthalmol. 1993 Jun;111(6):761-72. doi: 10.1001/archopht.1993.01090060049022.</citation>
<PMID>8512476</PMID>
</reference>
<results_reference>
<citation>Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Moser A, Brockhurst RJ, Hayes KC, Johnson CA, Anderson EJ, Gaudio AR, Willett WC, Schaefer EJ. Clinical trial of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment. Arch Ophthalmol. 2004 Sep;122(9):1297-305. doi: 10.1001/archopht.122.9.1297.</citation>
<PMID>15364708</PMID>
</results_reference>
<results_reference>
<citation>Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Moser A, Brockhurst RJ, Hayes KC, Johnson CA, Anderson EJ, Gaudio AR, Willett WC, Schaefer EJ. Further evaluation of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment: subgroup analyses. Arch Ophthalmol. 2004 Sep;122(9):1306-14. doi: 10.1001/archopht.122.9.1306.</citation>
<PMID>15364709</PMID>
</results_reference>
<verification_date>February 2023</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>February 22, 2023</last_update_submitted>
<last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 8, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>National Eye Institute (NEI)</investigator_affiliation>
<investigator_full_name>Carol Weigel DiFranco</investigator_full_name>
<investigator_title>coauthor/program manager</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Retinitis</mesh_term>
<mesh_term>Retinitis Pigmentosa</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Vitamin A</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000116
org study id: NEI-12
nct id: NCT00000116
lead sponsor:
has dmc: Yes
The purpose of this trial is to determine whether a nutritional supplement in addition to
vitamin A will slow the course of retinitis pigmentosa.
Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide
prevalence of approximately 1 in 4,000. Patients typically report night blindness and
difficulty with midperipheral visual field in adolescence. As the condition progresses, they
lose far peripheral visual field. Most patients have reductions in central vision by age 50
to 80 years. Based on electroretinograms (ERGs), the course of the disease can be slowed on
average among adults on 15,000 IU/day of vitamin A palmitate. While conducting the trial on
the effects of vitamin A on RP, it became apparent that another substance in the diet could
be affecting the course of the disease. This prompted the present randomized, controlled
trial.
This study is a randomized, controlled, double-masked trial with a planned duration of 5
years. Patients with the common forms of RP are assigned to either a test or a control group.
All receive 15,000 IU/day of vitamin A palmitate in addition to either 1200 mg/d of
docosahexaenoic acid or control capsules. Participants will not know the contents of the
supplement or the group to which they have been assigned until the end of the trial. The main
outcome measurement is the total point score on the Humphrey Field Analyzer (HFA). In
addition, computer-averaged 30-Hz cone ERG amplitudes and visual acuity are measured
annually.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: In this trial neither the participants, nor the clinicians, nor the investigators were aware of treatment group assignment.
measure: Change in Humphrey Field Analyzer (HFA) total point score 30-2 program
time frame: Annual percent change per year at each of 4 years of followup
description: Sum of points in Decibels of total points seen in 30-2 program. Higher scores = better vision/larger visual field
measure: Change in Humphrey Field Analyzer (HFA) total point score 30 -2 plus 30/60-2 programs combined
time frame: Annual percent change per year at each of four years of followup
description: Sum of points in decibels of total points seen in 30-2 and 30/60-2 programs combined- Higher scores = better vision/ larger visual field
measure: Change in 30Hz Electroretinogram ( ERG) amplitude
time frame: Annual percent change per year at each of four years of followup
description: Value in microvolts of response to 30hz ERG. Higher values = greater visual function
measure: Change in Early Treatment of Diabetic Retinopathy(EDTRS) Visual Acuity
time frame: Change in number of letters read per year at each of four years of followup.
description: Number of letters read per year. More letters read = better visual acuity
arm group label: Docosahexaenoic acid + Vitamin A
arm group type: Experimental
description: Participants randomized to this arm received 1200 mg/d docosahexaenoic acid and 15000 IU/d Vitamin A as retinyl palmitate
arm group label: Control fatty acid + Vitamin A
arm group type: Placebo Comparator
description: Patients randomized to this arm received 500 mg/d of fatty acid with no docosahexaenoic acid and 15000 IU/ Vitamin A as retinyl palmitate
intervention type: Dietary Supplement
intervention name: Vitamin A
description: 15000 IU/d as retinyl palmitate
arm group label: Control fatty acid + Vitamin A
arm group label: Docosahexaenoic acid + Vitamin A
intervention type: Dietary Supplement
intervention name: Docosahexaenoic acid
description: 1200 mg/d
arm group label: Docosahexaenoic acid + Vitamin A
intervention type: Dietary Supplement
intervention name: Control fatty acid
arm group label: Control fatty acid + Vitamin A
criteria:
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eliot Berson (Deceased), MD
role: Principal Investigator
affiliation: Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School
facility:
country: United States
citation: Berson EL, Rosner B, Sandberg MA, Hayes KC, Nicholson BW, Weigel-DiFranco C, Willett W. A randomized trial of vitamin A and vitamin E supplementation for retinitis pigmentosa. Arch Ophthalmol. 1993 Jun;111(6):761-72. doi: 10.1001/archopht.1993.01090060049022.
PMID: 8512476
citation: Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Moser A, Brockhurst RJ, Hayes KC, Johnson CA, Anderson EJ, Gaudio AR, Willett WC, Schaefer EJ. Clinical trial of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment. Arch Ophthalmol. 2004 Sep;122(9):1297-305. doi: 10.1001/archopht.122.9.1297.
PMID: 15364708
citation: Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Moser A, Brockhurst RJ, Hayes KC, Johnson CA, Anderson EJ, Gaudio AR, Willett WC, Schaefer EJ. Further evaluation of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment: subgroup analyses. Arch Ophthalmol. 2004 Sep;122(9):1306-14. doi: 10.1001/archopht.122.9.1306.
PMID: 15364709
responsible party type: Sponsor-Investigator
investigator affiliation: National Eye Institute (NEI)
investigator full name: Carol Weigel DiFranco
investigator title: coauthor/program manager
mesh term: Retinitis
mesh term: Retinitis Pigmentosa
mesh term: Vitamin A |
NCT0000xxxx/NCT00000117.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000117</url>
</required_header>
<id_info>
<org_study_id>NEI-13</org_study_id>
<nct_id>NCT00000117</nct_id>
</id_info>
<brief_title>Intravenous Immunoglobulin Therapy in Optic Neuritis</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine whether high-dose intravenous immunoglobulin (IVIg) is more effective than
placebo in restoring lost visual function (visual acuity) in optic neuritis (ON).

To determine the time course of recovery following IVIg administration. If the reports of
IVIg-associated clinical improvement occurring within 3 to 6 months following treatment can
be confirmed, this would provide indirect evidence that IVIg may promote central nervous
system (CNS) remyelination in optic neuritis and multiple sclerosis (MS).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Optic neuritis is the leading cause of transient, spontaneous, reversible visual loss in
young adults. Characteristically, patients present with central visual loss that peaks within
a few days and is often associated with eye pain. Visual loss may be complete. Spontaneous
recovery usually begins within 4 weeks, and marked recovery occurs within 1 to 3 months in
most patients. Although clinical improvement is the rule, not all patients recover fully, and
many are left with residual symptoms. Although there are limited pathological studies in
inflammatory ON, the pathological changes are thought to be virtually identical with those
seen in MS, with disruption of the blood-nerve (brain) barrier; primary demyelination with
axonal sparing; variable degrees of lymphocytic infiltration; an abundance of macrophages
around the inflammatory demyelination lesion; various degrees of remyelination; and, later,
oligodendrocyte loss, axonal loss, and gliosis.

Remyelination by oligodendrocytes occurs early in the MS lesion, as documented by myelin
sheaths that are abnormally thin relative to axon diameter. These thin myelin sheaths are
often seen prominently at the edge of demyelinated plaques. A recent series of studies has
shown that within weeks of the initial event, there is extensive oligodendrocyte regeneration
and remyelination. These immature oligodendrocytes express a series of developmentally
restricted antigens. This finding has been interpreted to suggest that the cells that
repopulate the acute plaque and that affect remyelination are newly generated and not
residual, mature oligodendrocytes. These observations support the possibility that factors
that promote remyelination could be used to improve clinical recovery in ON and MS.

Work at the Mayo Clinic, has shown that both immunoglobulin G (IgG) directed against spinal
cord antigens and purified polyclonal mouse IgG administered systemically promote extensive
remyelination in SJL mice chronically infected with Theiler's virus. In addition, tissue
culture studies suggest that IgG directed against CNS components may promote oligodendroglial
proliferation and differentiation. Thus, experimental evidence exists for the concept that
immunoglobulins may stimulate the proliferation and differentiation of oligodendrocytes. It
is possible that myelin components on the surface of oligodendrocytes could function as
receptors or components of receptors. Antibodies could mimic endogenous ligands, thereby
inducing the proliferation or differentiation of these cells.

In a preliminary, open-label pilot study of patients with chronic, steroid-unresponsive ON,
Drs. van Engelen, Hommes, and colleagues suggested that improvement in visual recovery could
be seen following IgG treatment in patients with chronic, stable ON. These encouraging but
preliminary basic and clinical studies have prompted us to design a double-blind and
placebo-controlled clinical trial of IVIg in patients with recently acquired but apparently
permanent muscle paralysis from MS (NS31506) and to develop this NEI-funded ON study
(U10EY1096301).

In this randomized, placebo-controlled, double-blind clinical trial, 60 patients were
assigned to receive either IVIg or a placebo over a period of 3 months. In order to be
eligible, patients who meet the inclusion criteria needed to have a stable loss of visual
function (unchanged between the pre-enrollment screening visit and the enrollment visit). All
patients wre re-examined at 3, 6, 9, and 12 months, with the primary outcome being the impact
of treatment on visual acuity at 6 months as determined by measurements on a retroilluminated
Early Treatment Diabetic Retinopathy Study chart at 4 meters.

One group of patients received 0.4 g/kg Gammimmune N intravenously daily for 5 days, and
thereafter once a month for 3 months (total: eight infusions). The other group of patients
received infusions of 0.1 percent human serum albumin in 10 percent maltose (placebo)
according to the identical protocol used for Gammimmune N.

The primary outcome measure was improvement in Logmar visual acuity by an average of 0.2 at 6
months. The secondary outcome measures included change in visual acuity at 3, 9, and 12
months, as determined on a retroilluminated ETDRS chart at 4 meters; change in visual fields
at 6 and 12 months; change in visual evoked responses at 3, 6, and 12 months; and change in
neurological examination (EDSS, FS, AI) at 3, 6, 9, and 12 months.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>August 1995</start_date>
<completion_date type="Actual">December 1997</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Optic Neuritis</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Immunoglobulin</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
To be eligible, patients must have a history of one or more episodes of previous
demyelinating optic neuritis occurring in the setting of classic, adult-onset definite MS
(clinically definite or laboratory-supported definite MS, or cranial MRI changes consistent
with MS). In most cases, onset of MS will have occurred between the ages of 18 and 45.
Patients must be younger than 50 years and must have apparently irreversible loss of visual
acuity that meets the following criteria:

Visual acuity must be worse than 20/40 for at least 6 months. Patients must be able to read
at least one letter on the 1-meter eye chart. Patients with no light perception or hand
movement vision only are not eligible.

The above level of visual dysfunction must be observed on at least two serial examinations
(separated by at least 1 month) in the Department of Ophthalmology at the Mayo Clinic.

Optic disc pallor must be present.

Patients must have impairment in the affected eye(s) on perimetry consistent with optic
nerve dysfunction and must have a visual field mean deviation of less than -4.00.

Patients must not have received ACTH or corticosteroids within the preceding 2 months.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>50 Years</maximum_age>
</eligibility>
<location>
<facility>
<name>Mayo Clinic, Department of Neurology</name>
<address>
<city>Rochester</city>
<state>Minnesota</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mayo Clinic</name>
<address>
<city>Rochester</city>
<state>Minnesota</state>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Neuritis</mesh_term>
<mesh_term>Optic Neuritis</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Immunoglobulins</mesh_term>
<mesh_term>Immunoglobulins, Intravenous</mesh_term>
<mesh_term>Antibodies</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000117
org study id: NEI-13
nct id: NCT00000117
lead sponsor:
To determine whether high-dose intravenous immunoglobulin (IVIg) is more effective than
placebo in restoring lost visual function (visual acuity) in optic neuritis (ON).
To determine the time course of recovery following IVIg administration. If the reports of
IVIg-associated clinical improvement occurring within 3 to 6 months following treatment can
be confirmed, this would provide indirect evidence that IVIg may promote central nervous
system (CNS) remyelination in optic neuritis and multiple sclerosis (MS).
Optic neuritis is the leading cause of transient, spontaneous, reversible visual loss in
young adults. Characteristically, patients present with central visual loss that peaks within
a few days and is often associated with eye pain. Visual loss may be complete. Spontaneous
recovery usually begins within 4 weeks, and marked recovery occurs within 1 to 3 months in
most patients. Although clinical improvement is the rule, not all patients recover fully, and
many are left with residual symptoms. Although there are limited pathological studies in
inflammatory ON, the pathological changes are thought to be virtually identical with those
seen in MS, with disruption of the blood-nerve (brain) barrier; primary demyelination with
axonal sparing; variable degrees of lymphocytic infiltration; an abundance of macrophages
around the inflammatory demyelination lesion; various degrees of remyelination; and, later,
oligodendrocyte loss, axonal loss, and gliosis.
Remyelination by oligodendrocytes occurs early in the MS lesion, as documented by myelin
sheaths that are abnormally thin relative to axon diameter. These thin myelin sheaths are
often seen prominently at the edge of demyelinated plaques. A recent series of studies has
shown that within weeks of the initial event, there is extensive oligodendrocyte regeneration
and remyelination. These immature oligodendrocytes express a series of developmentally
restricted antigens. This finding has been interpreted to suggest that the cells that
repopulate the acute plaque and that affect remyelination are newly generated and not
residual, mature oligodendrocytes. These observations support the possibility that factors
that promote remyelination could be used to improve clinical recovery in ON and MS.
Work at the Mayo Clinic, has shown that both immunoglobulin G (IgG) directed against spinal
cord antigens and purified polyclonal mouse IgG administered systemically promote extensive
remyelination in SJL mice chronically infected with Theiler's virus. In addition, tissue
culture studies suggest that IgG directed against CNS components may promote oligodendroglial
proliferation and differentiation. Thus, experimental evidence exists for the concept that
immunoglobulins may stimulate the proliferation and differentiation of oligodendrocytes. It
is possible that myelin components on the surface of oligodendrocytes could function as
receptors or components of receptors. Antibodies could mimic endogenous ligands, thereby
inducing the proliferation or differentiation of these cells.
In a preliminary, open-label pilot study of patients with chronic, steroid-unresponsive ON,
Drs. van Engelen, Hommes, and colleagues suggested that improvement in visual recovery could
be seen following IgG treatment in patients with chronic, stable ON. These encouraging but
preliminary basic and clinical studies have prompted us to design a double-blind and
placebo-controlled clinical trial of IVIg in patients with recently acquired but apparently
permanent muscle paralysis from MS (NS31506) and to develop this NEI-funded ON study
(U10EY1096301).
In this randomized, placebo-controlled, double-blind clinical trial, 60 patients were
assigned to receive either IVIg or a placebo over a period of 3 months. In order to be
eligible, patients who meet the inclusion criteria needed to have a stable loss of visual
function (unchanged between the pre-enrollment screening visit and the enrollment visit). All
patients wre re-examined at 3, 6, 9, and 12 months, with the primary outcome being the impact
of treatment on visual acuity at 6 months as determined by measurements on a retroilluminated
Early Treatment Diabetic Retinopathy Study chart at 4 meters.
One group of patients received 0.4 g/kg Gammimmune N intravenously daily for 5 days, and
thereafter once a month for 3 months (total: eight infusions). The other group of patients
received infusions of 0.1 percent human serum albumin in 10 percent maltose (placebo)
according to the identical protocol used for Gammimmune N.
The primary outcome measure was improvement in Logmar visual acuity by an average of 0.2 at 6
months. The secondary outcome measures included change in visual acuity at 3, 9, and 12
months, as determined on a retroilluminated ETDRS chart at 4 meters; change in visual fields
at 6 and 12 months; change in visual evoked responses at 3, 6, and 12 months; and change in
neurological examination (EDSS, FS, AI) at 3, 6, 9, and 12 months.
allocation: Randomized
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Immunoglobulin
criteria:
gender: All
minimum age: N/A
maximum age: 50 Years
facility:
facility:
country: United States
mesh term: Neuritis
mesh term: Optic Neuritis
mesh term: Immunoglobulins
mesh term: Immunoglobulins, Intravenous
mesh term: Antibodies |
NCT0000xxxx/NCT00000118.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000118</url>
</required_header>
<id_info>
<org_study_id>NEI-14</org_study_id>
<nct_id>NCT00000118</nct_id>
</id_info>
<brief_title>Ganciclovir Implant Study for Cytomegalovirus Retinitis</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine the therapeutic efficacy of a sustained-release intraocular drug delivery system
for ganciclovir therapy of cytomegalovirus (CMV) retinitis in patients with acquired
immunodeficiency syndrome (AIDS).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
CMV retinitis occurs in 20 to 30 percent of patients with AIDS and is the leading cause of
visual loss in these patients. At present, ganciclovir and foscarnet are the only drugs that
have been approved by the U.S. Food and Drug Administration for the treatment of CMV
retinitis. The therapeutic regimen for each drug consists of a 2-week induction period
followed by daily maintenance intravenous infusions. Unfortunately, CMV retinitis usually
progresses despite daily maintenance therapy, and both drugs are associated with significant
systemic toxicity that often limits their therapeutic usefulness. As an alternative to
intravenous administration, direct intravitreal injections of ganciclovir have been studied
and have been shown to be effective in delaying the progression of CMV retinitis. The short
half-life of the drug, however, necessitates one to two intraocular injections a week to
maintain therapeutic levels. Widespread adoption of this technique has been limited because
of the logistical difficulties and inherent risks associated with numerous intravitreal
injections.

A drug delivery system capable of continuous delivery of ganciclovir into the vitreous cavity
has been developed. The device consists of a 6-mg pellet of ganciclovir that is coated with a
series of polymers with variable permeability to ganciclovir. The device is surgically
implanted through the pars plana.

Thirty eyes of 26 patients with unilateral non-sight-threatening CMV retinitis were randomly
assigned to one of two groups: (1) immediate therapy with a device designed to release
ganciclovir into the vitreous cavity a over approximately a 4-month period or (2) deferred
treatment. In patients with bilateral non-sight-threatening CMV retinitis, one eye was
randomly assigned to receive a ganciclovir implant with the other eye assigned to deferred
treatment. (Note: The original trial design included a third randomized arm using a 2 ug/hour
device. This arm was dropped for logistical reasons after enrolling two patients.)

Patients assigned to immediate treatment underwent surgery to implant the ganciclovir device
within 48 hours of enrollment and baseline photographs. Postoperatively, patients were
evaluated the next day, weekly for 2 weeks, and then every 2 weeks until progression of CMV
retinitis occurred. At each examination, in both eyes, visual acuity with current correction
and best correction was determined using Early Treatment Diabetic Retinopathy Study eye
charts; intraocular pressure was determined; evidence of inflammation or cataract was
evaluated; and all retinal findings were documented. Any adverse event considered even
possibly related to the device or to the implantation procedure was documented. Standardized
nine-field fundus photographs were taken at each 2-week visit. The ganciclovir implant was
exchanged at 32 weeks or earlier if progression of CMV retinitis occurred.

The primary end point was time to CMV retinitis progression, defined as the time (days) from
initiating therapy until the advancement of 750-um over a 750 um front of any border of any
lesion was observed. Standardized nine-field photographs were taken at 2-week intervals and
analyzed in a masked fashion by the Fundus Photograph Reading Center to determine evidence of
CMV retinitis progression.

Secondary end points included time to development of CMV retinitis in the contralateral eye,
time to development of visceral CMV, and time to death.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>October 1992</start_date>
<completion_date type="Actual">December 1993</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>HIV Infections</condition>
<condition>Acquired Immunodeficiency Syndrome</condition>
<condition>Cytomegalovirus Retinitis</condition>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Sustained-Release Intraocular Drug Delivery System</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
All patients must have had AIDS as defined by the Centers for Disease Control and
Prevention and non-sight-threatening CMV retinitis Patients could not have been previously
treated with systemic ganciclovir or foscarnet and must not have had evidence of other
organ involvement with CMV. Patients must have had an absolute neutrophil count (ANC)
greater than 1,000 cells/mL and a platelet count greater than 25,000/mm3
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<link>
<url>http://www.nei.nih.gov/news/clinicalalerts/alert-soca-fgcrt.asp</url>
<description>Clinical Alert To Physicians And Others Who Treat Patients With AIDS</description>
</link>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/gipressrelease.asp</url>
<description>NEI Press Release-Eye Implant Effective in Treating CMV Retinitis</description>
</link>
<reference>
<citation>Martin DF, Parks DJ, Mellow SD, Ferris FL, Walton RC, Remaley NA, Chew EY, Ashton P, Davis MD, Nussenblatt RB. Treatment of cytomegalovirus retinitis with an intraocular sustained-release ganciclovir implant. A randomized controlled clinical trial. Arch Ophthalmol. 1994 Dec;112(12):1531-9. doi: 10.1001/archopht.1994.01090240037023.</citation>
<PMID>7993207</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>HIV Infections</mesh_term>
<mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
<mesh_term>Cytomegalovirus Retinitis</mesh_term>
<mesh_term>Retinitis</mesh_term>
<mesh_term>Immunologic Deficiency Syndromes</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000118
org study id: NEI-14
nct id: NCT00000118
lead sponsor:
To determine the therapeutic efficacy of a sustained-release intraocular drug delivery system
for ganciclovir therapy of cytomegalovirus (CMV) retinitis in patients with acquired
immunodeficiency syndrome (AIDS).
CMV retinitis occurs in 20 to 30 percent of patients with AIDS and is the leading cause of
visual loss in these patients. At present, ganciclovir and foscarnet are the only drugs that
have been approved by the U.S. Food and Drug Administration for the treatment of CMV
retinitis. The therapeutic regimen for each drug consists of a 2-week induction period
followed by daily maintenance intravenous infusions. Unfortunately, CMV retinitis usually
progresses despite daily maintenance therapy, and both drugs are associated with significant
systemic toxicity that often limits their therapeutic usefulness. As an alternative to
intravenous administration, direct intravitreal injections of ganciclovir have been studied
and have been shown to be effective in delaying the progression of CMV retinitis. The short
half-life of the drug, however, necessitates one to two intraocular injections a week to
maintain therapeutic levels. Widespread adoption of this technique has been limited because
of the logistical difficulties and inherent risks associated with numerous intravitreal
injections.
A drug delivery system capable of continuous delivery of ganciclovir into the vitreous cavity
has been developed. The device consists of a 6-mg pellet of ganciclovir that is coated with a
series of polymers with variable permeability to ganciclovir. The device is surgically
implanted through the pars plana.
Thirty eyes of 26 patients with unilateral non-sight-threatening CMV retinitis were randomly
assigned to one of two groups: (1) immediate therapy with a device designed to release
ganciclovir into the vitreous cavity a over approximately a 4-month period or (2) deferred
treatment. In patients with bilateral non-sight-threatening CMV retinitis, one eye was
randomly assigned to receive a ganciclovir implant with the other eye assigned to deferred
treatment. (Note: The original trial design included a third randomized arm using a 2 ug/hour
device. This arm was dropped for logistical reasons after enrolling two patients.)
Patients assigned to immediate treatment underwent surgery to implant the ganciclovir device
within 48 hours of enrollment and baseline photographs. Postoperatively, patients were
evaluated the next day, weekly for 2 weeks, and then every 2 weeks until progression of CMV
retinitis occurred. At each examination, in both eyes, visual acuity with current correction
and best correction was determined using Early Treatment Diabetic Retinopathy Study eye
charts; intraocular pressure was determined; evidence of inflammation or cataract was
evaluated; and all retinal findings were documented. Any adverse event considered even
possibly related to the device or to the implantation procedure was documented. Standardized
nine-field fundus photographs were taken at each 2-week visit. The ganciclovir implant was
exchanged at 32 weeks or earlier if progression of CMV retinitis occurred.
The primary end point was time to CMV retinitis progression, defined as the time (days) from
initiating therapy until the advancement of 750-um over a 750 um front of any border of any
lesion was observed. Standardized nine-field photographs were taken at 2-week intervals and
analyzed in a masked fashion by the Fundus Photograph Reading Center to determine evidence of
CMV retinitis progression.
Secondary end points included time to development of CMV retinitis in the contralateral eye,
time to development of visceral CMV, and time to death.
allocation: Randomized
primary purpose: Treatment
intervention type: Device
intervention name: Sustained-Release Intraocular Drug Delivery System
criteria:
gender: All
minimum age: N/A
maximum age: N/A
url: http://www.nei.nih.gov/news/clinicalalerts/alert-soca-fgcrt.asp
description: Clinical Alert To Physicians And Others Who Treat Patients With AIDS
url: http://www.nei.nih.gov/news/pressreleases/gipressrelease.asp
description: NEI Press Release-Eye Implant Effective in Treating CMV Retinitis
citation: Martin DF, Parks DJ, Mellow SD, Ferris FL, Walton RC, Remaley NA, Chew EY, Ashton P, Davis MD, Nussenblatt RB. Treatment of cytomegalovirus retinitis with an intraocular sustained-release ganciclovir implant. A randomized controlled clinical trial. Arch Ophthalmol. 1994 Dec;112(12):1531-9. doi: 10.1001/archopht.1994.01090240037023.
PMID: 7993207
mesh term: HIV Infections
mesh term: Acquired Immunodeficiency Syndrome
mesh term: Cytomegalovirus Retinitis
mesh term: Retinitis
mesh term: Immunologic Deficiency Syndromes |
NCT0000xxxx/NCT00000119.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000119</url>
</required_header>
<id_info>
<org_study_id>NEI-15</org_study_id>
<nct_id>NCT00000119</nct_id>
</id_info>
<brief_title>Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To investigate the safety and efficacy of a heparin surface-modified intraocular lens in
patients with uveitis undergoing cataract surgery.

To evaluate the safety and efficacy of intraocular lens implantation in patients with severe
uveitis.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Patients with uveitis are at high risk for significant complications following cataract
surgery with intraocular lens implantation. Complications may result from the surgery itself
or may develop after surgery as a result of the intraocular lens. Complications related to
intraocular lens implantation include iris adhesions to the intraocular lens, which can
result in lens capture; cellular deposits on the surface of the lens that can obscure vision;
and uveitis. Recent studies have identified giant cells on the anterior surface of
intraocular lenses in some patients with uveitis, appearing to indicate an intraocular
lens-induced inflammatory response. Some of these patients have required multiple YAG laser
procedures to remove these deposits.

Modification of the surface of the intraocular lens with a layer of heparin may provide a
more biocompatible surface. Preclinical studies have shown a reduction in the degree of
postoperative complications with the heparin surface-modified intraocular lens compared with
an unmodified lens. Although retrospective case series have examined the use of heparin
surface-modified intraocular lenses in patients with uveitis, a randomized, controlled
clinical trial has not been performed.

This is a randomized clinical trial examining the safety and efficacy of the heparin
surface-modified intraocular lens in patients with uveitis. Eighty patients with a history of
uveitis in an eye requiring cataract surgery will be randomized to receive a heparin
surface-modified intraocular lens or the same model of intraocular lens without surface
modification. The primary end point of the study will be the development of cellular deposits
on the anterior surface of the intraocular lens 1 year after surgery. These cellular deposits
will be assessed by a masked grader using standard photographs. Secondary end points will
include visual acuity, intraocular inflammation, development of anterior and posterior
synechiae, and corneal endothelial cell counts.
</textblock>
</detailed_description>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<start_date>March 1994</start_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Cataract</condition>
<condition>Uveitis</condition>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Heparin Surface-Modified Intraocular Lens</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Women and men 18 years or older with a documented history of uveitis in an eye requiring
cataract surgery are eligible for the study. In all patients, the eye must be free of
active inflammation for at least 3 months before surgery, with or without anti-inflammatory
medications. Exclusion criteria include corneal pathology or hazy media that preclude
evaluation of the intraocular lens, uncontrolled glaucoma, and diabetes mellitus. Monocular
patients and patients who cannot be followed for at least 1 year are also excluded.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<location>
<facility>
<name>National Institutes of Health</name>
<address>
<city>Bethesda</city>
<state>Maryland</state>
<zip>20892-1858</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>September 1999</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cataract</mesh_term>
<mesh_term>Uveitis</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Heparin</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000119
org study id: NEI-15
nct id: NCT00000119
lead sponsor:
To investigate the safety and efficacy of a heparin surface-modified intraocular lens in
patients with uveitis undergoing cataract surgery.
To evaluate the safety and efficacy of intraocular lens implantation in patients with severe
uveitis.
Patients with uveitis are at high risk for significant complications following cataract
surgery with intraocular lens implantation. Complications may result from the surgery itself
or may develop after surgery as a result of the intraocular lens. Complications related to
intraocular lens implantation include iris adhesions to the intraocular lens, which can
result in lens capture; cellular deposits on the surface of the lens that can obscure vision;
and uveitis. Recent studies have identified giant cells on the anterior surface of
intraocular lenses in some patients with uveitis, appearing to indicate an intraocular
lens-induced inflammatory response. Some of these patients have required multiple YAG laser
procedures to remove these deposits.
Modification of the surface of the intraocular lens with a layer of heparin may provide a
more biocompatible surface. Preclinical studies have shown a reduction in the degree of
postoperative complications with the heparin surface-modified intraocular lens compared with
an unmodified lens. Although retrospective case series have examined the use of heparin
surface-modified intraocular lenses in patients with uveitis, a randomized, controlled
clinical trial has not been performed.
This is a randomized clinical trial examining the safety and efficacy of the heparin
surface-modified intraocular lens in patients with uveitis. Eighty patients with a history of
uveitis in an eye requiring cataract surgery will be randomized to receive a heparin
surface-modified intraocular lens or the same model of intraocular lens without surface
modification. The primary end point of the study will be the development of cellular deposits
on the anterior surface of the intraocular lens 1 year after surgery. These cellular deposits
will be assessed by a masked grader using standard photographs. Secondary end points will
include visual acuity, intraocular inflammation, development of anterior and posterior
synechiae, and corneal endothelial cell counts.
allocation: Randomized
primary purpose: Treatment
intervention type: Device
intervention name: Heparin Surface-Modified Intraocular Lens
criteria:
gender: All
minimum age: 18 Years
maximum age: N/A
facility:
country: United States
mesh term: Cataract
mesh term: Uveitis
mesh term: Heparin |
NCT0000xxxx/NCT00000120.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000120</url>
</required_header>
<id_info>
<org_study_id>NEI-19</org_study_id>
<nct_id>NCT00000120</nct_id>
</id_info>
<brief_title>Clinical Trial of Eye Prophylaxis in the Newborn</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To compare the effectiveness of silver nitrate drops, erythromycin ointment, or no medication
in preventing neonatal conjunctivitis caused by Chlamydia trachomatis and other eye
infections.

To compare side effects of the two prophylactic agents.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Sexually transmitted diseases are a major cause of neonatal eye infections. All 50 States
require some eye treatment at birth to prevent gonorrheal eye infections. Approximately 3 to
4 million Americans acquire a genital chlamydial infection each year, and more than 150,000
infants are born to mothers with chlamydial infections. These infants are at high risk of
developing conjunctivitis and pneumonia.

In the State of Washington, one of three treatments is presently required by law to help
prevent gonorrheal eye infection in newborn babies: 1 percent silver nitrate drops,
erythromycin ointment, or tetracycline ointment. Although all three treatments appear to
prevent eye infections from gonorrhea, silver nitrate and erythromycin may also partially
prevent chlamydial conjunctivitis. However, silver nitrate may irritate and damage the eyes
of newborns.

If it is not known whether the mother is infected, it may be better not to give the drugs
routinely. It could not be clearly established from the medical literature whether the risk
to infants from no treatment was higher or lower than the risk from receiving a prophylactic
agent. Many parents at low risk for gonorrhea prefer that no prophylaxis be given to their
newborns. Moreover, Great Britain, which used no eye prophylactic agents for newborns for the
25 years preceding the study, has rates of neonatal conjunctivitis similar to those in the
United States. For these reasons, the Washington State Board of Health granted this study an
exemption from the State law to allow the investigators to evaluate scientifically the risks
and benefits of no treatment.

The study was a randomized, double-masked clinical trials planned to include 1,200 infants
born over 3 years. The trial compared the efficacy of two treatment regimens (silver nitrate
and erythromycin) in two treatment groups to the outcomes in a control group receiving no
prophylaxis. (Erythromycin was chosen over tetracycline as the antibiotic in this study
because it is more commonly used in the United States for ocular prophylaxis.)

Women were recruited from the University of Washington Medical Center-associated obstetric
units. Among the 2,577 women eligible for possible participation, 758 enrolled. Of these
participants, 89 were not randomized. Among the 669 randomized women, 39 were not available
for personal observation. These 39 were equally distributed among the three prophylaxis
groups. In the final participant group, the infants of 630 women were evaluable.

The infants were randomly assigned to one of these three groups in the delivery room. Infants
without conjunctivitis were monitored for 2 months after delivery. Infants who developed
conjunctivitis were monitored for 2 months after successful treatment of their infection. The
study included extensive efforts to determine the etiology of the conjunctivitis and to find
nasolacrimal duct obstruction.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>January 1985</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Chlamydia Infections</condition>
<condition>Ophthalmia Neonatorum</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Erythromycin Ointment</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Silver Nitrate Drops</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
The study included male and female infants delivered at University Hospital in Seattle,
Washington. Women were recruited after the 28th week of pregnancy and had to be
English-speaking. In addition, they planned to stay at the hospital at least 48 hours
following delivery and lived in the greater Seattle metropolitan area. Infants were
eligible whether they were delivered vaginally or by cesarean section. Excluded from the
study were siblings of infants enrolled in the study, women who were culture-positive for
gonorrhea, infants receiving systemic antimicrobials for reasons other than conjunctivitis,
women receiving antimicrobials at the time of delivery, and families unlikely to be
available for followup after delivery.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>1 Year</maximum_age>
</eligibility>
<reference>
<citation>Krohn MA, Hillier SL, Bell TA, Kronmal RA, Grayston JT. The bacterial etiology of conjunctivitis in early infancy. Eye Prophylaxis Study Group. Am J Epidemiol. 1993 Sep 1;138(5):326-32. doi: 10.1093/oxfordjournals.aje.a116862.</citation>
<PMID>8356971</PMID>
</reference>
<reference>
<citation>Bell TA, Grayston JT, Krohn MA, Kronmal RA. Randomized trial of silver nitrate, erythromycin, and no eye prophylaxis for the prevention of conjunctivitis among newborns not at risk for gonococcal ophthalmitis. Eye Prophylaxis Study Group. Pediatrics. 1993 Dec;92(6):755-60.</citation>
<PMID>8233733</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<keyword>Neonatal Conjunctivitis</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Chlamydia Infections</mesh_term>
<mesh_term>Ophthalmia Neonatorum</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Erythromycin</mesh_term>
<mesh_term>Erythromycin Estolate</mesh_term>
<mesh_term>Erythromycin Ethylsuccinate</mesh_term>
<mesh_term>Erythromycin stearate</mesh_term>
<mesh_term>Silver Nitrate</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000120
org study id: NEI-19
nct id: NCT00000120
lead sponsor:
To compare the effectiveness of silver nitrate drops, erythromycin ointment, or no medication
in preventing neonatal conjunctivitis caused by Chlamydia trachomatis and other eye
infections.
To compare side effects of the two prophylactic agents.
Sexually transmitted diseases are a major cause of neonatal eye infections. All 50 States
require some eye treatment at birth to prevent gonorrheal eye infections. Approximately 3 to
4 million Americans acquire a genital chlamydial infection each year, and more than 150,000
infants are born to mothers with chlamydial infections. These infants are at high risk of
developing conjunctivitis and pneumonia.
In the State of Washington, one of three treatments is presently required by law to help
prevent gonorrheal eye infection in newborn babies: 1 percent silver nitrate drops,
erythromycin ointment, or tetracycline ointment. Although all three treatments appear to
prevent eye infections from gonorrhea, silver nitrate and erythromycin may also partially
prevent chlamydial conjunctivitis. However, silver nitrate may irritate and damage the eyes
of newborns.
If it is not known whether the mother is infected, it may be better not to give the drugs
routinely. It could not be clearly established from the medical literature whether the risk
to infants from no treatment was higher or lower than the risk from receiving a prophylactic
agent. Many parents at low risk for gonorrhea prefer that no prophylaxis be given to their
newborns. Moreover, Great Britain, which used no eye prophylactic agents for newborns for the
25 years preceding the study, has rates of neonatal conjunctivitis similar to those in the
United States. For these reasons, the Washington State Board of Health granted this study an
exemption from the State law to allow the investigators to evaluate scientifically the risks
and benefits of no treatment.
The study was a randomized, double-masked clinical trials planned to include 1,200 infants
born over 3 years. The trial compared the efficacy of two treatment regimens (silver nitrate
and erythromycin) in two treatment groups to the outcomes in a control group receiving no
prophylaxis. (Erythromycin was chosen over tetracycline as the antibiotic in this study
because it is more commonly used in the United States for ocular prophylaxis.)
Women were recruited from the University of Washington Medical Center-associated obstetric
units. Among the 2,577 women eligible for possible participation, 758 enrolled. Of these
participants, 89 were not randomized. Among the 669 randomized women, 39 were not available
for personal observation. These 39 were equally distributed among the three prophylaxis
groups. In the final participant group, the infants of 630 women were evaluable.
The infants were randomly assigned to one of these three groups in the delivery room. Infants
without conjunctivitis were monitored for 2 months after delivery. Infants who developed
conjunctivitis were monitored for 2 months after successful treatment of their infection. The
study included extensive efforts to determine the etiology of the conjunctivitis and to find
nasolacrimal duct obstruction.
allocation: Randomized
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Erythromycin Ointment
intervention type: Drug
intervention name: Silver Nitrate Drops
criteria:
gender: All
minimum age: N/A
maximum age: 1 Year
citation: Krohn MA, Hillier SL, Bell TA, Kronmal RA, Grayston JT. The bacterial etiology of conjunctivitis in early infancy. Eye Prophylaxis Study Group. Am J Epidemiol. 1993 Sep 1;138(5):326-32. doi: 10.1093/oxfordjournals.aje.a116862.
PMID: 8356971
citation: Bell TA, Grayston JT, Krohn MA, Kronmal RA. Randomized trial of silver nitrate, erythromycin, and no eye prophylaxis for the prevention of conjunctivitis among newborns not at risk for gonococcal ophthalmitis. Eye Prophylaxis Study Group. Pediatrics. 1993 Dec;92(6):755-60.
PMID: 8233733
mesh term: Chlamydia Infections
mesh term: Ophthalmia Neonatorum
mesh term: Erythromycin
mesh term: Erythromycin Estolate
mesh term: Erythromycin Ethylsuccinate
mesh term: Erythromycin stearate
mesh term: Silver Nitrate |
NCT0000xxxx/NCT00000121.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000121</url>
</required_header>
<id_info>
<org_study_id>NEI-20</org_study_id>
<nct_id>NCT00000121</nct_id>
</id_info>
<brief_title>The Prism Adaptation Study (PAS)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine whether the preoperative use of prisms in eyeglasses can improve the outcome of
surgery for acquired esotropia, a type of strabismus.

To determine whether patients who respond to prism adaptation by developing a new stable
angle of -deviation have a better surgical result than do patients who do not respond to
prism adaptation.

To determine whether patients who respond to prism adaptation are more accurately corrected
by operating for the prism-adapted angle or the original angle of deviation.

To determine the usefulness of certain input variables (e.g., age at the time of surgery,
size of the deviation, visual acuity, binocular function, refractive error) in predicting
which patients are more likely to benefit from prism adaptation.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Acquired esotropia (crossed eyes that develop after a child reaches the age of 6 months)
accounts for 25 percent of all patients with misaligned eyes. Surgery to correct esotropia is
done primarily to attain functional use of the two eyes together. The cosmetic aspect of the
surgery is secondary. In 40 to 50 percent of cases, more than one operation is needed to
accomplish the primary goal, and in some cases even three and four operations are needed.

Preliminary studies from two eye care centers reported that the use of prisms on eyeglasses
for about a month before surgery led to good results after a single operation in more than 90
percent of patients. These uncontrolled preliminary studies pointed to the need for a
multicenter, randomized, controlled clinical trial designed to prove or disprove
scientifically the beneficial effect of prisms.

The Prism Adaptation Study was a double randomization trial involving 286 patients.
Three-fifths of the patients were randomly selected for prism adaptation before surgery. Of
the patients who responded to the prisms, one-half were randomly selected to have surgery
based on the amount of prism required to stabilize the deviation, and the other half had
surgery based on the amount of esotropia originally measured. Patients who did not respond to
the prisms also had surgery based on the amount of esotropia measured, as did the two-fifths
of the patients who did not undergo prism adaptation.

Patients were examined postoperatively at 1 week, 1 month, 3 months, 6 months, and 1 year. An
independent examiner, masked to the treatment assignment, evaluated the patient at the
6-month followup. The results were analyzed to determine whether the outcome was better in
patients who underwent prism adaptation or in those who underwent conventional treatment.
Because the examiner did not know what type of treatment a patient had received, he or she
would have no bias in evaluating the results.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>March 1984</start_date>
<completion_date type="Actual">May 1989</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Esotropia</condition>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Prisms in Eyeglasses</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
An eligible male or female must have been age 3 years or older (adults were included) and
must have had esotropia that occurred at age 6 months or older, with no history of previous
eye muscle surgery.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>3 Years</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<reference>
<citation>Efficacy of prism adaptation in the surgical management of acquired esotropia. Prism Adaptation Study Research Group. Arch Ophthalmol. 1990 Sep;108(9):1248-56. doi: 10.1001/archopht.1990.01070110064026.</citation>
<PMID>2100986</PMID>
</reference>
<reference>
<citation>Repka MX, Connett JE, Scott WE. The one-year surgical outcome after prism adaptation for the management of acquired esotropia. Ophthalmology. 1996 Jun;103(6):922-8. doi: 10.1016/s0161-6420(96)30586-1.</citation>
<PMID>8643248</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<keyword>strabismus</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Esotropia</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
| download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000121
org study id: NEI-20
nct id: NCT00000121
lead sponsor:
To determine whether the preoperative use of prisms in eyeglasses can improve the outcome of
surgery for acquired esotropia, a type of strabismus.
To determine whether patients who respond to prism adaptation by developing a new stable
angle of -deviation have a better surgical result than do patients who do not respond to
prism adaptation.
To determine whether patients who respond to prism adaptation are more accurately corrected
by operating for the prism-adapted angle or the original angle of deviation.
To determine the usefulness of certain input variables (e.g., age at the time of surgery,
size of the deviation, visual acuity, binocular function, refractive error) in predicting
which patients are more likely to benefit from prism adaptation.
Acquired esotropia (crossed eyes that develop after a child reaches the age of 6 months)
accounts for 25 percent of all patients with misaligned eyes. Surgery to correct esotropia is
done primarily to attain functional use of the two eyes together. The cosmetic aspect of the
surgery is secondary. In 40 to 50 percent of cases, more than one operation is needed to
accomplish the primary goal, and in some cases even three and four operations are needed.
Preliminary studies from two eye care centers reported that the use of prisms on eyeglasses
for about a month before surgery led to good results after a single operation in more than 90
percent of patients. These uncontrolled preliminary studies pointed to the need for a
multicenter, randomized, controlled clinical trial designed to prove or disprove
scientifically the beneficial effect of prisms.
The Prism Adaptation Study was a double randomization trial involving 286 patients.
Three-fifths of the patients were randomly selected for prism adaptation before surgery. Of
the patients who responded to the prisms, one-half were randomly selected to have surgery
based on the amount of prism required to stabilize the deviation, and the other half had
surgery based on the amount of esotropia originally measured. Patients who did not respond to
the prisms also had surgery based on the amount of esotropia measured, as did the two-fifths
of the patients who did not undergo prism adaptation.
Patients were examined postoperatively at 1 week, 1 month, 3 months, 6 months, and 1 year. An
independent examiner, masked to the treatment assignment, evaluated the patient at the
6-month followup. The results were analyzed to determine whether the outcome was better in
patients who underwent prism adaptation or in those who underwent conventional treatment.
Because the examiner did not know what type of treatment a patient had received, he or she
would have no bias in evaluating the results.
allocation: Randomized
primary purpose: Treatment
intervention type: Device
intervention name: Prisms in Eyeglasses
criteria:
gender: All
minimum age: 3 Years
maximum age: N/A
citation: Efficacy of prism adaptation in the surgical management of acquired esotropia. Prism Adaptation Study Research Group. Arch Ophthalmol. 1990 Sep;108(9):1248-56. doi: 10.1001/archopht.1990.01070110064026.
PMID: 2100986
citation: Repka MX, Connett JE, Scott WE. The one-year surgical outcome after prism adaptation for the management of acquired esotropia. Ophthalmology. 1996 Jun;103(6):922-8. doi: 10.1016/s0161-6420(96)30586-1.
PMID: 8643248
mesh term: Esotropia |
End of preview. Expand
in Data Studio
No dataset card yet
- Downloads last month
- 57