Evaluation and Treatment of Patients With Lung Disease Not Participating in Research

September 25, 2020 updated by: National Heart, Lung, and Blood Institute (NHLBI)

Evaluation and Treatment of Pulmonary Patients Not Participating in Research (Training Protocol)

This study was developed in order for the professional-staff at the Pulmonary-Critical Care Medical Branch (PCCMB) of the National Heart, Lung, and Blood Institute to maintain their skills and increase their understanding of lung diseases.

The study will permit PCCMB staff members to evaluate and treat patients with lung disease who do not meet the criteria for other research studies.

Study Overview

Status

Completed

Conditions

Detailed Description

The professional staff in the Cardiovascular and Pulmonary Branch (CPB) needs to maintain their clinical skills and to enhance their clinical knowledge. The purpose of this protocol is to permit CPB staff to evaluate and treat patients with pulmonary disease who do not meet the criteria for existing research protocols.

Study Type

Observational

Enrollment (Actual)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with pulmonary disease who do not meet the criteria for existing research protocols.

Description

  • INCLUSION CRITERIA:

Patients 8 years old and older with signs or symptoms of pulmonary disease of medical interest to the professional staff of CPB will be eligible for participation in this protocol. Only standard diagnostic procedures and conventional therapy will be performed. Patients will not be subjected to any research procedures. This protocol does not commit the NIH to medical or surgical treatment of protocol participants after discharge. Patients will be discharged to the referring physician.

Consenting to pregnancy testing in minors of childbearing age:

We will inform the minor during the assent process that for safety, we need to do a pregnancy test. She will also be told that if it is positive, we will counsel her and help her tell her parents. If the minor does not want to proceed she will be advised not to sign assent and her enrollment on this training protocol will end.

EXCLUSION CRITERIA:

Patients without symptoms of pulmonary disease will be excluded from this protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Pulmonary Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to permit PB staff to evaluate and treat patients with pulmonary disease who do not meet the criteria for existing research protocols.
Time Frame: 1 visit
The purpose of this protocol is to permit PB staff to evaluate and treat patients with pulmonary disease who do not meet the criteria for existing research protocols.
1 visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 1997

Primary Completion (Actual)

September 25, 2020

Study Completion (Actual)

September 25, 2020

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (Estimate)

November 4, 1999

Study Record Updates

Last Update Posted (Actual)

September 28, 2020

Last Update Submitted That Met QC Criteria

September 25, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 970061
  • 97-H-0061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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