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This research study aims to evaluate whether corticosteroids help prevent the recurrence of pleural effusions in patients with non-specific pleuritis diagnosed through pleural biopsy. It can lead to recurrent fluid buildup in the lungs, causing discomfort and requiring additional medical interventions. There is no established treatment to prevent recurrence, and this study seeks to determine whether steroids reduce fluid buildup or cause complications.
There will be two groups: one receiving corticosteroids (standard of care in the institution) and one not receiving corticosteroids (intervention group). The participation will last approximately 6 months, with in-person visits every 2 weeks for the first month, then monthly, along with possible telephone follow-ups. The study will monitor for pleural effusion recurrence, need for additional procedures, and potential side effects of corticosteroids.
This is a pilot study. Although there are forty people expected to take part in this research study based on institutional data, the number of patients included in the study will be determined by the number of patients with non-specific pleuritis diagnosed during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Corticosteroids | Experimental | Standard of care (corticosteroids) as per institutional practice. If the treatment is effective, patients continue for another 4 weeks while taking medication to prevent infections. If it's not effective, they begin a gradual dose reduction until stopping. |
|
| Patients with No Corticosteroids | Active Comparator | Patients will not receive any corticosteroids. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroid | Drug | Patients take 40 mg of prednisone daily for 4 weeks to help reduce inflammation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients screened | Screened defined as how many patients are evaluated for participation | every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months |
| Number of patients enrolled | Enrolled defined as how many screened patients actually join the study | every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months |
| Number of patients retained | Retention defined as how many enrolled patients continue participating over time | every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of recurrence | Incidence of recurrent pleural effusions attributable to symptoms requiring an intervention | every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Axel Duval, MD | Contact | 212-824-8546 | axel.duval@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Udit Chaddha, MBBS | Icahn School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
All of the individual participant data collected during the trial, after deidentification.
Beginning 9 months and ending 36 months following article publication.
Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals should be directed to udit.chaddha@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (link to be determined).
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| ID | Term |
|---|---|
| D010998 | Pleurisy |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
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| No Corticosteroid | Other | Patients do not take corticosteroid. |
|
| Mount Sinai Morningside | Recruiting | New York | New York | 10029 | United States |
|
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |