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| Name | Class |
|---|---|
| Dartmouth-Hitchcock Medical Center | OTHER |
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Collection of urine, blood, and tissue samples from patients undergoing hyperbaric oxygen therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: RC with HBOT | Participants with radiation cystitis schedule for hyperbaric oxygen therapy |
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| Cohort 2: HBOT Controls | Participants schedule for hyperbaric oxygen therapy without a history of pelvic radiation |
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| Cohort 3: Healthy Controls | Age and gender matched controls with no history of radiation exposure | ||
| Cohort 4: RC with no HBOT | Participants with radiation cystitis who elect not to undergo hyperbaric oxygen therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen Therapy | Other | Hyperbaric Oxygen Therapy (HBOT) is the only non-invasive treatment modality for Radiation Cystitis, performed by placing patients in chambers and introducing them to steep oxygen gradients (100% oxygen at a pressure of 240-250kPa) for 80 to 90 minutes per day in up to 60 consecutive sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of HBOT | Participants complete Hyperbaric Oxygen Therapy and final urine sample collection | From enrollment to 1 year after completion of HBOT treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of Specimen collection | For healthy controls and radiation cystitis patients not undergoing HBOT, | From enrollment until approximately 1 year after enrollment |
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Inclusion Criteria:
Cohort 1
Exclusion Criteria:
All Cohorts
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Potential patients will be identified in the clinical during standard of care appointments. Participants in a local hyperbarics medicine registry will be approached for their interest in participating in this study as well. Healthy volunteers will be recruited from postings on public bulletin boards and available local community ListServs. Recruitment materials are reviewed and approved by the local IRB.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Moses, MD | Contact | (603) 650-5091 | Rachel.A.Moses@hitchcock.org | |
| Amanda Wittemann | Contact | (603)653-0654 | Amanda.L.Wittemann@Hitchcock.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
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Urine and blood specimens will be banked for potential future use; Radiation Cystitis participants will additionally consent to having biopsy specimens banked for future studies comparing immunohistochemical staining for bladder inflammatory marker localization validation.
|
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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