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Changes in treatment pathway made recruitment unfeasible
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Inflamed joints in patients with rheumatoid arthritis and psoriatic arthritis are characterized by low oxygen levels and inflammation. We propose to investigate whether tiny bubbles (nanobubbles) when given in a drink can alter oxygen level in joints. These nanobubbles are so small that they can enter the bloodstream when given as a drink. This information will give new information on the role of oxygen in joint inflammation and could possibly lead to new treatment approaches in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nanobubble | Experimental | Sports drink nanobubble drink |
|
| control | Placebo Comparator | Flavoured drink- no active ingredients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanobubble drink | Dietary Supplement | Commercially available sports drink |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Synovial fluid pO2 | Change in synovial fluid pO2 between day 1 and day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hypoxia-inducible factor 1α (HIF-1α) protein levels in synovial tissues | Change in hypoxia-inducible factor 1α (HIF-1α) protein between day 1 and day 28 | |
| Treatment Satisfaction Questionnaire for Medication (C) | Validated PRO assessing: side effects, effectiveness, convenience and global satisfaction |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the absolute and relative cell count in synovial fluid and synovial biopsy | day 28 | |
| Change from baseline of synovial fibroblast protein expression | day 28 |
Inclusion Criteria:
• Participant is willing and able to give informed consent for participation in the study.
Exclusion Criteria:
• Currently on oxygen therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford University Hospitals NHS Trust | Oxford | OX3 7LD | United Kingdom |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Day28 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |