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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A00327-36 | Other Identifier | 2022-A00327-36 |
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There is a toxicity linked to the chronic use of nitrous oxide, leading to neurological disorders such as combined sclerosis of the spinal cord. One thus frequently observes patients presenting disorders of walking or paresthesias, of more or less resolving evolution being able to go until the need for using a wheelchair and more recently cases of thrombosis were reported Serum or urine N2O assays are rarely performed routinely, because they do not allow to ensure a real exposure due to the very short half-life of this gas in the body. Thus, other biological monitoring markers are mentioned in the literature, such as vitamin B12 or homocysteine. Unfortunately, there are still no recommendations for biological monitoring of nitrous oxide consumption. Moreover, underlying mechanisms leading to clinical outcomes remains misunderstood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects consuming nitrous oxide with clinical outcomes | Subjects who consume nitrous oxide and who have been hospitalized in this context and who present clinical signs determined during a neurological evaluation according to the PND (Peripheral Neuropathy Disability) score or who have had a thrombotic accident related to the consumption of nitrous oxide. |
| |
| Subjects consuming nitrous oxide without clinical outcomes | Subjects who consume nitrous oxide who do not present clinical signs related to this consumption and recruited during a routine medical consultation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood collection | Other | Biological analyses in the framework of care with conservation of blood samples |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood markers related to nitrous oxide consumption | Biomarkers of cobalamin metabolism, methionine cycle and oxidative stress | through study completion an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Blood markers related to nitrous oxide clinical outcomes. | Biomarkers of cobalamin metabolism, methionine cycle and oxidative stress and biological markers of neurological damage. | Baseline, at 4 weeks, at 3 months and at 6 months |
| Estimated and self-reported nitrous oxide consumption |
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Inclusion Criteria:
Exclusion Criteria:
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Patients using or having recently used nitrous oxide, and hospitalized during the study will be offered to participate in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillaume Grzych, MD | Contact | 0320445962 | +33 | guillaume.grzych@chu-lille.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BETHUNE | Recruiting | Béthune | France |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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whole blood, serum, plasma
| Baseline, at 4 weeks,and/or at 3 months and at 6 months |
| The severity of the clinical signs related to nitrous oxide consumption. | The severity of the signs noted during the interrogation and consultation of the patients by filling out a pre-established form listing the neurological signs (gait disorders evaluated by the PND score, presence of paresthesia and associated clinical signs (thrombotic and psychiatric events) | Baseline, at 4 weeks,and/or at 3 months and at 6 months |
| Boulogne Sur Mer | Recruiting | Boulogne-sur-Mer | France |
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| CALAIS | Recruiting | Calais | France |
|
| Lens | Recruiting | Lens | France |
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| Chu Lille | Recruiting | Lille | France |
|
| Nantes | Recruiting | Nantes | France |
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| Roubaix | Recruiting | Roubaix | France |
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| Rouen | Recruiting | Rouen | France |
|
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |