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Spinal cord trauma and the consequent paraplegia are possibly among the most devastating injuries in soldiers and during spine surgery, and are significant in the medical, social and financial aspects. Limited mobility, the need for assistance in all human activities, shame, and many medical complications related directly to the neural deficits make paraplegia an important target for prevention. Our study will evaluate the efficacy of Minocycline in two different groups:
2.OBJECTIVES
The primary objectives of the trial are to determine:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minocycline, Spinal Tumor patients, quality of life | Experimental |
| |
| Minocycline, Trauma patuents, quality of life | Experimental |
| |
| Placebo, Trauma patients, quality of life | Placebo Comparator |
| |
| Placebo, Spinal cord tumors, quality of life | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients | The Efficacy will be evaluated using the following measures:
| six months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of administrating minocycline at changing the natural history and rehabilitation of spinal cord trauma patients. | The Efficacy will be evaluated using the following measures:
|
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Inclusion Criteria:
Trauma patients with incomplete spinal cord syndromes related to fractures, dislocations, blunt trauma (central cord syndrome).
Exclusion Criteria:
Spinal tumors:
Inclusion Criteria:
1. Intrathecal extramedullary tumors, vertebral metastases or primary vertebral tumors causing cord compression with or without incomplete cord syndrome.
Exclusion criteria:
1.Intramedullary tumors or tumors causing complete cord syndrome
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamim Drenger, Prof. | Contact | drenger@ekmd.huji.ac.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Organization | Jerusalem | Israel |
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| placebo |
| Drug |
|
| six months |
| Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors? | Safety will be evaluated in a descriptive manner by recording all adverse events in the patient population by number and severity. The study will evaluate safety by assessing:
| six months |
| ID | Term |
|---|---|
| D013120 | Spinal Cord Neoplasms |
| C562573 | cyclopia sequence |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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