- In the process of the treatment
- Screening
- Baseline
- Follow-up（One week after surgery）
- Follow-up （One month after surgery）
- Follow-up （Three months after surgery）
- Follow-up （Six months after surgery）
- Follow-up （One year after surgery）
- Management and ethics documents
- ADR/ADE management system
- Research team
- Design, Methods
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Operation method | Posterior cranial fossa decompression(2×3cm area including posterior arch of atlas and foramen magnum)+Dural "Y" type incision+Cerebellar tonsillectomy and adhesions+Dural expansion
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Time of operation | 2022-11-08 |
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ChiariⅠmalformation confirmed by MR imaging, have corresponding clinical symptoms and signs | Yes
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All genders, age from 18-70 years old | Yes
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Signed informed consent | Yes
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Doctor | 林江凯 |
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Date | 2022-11-04 |
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Congenital diseases, psychotic or neurotic diseases, serious diseases of heart,lung,liver or kidney. | No
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Other Chiari malformations, or Chiari Ⅰmalformations combined with basilar invagination, atlantoaxial dislocation or scoliosis | No
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Other cervical diseases(such as tumor,trauma and degeneration) resulted in cervical pain, limbs numbness or weekness, sphincter disturbance or sexual dysfunction. | No
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Recently(<3y) drug using or psychological problems that could affect outcome | No
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Attned other clinical trials in last 3 monthes | No
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Pregnant women | No
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Doctor | 林江凯 |
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Date | 2022-11-08 |
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The patient does not cooperate with this study | |
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The patient died | |
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The patient asked to quit | |
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Doctor |
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Date |
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- General information
- Physical examination
- Nervous system examination
- Blood Routine Tests
- Serum Liver Function Tests
- HBV Markers Test
- Renel Function Test
- ECG
- Blood type
- Image Examinations
- Preoperative JOA score
- Neck Disabilitve Index NDI
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Name | CH XL |
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Sex | Man
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Age | 49 |
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ID | 8003866081 |
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Hospital number | H24653 |
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Birthplace | 贵州 |
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Nationality | 汉族 |
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Marital status | married
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Occupation | Freelance
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Admission date | 2022-11-04 |
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Diagnosis on Admission | 小脑扁桃体下疝畸形；脊髓空洞 |
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Smoking history | Daily Smoker
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Whether drinking | occasionally
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Family history | 无 |
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Medical history | 2015年车祸致右侧锁骨骨折 |
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General condition | 无异常 |
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Skin and lymph nodes | 无异常 |
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Head and neck region | 无异常 |
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Chest | 无异常 |
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Abdomen | 无异常 |
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Spine and limbs | 右手屈曲障碍，右手呈“爪”形 |
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Nervous system examination | 双上肢麻木、乏力、感觉减退、右上肢肌力4级，右前臂及小鱼际肌肉萎缩、关节伸展、屈曲障碍。 |
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Hb | 137 g/L |
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RBC | 4.04 X10*12/L |
40.90 % |
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WBC | 5.52 X10*9/L |
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PLT | 131 X10*9/L |
0.16 % |
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Date of test | 2022-11-04 |
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ALT | 14.90 IU/L |
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AST | 21.80 IU/L |
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ADA | U/L |
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GGT | 14.50 U/L |
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Serum bilirubin | 11.40 μmol/L |
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Indirect bilirubin | 9.20 umol/L |
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Direct bilirubin | 2.20 umol/L |
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Serum albumin | 37.50 g/L |
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Serum globulin | 25.10 g/L |
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Serum total protein | 62.60 g/L |
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A/G | 1.49 |
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Date of test | 2022-11-04 yyyy-mm-dd |
Negative
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Date of test | 2022-11-04 yyyy-mm-dd |
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UN | 3.69 mmol/L |
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Cr | 62.40 μmol/L |
mg/L |
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mg/L |
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SOD | U/mL |
118.73 ml/min/l |
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UA | 332.00 μml/L |
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Date of test | 2022-11-04 yyyy-mm-dd |
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ECG | Normal
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Description for the abnormal findings |
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Date of examination | 2022-11-04 yyyy-mm-dd |
Positive
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Type of imaging (s) | / / / |
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Assessment of CT/MRI | 小脑扁桃体下疝畸形；脊髓空洞 |
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Upper extremity motor function | Barely can eat with chopsticks
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Lower extremity motor function | Normal
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Upper limb sensory function | Mild sensory disorder or numbness
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Lower limb sensory function | Normal
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Torso sensory function | Mild sensory disorder or numbness
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Bladder | Normal
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Total | 13 |
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Total | 0 |
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Upper extremity motor function | ?Barely can eat with chopsticks
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Lower extremity motor function | Normal
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Upper limb sensory functio | Mild sensory disorder or numbness
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Lower limb sensory function | Normal
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Torso sensory function | Mild sensory disorder or numbness
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Bladder | Normal
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Total | 13 分 |
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Pain | Complete remission
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Not painful | Improvement
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Function | Can participate in less than 50% of life
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Complications | No complications
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Total | 13 |
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Whether to perform the chest CT | NO
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Whether to perform the head and neck CT | NO
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Whether to perform the spine CT | NO
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Whether to perform the spine MRI | Yes
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Occipital and neck pain | No
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Body or limbs feel abnormal | Yes
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Limb muscle strength decreased | Yes
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Dizziness pain | NO
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Bowel and bladder dysfunction | NO
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Sexual dysfunction | NO
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Autonomic nervous system dysfunction | NO
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With or without complications | NO
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specific description |
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- Image Examinations
- Symptom
- Complications
- JOA score
- Chicago Chiari Outcome Scale
- Neck Disabilitive Index NDI
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Whether to perform the chest CT | NO
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Whether to perform the head and neck CT | No
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Whether to perform the spine CT | No
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Whether to perform the spine MRI | No
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Occipital and neck pain | No
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Body or limbs feel abnormal | Yes
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Limb muscle strength decreased | Yes
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Dizziness pain | No
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Bowel and bladder dysfunction | No
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Sexual dysfunction | No
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Autonomic nervous system dysfunction | No
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With or without complications | No
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specific description |
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Upper limb motor function | Barely can eat with chopsticks
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Lower limb motor function | Normal
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Upper limb sensory function | Mild sensory disorder or numbness
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Lower limb sensory function | Normal
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Trunk sensory function | Mild sensory disorder or numbness
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bladder | Normal
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Total | 13 分 |
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Pain | Improvement
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Not painful | Improvement
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Function | Can participate in more than 50% of life
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Complications | No complications
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Total | 13 分 |
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Total | 0 分 |
- Image Examinations
- Symptom
- Complications
- JOA score
- Chicago Chiari Outcome Scale
- Neck Disabilitve Index NDI
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Whether to perform the chest CT | NO
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Whether to perform the head and neck CT | No
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Whether to perform the spine CT | No
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Whether to perform the spine MRI | No
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Occipital and neck pain | No
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Body or limbs feel abnormal | Yes
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Limb muscle strength decreased | Yes
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Dizziness pain | No
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Bowel and bladder dysfunction | No
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Sexual dysfunction | No
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Autonomic nervous system dysfunction | No
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With or without complications | No
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specific description |
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Upper extremity motor function | Barely can eat with chopsticks
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Lower extremity motor function | Normal
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Upper limb sensory function | Mild sensory disorder or numbness
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Lower limb sensory function | Normal
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Trunk sensory function | Mild sensory disorder or numbness
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Bladder | Normal
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Total | 13 分 |
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Pain | Improvement
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Not painful | Improvement
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Function | Completely normal
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Complications | No complications
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Total | 14 分 |
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Total | 0 分 |
- Image Examinations
- Symptom
- Complications
- JOA score
- Chicago Chiari Outcome Scale
- Neck Disabilitve Index NDI
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Whether to perform the chest CT | NO
|
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Whether to perform the head and neck CT | NO
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Whether to perform the spine CT | NO
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Whether to perform the spine MRI | NO
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Occipital and neck pain | No
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Body or limbs feel abnormal | Yes
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Limb muscle strength decreased | Yes
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Dizziness pain | No
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Bowel and bladder dysfunction | No
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Sexual dysfunction | No
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Autonomic nervous system dysfunction | No
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With or without complications | Yes
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specific description | 伤口处疼痛 |
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Upper extremity motor function | Barely can eat with chopsticks
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Lower extremity motor function | Normal
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Upper limb sensory function | Mild sensory disorder or numbness
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Lower limb sensory function | Normal
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Torso sensory function | Mild sensory disorder or numbness
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Bladder | Normal
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Total | 13 分 |
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Pain | Remain the same
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Not painful | Remain the same
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Function | Completely normal
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Complications | No complications
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Total | 12 分 |
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Total | 0 分 |
- Image Examinations
- Symptom
- Complications
- JOA score
- Chicago Chiari Outcome Scale
- Neck Disabilitve Index NDI
|
Whether to perform the chest CT | NO
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Whether to perform the head and neck CT | NO
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Whether to perform the spine CT | NO
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Whether to perform the spine MRI | NO
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Occipital and neck pain | NO
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Body or limbs feel abnormal | Yes
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Limb muscle strength decreased | Yes
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Dizziness pain | NO
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Bowel and bladder dysfunction | NO
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Sexual dysfunction | NO
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Autonomic nervous system dysfunction | NO
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With or without complications | NO
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Specific description |
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Upper extremity motor function | Barely can eat with chopsticks
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Lower extremity motor function | Normal
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Upper limb sensory function | Mild sensory disorder or numbness
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Lower limb sensory | Normal
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Torso sensory function | Mild sensory disorder or numbness
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Bladder | Normal
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Total | 13 分 |
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Pain | Remain the same
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Not painful | Remain the same
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Function | Completely normal
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Complications | No complications
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Total | 12 分 |
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Total | 0 分 |
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Whether got the informed consent? | Yes
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Date of sign the informed consent | 2022-11-08 xx年xx月xx日 |
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Types of violation | |
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Informed consent violant | |
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No. of the violance |
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Date of violance | yyyy-mm-dd-hh-min. |
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Inclusion and Exclusion criteria violation | |
yyyy-mm-dd-hh-min. |
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yyyy-mm-dd-hh-min. |
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Adverse events violantion | |
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yyyy-mm-dd-hh-min. |
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Follow-up violation | |
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yyyy-mm-dd-hh-min. |
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Loss of data violation | |
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yyyy-mm-dd-hh-min. |
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Data over the feild violation | |
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yyyy-mm-dd-hh-min. |
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Therapy or operation compliance violation | |
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yyyy-mm-dd-hh-min. |
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Any approach | |
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Date of action | yyyy-mm-dd-hh-min. |
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Violation information |
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Name of adverse event |
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Reason of adverse event |
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Start date | yyyymmdd |
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Interventions | |
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Interventions, please specify |
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Start date | yyyymmdd |
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Stop date | yyyymmdd |
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Attributed to the surgical plan | |
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Outcome of the event | |
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If recovered/resolved, the date is | yyyymmdd |
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Name of the recorder |
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Data | yyyymmdd |
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Site Investigator’s signature |
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Data | yyyymmdd |
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Southwest Hospital |
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Jiangkai Lin | |
|
Weihua Chu | |
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Guangjian He | |
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Xingsen Xue | |
|
Xin Chen | |
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Na Wu |