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Completed

NCT Number: NCT03294616

Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma

An innovative method of needleless transcutaneous electroacupuncture (TEA) using a newly developed watch-size stimulator is proposed. Weak electrical current will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. The stimulator can be attached to the skin near the acupuncture points and therefore daily activity of the patient does not need to be altered. Two experiments are designed to prove the feasibility of the proposed therapy for gastric complications of Scleroderma .

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No any systemic diseases;
  • no scleroderma; no history of gastrointestinal surgery;
  • no dyspeptic symptoms during the past 2 weeks;
  • not taking any medications except contraceptives during the past 2 weeks;
  • age 18 and older.

Exclusion criteria

  • History of any systemic diseases or surgeries;
  • allergic to adhesives; pregnancy;
  • unable to sign the consent form.

Treatment and study plan

transcutaneous electroacupuncture

Device

Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions

Other names: TEA

Primary outcomes

  1. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Time frame: 1 day

    On the first visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation

  2. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Time frame: 28 days

    On the second visit; The validated "University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0" (UCLA SCTC GIT2.0) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation

  3. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Time frame: 42 days

    On the third visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation

  4. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Time frame: 70 days

    The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation

  5. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Time frame: 1 day

    Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms

  6. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Time frame: 28 days

    Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms

  7. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Time frame: 42 days

    Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms

  8. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Time frame: 70 days

    Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms

  9. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Time frame: 1 day

    SF-36 questionnaire will be used to assess general quality of life

  10. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Time frame: 28 days

    SF-36 questionnaire will be used to assess general quality of life

  11. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Time frame: 42 days

    SF-36 questionnaire will be used to assess general quality of life

  12. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Time frame: 70 days

    SF-36 questionnaire will be used to assess general quality of life

  13. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Time frame: 1 day

    a validated method including 9 symptoms will be used to assess GI symptoms

  14. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Time frame: 28 days

    a validated method including 9 symptoms will be used to assess GI symptoms

  15. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Time frame: 42 days

    a validated method including 9 symptoms will be used to assess GI symptoms

  16. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Time frame: 70 days

    a validated method including 9 symptoms will be used to assess GI symptoms

Secondary outcomes

  1. effects of TEA on gastric motility

    Time frame: 1 week

    visit 1 in acute phase; gastric slow waves recording

  2. effects of TEA on gastric motility

    Time frame: 2 weeks

    visit 2 in acute phase; gastric slow waves recording

  3. effects of TEA on gastric motility

    Time frame: 3 weeks

    visit 3 in acute phase; gastric slow waves recording

  4. effects of TEA on gastric motility

    Time frame: 4 weeks

    visit 4 in acute phase; gastric slow waves recording

  5. effects of TEA on autonomic function

    Time frame: 1 week

    visit 1 in acute phase; heart rate variability recording

  6. effects of TEA on autonomic function

    Time frame: 2 weeks

    visit 2 in acute phase; heart rate variability recording

  7. effects of TEA on autonomic function

    Time frame: 3 weeks

    visit 3 in acute phase; heart rate variability recording

  8. effects of TEA on autonomic function

    Time frame: 4 weeks

    visit 4 in acute phase; heart rate variability recording

  9. effects of TEA on gastric motility

    Time frame: 1 day

    visit 1 in chronic phase; gastric slow waves recording

  10. effects of TEA on gastric motility

    Time frame: 28 days

    visit 2 in chronic phase; gastric slow waves recording

  11. effects of TEA on gastric motility

    Time frame: 42 days

    visit 3 in chronic phase; gastric slow waves recording

  12. effects of TEA on gastric motility

    Time frame: 70 days

    visit 4 in chronic phase; gastric slow waves recording

  13. effects of TEA on gastric motility

    Time frame: 1 day

    visit 1 in chronic phase; breath test will be used to assess gastric emptying

  14. effects of TEA on gastric motility

    Time frame: 28 days

    visit 2 in chronic phase; breath test will be used to assess gastric emptying

  15. effects of TEA on gastric motility

    Time frame: 42 days

    visit 3 in chronic phase; breath test will be used to assess gastric emptying

  16. effects of TEA on gastric motility

    Time frame: 70 days

    visit 4 in chronic phase; breath test will be used to assess gastric emptying

  17. effects of TEA on autonomic function

    Time frame: 1 day

    visit 1 in chronic phase; heart rate variability recording

  18. effects of TEA on autonomic function

    Time frame: 28 days

    visit 2 in chronic phase; heart rate variability recording

  19. effects of TEA on autonomic function

    Time frame: 42 days

    visit 3 in chronic phase; heart rate variability recording

  20. effects of TEA on autonomic function

    Time frame: 70 days

    visit 4 in chronic phase; heart rate variability recording

  21. effects of TEA on autonomic function

    Time frame: 1 day

    visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function

  22. effects of TEA on autonomic function

    Time frame: 28 days

    visit 2 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function

  23. effects of TEA on autonomic function

    Time frame: 42 days

    visit 3 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function

  24. effects of TEA on autonomic function

    Time frame: 70 days

    visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey visit 4 in chronic phase; will be used to assess autonomic function

  25. effects of TEA on autonomic function

    Time frame: 1 day

    baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  26. effects of TEA on autonomic function

    Time frame: 28 days

    baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  27. effects of TEA on autonomic function

    Time frame: 42 days

    baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  28. effects of TEA on autonomic function

    Time frame: 70 days

    baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  29. effects of TEA on autonomic function

    Time frame: 1 day

    30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  30. effects of TEA on autonomic function

    Time frame: 28 days

    30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  31. effects of TEA on autonomic function

    Time frame: 42 days

    30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  32. effects of TEA on autonomic function

    Time frame: 70 days

    30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  33. effects of TEA on autonomic function

    Time frame: 1 day

    60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  34. effects of TEA on autonomic function

    Time frame: 28 days

    60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  35. effects of TEA on autonomic function

    Time frame: 42 days

    60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  36. effects of TEA on autonomic function

    Time frame: 70 days

    60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  37. effects of TEA on autonomic function

    Time frame: 1 day

    baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  38. effects of TEA on autonomic function

    Time frame: 28 days

    baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  39. effects of TEA on autonomic function

    Time frame: 42 days

    baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  40. effects of TEA on autonomic function

    Time frame: 70 days

    baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  41. effects of TEA on autonomic function

    Time frame: 1 day

    30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  42. effects of TEA on autonomic function

    Time frame: 28 days

    30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  43. effects of TEA on autonomic function

    Time frame: 42 days

    30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  44. effects of TEA on autonomic function

    Time frame: 70 days

    30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  45. effects of TEA on autonomic function

    Time frame: 1 day

    60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  46. effects of TEA on autonomic function

    Time frame: 28 days

    60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  47. effects of TEA on autonomic function

    Time frame: 42 days

    60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  48. effects of TEA on autonomic function

    Time frame: 70 days

    60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  49. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 1 day

    baseline before the study; vasoactive intestinal peptide (VIP)

  50. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    baseline before the study; vasoactive intestinal peptide (VIP)

  51. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    baseline before the study; vasoactive intestinal peptide (VIP)

  52. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    baseline before the study; vasoactive intestinal peptide (VIP)

  53. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 1 day

    30 minutes after the testing meal; vasoactive intestinal peptide (VIP)

  54. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    30 minutes after the testing meal; vasoactive intestinal peptide (VIP)

  55. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    30 minutes after the testing meal; vasoactive intestinal peptide (VIP)

  56. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    30 minutes after the testing meal; vasoactive intestinal peptide (VIP)

  57. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 1 day

    60 minutes after the testing meal; vasoactive intestinal peptide (VIP)

  58. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    60 minutes after the testing meal; vasoactive intestinal peptide (VIP)

  59. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    60 minutes after the testing meal; vasoactive intestinal peptide (VIP)

  60. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    60 minutes after the testing meal; vasoactive intestinal peptide (VIP)

  61. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: day 1

    baseline before the study; interleukin-10 (IL-10)

  62. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    baseline before the study; interleukin-10 (IL-10)

  63. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    baseline before the study; interleukin-10 (IL-10)

  64. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    baseline before the study; interleukin-10 (IL-10)

  65. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 1 day

    30 minutes after the testing meal; interleukin-10 (IL-10)

  66. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    30 minutes after the testing meal; interleukin-10 (IL-10)

  67. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    30 minutes after the testing meal; interleukin-10 (IL-10)

  68. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    30 minutes after the testing meal; interleukin-10 (IL-10)

  69. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 1 day

    60 minutes after the testing meal; interleukin-10 (IL-10)

  70. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    60 minutes after the testing meal; interleukin-10 (IL-10)

  71. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    60 minutes after the testing meal; interleukin-10 (IL-10)

  72. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    60 minutes after the testing meal; interleukin-10 (IL-10)

  73. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 1 day

    baseline before the study; interferon α(IFNα)

  74. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    baseline before the study; interferon α(IFNα)

  75. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    baseline before the study; interferon α(IFNα)

  76. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    baseline before the study; interferon α(IFNα)

  77. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 1 day

    30 minutes after the testing meal; interferon α(IFNα)

  78. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    30 minutes after the testing meal; interferon α(IFNα)

  79. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    30 minutes after the testing meal; interferon α(IFNα)

  80. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    30 minutes after the testing meal; interferon α(IFNα)

  81. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 1 day

    60 minutes after the testing meal; interferon α(IFNα)

  82. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    60 minutes after the testing meal; interferon α(IFNα)

  83. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    60 minutes after the testing meal; interferon α(IFNα)

  84. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    60 minutes after the testing meal; interferon α(IFNα)

  85. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 1 day

    baseline before the study; interleukin-1 beta (IL-1β)

  86. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    baseline before the study; interleukin-1 beta (IL-1β)

  87. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    baseline before the study; interleukin-1 beta (IL-1β)

  88. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    baseline before the study; interleukin-1 beta (IL-1β)

  89. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 1 day

    30 minutes after the testing meal; interleukin-1 beta (IL-1β)

  90. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    30 minutes after the testing meal; interleukin-1 beta (IL-1β)

  91. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    30 minutes after the testing meal; interleukin-1 beta (IL-1β)

  92. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    30 minutes after the testing meal; interleukin-1 beta (IL-1β)

  93. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 1 day

    60 minutes after the testing meal; interleukin-1 beta (IL-1β)

  94. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    60 minutes after the testing meal; interleukin-1 beta (IL-1β)

  95. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    60 minutes after the testing meal; interleukin-1 beta (IL-1β)

  96. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    60 minutes after the testing meal; interleukin-1 beta (IL-1β)

  97. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 1 day

    baseline before the study; interleukin-6 (IL-6)

  98. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    baseline before the study; interleukin-6 (IL-6)

  99. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    baseline before the study; interleukin-6 (IL-6)

  100. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    baseline before the study; interleukin-6 (IL-6)

  101. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 1 day

    30 minutes after the testing meal; interleukin-6 (IL-6)

  102. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    30 minutes after the testing meal; interleukin-6 (IL-6)

  103. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    30 minutes after the testing meal; interleukin-6 (IL-6)

  104. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    30 minutes after the testing meal; interleukin-6 (IL-6)

  105. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 1 day

    60 minutes after the testing meal; interleukin-6 (IL-6)

  106. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    60 minutes after the testing meal; interleukin-6 (IL-6)

  107. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    60 minutes after the testing meal; interleukin-6 (IL-6)

  108. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    60 minutes after the testing meal; interleukin-6 (IL-6)

  109. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: day 1

    baseline before the study; tumor necrosis factor alpha(TNFα)

  110. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    baseline before the study; tumor necrosis factor alpha(TNFα)

  111. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    baseline before the study; tumor necrosis factor alpha(TNFα)

  112. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    baseline before the study; tumor necrosis factor alpha(TNFα)

  113. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 1 day

    30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

  114. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

  115. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

  116. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

  117. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 1 day

    60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

  118. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 28 days

    60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

  119. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 42 days

    60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

  120. effects of TEA on GI hormones and inflammatory cytokine

    Time frame: 70 days

    60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 27, 2017
Registry last updated
Nov 26, 2019

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View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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