| Trial registration number
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NCT04647656 |
Full text link
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04647656
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First author
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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Shani Zilberman-Itskovich, Dr.
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Contact
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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shani.zilberman@mail.huji.ac.il
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Registration date
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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2020-12-01
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Recruitment status
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Long covid
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
age above 18 years
reported post covid-19 cognitive deterioration that effect quality of life and persist at least 3 months after confirmed infection.
subject willing and able to read, understand and sign an informed consent
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Exclusion criteria
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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inability to attend scheduled clinic visits and/or comply with the study protocol
history of traumatic brain injury (tbi) or any other non covid brain pathology
active malignancy
substance use at baseline
severe or unstable physical disorders or major cognitive deficits at baseline
hbot for any reason prior to study enrolment
chest pathology incompatible with pressure changes (including moderate to severe asthma)
ear or sinus pathology incompatible with pressure changes
an inability to perform an awake brain mri
active smoking
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Number of arms
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Assaf-Harofeh Medical Center
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Inclusion age min
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Israel
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Type of patients
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Patients recovered from covid
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Severity scale
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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91
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primary outcome
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Cognitive health assessment (NeuroTrax)
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Notes
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 608, "treatment_name": "Hyperbaric oxygen", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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