Protocol summary
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Study aim
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The effect of seven-strain probiotic supplementation on some of the Thelpers, ICAM, VCAM, prooxidant-antioxidant balance, oxidative stress and inflammatory biomarkers and nutritional status in patients with head trauma admitted to intensive care unit
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Design
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Randomized, double-blinded, controlled trial
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Settings and conduct
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This study will be conducted on 46 patients with traumatic brain injury, admitted to the intensive care unit of Imam Reza Hospital and Shohada Hospital. Patients will be randomized into 2 equal groups of supplement or placebo and will receive probiotic and placebo respectively for 2 weeks.
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Participants/Inclusion and exclusion criteria
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- Age 60-18 years of both sexes
- GCS <8
- Nutrition through the nasal tube - stomach
- Willingness to cooperate by obtaining the consent of first-degree relatives
-Having an APACHE II score of 15–30
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Intervention groups
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Participants will be randomized into two groups of 23 people: intervention group (four probiotic capsules daily (every 6 hours)) or placebo group (four placebo capsules daily (every 6 hours)) and will use the supplement or placebo for 2 weeks.
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Main outcome variables
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Th-17, T-regulatory, Th10, TGF-β, IL-6, IL-1β, length of hospital stay, Damping rate, Respiratory tract infection, Weight, BMI, level of consciousness, Illness severity
General information
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Reason for update
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Addition of factors related to prooxidant and antioxidant indices
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100209003320N18
Registration date:
2020-09-07, 1399/06/17
Registration timing:
prospective
Last update:
2024-11-14, 1403/08/24
Update count:
3
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Registration date
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2020-09-07, 1399/06/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-09-20, 1399/06/30
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Expected recruitment end date
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2022-08-19, 1401/05/28
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of seven-strain probiotic supplementation on some of the Thelpers, ICAM, VCAM, prooxidant-antioxidant balance, oxidative stress and inflammatory biomarkers and nutritional status in patients with head trauma admitted to intensive care unit: a randomized controlled clinical trial
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Public title
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ٍEffect of probiotic on immune system and oxidative stress in intensive care unit patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 60 to 18 years
Low level of consciousness (GCS <8)
Nutrition through the nasal - stomach tube
Willingness to cooperate by obtaining the consent of first-degree relatives
Patients receiving gavage
Presence in the intensive care unit for at least 14 days
Having an APACHE II score of 15–30
Exclusion criteria:
Pregnancy- Breastfeeding
Parental nutrition (more than two days)
Taking immunosuppressive medications
Unstable hemodynamics
Intestinal obstruction; intestinal ischemia; short bowel syndrome
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
46
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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46 eligible patients will be randomly allocated to intervention and placebo groups using a software generated random permuted blocks. The generated random sequence will be kept in a protected location and administered by an independent third party who is blind to the trial throughout the study.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, the investigators, patients, those responsible for patient enrollment, administration of the intervention, and assessors (nurses) will be blinded to the type of the supplement (probiotic or placebo) received by each group. The person responsible for preparing the supplement capsules (who is completely unrelated to the study) will be asked to assign a three-digit code to each of the two capsules (probiotic and placebo) and keep the codes for himself until the end of the study and data analysis.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-08-10, 1399/05/20
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Ethics committee reference number
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IR.TBZMED.REC.1399.503
Health conditions studied
1
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Description of health condition studied
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Head Trauma
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ICD-10 code
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G44.31
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ICD-10 code description
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Acute post-traumatic headache
Primary outcomes
1
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Description
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Th-17, T-regulatory, Th10 cells
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Flowcytometry
2
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Description
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Duration of hospitalization and rate of attenuation
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Timepoint
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Daily
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Method of measurement
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Observation and questionnaire
3
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Description
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Respiratory tract infection
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Sputum Culture
4
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Description
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Serum levels of TGF-β
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Timepoint
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Beginning and end of the trial
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Method of measurement
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ELISA
5
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Description
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Serum levels of IL-6
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Timepoint
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Beginning and end of the trial
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Method of measurement
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ELISA
6
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Description
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Serum levels of IL-1β
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Timepoint
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Beginning and end of the trial
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Method of measurement
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ELISA
7
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Description
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Level of consciousness and severity of the disease
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Timepoint
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Daily
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Method of measurement
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GCS , APACHE and SOFA Questionnaire
8
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Description
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Weight
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Calculation based on formula
9
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Description
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Body mass index
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Calculation based on formula
Secondary outcomes
1
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Description
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Energy, macronutrients and antioxidant nutrients (vitamins A, E, C, selenium, zinc and copper) intake
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Food record (gavage) - Nutritionist 4 software
2
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Description
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Intercellular adhesion molecule-1 (ICAM-1)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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ELISA
3
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Description
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Vascular cell adhesion molecule 1 (VCAM-1)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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ELISA
4
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Description
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Pro-oxidant-Antioxidant Balance (PAB)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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ELISA
5
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Description
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Total antioxidant capacity (TAC)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Spectrophotometric method
6
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Description
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Malondialdehyde (MDA)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Spectrophotometric method
7
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Description
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Nitric oxide (NO)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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ELISA
8
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Description
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َArylesterase (ARE) activity
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Spectrophotometric method
Intervention groups
1
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Description
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Intervention group: Patients in this group will receive a probiotic supplement for 14 days. The supplement is: a capsule containing seven types of probiotics (produced by Zist takhmir Company made in Iran) and consumed four times a day (every 6 hours).
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients in this group will receive a placebo for 14 days. Placebo contains maltodextrin (product of Zist takhmir Company made in Iran) and will be consumed four times a day (every 6 hours).
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Data collected for the primary outcomes will be shared.
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When the data will become available and for how long
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Access starting 12 months after publication
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To whom data/document is available
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The data will only be available for people working in academic institutions.
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Under which criteria data/document could be used
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The data of the present study will only be accessible by other researchers, for conducting meta-analysis.
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From where data/document is obtainable
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Dr. Mehrangize Ebrahimi mamagani - Email: ebrahimimamagani@tbzmed.ac.ir- Tel: 00989141005681
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What processes are involved for a request to access data/document
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The applicant should provide a brief description of the aims and methods of his his Meta-analysis. His request will be assessed and, if agreed, the data will be emailed to the applicant. All these procedures will take no longer than 15 days.
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Comments
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