The overall objective of this plan micro changes Fleur fungal pit mouth , Oralmans candidiasis in patients treated with radiation before and after the treatment is rays with access to the target and the results of the project, can be applied to the adoption of clinical and artifices suitable for early diagnosis of yeast infections bacterial and using paraclinical indicators and also preventive measures to prevent Oralmans candidiasis in patients . to attain the objectives , sampling with sterile swap through the hole in his mouth patients treated with rays, abide by the moral norms and adopted a crowd and quantity of microorganism fungal organizer microflour patients with natural mucus direct testing in the environment and culture of the individual will be defined.Including Criteria basis introduced by a specialist patients Oncology and radiotherapy for radiation therapy and Excluding Criteria will include the presence or absence of any previous infections in the mouth, the previous record of anti - drugs , antifungal’s previous record and the lack of supress safety system , according to paraclinical experiments
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052322380N1
Registration date:2015-07-18, 1394/04/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-18, 1394/04/27
Registrant information
Name
Abdolhassan Kazemi
Name of organization / entity
Tabriz Uni. of Med. Sci.
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3745
Email address
kazemi1338@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-12-21, 1393/09/30
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of oral candidiasis outbreak in patients followed by radiation therapy
Public title
Survey of oral candidiasis outbreak in patients followed by radiation therapy
Purpose
Diagnostic
Inclusion/Exclusion criteria
patients followed by radiation therapy must be at this study. patients with out this situation can not be at this study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2015-03-02, 1393/12/11
Ethics committee reference number
93189
Health conditions studied
1
Description of health condition studied
Patients suffering malignant diaseases
ICD-10 code
Z51.0
ICD-10 code description
Radiotherapy session
Primary outcomes
1
Description
Identification and quantification of fungal microorganisms
Timepoint
before and after of radiation
Method of measurement
milimeter
Secondary outcomes
empty
Intervention groups
1
Description
Measure the diameter of the wound before and after radiation therapy
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Dr. Adolhasan Kazemi
Street address
golgasht street- medical university- Department of Parasitology
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sceinces
Full name of responsible person
Ahad Bazmani
Street address
Tabriz research center of infectious & tropical diseases
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sceinces
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Parasitology, Tabriz Faculty of Medicen
Full name of responsible person
Abdolhasan Kazemi
Position
PhD
Other areas of specialty/work
Street address
Kazemi Abdolhassan, Parasitology Dept., Faculty of Medicine, Tabriz Uni. of Med, Sci., Tabriz Iran
City
Tabriz
Postal code
5166614766
Phone
+98 41 3337 3745
Fax
Email
kazemi1338@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Faculty of Medicen
Full name of responsible person
Abdolhasan Kazemi
Position
PhD
Other areas of specialty/work
Street address
Kazemi Abdolhassan, Parasitology Dept., Faculty of Medicine, Tabriz Uni. of Med, Sci., Tabriz Iran
City
Tabriz
Postal code
5166614766
Phone
+98 41 3337 3745
Fax
Email
kazemi1338@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Faculty of Medicen
Full name of responsible person
Abdolhasan Kazemi
Position
PhD
Other areas of specialty/work
Street address
Kazemi Abdolhassan, Parasitology Dept., Faculty of Medicine, Tabriz Uni. of Med, Sci., Tabriz Iran
City
tabriz
Postal code
5166614766
Phone
+98 41 3337 3745
Fax
Email
kazemi1338@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)