Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT01078467
Eligibility Criteria:
* INCLUSION CRITERIA:
* Healthy male volunteers age 18 to 40.
* All volunteers must sign informed consent indicating their understanding that specimens and demographic information will be collected solely for research purposes.
EXCLUSION CRITERIA:
Subjects with known inflammatory, chronic, and infectious diseases. These conditions include but are not limited to:
* Diabetes
* Heart failure
* Pulmonary disease
* Rheumatoid arthritis
* Systemic lupus erythematosus
* Sarcoidosis
* Sj(SqrRoot)(Delta)grens syndrome
* Dermatomyositis
* Psoriasis
* Cellulitis
Patients with known bleeding disorders or conditions associated with bleeding. These conditions include but are not limited to:
* Hemophilia
* von Willebrand disease
* Protein C/S deficiency
* Antithrombin III deficiency
* Liver disease
* Patients on medications that interfere with blood clotting or blood thinners. These medications include but are not limited to: ibuprofen aspirin, warfarin (Coumadin), ticlopidine (Ticlid), clopidogrel (Plavix), and others.
* Subjects with clinically significant abnormal laboratory values will be ineligible
Complete blood count (CBC)
Platelet level: \<100 - \>500/ 10(3)/mcL\<TAB\>
Hemoglobin: \<10; \> 17.5gr/L\<TAB\>
Hematocrit: \<30; \>51%\<TAB\>
White blood cell count: \<3; \>12 10(3)/mcL
Partial thromboplastin time: \<20; \>42 sec
Prothrombin time: \<10; \>20 sec
C-reactive protein: \> 4 mg/L
Erythrocyte sedimentation rate: \>40 ml/h
* Recent unintentional weight loss of \>10 lbs over the past 6 weeks prior to screening
* Have undergone general or oral surgery within the last 30 days
* Treated with systemic steroids in the past 12 months
* Subjects with a history of abnormal scar formation (i.e., keloids, hypertrophic scarring)
* Subjects who have used tobacco products and/or betel nut within one month of the screening evaluation. Tobacco products include cigarette, pipe, cigar, and chewing tobacco
* Heavy drinkers defined as drinking greater than or equal to alcoholic drinks per day
* Subjects that, at the oral clinical examination, show any of the nonmalignant lesions associated with heavy smoking/tobacco chewing will be excluded. These findings include but are not limited to:
* Tooth stains
* abrasions
* smoker s melanosis
* acute necrotizing gingivitis
* burns
* erythematous or keratotic patches
* black hairy tongue
* nicotinic stomatitis
* palatal erosions
* Subjects with preneoplastic (leukoplakia, erythroplakia, submucous fibrosis) or neoplastic lesions
* Subjects with known or suspected allergies or adverse reactions to any of the agents used for skin preparation, local anesthesia, or pain control or with known or suspected allergy or adverse reaction to Prolene (polypropylene) sutures
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01078467
Study Brief:
Protocol Section:
NCT01078467