Clinical trial: Use of Modafinil in the Treatment of Tinnitus (NCT00591019)

Eligibility criteria:
Inclusion Criteria:

          -  The diagnosis of tinnitus should be established by subject through exam and history
             performed by study physician in Ear, Nose and Throat (ENT) clinic.

          -  Subjects will be age 20 or older.

          -  Subjects should have tinnitus symptoms severe enough to seek medical attention.

          -  Subjects will have been seen in the Hearing and Balance Center at University of
             Arkansas for Medical Sciences (UAMS).

          -  Subjects will have had an audiogram.

          -  Signed informed consent.

          -  Women of childbearing potential must have a negative pregnancy test at screening and
             before being prescribed the study drug.

          -  Peripheral neuropathy.

          -  Hematologic (minimal values) at screening Absolute neutrophil count > 1,500 mm^3
             Hemoglobin > 8.0 g/dl Platelet count > 100,000 mm^3

        Exclusion Criteria:

        Disease-Specific Concerns

          -  Subjects who have locally advanced breast cancer with skin ulceration will be excluded
             from this study due to the risk of worsening ulcers and healing difficulties

          -  Stage IV breast cancer

          -  Inflammatory breast cancer

        General Medical Concerns

          -  Subjects with Echo Cardiogram performance status 2, 3, and 4 are not eligible for this
             study

          -  Allergy to any component of the treatment regimen

          -  Women who are breast feeding

          -  Pregnancy or refusal to use effective contraception while participating in this study

          -  Inability to comply with study and/or follow-up procedures

          -  Subjects with secondary malignancy other than superficial skin cancer (squamous cell
             carcinoma and basal cell carcinoma of the skin) should be excluded

        Bevacizumab-Specific Concerns

          -  Current, recent (within 4 weeks of the first infusion of this study), or planned
             participation in an experimental drug study

          -  Blood pressure of > 150/100 mmHg. Essential hypertension well controlled with anti
             hypertensive is not an exclusion criterion

          -  Unstable angina

          -  New York Heart Association (NYHA) Grade II or greater congestive heart failure (see
             Appendix D)

          -  History of myocardial infarction within 6 months

          -  History of stroke within 6 months

          -  Clinically significant peripheral vascular disease

          -  Evidence of bleeding diathesis or coagulopathy

          -  Presence of central nervous system or brain metastases

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 0, anticipation of need for major surgical procedure during the course of
             the study

          -  Minor surgical procedures such as fine needle aspirations or core biopsies within 7
             days prior to Day 0

          -  Pregnant (positive pregnancy test) or lactating

          -  Urine protein: creatinine ratio >1.0 at screening

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to Day 0

          -  Serious, non-healing wound, ulcer, or bone fracture
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 99 Years

Patient description (medical language): A 47-year-old woman comes to the clinic complaining of dizziness.  She also has occasional nausea and ringing in her right ear.  The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal.  The dizziness improves spontaneously, and she feels fine between episodes.  Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl.  She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago.

Patient description (patient's own words): The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now.

Does the patient match the trial criteria? 1