Current Research with Inclusion/Exclusion Criteria

Holzer Clinic Department of Research
Extension 3792/3990

BioSante –LibiGel
(Treatment of Hypoactive Sexual Desire in Postmenopausal Women)

5 Year Study

Inclusion:

1. Women, 50 years of age or older
2. Menopause either naturally (at least 12 months amenorrheic) or after a bilateral salpingo-oophorectomy prior to natural menopause. Subjects with hysterectomy only must meet the following menopause criteria: 50 to </= 54 years must be experiencing hot flushes or receiving estrogen therapy for hot flushes (if these subjects are asymptomatic they require a serum FSH 30 U/mL); 54 years is considered postmenopausal.
3. At least one risk factor for cardiovascular disease including:
1. Age of 70 years or greater
2. Type I diabetes or Type 2 diabetes (fasting glucose > 125 mg/dL or taking an anti-diabetic drug); subjects with diet-controlled Type II diabetes must have an HgbA1C >6.5%.
3. Presently smoking at least 10 cigarettes per day (or equivalent, e.g. chews tobacco daily)
4. Taking antihypertensive medication (for treatment of hypertension)
5. Taking lipid-lowering medication
6. Documented history of cardiovascular disease, ie. Myocardial infarction, stroke, hospitalization for unstable angina/acute coronary syndrome, revascularization of the coronary, carotid, or peripheral circulations. (Must be > 6 months before randomization)
4. A clinical diagnosis of HSDD

Exclusion:

1. Any clinically significant skin abnormalities in the area of study drug application
2. Requires treatment with any of the following:
• Anti-androgens
• Tamoxifen
• Other selective estrogen receptor modulators (treatment and prevention of osteoporosis is acceptable)
3. Taking androgen therapy within 2 months prior to Randomization (Visit 2)
4. History of major psychiatric illness:
• Schizophrenia
• Bipolar disorder, major depression, other psychoses under current treatment that have required medication adjustment within 2 years of Screening Visit 1
5. History of myocardial infarction, stroke, hospitalization for unstable angina/acute coronary syndrome, revascularization of the coronary, carotid, or peripheral circulations, within 6 months of randomization.
6. History of bleeding disorder serious enough to require regular transfusions
7. History of scleroderma

BioSante –LibiGel
(Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women)

8 Month Study

Inclusion:

1. Is women, 30 to 65 years of age
2. Has undergone hysterectomy and bilateral salpingo-oophorectomy prior to natural menopause (i.e. subject was menstruating within 12 months prior to surgery). The bilateral oophorectomy must have been completed at least 6 months but not more than 15 years before Screening Visit 1.
3. Is taking a stable dose of estrogen therapy for at least 3 months before Screening Visit 1 and intends to continue that dose for the duration of the study.
4. Is in a stable, monogamous, heterosexual relationship that is perceived by the subject to be secure and communicative, for at least 1 year prior to Screening Visit 1.

Exclusion:

1. A history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation.
2. Any systemic skin diseases or local skin abnormalities in the area of application
3. A medical condition that could affect or interfere with sexual function (e.g., depression, anxiety, other psychiatric illness, dyspareunia, painful intercourse not relieved by vaginal lubricants, or physical limitations).
4. Using a systemic topical gel or cream estrogen therapy
5. Taking any of the following medications: Coumadin, glucocorticosteroids (inhaled acceptable), any antidepressants or anti-androgens
6. A history of malignant melanoma

Pfizer Inc
(Study of Cardiovascular Safety in Osteoarthritis or Rheumatoid Arthritis Patients with or at High Risk for Cardiovascular Disease Comparing Celecoxib with Naproxen and Ibuprofen)

42 Months Study

Inclusion:

1. Men and women, 18 years if age or older at time of consent
2. Clinical diagnosis of OA or RA with a duration of at least 6 months
3. All subjects must have a required regimen for at least 6 months and taken chronic analgesic therapy > 50% of the time.
4. Subject with established or at high risk for CVD defined as one of the following:
• Coronary disease
• Occlusive disease of non-coronary arteries
• Diabetes mellitus: clinical diagnosis of Type I or Type II diabetes

Exclusion:

1. Acute joint trauma with active symptoms
2. Planned surgical or other invasive procedure to be performed during the course of the study
3. Receiving treatment with oral corticosteroids at a daily does > 20 mg prednisone or equivalent
4. Requires and is receiving treatment with >325 mg aspirin/day

Sanofi-aventis ACT11308
(Randomized, double-blind, placebo-controlled study of the effect of a single injection of SAR164877{REGN475} on reduction of pain from vertebral fracture associated with osteoarthritis)

6 Visit/12 Week Study

Inclusion:

1. Patients with moderate to severe pain due to non-traumatic vertebral fracture (VF) with onset of pain within the last 5 days.
2. Written Informed Consent.

Exclusion:

1. Vertebral pain at screening and randomization <5 on “worst pain” pain intensity-numeric rating scale (PI-NRS)
2. Narcotic addiction
3. Post-fracture vertebral instability that might require vertebral stabilization procedure
4. Unwillingness to use study-defined rescue analgesia exclusively
5. <40 years or >80 years of age at screening

Roche Human Papilloma Virus

2.5 Year Trial

Inclusion Criteria:

1. Female, age 18 years and older
2. Providing written informed consent
3. Using effective birth control practice – 2 methods of contraception, one of which must be barrier, should be used
4. Pap smear documenting ASCUS, ASC-H, LSIL, HSIL within 3 months of screening
5. Diagnosis within 2 months prior to first dose of study drug of CIN 2/3 confirmed by colposcopy-directed punch biopsy

Exclusion Criteria:

1. Have colposcopically visible CIN 2/3 disease extending over more than 2 quadrants
2. Have had any previous excisional or ablative surgical treatment for CIN
3. Have vulvar (VIN) or vaginal (VAIN) intraepithelial neoplasia
4. Have previously received a prophylactic HPV vaccine
5. Have a serious, concomitant disorder, including active systemic infection requiring treatment
6. Prior history of a current malignancy other than adequately treated skin cancer
7. Proven or suspected immunosuppressive disorder or autoimmune disease
8. Have any significant cardiac, hepatic or renal disease
9. Breast feeding
10. Known allergy to eggs

Vidacare / Protocol 2008-02
(A Trial of a New Powered Bone Marrow Core Biopsy System {OnControl™ by Vidacare} Compared to Traditional Manual Devices)

Device Trial

Inclusion Criteria:

1. Must be over the age of 18 years
2. Must require a bone marrow core biopsy with or without aspiration

Exclusion Criteria:

1. Imprisoned patients
2. Pregnant patients
3. Cognitively impaired patients
4. Patients with one or more conditions precluding bone marrow biopsy
5. Patients requiring conscious sedation and/or narcotics for pain relief during the biopsy procedure
6. Patients who will have extra bone marrow removed for research purposes or for additional tests beyond routine evaluations (other than the requirements of this study)

Johnson and Johnson Protocol 28431754-DIA-3008
(A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ-28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus {The CANVAS Trial: CANagliflozin CardioVascular Assessment Study})

4 Years Clinical Study with Possible 2-4 Years Following

Inclusion Criteria:

1. Man or woman between 30 to 85 years of age with a diagnosis of T2DM with HbA1c level = 7.0 to = 10.5% at screening
2. Women must be postmenopausal, surgically sterile, abstinent, or practicing a highly effective method of birth control throughout the study, as local regulations permit.
3. Women of childbearing potential must have a negative urine ß-hCG pregnancy test at the screening and baseline visits.
4. History or high risk of CV disease defined on the basis of either:
   • Age =30 years with a history of a previous CV event defined as 1 or more of the following that occurred at least 30 days before screening for study run-in: myocardial infarction, stroke, percutaneous coronary intervention (PCI) or coronary artery bypass graft, or acute coronary syndrome (treatment in a hospital or emergency room as a result of 1 or more episodes of ischemic discomfort at rest, with associated ECG changes)
   • Age =50 years with 2 or more of the following risk factors at screening: micro- or macro-albuminuria, duration of T2DM of 10 years or more, low-density lipoprotein (LDL)-cholesterol of >4 mmp;: (>154 mg/dL) on treatment with a statin and/or fibrate, high-density lipoprotein (HDL)-cholesterol of <1mmol/L (<39 mg/dL), systolic blood pressure >140 mmHg on at least 1 blood pressure lowering treatment, or current cigarette smoker (one half pack or more of cigarettes per day).
5. Subjects must have signed Informed Consent indicating they understand the purpose of and procedures required for the study and are willing to participate in the study and abide by the restrictions specified in the protocol.

Exclusion Criteria:

1. Diagnosis of type 1 diabetes or prior history of ketoacidosis
2. Major CV event or cerebral or coronary revascularization within 30 days before screening for study run-in or a revascularization procedure planned for within 6 months after screening for study run-in, or clinical diagnosis of heart failure of New York Heart Association (NYHA) Class IV
3. Clinical diagnosis of significant renal impairment (eGFR <50 mL/min/1.73m²) or history of renal transplantation
4. ALT and AST levels >2.0 times the upper limit of normal or total bilirubin >1.5 times the upper limit of normal, at screening, unless in the opinion of the investigator and as agreed upon by the sponsor’s medical officer, the findings are consistent with Gilbert’s disease.
5. Any factor that in the opinion of the investigator would preclude a life expectancy of at least 1 year, may influence compliance with the study drug, or otherwise lead to incomplete adherence to the study protocol
6. History of malignancy within 5 years before screening (except squamous and basal cell carcinomas and cervical carcinomas in situ)
7. Any of the following:
   • concurrent use of any other SGLT2 inhibitor
   • an investigational drug within 4 weeks of the screening visit
   • rosiglitazone within 13 weeks before or following the screening visit
   • digoxin at the time of or following the screening visit
   • prior exposure to JNJ-28431754
   • known or anticipated allergies, hypersensitivity, or intolerance to JNJ-28431754 or its excipients