Weekly Clinical Trials in Progress

BREAST CANCER PREVENTION STUDY: The Preventive Cardiology Program at the UMDNJ-New Jersey Medical School is conducting a research study called ExCel sponsored by the National Cancer Institute of Canada Clinical trials group. The goal of the study is to evaluate the effect of Exemestane, a FDA approved drug on women at increased risk for breast cancer. Qualifications for participation are include: Women must be postmenopausal (over 35 years of age if surgical menopause) and be at increased risk for developing breast cancer. Some of the factors that could increase the risk are:

• Age
• Family history
• Age at first menstrual period
• Age at the time of first child's birth

Participants will receive study-related medical exams (including mammogram, bone mineral density test) and study medication. All study visits will be conducted in the Doctor's Office Center (DOC), 90 Bergen Street, Suite 4200, in Newark. Norman L. Lasser, MD, PhD, FAHA, director of the Preventive Cardiology Program, is the principal investigator. Postmenopausal women interested in participating in the study may call Roberta Silverberg at 973-972-6107 for additional information.

FEMALES PARTICIPANTS NEEDED: Efficacy and Safety of 2 Low-Dose Regimens of Conjugated Estrogen Cream Administration Vaginally in Postmenopausal Women With Atrophic Vaginitis. Are you Postmenopausal & Suffer from Vaginal Atrophy? Qualifications for this Research Study: Dryness, Itching, burning, painful intercourse, Postmenopausal women ages 45-80 in good health, intact uterus, last natural mentural cycle completed at least 12 months ago. At no cost: Study related physical exam, ECG, pap test, mammogram, blood test, transvaginal ultrasound, study medication. You will get $306.26 for compensation. For more information call Diane Brevet, study coordinator at 732-235-7799 or email: brevtdi@umdnj.edu or the Women's Health Institute @732-235-8664. Monday-Friday from 9 a.m. to 4 p.m. Principal Investigator: Gloria Bachmann, MD. All calls held in confidence.

WOMEN NEEDED: A Double-Blind, Randomized, Placebo- and Active-controlled Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogens Combinations for Treatment of Moderate to Severe Vulvar/Vaginal Atrophy in Postmenopausal Women. Are you postmenopausal and concerned about vaginal symptoms? If you are 40 to 65 years of age, have not had a hysterectomy or a period for at least 6 months, have at least one moderate to severe vaginal symptom such as dryness, irritation, or itching, or pain with sexual activity, you maybe eligible to participate in a clinical research study exploring an investigational medication to treat the vaginal symptoms of menopause. Qualified participants will receive at not cost: study related tests with investigational medication, study related medical and gynecological exams and mammogram. Compensation for time and travel is available for qualified participants. For more information call Diane Brevet, study coordinator at 732-235-7799 or email: brevtdi@umdnj.edu or the Women's Health Institute @732-235-8664. Monday-Friday from 9 a.m. to 4 p.m. Principal Investigator: Gloria Bachmann, MD. All calls held in confidence.

VOLUNTEERS NEEDED FOR A RESEARCH STUDY: Subjects needed for a study to determine if the anti-hypertensive drug labetalol has analgesic properties. Subjects must be 18 years or older, not pregnant, and with no history of asthma, diabetes, Chronic Obstructed Pulmonary Disease (COPD) and not taking any type of cardiovascular medications. The study will take place in a patient hospital room where there is monitoring equipment. Two types of pain stimulus will be administered (heat and electrical stimulation) and an intravenous line for administration of the study drug (labetalol vs. placebo) will be inserted. Participants will receive free baseline physical exam including EKG. The testing will be done in two sessions. The time commitment is four hours for each sessions. For further details, please contact Dr. Hank Bennett at 9730972-6623, email: bennethl@umdnj.edu or Dr. Glenn Atlas at 973-972-5254, email: atlasgm@umdnj.edu.

VOLUNTEERS NEED WHO HAVE PSORIATIC ARTHRITIS: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of CNTO1275, a Fully Human Anti-IL-12 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis. Are your joints achy? Do you have psoriatic arthritis? We are currently conducting research of an investigational medication in patients with psoriatic arthritis. To participate, you must be 18 years of age or older, have had a diagnosis of psoriatic arthritis for at least 6 months, have at least 3 swollen joints and 3 tender joints. Participants will receive all study-related evaluations and medication at no cost. To learn more about the trial, please call Patricia Hanas at 732-235-8063. Principal investigator is Melissa Magliocco, MD, RWJMS.

ADULTS WANTED FOR A PRE-DIABETES RESEARCH STUDY: The Metabolic Effects of Almond Consumption in Adults with Pre-Diabetes. The Institute for Nutrition Interventions, School of Health Related Professions and the Division of Endocrinology, New Jersey Medical School is conducting a 16-week randomized research trial for person with pre-diabetes to evaluate whether almond consumption will lower risk of developing type 2 diabetes. Qualifications for study participation: must be over the age of 18 years, English speaking, have pre-diabetes (fasting blood glucose between 100 to 125 mg/dl, or, casual blood glucose> 140-199 mg/dl) and a BMI 20-35 kg/m2. Volunteers will receive study related exams, blood work, body composition tests, nutrition counseling, stipend and travel compensation. All study visits will be conducted at the University of Medicine and Dentistry of New Jersey, Newark campus. For more information call Michelle Wien, DrPh, RD at 973-972-9487, principal investigator or David Bleich, MD, at 973-972-6170.

VOLUNTEERS NEEDED FOR AN ENVIRONMENTAL HEALTH RESEARCH STUDY: The Effects of Diesel Exhaust and Stress on the Acute Phase Response and Symptoms in the Chemically Intolerant. Participants must be healthy, non-smoker and be between 21 and 45 years of age. The purpose of this study is to test the health effects of the combination of psychological stressors and controlled exposures to diesel exhaust in order to help understand the unexplained illnesses reported by veterans who served in the Gulf War. Medical exam at no cost and up to $400 compensation offered at completion of study. Requires completion of 2 exposure sessions of 2-1/2 hours each in the A.M. and follow-up visits at 6 hours and at 24 hours after each exposure session. The study is conducted on Busch Campus, Piscataway, NJ. Diesel exhaust is similar to levels found in road tunnels. Measurement of responses to diesel exhaust and a stressful task include questionnaires, nasal washings, collection of mucus from lungs, blood samples. For more information call 732-235-01243 ext. 625.

PARTICIPANTS NEEDED FOR A CHILDHOOD AUTISM STUDY: Oxcarbaziphine Versus Placebo in Childhood Autism. Children aged 5 - 17 are needed to participate in a 12 week clinical drug study on autism at UMDNJ-Robert Wood Johnson Medical School, Division of Child and Adolescent Psychiatry in Piscataway. The purpose of the study is to explore treatment options for children with autism. To be eligible, participants must have a diagnosis of autism and participants must be willing to undergo an interview. The interview and questionnaires may take up to four hours to complete. The interview can be completed at the second visit if necessary. Those who qualify will be closely monitored by the study doctor. Medication will be provided at no cost. Sherie Novotny, MD, is the principal investigator. For more information call Kurt Bopp, clinical research coordinator at 732-235-5690.

VOLUNTEERS NEEDED: Efficacy of Pripiprazole vs. Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children. Children aged 5 - 17 are needed to participate in a 8 week clinical drug study on autism at UMDNJ-Robert Wood Johnson Medical School, Division of Child and Adolescent Psychiatry in Piscataway. The purpose of the study is to explore treatment options for children with autism. To be eligible, participants must have a diagnosis of autism and participants must be willing to undergo an interview. The interview and questionnaires may take up to four hours to complete. The interview can be completed at the second visit if necessary. Those who qualify will be closely monitored by the study doctor. Medication will be provided at no cost. Sherie Novotny, MD, is the principal investigator. For more information call Kurt Bopp, clinical research coordinator at 732-235-5690.

PARTICIPANTS NEEDED FOR A RESEARCH STUDY ON GASTROINTESTINAL PROBLEMS IN AUTISTIC CHILDREN: Oral Human Immunoglobulin in Autism: A Randomized Phased II Trial To Evaluate The Safety and Efficacy of Oral Human Immunoglobulin in The Treatment of Gastrointestinal Dysfunction Associated with Autistic Disorder in Pediatric Patients Form 2 to 18 Years of Age. Attention Parents/Caregivers of Children Diagnosed with Austim: As many as 50% of children with autistic disorder experience regular gastrointestinal problems, including: chronic diarrhea or constipation, bloating, gas and abdominal pain. Although these symptoms are common and can significantly impact the quality of life of autistic children and their families, very little is known about their cause or appropriate treatments. Dr. Sherie Novonty at UMDNJ-Robert Wood Johnson Medical School is conducting a research study to evaluate an investigational medication for gastrointestinal problems in autistic children. If your child is between 2 and 17 years old and experiences some of the symptoms described above, he or she may be eligible to participate in the study. Research volunteers will receive study medication and medical care at no cost. To find out more about the study, call Kurt Bopp, clinical research coordinator, at 732-235-5690.

VOLUNTEERS NEEDED: Motivational Interventions for Tobacco Dependence Treatment among continuing Smokers with Medical Illness. Do you smoke cigarettes? Are you at least 18 years old? Do you have a medical condition? (Examples: cancer, heart disease, lung disease, diabetes, high blood pressure or cholesterol, circulation problems, cataracts, acid reflux, ulcers, osteoporosis, abnormal pap test and erectile dysfunction). If you answered YES to these, you may be eligible to participate in a study to discuss your smoking. You do NOT need to want to quit smoking. Participants will be asked to meet for 1 hour in person and have a 20 minute telephone follow-up. Participants will be compensated with a $25 Gift Card. Michael Steinberg, MD, MPH is principal investigator. For more information call 732-235-7149.

PARTICIPANTS NEEDED: Medication Interventions for Tobacco Dependence Treatment among continuing Smokers with Medical Illness. Are you at least 18 years old? Do you smoke cigarettes? Do you have a medical condition? (Examples: cancer, heart disease, lung disease, diabetes, high blood pressure or cholesterol, circulation problems, cataracts, acid reflux, ulcers, osteoporosis, abnormal pap test and erectile dysfunction). If you answered YES to these, you may be eligible to participate in a clinical study to STOP SMOKING. All medications used are FDA approved and at NO COST to you. Michael Steinberg, MD, MPH is principal investigator. For more information call 732-235-7149.

VOLUNTEERS NEEDED FOR A STUDY TO RELIEVE SYMPTOMS OF DRY SKIN: Double-Blind, Bilateral, Vehicle-Controlled, Randomized Trial of Neuroskin Forte to Relieve Symptoms of Dry Skin. Need relief from dry skin caused by psoriasis or eczema? Volunteers needed to participate in a clinical trial for Neuroskin Forte, a topical, non-steroid spray, to help reduce dryness, scaling and itching, and placebo (something that looks like the study spray but does not have an active ingredient) associated with psoriasis or eczema. Participants must have eczema or psoriasis on both sides of the body with "target" lesions that measure at least 1.5 cm diameter. The study is approximately 10 weeks with 7 visits to the Center. Must be at least 18 years of age. Principal investigator is Melissa Magliocco, MD, RWJMS. For additional information, or to see if you qualify, call Patricia Hanas at 732-235-8063.

PARTICIPANTS NEEDED FOR ACID REFLUX STUDY: Do you have chronic acid reflux, heartburn or indigestion? Acid reflux can, over time, cause damage to the white lining of the esophagus, replacing it with an abnormal red lining called Barrett's Esophagus (BE). Over time, BE can develop into esophageal cancer. A study now being conducted at CINJ and RWJUH is designed to detect people who may develop BE, in the hopes of ultimately preventing the onset of esophageal cancer. Participants must have symptoms related to acid reflux and it must be at least one year since their last upper endoscopy. Patients who show signs of being susceptible to BE may also be eligible for a prevention study upon completion of the acid reflux study. Dr. Kiron Das, MD, PhD, is the principal investigator. For more information or to participate in this cancer prevention study, contact The Cancer Institute of New Jersey at 1-866-654-9898 and select option 3.

FEMALE VOLUNTEERS NEEDED: Are you a woman still suffering with hot flashes? Maybe we can help. If you're at least 40 years old and are naturally or surgically postmenopausal, you may be eligible to participate in a nation-wide research study evaluating a low-dose hormone patch for the relief of hot flash symptoms. The patches used in this study contain lower doses of a currently marketed FDA-approved patch, and are now being studied for the relief of hot flashes. If you participate in this study, you will receive, at not cost to you: Complete Physical Exams by a licensed Physician, study related medical care and study medication (patches). You will also receive compensation for your time and travel. So, if you're still suffering with hot flashes, call now for more information or to see if you qualify.

VOLUNTEERS NEEDED FOR "JUPITER": A Randomized Double-Blind, Placebo-Controlled, Multicenter, Phase III Study of Rosuvastatin (Crestor) 20 mg in the Primary Prevention of Cardiovascular Events Among Subjects with Low Levels of LDL Cholesterol and Elevated Levels of C-Reactive Protein. Even if you have a normal cholesterol level you may still be at risk for heart attack or stroke. The Preventive Cardiology Program is conducting a research trial, called JUPITER, to evaluate whether statin medication will lower the risk of heart attack or stroke in people with normal levels of cholesterol BUT with high levels of C-Reactive Protein (CRP), a measure of inflammation. Qualifications for study participation: men must be 55 or older, women must be 65 or older, and have no prior history of heart attack, stroke, diabetes or chronic arthritis. Also, you may not be taking hormone replacement therapy or any medications to lower cholesterol. Qualified participants will receive study related medical exams, blood work (including CRP), and study medication. All study visits will be conducted at the Doctors Office Center, 90 Bergen Street, Suite 4200, Newark. Norman L. Lasser, MD, PhD, is the principal investigator of the JUPITER study and director of the Preventive Cardiology Program at New Jersey Medical School. Dr. Lasser can be reached at 973-972-4001, For more information, call Roberta Silverberg at 973-972-6107.

STUDY VOLUNTEERS NEEDED: A 3-week, Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarte (SEROQUEL) Immediate Release Tablets in Daily Doses of 400 mg and 600 mg Compared with Placebo in the Treatment of Children and Adolescents with Biopolar 1 Mania. Has your child been diagnosed with bipolar disorder (manic depressive illness)? Dr. Theodore Petti at RWJMS is conducting a research study of an investigational medication for children and adolescents (ages 10-17 years). Your child may qualify if he/she experiences some or all of these symptoms: Extreme shifts in energy, mood, or behavior (mood swings), difficulty functioning in school, with friends or at home, sleep changes, impulsivity, excessive irritability, inability or reduced ability to concentrate. Qualified participants will receive medical and psychological evaluations, treatment, investigational medication and close medical supervision at no cost. For more information, contact Kurt Bopp at 732-235-5690.

PARTICIPANTS NEEDED: New Jersey Clinical Drug Trials for Alzheimer's Disease and Related Dementia Disorders. COPSA (Comprehensive Services on Aging) Institute for Alzheimer's Disease and Related Disorders is New Jersey's designated resource center and dementia diagnostic clinic. The following is information about clinical drug trials available through the COPSA Institute:

1. We are seeking patients, age 50 years and older, with generally good health and a diagnosis of severe Alzheimer's disease to participate in a research study that evaluates the safety and effectiveness of a drug that may improve your memory for treating severe Alzheimer's disease. The medication has already been approved by the FDA for treating mild/moderate Alzheimer's disease. This is a two-part study totaling 36 weeks in length. The first 24 weeks of the study the patients will either receive the FDA approved medication or a sugar pill. For the remaining 12 weeks all patients will receive the FDA approved medication.

2. We are seeking patients 50 years and older with generally good health and diagnosed with Alzheimer's disease to participate in a research study evaluating the safety and effectiveness of memantine (Namenda®) augmented with galantamine (Reminyl®) in the treatment of patients with moderate to severe Alzheimer's disease. Both these medications have been approved by the FDA. This study will also look at what effect the combination of these two medications has on memory and day to day function. Eligible subjects must be taking Reminyl® 16 or 24mg per day, be at a stable dose for at least 6 weeks prior to entering the study, and must continue at that dose for the entire study in order to participate. All study medications, which include both Reminyl ® and Namenda®, will be provided at no cost.

3. We are seeking patients 55 years and older with generally good health and diagnosed with Alzheimer's disease to participate in a research study evaluating the safety and effectiveness of huperzine A (an herb from China) in the treatment of Alzheimer's disease. This study will also look at what effects this medication has on memory and day to day activities. The study will last approximately 6 months. For the first 16 weeks of the study patients will receive either huperzine or a sugar pill; for the remainder of the study all patients will be receiving huperzine.

VOLUNTEERS NEEDED: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Single-Attach Evaluation of the Efficacy "amp; Tolerability of Trexima (sumatriptan 85mg/naproxen sodium 500mg) Tablets vs. Placebo When Administered During the Mild Pain Phase of a Migraine. Sponsor ID#101998. If you suffer from moderate or severe migraines, you may be eligible to participate in this clinical research study of an investigational oral drug for the treatment of migraines. We are looking for males or females between the ages of 18 to 65, generally healthy, who have had 2 or 6 migraines per month for the past 3 months and typically have moderate or severe migraines that begin with mild pain. This study requires 2 office visits. All study-related office visits, medical evaluations, and study medication will be provided to qualified study participants at no cost.

SCHIZOPHRENIA RESEARCH STUDY FOR ADOLESCENTS: Do you know an adolescent, aged 13-17, who is experiencing any of the following symptoms? Disorganized speech that is incoherent at times. Seeing things that are not there. Often appears distracted. Appearing to hear voices when no one is there. An inability to focus on tasks. Disorganized thoughts and behaviors. Social withdrawal. Feeling like people are out to get them. Dr. Theodore Petti at UMDNJ-Robert Wood Johnson Medical School, Division of Child and Adolescent Psychiatry, is conducting a medical study to evaluate the safety and effectiveness of an atypical antipsychotic medication involving adolescents who have symptoms of schizophrenia. Qualified participants will receive study related medication and study related evaluations all funded by a major pharmaceutical company. Health insurance is not needed to participate. For more information on this medical research study, contact Kurt Bopp, clinical research coordinator, at 732-235-5690.

CHILDREN NEEDED FOR CHILDHOOD AUTISM: Children aged 5 through 17 are needed to participate in a 12 week clinical study on autism at UMDNJ-Robert Wood Johnson Medical School, Division of Child and Adolescent Psychiatry, Piscataway. The purpose of the study is to explore treatment options for children with autism. To be eligible, participants must have a diagnosis of autism and must be willing to undergo an interview. The interview and questionnaires may take up to four hours to complete. The interview can be completed at the second visit if necessary. Those who qualify will be closely monitored by the study doctor. Medication will be provided at no cost. Sherie Novotny, MD, is the principal investigator. For more information call Kurt Bopp, clinical research coordinator, at 732-235-5690.

SEEKING VOLUNTEERS: Adult volunteers ages 18-65 are needed to participate in a 16 week clinical drug study on schizophrenia and anxiety at UMDNJ-University Behavioral HealthCare, Extended Treatment, New Brunswick. The purpose of the study is to explore treatment options for patients with schizophrenia and social anxiety symptoms. To be eligible, participants must have a diagnosis of schizophrenia or schizoaffective disorder and must be willing to undergo an interview. Those who qualify may receive up to $280 for their participation plus an additional $20 for each visit if travel is involved. Theodore Petti, MD, MPH, is the principal investigator. For more information call Kurt Bopp, clinical research coordinator, at 732-235-5690.

MEN NEEDED: A Double-Blind Placebo-Controlled Study of Leuprolide Acetate Depot in the Treatment of Alzheimer's Disease in Men. UMDNJ-SOM is conducting clinical trials that researchers hope could alter the progression of Alzheimer's disease (AD), lead to enhanced treatment of the disease, or reduce the risk of dementia. One such study is the ALADDIN Clinical Trial. The ALADDIN study is a one-year study that will evaluate the effectiveness of leuprolide, an FDA-approved drug for treating hormone related conditions, in improving cognitive function and slowing the progression of Alzheimer's disease. Study participants can remain on their current medications. Eligible participants for the trial must be men 65 or older with a prior diagnosis of probable AD (mild to moderate stages). Participants will receive study medication every three months and meet with specially trained staff approximately nine times during the year for testing and evaluation. Please call 856-566-6003 to volunteer or learn more about the ALADDIN Alzheimer's disease study.

VOLUNTEERS NEEDED for a "Phase II Trial To Assess the Effects of Green Tea in Oral Leukoplakia." In this study, green tea is being considered as a potential agent in the treatment of leukoplakia, a pre-malignant lesion of the mouth that often precedes oral cancer. Lozenges containing green tea will be taken by participants eight times per day for twelve weeks to see if the leukoplakia lesions get smaller. If you have oral leukoplakia lesions you may be eligible to participate in this study. Contact The Cancer Institute of New Jersey at 866-654-9898 and select option #3 for more information.

MALE VOLUNTEERS NEEDED: The Cancer Institute of New Jersey is conducting a study of new treatments for men who have a genetic and morphologic precursor to prostate cancer called high-grade prostatic intraepithelial neoplasia, or simply PIN. Currently, there is no prevention regimen against PIN. However, recent clinical data demonstrates that Calcitriol, a vitamin derivative, can be effective in protecting against prostate cancer. This study will look at the effects of Calcitriol on PIN, and track the prostate specific antigen (PSA) during the course of treatment. The study lasts approximately 32 weeks and eligible participants cannot have been previously diagnosed with prostate cancer. The principal investigator is Dr. Robert DiPaola. For more information about the study, contact Cesar Faigal, RN, at 732-235-9466 or 1-866-654-9898, then select option 3.

PARTICIPANTS NEEDED: A Phase IV, Randomized Study, Comparing Betaseron with Copaxone in Patients with Relapsing-remitting or Clinically Isolated Forms of Multiple Sclerosis. Patients must be between the ages of 18 and 55 and never have been on any type of multiple sclerosis treatment in the past. Any questions, call Kim Tulloch, RN, study coordinator at 973-972-6177.

VOLUNTEERS NEEDED FOR A STUDY ON GHRELIN, AN APPETITE CONTROL HORMONE: Seeking slim African-American and Caucasian women between the ages of 18 to 59 to volunteer as controls for a study investigating ghrelin levels after weight loss surgery. Involves a one-time blood draw. Volunteers will not receive any payment for participating. Volunteers can learn their ghrelin and cholesterol levels. For more information or to see if you qualify, call Dr. Bale, Obesity Treatment Center, Newark, at 973-972-2540.

VOLUNTEERS NEEDED: Straitened is conducting a research study investigating the potential for the development of cataracts in patients with schizophrenia. To participate you must be between the ages of 18 and 65 and diagnosed with schizophrenia or schizoaffective disorder. During the study you will be receiving seroquel or risperdal. This study will be conducted over a two year time frame and require 28 visits. Monetary compensation is provided for time and travel. For more information, or to see if you qualify, call Louise at 1-888-602-9900.

VOLUNTEERS NEEDED FOR A BORDERLINE PERSONALITY DISORDER STUDY: Do you have symptoms of feeling abandoned, anxiety, anger, feeling bad about yourself and difficulty in relationships with others? Eli Lilly is conducting a research study assessing whether the antipsychotic drug Zyprexa (olanzapine) will be effective in controlling symtoms of borderline personality disorder (BPD). The study is looking for men or women 18 to 65 years of age, with this diagnosis. The study will last-up to 24 weeks. Subjects who qualify will be closely monitored by a faculty psychiatrist and receive study medication at no charge. They will be compensated up to $600 for participation in the study. For more information, or to see if you qualify, call Louise at 1-888-602-9900.

FEMALES WANTED FOR AN OSTEOPOROSIS RESEARCH STUDY: A Double-Blind, Randomized, Placebo-Controlled, MultiCenter Four Week Study to Assess The Effect Of Alendronate 70 MG and vitamin D3 IU Once Weekly On Fractional Calcium Absorption in Postmenopausal Osteoporotic Women. Participants must be generally healthy postmenopausal women and not taking other drugs for osteoporosis. Volunteers will receive bone density tests, visits and evaluations, investigational drugs, calcium supplements and travel compensation. For more information call Shelly Greenhaus, RN, at 732-235-7751, Stephen H. Schneider, MD, principal investigator.

IMPROVED DIABETES CONTROL MAY BE JUST A BREATH AWAY: A One-Year, Open, Randomized, Parallel Three-Arm Study, Comparing Exubera (Insulin Dry Powder Pulmonary Inhaler) vs. Avandia (Rosiglitazone Maleate) as Add-on Therapy vs. Exubera Substitution of Sulfonylurea in Patients with Type 2 Diabetes, Poorly Controlled on Combination Sulfonylurea and Metformin Treatment. If you have had type 2 diabetes for a least 6 months and are between 18 and 80 years old, taking 2 oral medications to treat your type 2 diabetes ( not Actos or Avandia), not taking insulin shots and a nonsmoker, you may qualify to participate in a new one-year research study using an investigational form of inhaled insulin. Approximately 600 people will participate at 60 study centers. Participants will receive study-related checkups, nutritional counseling and medication at no charge. This may help others by contributing to medical research. For more information, please contact Shelly Greenhaus, RN, BSN, MPH, Division of Endocrinology, Metabolism and Nutrition, at 732-235-7751.

VOLUNTEERS NEEDED WITH DIABETES: A Multicenter, Double Blind, Randomized, Parallel Group Study to Compare the Effect of 24 Weeks Treatment With LAF237 (50mg qd or bid) to Placebo as Add-on Therapy to Pioglitzaone 45 mg qd in Patients With Type 2 Diabetes Inadequately Controlled With Thazolidinedione Monotherapy. Participants must be between the ages of 18 through 80 for investigational drug study of a new diabetes pill for the treatment of Type 2 diabetes mellitus. No charge for physical exam, study medications and relevant laboratory tests. Monetary compensation provided. To see if you qualify, call Shelly Greenhaus, RN, at 732-235-7751. Stephen H. Schneider, MD, is principal investigator.

PARTICIPANTS NEED FOR TYPE 2 STUDY: A Comparison of Prandial Insulin Lispro Mixtures Therapy to Glargine Basal-Bolus Therapy With Insulin Lispro on the Overall Glycemic Control of Patients With Type 2 Diabetes Previously Treated With Oral Agents Combined With Insulin Glargine. Are you between the ages of 30 and 75, have type 2 diabetes and currently being treated with Lantus (Insulin Glargine) in combination with one or two oral diabetic medications? If the answer is yes, call Shelly Greenhaus, RN, at 732-235-7751. We are studying a new diabetes treatment to determine if it controls your diabetes more effectively than your current treatment plan. All study-related care is provided at no cost to qualified participants, including physical examinations, glucose meters and supplies, study medication, and laboratory tests. Stephen Schneider, MD, is principal investigator.

SCHIZOPHRENIA RESEARCH STUDY FOR ADOLESCENTS: Do you know an adolescent, aged 13-17, who is experiencing any of the following symptoms? " Disorganized speech that is incoherent at times " Seeing things that are not there " Often appears distracted " Appearing to hear voices when no one is there " An inability to focus on tasks " Disorganized thoughts and behaviors " Social withdrawal " Feeling like people are out to get them Dr. Theodore Petti at UMDNJ-Robert Wood Johnson Medical School, Division of Child and Adolescent Psychiatry, is conducting a medical research study to evaluate the safety and effectiveness of an atypical antipsychotic medication involving adolescents who have symptoms of schizophrenia. Qualified participants will receive study related medication and study related evaluations all funded by a major pharmaceutical company. Health insurance is not needed to participate. For more information on this medical research study, please contact Kurt Bopp, Clinical Research Coordinator, at 732-235-5690.

FEMALE VOLUNTEERS NEEDED: The National Institutes of Health, in conjunction with UMDNJ-New Jersey Medical School-Newark campus and University Reproductive Associates, PC, are conducting a study of new treatments for infertility in women with irregular menstrual cycles. Women with 8 or fewer menstrual cycles per year are often suffering from anovulation (not ovulating or releasing an egg each month) due to a hormonal imbalance termed polycystic ovary syndrome (PCO syndrome). This study will try to find out which medicine or combination of medicines is the most effective and safe way to restore ovulation and fertility in these women. Patients meeting eligibility criteria will receive free medicine and treatment for up to 30 weeks. They will also receive compensation for their time and travel. The principal investigator for the study is Dr. Peter McGovern. For more information about the study, contact Amy Solnica, RN at 973-972-3633, 973-972-2235 or 201-288-6330.

PARTICIPANTS NEEDED FOR AN ENDOMETRIAL (UTERINE) CANCER STUDY: The Cancer Institute of New Jersey is testing whether a medicated intrauterine device can prevent endometrial cancer and precancer. Women who are heavy are at increased risk of endometrial cancer. MIRENA® is an intrauterine system that contains the medication levonorgestrel. It is usually used to prevent pregnancy. MIRENA®has been used successfully in small studies to treat endometrial precancer (hyperplasia) and cancer. To be eligible for this study women must be between the ages of 40 and 50 and be very heavy (obese). For example, a women who is 5 feet 5 inches must weight at least 240 pounds. Women will have pelvic exams and endometrial biopsies during the study. Potential participants should be willing to have MIRENA® inserted and be able to keep a record of vaginal bleeding. Participants will be seen at The Cancer Institute of New Jersey approximately 7 times during the study. For more information, call CINJ at 1-866-654-9898.

CALL FOR CONTROLS: Would you like to participate in a research study? Would you like to help to further research in neurodevelopmental disorders and neurological disease? You can help out by being a control and earn $10! Investigators at RWJMS are inviting individuals meeting the following criteria to participate in a genetics research study: NO history in yourself of any of the following: ADHD, autism, biopolar disorder, birth defects, cerebral palsy, dyslexia/learning disorder, obsessive-compulsive disorder, schizophrenia, spina Bifida and Tourette syndrome. NO history in your parents, siblings, or children of any of the mentioned. If you think you fit the criteria, and you are interested in participating, please contact us at 732-235-4508. Thank you for your interest.

PARTICIPANTS NEEDED: Do you feel sad, irritable, tired and uninterested? Do you have concentration, appetite, and sleep problems? You may be suffering from Depression. Dr. Paul Lehrer at RWJMS is conducting a research study using a new non-drug technique to treat depression. Treatment does not involve medication. Participants must be ages 18-75 and medically stable. The investigational treatment is provided at no cost. If you or someone you know is interested, please call Dr. Karavidas at 732-235-4628.

SMOKERS WITH SCHIZOPHRENIA NEEDED FOR RESEARCH STUDY: Treatment of Addiction to Nicotine in Schizophrenia (TANS) is a four-year, NIDA funded project designed to help smokers with schizophrenia or schizoaffective disorder quit smoking. We are offering a treatment protocol utilizing the nicotine patch and blending evidence-based tobacco dependence and mental health treatments. Treatment is free and participants are paid for completing research questionnaires. For further information, or to refer a patient, please contact Dr. Marc Steinberg at 732-235-8222 or at marc.steinberg@umdnj.edu

VOLUNTEERS NEEDED: Escitalopram Treatment of Depression and Irritability Due to Traumatic Brain Injury. Head injuries can cause poor concentration, low energy, mood swings, social withdrawal and irritability. Dr. Edward Kim is conducting a research trial that may help. Seeking men and women to participate in a research study evaluating Lexapro™ in the treatment of depression that develops after a head injury. Lexapro™ is approved by the FDA to treat depression, but has not received approval for the treatment of depression due to head trauma. To be eligible for the study, you must have had a head injury at least 3 months ago, be between the ages of 18 and 60 and medically stable. There are visits once a week for the study. Related medical care including the study medication, will be prescribed at no cost while you are enrolled in the study. Females of childbearing age must agree to use an effective form of birth control during the study. Please call Anjali Patel at 732-235-5840. to find out more details about the study.

PARTICIPANTS NEEDED to study Aripiprazole in patients with treatment-resistant generalized anxiety disorder. Nervous or anxious? Do you suffer from these symptoms, excessive worry, nervousness, restlessness, irritability, sleeping problems, are you unable to concentrate and medication treatments haven't helped? Dr. Matthew Menza at RWJMS is conducting a 6-week study of treatment-resistant generalized anxiety disorder (GAD) with investigational medications. All research care including an extensive psychiatric evaluation is provided at no cost to those who qualify. Participants are paid $30 for each study. If you or someone you care about is interested in participating, please call Regine Rousso, toll free at 1-877-RWJ-HOPE (1-877-795-4673.)

VOLUNTEERS NEEDED for an NIH-funded study of sleep and function in persons who have heart failure. The purpose of the study is to learn about the sleep of people who have congestive heart failure (CHF) and understand how sleep contributes to daily symptoms and activity. Study participants will receive $50 at the completion of the study. For information on how you may qualify to participate, contact the study coordinator at 973-972-3780 or campbed1@umdnj.edu , or Dr. Nancy Redeker at 973-972-8541.

VOLUNTEERS NEEDED FOR A TYPE 2 DIABETES STUDY: Do you have type 2 diabetes? Are you between 18 and 80 years old? Are you taking more than one oral medication to treat your type 2 diabetes? Would you like to try a new delivery system for managing your type 2 diabetes? If you answer yes to all of the above questions, you may be eligible to receive investigational inhaled insulin in a clinical trial. The trial will compare the effects of a combination of oral diabetes medications with that of inhaled insulin taken with a combination of oral diabetes medications, or inhaled insulin taken with a single oral diabetes medication. Qualified participants will receive confidential, study-related exams from diabetes specialists, as well as nutritional counseling, laboratory tests, a home blood sugar testing machine and all study medication at no charge. If you currently smoke or have a severe medical condition, you will not be eligible to participate. For more information contact Shelley Greenhaus, RN, at 732-235-7751 between the hours of 2 to 4 p.m. Stephen H. Schneider, MD, is prinicpal investigator.

CHILDREN NEEDED FOR CHILDHOOD AUTISM: Children aged 5 through 17 are needed to participate in a 12 week clinical study on autism at UMDNJ-Robert Wood Johnson Medical School, Division of Child and Adolescent Psychiatry, Piscataway. The purpose of the study is to explore treatment options for children with autism. To be eligible, participants must have a diagnosis of autism and must be willing to undergo an interview. The interview and questionnaires may take up to four hours to complete. The interview can be completed at the second visit if necessary. Those who qualify will be closely monitored by the study doctor. Medication will be provided at no cost. Sherie Novotny, MD, is the principal investigator. For more information call Kurt Bopp, clinical research coordinator, at 732-235-5690.

VOLUNTEERS NEEDED FOR BRAIN IMAGING FOR ACUPUNCTURE: Healthy subjects needed for acupuncture study. Participants must be between the ages of 18 to 70, male or female (not pregnant). The study is 1 hour per session, 4 sessions per study. Volunteers will receive a free copy of their IMR brain images. For more information call Dr. Wen-Ching Liu at 973-972-2281 ( wliu@umdnj.edu ) or Dr. Susan Feldman at 973-972-4797 ( sufeldma@umdnj.edu ).

SEEKING VOLUNTEERS: Adult volunteers ages 18-65 are needed to participate in a 16 week clinical drug study on schizophrenia and anxiety at UMDNJ-University Behavioral HealthCare, Extended Treatment, New Brunswick. The purpose of the study is to explore treatment options for patients with schizophrenia and social anxiety symptoms. To be eligible, participants must have a diagnosis of schizophrenia or schizoaffective disorder and must be willing to undergo an interview. Those who qualify may receive up to $280 for their participation plus an additional $20 for each visit if travel is involved. Theodore Petti, MD, MPH, is the principal Investigator. For more information call Kurt Bopp, Clinical Research Coordinator, at 732-235-5690.