CLINICAL TRIALS: Call for Volunteers

Colon Imaging Study

A colon imaging study is being conducted at UMDNJ-New Jersey Medical School to help doctors identify the best test to screen for colon cancer. Participants will undergo three different tests commonly used to screen for colon cancer (barium enema, virtual colonoscopy and colonoscopy). The benefits of having three tests are:

• fewer chances of cancerous lesions will be missed during examination; and,

• virtual colonoscopy, an X-ray of the abdomen and pelvis, may detect other problems outside the colon.

To qualify, volunteers must be adults who have found blood in their stool, who have iron deficiency anemia, or who have a family history of colon cancer or adenoma.

Mark Sterling, MD, is the principal investigator. For more information call study coordinator Carolyn Rogers, RN, at 973-972-1267.

Chronic Fatigue Syndrome

UMDNJ-New Jersey Medical School is currently conducting multiple studies to investigate the possible causes of medically unexplained fatigue and pain in disorders such as chronic fatigue syndrome (CFS) and fibromyalgia (FM). Patients who may have CFS or FM and healthy comparison subjects are needed to participate in the studies. Volunteers must be between the ages of 18 and 55. Medical evaluations and fitness tests are provided at no cost. Participants will be compensated for their time up to $200 per study. The NJ Chronic Fatigue Syndrome Cooperative Research Centers are located at the UMDNJ-Newark campus and at the VA Medical Center in East Orange.

Benjamin H. Natelson, MD, is the principal investigator for the studies. For more information call 800-248-8005 or visit the Web page (www.umdnj/cfsweb/CFS).

Targeting Women’s Health

Volunteers are needed to participate in a research study targeting women’s health issues, such as the menstrual cycle, at the University of Medicine and Dentistry of New Jersey and the VA New Jersey Health Care System in East Orange. The participants for ths non-invasive study should be between the ages of 18 and 40. The hours are flexible, the study will be conducted at both sites, and participants will be compensated for their time.

Richard Servatius, PhD, is the principal investigator for the study. For additional information contact Wisly Paul at 973-676-1000, ext. 1147 or Charlie Sheridan at 973-676-1000, ext. 1148.

Hormone Study

Women are being sought to participate in a hormone study at UMDNJ-New Jersey Medical School in the Department of Obstetrics/ Gynecology and Women’s Health. The purpose of the study is to understand the hormonal changes that occur as women approach menopause. Hormone levels in the blood will be measured at different times of the menstrual cycle. To qualify, volunteers must be between the ages of 20 and 35 (control group), or 46 to 51 years old. In addition, they must be healthy non-smokers, not pregnant or overweight, not using any hormones, and have regular menstrual cycles. Participants will receive a payment of $75 to $125 per menstrual cycle.

Susanna Park, MD, is the principal investigator. For more information call Dr. Park at 973-972-5136.

Women’s Fertility Study

The National Institutes of Health, in conjunction with UMDNJ-New Jersey Medical School, and University Reproductive Associates, PC, are conducting a study of new treatments for infertility in women with irregular menstrual cycles. Women with eight 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). The study will investigate which medicine or combination of medicines is the most effective and safe way to restore ovulation and fertility in these women. Those who meet the criteria for eligibility will receive medication at no cost and treatment for up to 30 weeks. They will be compensated for their time and travel.

The principal investigator for the study is Peter McGovern, MD. For more information, call Amy Solnica, RN, at 973-972-3633, 973-972-2235 or 201-288-6330.

Women’s Research Study

A research study for women is being conducted at UMDNJ-Robert Wood Johnson Medical School in New Brunswick for the treatment of heavy menstrual bleeding. The goal of the project is to determine if this condition is due to an underlying bleeding disorder. To be eligible to participate, volunteers must be between the ages of 13 and 55. Those who qualify will be compensated $50 for their participation.

Claire Philipp, MD, Division of Hematology, is the principal investigator. For more information contact Robin Schwartz, CCRC, at 732-235-6103.

Bone Loss Prevention Study

Women between the ages of 40 and 60 who are at least one year postmenopausal may be eligible for a bone loss prevention study at UMDNJ-Robert Wood Johnson Medical School in New Brunswick. The study examines the effect of nitroglycerin ointment compared to plain ointment in stopping or slowing down bone thinning. Volunteers will receive a free bone density scan at their initial screening visit, as well as parking validation. Once randomized, volunteers will receive $25/visit.

Primary investigator is Sunil Wimalawansa, MD, PhD. Contact the NOVEL study at 732-235-8938 or on line (http://www2.umdnj.edu /novelweb/NOVEL).

Depression and Low Sexual Desire

Minority women are being sought to participate in a study for depression and low sexual desire at UMDNJ-Robert Wood Johnson Medical School in New Brunswick. To be eligible to participate, volunteers must be taking antidepressant medication and have noticed a decrease in their sex drive. The study offers 10 weeks of free treatment for depression and sexual concerns, and will compensate each participant up to $150.

Matthew Menza, MD, and Roseanne Dobkin, PhD, are co-principal investigators for the study. For more information contact Dr. Dobkin at 732-235-4051.

Women’s Health Study

Women are needed to participate in a six-month research study at UMDNJ-Robert Wood Johnson Medical School in New Brunswick. Volunteers must be between the ages of 18 and 80 with vaginal itching, burning and tenderness, and pain during intercourse. A pelvic examination, Pap smear, blood studies, and urine examination will be performed during the study.

Gloria Bachmann, MD, Women’s Health Institute, is the principal investigator. For more information call Joan Hammond, RN-C, APN, at 732-235-7799.

Postmenopausal Women

The Women’s Health Institute at UMDNJ-Robert Wood Johnson Medical School in New Brunswick is seeking female volunteers to participate in a two-year national study of an investigational drug. The purpose of the study is to evaluate menopausal symptoms such as hot flushes, vaginal dryness, uterine bleeding and osteoporosis. To be eligible, participants must be in good health, between the ages of 40 and 75, at risk for osteoporosis, and at least five years should have passed since their last natural menstrual cycle. Those who qualify will receive study related physical exams and study medication, laboratory tests, mammogram, bone density testing, electrocardiogram and endometrial biopsy at no cost. Upon completion of the study, participants will receive up to $450.

Gloria Bachmann, MD, is the principal investigator. For more information, call 732-235-7292 or 732-235-7633.

Heart/Blood Vessel Disease

Women between the ages of 48 and 60, who are non-smokers, overweight, postmenopausal (no menstrual cycle) for one year, and have high-normal or mildly elevated blood pressure are needed to participate in a research study for heart and blood vessel disease in women. The purpose of the study is to observe how certain medications affect the function of cells lining the blood vessels and to learn more about heart and blood vessel disease in women. The study involves six office visits over 14 weeks, study-related examinations, blood studies, urine examination, electrical tracing of the heart (ECG), and ultrasound of the artery in the arm. Up to $150 compensation will be provided for completion of the study.

Conducted at UMDNJ-Robert Wood Johnson Medical School in New Brunswick, the study is being directed by principal investigator Gloria Bachmann, MD, Women’s Health Institute. For more information, call Dr. Bachmann at 732-235-7633 or M. Fran Christ, RN, APN, C, at 732-235-7292.

A New Contraceptive Gel Study

The Women’s Health Institute in New Brunswick is conducting a seven-month research project to evaluate a new contraceptive gel with diaphragm. Women in good health between the ages of 18 and 40 are being sought to participate. Participants will receive study- related exams, contraception, and laboratory tests at no cost. Monetary compensation up to $200 will be provided to those who complete the study.

Charletta Ayers, MD, MPH, Women’s Health Institute at UMDNJ-Robert Wood Johnson Medical School, is the principal investigator. For more information call 732-235-7292, Monday thru Friday from 9 AM to 5 PM.

Diabetes Mellitus

Volunteers age 18 to 65 with diabetes mellitus are needed to participate in a study of a new investigational drug for diabetic neuropathy at UMDNJ-Robert Wood Johnson Medical School in New Brunswick. To be eligible, volunteers must be experiencing numbness or pain in their hands or feet. The study offers a physical exam and study tablets, and relevant laboratory tests at no cost. Compensation will be provided for time and travel.

Stephen H. Schneider, MD, is the principal investigator. For additional information call Shelley Greenhaus, RN, at 732-235-7751.

Managing Type II Diabetes

Managing Type II diabetes is the goal of a study being conducted in the Department of Medicine at UMDNJ-Robert Wood Johnson Medical School in New Brunswick. Volunteers between the ages of 18 and 80, taking more than one oral medication to treat Type II diabetes, and who are interested in trying a new delivery system for managing this condition are needed for participation. The study 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. Volunteers may be eligible to receive investigational inhaled insulin in a clinical trial. Qualified participants will receive confidential, study-related exams from diabetes specialists, nutritional counseling, laboratory tests, a home blood sugar testing machine, and all study medication at no charge. Volunteers who smoke or have a severe medical condition will not be eligible to participate.

Stephen H. Schneider, MD, is the principal investigator. For more information contact Shelley Greenhaus, RN, at 732-235-7751 between 2 and 4 PM.

Diabetes Study

An investigational drug study of a new diabetes pill for the treatment of Type II diabetes mellitus is being conducted at UMDNJ–Robert Wood Johnson Medical School in New Brunswick. The study will last for 21 weeks and needs volunteers with diabetes between the ages of 21 and 70. Those who qualify will receive a physical exam, study medications, and relevant laboratory tests at no cost. Monetary compensation will be provided for travel expenses.

Stephen H. Schneider, MD, is the principal investigator. For more information call Shelley Greenhaus, RN, at 732-235-7751.

Health Effects of Hydrogen Sulfide

UMDNJ–Robert Wood Johnson Medical School in Piscataway is seeking volunteers to participate in a research study that will investigate the health effects of hydrogen sulfide. To be eligible, volunteers must be healthy non-smokers between the ages of 20 and 40. They will be required to complete four consecutive weekly sessions of four hours and one follow-up session of one hour conducted two weeks later. A screening medical exam, measurement of responses to typical environmental levels of hydrogen sulfide (rotten egg smell), questionnaires, tests of attention/concentration, and nasal and blood samples will be collected. All sessions will take place in the mornings on the Busch Campus at the Environmental & Occupational Health Sciences Institute on Frelinghuysen Road in Piscataway. Upon completion of the study, participants will receive up to $500.

Nancy Fiedler, PhD, Environmental & Occupational Health Sciences Institute, is the principal investigator of the study. For more information call 732-445-0123 ext. 625.

Parkinson’s Disease

Researchers at UMDNJ-School of Osteopathic Medicine in Stratford are in need of volunteers with Parkinson’s disease who want to continue living life to the fullest. A research study is being conducted to evaluate the safety and effectiveness of an investigational medication that may slow or delay the progression of symptoms associated with Parkinson’s disease. Men and women who were age 30 or older at the time of diagnosis and experience resting tremor, rigidity or slowing of movements may qualify for the study. Participants must be willing and able to give informed consent in order to participate. They will receive medical care from a specialist and all study-related medication will be provided. During their participation, they can continue to see their personal physician for non-study related healthcare.

The study is being conducted by the Parkinson’s Study Group (PSG) and is sponsored by Cephalon, Inc., West Chester, Pennsylvania. The principal investigator is David Podaskalny, DO. For additional information contact Lisa Giffin, LPN, CCRC, Center for Aging, at 856-566-6356.

Alzheimer’s Disease

UMDNJ–School of Osteopathic Medicine in Stratford is conducting a study on Alzheimer’s disease. The focus of the study is to find the most effective medications for symptoms such as delusions, agitation, aggressive behavior and hallucinations, and to improve the quality of life of patients, their families, and caregivers.

The Alzheimer’s Disease Study is comparing the effectiveness of four FDA-approved medications (olanzapine - Zyprexa®, quetiapine - Seroquel®, risperidone - Risperdal®, and citalopram - Celexa®) for these symptoms. At the beginning of the study, some participants may receive placebo (inactive pills) before they receive one of the study medications; they will not remain on placebo if they do not improve.

A specially trained physician and treatment team will carefully monitor each participant throughout the study and will coordinate with the participant’s regular healthcare provider. Patients will continue to see their physicians for routine medical care. Medication and medical care that are part of the study are provided at no cost. Participants will have follow-up visits for nine months with approximately 12 outpatient clinic visits.

A family member or caregiver who has regular contact with the patient must be available to participate in the study. Educational materials on Alzheimer’s disease and advice on managing difficult behavior will be provided.

The principal investigator for the study is Stephen Scheinthal, DO. For additional information call Lisa Giffin, LPN, CCRC, Center for Aging, at 856-566-6356.

Asthma

The Department of Medicine at Cooper Hospital/University Medical Center in Camden is currently recruiting volunteers to participate in an asthma study. Participants must be non-smokers between the ages of 15 and 65 with a history of asthma. The study offers free testing, examinations and generous compensation for participants’ time and travel.

The principal investigator is Robin Gross, MD. For more information contact either Robin Gross, MD, at 856-342-2407, or Patricia Niblack, MLT, at 856-968-7269.