Winthrop Hospital Clinical Trials Center

2006-03-03 / Community

Centrally located and easily accessible by mass transit, the Clinical Trials Center at Winthrop-University Hospital in Mineola offers patients the opportunity to participate in FDA-approved clinical trials. Through the Center's efforts, eligible participants have access to medications and treatments that may not yet be available to the public. All clinical studies are supervised by physicians who are Board Certified in their respective specialties and carried out under the auspices of an independent Institutional Review Board whose sole purpose is to oversee the protection of clinical trial participants.

Participants in our studies may receive physical exams, laboratory tests, diagnostic evaluations and study medication at no cost. Compensation for time and travel is often provided. Patients do not need health insurance to participate.

We are currently conducting studies and seeking volunteers for a variety of areas. Some of the studies and eligibility requirements are as follows:

Chronic Obstructive Pulmonary Disorder (COPD) - criteria includes men and women over 40 years of age who have a clinical diagnosis of COPD with symptoms for more than two years; volunteers must be current or previous smokers with a smoking history of 10 or more pack years (one pack year is equivalent to smoking 20 cigarettes per day each year). Study will determine the effectiveness of an investigational medication.

Constipation-predominant Irritable Bowel Syndrome - women between the ages of 18 to 65 who have a documented diagnosis of constipation-predominant IBS are eligible to apply. Study will determine if an investigational medication relieves the overall symptoms of constipation-predominant IBS in women.

Epilepsy - men and women at least 16 years old who are on a stable antiepileptic drug regimen that includes carbamazephine or phenytoin are eligible. Study is testing the effects of two marketed drugs in patients with epilepsy.

Pediatric Gastroesophageal Reflux Disease (GERD) - boys and girls, ages 12 to 16, who have symptoms of GERD (frequent heartburn, especially when lying down, liquid backing up into the throat, a sour or bitter taste in the mouth or a sore throat or hoarse voice) or a diagnosis of GERD are candidates. Trial will study a medication used to relieve the symptoms of GERD.

Type 2 Diabetes - volunteers must be between the ages of 18 and 75, have a diagnosis of Type 2 Diabetes for at least one month, and have trouble controlling their condition with diet and exercise; participants must not have previously taken any medication for diabetes. Study will evaluate the effectives of an investigational medication during a 13-week period.

Type 2 Diabetes & Inhaled Insulin - men and women between the ages of 18 and 80, nonsmokers, who have had Type 2 Diabetes for at least six months; they must be taking at least two oral medications for diabetes to be eligible. Purpose is to test the effectiveness of an investigational inhaled insulin medication.

Adolescent Migraine - participants must be between 12 to 17 years of age and have a history of migraines for at lease one year; must have at least 24 hours with no headaches between migraine attacks to qualify. Study will evaluate the effectiveness of a medication in treating migraines in adolescents.

Osteoarthritis of the Hip or Knee - volunteers must be between the ages of 18 and 80 who have been diagnosed with osteoarthritis of the knee or hip joint; must have taken nonsteroidal anti-inflammatory drugs to control their pain within the past month. Study will determine the effectiveness of a medication used to relieve the pain of osteoarthritis of the hip or knee.

Restless Legs - participants must be between the ages of 18 to 75 who meet the diagnosis of Idiopathic Restless Legs Syndrome; must be available for 13 visits over a period of approximately 8 months. Study will evaluate the effectiveness and safety of an investigational patch medication for RLS.

Stress Urinary Incontinence - women between the ages of 18 to 65, who experience involuntary leakage of urine on exertion, sneezing or coughing at least 7 times a week; must have experienced these symptoms for over three months to be eligible. Study will determine if the investigational medication controls urine leakage caused by everyday activities.

Other studies, such as high cholesterol, Crohn's disease, rheumatoid arthritis, pulmonary hypertension, asthma, multiple sclerosis (MS), and recent wrist fracture are also being conducted.

For more information about participating in our clinical research trials, call 516 663-9582 or visit www.winthrop.orgdepartments/clinical/ctn.

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