Call for Volunteers

Oral Candida or Thrush Study A study to test a new topical form of a commonly used medication for candida and thrush is being conducted at UMDNJ-New Jersey Dental School. Volunteers between the ages of 2 and 90 who currently have one of these infections are needed to participate. To qualify, participants must be experiencing symptoms, which include a sore mouth, bad taste, red areas and white patches in their mouths, or cracks at the corners of their mouths. Those eligible will receive exams and medication for the infection at no cost.

The principal investigator for the study is Randall Wilk, DDS, MD, PhD. For more information call Fran Devonshire, RN, at 973-972-4777.

Type II Diabetes A Diabetes Outcome Progression Trial (ADOPT) is being conducted by SmithKline Beecham in the Department of Medicine at Cooper Hospital/University Medical Center in Camden. The purpose of this long-term research study is to compare the effects of three FDA-approved medications on TYPE II diabetes (adult onset). To qualify for the study, volunteers must be between the ages of 30 and 75, diagnosed with TYPE II diabetes in the last two years, treated with diet and exercise only, and never treated with an oral glucose-lowering drug. Qualified participants will receive an assessment by a physician, laboratory tests and study medication at no cost.

Arnaud Bastien, MD, is the principal investigator for this clinical trial at Cooper Hospital/University Medical Center. For more information or to register for consideration for future studies, call 1-888-914-7400 or visit our web site at www.newdiabetes.com.

Constraint-Induced Therapy The Kessler Medical Rehabilitation Research and Education Corporation in West Orange is conducting a study on the use of modified constraint-induced therapy on individuals who have experienced a sub-acute stroke. The objective of the study is to measure the efficacy of a modified constraint-induced therapy in improving upper extremity (UE) function and reducing UE impairment. Twenty-one sub-acute stroke patients ages 18 to 95 with moderate upper extremity involvement are needed to participate.

The principal investigator for the study is Stephen J. Page, PhD. For more information call the Kessler Medical Rehabilitation Research and Education Corporation at 973-243-6989.

Effectiveness of Botox on Lower Limb Spasticity A study is being conducted at the Kessler Medical Rehabilitation Research and Education Corporation in West Orange for incomplete spinal cord injured (SCI) individuals with lower limb spasticity. The purpose of this study is to develop a method of utilizing electromyograph (EMG) outcome measures to quantitatively express the kinematic alterations in gait arising from Botox injections into the spastic muscles of TBI patients. The changes in spastic activity will be measured by dynamic EMG during gait. In addition, gait temporal spatial features and 3D kinematics will measure functional gait changes as a result of the Botox intervention. The study will also investigate whether quantitative gait analysis can better identify the muscles required for injections than observational gait analysis.

Sue Ann Sisto, PhD, PT, is the principal investigator of the study. For more information call Dr. Sisto at 972-243-6888.

Adults With Active Crohn's Disease A study is being conducted at UMDNJ-Robert Wood Johnson Medical School in New Brunswick to evaluate the safety and efficacy of an experimental drug. This drug is a substance similar to a protein that the human body makes naturally and has an affect on immune response - how the body defends itself. Adults with active Crohn's disease, who may or may not be taking steroids, are needed for participation. Participants will be randomized - assigned by chance like the toss of a coin - to receive either placebo (an inactive study drug), or 1 mg or 2 mg of the active study drug by subcutaneous self-injection (inserted beneath the layer of the skin). The experimental drug will be taken once per week for 24 weeks. Patients will be seen every two weeks during the first three months and every four weeks for the last six months. Women must not be breast-feeding and must not be pregnant at enrollment or during the study. Study related care is provided at no cost.Kiron Das, MD, PhD, is the principal investigator for the study. For further information, including study participation requirements and eligibility, contact the study coordinator, Emily Kosa, RN, at 732-235-6360.

Diabetes and High Cholesterol UMDNJ-Robert Wood Johnson Medical School in New Brunswick is conducting a drug study to help lower cholesterol levels in individuals who suffer from diabetes and high cholesterol. Volunteers between the ages of 30 and 70, who take Actos or Avandia to control their diabetes, may be eligible to participate. Participants will receive a physical exam, study medications and relevant laboratory tests at no cost.

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

High Cholesterol Volunteers between the ages of 21 and 70 are needed to participate in an investigational drug study at UMDNJ-Robert Wood Johnson Medical School in New Brunswick. The purpose of the study is to evaluate the effectiveness of Zocor and Lipitor, which may lower blood cholesterol and risk of heart disease. Participants will receive a physical exam, study medications and relevant laboratory tests at no cost. Avedis K. Khachadurian, MD, is the principal investigator.

Stephen H. Schneider, MD, and Louis F. Amorosa, MD, are co-investigators for the study. For more information call Shelley Greenhaus, RN, at 732-235-7751.

Diabetes The Department of Medicine at UMDNJ-Robert Wood Johnson Medical School in New Brunswick is looking for volunteers between the ages of 70 and 85 to participate in a diabetes study. To be eligible, volunteers must not be taking medication to control their blood sugar. Participants will receive a physical exam, study tablets and relevant laboratory tests at no cost.

The principal investigator for the study is Avedis K. Khachadurian, MD. For more information call Shelley Greenhaus, RN, at 732-235-7751.

Insulin Therapy Volunteers are sought to participate in a diabetes study at UMDNJ-Robert Wood Johnson Medical School in New Brunswick. The study involves the use of a new insulin - taken once at night - which was recently approved by the FDA. Individuals whose diabetes is poorly controlled by pills may require insulin therapy. Volunteers must be between the ages of 30 and 70 to participate. They will receive a physical exam, study medications and relevant laboratory tests at no cost. Monetary compensation is provided.

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

The Study of Tamoxifen and Raloxifen Breast Cancer e to Prevent The Cooper Cancer Institute in Voorhees has been selected to participate in the National Surgical Adjuvant Breast and Bowel Project's (NSABP) Study of Tamoxifen and Raloxifene (STAR). The study, sponsored by the National Cancer Institute (NCI), needs 22,000 women to participate nationwide. Volunteers must be postmenopausal women age 35 and older who are at increased risk for developing breast cancer. In STAR, the drugs tamoxifen and raloxifene will be compared for their effectiveness in reducing the occurrence of breast cancer in postmenopausal women. Participants will receive either tamoxifen or raloxifene for five years.

The principal investigator for the study is Generosa Grana, MD. For more information call the Cooper Cancer Institute at 856-325-6757.

Anemia Volunteers are needed to participate in a study to evaluate the effectiveness, ability to improve the quality of life, and the safety of the drug Procrit when taken once a week for the treatment of anemia of chronic disease in the elderly. Procrit is a drug approved by the FDA but is investigational in this setting.

The study is being conducted at the Cooper Cancer Institute in Voorhees by the Department of Research. Participants must have a hemoglobin of 11.0 g/dl or less to be eligible to participate. Those selected will receive a physical exam, study medication and relevant laboratory tests at no cost.

Jack Goldberg, MD, is the principal investigator. For further details and to find out if you qualify, call 856-325-6759.

Gait Recovery for Above-Knee Amputees An investigation to develop a computer-generated model that accurately simulates pathological gait deviations in above-knee amputee patients, and to assess the kinematic and metabolic changes when using temporary prosthetic devices as compared to permanent prosthetic devices, is being done at the Kessler Medical Rehabilitation Research and Education Corporation in West Orange. An additional goal is to accurately evaluate the changes in the functional measures (i.e., kinematic, metabolic and mechanical energy) that occur as a patient transitions from the temporary prosthesis to the permanent prosthesis. Twenty unilateral, above-knee amputees, with no age restriction, who have been fitted with both temporary and permanent prosthetic lower limbs and are able to ambulate with a cane, or even less support, are needed.

Sue Ann Sisto, PhD, PT, is the principal investigator of the study. For more information call Dr. Sisto at 973-243-6888.

Muscular Activity Analysis During Squat Researchers at the Kessler Medical Rehabilitation Research and Education Corporation in West Orange are conducting a study to determine the amount of muscle activity necessary to perform a physiologically "correct" squat as compared to the muscular effort required for a subject-defined squat. They hypothesize that a natural, deep knee bend recruits more distal leg muscles, whereas a more biomechanically sound squat recruits more proximal hip musculature. The order and location of lower limb muscle recruitment patterns is being critically analyzed using both video and electromyographic data. Twenty participants from age 20 to 30 are being recruited. Ten subjects without any knee pathology are needed during the initial phase to test the hypothesis of a reduction in joint reaction movements. Ten additional individuals with either patello-femoral pain or anterior cruciate ligament (ACL) injury/repair will be included in the study. This group is needed for examination of the same parameters when knee pathology is present. Only those who receive clearance from their physician will be accepted. Individuals will be excluded if they have performed squat exercise training within the previous year at a frequency of at least twice per week for a period greater than three months, or if they have insufficient range-of-motion in the lower extremities as determined by forward bending motion test. Contact the principal investigator, William Roman, PhD, PT, at 973-731-3900, ext. 2285.

The Cancer Institute of New Jersey Recruiting Patients for Breast Cancer Prevention Trial The Cancer Institute of New Jersey (CINJ) in New Brunswick is seeking postmenopausal women over age 35 to participate in a new clinical trial aimed at preventing breast cancer. The Study of Tamoxifen and Raloxifene (STAR) is being conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP) and is supported by the National Cancer Institute (NCI). The new study will examine whether raloxifene, a drug similar to tamoxifen, is equally effective in preventing breast cancer and if it offers any additional benefits than those obtained by tamoxifen. CINJ is looking for 100 participants per year over a five-year period to take part in the study. A total of 22,000 women are expected to participate in the study nationwide. Participants will be given either tamoxifen or raloxifene and monitored regularly through scheduled health examinations by trained professionals.

Deborah Toppmeyer, MD, is the principal investigator for the study. For additional information call 732-235-7212.

A Comparison of Dynamic Stability in Walking Between Healthy Elderly Individuals and Individuals with Total Hip Arthroplasty A study to determine if gait characteristics are related to functional outcome, disability and quality-of-life is being done at Kessler Medical Rehabilitation Research and Education Corporation in West Orange in the Human Performance and Movement Analysis Laboratory. An evaluation of a three-dimensional motion analysis provides more precise quantitative data of human walking, which may identify subtle differences in gait patterns not observed by the clinician. Subtle differences in quantitative gait analysis may prove valuable in identifying significant differences in gait in subjects with disabilities. Identification will utilize the Vicon three-dimensional motion analysis system to investigate the walking characteristics of individuals with total hip replacements (THR) and healthy normal 65 or older individuals. Participants will be asked to walk a 30-foot walkway while six infrared cameras videotape their walking pattern. Volunteers will have up to 23 reflective markers placed on their body for the cameras to identify. The computer software converts these markers to a stick figure image, which is used to measure quantitative characteristics of the participant's gait.

Martha Macht-Sliwinski, MA, PT, is the principal investigator of the study. For additional information call 732-243-6888.

The Generation Effect in a Neurologically Impaired Population A study is being conducted on the generation effect in individuals with multiple sclerosis (MS) and traumatic brain injury. The generation effect, the observation that items generated by subjects are better remembered than items simply read, had been shown to be relatively robust within the normal population. Maximization of this effect leads to improvements in memory in a variety of conditions in numerous samples of healthy subjects. Few existing studies examine the utility of the generation effect in improving memory abilities of neurologically impaired individuals. Through a series of two experiments, this study will examine the utility of the generation effect in a group of 30 individuals with traumatic brain injury and a group of 30 individuals with MS. Ecompared to an age- and educationallyach group will be matched healthy control on a number of neuropsychological measures, including a generation effect protocol.

For more information contact the principal investigator, Nancy Donofrio, PhD, at Kessler Medical Rehabilitation Research and Education Corporation in West Orange at 973-731-3900, ext. 2383.