Partners Research Studies Seeking Volunteers Healthy volunteer studies 1. Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans (SUGAR MGH) Do you think you might be at risk for diabetes? Does anyone in your family have diabetes? Are you overweight? If you are interested in participating in a new research study… We need your help! The Center for Human Genetic Research at Massachusetts General Hospital seeks men and women over the age of 18 who are not currently on diabetes medication for a research study exploring the influence of genetic background on the response to established type 2 diabetes treatments. Participants will be asked to visit the hospital twice in seven days. The total time commitment is five hours for the first visit and three hours for the second visit. Compensation will be provided up to $100 and a free meal. Contact Rebecca at (617)643-5419 or email rfanelli@partners.org 2. Effects of Anorexia Nervosa on Peak Bone Mass Anorexia nervosa can cause bone loss at an early age. We are examining the effect of estrogen administration on bone density and bone metabolism. Eligible candidates will stay in the Massachusetts General Hospital Clinical Research Center overnight four times over the course of one and a half years, and will need to be seen in the outpatient unit of the Clinical Research Center seven times. The research study will include bone density and hormonal evaluations. Estrogen (a natural female hormone) may be administered to girls with anorexia nervosa. Up to $1,050 compensation and parking is offered. Eligibility Criteria: We are seeking 12 to 18 year old adolescent girls with anorexia nervosa and 12 to 18 year old healthy adolescent girls. Please contact Jenna Stark at 617 726 8201 or jnstark@partners.org for more information Posted 8/27/08 3. Exploratory Analysis of Stress Reduction Have you ever considered implementing a daily stress reduction technique into your life to relieve your stress? If so, we may be able to help: Researchers at Massachusetts General Hospital are conducting a study on the effectiveness of a stress reduction program. Study participants will receive a FREE eight week stress reduction course to be held at MGH (a $800 value). Classes are held one evening a week on Tuesdays for 1.5 hours at MGH. The study does not require the use of any medications. Study participants are required to attend 2 laboratory sessions and regularly practice learned stress reduction exercises. Compensation will be up to $100 for completing all testing. For more information or to enroll in the study, please call 1-866-449-6779 or email the address below. 4. An Open Label Phase I/II Study of the Safety and Dopamine Transporter Binding Properties of C-11 Altropane in Normal Human Subjects and in Subjects with ADHD Description: Healthy, right-handed adults (18-55 years old) are invited to participate in a study testing an investigational drug for its ability to bind to certain areas of the brain using an approved PET scanning method. The study will involve 3 office visits. Subjects will be reimbursed up to $200 for their participation. Please email Jess at jmartin8@partners.org for more information. 5. Growth Hormone, Cardiovascular Risk and Visceral Adiposity Healthy Women Study We are conducting a research study to examine body composition, hormone levels and heart disease at Massachusetts General Hospital. You may be eligible if you are between 25 and 45 years old, not overweight, a non-smoker, have regular menstrual periods, and do not take medicines for weight loss, cholesterol, blood sugar, or birth control. The study requires two outpatient visits. Subjects receive a physical examination, MRI, nutritional analysis, as well as bone density and blood tests at no cost. No investigational medications are involved. $250 payment for participation available to those who qualify. For more information contact Danielle Brick at (617) 724-0785 or dbrick@partners.org. 6. Participant Database for Persons Interested in Research Studies of Developmental Disorders To create a registry of eligible subjects for our studies, we are currently seeking Posted 8/27/08 • Children without any Developmental Disorders • Children with Autism Spectrum Disorders and their Siblings • Children with Language Disorders or Delay How do children with autism process information differently from children without autism? Are there biological markers that may make it possible to diagnose autism at younger ages? How about language disorders? Why do those happen? Our research team is working on several exciting research projects to address these questions. The studies focus on brain development and information processing using some of the latest advances in noninvasive brain imaging techniques. We hope that in the future, our research will not only advance our understanding of the field, but also contribute to the development of new treatments. Therefore, we are creating a registry for children/teenagers ages 3-12 interested in participating in our rese arch studies, including children/teenagers without any developmental disorders, children/teenagers with autism spectrum disorders, their younger siblings, and children/teenagers with language disorders or delay. Participation in the registry would require 1-2 visits for 2-3 hours each, to complete questionnaires common to all of our studies. After you complete the questionnaires, we will contact you about studies for which you are eligible. Compensation for your time and travel expenses will be provided. If you and your child are interested in participating in the studies, please call our Research Coordinator, at (617) 966-9766, or contact us by email at TRANSCEND@partners.org We look forward to hearing from you and answering any questions you might have about the studies! ----------------------------------------TRANSCEND Research Program Treatment Research and NeuroSCience Evaluation of Neurodevelopmental Disorders 7. Mitochondrial Function in Pediatric Obesity Healthy Children for Research Study • 8-18 years old • normal weight or overweight You may be eligible for a research study to evaluate how the body processes sugar at the Massachusetts General Hospital and MIT. Study involves: • 4 hour visit at the MIT Clinical Research Center • 1 hour MRI scan Subjects receive a comprehensive evaluation and a $100 gift card. Please contact Matthew Kron at 617 643-4420 or mkron@partners.org or Amy Fleischman, MD at 617 724-3572 or afleischman@partners.org MGH Program in Nutritional Metabolism Posted 8/27/08 8. Prevalence and Metabolic Consequences of Growth Hormone Deficiency in Abdominal Obesity Overweight? Large Waist Size? If you are a male or pre-menopausal female between 18-55 years old, overweight with a large waist size, and without diabetes you may qualify for a metabolism research study. Participants will receive: • 2 outpatient visits (4-6 hours each) for blood draws and radiological studies. • Physical exam • Evaluation of growth hormone level • Evaluation of your risk of heart disease and of how your body processes sugar • $50 compensation after screening visit and an additional $75 compensation after study visit Please call: David Mun (617) 724-0248 Massachusetts General Hospital Harvard Medical School 9. Effect of Race on Gonadotropin Responses to Short Term Negative and Positive Feeback Effects of Gonadal Steroids The Reproductive Endocrine Unit at the Massachusetts General Hospital seeks healthy African American women ages 18-35 with normal menstrual cycles and on no medication (including birth control pills) for a 5 day in-patient research study. Participants compensated up to $ 1000 stipend. Call Teresa at (617) 726-8484 or email: talati@partners.org. 10. Effect of Race on Gonadotropin Responses to Short Term Negative and Positive Feedback Effects of Gonadal Steroids The Reproductive Endocrine Unit at the Massachusetts General Hospital seeks healthy Caucasian women ages 18-45 with normal menstrual cycles and on no medication (including birth control pills) for a 5 day inpatient research study. Participants compensated up to $ 1000 stipend. Call Teresa at (617) 726-8484 or email: talati@partners.org. Posted 8/27/08 Disease-specific studies 11. Evaluation of Digital Subtraction Bowel Cleansing and Automated Polyp Detection in CT Colonography (Virtual Colonoscopy) Do you have a Colonoscopy appointment scheduled at Massachusetts General Hospital? We are seeking volunteers for a research study evaluating Virtual Colonoscopy using a laxative-free bowel preparation. CT colonography (Virtual Colonoscopy) consists of a low X-ray dose CAT scan, which is performed after gently filling the colon with carbon dioxide. The images of the colon are reconstructed into a computer model, which allows for a minimally-invasive screening of the colon for abnormalities such as polyps and masses. Instead of drinking a laxative to empty the bowel prior to the colon test, study participants drink a contrast solution during the laxative-free bowel preparation. The laxative-free bowel preparation regimen is intended to be more comfortable for patients than current bowel preparations. Participants in this research study: 1. Must be available for two study visits: a 30 minute information visit and a 30 minute CT Colonography test (total duration of second visit: 1hour). 2. Will be asked to follow a low fiber diet as well as drink a small amount of contrast solution with meals and snacks for the two days prior to the second visit (i.e., prior to the CT colonography). 3. Will receive study related laxative-free bowel prep and CT Colonography test at no cost. 4. Must have the standard Colonoscopy ordered by your physician between 1-4 weeks after the CT Colonography test. (The cost of the standard Colonoscopy is not covered by the study.) Participants will receive free parking for the two study visits, plus a $70 payment for participation upon completing all study requirements. Eligibility Criteria: You may be eligible to participate in the research study if you: 1. Are 50-80 years old 2. Have a Colonoscopy scheduled at MGH, either for routine colon screening or because of a family history of colon cancer or a change in bowel habits. 3. Have not had a Colonoscopy or Sigmoido scopy in the past 5 years The standard colonoscopy is REQUIRED for inclusion in the study, as part of a reference standard comparison. Posted 8/27/08 12. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Efficacy and Safety of TZP-101 when Administered as a 30 Minute I.V. Infusion to Subjects with Severe Gastroparesis due to Diabetes Mellitus (TZP-101-CL-G004) Do You Have Type 1 or Type 2 Diabetes and have been diagnosed with Gastroparesis? Massachusetts General Hospital is seeking volunteers to participate in a Clinical Research Study using an investigational medication. To qualify you must be: • 18-80 years of age • Diagnosed with Type 1 or Type 2 Diabetes Mellitus • Diagnosed with gastroparesis • Male or Female must be willing to use contraceptives (birth control) to prevent pregnancy • Able and willing to participate up to 35 days from screening through follow-up, including 5 consecutive overnight stays Do you have any of the following conditions: • vomiting of undigested food—sometimes several hours after a meal • early feeling of fullness after only a few bites of food • abdominal bloating • nausea • pain in the upper abdomen Qualified participants will receive research study related: • Lab Assessments • EKG’s • Investigational Medication Monetary compensatio n is available for eligible subjects. 13. Brain Response to Motion Sickness with Acupuncture Prophylaxis Massachusetts General Hospital’s Department of Gastroenterology is conducting a clinical research study to understand what parts of the brain are involved when one receives relieving acupuncture for motion sickness produced by nausea stimulations. We encourage you to inquire if you: • Suffer from motion sickness • Are a healthy non-pregnant female • Are between 18 – 64 years of age • Have never had acupuncture done before • Are right-handed Posted 8/27/08 The study will require 4 study visits, which will take approximately 4 weeks to complete. The study will include questionnaire, nausea stimulation, acupuncture and taking images of the brain with the use of functional Magnetic Resonance Imaging (MRI). 14. Mitral Valve Prolapse genetic study The Center for Human Genetic Research and the Cardiac Ultrasound Lab at MGH are looking for subjects and or their family members with Mitral Valve Prolapse. Subjects will be enrolled into a genetic study that will involve an echo-diagnosis of MVP and a one time blood draw of approximately 8 teaspoons. All participants that come to MGH will be reimbursed for parking. Time commitment will be no longer than 1 hour. If you are interested please contact Leah Rastiello at 617-821-0495 or by email: lrastiello@chgr.mgh.harvard.edu 15. An Open-Label Pilot Study of Namenda (memantine hydrochloride) in Adult Subjects with Attention Deficit Hyperactivity Disorder (ADHD) The main aim of this research study is to assess the effectiveness and tolerability of an investigational medication in Adults with Attention Deficit Hyperactivity Disorder (ADHD) and Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS). ADHD NOS is a label used to describe adults who have symptoms of ADHD that can appear in late childhood, or even adulthood. This study is a 12-week open-label (involves active medication only, no chance of placebo) trial of Namenda. Namenda is FDA approved for the treatment of Alzheimer’s disease, but is not approved for treatment of ADHD. Study participation could last for up to 14 weeks from the initial psychiatric evaluation. Participants will receive an evaluation and study visits at no cost. 16. Open-label Study of Quetiapine for Mania in Preschool Children 4 to 6 Children between the ages of 4-6 years old who have, or display symptoms of bipolar disorder (explosiveness, mood swings, irritability, or violent behavior) are invited to participate in an 8-week research study to determine the effectiveness and safety of a medication called Seroquel (quetiapine) in the treatment of children with bipolar disorder. After undergoing a comprehensive evaluation by medical doctors with a specialty in this area, children who are found eligible to participate in this research study will be treated with Seroquel and will have weekly visits for 8 weeks in an effort to closely monitor each child’s response to the medication. Eligible participants will receive study-related evaluations and weekly study visits with our study doctors at no cost. Eligibility Criteria: Children ages 4-6 with Bipolar disorder Posted 8/27/08 17. Open-Label Study of Invega for the Treatment of Mania in Children and Adolescents ages 6-17 with Bipolar I, Bipolar II, and Bipolar Spectrum Disorder Children between the ages of 6-17 years old who have, or display symptoms of bipolar disorder (explosiveness, mood swings, irritability, or violent behavior) are asked to participate in an 8-week research study to determine the effectiveness and safety of a medication called Invega (paliperidone) in the treatment of children with bipolar disorder. After undergoing a comprehensive evaluation by medical doctors with a specialty in this area, children who are found eligible to participate in this research study will be treated with Invega and will have weekly visits for 8 weeks in an effort to closely monitor each child’s response to the medication. Eligible participants will receive study-related evaluations and weekly study visits with our study doctors at no cost. 18. A Randomized Placebo Controlled Clinical Trial of Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents ages 6-17 with Bipolar Spectrum Disorder Children and adolescents between the ages of 6-17 years old who have, or display symptoms of bipolar disorder (explosiveness, mood swings, irritability, or violent behavior) are are being asked to participate in a 12-week research study to determine the effectiveness and safety of a natural substance called Omega-3 Fatty Acid (fish oil) with a second generation antipsychotic medication, aripiprazole, in the treatment of children with bipolar disorder. After undergoing a comprehensive evaluation by medical doctors with a specialty in this area, children and adolescents who are found eligible to participate in this research study will be treated with Omega-3 Fatty Acid or placebo and aripiprazole and will have weekly visits for 6 weeks followed by biweekly visits for the remaining 6 weeks. This visits will be to closely monitor each child’s response to the Omega-3 fatty Acid or placebo and aripiprazole. Eligible participants will receive studyrelated evaluations and weekly study v isits with our study doctors at no cost. For more information, please call (617) 724-4MGH. 19. Efficacy and Safety/Tolerability of Methylphenidate Transdermal System (MTS) for Before-School Dysfunction in Children with Attention Deficit Hyperactivity Disorder (ADHD) Does your child experience inattention, restlessness, distractibility, and/or hyperactivity? These symptoms may be signs of Attention Deficit Hyperactivity Disorder (ADHD). The Pediatric Psychopharmacology Unit at Massachusetts General Hospital is conducting a clinical research study looking at ADHD in children ages 6-12. Evaluation, study visits and study medication are provided at no cost to participants. For more information please call (617) 724-ADHD Posted 8/27/08 20. A Characterization Study of Young Adults with Autism Spectrum Disorders The purpose of this study is to help us understand how young adults with autism spectrum disorders (ASDs) are doing in academics, at work, and with peers, after graduating from high school. WHO: Young adults with ASD who have recently graduated from high school. WHAT: One or two study visits (total of about 5 hours) that include: -Neuropsychological testing that includes math problems, computer tasks, and vocabulary; -Answering questions about behavior, sleep habits, family, and social life; -Optional (not required) genetic testing using participant’s saliva. *Participants and their parents will each receive $25 for completing the study procedures. If you would like to learn more, please call: (617) 503-1011 or email us at: MGHASDprogram@partners.org 21. Pilot Treatment Study of Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents with Bipolar Disorder Dr. Gagan Joshi is conducting a research study at the MGH Pediatric Psychopharmacology Research Unit for children and adolescents with Bipolar Disorder and Obsessive-Compulsive Disorder (OCD). The study is designed to use fluoxetine to treat OCD symptoms for subjects who are adequately mood stabilized on a regimen based on standard clinical care. Subjects may enter the study if their mood symptoms are adequately stabilized and they continue to experience OCD symptoms. All participating subjects will receive the study medication – Fluoxetine (study does not involve placebo, which looks like study drug but contains no active medication). Subjects will continue on their mood medication during the study period. The study would involve weekly visits with a maximum of 14 weeks commitment. Eligibility Criteria: We are looking for male and female subjects 6-17 years of age. Subjects may enter the study if their mood symptoms are adequately stabilized and they continue to exper ience OCD symptoms. 22. Bipolar and Alcohol Use Research Study Do you have bipolar disorder? Do you drink alcohol? Posted 8/27/08 If so, you may be eligible to participate in a research study at Massachusetts General Hospital’s Bipolar Clinic and Research Program examining the effect of a medication treatment on drinking in patients with bipolar disorder. This study involves a thorough evaluation, followed by 10 study visits over a 6-month period. Eligible patients will receive study visits, laboratory tests, study medication and physical examinations at no cost, and will also receive $100 in Whole Foods vouchers for completing the study. For more information, please call 1-866-99-MOODS. 23. The Genetics of Polycystic Ovary Syndrome This research study is designed to determine the gene(s) that might cause Polycystic Ovarian Syndrome. The study entails a questionnaire and medical history, a physical exam, ultrasound of the ovaries and blood tests for hormones and DNA testing. Eligibility Criteria: Women who: Are between 18 and 40 years old, Have irregular menstrual cycles (fewer than nine per year), Are not on any hormone medications (no birth control pills) for three months, Have acne and/or excessive hair growth, AND: Normal healthy women for controls. 24. Growth Hormone, Cardiovascular Risk and Visceral Adiposity Are you struggling with your weight? We are conducting a research study at the Massachusetts General Hospital to determine whether a treatment can decrease body fat and reduce the risk of heart disease. You may be eligible if you are between 18 and 45 years old; weigh less than 280lbs; non-smoker; have regular menstrual periods if you are a woman; and do not take medicines for weight loss, cholesterol, blood sugar, or birth control. The study includes nine visits over twelve months with compensation up to $2200. Please contact Danielle Brick at 617-724-0785 or dbrick@partners.org. 25. Effects of Growth Hormone Administration on Cardiovascular Risk Markers in Men and Women with Cured Acromegaly Effects of Growth Hormone Administration on Cardiovascular Risk Markers in Men and Women with Cured Acromegaly This 12-month research study will evaluate the relationship between growth hormone (GH) levels and heart disease in subjects cured of acromegaly. GH is a hormone that the pituitary gland normally produces, and GH deficiency is associated with an increased risk for heart disease. This study investigates whether physiologic GH replacement therapy will reduce cardiovascular risk in men and women ages 18 to 75 with GH deficiency Posted 8/27/08 following cure of acromegaly. Eligible subjects may undergo 8 to 10 outpatient hospital visits which will include measurements of metabolism, body fat and muscle, as well blood tests reflecting the health of blood vessels. Subjects will be remunerated up to $300 for their participation. We will also enroll subjects cured from acromegaly who are GH sufficient or who are GH deficient but have a contraindication to receiving GH for a cros s-sectional study involving body composition and cardiovascular risk marker measurements. For more information, please contact Gwenda Graham at (617) 724-7129 or ggraham1@partners.org Posted 8/27/08