Research : Clinical Trials & Studies

Current Clinical Trials

ASPIRE US (Aripiprazole Intramuscular Depot Program in Schizophrenia)
- Purpose
  ASPIRE, a worldwide research study, is now underway to evaluate an investigational long-acting medication for schizophrenia.
  
  Investigator(s)
  Steven Dubovsky, MD
  
  Requirements
  
  Reimbursement
  Yes
  
  Eligibility
  You may be able to participate if you are 18 to 60 years of age and have been diagnosed with schizophrenia for at least three years.
  
  Location
  Erie County Medical Center
  
  Contact
  Sevie Kandefer
  
  Phone
  716-898-4038
  
  Sponsor
  Otsuka Pharmaceutical Development & Commercialization, Inc.
A Comparison of Two Parenting Programs for Mothers and Fathers of Children with ADHD
- Purpose
  The purpose of this study is to compare two formats of parent training programs for mothers and fathers of children with ADHD.
  
  Investigator(s)
  Gregory A. Fabiano & William E. Pelham
  
  Requirements
  Mothers and fathers of children 6-12 who show signs of inattention, overactivity, impulsivity, and/or noncompliant behavior are eligible to apply.
  
  Contact
  COACHES program
  
  Phone
  829-2244 x124
  
  Sponsor
  National Institutes of Mental Health
NEW CLINICAL TRIAL
A Multicenter, Prospective, Long-Term, Observational Registry of Pediatric Patients with Inflammatory Bowel Disease.
- Detail
  Crohn’s Disease (CD) is characterized by inflammation (the changes that happen when tissues in the body are injured) and ulceration (open sore) of the small and/or large intestines. Ulcerative colitis(UC)s is characterized by inflammation of the large intestine (colon). Indeterminate colitis (IC) is a sub-group of inflammatory bowel disease that cannot be characterized as either CD or UC. Patients with CD, UC and IC suffer from symptoms such as diarrhea, abdominal pain, rectal bleeding, weight loss, difficulty growing and fever. CD, UC and IC can be treated with medications that suppress the immune system (the body system involved in inflammations and infections), or in some cases surgery. This research study is an observational research study (a registry) designed to gain information on pediatric patients with inflammatory bowel disease (IBD).
  
  Purpose
  The purpose of the study is to obtain long-term safety information on participants disease and medications that participants received or are receiving for his/her inflammatory bowel disease.
  
  Investigator(s)
  Susan S. Baker, MD, PhD, Principal Investigator Robert D. Baker, MD, PhD, Sub-Investigator Daniel Gelfond, MD, Sub-Investigator Humaira Hashmi, MD, Sub-Investigator Anita M. Crawley, RN, PNP, Sub-Investigator Casey Gajewski, RN, PNP, Sub-Investigator
  
  Requirements
  Participants will be patients of the Digestive Diseases and Nutrition Center at Women & Children’s Hospital of Buffalo and will have biannual direct contact preferably a medical encounter(office visit) and review of participant’s medical record where the following will be collected: subject’s height, weight, information about participant’s disease and completion of a Quality of Life Questionnaire.
  
  Reimbursement
  Subjects will receive $20 for each Quality of Life Questionnaire that is completed (biannually).
  
  Eligibility
  Patients under 17 years of age at the time of study enrollment diagnosed with Inflammatory Bowel Disease at least 2 months.
  
  Location
  Within the clinic offices of the Digestive Diseases and Nutrition Center of Women & Children’s Hospital of Buffalo located at: 140 Hodge Street, Buffalo, NY 14222, Sterling Medical Park at 200 Sterling Road, Orchard Park, NY 14127, or UB Commons at 1400-1430 Sweet Home Road, Amherst, NY 14228.
  
  Contact
  Susan S. Baker, MD, PhD or Christine M. Roach, RN, BSN, Study Coordinator
  
  Phone
  716-878-7199
  
  Sponsor
  Centocor Ortho Biotech, Inc f/k/a Centocor
A Phase 3, multi-center, randomized, double-blind placebo-controlled study to evaluate the safety and tolerability of Dimebon (PF-01913539) for up to 26-weeks in patients with mild to moderate Alzheimer’s disease
- Investigator(s)
  Steven Dubovsky, MD
  
  Location
  Erie County Medical Center
  
  Contact
  Sevie Kandefer, MS
  
  Phone
  716-898-4038
  
  Sponsor
  Pfizer Inc.
Rapid Pediatric Psychiatric Consultation -Quality Assurance Protocol
- Purpose
  The shortage of child psychiatrists is particularly acute in Western New York. A consultant may be able to help to meet the needs of the large number of psychiatric problems being treated in primary practices. The overall goal of this early intervention project is to demonstrate the clinical benefits and cost efficacy of a consultation service (comprehensive psychiatric evaluation) for high-risk children and adolescents with psychiatric disorders and treated in pediatrics and family medicine setting.
  
  Investigator(s)
  PI: Dr. Steven Dubovsky; Co-Is: Drs. Jennifer Haak, David Kaye, Bruce Miller, Beth Smith, James Waxmonsky
  
  Sponsor
  Tower Foundation & Blue Cross of WNY
Olanzapine-Associated Weight Gain in Healthy Males
- Purpose
  Olanzapine is associated with weight gain, hyperlipidemia, and type II diabetes among psychiatric patients. Our studies are designed to gather data regarding the processes that potentially underly these effects, but among individuals without major psychiatric disorders. We will determine whether olanzapine is associated with changes in weight, dietary intake, food reinforcement value, physical activity, D2 receptor availability, glucose tolerance, insulin responsiveness, and inflammatory response. Further, we will examine the effect of the dopamine transporter gene polymorphism (SLC6A3), the dopamine D2 receptor gene polymorphism (DRD2), and the hydroxytrytamine 2c (5-HT2c) receptor gene polymorphism (-759 T/C) on food intake and weight gain during olanzapine treatment.
  
  Investigator(s)
  PI: Steven Dubovsky, MD; Co-Is: Drs. Ed Bednarczyk, Leonard Epstein, Kenneth Leonard, John Leddy, Paresh Dandona, Manish Upadhyay, Elsa Daurignac
Prevalence of Bipolar Disorder in Family Practice
- Purpose
  Bipolar disorder is under-recognized and inadequately treated in primary care, resulting in worsening of symptoms, decreased levels of functioning, and increased risk of suicide. This project is using a practice-based research network to estimate the prevalence of bipolar disorder in family practice. Simultaneously, a diagnostic instrument called the M.I.N.I is tested for its usefulness in primary care. The overall goal of this project is to identify appropriate screening methods in order to make early and correct diagnosis of the bipolar spectrum of disorders in primary care.
  
  Investigator(s)
  Kim Griswold, MD; Linda Pessar, MD (Consultant: Steven Dubovsky, MD)
WARCEF
- Detail
  Warfarin vs. Aspirin in Reduced Cardiac Ejection Fraction
  
  Purpose
  The purpose of this study is to determine whether warfarin (INR) or aspirin (325 mg/day) is superior for preventing all cause mortality and stroke combined in patients with ejection fraction (EF) < 30% when balanced against any risk of intra-cerebral hemorrhage.
  
  Investigator(s)
  DR. SUSAN GRAHAM Sub Investigator: Virginia Hart, RN
  
  Reimbursement
  YES
  
  Eligibility
  PATIENTS WITH A LOW EJECTION FRACTION WITH HEART FAILURE
  
  Location
  BUFFALO GENERAL HOSPITAL
  
  Contact
  MARY BONORA
  
  Phone
  716.859.4641
  
  Sponsor
  NIH
EFFECT OF JANUVIA (SITAGLIPTIN) ON OXIDATIVE STRESS IN OBESE TYPE 2 DIABETIC SUBJECTS
- Detail
  Obesity and diabetes are states of increased inflammation and can influence the free radicals and inflammatory markers (chemicals in the blood which increase due to inflammation in the body) and are also major risk factors for atherosclerotic disease. In this study we want to see the effect of sitagliptin on these markers. We believe that Sitagliptin may exert an anti-inflammatory effect in the human.
  
  Purpose
  The purpose of this study is to determine if the addition of sitagliptin to diabetic patients will provide added benefit. We believe that sitagliptin provides these added benefits by suppressing free radicals (charged substances that cause damage to the body) and inflammation
  
  Investigator(s)
  Paresh Dandona, MD
  
  Reimbursement
  $150-$250
  
  Eligibility
  You are being asked to participate in this study because you have been diagnosed with type 2 diabetes mellitus, are obese and are on oral medication for your diabetes
  
  Location
  Millard Fillmore Hospital Gates Circle Buffalo NY 14209
  
  Contact
  Teekam Lohano
  
  Phone
  716-887-5104
  
  Sponsor
  Merck
Vascular Benefits of Adding Carvedilol CR to Type 2 Diabetic Patients on ACEi: Effects on Oxidative Stress and Inflammation.
- Detail
  Lisniopril is a blood-pressure lowering drug that belongs to a class of medications called Angiotensin-Converting Enzyme inhibitors or ACEi. Carvedilol belongs to a class of blood pressure lowering medications called beta-blockers that are used for the treatment of high blood pressure, especially in patients with coronary heart disease. Diabetics are known to be at increased risk of coronary artery disease (disease affecting the vessels supplying blood to the heart). Controlled-release carvedilol (Carvedilol CR) is approved by the FDA. In this study, clinical trial formulation of controlled-release carvedilol will be used.
  
  Purpose
  The purpose of this study is to determine if the addition of carvedilol to diabetic patients with high blood pressure who are already receiving the blood pressure medication
  
  Investigator(s)
  Paresh Dandona, MD
  
  Reimbursement
  $400
  
  Eligibility
  You are being asked to participate in this study because you have been diagnosed with type 2 diabetes mellitus for at least four months, have high blood pressure and have been on treatment with the cholesterol-lowering drugs called statins for at least four months.
  
  Location
  Millard Fillmore Hospital Gates Circle Buffalo NY 14209
  
  Contact
  Teekam Lohano
  
  Phone
  716-887-5104
  
  Sponsor
  GlaxoSmithKline
NEW CLINICAL TRIAL
Effect of Androgel on Atherogenesis, Inflammation, Cardiovascular Risk Factors And Adiposity in Type 2 Diabetic Males with Hypogonadotrophic Hypogonadism.: a Prospective, Randomized and Controlled-Study.
- Detail
  Testosterone is the male sex hormone. This study is being conducted in men with type 2 diabetes, both with normal and low levels of testosterone. We have previously shown that men with type 2 diabetes have as much as a 1 in 3 chance of having low testosterone. The study will determine if there is any effect of testosterone replacement in those with low levels of testosterone. Testosterone replacement will be in the form of Androgel, a commercially available testosterone gel
  
  Purpose
  The purpose of this study is to examine the effects of testosterone deficiency in men with diabetes. This will be done by comparing the changes in several body response indicators following treatment with testosterone in diabetic men with low testosterone levels and comparing them to diabetic men with low testosterone who are not treated with testosterone. These groups will also be compared with diabetic men who have normal testosterone levels.
  
  Investigator(s)
  Paresh Dandona, MD
  
  Reimbursement
  $400
  
  Eligibility
  You are being asked to participate because you are a male, with type 2 diabetes, between the ages of 30–60 years and have low or normal testosterone levels
  
  Location
  Millard Fillmore Hospital Gates Circle Buffalo NY 14209
  
  Contact
  Teekam Lohano
  
  Phone
  716-887-5104
  
  Sponsor
  Solvay Pharmaceuticals
Effect of AndroGel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males with Hypogonadism
- Detail
  The purpose of this study is to examine the effect of having testosterone deficiency in men with diabetes. This will be done by comparing the changes in several body response indicators following treatment with testosterone in diabetic men with low testosterone levels and comparing them to diabetic men with low testosterone who are not treated with testosterone.
  
  Investigator(s)
  Paresh Dandona, MD
  
  Requirements
  You are being asked to participate because you are a diabetic male between the ages of 30–75 years and have low testosterone levels.
  
  Reimbursement
  $200 4-6 week after completion of study
  
  Location
  Millard Fillmore Hospital Gates Circle Buffalo NY 14209
  
  Contact
  Teekam Lohano
  
  Phone
  716-887-5104
  
  Sponsor
  Solvay Pharmaceuticals
The Suppression of Toll like Receptors (TLR) by Insulin
- Detail
  Toll-like receptors (TLRs) are a class of receptors in the body that recognize foreign agents such as microbes once they have breached physical barriers such as the skin or intestinal tract mucosa. TLRs then activate immune cell responses. We would like to invite you to participate in this study to evaluate the effect of a intravenous (administered through a vein) infusion of insulin on inflammation and TLR function
  
  Purpose
  The purpose of the study is to see if insulin, which controls blood sugar in the body, will have an effect on Toll like receptors (TLR). This effect will be monitored by keeping blood sugar level at a normal level
  
  Investigator(s)
  Paresh Dandona, MD
  
  Reimbursement
  $2100
  
  Eligibility
  You are being asked to participate because you are a male, with type 2 diabetes, between the ages of 30–60 years and have low or normal testosterone levels
  
  Location
  Millard Fillmore Hospital Gates Circle Buffalo NY 14209
  
  Contact
  Teekam Lohano
  
  Phone
  716-887-5104
  
  Sponsor
  American Diabetes Association
Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR)
- Detail
  600 children from 15 clinical sites in the United States will be randomized into one of two groups, antimicrobial prophylaxis or placebo. Participants will be closely monitored by telephone contact , clinic visits and DMSA renal scan
  
  Purpose
  The primary purpose of the study is to determine whether daily antimicrobial prophylaxis is superior to placebo in managing children with Vesicoureteral Reflux (VUR)
  
  Investigator(s)
  Saul P. Greenfield, MD
  
  Requirements
  Childen age 1 month to 6 years, with documented first or second UTI prior to VUR diagnosis, VUR grade I-IV based on VCUG
  
  Reimbursement
  up to $150.00 at completion of 24 month enrollment
  
  Location
  Women and Children's Hospital of Buffalo
  
  Contact
  Allyson Fried, MS, PNP
  
  Phone
  716-878-7306
  
  Sponsor
  NIH/NIDDK
AIM-HIGH "ATHEROTHROMBOSIS INTERVENTION IN METABOLIC SYNDROME with low HDL/HIGH TRIGLYCERIDE and IMPACT ON GLOBAL HEALTH OUTCOMES
- Detail
  Does the addition of Niaspan ® increase HDL (good cholesterol) and prevent future heart attacks and strokes
  
  Purpose
  Purpose Does the addition of Niaspan ® increase HDL (good cholesterol) and prevent future heart attacks and strokes
  
  Investigator(s)
  Ajay Chaudhuri, MD
  
  Requirements
  Age > 45, previous Heart attack or stroke with High Cholesterol
  
  Reimbursement
  Yes
  
  Eligibility
  Age > 45, previous Heart attack or stroke with High Cholesterol
  
  Location
  Millard Fillmore Hospital Gates Circle Buffalo NY 14209
  
  Sponsor
  Abbott pharmaceutical
COMPASS3
- Detail
  An Open-Label, Multi-Center Study Employing a Targeted 6-MWT Distance Threshold Approach to Guide Bosentan-Based Therapy and to Assess the Utility of MRI on Cardiac Remodeling (COMPASS 3)
  
  Purpose
  This trial is a multicenter open-label, phase 4 trial to determine the percentage of patients that achieve a target 6 MWT distance threshold utilizing a bosentan-based, stepped approach to therapy.
  
  Investigator(s)
  William J. Gibbons, MD - Principal Investigator Sub- Investigator - Susan P. Graham, MD Sub-Investigator - Eileen Daetsch, NP
  
  Requirements
  PATIENTS WITH PULMONARY HYPERTENSION
  
  Reimbursement
  YES
  
  Location
  BUFFALO GENERAL HOSPITAL
  
  Contact
  MARY BONORA
  
  Phone
  716.859.4641
  
  Sponsor
  Actelion
M & M
- Detail
  A phase III, double-blind, randomized placebo-controlled study, to evaluate the effects of RO4607381 on cardiovascular (CV) risk in stable CHD patients, with a documented recent Acute Coronary Syndrome (M&M)
  
  Purpose
  This trial is a multicenter, international double-blind, randomized, placebo-controlled, parallel group, study in patients recently hospitalized for an acute coronary syndrome. The primary objective of this trial is to evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable CHD patients, with a documented recent ACS.
  
  Investigator(s)
  DR. SUSAN GRAHAM SUB INVESTIGATOR: EILEEN DAETSCH, NP
  
  Reimbursement
  YES
  
  Eligibility
  PATIENTS WITH CORNARY RISK FACTORS WITH HIGH HYPER LIPIDEMIA
  
  Location
  BUFFALO GENERAL HOSPITAL
  
  Contact
  MARY BONORA
  
  Phone
  716.859.4641
  
  Sponsor
  Hoffmann-LaRoche, Inc
NAVIGATOR
- Detail
  : A multinational, randomized, double-blind, placebo-controlled, forced titration, 2x2 factorial design study of the efficacy and safety of long term administration of nateglinide and valsartan in the prevention of diabetes and cardiovascular outcomes in subjects with impaired glucose tolerance (IGT) (NAVIGATOR)
  
  Purpose
  The purpose of this study is to evaluate the effect of long-term administration of nateglinide and valsartan on the progression to diabetes in subjects with impaired glucose tolerance at increase risk of a cardiovascular event.
  
  Investigator(s)
  DR. SUSAN GRAHAM
  
  Reimbursement
  YES
  
  Eligibility
  PRE DIABETIC PATIENTS WHO HAVE CARDIOVASCULAR DISEASE
  
  Location
  b
  
  Contact
  MARY BONORA
  
  Phone
  716.859.4641
  
  Sponsor
  Novartis Pharmaceutical Corp.
TOPCAT
- Detail
  Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT)
  
  Purpose
  This trial is a multicenter, international, randomized, double blind placebo-controlled trial of spironolactone, an aldosterone antagonist, in 4500 adults with heart failure and left ventricular ejection fraction of at lest 45%, recruited from over 150 clinical centers.
  
  Investigator(s)
  DR. SUSAN GRAHAM Sub- investigator - Eileen Daetsch, NP
  
  Reimbursement
  Yes
  
  Eligibility
  PRESERVED LEFT VENTRICULARE EJECTION FUNCTION
  
  Location
  BUFFALO GENERAL HOSPITAL
  
  Contact
  MARY BONORA
  
  Phone
  716.859.4641
  
  Sponsor
  NIH
Study of Insulin for Anti-Inflammatory Action
- Detail
  Detail In our previous studies we have found that insulin reduces the inflammation in the blood in overweight individuals. We know that insulin is used as a treatment to reduce blood sugars in diabetics. We also know that insulin infusion is safe and reduces inflammatory mediators in obese. But it has not yet known whether insulin reduces inflammation in the blood vessels in normal subjects, thin diabetics or overweight diabetics. Therefore we want to investigate whether insulin can cause reduction of inflammatory markers in the blood vessels in these individuals
  
  Purpose
  Anti-inflammatory effect of insulin
  
  Investigator(s)
  Paresh Dandona, MD
  
  Reimbursement
  $300 4-6 weeks after completion of study
  
  Eligibility
  Type 1 Diabetic or Type 2 Diabetic and obese
  
  Location
  Millard Fillmore Hospital Gates Circle Buffalo NY 14209
  
  Contact
  Teekam Lohano
  
  Phone
  716-887-5104
SmartPill Colonic Transit Time Validation Study in Patients With Chronic Constipation
- Detail
  The University at Buffalo Gastroenterology Division is conducting a research study to compare two methods of measuring motility of the gastrointestinal tract in patients with constipation
  
  Purpose
  Participate in a two week, approximately 3 visit study. Subjects will undergo a GI transit test lasting up to 5 days and be required to ingest a meal, 4 capsules over a period of 3 days, and undergo 2 x-rays.
  
  Investigator(s)
  Dr. Michael Sitrin, Dr. A. Gupta
  
  Requirements
  Subjects with constipation (age 18-80 years)
  
  Location
  Gastroenterology offices at ECMC and Dent Tower
  
  Contact
  Valerie
  
  Phone
  834-9200 x5835
NEW CLINICAL TRIAL
A Randomized, Double-Blind, Parallel-Group Study to Assess the Safety and Efficacy of Asacol (1.2 to 4.8 g/day) Administered as 400 mg Delayed-Release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis.
- Detail
  Ulcerative Colitis (UC) is a type of inflammatory bowel disease characterized by diffuse, continuous inflammation of the colon. This study is being conducted in children between 5 to 17 years of age with mildly-to-moderately active UC to assess the safety and efficacy (how well it works) of high dose and low dose of Asacol given as 400 mg delayed-release tablets every 12 hours for 6 weeks. The study medication has already been approved for use in adults. All participants in this research study will receive active study medication; however, various strengths of the medication will be used.
  
  Purpose
  To provide information about the process by which the Investigational drug is absorbed, distributed, broken down, and eliminated by the body. Another purpose of the study is to look at the safety and tolerability of Asacol (mesalamine) in the pediatric and adolescent population.
  
  Investigator(s)
  Robert D. Baker, MD, PhD, Principal Investigator Susan S. Baker, MD, PhD, Sub-Investigator Daniel Gelfond, MD, Sub-Investigator Humaira Hashmi, MD, Sub-Investigator Anita M. Crawley, RN, PNP, Sub-Investigator Casey Gajewski, RN, PNP, Sub-Investigator
  
  Requirements
  Participants will be randomly assigned to one of two treatment groups based on their weight and disease severity at the time of study entry. The study will last for 6 weeks and will require you to visit the clinic at least 3-4 times. The first visit is called a Screening Visit and will occur up to 7 days before starting study medication. If eligible, you will then be seen by the study doctor and/or study staff on Day 1 (day of first dose of study medication), Week 3 and Week 6, with a telephone call at Week 1 after starting the study.
  
  Reimbursement
  Subjects will receive $50 at each clinic visit to help cover the cost of traveling to the study doctor, for expenses that you may have during your visits to the study site, and for your time. There is no cost to participants for study medication, doctor visits, examinations or laboratory tests that are part of the study.
  
  Eligibility
  Patients with mildly-to moderately active Ulcerative Colitis between the age of 5 through 17 are being asked to participate. Tablets must be swallowed whole and not chewed or crushed. Study Coordinator can work with younger children to help teach them to swallow pills with Ora-flo swallowing cup.
  
  Location
  Within the clinic offices of the Digestive Diseases and Nutrition Center of Women & Children’s Hospital of Buffalo located at: 140 Hodge Street, Buffalo, NY 14222, Sterling Medical Park at 200 Sterling Road, Orchard Park, NY 14127, or UB Commons at 1400-1430 Sweet Home Road, Amherst, NY 14228.
  
  Contact
  Robert D. Baker, MD, PhD Study Coordinator, Christine M. Roach, RN, BSN
  
  Phone
  (716) 878-7199
  
  Sponsor
  Procter and Gamble Pharmaceuticals.
NEW CLINICAL TRIAL
ASPIRE (Aripiprazole Intramuscular Depot Program in Schizophrenia) long-acting injectable formulation of Abilify (FDA, IRB approved Otsuka Study 31-07-247)
- Purpose
  ASPIRE, a worldwide research study, is now underway to evaluate an investigational long-acting medication for schizophrenia.
  
  Investigator(s)
  Jeffery Jerome Grace, MD PC
  
  Reimbursement
  Yes
  
  Eligibility
  You may be able to participate if you are 18 to 60 years of age and have been diagnosed with schizophrenia for at least three years.
  
  Location
  1300 Niagara Street, Buffalo NY 14213
  
  Contact
  Dr. Eileen Trigoboff
  
  Phone
  716-882-1221
  
  Sponsor
  Otsuka Pharmaceutical Development & Commercialization, Inc.
Self Administered Treatment for irritable bowel syndrome
- Purpose
  The goals of this study are to assess the short- and long-term efficacy of brief self administered treatment with reference to a clinic based, therapist administered behavioral treatment program and a education program. Secondary aims seek to specify the conditions under which CBT may (or may not) achieve its effects, why and how these effects are achieved and at what economic cost
  
  Investigator(s)
  Jeffrey Lackner, Psy.D.
  
  Requirements
  One-year study. Individuals attend 4-10 treatments sessions over a 3month period. Outcome evaluations are conducted after 3, 6, 9, and 12 month period
  
  Reimbursement
  up to $200
  
  Eligibility
  Adult males or females with irritable bowel syndrome
  
  Location
  University at Buffalo
  
  Contact
  Rebecca Firth
  
  Phone
  (716) 898-6254
  
  Sponsor
  Behavioral Medicine Clinic
PARAPET or Prediction of ARRhythmic Events with Positron Emission Tomography
- Detail
  Participants can plan on spending a half day at the VA. They will have an echocardiogram, IV line placement, blood sampling, cardiac PET scans (utilizing NH3, HED and FDG isotopes and a GIK infusion) and wear a 24 hour EKG monitor
  
  Investigator(s)
  James A. Fallavollita, MD John M. Canty, MD
  
  Reimbursement
  $50.00
  
  Eligibility
  Men and women
  
  Location
  Veterans Administration Healthcare System of Western New York (Buffalo VA Hospital)
  
  Contact
  Suzanne M. Michalek, RN, MS
  
  Phone
  (716)829-2500
  
  Sponsor
  National Heart, Lung and Blood Institute
Adaptive Interventions for Children with ADHD
- Purpose
  The goal of the study is to determine whether children with ADHD should be treated with medication, behavior therapy, or both, and in what order these treatments should be given.
  
  Investigator(s)
  William E. Pelham, Jr., Ph.D. Co-Investigator(s) Lisa Burrows-MacLean, Ph.D. Gregory A. Fabiano, Ph.D. Martin T. Hoffman, M.D. Greta M. Massetti, Ph.D. Daniel A. Waschbusch, Ph.D. James G. Waxmonsky, M.D. Randolph L. Carter, Ph.D.
  
  Eligibility
  Children between the ages of 5-12 who show signs of inattention, overactivity, impulsivity or have difficulty following rules and are enrolled in regular education classes
  
  Phone
  (716) 829-2244 ext 5.
  
  Sponsor
  Center for Children and Families
The Dissemination Of State-Of-The-Art, Award-Winning Summer Treatment Programs For Childhood ADHD
- Purpose
  This project to establish and ensure the sustainability of 5 Summer Treatment Programs for children with Attention Deficit Hyperactivity Disorder (ADHD). These programs would be established in cooperation with area schools and mental health agencies in Western New York .
  
  Investigator(s)
  William E. Pelham, Jr., Ph.D.
  
  Eligibility
  To be considered for site selection, agencies must demonstrate, among other requirements: (1) that they serve a low income population; (2) that they have sufficient financial, staffing, and facility resources necessary to support an STP; and (3) that they have developed a plan for sustaining the program following the grant (e.g., financial, staffing). Contact Lisa Burrows-MacLean, Ph.D. for more information.
  
  Phone
  (716) 829-2244 ext 5.
  
  Sponsor
  The John R. Oishei Foundation
Effects of rewards on attention, memory, and inhibiting in children with and without ADHD
- Detail
  NIMH Parent Grant Title: Inhibitory Control and Clinical Response in ADHD
  
  Purpose
  Investigating separate and combined effects of motivational incentives and medication relative to normal control performance. Specific goals include relating results of the cognitive tasks to measures of behavior and classroom performance taken in a naturalistic setting to bridge the gap between laboratory studies and behavioral studies.
  
  Investigator(s)
  Larry Hawk, Ph.D. William E. Pelham, Jr., Ph.D. Jerry Richards, Ph.D. James G. Waxmonsky, M.D Craig Colder, Ph.D.
  
  Eligibility
  Children between the ages of 9 and 12 with ADHD, as well as typically-developing comparison children in the same age range. Check with study staff for more information.
  
  Location
  106 Diefendorf Hall
  
  Contact
  Dominica Vito, R.N., Project Coordinator
  
  Phone
  (716) 829-2244 ext 116.
  
  Sponsor
  National Institute of Mental Health Center for Children and Families
A Phase 3 Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients with Schizophrenia
- Purpose
  The purpose of this research study is to compare the safety and effectiveness of the new experimental drug, lurasidone HCl, with placebo (a pill that contains no active drug and is often referred to as ‘sugar pill’) when given to subjects with chronic schizophrenia who experience a worsening of their illness.
  
  Investigator(s)
  Steven Dubovsky, MD
  
  Requirements
  The acute phase of the study lasts a total of 9 weeks, which includes the Screening (visit 1), Washout (visit 2) and Baseline (visit 3) visits plus the 6-week, double-blind treatment period (visits 4, 5, 6, 7, 8, 9 and 10). Subjects who successfully complete the full treatment period (acute phase) of the study have the option to continue in a 22 1/2 month, open-label phase.
  
  Reimbursement
  Participants are paid $25 per completed out-patient visit for expenses incurred while participating (for example, parking, travel time and meals).
  
  Eligibility
  Participants must be 18 years or older and have been diagnosed with schizophrenia.
  
  Location
  Erie County Medical Center
  
  Contact
  Sevie Kandefer, MS
  
  Phone
  716-898-4038
  
  Sponsor
  Dainippon Sumitomo Pharma America, Inc.
Treating Pre-School Children at Risk for Overweight in the Primary care Setting
- Purpose
  It is a program involving overweight children and one overweight parent. The program is designed to promote healthy lifestyle changes which will foster increased activity, healthier food choices, decreased energy intake and behavioral changes.
  
  Investigator(s)
  Dr Teresa Quattrin, Dr James Roemmich, Dr Leonard Epstein, Dr Jihnhee Yu
  
  Requirements
  2 year study. Parents and Children attend weekly, biweekly and monthly sessions over a 6 month period. Sessions will then occur every 8-10 weeks and then quarterly into year 2 of the study. The sessions will occur at there Pediatricians office.
  
  Reimbursement
  Parents will be reimbursed for following the set protocol.
  
  Eligibility
  Children age 2-5 years with a Body Mass Index (BMI) over the 85%tile and one parent with a BMI > 27kg/m2.
  
  Location
  Amherst Pediatrics, Suburban Pediatrics, Hodge Pediatrics, Jesse Nash Clinic, Town Garden Pediatrics
  
  Contact
  Michelle Ecker
  
  Phone
  716-878-7609
  
  Sponsor
  NIH
Metabolic Cerebral Imaging in Incipient Dementia Trial (MCI-ID)
- Detail
  This Centers for Medicare and Medicaid Services (CMS) approved trial, called Metabolic Cerebral Imaging in Incipient Dementia Trial (MCI-ID) has been established as a multi-center prospective, randomized trial for which UCLA serves as the central coordinating site. The University at Buffalo site has already been officially registered with CMS as an approved site for carrying these studies.
  
  Purpose
  The aims of the Metabolic Cerebral Imaging in Incipient Dementia Trial (MCI-ID) trial are to measure how knowledge of the cerebral metabolic information will 1. influence diagnosis and management of patients being evaluated for symptoms of cognitive decline. 2. impact upon there long term clinical outcomes.
  
  Investigator(s)
  Hani A. Nabi, M.D. ,Ph.D. University at Buffalo Daniel Silverman, M.D., UCLA
  
  Reimbursement
  None
  
  Eligibility
  Patients suffering from documentible decline of cognitive function in the absence of overt dementia.
  
  Location
  Advanced Molecular Imaging Services 3980 Sheridan Dr Amherst, NY 14226
  
  Contact
  Deborah A Erb
  
  Phone
  716-838-5889
  
  Sponsor
  Centers for Medicare and Medicaid Services (CMS)
TUMOR HYPOXIA IMAGING WITH CU-62 ATSM: A PILOT STUDY
- Detail
  You are being asked to participate in a clinical research study because you have been diagnosed with cancer. We are evaluating a new type of imaging using a Pet tracer that measures the low amounts of oxygen in your tumor, a condition known as hypoxia, which makes the tumor more resistant to treatment as well as a higher rate of treatment failures. The chemical compound, referred to as ATSM, which is selectively retained within hypoxic cells, is attached to a radioactive form of copper, a naturally occurring mineral within our body. This new way of imaging cancers with a combination of PET/CT that identifies hypoxia, might in the future improve medical care by increasing our understanding of how to treat oxygen-poor cancers. T
  
  Purpose
  The purpose of this study is to understand the distribution of Cu-62 ATSM in patients with newly diagnosed or recurrent lung and head and neck cancers undergoing treatment and recurrent cancers of the gastrointestinal and genitourinary tracts, or relapsing/recurrent lymphomas. It will also evaluate the role of Cu-62 ATSM as biomarker predictive of the behaviour of recurrent cancers of lung, head and neck, gastrointestinal/genitourinary tracks and lymphoma.
  
  Investigator(s)
  Hani A Nabi, MD, PhD Department of Nuclear Medicine
  
  Reimbursement
  None
  
  Eligibility
  New or recurrent lung and head and neck cancers, recurrent tumor of the gastrointestinal/genitourinary tract and lymphomas.
  
  Location
  Advanced Molecular Imaging Services 3980 Sheridan Dr Amherst, NY 14226
  
  Contact
  Deborah A Erb
  
  Phone
  716 838-5889
  
  Sponsor
  Department of Nuclear Medicine
S.N.A.C. Study
- Purpose
  The purpose of this study is to examine the interaction between eating and social activities in children.During the session participants will perform a computer task to earn food or activity points. After the computer task participants will be allowed to spend their food and activity points.
  
  Investigator(s)
  Dr. Salvy
  
  Requirements
  Children attend a single 90 minute session at UB.
  
  Reimbursement
  Participants will be compensated for their time.
  
  Eligibility
  Children between the ages of 9 and 11 years
  
  Location
  Farber Hall
  
  Phone
  829-3400 ext. 13
  
  Sponsor
  Division of Behavioral Medicine
Childhood Weight Control Program
- Purpose
  The program focuses on modifying eating and activity behaviors to lose weight and become healthier.Parents and children learn fun ways to eat healthier and be more active, and parents learn ways to positively motivate their child to change their health behaviors.
  
  Investigator(s)
  Dr. Epstein
  
  Requirements
  One-year study. Parents and children attend weekly, bi-weekly and monthly sessions over a six month period. Outcome evaluations are conducted after six and twelve months.
  
  Eligibility
  Overweight 8-12 year old children and their parents.
  
  Location
  Farber Hall
  
  Phone
  829-3400 ext. 21
  
  Sponsor
  Division of Behavioral Medicine
Dopamine and Eating Study
- Purpose
  The purpose of this study is to determine whether motivation to eat is related to the genetics of the dopamine system. Adults 18-50 years of age are eligible to participate in this study. During the study, participants will be asked to complete a taste test and play a computer game to earn portions of their favorite food.
  
  Investigator(s)
  Dr. Epstein
  
  Requirements
  Three visits to UB; visits 1 and 2 take 60-90 minutes, visit 3 takes 30 minutes. Participants are also asked to provide a saliva sample.
  
  Reimbursement
  Participants will be reimbursed for their time.
  
  Eligibility
  Adults 18-50 years of age are eligible to participate in this study.
  
  Location
  Farber Hall
  
  Phone
  829-3400 ext. 28
  
  Sponsor
  Division of Behavioral Medicine
Grocery Store Study
- Purpose
  The purpose of this study is to look at factors that influence mother's food purchases. During the first and second session, mothers will complete two short tasks. In one task mothers will make choices between different monetary rewards and in the other task, mothers will play a computer game to earn points for portions of food. During the third session, mothers will be given a certain amount of money to purchase food for their family in a hypothetical grocery store.
  
  Investigator(s)
  Dr. Epstein
  
  Requirements
  The study requires three 60-90 minute visits at UB.
  
  Reimbursement
  Mothers will be reimbursed for their time
  
  Eligibility
  Mothers of 6 to 18 year old children
  
  Location
  Farber Hall
  
  Phone
  829-3400 ext. 28
  
  Sponsor
  Division of Behavioral Medicine
TV and Activity Study
- Purpose
  The purpose of this study is to determine if limiting television and computer time changes children's physical activity.Throughout the study we will measure children's physical activity with an accelerometer - a small pager-sized device that clips onto your child's waistband - and their food intake. Eligible families will have TV allowance devices, electronic boxes used to measure TV and computer use, installed on each TV and computer. The TV allowance device can be use to limit TV and computer use by programming it to allow a specific number of hours per week.
  
  Investigator(s)
  Dr. Epstein
  
  Requirements
  Nine-week study. Families will come to the University at Buffalo three times, once for an orientation of the study and twice for screening appointments. Study personnel will come to families' homes 5 times over the 9 week period to install the devices, to check data, and to remove devices.
  
  Reimbursement
  Children and families will be reimbursed for their participation in the study.
  
  Eligibility
  -
  
  Location
  Farber Hall
  
  Phone
  829-3400 ext. 17
  
  Sponsor
  Division of Behavioral Medicine
Neighborhood and Park Study
- Purpose
  The study is looking at how neighborhood and park design are related to the physical activity of children. Children who participate in this study will wear a pager-sized physical activity monitor that is worn around the waist to measure their daily physical activity and a global positioning system (GPS) unit that is worn around the wrist to track where they have been physically active. Due to the nature of the study, appointments are scheduled only during the spring, summer, and early fall seasons.
  
  Investigator(s)
  Dr. Roemmich
  
  Requirements
  One-week study. Children will visit Delaware Park twice within the week and will also be asked to record all of their activities in a behavior log.
  
  Reimbursement
  -
  
  Eligibility
  Eligible children must be between the ages of 8 and 15 years and live within one mile of Delaware Park.
  
  Location
  Farber Hall
  
  Phone
  829-3400 ext. 23
  
  Sponsor
  Division of Behavioral Medicine
Self-Control Study
- Purpose
  The purpose of this study is to determine how reading, exercising, or giving a speech influences children's self-control to eat cookies. Children will read magazines or color, ride a bicycle, or give a speech. They will then be given a choice of cookies to eat. Heart rate, blood pressure and stress levels will be measured throughout the study.
  
  Investigator(s)
  Dr. Roemmich
  
  Requirements
  Children will come to the University at Buffalo for 1 visit that will last approximately 1.5 hours.
  
  Reimbursement
  Both adolescents and parents will be reimbursed for participating in the study.
  
  Eligibility
  Eligible children must be between the ages of 7 and 9 years, cannot have any conditions that would prevent them from exercising, have no food allergies, and cannot be taking any medications.
  
  Location
  Farber Hall
  
  Phone
  829-3400 ext. 30
  
  Sponsor
  Division of Behavioral Medicine
Food Purchases Study
- Purpose
  The purpose of this study is to assess the effects of peer influences on snack purchases in adolescents. During the session teens will be given a certain amount of money to use to purchase foods and beverages in a hypothetical convenience store setting.
  
  Investigator(s)
  Dr. Salvy
  
  Requirements
  Children attend a single one-hour session at UB.
  
  Reimbursement
  Participants will be compensated for their time.
  
  Eligibility
  Children between the ages of 12 and 14 years
  
  Location
  Farber Hall
  
  Phone
  829-3400 ext. 13
  
  Sponsor
  Division of Behavioral Medicine
Videos, Games, and Eating Study
- Purpose
  The purpose of this study is to examine the influence of friends and peers on food intake and activity in a modeling paradigm. During the session one participant will watch a 15 minute video. Afterwards both participants will be allotted 45 minutes of free time to play board games and sample food items.
  
  Investigator(s)
  Dr. Salvy
  
  Requirements
  Children attend a single 90 minute session at UB.
  
  Reimbursement
  Participants will be compensated for their time.
  
  Eligibility
  Children between the ages of 12 and 14 years
  
  Location
  Farber Hall
  
  Phone
  829-3400 ext. 13
  
  Sponsor
  Division of Behavioral Medicine
Neighborhood Environment Study
- Purpose
  The purpose of this study is to examine how the neighborhood environment influences the physical activity of adolescents aged 12-15 years when television and computer time is reduced (limited). Eligible youth and their parents will have their physical activity measured at the beginning, middle, and end of the study by wearing a pager-sized physical activity monitor that is worn around the waist for one week. Adolescents will also wear a global positioning system (GPS) unit that is worn around the wrist to track where they have been physically active. Adolescents and parents will be asked to record all of their activities in a behavior log when they are wearing the equipment. Families will have a TV Allowance on each TV and computer monitor. These devices will measure TV and computer use and may also be used to reduce the amount of time the adolescent can watch TV or use the computer.
  
  Investigator(s)
  Dr. Roemmich
  
  Requirements
  Fourteen-week study. Families will come to the University at Buffalo 5 times to complete study measurements and study personnel will visit families' homes 6 times to install the devices, to check data, and to remove devices.
  
  Reimbursement
  Both adolescents and parents will be reimbursed for participating in the study.
  
  Eligibility
  Adolescents aged 12-15 years and their families.
  
  Location
  Farber Hall
  
  Phone
  829-3400 ext. 30
  
  Sponsor
  Division of Behavioral Medicine
Exercise treatment for Post Concussion Syndrome
- Detail
  The University at Buffalo/University Sports Medicine Concussion Clinic has a research program to compare exercise modalities for Post Concussion Syndrome in athletes and non-athletes.
  
  Purpose
  To test the effectiveness of various modalities of exercise for the treatment of post concussion syndrome and to evaluate the physiological responses to the treatment.
  
  Investigator(s)
  John Leddy MD, Barry Willer PhD, David Pendergast EdD, Karl Kozlowski PhD, Len Epstein PhD
  
  Requirements
  Ability to travel to the University at Buffalo (Main Street Campus) for up to three months or more for regular treatment
  
  Reimbursement
  Participants will receive a full evaluation, and those that qualify will receive treatment. Participants may be compensated for travel expenses.
  
  Eligibility
  - Adults (at least 18 years of age) - Concussion symptoms for more than six weeks
  
  Location
  160 Farber Hall and CRESE, South Campus
  
  Contact
  John Leddy MD
  
  Phone
  (716) 829-2070
  
  Sponsor
  University at Buffalo/University Sports Medicine Concussion Clinic
A Phase 3, Multi-Center, Souble-Blind Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Anti-TNF Monoclonal Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease (Abbott M06-806)
- Detail
  Crohn's Disease (CD) is a type of inflammatory bowel disease characterized by diffuse, continuous inflammation of the small and large intestines. This study is being conducted in children between 6 to 17 years of age with moderate to severe CD to assess the safety and effectiveness (how well it works) of adalimumab. The study medication has already been approved for use in adults but is investigational in use with children. All participants in this research study will receive active study medication; however, various strengths of the medication will be used.
  
  Purpose
  To provide information about the process by which the Investigational drug is absorbed, distributed, broken down, and eliminated by the body. Another purpose of the study is to look at the safety and tolerability of adalimumab (Humira) in the pediatric and adolescent population
  
  Investigator(s)
  Susan S. Baker, MD, PhD, Principal Investigator Robert D. Baker, MD, PhD, Sub-Investigator Daniel Gelfond, MD, Sub-Invesetigator Raza Ali Patel, MD, Sub-Investigator Humaira Hashmi, MD, Sub-Investigator Anita M. Crawley, RN, PNP, Sub-Investigator Casey M. Gajewski, RN, PNP, Sub-Investigator
  
  Requirements
  Subjects who qualify for this study will participate in two dosing periods, a 4-week open-label induction period (active study drug with known drug dosage) and a 48-week double-blind period (active study drug will be given but neither participant nor physician will know the exact dosage of the study medication). Subjects will be required to be seen frequently in the GI clinic at Women & Children's Hospital of Buffalo.
  
  Reimbursement
  Subjects will receive $25 at each clinic visit to help cover the cost of traveling to the study doctor, for expenses that you may have during your visits to the study site, and for your time. There is no cost to participants for study medication, doctor visits, examinations, electrocardiograms, x-ray testing, or laboratory tests that are part of the study.
  
  Eligibility
  Patients with moderate to severe Crohn's Disease between the ages of 6 through 17 are being asked to participate.
  
  Location
  Within the clinic offices of the Digestive Diseases and Nutrition Center of Women & Children's Hospital of Buffalo located at: 140 Hodge Street, Buffalo, NY 14222
  
  Contact
  Susan S. Baker, MD, PhD or Study Coordinator, Christine M. Roach, RN, BSN
  
  Phone
  716-878-7199
  
  Sponsor
  Abbott Laboratories
Preliminary Clinical Application of 11C-Choline Positron Emission Tomography in Prostate Cancer Patients
- Detail
  You are being asked to participate in a clinical research study because you have been diagnosed with prostate cancer. We are evaluating a new type of imaging using radiolabeled choline, an essential amino acid that is taken up by cancer tissues, such as prostate, esophageal, breast and brain tumors. Choline is an essential nutrient. This new way of imaging cancers with a combination of PET/CT might in the future improve medical care by increasing our understanding of how to diagnose and treat cancers. The purpose of this study is to understand the distribution of C-11 choline in patients with newly diagnosed prostate cancer undergoing surgery.. It will also evaluate the role of C-11 choline PET/CT scan in patients with recurrent cancers as well as looking at its ability to assess reponse to therapy
  
  Purpose
  Prostate cancer is the most common cancer among men in North America. It has been estimated that in 2000, approximately 185,000 men will be diagnosed with the disease and over 31,900 men will die from it in the United States alone (1). Surgery and radiation therapy represent the mainstays of prostate cancer treatment. Accurate preoperative prostate cancer staging is desired by urologists in counseling patients as to the probability of cure by different treatments and in assessing therapeutic option (2). Because of the limitations of clinical staging (mostly understating of early extra capsular invasion) a variety of imaging techniques have been evaluated for their ability to improve staging accuracy.
  
  Investigator(s)
  H. A. Nabi, M.D., Ph.D., F.A.C.N.P. Department of Nuclear Medicine (716) 838-5889
  
  Requirements
  You are being asked to participate because 1) you have cancer of the prostate gland and you are scheduled to have it surgically removed ,or2) you have had prostate cancer in the past that was treated, but is now suspected of regrowth because of a rising PSA level in your blood, or 3) you have new prostate cancer or the regrowth of prostate cancer and are undergoing treatment.
  
  Reimbursement
  none
  
  Eligibility
  Male patients with prostate cancer
  
  Location
  Advanced Molecular Imaging Services 3980 Sheridan Drive Amherst, N.Y. 14226
  
  Contact
  Deb Erb
  
  Phone
  716 838-5889
  
  Sponsor
  Department of Nuclear Medicine
Comparison of 124Iodine PET with Iodine-131 Whole Body Gamma Scintigraphy and 18FDG PET in Differentiated Thyroid Carcinoma: A Prospective Clinical Trial
- Detail
  Despite expert surgery, a small amount of normal thyroid tissue is commonly left in the thyroid bed following removal of a thyroid cancer. Patients are often treated with 131I after surgery to destroy the remaining thyroid. About six months later, a diagnostic whole body scan (DWBS) is done with 131I to see whether any tumor is left that still can pick up some iodine. If the scan is positive, it confirms that there is still tumor present. Unfortunately, thyroid cancer does not pick up iodine very well and so a negative test does not mean there is no thyroid tumor left. The poor resolution with 131I can mean a diagnostic whole body will not detect the tumor. Another test is becoming more widely used to detect recurrent or persistent disease. It involves injecting TSH and measuring the serum thyroglobulin level: if the level rises more than 2 ug/ml, there is a high likelihood that tumor is present. PET scanning can detect a different isotope of iodine 124I. Recent studies indicate that when a 124I PET scan is combined with a CT scan, the detection and localization of residual thyroid tumors is improved. We wish to study the CT/124I PET method for finding the spread of thyroid cancer, for estimating the size of tumors, and for calculating the dose of 131I required to eliminate the cancer.
  
  Purpose
  The isotope 131I has been used for 50 years to treat thyroid cancer, even though 131I scans do not provide very good picture of where the isotope is located. The purpose of this study is to determine whether using the iodine isotope [124I] and doing a combined CT and PET scan would be better way to detect the spread of thyroid cancer, to study tumor size, and to study iodine metabolism in normal thyroid and thyroid cancer.
  
  Investigator(s)
  Hani A. Nabi, M.D., Ph.D.
  
  Reimbursement
  None
  
  Location
  The study will be conducted at University Nuclear Medicine, Inc., 3980 Sheridan Drive, Amherst, New York 14226 (PET/CT) and 1616 Kensington Avenue, Buffalo, New York 14215 (Iodine-131 whole body scans).
  
  Contact
  Debra Erb
  
  Phone
  716 838-5889
  
  Sponsor
  Department of Nuclear Medicine
SmartPill Colonic Transit Time Validation Study in Patients With Chronic Constipation
- Detail
  The SmartPill GI Monitoring System offers an alternative non-invasive method for characterizing disorders of the stomach. The system consists of an ingestible capsule that houses sensors for pH, temperature, and pressure, a receiver for receiving and storing signals from the capsule, and software for displaying data on a personal computer. The capsule samples at regular intervals and transmits the sensed pH, pressure, and temperature data to a portable receiver worn by the subject. After test completion, the recorded data is downloaded to a personal computer for subsequent evaluation. This trial is for subjects 18 years of age to 80 years of age.
  
  Purpose
  The primary aim of this research study is to assess the equivalence of SP to ROM through characterization of device agreement using SP cutoffs for colonic and whole gut transit (59hrs and 73 hrs respectively) derived from the above mentioned study. The cutoffs are derived from the 95th percentile of the healthy subjects in the study. Demonstration of agreement will also serve to validate these SP cutoffs. Device agreement will be evaluated by comparing the percentage of subjects identified with slow transit versus normal transit with SmartPill to the percentage of subjects identified with slow versus normal transit with ROM in the study population. The colonic transit time results will serve as the primary measure for slow versus normal transit for SmartPill. For ROM test we will employ the Metcalf protocol which provides a measure of whole gut transit to compare the SmartPill results to. Additionally, we will characterize gastric emptying and small bowel transit time of the SmartPill in this population. The SmartPill test will be administered simultaneously with ROM. A modified Metcalf procedure will be employed for characterization of slow transit by ROM.
  
  Investigator(s)
  PI: Dr. Michael Sitrin; Co-I: Dr. Alok Gupta
  
  Requirements
  Males and females between ages of 18-80 years of age with symptoms of chronic functional constipation for at least one year. Self reported bowel movement frequency of < 2 bowel movements/week for at least 3 of the last 6 months. Presenting at least one of the following symptoms as defined by Rome III criteria Feeling of incomplete evacuation with > 25% of bowel movements Digital maneuvers with > 25% of bowel movements Hard stools with > 25% of bowel movements Feeling of blockage with > 25% of bowel movements Straining with > 25% of bowel movements Constipation, not abdominal pain, as the predominant symptom. Ability to stop laxatives, prokinetic agents, and narcotic analgesic agents 3 days prior to SP and ROM ingestion visit and during the study period. Ability to stop proton pump inhibitors for seven days and Histamine2 blockers for three days prior to and the day of SmartPill ingestion. No evidence of metabolic disease (hypothyroidism, uncontrolled diabetes, electrolyte imbalance). A normal colonoscopy or barium enema within 5 years for individuals over 50 years of age.
  
  Reimbursement
  time and travel expenses
  
  Eligibility
  Ages Eligible for Study: 18 Years to 80 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No
  
  Location
  Gastroenterology offices at ECMC and Dent
  
  Contact
  Alok Gupta, MD/Valerie Andersen
  
  Phone
  (716)460-1072/(716)834-9200x5835
  
  Sponsor
  SmartPill Corporation
A Randomized, Double-Blind, Parallel-Group Study to Assess the Safety and Efficay of Asacol (1.2 to 4.8 g/day) 400 mg Delayed-Release Tablets Given twice Daily for 26 Weeks to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis.
- Detail
  Ulcerative Colitis (UC) is a type of inflammatory bowel disease characterized by diffuse, continuous inflammation of the colon. This study is being conducted in children between 5 to 17 years of age in remission of UC to assess the safety and efficacy (how well it works) of high dose and low dose of Asacol given as 400 mg delayed-release tablets twice daily for 26 weeks for maintaining remission in children and adolescents with ulcerative colitis. The study medication has already been approved for use in adults. All participants will receive active study medication; however, various strengths of the medication will be used.
  
  Purpose
  To look at the safety and tolerability of Asacol (mesalamine) in the pediatric and adolescent population and assessment of the disease activity.
  
  Investigator(s)
  Robert D. Baker, MD, PhD, Principal Investigator Susan S. Baker, MD, PhD, Sub-Investigator Daniel Gelfond, MD, Sub-Investigator Humaira Hashmi, MD, Sub-Investigator Raza A. Patel, MD, MPH, Sub-Investigator Sonal Desai, MD, Sub-Investigator Anita M. Crawley, RN, PNP, Sub-Investigator Casey Gajewski, RN, PNP, Sub-Investigator
  
  Requirements
  Participants will be randomly assigned to one of two treatment groups based on their weight at the time of study entry. The study will last for 26 weeks and will require you to visit the clinic at least 3-4 times. The first visit is called the Screening Visit and will occur up to 7 days before starting study medication. If eligible, you will then be seen by the study doctor and/or study staff on Day 1 (day of first dose of study medication), Week 12 and Week 26, with a telephone call at Week 6 after starting the study and Week 18. There will be a follow-up phone call 1 week after completing the study medication.
  
  Reimbursement
  Subjects will receive compensation at each clinic visit to help cover the cost of traveling to the study doctor, for expenses that you may have during your visit to the study site, and for your time. There is no cost to participants for study medication, doctor visits, examinations or laboratory tests that are part of the study.
  
  Eligibility
  Patients with Ulcerative Colitis currently in remission (without dymptoms) between the age of 5 through 17 are being asked to participate. Tablets ust be swallowed whole and not chewed or crushed. Study Coordinator can work with younger children to help teach them to swallow pills with an Oralflo swallowing cup.
  
  Location
  Within the clinic offices of the Digestive Diseases and Nutrition Center of Women & Children's Hospital of Buffalo located at: 140 Hodge Street, Buffalo, NY 14222, Sterling Medical Park at 200 Sterling Road, Orchard Park, NY 14127, or UB Commons at 1400-1430 Sweet Home Road, Amherst, NY 14228
  
  Contact
  Robert D. Baker, MD, PhD Study Coordinator: Christine M. Roach, RN, BSN
  
  Phone
  (716) 878-7199
  
  Sponsor
  Proctor and Gamble Pharmaceuticals
Inflammation In obesity: Modulation by Weight Loss
- Detail
  The purpose of this research is to evaluate the status of inflammation in obese people compared to that of lean people and to see if the inflammatory changes in the obese can be reversed by weight loss. Inflammation has an effect on hardening of the arteries also called atherosclerosis. This research will evaluate whether the changes in inflammation bring about changes in arteries to protect them from atherosclerosis.
  
  Investigator(s)
  Paresh Dandona, MD
  
  Requirements
  Lean Males and Female Obese Male and Females
  
  Reimbursement
  $275 for lean male and female group 6-8 week after completion of study $525 for Obese male and female group 6-8 week after completion of study
  
  Eligibility
  Lean and obese subject without any systemic medical problem
  
  Location
  Millard Fillmore Hospital Gates Circle Buffalo NY 14209
  
  Contact
  Teekam Lohano
  
  Phone
  716-887-5104
  
  Sponsor
  NIH

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Other Clinical Trials in the Area

- Roswell Park Cancer Institute