Split (3)

train · 29.5k rows

FEATURE_phases list	FEATURE_enrollmentCount int64	FEATURE_allocation string	FEATURE_interventionModel string	FEATURE_primaryPurpose class label	FEATURE_masking class label	FEATURE_healthyVolunteers bool	FEATURE_sex class label	FEATURE_oversightHasDmc bool	FEATURE_briefSummary string	FEATURE_detailedDescription string	FEATURE_conditions string	FEATURE_conditionsKeywords string	FEATURE_protocolPdfText string	FEATURE_numArms int64	FEATURE_armDescriptions string	FEATURE_armGroupTypes list	FEATURE_numInterventions int64	FEATURE_interventionTypes list	FEATURE_interventionDescriptions string	FEATURE_interventionNames string	FEATURE_numLocations int64	FEATURE_locationDetails string	LABEL_ct_level_ade_population int64	METADATA_nctId string	METADATA_overallStatus class label	METADATA_completionDate date32	METADATA_startDate date32	METADATA_leadSponsorName string	METADATA_leadSponsorClass class label	METADATA_hasProtocol bool	METADATA_hasSap bool	METADATA_hasIcf bool	METADATA_protocolPdfLinks string	METADATA_wilson_lower_bound float32
[ 3 ]	50	NON_RANDOMIZED	PARALLEL	2DIAGNOSTIC	0NONE	false	1FEMALE	null	The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy.	null	Breast Neoplasms		null	1	arm 1: high dose once daily	[ 0 ]	1	[ 0 ]	intervention 1: high dose once daily	intervention 1: BIBW 2992	14	Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Charleroi \| N/A \| Belgium \| 4.44448 \| 50.41136 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Wilrijk \| N/A \| Belgium \| 4.39513 \| 51.16734 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Düsseldorf \| N/A \| Germany \| 6.77616 \| 51.22172 Erlangen \| N/A \| Germany \| 11.00783 \| 49.59099 Essen \| N/A \| Germany \| 7.01228 \| 51.45657 Kiel \| N/A \| Germany \| 10.13489 \| 54.32133 Mainz \| N/A \| Germany \| 8.2791 \| 49.98419 München \| N/A \| Germany \| 13.31243 \| 51.60698 Wiesbaden \| N/A \| Germany \| 8.24932 \| 50.08258	50	NCT00425854	1COMPLETED	2009-05-01	2006-11-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	5	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to identify the maximum tolerated dosage of sodium phenylbutyrate in children with spinal muscular atrophy type I; and to determine if the drug has an effect on SMN mRNA and protein levels.	Spinal muscular atrophy (SMA) is a genetic, neuromuscular disorder caused by progressive degeneration of motor neurons in the spinal cord, which results from the loss of survival motor neuron (SMN) protein. The disorder is characterized by weakness and wasting of the voluntary muscles and is a leading cause of hereditary infant death. Sodium phenylbutyrate-a drug used to treat urea cycle disorders-may increase the amount of SMN protein in the body and consequently may decrease the severity of SMA. However, this has not yet been proven. In this multicenter trial, physicians will evaluate multiple dosage levels of sodium phenylbutyrate to determine the maximum tolerated dose (MTD), or the highest dose that can be safely given to children with SMA type I. The initial dosage tested will be 500 mg/kg/day. Depending upon tolerability, subsequent groups may receive dosages of 675, 900, or 1200 mg/kg/day. Blood levels of SMN mRNA and protein will also be measured to determine whether sodium phenylbutyrate can increase the amount of these two biomarkers in the blood. Up to 24 children will be enrolled in the study, and will be on sodium phenylbutyrate for 12 weeks. The MTD will be determined based on safety data from Day 0 through the Day 29 visit. Participants will continue to be monitored for safety and SMN mRNA and protein levels through the 12 week study drug administration period. Potential participants will be screened by having their complete medical and treatment histories recorded, as well as undergoing a physical examination, laboratory tests, and an electrocardiogram (EKG). Parents of eligible participants will receive a supply of sodium phenylbutyrate and instructions on how to administer the drug. Participants will return to the clinic on days 8, 22, 29, and at weeks 8 and 12 of the study to update their medical and treatment histories, have a physical exam, and have blood and urine collected for laboratory testing. A follow-up clinic visit will occur approximately 14 days after the last dose of sodium phenylbutyrate is given. During this visit participants will update their complete medical and treatment histories and have a physical examination. Duration of the study is about 14 weeks. Information from this study, which is part of the NINDS Pilot Therapeutics Network (NPTUNE), may be used for future studies to determine if sodium phenylbutyrate is effective for treating SMA, and if the drug has an effect on SMA symptoms.	Spinal Muscular Atrophy Type I	spinal muscular atrophy type I SMA type I spinal muscular atrophy SMA sodium phenylbutyrate motor neuron disease neuromuscular survival motor neuron SMN dose escalation	null	1	arm 1: Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The dosage of the next cohort was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage.	[ 0 ]	1	[ 0 ]	intervention 1: 500 mg/kg/day, depending upon tolerability subsequent dosages may increase to 675, 900, or 1200 mg/kg/day to identify maximum tolerated dose (MTD) and then an additional 6 participants will enroll at the MTD.	intervention 1: sodium phenylbutyrate	5	Stanford \| California \| United States \| -122.16608 \| 37.42411 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 New York \| New York \| United States \| -74.00597 \| 40.71427 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Dallas \| Texas \| United States \| -96.80667 \| 32.78306	5	NCT00439218	6TERMINATED	2009-05-01	2008-01-01	Westat	7OTHER	false	false	false	null	0
[ 5 ]	621	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events	null	Asthma	fluticasone propionate long-term study Salmeterol FLOVENT 250 Asthma ADVAIR 250	null	2	arm 1: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID arm 2: Fluticasone propionate 250 mcg BID	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID intervention 2: Fluticasone propionate 250 mcg BID	intervention 1: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID intervention 2: Fluticasone propionate 250 mcg BID	74	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Rancho Mirage \| California \| United States \| -116.41279 \| 33.73974 Riverside \| California \| United States \| -117.39616 \| 33.95335 San Jose \| California \| United States \| -121.89496 \| 37.33939 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Fort Collins \| Colorado \| United States \| -105.08442 \| 40.58526 Fort Collins \| Colorado \| United States \| -105.08442 \| 40.58526 Stamford \| Connecticut \| United States \| -73.53873 \| 41.05343 Coral Gables \| Florida \| United States \| -80.26838 \| 25.72149 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Pensacola \| Florida \| United States \| -87.21691 \| 30.42131 Tallahassee \| Florida \| United States \| -84.28073 \| 30.43826 Tamarac \| Florida \| United States \| -80.24977 \| 26.21286 Columbus \| Georgia \| United States \| -84.98771 \| 32.46098 Conyers \| Georgia \| United States \| -84.01769 \| 33.66761 Lilburn \| Georgia \| United States \| -84.14297 \| 33.8901 South Bend \| Indiana \| United States \| -86.25001 \| 41.68338 Metairie \| Louisiana \| United States \| -90.15285 \| 29.98409 Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067 Wheaton \| Maryland \| United States \| -77.05526 \| 39.03983 Ypsilanti \| Michigan \| United States \| -83.61299 \| 42.24115 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Bozeman \| Montana \| United States \| -111.03856 \| 45.67965 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Cherry Hill \| New Jersey \| United States \| -75.03073 \| 39.93484 Great Neck \| New York \| United States \| -73.72846 \| 40.80066 New York \| New York \| United States \| -74.00597 \| 40.71427 Utica \| New York \| United States \| -75.23266 \| 43.1009 Asheville \| North Carolina \| United States \| -82.55402 \| 35.60095 High Point \| North Carolina \| United States \| -80.00532 \| 35.95569 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Tigard \| Oregon \| United States \| -122.77149 \| 45.43123 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 East Providence \| Rhode Island \| United States \| -71.37005 \| 41.81371 Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399 Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399 Gaffney \| South Carolina \| United States \| -81.64982 \| 35.07179 Orangeburg \| South Carolina \| United States \| -80.85565 \| 33.49182 Spartanburg \| South Carolina \| United States \| -81.93205 \| 34.94957 Union \| South Carolina \| United States \| -81.62371 \| 34.71541 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Corsicana \| Texas \| United States \| -96.46887 \| 32.09543 El Paso \| Texas \| United States \| -106.48693 \| 31.75872 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Olympia \| Washington \| United States \| -122.90169 \| 47.04491 West Allis \| Wisconsin \| United States \| -88.00703 \| 43.01668 Buenos Aires \| Buenos Aires \| Argentina \| N/A \| N/A Buenos Aires \| Buenos Aires \| Argentina \| N/A \| N/A Ciudad Autonoma de Buenos Aires \| Buenos Aires \| Argentina \| N/A \| N/A La Plata \| Buenos Aires \| Argentina \| -57.95442 \| -34.92126 Nueve de Julio \| Buenos Aires \| Argentina \| -60.88463 \| -35.44394 Vicente López \| Buenos Aires \| Argentina \| -58.4737 \| -34.52947 Salvador \| Estado de Bahia \| Brazil \| -38.49096 \| -12.97563 Belo Horizonte \| Minas Gerais \| Brazil \| -43.93778 \| -19.92083 Recife \| Pernambuco \| Brazil \| -34.88111 \| -8.05389 Porto Alegre \| Rio Grande do Sul \| Brazil \| -51.23019 \| -30.03283 Mississauga \| Ontario \| Canada \| -79.6583 \| 43.5789 Charlottetown \| Prince Edward Island \| Canada \| -63.1256 \| 46.23459 Saskatoon \| Saskatchewan \| Canada \| -106.66892 \| 52.13238 Cavite \| N/A \| Philippines \| 120.76978 \| 15.67785 Lipa City \| N/A \| Philippines \| 121.1631 \| 13.9411 Quezon City \| N/A \| Philippines \| 121.0509 \| 14.6488	621	NCT00452699	1COMPLETED	2009-05-01	2007-05-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 5 ]	72	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	true	In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. However, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients as well as more likely to cause EPS (extrapyramidal symptoms). Of late in our emergency room, we started using high dose Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising results.	In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. However, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients as well as more likely to cause EPS (extrapyramidal symptoms). Of late in our emergency room, we started using high dose Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising results. This study is designed to compare the efficacy and safety of Quetiapine with the routine "cocktail for treatment of agitation. The primary purpose of this study is to determine the efficacy and safety of Quetiapine by using high dose Quetiapine (300 mg) PO to treat agitated patients in the psychiatric emergency room. The secondary purpose is to test the immediate effect on agitation caused by illicit drug abuse or the alcohol abuse.	Agitation		null	4	arm 1: Quetiapine is being used in an ER setting on agitated patients, being administered orally. arm 2: "Haloperidol" is being used in an ER setting on agitated patients, administered IM. This is being used in combination with lorazepam and cogentin. We are comparing the use of this "cocktail" to quetiapine alone. arm 3: "Lorazepam" is being used in an ER setting on agitated patients, administered IM.This is being used in combination with haloperidol, and cogentin. We are comparing the use of this "cocktail" to quetiapine alone. arm 4: "Cogentin" is being used in an ER setting on agitated patients, administered IM. This is being used in combination with haloperidol, and lorazepam. We are comparing the use of this "cocktail" to quetiapine alone.	[ 1, 1, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary up to a maximum dose of Quetiapine 600mg PO QD intervention 2: given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary intervention 3: given in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary. intervention 4: given in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary.	intervention 1: Quetiapine intervention 2: Haloperidol intervention 3: Lorazepam intervention 4: Cogentin	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	72	NCT00457366	1COMPLETED	2009-05-01	2006-05-01	University of Southern California	7OTHER	false	false	false	null	0
[ 0 ]	80	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	0ALL	false	The purpose of this study is to determine if milk and molasses enema or PEG 3350 works better for treatment of fecal impaction in children who are constipated.	Constipation is a common condition in childhood and occurs without evidence of a pathological condition in most children. Symptoms range from decreased appetite to abdominal pain and constipation is frequently diagnosed in children evaluated in emergency departments. A general guideline for constipation treatment is fecal impaction removal before initiation of maintenance therapy. Disimpaction may be achieved using various oral therapies (e.g. including Polyethylene Glycol 3350 or PEG); however, rectal therapies, most commonly enemas, are frequently used, especially in the emergency/urgent care setting. The optimal treatment has not been established. There are no published randomized studies that compare effectiveness of oral versus rectal treatments. Comparison: One milk and molasses enema given to the patient in the emergency department compared to three oral doses of PEG 3350 for relief of symptoms due to fecal impaction and constipation.	Constipation	constipation treatment fecal impaction pediatric	null	2	arm 1: Rectal enema containing mixture of milk and molasses arm 2: Medication to be taken orally once each day for three consecutive days	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance intervention 2: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance	intervention 1: PEG 3350 intervention 2: milk and molasses enema	1	Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973	79	NCT00467350	6TERMINATED	2009-05-01	2006-12-01	Children's Mercy Hospital Kansas City	7OTHER	false	false	false	null	0
[ 0 ]	20	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Primary Objective: 1\. To determine whether the primary endpoint: the composite success rate, defined as the proportion of patients who are alive at day 100; and are without grade 3-4 Graft versus Host Disease (GVHD); and are without grade 4 toxicity (unrelated to infection); and have engrafted, is likely to be at least 40%. Secondary Objectives: 1. To determine the cumulative incidence of chronic graft versus host disease. 2. To determine the overall and disease free survival.	The combination of drugs used for this study will help to weaken your immune system, which may help to allow the donor's blood stem cells to engraft (grow) in your body. Anti-thymocyte globulin (also called ATG or thymoglobulin) is designed to help reduce the risk of transplant rejection and to help prevent graft versus host disease. Rituximab is designed to attach to lymphoma cells, which may cause them to die. If you are found to be eligible to take part in this study, you will be admitted to the hospital 12 days before the blood stem cell transplant (BSCT), in order to start the pre-transplant treatments and testing. You will have blood (about 1 tablespoon) drawn for routine tests every day while you are in the hospital (before and after the transplant). After the transplant, this blood will be used to check the status of the transplant and watch for any side effects. You will receive radiation therapy (total lymphoid irradiation) for a total of 10 days before the planned transplant. Radiation therapy will not be given on the weekends. The last radiation treatment will be on the morning of the day you receive your stem cell transplant. For a total of 5 days after admission to the hospital, you will also receive ATG. ATG will be given through a catheter (plastic tube) that is placed into the large chest vein. The catheter (called a central venous catheter) will stay in place throughout treatment. You will receive certain drugs as premedication to try to prevent an allergic reaction to the ATG. These may include drugs like acetaminophen (Tylenol), diphenhydramine (Benadryl), and/or steroids which may include solumedrol or prednisone. Tylenol is given by mouth, and Benadryl and steroids are given either by vein (over 10-15 minutes) or by mouth. The combination of ATG and radiation will weaken your immune system. A weakened immune system may help to allow your body to "accept" donor cells, and it may decrease the chance of your body rejecting the cells. If your diagnostic biopsy showed that a certain protein was found on your tumor cells, you may also receive rituximab therapy. If you are eligible for rituximab treatment, you will receive the drug once a week for 4 weeks. You will receive rituximab through the central venous catheter or through a vein over 6-8 hours. The first dose will be given on an outpatient basis at 13 days before the stem cell transplant. The next 3 doses may be given in the hospital or on an outpatient basis. You will receive rituximab 6 days before the transplant, and then 1 and 8 days after the transplant. Tylenol and steroids will be given before the rituximab to try to prevent an allergic reaction. You will be given tacrolimus to try to prevent graft versus host disease (when the donor's immune cells react against the recipient's body, attacking the recipient's cells and tissues). You will receive tacrolimus either through the central venous catheter (over 24 hours each time) or by mouth starting 3 days before the stem cell transplant. You will continue receiving tacrolimus as long as your doctor feels it is necessary, which could be anywhere from about 3 months to several years. This will depend on factors such as whether or not you have graft versus host disease, how many donor cells are in your blood, and the status of your disease. Cellcept (MMF) will also be given to try to prevent graft versus host disease, starting 1 day after the transplant and continuing through Days 28-42 after the transplant. The MMF will be given twice a day through the central venous catheter over 2 hours, or by mouth. After the pre-transplant treatments and testing are finished, you will have the blood stem cell transplant. Blood stem cells from a donor will be infused over about 1 hour through your central venous catheter. This can be done while you are in the hospital or on an outpatient basis at M. D. Anderson. Steroids and Benadryl will be given through the catheter before the stem cell transplant to try to prevent an allergic reaction. The catheter will be removed once you no longer need to be given fluids, blood products, and other treatments through the catheter for graft versus host disease. This may take anywhere from 3 months after the transplant to several years. You will have additional blood (about 2 tablespoons) drawn, bone marrow aspirations and biopsies, chest CT scans, and/or chest x-rays performed as needed to check the effects of the transplant. You will have transfusions of blood and platelets as needed, and you will have to sign a separate consent document for these transfusions. Blood (about 1 tablespoon each time) will also be drawn at least 2-3 times a week for at least 100 days after the transplant, or longer if the study doctor feels it is necessary. Treatment will be given in the hospital or an outpatient basis at M. D. Anderson. You may need to stay in the hospital for 3-4 weeks. You will be taken off the study if your disease gets worse. This is an investigational study. The FDA has approved the drugs used in this study. Their use together in this study is investigational. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson Cancer Center.	Lymphoma Leukemia	Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia Hodgkin's Lymphoma Lymphoma Leukemia Mycophenolate Mofetil Tacrolimus Thymoglobulin Total Lymphoid Irradiation	null	1	arm 1: Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m\^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)	[ 0 ]	4	[ 0, 4, 3, 0 ]	intervention 1: 1.5 mg/kg by vein on Days -11 to -7. intervention 2: 80 cGy daily on days -11 to -7 and -4 to 0. intervention 3: PBSC infusion administered on day 0. intervention 4: 375 mg/m\^2 by vein on days -13, -6, 1, \& 8. Only those patients whose tumors express CD20 will receive Rituximab.	intervention 1: Thymoglobulin intervention 2: Total Lymphoid Irradiation intervention 3: Peripheral Blood Stem Cell Infusion intervention 4: Rituximab	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	19	NCT00476229	1COMPLETED	2009-05-01	2006-06-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 4 ]	64	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	true	The purpose of the study is to compare two types of treatment for atrial fibrillation (AF) that are designed to treat the symptoms of atrial fibrillation. The treatments being compared are: * A single catheter ablation procedure with the investigational EAS, a visually-guided, light-energy catheter * Standard drug therapy (antiarrhythmic drugs) To learn more about the CardioFocus ENABLE investigational clinical study, please contact the study site closest to you. Eligibility Criteria Persons with paroxysmal atrial fibrillation may be eligible for this study. Other study eligibility criteria include: * 18 to 80 years of age * Frequent episodes of AF * Failed at least 1 drug treatment for AF (beta-blockers or standard AADs) * Other criteria	null	Atrial Fibrillation	AF PAF paroxysmal atrial fibrillation ablation failed drugs	null	2	arm 1: Single ablation procedure with Endoscopic Ablation System arm 2: Medication	[ 0, 1 ]	2	[ 1, 0 ]	intervention 1: Single ablation procedure with Endoscopic Ablation System intervention 2: Medication as prescribed by physician.	intervention 1: Endoscopic Ablation System intervention 2: Standard Anti-arrhythmic Drug (AAD) Therapy	18	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Santa Monica \| California \| United States \| -118.49138 \| 34.01949 Atlantis \| Florida \| United States \| -80.10088 \| 26.5909 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Davenport \| Iowa \| United States \| -90.57764 \| 41.52364 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Royal Oak \| Michigan \| United States \| -83.14465 \| 42.48948 New York \| New York \| United States \| -74.00597 \| 40.71427 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681	64	NCT00477230	6TERMINATED	2009-05-01	2007-03-01	CardioFocus	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	23	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The objective is to evaluate the cytogenetic response to Dasatinib (BMS-354825) administered for 24 weeks in subjects with Imatinib resistant or intolerant chronic phase chronic myeloid leukemia (CML) once daily (QD) or twice daily. (BID)	null	Myeloid Leukemia, Chronic	Imatinib resistant or intolerant chronic phase CML	null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: tablets, Oral, 100 mg, once daily intervention 2: tablets, Oral, 50 mg, twice daily	intervention 1: Dasatinib intervention 2: dasatinib	9	Nagoya \| Aichi-ken \| Japan \| 136.90641 \| 35.18147 Nishinomiya-Shi \| Hyōgo \| Japan \| N/A \| N/A Kagoshima \| Kagoshima-ken \| Japan \| 130.55 \| 31.56667 Isehara-Shi \| Kanagawa \| Japan \| N/A \| N/A Kyoto \| Kyoto \| Japan \| 135.75385 \| 35.02107 Hamamatsu \| Shizuoka \| Japan \| 137.73333 \| 34.7 Bunkyo-Ku \| Tokyo \| Japan \| N/A \| N/A Chuo-Ku \| Tokyo \| Japan \| N/A \| N/A Shibuya-Ku \| Tokyo \| Japan \| N/A \| N/A	46	NCT00482703	1COMPLETED	2009-05-01	2007-05-01	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	0
[ 3, 4 ]	291	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).	This is a randomized (study medication assigned by chance), double-blind (neither the Physician nor the participant know about the study medication), placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions \[treatments\]) study to evaluate an appropriate intravenous (through a vein in the arm) golimumab induction dose and to demonstrate the safety and efficacy of intravenous induction dosing with golimumab in participants with moderately to severely active UC. At Week 6, participants will be asked to participate in an additional 1-year maintenance study. Participants not entering the 1-year golimumab maintenance study will be evaluated for safety at Week 16. The duration of study will be 6 weeks for participants who enter the 1-year golimumab maintenance study and 16 weeks for participant who do not enter the 1-year golimumab maintenance study.There are 2 parts in this study. Part 1 is Phase 2 "dose-ranging" portion of study. Participants enrolled in Part 1, will receive a single intravenous infusion of either matching placebo for golimumab or 1 milligram (mg) per kilogram(kg), 2 mg per kg or 4 mg per kg of golimumab. Part 2 of the study is called "dose-confirming" and newly enrolled participants will receive same doses studied in Part 1, until the doses for Part 2 are selected and Phase 3 begins. At the time that the final doses are selected, all newly enrolled participants will receive 1 of the selected doses or matching placebo; this is the start of the Phase 3 portion of the study. Participants will primarily be assessed using Mayo Score (it is a score developed for measuring disease activity). Participants' safety and quality of life will also be monitored throughout the study.	Colitis, Ulcerative	Colitis, ulcerative Golimumab CNTO 148	null	4	arm 1: Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0 arm 2: Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0. arm 3: Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0. arm 4: Golimumab 4 mg per kg, intravenous (IV) infusion administered at Week 0.	[ 2, 0, 0, 0 ]	4	[ 10, 0, 0, 0 ]	intervention 1: Matching placebo for golimumab, intravenous infusion administered at Week 0 intervention 2: Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0 intervention 3: Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0 intervention 4: Golimumab 4 mg per kg intravenous (IV) infusion at Week 0	intervention 1: Placebo intervention 2: Golimumab 1 mg per kg intervention 3: Golimumab 2 mg per kg intervention 4: Golimumab 4 mg per kg	108	Orange \| California \| United States \| -117.85311 \| 33.78779 Roseville \| California \| United States \| -121.28801 \| 38.75212 Littleton \| Colorado \| United States \| -105.01665 \| 39.61332 Bristol \| Connecticut \| United States \| -72.94927 \| 41.67176 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Fort Dodge \| Iowa \| United States \| -94.16802 \| 42.49747 Topeka \| Kansas \| United States \| -95.67804 \| 39.04833 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Laurel \| Maryland \| United States \| -76.84831 \| 39.09928 Dearborn \| Michigan \| United States \| -83.17631 \| 42.32226 Troy \| Michigan \| United States \| -83.14993 \| 42.60559 Mexico \| Missouri \| United States \| -91.88295 \| 39.16976 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Lebanon \| New Hampshire \| United States \| -72.25176 \| 43.64229 Great Neck \| New York \| United States \| -73.72846 \| 40.80066 Huntington \| New York \| United States \| -73.42568 \| 40.86815 New York \| New York \| United States \| -74.00597 \| 40.71427 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Kinston \| North Carolina \| United States \| -77.58164 \| 35.26266 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Tulsa \| Oklahoma \| United States \| -95.99277 \| 36.15398 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Germantown \| Tennessee \| United States \| -89.81009 \| 35.08676 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Galveston \| Texas \| United States \| -94.7977 \| 29.30135 Burlington \| Vermont \| United States \| -73.21207 \| 44.47588 Christiansburg \| Virginia \| United States \| -80.40894 \| 37.12985 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Bellevue \| Washington \| United States \| -122.20068 \| 47.61038 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389 Adelaide \| N/A \| Australia \| 138.59863 \| -34.92866 Brisbane \| N/A \| Australia \| 153.02809 \| -27.46794 Malvern \| N/A \| Australia \| 145.02811 \| -37.86259 Innsbruck \| N/A \| Austria \| 11.39454 \| 47.26266 Bonheiden \| N/A \| Belgium \| 4.54714 \| 51.02261 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Rousse \| N/A \| Bulgaria \| 25.9534 \| 43.84872 Varna \| N/A \| Bulgaria \| 27.91667 \| 43.21667 Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Victoria \| British Columbia \| Canada \| -123.35155 \| 48.4359 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Kingston \| Ontario \| Canada \| -76.48098 \| 44.22976 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Saskatoon \| Saskatchewan \| Canada \| -106.66892 \| 52.13238 Clichy \| N/A \| France \| 2.30952 \| 48.90018 Lille \| N/A \| France \| 3.05858 \| 50.63297 Nice \| N/A \| France \| 7.26608 \| 43.70313 Hamburg \| City state of Hamburg \| Germany \| 9.99302 \| 53.55073 Berlin \| State of Berlin \| Germany \| 13.41053 \| 52.52437 Herne \| N/A \| Germany \| 7.22572 \| 51.5388 Magdeburg \| N/A \| Germany \| 11.62916 \| 52.12773 Békéscsaba \| N/A \| Hungary \| 21.1 \| 46.68333 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Gyõr \| N/A \| Hungary \| N/A \| N/A Gyulai Ut 18 \| N/A \| Hungary \| N/A \| N/A Miskolc \| N/A \| Hungary \| 20.77806 \| 48.10306 Pécs \| N/A \| Hungary \| 18.23083 \| 46.0725 Székesfehérvár \| N/A \| Hungary \| 18.41034 \| 47.18995 Szombathely \| N/A \| Hungary \| 16.62155 \| 47.23088 Hyderabad Andh Prad \| N/A \| India \| N/A \| N/A Jaipur \| N/A \| India \| 75.78781 \| 26.91962 Lucknow \| N/A \| India \| 80.92313 \| 26.83928 Ludhiana \| N/A \| India \| 75.85379 \| 30.91204 Pune \| N/A \| India \| 73.85535 \| 18.51957 Afula \| N/A \| Israel \| 35.2892 \| 32.60907 Hedera \| N/A \| Israel \| N/A \| N/A Jerusalem \| N/A \| Israel \| 35.21633 \| 31.76904 Kfar Saba \| N/A \| Israel \| 34.90694 \| 32.175 Tel Aviv \| N/A \| Israel \| 34.78057 \| 32.08088 Daugavpils \| N/A \| Latvia \| 26.53333 \| 55.88333 Riga \| N/A \| Latvia \| 24.10589 \| 56.946 Klaipėda \| N/A \| Lithuania \| 21.13912 \| 55.7068 Šiauliai \| N/A \| Lithuania \| 23.31667 \| 55.93333 Vilnius LT \| N/A \| Lithuania \| N/A \| N/A Amsterdam \| N/A \| Netherlands \| 4.88969 \| 52.37403 Groningen \| N/A \| Netherlands \| 6.56667 \| 53.21917 Leiden \| N/A \| Netherlands \| 4.49306 \| 52.15833 Rotterdam \| N/A \| Netherlands \| 4.47917 \| 51.9225 Auckland \| N/A \| New Zealand \| 174.76349 \| -36.84853 Hastings \| N/A \| New Zealand \| 176.84918 \| -39.6381 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Częstochowa \| N/A \| Poland \| 19.12409 \| 50.79646 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Skierniewice \| N/A \| Poland \| 20.15837 \| 51.95485 Sopot \| N/A \| Poland \| 18.56003 \| 54.4418 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Timișoara \| N/A \| Romania \| 21.22571 \| 45.75372 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Yaroslavl \| N/A \| Russia \| 39.87368 \| 57.62987 Belgrade \| N/A \| Serbia \| 20.46513 \| 44.80401 Bratislava \| N/A \| Slovakia \| 17.10674 \| 48.14816 Nitra \| N/A \| Slovakia \| 18.08453 \| 48.30763 Prešov \| N/A \| Slovakia \| 21.23393 \| 48.99839 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Donetsk \| N/A \| Ukraine \| 37.80224 \| 48.023 Ivano \| N/A \| Ukraine \| N/A \| N/A Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Vynnytsya \| N/A \| Ukraine \| N/A \| N/A	290	NCT00488774	6TERMINATED	2009-05-01	2007-08-01	Janssen Research & Development, LLC	4INDUSTRY	false	false	false	null	0
[ 4 ]	338	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to compare the safety and effectiveness of bevasiranib given either every 8 weeks or every 12 weeks after an initial pre-treatment with 3 injections of Lucentis® (ranibizumab injection) compared to Lucentis® given every 4 weeks to people with wet AMD. Patients will be assigned at random (like tossing a coin) to receive one of three treatments options for 104 weeks.	null	Macular Degeneration	AMD Macular Degeneration bevasiranib COBALT study age related macular degeneration wet AMD wet age related macular degeneration	null	3	arm 1: Lucentis® (0.5mg) every 4 weeks. arm 2: Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6. arm 3: Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6.	[ 1, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks intervention 2: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.	intervention 1: bevasiranib intervention 2: ranibizumab	60	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Fresno \| California \| United States \| -119.77237 \| 36.74773 Mountain View \| California \| United States \| -122.08385 \| 37.38605 Pasadena \| California \| United States \| -118.14452 \| 34.14778 Poway \| California \| United States \| -117.03586 \| 32.96282 Sacramento \| California \| United States \| -121.4944 \| 38.58157 Santa Ana \| California \| United States \| -117.86783 \| 33.74557 Ventura \| California \| United States \| -119.29317 \| 34.27834 Waterbury \| Connecticut \| United States \| -73.0515 \| 41.55815 Altamonte Springs \| Florida \| United States \| -81.36562 \| 28.66111 Boynton Beach \| Florida \| United States \| -80.06643 \| 26.52535 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Tallahassee \| Florida \| United States \| -84.28073 \| 30.43826 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Winter Haven \| Florida \| United States \| -81.73286 \| 28.02224 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Shawnee Mission \| Kansas \| United States \| -94.66583 \| 39.02 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Towson \| Maryland \| United States \| -76.60191 \| 39.4015 Florissant \| Missouri \| United States \| -90.32261 \| 38.78922 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Portsmouth \| New Hampshire \| United States \| -70.75766 \| 43.07704 Lawrenceville \| New Jersey \| United States \| -74.7296 \| 40.29733 Livingston \| New Jersey \| United States \| -74.31487 \| 40.79593 Teaneck \| New Jersey \| United States \| -74.01597 \| 40.8976 Albany \| New York \| United States \| -73.75623 \| 42.65258 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 Southern Pines \| North Carolina \| United States \| -79.39225 \| 35.17405 Beachwood \| Ohio \| United States \| -81.50873 \| 41.4645 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Lakewood \| Ohio \| United States \| -81.79819 \| 41.48199 Toledo \| Ohio \| United States \| -83.55521 \| 41.66394 Ashland \| Oregon \| United States \| -122.70948 \| 42.19458 Bala-Cynwyd \| Pennsylvania \| United States \| -75.23407 \| 40.00761 West Columbia \| South Carolina \| United States \| -81.07398 \| 33.99349 Rapid City \| South Dakota \| United States \| -103.23101 \| 44.08054 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Abilene \| Texas \| United States \| -99.73314 \| 32.44874 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Galveston \| Texas \| United States \| -94.7977 \| 29.30135 Houston \| Texas \| United States \| -95.36327 \| 29.76328 McAllen \| Texas \| United States \| -98.23001 \| 26.20341 Tyler \| Texas \| United States \| -95.30106 \| 32.35126 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931 Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Mississauga \| Ontario \| Canada \| -79.6583 \| 43.5789 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Regina \| Saskatchewan \| Canada \| -104.6178 \| 50.45008	336	NCT00499590	6TERMINATED	2009-05-01	2007-08-01	OPKO Health, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	101	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	false	The purpose of this study is to examine the efficacy and safety of OPC-249 by once daily inhalation at 0 (placebo), 30, 60 or 120 IU for 4 weeks in patients with pain due to osteoporosis.	null	Pain Due to Osteoporosis		null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 2, 1, 1, 1 ]	1	[ 0 ]	intervention 1: 1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)	intervention 1: OPC-249	5	Chubu Region \| N/A \| Japan \| N/A \| N/A Hokkaido Region \| N/A \| Japan \| N/A \| N/A Kanto Region \| N/A \| Japan \| N/A \| N/A Kinki Region \| N/A \| Japan \| N/A \| N/A Kyushu Region \| N/A \| Japan \| N/A \| N/A	101	NCT00504426	1COMPLETED	2009-05-01	2007-07-01	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	0
[ 4 ]	136	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo.	Normally chronic tumor related pain is controlled when subjects receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. Tapentadol, a newly synthesized drug with an Prolonged Release (ER) formulation, also acts as a centrally acting pain reliever but has a dual mode of action. The aim of this trial is to investigate the effectiveness (level of pain control) and safety (side effects) of Tapentadol Prolonged Release (ER) compared to a tablet with no active ingredient drug (placebo) and a corresponding dose of Morphine (an opioid commonly used to treat tumor related pain). This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, randomized-withdrawal, multicenter trial. To maintain the blind all subjects were re-randomized at the start of the maintenance period. To maintain the blind all tapentadol subjects were re-randomized at the start of the maintenance period. Subjects that received morphine in the titration period continued in the maintenance period on morphine. The trial includes a 2 week titration phase starting with either 45 mg Morphine Sulfate Controlled Release (CR) twice daily or 100 mg tapentadol ER taken twice daily (bid). Based on effectiveness and side effects participants can up-titrate in steps of 50 mg Tapentadol ER or 15 mg Morphine Sulfate CR to a maximal dose of 250 mg Tapentadol ER bid or 90 mg Morphine Sulfate CR twice daily respectively. If subjects meet the stabilization criteria at the end of the titration phase they will be re-randomized to either placebo or active treatment and will continue 4 weeks at the last dose level in the maintenance phase. Assessments of pain relief, defined as a responder include the pain intensity numeric rating scale (NRS). The Patient Global Impression of Change scale (PGIC) will also be used as a secondary efficacy endpoint. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of tapentadol.	Pain Neoplasm Cancer	Chronic Tumor Related Pain Analgesic Tapentadol Extended Release Morphine Sulfate Controlled Release Pain assessment Placebo	null	3	arm 1: Oral Tapentadol 100 mg to 250 mg twice daily. Followed by matching placebo in the maintenance (i.e. randomized withdrawal phase). arm 2: Oral Morphine 45 mg to 90 mg twice daily. arm 3: Oral Tapentadol 100 mg to 250 mg twice daily.	[ 2, 1, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: None intervention 2: Participant started the trials with 45 mg morphine controlled release twice daily. Upward titration could then occur at a minimum of 3-day intervals in increments of 15 mg morphine twice daily. The maximum dose of morphine controlled release was 90 mg twice daily. Downward titration (but not below 45 mg twice daily) was permitted. In the maintenance phase participants continued on the dose level established in titration phase. Participants randomized to the morphine arm remained on morphine if they qualified for the maintenance phase of the study. The participants were maintained on the dose established at the end of the titration phase. The adverse events listed were documented in the maintenance phase. intervention 3: Participant randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily. intervention 4: The participants re-randomized to receive tapentadol prolonged release in the maintenance phase were maintained on the dose established in the titration phase. intervention 5: After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses). Participant started the trials with 45 mg morphine controlled release twice daily. Upward titration could then occur at a minimum of 3-day intervals in increments of 15 mg morphine twice daily. The maximum dose of morphine controlled release was 90 mg twice daily. Downward titration (but not below 45 mg twice daily) was permitted.	intervention 1: Tapentadol in the Titration Phase intervention 2: Morphine in the Maintenance Phase intervention 3: Matching Placebo in the Maintenance Phase after Tapentadol in the Titration Phase intervention 4: Tapentadol in the Maintenance Phase intervention 5: Morphine in the Titration Phase	37	St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Elkhart \| Indiana \| United States \| -85.97667 \| 41.68199 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Cedarhurst \| New York \| United States \| -73.7243 \| 40.62288 Glens Falls \| New York \| United States \| -73.64401 \| 43.30952 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Canton \| Ohio \| United States \| -81.37845 \| 40.79895 La Plata \| Buenos Aires \| Argentina \| -57.95442 \| -34.92126 Pergamino \| Buenos Aires \| Argentina \| -60.57462 \| -33.89101 Quilmes \| Buenos Aires \| Argentina \| -58.25454 \| -34.72065 Villa Domínico \| Buenos Aires \| Argentina \| -58.33035 \| -34.69421 Rosario \| Santa Fe Province \| Argentina \| -60.63932 \| -32.94682 Rosario \| Santa Fe Province \| Argentina \| -60.63932 \| -32.94682 San Miguel de Tucumán \| Tucumán Province \| Argentina \| -65.21051 \| -26.81601 Ciudad de Buenos Aires \| N/A \| Argentina \| N/A \| N/A Santa Fe \| N/A \| Argentina \| -60.70868 \| -31.64881 Coquimbo \| N/A \| Chile \| -71.33947 \| -29.95332 Santiago \| N/A \| Chile \| -70.64827 \| -33.45694 Santiago \| N/A \| Chile \| -70.64827 \| -33.45694 Santiago \| N/A \| Chile \| -70.64827 \| -33.45694 Talcahuano \| N/A \| Chile \| -73.11684 \| -36.72494 Temuco \| N/A \| Chile \| -72.59738 \| -38.73628 Valparaíso \| N/A \| Chile \| -71.62963 \| -33.036 Nice \| N/A \| France \| 7.26608 \| 43.70313 Orléans \| N/A \| France \| 1.90389 \| 47.90289 Villejuif \| N/A \| France \| 2.35992 \| 48.7939 Daugavpils \| N/A \| Latvia \| 26.53333 \| 55.88333 Riga \| N/A \| Latvia \| 24.10589 \| 56.946 Cherkasy \| N/A \| Ukraine \| 32.05738 \| 49.44452 Donetsk \| N/A \| Ukraine \| 37.80224 \| 48.023 Donetsk \| N/A \| Ukraine \| 37.80224 \| 48.023 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Lviv \| N/A \| Ukraine \| 24.02324 \| 49.83826 Poltava \| N/A \| Ukraine \| 34.55367 \| 49.58925	140	NCT00505414	6TERMINATED	2009-05-01	2007-06-01	Grünenthal GmbH	4INDUSTRY	false	false	false	null	0
[ 4 ]	84	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The objective of this open-label extension is to assess the long-term effect of the 24-hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non-motor symptoms of Parkinson's disease. The long-term safety and tolerability of the rotigotine transdermal patch will also be evaluated.	null	Parkinson's Disease	Neupro® Rotigotine Parkinson's Disease	null	1	arm 1: Rotigotine Transdermal Patch	[ 0 ]	1	[ 0 ]	intervention 1: Rotigotine transdermal patches: 10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h) Optimal dosing: The maximum rotigotine dose allowed is 16mg/24h	intervention 1: Rotigotine	21	St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Salisbury \| North Carolina \| United States \| -80.47423 \| 35.67097 Concord \| N/A \| Australia \| 151.10381 \| -33.84722 Oulu \| N/A \| Finland \| 25.46816 \| 65.01236 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Dresden \| N/A \| Germany \| 13.73832 \| 51.05089 Kassel \| N/A \| Germany \| 9.5 \| 51.31667 Marburg \| N/A \| Germany \| 8.77069 \| 50.80904 Naumburg \| N/A \| Germany \| 11.80979 \| 51.14987 Ulm \| N/A \| Germany \| 9.99155 \| 48.39841 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Nyíregyháza \| N/A \| Hungary \| 21.71671 \| 47.95539 Chieti \| N/A \| Italy \| 14.16494 \| 42.34827 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Christchurch \| N/A \| New Zealand \| 172.63333 \| -43.53333 Olyszytn \| N/A \| Poland \| N/A \| N/A Cape Town \| N/A \| South Africa \| 18.42322 \| -33.92584 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Lancashire \| N/A \| United Kingdom \| N/A \| N/A Liverpool \| N/A \| United Kingdom \| -2.97794 \| 53.41058	84	NCT00519532	6TERMINATED	2009-05-01	2007-07-01	UCB Pharma	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	20	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study will test a new, extended release form of hydrocortisone called Chronocort in patients with congenital adrenal hyperplasia (CAH). People with CAH do not make enough of the adrenal hormones cortisol and aldosterone, and their adrenal glands make too much of the sex hormone androgen. Medicines called glucocorticoids (hydrocortisone, dexamethasone and prednisone) are currently used to treat CAH, but finding the best dose of these drugs that effectively lowers androgens without causing undesirable side effects, such as weight gain and slow growth rate in children, is often difficult to achieve. Adolescents and adults with CAH due to 21-hydroxylase deficiency may be eligible for this study. Children 16 years of age and older are eligible with confirmation by bone age that they are no longer growing. Participants undergo the following tests and procedures during two inpatient visits one month apart at the NIH Clinical Center: * Medical history and physical examination. * Medications: Following 7 days of Cortef (standard drug treatment for CAH), patients begin taking Chronocort on day 3 of hospitalization and continue the tablets once a day for 1 month. * Blood tests: A catheter (plastic tube) is inserted in a vein and left in place for frequent blood draws in order to avoid repeated needlesticks. Blood is drawn for chemistries, blood count, pregnancy test in women, and for serial tests (up to 26 samples in a 24-hour period) to measure hormone levels. * 24-hour urine test. * Height and weight measurements. Between the two hospitalizations, patients are contacted by NIH weekly to check for possible side effects from Chronocort. Two weeks after the first visit, patients also will have blood drawn by their regular doctor or a local clinic. A few days before the second hospitalization, patients undergo a 20-minute telephone questionnaire about energy level and well being. About 30 days after discharge from the second hospitalization, patients are followed up with a telephone call to see how they are doing.	Congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency is a disease of the adrenal cortex characterized by cortisol deficiency with or without aldosterone deficiency, and androgen excess. The severe or classic form occurs in 1 in 15,000 births worldwide, while the mild non-classic form is a common cause of hyperandrogenism. The discovery of glucocorticoid therapy as a treatment for CAH occurred in the 1950's resulting in patients with classic CAH surviving to live a normal lifespan. However, existing treatment is suboptimal and many unresolved clinical problems exist. Standard hormone replacement often fails to normalize the growth and development of children with CAH, and adults may experience iatrogenic Cushing syndrome, hyperandrogenism, infertility or the development of the metabolic syndrome. Chronocort, a newly-developed formulation of hydrocortisone, results in a slow release of hydrocortisone that is designed to mimic the normal cortisol circadian rhythm. This new medical strategy, physiologic cortisol replacement, offers the prospect of an improved outcome of treatment. Chronocort has been safely given to healthy adult males in pharmacokinetic studies. This first ever study in patients with CAH is a pharmacokinetic/pharmacodynamic study comparing Chronocort to Cortef, the conventional immediate-release form of hydrocortisone.	Congenital Adrenal Hyperplasia 21-Hydroxylase Deficiency Adrenogenital Syndrome	Congenital Adrenal Hyperplasia Hydrocortisone Pharmacokinetic Pharmacodynamic	null	1	arm 1: Cortef 3 times daily(total dose 30 mg)for minimum of 7 days followed by Chronocort 30 mg once daily nigh time dose for 28 +/- 3 days duration	[ 0 ]	2	[ 0, 0 ]	intervention 1: Chronocort 30 mg once daily nigh time dose for 28 +/- 3 days duration intervention 2: Cortef 3 times daily(total dose 30 mg)for minimum of 7 days	intervention 1: Chronocort intervention 2: Cortef	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	28	NCT00519818	1COMPLETED	2009-05-01	2007-08-01	Neurocrine UK Limited	4INDUSTRY	false	false	false	null	0
[ 3 ]	10	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	1SINGLE	true	0ALL	false	With this study, the investigators will like to determine if taking a dose of the study medication, called Polypodium leucotomos (PL), prevents some of the changes in the skin caused by the adverse effects of UVA, a type of ultraviolet light.	null	Aging Skin Abnormalities	Polypodium leucotomos, Ultraviolet Rays, Heliocare, calaguala, anapsos Skin Aging and Damage	null	2	arm 1: Subject is given a 7.5 mg/kg dose of Polypodium leucotomos. arm 2: Subject is not given any treatment.	[ 0, 4 ]	1	[ 0 ]	intervention 1: Subject is given a 7.5 mg/kg oral dose of Polypodium leucotomos during Baseline visit, and again at 8 hours and 2 hours before the Follow-up visit #2.	intervention 1: Polypodium leucotomos	1	Miami \| Florida \| United States \| -80.19366 \| 25.77427	10	NCT00520910	1COMPLETED	2009-05-01	2007-08-01	University of Miami	7OTHER	false	false	false	null	0
[ 3 ]	31	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The study will test the safety and tolerability of Apremilast twice a day in participants with recalcitrant plaque type psoriasis.	This is a phase 2, multicenter, open-label, study to evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics and efficacy of Apremilast in participants with recalcitrant plaque-type psoriasis. Approximately 31 participants were enrolled and received 20 mg apremilast orally BID and, in participants who are non-responders after 84 days of apremilast, 30 mg Apremilast over the course of the two study treatment phases. The study consisted of four phases: Screening Phase - up to 35 days, Treatment Phase of 84 days, Extension Phase of 84 days and a Observational Follow-up Phase of 28 days. During the Treatment Phase, participants received two 20 mg Apremilast capsules each day. Following the Treatment Phase, participants had the option to continue on treatment during the Extension Phase. During the Extension Phase, participants either continued to take two 20 mg or dose escalated to two 30 mg of Apremilast each day. Participants who were considered responders (achieved a Psoriasis Area and Severity Index (PASI-75) at the beginning of the Extension Phase continued on 20 mg twice per day (BID) while the remaining participants received 30 mg capsules BID. The Extension Phase was introduced after some participants had already completed the study; therefore, there were several participants who never had the opportunity to continue into the Extension Phase. All participants were asked to participate in a 4-week post-treatment observational follow-up phase either upon completion of the study or upon discontinuation of study drug for those participants who terminated the study early.	Psoriasis-Type Psoriasis Plaque-Type Psoriasis	Apremilast, Psoriasis, PASI-75, sPGA	null	1	arm 1: Apremilast 20 mg or 30 mg orally twice per day	[ 0 ]	1	[ 0 ]	intervention 1: 20 mg PO (by mouth) twice per day (BID) for 84 days and then an additional 84 days during the optional treatment extension period. For subjects meeting the dose escalation criteria, dosage during the optional treatment extension period can be increased to 30 mg BID.	intervention 1: Apremilast	4	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Dallas \| Texas \| United States \| -96.80667 \| 32.78306	41	NCT00521339	1COMPLETED	2009-05-01	2007-08-01	Amgen	4INDUSTRY	false	false	false	null	0
[ 0 ]	12	RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, abnormal cells are killed. Photodynamic therapy using topical aminolevulinic acid may be effective against actinic keratosis. PURPOSE: This randomized clinical trial is studying how well different photodynamic therapy regimens using topical aminolevulinic acid work in treating patients with actinic keratosis.	OBJECTIVES: Primary * To determine, using fluorescence measurements, the protoporphyrin IX (PpIX) accumulation in thin actinic keratoses (AK) and actinically damaged skin on the face, scalp, and upper torso (stratum 1) and the PpIX accumulation in thick AK and actinically damaged skin on the arms and legs (stratum 2) as a function of skin preparation, aminolevulinic acid (ALA) application time, and body site. * To determine the extent that the PpIX is photobleached by the treatment light. Secondary * To assess the effects of different treatment conditions on acute reactions of AK and sun damaged skin to ALA-photodynamic therapy (PDT) occurring 24-48 hours after PDT. * To assess the effects of different treatment conditions on the efficacy of ALA-PDT. * To examine the histological response to ALA-PDT. * To determine, using fluorescence measurements, the PpIX accumulation in incidental thick AK that may occur in stratum 1, and the PpIX accumulation in incidental thin AK that may occur in stratum 2 as a function of skin preparation, ALA application time and body site. * To determine the extent that the PpIX in these incidental lesions is photobleached by treatment light. OUTLINE: The randomization is a two-step restricted block process for application time and skin preparation, followed by randomization for light dose (1 vs 2 pulses) within the anatomic site. Within each stratum (stratum 1 or 2), lesions in each separate anatomic area (face and neck, scalp, upper torso; arms, legs) are randomized to receive 1 of 3 pretreatment skin preparation before receiving topical aminolevulinic acid (ALA): pretreatment with acetone, gentle abrading, or no pretreatment. Patients are randomized to receive ALA at different times before the photodynamic therapy (PDT). * Arm I: Patients receive topical ALA 2 hours before PDT. * Arm II: Patients receive topical ALA 4 hours before PDT. * Arm III: Patients receive topical ALA 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment. * Arm IV: 1 Vbeam laser pulse (photodynamic therapy) is applied to the subunit. * Arm V: 2 Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart. Patients with progressive lesions or lesions that have not responded after 3 treatments may receive diagnostic biopsy to check for invasive squamous cell carcinoma and referred to treatment off study. Patients undergo biopsies at baseline, before and after ALA application prior to light treatment, and up to 24 hours after light treatment to analyze cytokines and genes specific to actinic keratoses.	Precancerous/Nonmalignant Condition	actinic keratosis	null	5	arm 1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT. arm 2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart	[ 0, 0, 0, 0, 0 ]	2	[ 0, 3 ]	intervention 1: None intervention 2: None	intervention 1: aminolevulinic acid intervention 2: laser therapy	1	Buffalo \| New York \| United States \| -78.87837 \| 42.88645	0	NCT00524485	6TERMINATED	2009-05-01	2005-05-01	Roswell Park Cancer Institute	7OTHER	false	false	false	null	0
[ 3 ]	52	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	2MALE	false	This exploratory study will be conducted open label in a single investigational clinical unit. Altogether 52 patients with benign prostate hyperplasia (BPH) will be randomly assigned to receive 4 different treatments with degarelix.	The present study aims at exploring the potential of the currently available formulation of degarelix to treat BPH with only a short transient lowering of the serum testosterone concentration to or below the castration level defined as 0.5 ng/mL. Two doses and two dosing regimens (32 and 64 mg administered either as a single administration or as two administrations separated by 14 days) will be evaluated for 42 days.	BPH	Benign Prostate Hyperplasia BPH PK/PD GnRH antagonist	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Two doses of 16 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days. intervention 2: One dose of 32 mg administered as a single administration will be evaluated for 42 days. intervention 3: Two doses of 32 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days. intervention 4: One dose of 64 mg administered as a single administration will be evaluated for 42 days.	intervention 1: Degarelix intervention 2: Degarelix intervention 3: Degarelix intervention 4: Degarelix	1	Mönchengladbach \| N/A \| Germany \| 6.44172 \| 51.18539	50	NCT00527488	1COMPLETED	2009-05-01	2007-10-01	Ferring Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	98	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The purpose of this Phase 2 randomized study is to evaluate the efficacy and safety of treatment with a regimen of VELCADE, dexamethasone, and thalidomide (VDT) or VELCADE, dexamethasone, thalidomide, and cyclophosphamide (VDTC) in subjects with newly diagnosed symptomatic multiple myeloma who have received no prior treatment and are candidates to receive high-dose therapy and autologous bone marrow/stem cell transplantation.	null	Multiple Myeloma		null	2	arm 1: bortezomib, dexamethasone, and thalidomide arm 2: bortezomib, dexamethasone, thalidomide, and cyclophosphamide	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: VELCADE (bortezomib) twice weekly for 4 cycles (4 doses per cycle), prior to high-dose chemotherapy (HDT) and stem cell transplantation(SCT). Subjects will receive VELCADE 1.3 mg/m2 as an intravenous (i.v.) bolus injection on Days 1,4,8, and 11, followed by a 10 day rest period (Days 12 to 21) Dexamethasone 40 mg/day will be given by mouth (p.o.) on Days 1-4 and Days 9-12 in each of 4 cycles. Thalidomide will be given by mouth (p.o.)every day, starting on Day 1 of Cycle 1 (e.g. the same day of the first dose of VELCADE) and continuing until Day 21 of Cycle 4 at a dose of 100 mg/day (bedtime). intervention 2: VELCADE (bortezomib) twice weekly for 4 cycles (4 doses per cycle), prior to high-dose chemotherapy(HDT)and stem cell transplantation(SCT). Subjects will receive VELCADE 1.3 mg/m2 as an intravenous (i.v.) bolus injection on Days 1,4,8, and 11, followed by a 10 day rest period (Days 12 to 21). Dexamethasone 40 mg/day will be given by mouth (p.o.) on Days 1-4 and Days 9-12 in each of 4 cycles. Thalidomide will be given by mouth (p.o.) every day, starting on Day 1 of Cycle 1 (e.g., the same day of the first dose of VELCADE) and continuing until Day 21 of Cycle 4 at a dose of 100 mg/day (bedtime). Cyclophosphamide will be given as an intravenous (i.v.) dose of 400 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for a total of 4 cycles.	intervention 1: bortezomib, dexamethasone, and thalidomide intervention 2: bortezomib, dexamethasone, thalidomide, and cyclophosphamide	1	Vienna \| Vienna \| Austria \| 16.37208 \| 48.20849	98	NCT00531453	1COMPLETED	2009-05-01	2007-10-01	Millennium Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	1,742	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR and bupropion SR are safe and effective in the treatment of obesity.	Two Phase II clinical trials demonstrated that a combination of bupropion SR and naltrexone is associated with greater weight loss than bupropion SR alone, naltrexone alone, or placebo in subjects with uncomplicated obesity. The current study investigated the safety and efficacy of 2 doses of the combination of naltrexone SR and bupropion SR compared to placebo in obese subjects with uncomplicated obesity and in those with overweight/obesity and hypertension and/or dyslipidemia.	Obesity Overweight	Obesity Antiobesity agents Antiobesity drugs Overweight drug therapy Obese drug therapy Weight loss drug effects Bupropion administration and dosage Naltrexone administration and dosage Double blind method Combination drug therapy Delayed action preparations	null	3	arm 1: Naltrexone SR 16 mg/Bupropion SR 360 mg /day with ancillary therapy arm 2: Naltrexone SR 32 mg/Bupropion SR 360 mg /day with ancillary therapy arm 3: Placebo with ancillary therapy	[ 0, 0, 2 ]	4	[ 0, 0, 0, 5 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling	intervention 1: Naltrexone SR 16 mg/Bupropion SR 360 mg /day intervention 2: Naltrexone SR 32 mg/Bupropion SR 360 mg /day intervention 3: Placebo intervention 4: Ancillary therapy	34	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Fairhope \| Alabama \| United States \| -87.90333 \| 30.52297 Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Orange \| California \| United States \| -117.85311 \| 33.78779 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Honolulu \| Hawaii \| United States \| -157.85833 \| 21.30694 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 Slidell \| Louisiana \| United States \| -89.78117 \| 30.27519 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Springfield \| Massachusetts \| United States \| -72.58981 \| 42.10148 Reno \| Nevada \| United States \| -119.8138 \| 39.52963 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Cordova \| Tennessee \| United States \| -89.7762 \| 35.15565 Jackson \| Tennessee \| United States \| -88.81395 \| 35.61452 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	1,711	NCT00532779	1COMPLETED	2009-05-01	2007-10-01	Orexigen Therapeutics, Inc	4INDUSTRY	false	false	false	null	0
[ 3 ]	503	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	true	The primary objective is to evaluate the safety and feasibility of using M118 as an anticoagulant in the target population of subjects with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). The secondary objectives are to evaluate the effect of M118 on procedural indices including procedure success, abrupt closure, post-procedure TIMI flow, and catheter thrombus. Substudy Primary Objective The primary objective of the substudy is to characterize the pharmacokinetic and pharmacodynamic profile of M118 among subjects with stable coronary artery disease undergoing elective PCI.	null	Coronary Artery Disease (CAD)	Percutaneous Coronary Intervention (PCI)	null	4	arm 1: Venous injection (IV) of 70 units per kilogram (U/kg) of unfractionated heparin prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given. arm 2: Venous injection of 50 international units per kilogram (IU/kg) of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given. arm 3: Venous injection of 75 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given. arm 4: Venous injection of 100 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.	[ 1, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: intravenous (IV) infusion intervention 2: IV infusion	intervention 1: M118 intervention 2: Unfractionated Heparin	44	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Fort Lauderdale \| Florida \| United States \| -80.14338 \| 26.12231 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Ormond Beach \| Florida \| United States \| -81.05589 \| 29.28581 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Barrington \| Illinois \| United States \| -88.13619 \| 42.15391 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Rock Island \| Illinois \| United States \| -90.57875 \| 41.50948 Davenport \| Iowa \| United States \| -90.57764 \| 41.52364 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Grand Blanc \| Michigan \| United States \| -83.62995 \| 42.92753 Duluth \| Minnesota \| United States \| -92.10658 \| 46.78327 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Zanesville \| Ohio \| United States \| -82.01319 \| 39.94035 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Rapid City \| South Dakota \| United States \| -103.23101 \| 44.08054 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Amarillo \| Texas \| United States \| -101.8313 \| 35.222 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Victoria \| Texas \| United States \| -97.0036 \| 28.80527 Waco \| Texas \| United States \| -97.14667 \| 31.54933 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884	503	NCT00543400	1COMPLETED	2009-05-01	2007-09-01	Momenta Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	140	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	null	This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.	null	Postmenopausal Osteoporosis		null	2	arm 1: Participants received monthly oral ibandronate (150 milligrams \[mg\]) for 12 months. arm 2: Participants received monthly oral placebo for 12 months.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: po monthly for 12 months intervention 2: 150mg po monthly for 12 months	intervention 1: Placebo intervention 2: ibandronate	15	Hämeenlinna \| N/A \| Finland \| 24.46434 \| 60.99596 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Hyvinkää \| N/A \| Finland \| 24.86667 \| 60.63333 Jyväskylä \| N/A \| Finland \| 25.72088 \| 62.24147 Jyväskylä \| N/A \| Finland \| 25.72088 \| 62.24147 Kuopio \| N/A \| Finland \| 27.67703 \| 62.89238 Lahti \| N/A \| Finland \| 25.66151 \| 60.98267 Oulu \| N/A \| Finland \| 25.46816 \| 65.01236 Oulu \| N/A \| Finland \| 25.46816 \| 65.01236 Tampere \| N/A \| Finland \| 23.78712 \| 61.49911 Tampere \| N/A \| Finland \| 23.78712 \| 61.49911 Turku \| N/A \| Finland \| 22.26869 \| 60.45148 Vantaa \| N/A \| Finland \| 25.04099 \| 60.29414	140	NCT00545051	1COMPLETED	2009-05-01	2006-05-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 5 ]	125	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This is a two-arm, parallel, randomized, double-blind, placebo-controlled Phase 4 multicenter trial to compare the whole day efficacy of atomoxetine versus placebo in children aged 6 through 12 years with Attention-Deficit/Hyperactivity Disorder (ADHD) treated in an inpatient, day-patient and outpatient setting in Germany. Core symptoms will be measured during once or bi-weekly visits, three times per visit-day, by a computer based Continuous Performance Test. Following an initial 3-28-day screening and washout phase, patients will be assigned to double-blind treatment with atomoxetine or placebo. In the verum arm, a one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day.	null	Attention Deficit Hyperactivity Disorder		null	2	arm 1: 0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose. arm 2: Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: A one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day. 3 capsules of study medication have to be taken once daily in the morning, with or without food. intervention 2: 3 capsules of placebo have to be taken once daily in the morning, with or without food.	intervention 1: Atomoxetine intervention 2: Placebo	16	Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Datteln \| N/A \| Germany \| 7.3453 \| 51.65598 Dorsten \| N/A \| Germany \| 6.96514 \| 51.66166 Düsseldorf \| N/A \| Germany \| 6.77616 \| 51.22172 Eberswalde \| N/A \| Germany \| 13.81951 \| 52.83492 Freiburg im Breisgau \| N/A \| Germany \| 7.85222 \| 47.9959 Fulda \| N/A \| Germany \| 9.67518 \| 50.55162 Giessen \| N/A \| Germany \| 8.67554 \| 50.58727 Hagen \| N/A \| Germany \| 7.47168 \| 51.36081 Hanover \| N/A \| Germany \| 9.73322 \| 52.37052 Kehl \| N/A \| Germany \| 7.81523 \| 48.57297 Mannheim \| N/A \| Germany \| 8.46694 \| 49.4891 München \| N/A \| Germany \| 13.31243 \| 51.60698 Solingen \| N/A \| Germany \| 7.0845 \| 51.17343 Wolfenbüttel \| N/A \| Germany \| 10.54095 \| 52.16442	125	NCT00546910	1COMPLETED	2009-05-01	2007-10-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 3 ]	38	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The present pharmacokinetic (PK)-pharmacodynamic (PD) study will explore the toxicity and antileukemic response during the initial 3 months of individualised therapy of children and young adults with acute lymphoblastic leukemia (ALL). The investigators will on an individual toxicity-titrated basis attempt to increase the dose intensity of the 6-mercaptopurine used in the two-months post-remission treatment phase of lower risk childhood ALL. This will be performed together with continuous PEG-ASP (every 2nd week) and interspersed HD-MTX (5 g/m\^2) every 3rd week. Thus, the trial will also test the feasibility of this particular drug combination.	In addition to the details above we will also explore * the relationship of the post-HD-MTX MRD-levels with the dose of 6MP, TPMT-activity, DNA-6TGN, E-6TGN, E-MeMP, E-MTX, and presence of ASP-antibodies, * the early development of anti-ASP antibodies during continuous PEG-ASP therapy. The study could improve the understanding of the pharmacodynamics of the 6MP/HD-MTX interaction in combination with PEG-ASP.	Leukemia, Lymphocytic, Acute	Leukemia, Lymphocytic, Acute [C04.557.337.428.511] 6-mercaptopurine methotrexate asparaginase	null	1	arm 1: All patients received basic daily 6MP (6-mercaptopurine) (25 mg/m\^2) and in addition high-dose methotrexate(HDM) every 3rd week (3 times HDM in total) and PEG-asparaginase every 14th day. Patients increased the dose of 6MP 2 weeks after each HDM if if the myelotoxicity had been acceptable. This means 2 increments since the study stopped 2 weeks after the last HDM	[ 0 ]	1	[ 0 ]	intervention 1: Standard dose 25 mg/m\^2/day. Can be increased up to 75 mg/m\^2/day if the myelosuppression is acceptable (ANC\>0.5 T-count \>50)	intervention 1: 6-mercaptopurine	3	Copenhagen \| N/A \| Denmark \| 12.56553 \| 55.67594 Odense \| N/A \| Denmark \| 10.38831 \| 55.39594 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716	38	NCT00548431	1COMPLETED	2009-05-01	2007-12-01	Rigshospitalet, Denmark	7OTHER	false	false	false	null	0
[ 0 ]	101	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine whether treating apathy with methylphenidate or medical Crisis counselling will increase adherence to weight loss programs thereby increasing their effectiveness	Title: The role of Apathy in the effectiveness of weight loss interventions in obese patients Objective: Obesity is a major public health problem. Apathy is a common behavioral problem characterized by loss of initiative, poor motivation and persistence. Presence of apathy impairs the self-care behavior in obese patients. Lack of novelty might impair a patient's ability to seek new interactions, life styles and new treatment options for obesity. Lack of motivation might impair a patient's ability to initiate exercise regimen or diet whereas lack of persistence impairs the compliance with these regimens. Thus, apathy influences all stages of self-care. We hypothesize that the treatment of apathy will result in better adherence to weight loss interventions in obese veterans enrolled in the MOVE program. Research Design: A prospective open label randomized study. Group 1 will have patients with obesity as defined as BMI\>30, and apathy defined as AES score of \> 40. This group will be treated with standard nutrition counseling. Group 2 will have patients with obesity and apathy as defined above and will receive the MOVE enhancement program alone (The MOVE program is a national VA weight loss program). Group 3 will be treated with methylphenidate along with the MOVE enhancement program. Group 4 will be treated with medical crisis counseling along with the MOVE enhancement program. Group 5 will be treated with methylphenidate, and the medical crisis counseling along with the MOVE enhancement program. Methodology: 30 patients meeting the criteria will be enrolled in each of the five arms. All patients will be in the study for duration of six months. All patients in the methylphenidate arm will be started at 5mg twice daily and titrated to 10mg twice daily at two weeks. Patients will be assessed on regular intervals using the Apathy Evaluation Scale, Hamilton Depression Scale and the Patient activation measure. MOVE sessions will be held once weekly from the 2nd visit to the end of the study. Medical Crisis Counseling visits will be every week for nine sessions and then every other week till the end of the study Clinical Relationships/Significance: The prevalence of obesity in the general population is over 30%. However the prevalence of obesity in the VA health system is almost 70%. Since obesity predisposes to several co-morbid conditions such as hypertension, diabetes and cardiovascular disease, it is important to develop interventions that are effective in inducing weight loss. Since apathy plays a large role in the self care behaviours that lead to obesity, treating apathy may improve adherence to weight loss programs	Obesity Apathy	apathy obesity methylphenidate MOVE medical crisis counselling	null	5	arm 1: standard nutrition counselling arm 2: MOVE -weight loss intervention arm 3: MOVE plus medical crisis counselling arm 4: MOVE plus methylphenidate arm 5: MOVE plus methyphenidate plus medical crisis counselling	[ 4, 0, 0, 0, 0 ]	8	[ 5, 5, 5, 0, 5, 0, 5, 5 ]	intervention 1: is a VA based multidesciplinary weight loss intervention intervention 2: group counselling sessions intervention 3: is a VA based multidesciplinary weight loss intervention intervention 4: methyphenidate will be used to treat apathy dose 10mg bid intervention 5: is a VA based multidesciplinary weight loss intervention intervention 6: methyphenidate will be used to treat apathy dose 10mg bid intervention 7: group counselling sessions intervention 8: is a VA based multidesciplinary weight loss intervention	intervention 1: MOVE intervention 2: medical crisis councelling intervention 3: MOVE intervention 4: methyphenidate intervention 5: MOVE intervention 6: methyphenidate intervention 7: medical crisis councelling intervention 8: MOVE	1	Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626	101	NCT00548652	1COMPLETED	2009-05-01	2007-08-01	VA Nebraska Western Iowa Health Care System	1FED	false	false	false	null	0
[ 3 ]	80	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	true	Cigarette smoking continues to be a major public health problem. Tobacco dependence interventions, as recommended by the USPHS Clinical Practice Guideline are not effective for all smokers. A need exists for new medications to treat various aspects of tobacco dependence, such as the reinforcing effects of nicotine, relief of nicotine withdrawal symptoms and prevention of early relapse. The neurobiology of the effect of methylphenidate is similar to that of the reinforcing effects of nicotine. In a small previous study, methylphenidate was reported to improve nicotine withdrawal symptoms and short term quit rates. Methylphenidate is well tolerated, has low abuse potential, and is less expensive compared to other tobacco dependence interventions. ConcertaTM, a long acting preparation of methylphenidate, is administered once a day, has similar bioavailability as the generic drug administered 3 times a day and has an overall similar or improved efficacy compared to generic methylphenidate. We plan to obtain preliminary efficacy data in a randomized, placebo-controlled phase II study assessing the effect of methylphenidate in cigarette smokers for increasing 7-day point prevalence smoking abstinence at end of treatment and 7-day point prevalence and prolonged smoking abstinence at 6-months. Critical and systematic evaluations of newer, innovative, and well-tolerated treatments to help treat tobacco use and dependence will provide a wider choice of therapeutic agents to smokers wishing to become abstinent from tobacco use.	Once enrolled in study, the subject will be put in one of 2 groups by chance (as in the flip of a coin). They will either receive methylphenidate or a placebo. Everyone in study will receive nicotine dependence counseling based on the intervention manual "Smoke Free and Living It". Everyone will be asked to complete weekly study visits for 8 weeks and one follow-up phone call at week 16 and a final study visit at week 24. The target quit day is the day after visit 4 (week 2 + 1 day). In the first two weeks after starting study medication they will slowly build up to 3 pills a day. For weeks 2 through 8 they will continue to take 3 pills a day.	Smoking	nicotine dependence tobacco dependence	null	2	arm 1: 54 mg Methylphenidate per day for 8 weeks. Allowing for a ramp up in the first two weeks (starting dose is 18 mg/day). arm 2: non-active (sugar pill)designed to be a look-alike to the methylphenidate. Given at the same frequency and dosage look-alike to the active comparator (methylphenidate 54 mg)	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 54 mg Methylphenidate per day for 8 weeks. Allowing for a ramp up in the first two weeks (starting dose is 18 mg/day). intervention 2: non-active (sugar pill)designed to be a look-alike to the methylphenidate. Given at the same frequency and dosage look-alike to the active comparator (methylphenidate 54 mg)	intervention 1: Methylphenidate intervention 2: Placebo	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	80	NCT00549640	1COMPLETED	2009-05-01	2008-01-01	Mayo Clinic	7OTHER	false	false	false	null	0
[ 4 ]	1,267	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.	null	Obesity	Obesity, morbid obesity	null	3	arm 1: VI-0521; low dose phentermine/topiramate (PHEN/TPM 3.75 mg/23 mg) arm 2: Top Dose VI-0521 consisting of 15 mg of Phentermine and 92 mg of Topiramate. arm 3: Placebo to match	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: 3.75 mg phentermine/23 mg topiramate intervention 2: 15 mg phentermine/92 mg topiramate intervention 3: Placebo matched phentermine/topiramate	intervention 1: VI-0521 intervention 2: VI-0521 intervention 3: Placebo matched phentermine/topiramate	5	San Diego \| California \| United States \| -117.16472 \| 32.71571 Ridgefield \| Connecticut \| United States \| -73.49818 \| 41.28148 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Toledo \| Ohio \| United States \| -83.55521 \| 41.66394 Austin \| Texas \| United States \| -97.74306 \| 30.26715	1,264	NCT00554216	1COMPLETED	2009-05-01	2007-11-01	VIVUS LLC	4INDUSTRY	false	false	false	null	0
[ 5 ]	20	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	AD is a disease found in children; the focus of the study is the mechanisms associated in children with AD induced by food allergies. This study will be a randomized, double-blind, placebo-controlled, parallel group trial conducted in participants diagnosed with atopic dermatitis and food allergies. The study duration for participants will be approximately 9 weeks. A total of 20 participants will be recruited for the entire study. Each arm will consist of 10 participants.The study will enroll 20 children, male or female, 1 - 8 years of age with atopic dermatitis (AD) associated with food allergens, previously documented by skin or RAST test, before enrollment. Atopic dermatitis and gastrointestinal (GI) symptoms will be scored and followed throughout the study.	null	Atopic Dermatitis	Atopic Dermatitis (Eczema) associated with food allergies	null	2	arm 1: Montelukast arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age intervention 2: Oral granules or chewable tablet, PO QD (given oral daily)	intervention 1: Montelukast intervention 2: Placebo	2	Centennial \| Colorado \| United States \| -104.87692 \| 39.57916 Thornton \| Colorado \| United States \| -104.97192 \| 39.86804	20	NCT00557284	1COMPLETED	2009-05-01	2008-03-01	1st Allergy & Clinical Research Center	7OTHER	false	false	false	null	0
[ 3 ]	52	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to assess the effect of telaprevir on early hepatitis (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who are chronically (lasting a long time) infected with genotype 2 or 3 HCV.	This is a Phase 2a multicenter (when more than one hospital or medical school team work on a medical research study), partially blinded, randomized (study drug assigned by chance) stratified (arrange in groups for analysis of results e.g., stratify by age, sex, etc.) for genotype, multiple dose study. The trial will consist of Screening period (6 weeks), Treatment period (24 or 26 weeks) and Follow-up period (24 weeks). The Treatment period will include 2 weeks investigational treatment phase and a 24 week standard treatment phase. All the eligible participants who were never treated for HCV will be enrolled for the trial and will receive the investigational treatment regimen to which they have been randomly assigned for 2 weeks. After this in the standard treatment phase participants will receive the standard treatment of care consisting of pegylated interferon (Peg-IFN)-alfa-2a 180 microgram once weekly and ribavirin (RBV) 400 milligram twice per day. Efficacy will primarily be evaluated by HCV viral load quantification. Participant's safety will be monitored throughout the study.	Hepatitis C, Chronic	Hepatitis C, Chronic Genotype 2 Genotype 3 Telaprevir	null	6	arm 1: Participants who are never treated for chronic hepatitis C (inflammation of the liver) genotype 2 will receive telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants will then be treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of pegylated interferon 180 microgram (mcg) will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 26 weeks. arm 2: Participants who are never treated for CHC genotype 2 will receive TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks. arm 3: Participants who are never treated for CHC genotype 2 will receive TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks. arm 4: Participants who are never treated for CHC genotype 3 will receive TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants will then be treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 26 weeks. arm 5: Participants who are never treated for CHC genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks. arm 6: Participants who are never treated for CHC genotype 3 will receive TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks.	[ 0, 0, 1, 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks. intervention 2: Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 \& PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group. intervention 3: Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks.	intervention 1: Telaprevir intervention 2: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment) intervention 3: Placebo	7	Clichy \| N/A \| France \| 2.30952 \| 48.90018 Créteil \| N/A \| France \| 2.46569 \| 48.79266 Lyon \| N/A \| France \| 4.84671 \| 45.74846 Paris \| N/A \| France \| 2.3488 \| 48.85341 Vandœuvre-lès-Nancy \| N/A \| France \| 6.17114 \| 48.66115 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	49	NCT00561015	1COMPLETED	2009-05-01	2007-12-01	Tibotec BVBA	4INDUSTRY	false	false	false	null	0
[ 4 ]	294	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the tolerability, safety and treatment response of flexible doses of paliperidone extended-release (ER; designed to slowly release a drug in the body over an extended period of time) tablets in participants with acute schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).	This is an open-label (all people know the identity of the intervention), single-arm (getting one dose of medicine), multi-center (conducted in more than 1 center) study to evaluate tolerability, safety and efficacy of flexible daily doses of paliperidone ER in participants with acute schizophrenia. All participants will be given paliperidone ER once daily at a dose of 3, 6, 9, or 12 milligram (mg) tablets orally depending on Investigator's discretion, based on participant's clinical response and tolerability towards paliperidone ER. The duration of the core phase of the treatment will be 6 weeks and the participants who will complete this phase, respond well and would like to continue, will be eligible to be enrolled in an extension phase, which is no longer than 12 months. Efficacy will primarily be evaluated by treatment response evaluated through total Positive and Negative Syndrome Scale (PANSS) score. Participants' safety will be monitored throughout the study.	Schizophrenia	Schizophrenia Paliperidone Extended Release (ER) Invega	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion will be given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.	intervention 1: Paliperidone	30	Zagreb \| N/A \| Croatia \| 15.97798 \| 45.81444 Dieppe \| N/A \| France \| 1.07772 \| 49.9216 La Charité-sur-Loire \| N/A \| France \| 3.01667 \| 47.18333 Metz \| N/A \| France \| 6.17269 \| 49.11911 Augsburg \| N/A \| Germany \| 10.89851 \| 48.37154 Bonn \| N/A \| Germany \| 7.09549 \| 50.73438 Mainz \| N/A \| Germany \| 8.2791 \| 49.98419 Mannheim \| N/A \| Germany \| 8.46694 \| 49.4891 München \| N/A \| Germany \| 13.31243 \| 51.60698 Rostock \| N/A \| Germany \| 12.14049 \| 54.0887 Wasserburg \| N/A \| Germany \| 10.2693 \| 48.44105 Be-Er Ya-Acov \| N/A \| Israel \| N/A \| N/A Beersheba \| N/A \| Israel \| 34.7913 \| 31.25181 Hod HaSharon \| N/A \| Israel \| 34.8932 \| 32.15934 Pardesiyya \| N/A \| Israel \| 34.90911 \| 32.30577 Ramat Gan \| N/A \| Israel \| 34.81065 \| 32.08227 Klaipėda \| N/A \| Lithuania \| 21.13912 \| 55.7068 Šiauliai \| N/A \| Lithuania \| 23.31667 \| 55.93333 Vilnius \| N/A \| Lithuania \| 25.2798 \| 54.68916 Gda Sk Poland \| N/A \| Poland \| N/A \| N/A Gmina Świecie \| N/A \| Poland \| 18.44742 \| 53.40953 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Lublin \| N/A \| Poland \| 22.56667 \| 51.25 Lubliniec \| N/A \| Poland \| 18.6844 \| 50.66897 Skąpe \| N/A \| Poland \| 18.61539 \| 53.21703 Torun \| N/A \| Poland \| 18.59814 \| 53.01375 Ząbki \| N/A \| Poland \| 21.10539 \| 52.29271 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Cluj-Napoca \| N/A \| Romania \| 23.6 \| 46.76667 Craiova \| N/A \| Romania \| 23.8 \| 44.31667	294	NCT00566631	1COMPLETED	2009-05-01	2007-07-01	Janssen-Cilag International NV	4INDUSTRY	false	false	false	null	0
[ 2 ]	7	NA	SINGLE_GROUP	9OTHER	0NONE	false	0ALL	false	Many children with end stage renal disease develop hyperlipidemia. HMG-CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors, such as pravastatin, are typical treatments for hyperlipidemia. However, we do not know how pravastatin is metabolized in patients on dialysis. This study is designed to provide preliminary pharmacokinetic data for pravastatin in pediatric patients on peritoneal dialysis.	This is a single-dose pilot study to evaluate the pharmacokinetic profile of pravastatin in 7 pediatric and adolescent subjects ranging from 12 months to 16 years of age who are on dialysis. The study group will be comprised of healthy children receiving continuous cycling peritoneal dialysis (CCPD). Pravastatin dosing will be 10 mg in all subjects. Blood, urine, and dialysate samples will be obtained over a 24-hour period post-dose for measurement of pravastatin concentrations. Safety evaluations will include adverse events (AEs), physical examination, vital signs, and clinical laboratory evaluations.	End Stage Renal Disease	pravastatin, peritoneal dialysis, pediatric patients	null	1	arm 1: PK profile of pravastatin	[ 5 ]	1	[ 0 ]	intervention 1: A single 10 mg dose of pravastatin will be administered 3 mL blood samples for pravastatin Pharmacokinetic evaluations will be collected at 0.5, 1, 2, 3, 4, 6, and 8 hours. 5 mL blood samples for pravastatin PK and laboratory evaluations will be drawn at pre-dose and 24 hours. Vital Signs and Physical Exams will also be done throughout the study	intervention 1: pravastatin	1	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648	7	NCT00571194	6TERMINATED	2009-05-01	2007-09-01	Arkansas Children's Hospital Research Institute	7OTHER	false	false	false	null	0
[ 3 ]	80	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	false	Gabapentin is an anti-epileptic agent that has shown preliminary evidence of efficacy for improving symptoms of cocaine and alcohol withdrawal in pilot studies. Since the neurobiology of alcohol, cocaine and nicotine withdrawal is similar, the preliminary evidence of efficacy of gabapentin for symptoms of alcohol and cocaine withdrawal suggests, that gabapentin might likely help nicotine withdrawal symptoms and thus tobacco abstinence. The effect of gabapentin on two of the neurotransmitters, gamma-aminobutyric acid (GABA) and glutamate further suggest a potential therapeutic mechanism for gabapentin in tobacco abstinence. However, the exact mechanism of action of gabapentin is currently not known. We have recently completed an open label pilot trial of gabapentin for tobacco abstinence involving 50 smokers. The findings from that study provide promising preliminary results and suggest that further testing of gabapentin for helping cigarette smokers quit tobacco use is worth pursuing. Overall, gabapentin is well tolerated and has low abuse potential. Our goal is to evaluate novel, safe, acceptable, and effective therapies that may help increase tobacco abstinence rates. Currently, no randomized trials testing the efficacy of gabapentin for smoking abstinence have been published. While our previous study provides promising evidence regarding the potential efficacy of gabapentin for smoking abstinence, an additional dose ranging study is needed prior to pursuing a large randomized trial. The primary aim of the dose ranging study will be to obtain additional evidence of efficacy, and information on the optimal dose of gabapentin to employ in the larger randomized controlled trial.	A total of 120 participants will be recruited in this study and randomly assigned to one of the three groups. Participants in group A will receive gabapentin 1800-mg/day orally for 12-weeks while participants in group B will receive gabapentin 2700-mg/day orally for 12-weeks. Participants in group C will receive a matching placebo for the same duration. We have selected this dose regimen based on our experience with using gabapentin in the pilot study. The present study is designed as a randomized, blinded, placebo-controlled, three-arm, parallel-group, dose-ranging, phase II clinical trial. In addition to receiving gabapentin or placebo, all subjects will receive a brief behavioral counseling intervention during participation in the study.	Cigarette Smoking Tobacco Use	tobacco smoking gabapentin abstinence	null	3	arm 1: Non active placebo pill arm 2: Gabapentin - 1800 mg/day arm 3: Gabapentin - 2700 mg/day	[ 2, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Placebo pill - non active sugar pill designed to look alike to the gabapentin medication intervention 2: gabapentin - 1800 mg/day for 12 weeks. intervention 3: gabapentin - 2700 mg/day for 12 weeks.	intervention 1: Placebo intervention 2: Gabapentin - 1800 mg/day intervention 3: Gabapentin - 2700 mg/day	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	80	NCT00578552	1COMPLETED	2009-05-01	2007-10-01	Mayo Clinic	7OTHER	false	false	false	null	0
[ 0 ]	11	RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	To determine whether intensive glucose control results in improved mortality and reduced hospital stay length by performing a randomized trial of intensive glucose management (blood glucose goal 110 mg/dl) using continuous IV insulin and glucose vs. non-intensive glucose management (goal 200 mg/dl)	TO determine whether there are fewer infections, days without a fever, days on antibiotics given for an infection and time to marrow engraftment are improved by intensive glucose management; and to determine whether there is evidence of a reduction in measures of inflammation in patients randomized to intensive glucose management and whether reduction of inflammation is associated with outcome.	Hyperglycemia Hematopoietic Stem Cell Transplantation	Hyperglycemia Hematopoietic stem cell transplantation Bone marrow transplant High blood sugar	null	2	arm 1: Regular Sliding Scale Insulin administration for hyperglycemia arm 2: MiniMed Paradigm monitoring device for hyperglycemia	[ 1, 0 ]	2	[ 0, 1 ]	intervention 1: Use of sliding scale insulin as per Appendix 1 intervention 2: Automated insulin delivery system	intervention 1: Regular Insulin intervention 2: Deployment of the MiniMed Paradigm monitoring device	1	Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756	11	NCT00582036	6TERMINATED	2009-05-01	2007-02-01	University of Oklahoma	7OTHER	false	false	false	null	0
[ 0 ]	12	NA	SINGLE_GROUP	2DIAGNOSTIC	0NONE	false	0ALL	null	The purpose of this study is to find out whether the monoclonal antibody 8H9 is useful in finding tumors in your body. Antibodies are protein found naturally in blood. They can fasten themselves to bacteria and viruses. They can stimulate white cells and blood proteins to kill tumors. The antibody 8H9 was made from mouse white cells. The white cells that secrete this antibody have been made to live for ever. They manufacture large amounts of 8H9 for patient use. Although other monoclonal antibodies have been safely tested in people, the antibody 8H9 has never been given to a human patient.	To test if intravenous injections of iodine-131 labeled murine monoclonal antibody 8H9 can detect primary and metastatic solid tumors. A total of 60 patients will be accrued over a period of 2 years.	CNS Cancer Neuroblastoma Sarcoma		null	1	arm 1: This is an open-label single arm study of 131 I-8H9. injected intravenously at 10mCi/1.73m\^2 dose \[intended specific activity of '20mCi/mg protein\] preceded by administration of 50mg/1.73m2 of unlabeled -8H9.	[ 0 ]	2	[ 0, 0 ]	intervention 1: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m\^2 dose \[intended specific activity of \~20 mCi/mg protein\] intervention 2: administration of 50mg/1.73m\^2 of unlabeled 8H9.	intervention 1: 131I-8H9 intervention 2: 8H9	1	New York \| New York \| United States \| -74.00597 \| 40.71427	5	NCT00582608	6TERMINATED	2009-05-01	2001-10-01	Memorial Sloan Kettering Cancer Center	7OTHER	false	false	false	null	0
[ 3, 4 ]	49	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Autism is a complex neurodevelopmental disorder that is thought to involve an interaction between multiple and variable susceptibility genes, environmental factors, and epigenetic effects. Great concern has been raised about the marked increase in the prevalence of autism spectrum disorders in the last decade. Risperidone, the most studied atypical antipsychotic used in children, has been shown to improve severe behavioral difficulties in over half of children with autism who have these difficulties. However, not all children with autism and severe behavioral problems respond to risperidone, and for a few, it has significant side effects. Two controlled studies and numerous open-label and long term studies in children with autism spectrum disorders using the atypical antipsychotic risperidone show a significant decrease of associated serious behavioral problems. The use of atypical antipsychotics is of great concern, however, because of their significant side effects and the fact that only two-thirds of children positively respond. Ways to predict response, appropriate dosage and serious side effects are needed.	For this study, we will identify 40 children (4 to 18 years old) with autism who also have serious behavioral problems. We will then treat them with risperidone. Blood samples will be obtained prior to treatment and at eight weeks of treatment or study exit. At that time, efficacy will be assessed using the Clinical Global Impression-Improvement scale (CGI-I) and the Irritability subscale of the Aberrant Behavior Checklist (ABC). Blood genomic profiles before and after risperidone treatment will be determined using Affymetrix oligonucleotide microarrays combined with RT-PCR. Blood genomic profiles are shown to predict medication response for disorders such as cancer and epilepsy. This exploratory or discovery study will use blood genomic profiles before and after risperidone treatment in children with autism and severe behavioral difficulties to determine if the profiles can predict response to treatment. The ultimate goal of this line of research is to develop methods to predict which medications work for which child before initiating treatment, to predict which child might develop particular side effects, and to identify new treatment targets for future medication development. Risperidone will be started at 0.5 mg at bedtime for 4 days and, if the current dosage is tolerated as evidenced by no more than mild sedation, no EPS or other moderate to severe AEs, and if there are continued behavioral symptoms, the dose will be increased to 1 mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5 mg will be added in the AM for a daily total of 1.5 mg. After that, dosages may be increased if there does not appear to be an adequate clinical response. Dosage will not be increased if there are side effects (e.g. excessive sedation, salivation, EPS, lactation) and may be decreased if it is not tolerated. If the investigator determines that a significant adverse reaction occurs or if the subject or his or her family wants to stop the study, the medication will be tapered or stopped depending on the dose and reason for stopping and the subject will be offered alternative treatment at the M.I.N.D. Institute Clinic or referred elsewhere. This dosing schedule mirrors that used in the two recent positive trials of risperidone for treating severe behavioral problems in autism (McCracken et al., 2002; Shea et al., 2004).	Autism		null	1	arm 1: Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.	[ 0 ]	1	[ 0 ]	intervention 1: Dose will start at 0.5 mg and may be increased throughout the course of the study if no adverse events occur	intervention 1: Risperidone	1	San Francisco \| California \| United States \| -122.41942 \| 37.77493	49	NCT00584701	1COMPLETED	2009-05-01	2008-01-01	University of California, San Francisco	7OTHER	false	false	false	null	0
[ 5 ]	39	NON_RANDOMIZED	PARALLEL	null	0NONE	true	0ALL	false	This will be an open label study using daily does of up to 126mg/day of Concerta in the treatment of children and adolescents, ages 12-17, who meet DSM-IV criteria for ADHD. Specific hypotheses are as follows: Hypothesis 1: Children and adolescents with ADHD will have significantly higher ACC and DLPFC Glutamate/myo-Inositol containing compounds (Glu/Ino) and Glutamate/creatine + phosphocreatine (Glu/Cr) than matched HCS. Hypothesis 2: After six weeks of treatment, OROS methylphenidate will lower ACC and DLPFC Glu/Ino and Glu/Cr levels in children with ADHD who are methylphenidate responders.	The primary objective of this study is to use 1H MRS to assess Glutamate (Glu), myo-Inositol (Ino), and creatine + phosphocreatine (Cr) levels in brain regions of interest in 20 children with ADHD between the ages of 12-17 years old, before and after a six-week open treatment trial with OROS methylphenidate. For comparison, 1H MRS will also be obtained from 20 controls matched by age and gender. We also will scan 20 children with ADHD between the ages of 12-17 years old that are currently enrolled in the protocol entitled "Prevention of Cigarette Smoking in ADHD Youth with Concerta" (2003-P-001313) and on a stable dose of Concerta. These 20 children will be scanned once while on medication and once while off medication	ADHD	HMRS Scanning ADHD Child Adolescent HMRS Scans	null	2	arm 1: None arm 2: Healthy Volunteer Control group	[ 0, 5 ]	2	[ 0, 10 ]	intervention 1: Concerta is given in capsule form with a minimum dose of 18 mg/day and a max of 126 mg/day. Subjects take Concerta once per day for 6 weeks. intervention 2: No intervention	intervention 1: OROS methylphenidate intervention 2: No intervention	1	Cambridge \| Massachusetts \| United States \| -71.10561 \| 42.3751	39	NCT00593112	1COMPLETED	2009-05-01	2006-11-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0
[ 3 ]	70	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard of daily wound care is safe and effective in treating mildly infected skin ulcers compared to treatment with an oral antibiotic (levofloxacin) and standard daily wound care.	Infected skin ulcers in patients with diabetes can be very debilitating because they are difficult to heal. Diabetic ulcers are responsible for frequent health care visits, and are a major predictor of amputation. Diabetic ulcers can be caused by a patient's inability to sense pain or warmth as well as peripheral vascular disease, which causes diminished blood flow to the foot. Early aggressive treatment is necessary to treat infection and prevent the need for amputation. Gentamicin is an antibiotic that is effective in treating certain kinds of infection. Collagen is a protein that is found in all mammals. The gentamicin-collagen sponge is a thin flat sponge made out of collagen that comes from cow tendons and containing gentamicin. When applied to an open ulcer, the collagen breaks down and the gentamicin is released into the ulcer, but very little is absorbed into the blood stream. The high levels of gentamicin in the open infected ulcer may help treat the infection. In this study, all subjects will be given the necessary supplies and taught how to take care of their foot ulcer. Subjects who are randomly assigned to the gentamicin-collagen sponge treatment group will place a gentamicin-collagen sponge on their ulcer during daily wound care. Subjects who are randomly assigned to the oral levofloxacin treatment group will also perform daily wound care, but they will not be given the gentamicin-collagen sponge. Instead they will be given the antibiotic, levofloxacin to take by mouth during the treatment period.	Diabetic Foot Ulcer	Diabetic Foot Ulcer	null	2	arm 1: Daily topical gentamicin sponge and standard daily wound care arm 2: Daily oral levofloxacin 750 mg and standard daily wound care	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Inserted daily into open ulcer intervention 2: 750mg oral levofloxacin daily	intervention 1: gentamicin-collagen sponge intervention 2: Levofloxacin	1	Pasadena \| Maryland \| United States \| -76.57108 \| 39.119	69	NCT00593567	1COMPLETED	2009-05-01	2007-12-01	Innocoll	4INDUSTRY	false	false	false	null	0
[ 5 ]	40	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This is a pilot study designed to examine the potential efficacy and tolerability of zonisamide compared to placebo for the treatment of alcohol dependence.	Zonisamide is an antiepileptic medication which has similar clinical and pharmacologic effects to topiramate, a medication that has demonstrated efficacy in a randomized clinical trial for treatment of alcoholism. Because zonisamide is potentially better tolerated and easier to titrate in the outpatient setting than topiramate, it may offer important clinical advantages in the treatment of alcoholism. This is a small 12-week placebo-controlled pilot study examining tolerability and potential efficacy in anticipation of a larger, placebo-controlled trial of zonisamide for treatment of alcohol dependence. It is a randomized, double-blind trial of zonisamide vs. placebo at flexible dosages of 100-500mg/day in alcoholics receiving ambulatory psychosocial treatment. Participants will take part in six individual Cognitive-Behavioral based therapy sessions, which are focused on learning coping skills. Participants must endorse a goal of either cutting down their drinking to non-hazardous levels, or abstinence.	Alcoholism Alcohol Abuse Alcohol Dependence	Zonisamide Pharmacotherapy Alcohol dependence anticonvulsant	null	2	arm 1: Zonisamide arm 2: placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: flexible dosages of 100-500mg/day intervention 2: Placebo	intervention 1: zonisamide intervention 2: Placebo	1	Farmington \| Connecticut \| United States \| -72.83204 \| 41.71982	40	NCT00595556	1COMPLETED	2009-05-01	2006-07-01	UConn Health	7OTHER	false	false	false	null	0
[ 3 ]	121	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The primary purpose of this study is to determine the efficacy and safety of three dose levels of cobiprostone as compared to placebo in OA/RA patients treated with an NSAID for 20 months.	null	NSAID-induced Gastroduodenal Injury Ulcers Rheumatoid Arthritis Osteoarthritis		null	4	arm 1: Participants receive matching placebo capsules for 20 months arm 2: Participants receive 18 mcg cobiprostone once daily (QD) for 20 months arm 3: Participants receive 18 mcg cobiprostone twice daily (BID) for 20 months arm 4: Participants receive 18 mcg cobiprostone three times daily (TID) for 20 months	[ 2, 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 18 mcg cobiprostone capsules for oral administration intervention 2: Matching placebo capsules for oral administration intervention 3: Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.	intervention 1: Cobiprostone intervention 2: Placebo intervention 3: Non-steroidal anti-inflammatory drug	19	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Chula Vista \| California \| United States \| -117.0842 \| 32.64005 Loma Linda \| California \| United States \| -117.26115 \| 34.04835 Mission Hills \| California \| United States \| -120.43683 \| 34.68609 Palm Springs \| California \| United States \| -116.54529 \| 33.8303 Sepulveda \| California \| United States \| -118.28285 \| 34.16167 Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Great Neck \| New York \| United States \| -73.72846 \| 40.80066 New York \| New York \| United States \| -74.00597 \| 40.71427 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Duncansville \| Pennsylvania \| United States \| -78.4339 \| 40.42341 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681	121	NCT00597818	1COMPLETED	2009-05-01	2007-08-01	Sucampo Pharma Americas, LLC	4INDUSTRY	false	false	false	null	0
[ 4 ]	51	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The primary objective of this study is to explore the efficacy of Nasonex (mometasone furoate nasal spray) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma. A secondary objective is to evaluate the efficacy of Nasonex in relieving the subject's symptoms of allergic rhinitis and asthma.	The primary objective is to explore the efficacy of mometasone furoate nasal spray (MFNS) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). In addition, there are two secondary objectives. The first secondary objective is to evaluate the efficacy of MFNS in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma as measured by the Rhinasthma Upper Airways Score, the Rhinasthma Lower Airways Score, and the Rhinasthma Respiratory Allergy Impact Score. The second secondary objective is to evaluate the efficacy of MFNS in relieving the subject's symptoms of allergic rhinitis and asthma as measured by the Total 5 Symptoms Score (T5SS) and the Global Symptom Score (T5SS+asthma symptoms) and by the use of rescue medication on demand.	Allergic Rhinitis Asthma		null	2	arm 1: Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning. arm 2: Placebo nasal spray once daily (two puffs per nostril) in the morning.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning. intervention 2: Placebo nasal spray once daily (two puffs per nostril) in the morning.	intervention 1: Mometasone furoate nasal spray (MFNS) intervention 2: Placebo nasal spray	0	null	51	NCT00599027	1COMPLETED	2009-05-01	2008-05-01	Organon and Co	4INDUSTRY	false	false	false	null	0
[ 4 ]	701	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control	null	Diabetes Mellitus, Type 2		null	2	arm 1: Patients receive linagliptin 5 mg tablets once daily arm 2: Patients receive placebo tablets matching linagliptin 5 mg tablets once daily	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Patients receive linagliptin 5 mg tablets once daily intervention 2: Patients receive linagliptin 5 mg tablets once daily	intervention 1: linagliptin intervention 2: linagliptin	82	Chula Vista \| California \| United States \| -117.0842 \| 32.64005 Spring Valley \| California \| United States \| -116.99892 \| 32.74477 Walnut Creek \| California \| United States \| -122.06496 \| 37.90631 Northglenn \| Colorado \| United States \| -104.9872 \| 39.88554 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 Gurnee \| Illinois \| United States \| -87.90202 \| 42.3703 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Mentor \| Ohio \| United States \| -81.33955 \| 41.66616 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Greer \| South Carolina \| United States \| -82.22706 \| 34.93873 Simpsonville \| South Carolina \| United States \| -82.25428 \| 34.73706 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Federal Way \| Washington \| United States \| -122.31262 \| 47.32232 Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Břeclav \| N/A \| Czechia \| 16.88203 \| 48.75897 Hodonín \| N/A \| Czechia \| 17.13244 \| 48.84893 Olomouc \| N/A \| Czechia \| 17.25175 \| 49.59552 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Jyväskylä \| N/A \| Finland \| 25.72088 \| 62.24147 Kuopio \| N/A \| Finland \| 27.67703 \| 62.89238 Oulu \| N/A \| Finland \| 25.46816 \| 65.01236 Seinäjoki \| N/A \| Finland \| 22.82822 \| 62.79446 Turku \| N/A \| Finland \| 22.26869 \| 60.45148 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Piraeus \| N/A \| Greece \| 23.64619 \| 37.94203 Andhra Pradesh \| N/A \| India \| N/A \| N/A Bangalore \| N/A \| India \| 77.59369 \| 12.97194 Bangalore \| N/A \| India \| 77.59369 \| 12.97194 Chennai \| N/A \| India \| 80.27847 \| 13.08784 Chennai \| N/A \| India \| 80.27847 \| 13.08784 Hyderabad \| N/A \| India \| 78.45636 \| 17.38405 Jaipur \| N/A \| India \| 75.78781 \| 26.91962 Karnataka \| N/A \| India \| N/A \| N/A Mangalore \| N/A \| India \| 74.85603 \| 12.91723 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 Nagpur \| N/A \| India \| 79.08491 \| 21.14631 Nashik \| N/A \| India \| 73.79096 \| 19.99727 Trivandrum \| N/A \| India \| 76.94924 \| 8.4855 Uttar Pradesh \| N/A \| India \| N/A \| N/A Afula \| N/A \| Israel \| 35.2892 \| 32.60907 Haifa \| N/A \| Israel \| 34.99928 \| 32.81303 Holon \| N/A \| Israel \| 34.77918 \| 32.01034 Jerusalem \| N/A \| Israel \| 35.21633 \| 31.76904 Nahariya \| N/A \| Israel \| 35.09814 \| 33.00892 Safed \| N/A \| Israel \| 35.496 \| 32.96465 Tel Aviv \| N/A \| Israel \| 34.78057 \| 32.08088 Aguascalientes, Ags. \| N/A \| Mexico \| -102.2843 \| 21.88262 cOL OBREGON,León, Guanajuato \| N/A \| Mexico \| N/A \| N/A Col. Lomas de San Francisco, Monterrey \| N/A \| Mexico \| -100.31721 \| 25.68435 Col. Mitras Centro, Monterrey, N.L. \| N/A \| Mexico \| -100.31721 \| 25.68435 Col.Americana, Guadalajara, Jalisco \| N/A \| Mexico \| N/A \| N/A Colonia Tlalpan, Mexico \| N/A \| Mexico \| -98.43784 \| 18.88011 Faccionamiento Lomas de Campestre,AGUASCAL \| N/A \| Mexico \| N/A \| N/A Lomas de Reforma \| N/A \| Mexico \| -99.23404 \| 19.40339 Mexico \| N/A \| Mexico \| -98.43784 \| 18.88011 Tlalpan-México D,F \| N/A \| Mexico \| N/A \| N/A Christchurch \| N/A \| New Zealand \| 172.63333 \| -43.53333 Dunedin \| N/A \| New Zealand \| 170.50361 \| -45.87416 Otahuhu \| N/A \| New Zealand \| 174.84019 \| -36.9382 Tauranga \| N/A \| New Zealand \| 176.16667 \| -37.68611 Wellington \| N/A \| New Zealand \| 174.77557 \| -41.28664 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Novosibirsk \| N/A \| Russia \| 82.94339 \| 55.03442 Perm \| N/A \| Russia \| 56.25017 \| 58.01046 Tomsk \| N/A \| Russia \| 84.98204 \| 56.50032 Härnösand \| N/A \| Sweden \| 17.93794 \| 62.63228 Malmo \| N/A \| Sweden \| 13.00073 \| 55.60587 Uddevalla \| N/A \| Sweden \| 11.9424 \| 58.34784 Uppsala \| N/A \| Sweden \| 17.63889 \| 59.85882 Uppsala \| N/A \| Sweden \| 17.63889 \| 59.85882	700	NCT00601250	1COMPLETED	2009-05-01	2008-01-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 4 ]	1,058	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with insufficient glycaemic control.	null	Diabetes Mellitus, Type 2		null	2	arm 1: linagliptin 5 mg once daily arm 2: placebo matching linagliptin 5 mg tablets	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: active intervention 2: placebo to linagliptin 5 mg	intervention 1: linagliptin intervention 2: placebo	100	Capital Federal \| N/A \| Argentina \| N/A \| N/A Capital Federal \| N/A \| Argentina \| N/A \| N/A Capital Federal \| N/A \| Argentina \| N/A \| N/A Capital Federal \| N/A \| Argentina \| N/A \| N/A Capital Federal \| N/A \| Argentina \| N/A \| N/A Corrientes \| N/A \| Argentina \| -58.8344 \| -27.46784 Córdoba \| N/A \| Argentina \| -64.18853 \| -31.40648 Córdoba \| N/A \| Argentina \| -64.18853 \| -31.40648 Mar del Plata \| N/A \| Argentina \| -57.5562 \| -38.00042 Mar del Plata \| N/A \| Argentina \| -57.5562 \| -38.00042 Mendoza \| N/A \| Argentina \| -68.84582 \| -32.88946 Parque Velez Sarfield \| N/A \| Argentina \| N/A \| N/A Rosario \| N/A \| Argentina \| -60.63932 \| -32.94682 Salta \| N/A \| Argentina \| -65.41999 \| -24.80645 Bruges \| N/A \| Belgium \| 3.22424 \| 51.20892 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Edegem \| N/A \| Belgium \| 4.44504 \| 51.15662 Genk \| N/A \| Belgium \| 5.50082 \| 50.965 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Huy \| N/A \| Belgium \| 5.23284 \| 50.51894 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Etobicoke \| Ontario \| Canada \| -79.56985 \| 43.64415 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Oakville \| Ontario \| Canada \| -79.68292 \| 43.45011 Sarnia \| Ontario \| Canada \| -82.40407 \| 42.97866 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Montague \| Prince Edward Island \| Canada \| -62.64866 \| 46.16681 Saskatoon \| Saskatchewan \| Canada \| -106.66892 \| 52.13238 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Chengdu, Sichuan Province \| N/A \| China \| 104.06667 \| 30.66667 Dalian \| N/A \| China \| 121.60222 \| 38.91222 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Haerbin \| N/A \| China \| N/A \| N/A Nanjing, Jiangsu Province \| N/A \| China \| 118.77778 \| 32.06167 Qingdao \| N/A \| China \| 120.38042 \| 36.06488 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Shenyang \| N/A \| China \| 123.43278 \| 41.79222 Weizikeng \| N/A \| China \| 116.60218 \| 26.6475 Wuhan \| N/A \| China \| 114.26667 \| 30.58333 Wuhan, Hubei Province \| N/A \| China \| 114.26667 \| 30.58333 Xian, Shanxi Province \| N/A \| China \| 108.92861 \| 34.25833 Aschaffenburg \| N/A \| Germany \| 9.15214 \| 49.97704 Bad Mergentheim \| N/A \| Germany \| 9.77361 \| 49.4925 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Bosenheim \| N/A \| Germany \| 7.91382 \| 49.84472 Dresden \| N/A \| Germany \| 13.73832 \| 51.05089 Mainz \| N/A \| Germany \| 8.2791 \| 49.98419 Neuwied \| N/A \| Germany \| 7.47057 \| 50.4336 Nuremberg \| N/A \| Germany \| 11.07752 \| 49.45421 Saarbrücken \| N/A \| Germany \| 7.00982 \| 49.23262 Manila \| N/A \| Philippines \| 120.9822 \| 14.6042 Marikina City \| N/A \| Philippines \| 121.1133 \| 14.6481 Pasig \| N/A \| Philippines \| 121.0614 \| 14.58691 Quezon City \| N/A \| Philippines \| 121.0509 \| 14.6488 San Juan City \| N/A \| Philippines \| 121.0333 \| 14.6 Arkhangelsk \| N/A \| Russia \| 40.55291 \| 64.54717 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Rostov-on-Don \| N/A \| Russia \| 39.72328 \| 47.23135 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Samara \| N/A \| Russia \| 50.15 \| 53.20007 Busan \| N/A \| South Korea \| 129.03004 \| 35.10168 Daegu \| N/A \| South Korea \| 128.59111 \| 35.87028 Incheon \| N/A \| South Korea \| 126.70515 \| 37.45646 Jeonju \| N/A \| South Korea \| 127.14889 \| 35.82194 Pusan \| N/A \| South Korea \| 128.3681 \| 36.3809 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Suwon \| N/A \| South Korea \| 127.00889 \| 37.29111 Changhua \| N/A \| Taiwan \| 120.5512 \| 24.0692 Taichung \| N/A \| Taiwan \| 120.6839 \| 24.1469 Tainan City \| N/A \| Taiwan \| 120.21333 \| 22.99083 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Taoyuan District \| N/A \| Taiwan \| 121.3187 \| 24.9896 Erzurum \| N/A \| Turkey (Türkiye) \| 41.27694 \| 39.90861 Istanbul \| N/A \| Turkey (Türkiye) \| 28.94966 \| 41.01384 Izmir \| N/A \| Turkey (Türkiye) \| 27.13838 \| 38.41273 Konya \| N/A \| Turkey (Türkiye) \| 32.48464 \| 37.87135 Ashford \| N/A \| United Kingdom \| 0.87376 \| 51.14648 Baillieston, Glasgow \| N/A \| United Kingdom \| N/A \| N/A Bath \| N/A \| United Kingdom \| -2.36172 \| 51.3751 Burbage \| N/A \| United Kingdom \| -1.67087 \| 51.35184 Bury Saint Edmonds \| N/A \| United Kingdom \| N/A \| N/A Cardiff \| N/A \| United Kingdom \| -3.18 \| 51.48 Glasgow \| N/A \| United Kingdom \| -4.25763 \| 55.86515 Penarth \| N/A \| United Kingdom \| -3.17342 \| 51.4386 Reading \| N/A \| United Kingdom \| -0.97113 \| 51.45625 Waterloo, Liverpool \| N/A \| United Kingdom \| N/A \| N/A	1,055	NCT00602472	1COMPLETED	2009-05-01	2008-02-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 2 ]	19	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Investigate safety, tolerability and pharmacokinetics of CP-751,871 when given in combination with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer	null	Carcinoma, Non-Small-Cell Lung	CP-751,871, Non-small cell lung cancer, Phase 1	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Chemotherapy (carboplatin and paclitaxel) and CP-751,871 (6, 10 or 20mg/kg) will be administered by intravenous infusion every three weeks.	intervention 1: CP-751,871 + carboplatin + paclitaxel	1	Chuo-ku \| Tokyo \| Japan \| N/A \| N/A	19	NCT00603538	1COMPLETED	2009-05-01	2008-01-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 5 ]	241	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.	null	Opiate Dependence Drug Dependence		null	2	arm 1: Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) during Weeks 2-4 with weekly access to take-home doses as of Week 2. arm 2: Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) during Weeks 2-4 with weekly access to take-home doses as of Week 2.	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Suboxone sublingual tablet 4 mg/1 mg - 24 mg/6 mg, daily for 28 days intervention 2: Subutex sublingual tablet 4-24 mg, daily for 28 days	intervention 1: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484 intervention 2: Subutex, Buprenorphine Hydrochloride, SCH 28444	0	null	240	NCT00605033	1COMPLETED	2009-05-01	2008-03-01	Indivior Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	61	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours for at least 24 hours.	null	Burns		null	2	arm 1: None arm 2: None	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: 800 milligrams of intravenous ibuprofen (patients greater 12 years of age) or 10 milligrams/kilograms (patients greater than 12 years; maximum of 400 milligrams) every 6 hours intervention 2: Placebo	intervention 1: Caldolor intervention 2: Placebo	5	Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Baroda \| Kothi \| India \| 76.65 \| 25.5 Mumbai \| Sion \| India \| 72.88261 \| 19.07283 Pune \| N/A \| India \| 73.85535 \| 18.51957	61	NCT00606489	1COMPLETED	2009-05-01	2007-11-01	Cumberland Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 4 ]	12	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	To evaluate the effects of paricalcitol injection on cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have left ventricular hypertrophy (LVH).	null	Chronic Kidney Disease (CKD) Stage 5 Hypertrophy, Left Ventricular	Zemplar, paricalcitol, PRIMO II	null	2	arm 1: Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis arm 2: Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Paricalcitol Injection 4 mcg/mL intravenously three times a week during dialysis intervention 2: Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis	intervention 1: paricalcitol injection 4 mcg/mL intervention 2: Placebo Injection 4 mcg/mL	76	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Bakersfield \| California \| United States \| -119.01871 \| 35.37329 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Dimas \| California \| United States \| -117.80673 \| 34.10668 Simi Valley \| California \| United States \| -118.78148 \| 34.26945 Arvada \| Colorado \| United States \| -105.08748 \| 39.80276 Westminster \| Colorado \| United States \| -105.0372 \| 39.83665 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Evanston \| Illinois \| United States \| -87.69006 \| 42.04114 Evergreen Park \| Illinois \| United States \| -87.70172 \| 41.72059 Gurnee \| Illinois \| United States \| -87.90202 \| 42.3703 Rockville \| Maryland \| United States \| -77.15276 \| 39.084 Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Liverpool \| New South Wales \| Australia \| 150.92588 \| -33.91938 Sydney \| New South Wales \| Australia \| 151.20732 \| -33.86785 Wooloongabba \| Queensland \| Australia \| N/A \| N/A Parkville \| Victoria \| Australia \| 144.95 \| -37.78333 Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Pizen \| N/A \| Czechia \| N/A \| N/A Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Coburg \| N/A \| Germany \| 10.96384 \| 50.25937 Dortmund \| N/A \| Germany \| 7.466 \| 51.51494 Düsseldorf \| N/A \| Germany \| 6.77616 \| 51.22172 Nettetal \| N/A \| Germany \| 6.28333 \| 51.31667 Würzburg \| N/A \| Germany \| 9.95121 \| 49.79391 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Thessaloniki \| N/A \| Greece \| 22.93086 \| 40.64361 Bologna \| N/A \| Italy \| 11.33875 \| 44.49381 Monza \| N/A \| Italy \| 9.27246 \| 45.58005 Pavia \| N/A \| Italy \| 9.15917 \| 45.19205 Trieste \| N/A \| Italy \| 13.77678 \| 45.64953 Katowice \| N/A \| Poland \| 19.02754 \| 50.25841 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Szczecin \| N/A \| Poland \| 14.55302 \| 53.42894 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Caguas \| N/A \| Puerto Rico \| -66.0485 \| 18.23412 Rio Piedras \| N/A \| Puerto Rico \| -66.04989 \| 18.39745 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Cluj-Napoca \| N/A \| Romania \| 23.6 \| 46.76667 Cluj-Napoca \| N/A \| Romania \| 23.6 \| 46.76667 Iași \| N/A \| Romania \| 27.6 \| 47.16667 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Córdoba \| N/A \| Spain \| -4.77275 \| 37.89155 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Palma de Mallorca \| N/A \| Spain \| 2.65024 \| 39.56939 Pamplona \| N/A \| Spain \| -1.64323 \| 42.81687 Seville \| N/A \| Spain \| -5.97317 \| 37.38283 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Taoyuan District \| N/A \| Taiwan \| 121.3187 \| 24.9896 Xinzhuang \| N/A \| Taiwan \| 120.3713 \| 23.916 Coventry \| N/A \| United Kingdom \| -1.51217 \| 52.40656 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 Salford \| N/A \| United Kingdom \| -2.29042 \| 53.48771	12	NCT00616902	6TERMINATED	2009-05-01	2009-01-01	Abbott	4INDUSTRY	false	false	false	null	0
[ 0 ]	15	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	4QUADRUPLE	true	0ALL	false	Clopidogrel is a medication that is used to decrease the ability of platelets to form blood clots. The theory has been proposed that, in patients with coronary artery disease or stroke, increased platelet function after discontinuation of clopidogrel therapy is associated with an increased clotting risk. However, this theory has never been rigorously tested. The goal of this research is to determine whether discontinuation of clopidogrel results in increased platelet function.	In this study, we will address the question: does discontinuation of clopidogrel result in platelet hyperreactivity? We will perform a double-blind, placebo-controlled, crossover study in normal subjects, in whom platelet reactivity will be measured before clopidogrel or placebo, during clopidogrel or placebo, and at various time points after discontinuation of clopidogrel or placebo. The dose of clopidogrel will be the standard, FDA-approved dose: 75 mg daily. All subjects will be treated with aspirin 81 mg daily throughout the 57 days of study assessment in both the clopidogrel arm and the placebo arm, because the clinically relevant question is: in patients who remain on aspirin, does discontinuation of clopidogrel result in platelet hyperreactivity?	Blood Platelets Clopidogrel	blood platelets platelet aggregation inhibitors antiplatelet drugs clopidogrel	null	2	arm 1: The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 43 days. arm 2: The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 43 days.	[ 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Clopidogrel 75mg plus aspirin 81mg, tablet by mouth daily for 14 days. intervention 2: Placebo plus aspirin 81 mg, tablet by mouth daily for 14 days. intervention 3: Aspirin 81mg tablet by mouth continued daily alone for 43 days after day 14.	intervention 1: clopidogrel + aspirin intervention 2: placebo intervention 3: Aspirin	1	Worcester \| Massachusetts \| United States \| -71.80229 \| 42.26259	30	NCT00619073	1COMPLETED	2009-05-01	2008-04-01	University of Massachusetts, Worcester	7OTHER	false	false	false	null	0
[ 4 ]	503	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	To investigate efficacy, safety and tolerability of BI 1356 versus placebo	null	Diabetes Mellitus, Type 2		null	2	arm 1: linagliptin 5 mg once daily arm 2: placebo matching linagliptin 5 mg tablets	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: active intervention 2: placebo	intervention 1: linagliptin intervention 2: placebo	69	Krapinske Toplice \| N/A \| Croatia \| 15.84333 \| 46.09333 Slavonski Brod \| N/A \| Croatia \| 18.01556 \| 45.16028 Andhra Pradesh \| N/A \| India \| N/A \| N/A Bangalore \| N/A \| India \| 77.59369 \| 12.97194 Bangalore \| N/A \| India \| 77.59369 \| 12.97194 Chennai \| N/A \| India \| 80.27847 \| 13.08784 Ghaziabad \| N/A \| India \| 77.43915 \| 28.66535 Hyderabad \| N/A \| India \| 78.45636 \| 17.38405 Jaipur \| N/A \| India \| 75.78781 \| 26.91962 Maharashtra \| N/A \| India \| N/A \| N/A Mangalore \| N/A \| India \| 74.85603 \| 12.91723 Manipal \| N/A \| India \| 74.78333 \| 13.35 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 Nashik \| N/A \| India \| 73.79096 \| 19.99727 Tamilnadu \| N/A \| India \| N/A \| N/A Trivandrum, Kerala \| N/A \| India \| 76.94924 \| 8.4855 Giv‘atayim \| N/A \| Israel \| 34.81253 \| 32.07225 Haifa \| N/A \| Israel \| 34.99928 \| 32.81303 Holon \| N/A \| Israel \| 34.77918 \| 32.01034 Jerusalem \| N/A \| Israel \| 35.21633 \| 31.76904 Nahariya \| N/A \| Israel \| 35.09814 \| 33.00892 Safed \| N/A \| Israel \| 35.496 \| 32.96465 Catanzaro \| N/A \| Italy \| 16.60086 \| 38.88247 Genova \| N/A \| Italy \| 11.87211 \| 45.21604 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Pisa \| N/A \| Italy \| 10.4036 \| 43.70853 Roma \| N/A \| Italy \| 11.10642 \| 44.99364 Alor Star \| N/A \| Malaysia \| 100.36014 \| 6.12104 Kelantan Kota Bahru \| N/A \| Malaysia \| N/A \| N/A Kuala Lumpur \| N/A \| Malaysia \| 101.68653 \| 3.1412 Kuala Lumpur \| N/A \| Malaysia \| 101.68653 \| 3.1412 Perak \| N/A \| Malaysia \| 102.5862 \| 3.8682 Perak \| N/A \| Malaysia \| 102.5862 \| 3.8682 Pulau Pinang \| N/A \| Malaysia \| 102.56667 \| 3.55 Andijk \| N/A \| Netherlands \| 5.22222 \| 52.74667 Castricum \| N/A \| Netherlands \| 4.66944 \| 52.54833 Deurne \| N/A \| Netherlands \| 5.79722 \| 51.46 Ewijk \| N/A \| Netherlands \| 5.7375 \| 51.87 Losser \| N/A \| Netherlands \| 7.00417 \| 52.26083 Oude Pekela \| N/A \| Netherlands \| 7.00972 \| 53.10417 Poortvliet \| N/A \| Netherlands \| 4.14306 \| 51.54417 Rijswijk \| N/A \| Netherlands \| 4.32501 \| 52.03634 Roelofarendsveen \| N/A \| Netherlands \| 4.63333 \| 52.20333 Wildervank \| N/A \| Netherlands \| 6.8625 \| 53.08083 Lublin \| N/A \| Poland \| 22.56667 \| 51.25 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Zabrze \| N/A \| Poland \| 18.78576 \| 50.32492 Brasov \| N/A \| Romania \| 25.60613 \| 45.64861 Galati \| N/A \| Romania \| 28.05028 \| 45.43687 Banská Bystrica \| N/A \| Slovakia \| 19.15349 \| 48.73946 Bratislava \| N/A \| Slovakia \| 17.10674 \| 48.14816 Bratislava \| N/A \| Slovakia \| 17.10674 \| 48.14816 Bratislava \| N/A \| Slovakia \| 17.10674 \| 48.14816 Nové Mesto nad Váhom \| N/A \| Slovakia \| 17.8309 \| 48.75763 Šamorín \| N/A \| Slovakia \| 17.30972 \| 48.03015 Bangkok \| N/A \| Thailand \| 100.50144 \| 13.75398 Khon Kaen \| N/A \| Thailand \| 102.833 \| 16.44671 Dnipro \| N/A \| Ukraine \| 35.04066 \| 48.46664 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Lviv \| N/A \| Ukraine \| 24.02324 \| 49.83826 Vinnitsa \| N/A \| Ukraine \| 37.71861 \| 49.84639 Zaporizhzhya \| N/A \| Ukraine \| 35.11714 \| 47.85167	503	NCT00621140	1COMPLETED	2009-05-01	2008-02-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 4 ]	540	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) according to the Los Angeles classification.	null	Reflux Esophagitis	Reflux Esophagitis	null	2	arm 1: Esomeprazole and Omeprazole arm 2: Esomeprazole	[ 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 10mg once daily oral administration intervention 2: 20mg once daily oral administration intervention 3: 10mg once daily oral administration	intervention 1: Esomeprazole intervention 2: Esomeprazole intervention 3: Omeprazole	44	Akita \| Akita \| Japan \| 140.11667 \| 39.71667 Kashiwa \| Chiba \| Japan \| 139.97732 \| 35.86224 Kisarazu \| Chiba \| Japan \| 139.93254 \| 35.38329 Kōriyama \| Fukishima \| Japan \| 140.38333 \| 37.4 Nihonmatsu \| Fukishima \| Japan \| 139.26427 \| 37.96201 Nishishirakawa \| Fukishima \| Japan \| N/A \| N/A Fukuoika \| Fukuoka \| Japan \| N/A \| N/A Fukuoka \| Fukuoka \| Japan \| 130.41667 \| 33.6 Kurume \| Fukuoka \| Japan \| 130.51667 \| 33.31667 Nukaya \| Fukuoka \| Japan \| N/A \| N/A Fukuoka \| Fukuolka \| Japan \| 130.41667 \| 33.6 Kōriyama \| Fukushima \| Japan \| 140.38333 \| 37.4 Shirakawa \| Fukushima \| Japan \| 140.26211 \| 37.11954 Sugawa \| Fukushima \| Japan \| N/A \| N/A Gifu \| Gifu \| Japan \| 136.76039 \| 35.42291 Maebashi \| Gunma \| Japan \| 139.08333 \| 36.4 Yasunaka \| Gunma \| Japan \| N/A \| N/A Sapporo \| Hokkaido \| Japan \| 141.35 \| 43.06667 Hitachi \| Ibaraki \| Japan \| 140.65 \| 36.6 Mito \| Ibaraki \| Japan \| 140.45 \| 36.35 Tsukuba \| Ibaraki \| Japan \| 140.11667 \| 36.08333 Sakaidechō \| Kagawa-ken \| Japan \| 133.8356 \| 34.32278 Takamatsu \| Kagawa-ken \| Japan \| 134.05 \| 34.33333 Fujisawa \| Kanagawa \| Japan \| 139.47666 \| 35.34926 Kawasaki \| Kanagawa \| Japan \| 139.71722 \| 35.52056 Sagamihara \| Kanagawa \| Japan \| 139.24167 \| 35.56707 Yokohama \| Kanagawa \| Japan \| 139.65 \| 35.43333 Kyoto \| Kyoto \| Japan \| 135.75385 \| 35.02107 Shibata \| Myagi \| Japan \| 139.33333 \| 37.95 Kiso \| Nagano \| Japan \| 137.69028 \| 35.84036 Matsumoto \| Nagano \| Japan \| 137.96667 \| 36.23333 Ōita \| Oita Prefecture \| Japan \| 131.6 \| 33.23333 Fujiidera \| Osaka \| Japan \| 135.5974 \| 34.5676 Toyonaka \| Osaka \| Japan \| 135.46932 \| 34.78244 Shizuoka \| Shizuoka \| Japan \| 138.38333 \| 34.98333 Ohtawara \| Tochigi \| Japan \| N/A \| N/A Toshima-ku \| Tokayo \| Japan \| N/A \| N/A Adachi City \| Tokyo \| Japan \| 139.80761 \| 35.76318 Hachiōji \| Tokyo \| Japan \| 139.32389 \| 35.65583 Kiyose \| Tokyo \| Japan \| 139.53014 \| 35.77952 Setagaya City \| Tokyo \| Japan \| 139.64715 \| 35.64188 Shinagawa \| Tokyo \| Japan \| N/A \| N/A Tottori-shi \| Tottori \| Japan \| 134.23333 \| 35.5 Shimonoseki \| Yamaguchi \| Japan \| 130.93713 \| 33.95548	563	NCT00634114	1COMPLETED	2009-05-01	2008-01-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 5 ]	14	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to the effects of immediate-release carbidopa/levodopa on non-motor symptoms of end-of-dose wearing off in persons who have Parkinson's disease.	null	Parkinson's Disease	Idiopathic Parkinson's disease carbidopa/levodopa/entacapone non-motor symptoms motor-symptoms	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study. intervention 2: Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.	intervention 1: Carbidopa/levodopa/entacapone intervention 2: Immediate release carbidopa/levodopa	21	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Aliso Viejo \| California \| United States \| -117.72712 \| 33.56504 Irvine \| California \| United States \| -117.82311 \| 33.66946 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 Port Charlotte \| Florida \| United States \| -82.09064 \| 26.97617 Topeka \| Kansas \| United States \| -95.67804 \| 39.04833 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Columbia \| Missouri \| United States \| -92.33407 \| 38.95171 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Commack \| New York \| United States \| -73.29289 \| 40.84288 Syracuse \| New York \| United States \| -76.14742 \| 43.04812 Syracuse \| New York \| United States \| -76.14742 \| 43.04812 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Monroeville \| Pennsylvania \| United States \| -79.7881 \| 40.42118 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Temple \| Texas \| United States \| -97.34278 \| 31.09823	14	NCT00642356	6TERMINATED	2009-05-01	2008-03-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 3 ]	523	NON_RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	true	The purpose of this study is to provide safety and tolerability data for AZD0837 during long-term treatment (5 years) in patients with non-valvular atrial fibrillation (AF) and one or more additional risk factors for stroke and systemic embolic events (moderate to high risk patients).	null	Persistent or Permanent Nonvalvular Atrial Fibrillation		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od intervention 2: Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5	intervention 1: AZD0837 intervention 2: VKA INR 2-3	0	null	523	NCT00645853	1COMPLETED	2009-05-01	2007-10-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 4 ]	350	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of the study is to compare the safety and efficacy, with regards to the signs and symptoms, of MR prednisone (Lodotra®) versus placebo in combination with standard Disease Modifying Anti-Rheumatic Drug (DMARD) treatment in patients with active rheumatoid arthritis.	Study with completed results acquired from Horizon in 2024.	Rheumatoid Arthritis	Signs and Symptoms Autoimmune Diseases Joint Diseases Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Predniso(lo)ne	null	2	arm 1: Modified Release (MR) prednisone 5 mg arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 1 x 5 mg daily intervention 2: 1x daily	intervention 1: MR prednisone intervention 2: Placebo	52	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Pacific Palisades \| California \| United States \| -118.52647 \| 34.04806 San Diego \| California \| United States \| -117.16472 \| 32.71571 Upland \| California \| United States \| -117.64839 \| 34.09751 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Wheat Ridge \| Colorado \| United States \| -105.07721 \| 39.7661 Palm Harbor \| Florida \| United States \| -82.76371 \| 28.07807 Tamarac \| Florida \| United States \| -80.24977 \| 26.21286 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Vero Beach \| Florida \| United States \| -80.39727 \| 27.63864 Springfield \| Illinois \| United States \| -89.64371 \| 39.80172 Elizabethtown \| Kentucky \| United States \| -85.85913 \| 37.69395 Fall River \| Massachusetts \| United States \| -71.15505 \| 41.70149 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Reno \| Nevada \| United States \| -119.8138 \| 39.52963 Belmont \| North Carolina \| United States \| -81.0373 \| 35.24292 Perrysburg \| Ohio \| United States \| -83.62716 \| 41.557 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Greer \| South Carolina \| United States \| -82.22706 \| 34.93873 Rock Hill \| South Carolina \| United States \| -81.02508 \| 34.92487 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Bellevue \| Washington \| United States \| -122.20068 \| 47.61038 Windsor \| Ontario \| Canada \| -83.01654 \| 42.30008 Bad Nauheim \| N/A \| Germany \| 8.73859 \| 50.36463 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 München \| N/A \| Germany \| 13.31243 \| 51.60698 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Debrecen \| N/A \| Hungary \| 21.62444 \| 47.53167 Debrecen \| N/A \| Hungary \| 21.62444 \| 47.53167 Kecskemét \| N/A \| Hungary \| 19.69128 \| 46.90618 Kiskunhalas \| N/A \| Hungary \| 19.48479 \| 46.43402 Pécs \| N/A \| Hungary \| 18.23083 \| 46.0725 Szolnok \| N/A \| Hungary \| 20.2 \| 47.18333 Szombathely \| N/A \| Hungary \| 16.62155 \| 47.23088 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Lublin \| N/A \| Poland \| 22.56667 \| 51.25 Poznan \| N/A \| Poland \| 16.92993 \| 52.40692 Sopot \| N/A \| Poland \| 18.56003 \| 54.4418 Torun \| N/A \| Poland \| 18.59814 \| 53.01375 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1 Bristol \| N/A \| United Kingdom \| -2.59665 \| 51.45523 Lincolnshire \| N/A \| United Kingdom \| N/A \| N/A Metropolitan Borough of Wirral \| N/A \| United Kingdom \| -3.10501 \| 53.37616	350	NCT00650078	1COMPLETED	2009-05-01	2008-03-01	Amgen	4INDUSTRY	false	false	false	null	0
[ 3 ]	102	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	To examine the clinical efficacy of sertraline (200 mg/day) alone or sertraline in combination with gabapentin. The purpose of this study is to examine whether the antidepressant sertraline alone or combined with gabapentin delays time to relapse relative to placebo in recently abstinent cocaine-dependent volunteers who are also depressed. In addition, whether depressive symptoms or genetic factors influence treatment response to the study medications will be examined. Our hypothesis is that those on combined sertraline-gabapentin will show a longer period of abstinence than those on sertraline alone or placebo.	Subjects enrolled in this 12-wk, double blind, randomized, placebo-controlled, clinical trial are admitted to a residential facility in North Little Rock (RCA-NLR) and randomized by depressive symptom severity to receive one of the following: sertraline alone (200 mg/day), sertraline (200 mg/day) plus gabapentin (1200 mg/day), or placebo. Subjects are expected to participate in the Substance Abuse Day Treatment Program while residing on the RCA-NLR and being inducted onto the maintenance dose of study medication (weeks 1-2). When participants transfer to the Outpatient Treatment Research Unit (TRU) at the start of their third week, they will continue to receive study medications or placebo (weeks 3-12) and they will be expected to participate in weekly individual cognitive behavioral therapy. Supervised urines and vital signs will be obtained thrice weekly; self-reported adverse effects, mood and drug use self-reports will be obtained once weekly. At the end of 12 weeks, participants will be tapered off the study medication over a five-day period, discharged from the study, and referred to an appropriate treatment or treatment/research program in the community if they are interested.	Cocaine Dependence Depressive Symptoms	cocaine dependence depressive symptoms relapse sertraline gabapentin	null	3	arm 1: Placebo capsules arm 2: sertraline (200 mg/day) arm 3: sertraline (200 mg/day) plus gabapentin (1,200 mg/day)	[ 2, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Sertraline hydrochloride (200 mg/day) will be administered once daily. While subjects are at RCA-NLR they initially receive 50 mg/day of sertraline. This dose is gradually increased over a 3-week period until subjects receive 200 mg. When subjects are transferred to the outpatient program, they will be administered capsules once weekly, with take-home doses given in blister packs to take once a day for the rest of the week. intervention 2: Placebo (cellulose or lactose) administered twice per day for 12 weeks. intervention 3: Gabapentin (Neurontin; Parke-Davis; 1200 mg/day) will be administered twice daily. Initially, patients will receive 200 mg twice daily on days 1-5, 400 mg twice daily on days 6-10, then 600 mg twice daily on days 11 on. Subjects are then maintained on this dose for the duration of the trial, unless side-effects are too severe, in which case the dose of gabapentin is decreased to no less 800 mg/day. If symptoms persist, subjects' participation would then be terminated.	intervention 1: sertraline intervention 2: Placebo intervention 3: gabapentin	1	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648	102	NCT00654953	1COMPLETED	2009-05-01	2006-01-01	University of Arkansas	7OTHER	false	false	false	null	0
[ 2 ]	21	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral absorption is evaluated through the drug recovery in urine.	This trial aims to evaluate the oral adsorption of nepadutant (0.1 or 0.5 mg/Kg given as one single dose as oral solution) in infants divided in three age strata (from 6 to 24 weeks old). Oral absorption is evaluated by measuring the amount of nepadutant in the urine output collected during the 24 hours after oral administration with special diapers. Safety and tolerability of the drug will be evaluated by monitoring any changes in signs/symptoms at medical examination and vital signs during the fist 4 hours post-dose in the Hospital site and then by the parents at home up to 24 hours and 1 week post nepadutant administration.	Infantile Colic Infantile Functional Gastrointestinal Disorders	Infantile colic Abdominal Cramps Colicky Pain Functional gastrointestinal disorders	null	2	arm 1: Nepadutant 0.1 mg/kg arm 2: Nepadutant 0.5 mg/kg	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old) intervention 2: 0.5 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)	intervention 1: Nepadutant intervention 2: Nepadutant	3	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	20	NCT00655083	1COMPLETED	2009-05-01	2008-03-01	Menarini Group	4INDUSTRY	false	false	false	null	0
[ 3 ]	141	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.	null	Hemostasis		null	2	arm 1: None arm 2: SURGICEL™ Absorbable Hemostat	[ 0, 1 ]	2	[ 0, 1 ]	intervention 1: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). intervention 2: Absorbable hemostat	intervention 1: Fibrin Pad intervention 2: SURGICEL™	11	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 New Hyde Park \| New York \| United States \| -73.68791 \| 40.7351 Allentown \| Pennsylvania \| United States \| -75.49018 \| 40.60843 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328	141	NCT00658723	1COMPLETED	2009-05-01	2008-03-01	Ethicon, Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	15	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	With Institutional Ethics Board approval and signed informed consent, a pilot investigation was conducted in which 15 adult patients scheduled to undergo a thoractomy were randomly assigned to receive 1) 150 mg pregabalin 1 hour preoperatively and then 7 days postoperatively (BID) or 2) 300 mg pregabalin 1 hour preoperatively and 7 days postoperatively (BID) or 3) placebo for same regimen to assess the feasibility, safety and compliance of this drug regimen on this patient population. This assessment was necessary in order to plan a future fully powered randomized controlled trial looking at the efficacy of perioperative pregabalin ifor reducing the incidence/severity of chronic post-thoracotomy pain.	Chronic post thoracotomy pain syndrome (CPTPS) is a significant problem that has important effects on patients' daily activities. The severity of postoperative pain and the central sensitization associated with it are thought to play a role in the chronification of acute pain. Gabapentin has been shown to be effective in reducing acute post-surgical pain and treating CPTPS. There is conflicting data regarding its effects on the development of chronic post-surgical pain. Although pregabalin is similar to gabapentin there are only a few studies examining its use in the modification of post-surgical pain but evidence suggests that it might be effective. There are no studies examining the effect of pregabalin on the development of chronic post-surgical pain. Our hypothesis is that perioperative use of pregabalin will decrease the incidence of CPTPS. Our ultimate goal is to conduct a multi-center study assessing the effect of perioperative oral pregabalin on the development of CPTPS. Prior to this, we will carry out a prospective, randomized, placebo controlled, double-blinded pilot study to assess the feasibility, safety, and compliance associated with perioperative use of oral pregabalin in patients undergoing video assisted thoracotomy surgery (VATS) or open thoracotomy procedures.	Chronic Pain	Thoracotomy Post-surgical Pregabalin	null	2	arm 1: Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=3) or Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=4). arm 2: An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. intervention 2: An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op (N=8)	intervention 1: Pregabalin intervention 2: Placebo	1	Kingston \| Ontario \| Canada \| -76.48098 \| 44.22976	15	NCT00663962	1COMPLETED	2009-05-01	2008-04-01	Queen's University	7OTHER	false	false	false	null	0
[ 4 ]	99	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	false	This study is being carried out to see if budesonide with HFA is effective, safe and well tolerated compared with budesonide CFC. Budesonide HFA has been already given in other research studies, in both healthy volunteers and subjects with asthma.	null	Asthma	Asthma hyperreactivity	null	4	arm 1: Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks arm 2: Budesonide HFA 400 mcg twice daily for 2 weeks arm 3: Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks arm 4: Budesonide CFC 400 mcg twice daily for 2 weeks	[ 1, 1, 1, 1 ]	2	[ 0, 0 ]	intervention 1: standard daily inhaled dose intervention 2: standard daily inhaled dose	intervention 1: Budesonide HFA intervention 2: Budesonide CFC	3	King of Prussia \| Pennsylvania \| United States \| -75.39602 \| 40.08927 Dundee \| Scotland \| United Kingdom \| -2.97489 \| 56.46913 Perth \| Scotland \| United Kingdom \| -3.43139 \| 56.39522	331	NCT00667992	1COMPLETED	2009-05-01	2008-04-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 0 ]	57	NON_RANDOMIZED	PARALLEL	1PREVENTION	0NONE	true	1FEMALE	true	The purpose of this study is to see if women presenting for emergency contraception (EC) are willing to accept the copper intrauterine device (IUD). This study will also compare the use of effective methods of contraception between women who selected the copper IUD or Plan B 6 months after they received EC.	This study seeks to estimate the acceptance of Copper IUD use amongst people presenting for EC. This will be accomplished by offering all women who present for EC at participating Planned Parenthood Association of Utah (PPAU) clinics during the study period the option of having the copper IUD or Plan B. Women who agree to study participation will be followed for 6 months. The primary outcome for the study is the use of a reliable method of contraception 6 months after presenting for EC. Secondary outcomes measured will be pregnancies, abortions, repeat Plan B use, presence of gonorrhea or Chlamydia infection at the time of presentation for EC, number of days to first bleeding episode and duration of that bleeding episode, further bleeding patterns, frequency of unprotected intercourse, use of a barrier method for prevention of sexually transmitted infections, patient satisfaction with the chosen method and symptoms possibly related to contraception use. Patients selecting the IUD will be assessed for IUD expulsion, perforation, and removal.	Pregnancy	contraception emergency contraception pregnancy prevention after unprotected intercourse	null	2	arm 1: IUD arm 2: Oral levonorgestrel	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Copper T380 IUD intervention 2: 1.5 mg	intervention 1: Copper T380 IUD intervention 2: levonorgestrel	1	West Valley City \| Utah \| United States \| -112.00105 \| 40.69161	57	NCT00669396	1COMPLETED	2009-05-01	2008-04-01	University of Utah	7OTHER	false	false	false	null	0
[ 2, 3 ]	25	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	false	The objectives of the study are: 1. To evaluate the effect of ABT-335 (choline fenofibrate) on several parameters of RCT (reverse cholesterol transport) in men and post-menopausal women diagnosed with dyslipidemia (i.e., low high-density lipoprotein \[HDL\] cholesterol levels and elevated triglyceride \[TG\] concentrations). 2. To evaluate longitudinal changes in several parameters of RCT in subjects with low HDL. 3. To obtain pilot data for power calculations for subsequent comparative study.	This trial assesses the effects of ABT-335 on RCT as measured by cholesterol efflux or rate of appearance of cholesterol (Ra in mg/kg/hr), cholesterol excretion (%/day), RCT efflux (mg/kg/day) and de novo cholesterol synthesis (%) during a baseline period (7 days) and during a treatment period (94 days). The goal of using RCT to reverse atherosclerosis is to increase the rate of cholesterol export or "efflux" from the tissues and plaques. An increase in this cholesterol efflux rate should shrink arterial plaques by decreasing their static accumulation of cholesterol. While some currently marketed drugs have a positive impact on RCT by increasing the rate of cholesterol excretion from the body, no drug has yet been approved to increase the rate of cholesterol efflux from the tissues	Dyslipidemia		null	1	arm 1: ABT-335 (choline fenofibrate)	[ 0 ]	1	[ 0 ]	intervention 1: 135 mg choline fenofibrate daily(oral, capsule)	intervention 1: choline fenofibrate	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	25	NCT00673881	1COMPLETED	2009-05-01	2008-03-01	Radiant Research	7OTHER	false	false	false	null	0
[ 5 ]	61	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This study aims to compare the efficacy of ranibizumab and verteporfin PDT combination treatment and verteporfin PDT monotherapy vs.ranibizumab monotherapy alone in achieving complete regression of polyps in patients with symptomatic macular polypoidal choroidal vasculopathy.	null	Polypoidal Choroidal Vasculopathy	Polypoidal choroidal vasculopathy PCV Age-related macular degeneration (AMD) variant vision polyps indocyanine green angiography verteporfin ranibizumab photodynamic therapy	null	3	arm 1: Photodynamic therapy with verteporfin in combination with ranibizumab injection. Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity. arm 2: Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity. arm 3: Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.	[ 0, 1, 1 ]	2	[ 0, 0 ]	intervention 1: After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, light application of 50 J/cm\^2 to the study eye was begun 15 minutes after the start of infusion. intervention 2: Ranibizumab at dose of 0.5 mg administered as an intravitreal injection.	intervention 1: Verteporfin Photodynamic Therapy intervention 2: Ranibizumab	5	Hong Kong \| N/A \| Hong Kong \| 114.17469 \| 22.27832 Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Bangkok \| N/A \| Thailand \| 100.50144 \| 13.75398	61	NCT00674323	1COMPLETED	2009-05-01	2008-04-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 0 ]	10	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	1FEMALE	false	Urinary tract infection (UTI) is the most common complication after surgery for prolapse or urinary incontinence. UTIs are painful and have the potential to turn into kidney infections. We are asking women who self-catheterize after surgery to try either an antibiotic or a placebo pill so we can see if we can prevent UTIs without causing side effects. This study will not require any additional visits or blood draws. You will be asked to answer some questions, keep a brief diary of your experience, and immediately report any symptoms of a UTI to your doctor.	Abstract: Specific aim: to determine if extended release nitrofurantoin antibiotic prophylaxis administered to patients performing clean intermittent self-catheterization (CISC) after pelvic organ prolapse and/or urinary incontinence surgery decreases the incidence of symptomatic urinary tract infection (UTI) compared with placebo. Study Design: Randomized double-blind placebo-controlled trial. Methods: Consented patients who undergo urogenital surgery and fail their post-operative voiding trial will be randomized to either extended release nitrofurantoin 100mg or an identical appearing placebo capsule to be taken daily while performing CISC and for three subsequent days after stopping CISC. Catheterized urine specimens will be sent for culture and sensitivity when women report symptoms consistent with cystitis. Symptomatic UTI will be defined using strict culture-based definitions. We anticipate that the study will end within 6 weeks of starting CISC. Data Analysis: Primary and secondary outcomes will be evaluated with Student t test and Fisher exact test. Sample Size: Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 33% to 10%, with 80% power, and a two-sided alpha of 0.05, and a 10% dropout rate, we should recruit a total of 108 patients.	Urinary Tract Infections	urinary catheterization urinary tract infection urinary incontinence pelvic floor prolapse antibiotics	null	2	arm 1: extended release nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC arm 2: identical appearing placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC intervention 2: Placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC	intervention 1: Nitrofurantoin intervention 2: Placebo	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	10	NCT00678041	6TERMINATED	2009-05-01	2008-05-01	University of Pittsburgh	7OTHER	false	false	false	null	0
[ 5 ]	3	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This was a Phase IV, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the effect of Pulmozyme on pulmonary function, health-related quality of life (HRQOL), and respiratory symptoms in 3- to 5-year-old children with cystic fibrosis (CF). Approximately 40 patients were planned to be enrolled in this study. However, only 3 patients were eligible for random allocation and received treatment: 1 patient in the Pulmozyme group and 2 patients in the placebo group. All 3 patients completed the study assessments but did not have usable pulmonary function test (PFT) data.	null	Cystic Fibrosis	Pulmozyme CF	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days intervention 2: 2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days	intervention 1: Dornase alfa intervention 2: Placebo	0	null	3	NCT00680316	6TERMINATED	2009-05-01	2008-06-01	Genentech, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	1,649	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.	CT Gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. Based on numerous nonclinical pharmacology studies of each active ingredient, it is expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory.	Acne Vulgaris Acne	Acne Vulgaris Acne	null	4	arm 1: CT Gel arm 2: Clindamycin Gel (clindamycin) arm 3: Tretinoin Gel (tretinoin) arm 4: Vehicle Gel	[ 0, 1, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks intervention 2: Clindamycin 1% gel applied topically once daily in the evening for 12 weeks intervention 3: Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks intervention 4: Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks	intervention 1: CT Gel intervention 2: Clindamycin Gel (clindamycin ) intervention 3: Tretinoin Gel (tretinoin) intervention 4: Vehicle Gel	32	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Fremont \| California \| United States \| -121.98857 \| 37.54827 San Diego \| California \| United States \| -117.16472 \| 32.71571 Longmont \| Colorado \| United States \| -105.10193 \| 40.16721 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miramar \| Florida \| United States \| -80.23227 \| 25.98731 Ormond Beach \| Florida \| United States \| -81.05589 \| 29.28581 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Fridley \| Minnesota \| United States \| -93.26328 \| 45.08608 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Yardley \| Pennsylvania \| United States \| -74.846 \| 40.24566 Johnston \| Rhode Island \| United States \| -71.50675 \| 41.82186 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Austin \| Texas \| United States \| -97.74306 \| 30.26715 College Station \| Texas \| United States \| -96.33441 \| 30.62798 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389 Belize City \| N/A \| Belize \| -88.19756 \| 17.49952 Belize City \| N/A \| Belize \| -88.19756 \| 17.49952 Waterloo \| Ontario \| Canada \| -80.51639 \| 43.4668 Windsor \| Ontario \| Canada \| -83.01654 \| 42.30008 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884	1,649	NCT00689117	1COMPLETED	2009-05-01	2008-04-01	Stiefel, a GSK Company	4INDUSTRY	false	false	false	null	0
[ 4 ]	726	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.	null	Open-angle Glaucoma Ocular Hypertension		null	2	arm 1: One drop self-administered in the study eye(s) once daily for 90 days arm 2: One drop self-administered in the study eye(s) once daily for 90 days	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as travoprost. intervention 2: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as latanprost.	intervention 1: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) intervention 2: Latanoprost ophthalmic solution 0.005% (XALATAN®)	0	null	726	NCT00690794	1COMPLETED	2009-05-01	2008-07-01	Alcon Research	4INDUSTRY	false	false	false	null	0
[ 4 ]	965	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential hypertension. All three regimens are expected to be well tolerated.	null	Hypertension	Blood pressure hypertension elderly	null	3	arm 1: 1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily arm 2: 1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily arm 3: 1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily	[ 0, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 1 capsule amlodipine 5 mg orally once daily intervention 2: 1 capsule valsartan 80 mg orally once daily intervention 3: 1 capsule valsartan 40 mg orally once daily intervention 4: 1 capsule placebo to match valsartan orally once daily	intervention 1: Amlodipine 5 mg intervention 2: Valsartan 80 mg intervention 3: Valsartan 40 mg intervention 4: Placebo	18	Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Chrudim \| N/A \| Czechia \| 15.79558 \| 49.95109 Hodonín \| N/A \| Czechia \| 17.13244 \| 48.84893 Jičín \| N/A \| Czechia \| 15.35162 \| 50.43723 Náchod \| N/A \| Czechia \| 16.16289 \| 50.4167 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Joensuu \| N/A \| Finland \| 29.76316 \| 62.60118 Kerava \| N/A \| Finland \| 25.105 \| 60.40338 Tampere \| N/A \| Finland \| 23.78712 \| 61.49911 Paris \| N/A \| France \| 2.3488 \| 48.85341 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Rome \| N/A \| Italy \| 12.51133 \| 41.89193 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Bratislava \| N/A \| Slovakia \| 17.10674 \| 48.14816 Valencia \| N/A \| Spain \| -0.37966 \| 39.47391 Malmo \| N/A \| Sweden \| 13.00073 \| 55.60587	818	NCT00699192	1COMPLETED	2009-05-01	2008-05-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 0 ]	3	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine whether cysteamine bitartrate, an FDA-approved drug for a non-psychiatric condition, is safe and effective for the treatment of major depression.	Major depressive disorder (MDD) is a chronic, disabling illness affecting about 17% of the general population. Despite advances in treatment, about two-thirds of patients fail to respond to an initial trial of pharmacotherapy. Brain-derived neurotrophic factor (BDNF) is a neural growth-promoting polypeptide found in the central nervous system, and has been implicated in the pathophysiology and potential treatment of MDD. A multitude of studies have shown low levels of BDNF in subjects with MDD, which have normalized after treatment with an antidepressant. Traditional antidepressants such as serotonin reuptake inhibitors may increase BDNF via an indirect intracellular pathway. The current study drug, cysteamine bitartrate (Cystagon), is FDA approved for the treatment nephropathic cystinosis and has been shown to increase BNDF in neuronal tissue, and to stimulate cell growth. Cysteamine has already been investigated in humans as a potential treatment for Huntington's Disease. Given the evidence of decreased levels in major depression, and subsequent increase post-treatment with antidepressants, BDNF may play a key role in developing novel treatments for patients who have failed conventional agents. Therefore, drugs that can demonstrably increase central BDNF, such as cysteamine, may have significant potential as novel antidepressant medications.	Major Depressive Disorder	Major depressive disorder, depression neurotrophic brain-derived neurotrophic factor antidepressant cysteamine	null	1	arm 1: Participants received cysteamine bitartrate by mouth up to 300 mg three times daily.	[ 0 ]	1	[ 0 ]	intervention 1: All enrolled participants will begin open treatment with cysteamine on the first visit of the experimental period (after screening, medical clearance and medication washout period if necessary). The dosing schedule is a flexible regimen starting at 150 mg PO three times daily. After one week, patients without intolerable side effects will increase the dose to 300 mg three times daily. The titration schedule will continue up to a maximum of 1800 mg a day. In case of adverse events, the investigator may decrease the dose by 150 mg daily.	intervention 1: cysteamine bitartrate	1	New York \| New York \| United States \| -74.00597 \| 40.71427	3	NCT00715559	6TERMINATED	2009-05-01	2008-07-01	Icahn School of Medicine at Mount Sinai	7OTHER	false	false	false	null	0
[ 3, 4 ]	12	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.	You are invited to participate in a research study which evaluates the effectiveness of mifepristone (RU 486) in rapidly reducing the symptoms associated with schizoaffective disorder. Our group believes that the cognitive deficits (a decline in the ability to think clearly) and psychosis (hallucinations or delusions) exhibited in some affective disorders are driven by an excess of stress hormone effects (hypercortisolemia). Often the origin of this hormonal imbalance is unknown. Current treatment for schizoaffective disorder (characterized by mood swings and hallucinations and/or delusions) involves using a combination of antidepressant medication (for mood elevation), mood stabilizing medications (to prevent extreme high and low moods) and antipsychotic medication (for the correction of altered thinking). While these therapies are often effective, they can take several weeks or longer to work. We hope to uncover a quick, effective, safe therapy for the treatment of individuals with your condition.	Psychotic Disorders Depressive Disorder, Major Depressive Disorder		null	2	arm 1: Patients will be randomized to placebo arm 2: Patients will be randomized to mifepristone	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: 600 mg of mifepristone intervention 2: Placebo comparator	intervention 1: Mifepristone intervention 2: Placebo Oral Tablet	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	12	NCT00725270	6TERMINATED	2009-05-01	1998-04-01	Stanford University	7OTHER	false	false	false	null	0
[ 0 ]	63	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Blinded study using oral gabapentin in load pre-operative (15mg/kg) and maintenance 5mg/kg three times a day (TID) for 5 days or discharge, Patient Controlled Analgesia (PCA) morphine and placebo group with similar pills, also PCA morphine. The goal is to measure morphine usage and incidence of morphine side effects (pruritis, days foley, days to first stool, sedation, pain scores, PCA use).	Healthy, American Society of Anesthesia (ASA) 1-2 Idiopathic Scoliosis patients for spinal fusion. Blinded, drug only known by hospital pharmacist. Study group 1- Gabapentin 15mg/kg with premed, 5/kg TID for 5 days of discharge, standard PCA morphine with dose and basal Study Group 2- Capsules resembling neurontin, with standard PCA morphine No remifentanil, clonidine, ketamine N=60 First patient enrolled 6/06 Last patient enrolled 7/15/08	Postoperative Pain	Gabapentin Pediatric Spinal Fusion Narcotic Use	null	2	arm 1: Gabapentin arm 2: Placebo Comparator -- pill matched in appearance to gabapentin	[ 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge intervention 2: None intervention 3: Administered as needed	intervention 1: Gabapentin intervention 2: Placebo intervention 3: Morphine	0	null	59	NCT00726999	1COMPLETED	2009-05-01	2006-06-01	Medical College of Wisconsin	7OTHER	false	false	false	null	0
[ 3 ]	16	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	true	0ALL	true	The investigators hypothesize that varenicline will dose dependently attenuate the subjective effects of cigarettes after a period of abstinence. Also, treatment with varenicline will dose dependently weaken the severity of nicotine withdrawal symptoms. Thirdly, we hypothesize that treatment with varenicline will dose dependently decrease cigarette self-administration in the model proposed.	Tobacco use is the leading preventable cause of death in the U.S.A. Every year 400,000 people die from cigarette smoking and in 2006, one out of every five deaths in the US were smoking related. Recent advances in laboratory studies of tobacco effects in humans and in understanding the effects of nicotine on the brain and behavior present an opportunity to advance medication development. The addictive properties of nicotine are thought to be a result of nicotine triggering the acute release of dopamine, a pleasurable event that a person seeks to repeat. Varenicline is a partial agonist of the nicotine receptors, therefore also triggering the release of dopamine but in a more sustained and moderate manner, which could counter the low dopamine levels arising from a lack of nicotine and therefore aid craving. Also, by binding to these nicotine receptors in advance of smoking, it could stop nicotine from binding and creating pleasurable effects. This study will assess the effect of acute treatment with varenicline and placebo on early tobacco withdrawal, acute effects of cigarettes and cigarette self-administration in cigarette-smoking volunteers. After overnight abstinence, participants will come into the lab and receive acute treatment with varying doses of varenicline or placebo and perform computer tests and fill out questionnaires. Then they will be given the opportunity to smoke under operational conditions (cigarette versus money choice). This study will employ a within-group, double-blind, randomized and counterbalanced design. The main goal of this project is to improve the current laboratory model of smoking cessation and study the mechanism involved in smoking maintenance. We hypothesize that varenicline will dose-dependently: 1) decrease nicotine withdrawal symptoms, 2) decrease acute effects of cigarettes and 3) decrease self-administration of cigarettes in the laboratory paradigm. Showing the effectiveness of varenicline in the proposed laboratory model will confirm the model's predictive validity to detect clinically effective medication.	Nicotine Dependence		null	4	arm 1: Each participant participates in 4 consecutive interventions in random order. 1. Placebo, 1 capsule before the session 2. 0.5 mg varenicline, 1 capsule before the session 3.1 mg varenicline, 1 capsule before the session 4\. 2 mg varenicline, 1 capsule before the session arm 2: Each participant participates in 4 consecutive interventions in random order. 1.0.5 mg varenicline, 1 capsule before the session 2. 1 mg varenicline, 1 capsule before the session 3.2 mg varenicline, 1 capsule before the session 4. Placebo, 1 capsule before the session arm 3: Each participant participates in 4 consecutive interventions in random order. 1.1 mg varenicline, 1 capsule before the session 2. 2 mg varenicline, 1 capsule before the session 3.Placebo, 1 capsule before the session 4. 0.5 mg varenicline, 1 capsule before the session arm 4: Each participant participates in 4 consecutive interventions in random order. 1.2 mg varenicline, 1 capsule before the session 2. Placebo, 1 capsule before the session 3. 0.5 mg varenicline, 1 capsule before the session 4. 1 mg varenicline, 1 capsule before the session	[ 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: 4 doses of Varenicline. 1 capsule of either dose (0mg, 0.5mg, 1mg, 2 mg) in the morning on days at least 5 days apart. intervention 2: 1 dose of placebo	intervention 1: Varenicline intervention 2: Placebo	1	New York \| New York \| United States \| -74.00597 \| 40.71427	16	NCT00731055	1COMPLETED	2009-05-01	2008-02-01	New York State Psychiatric Institute	7OTHER	false	false	false	null	0
[ 4 ]	479	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	true	The main goals of the study are to assess benefits of higher doses of the nicotine patch prior to smoking cessation for high- and low-dependent smokers, and to investigate the potential relationship between genetic factors and smoking cessation success. There will be a two-week double-blind pre-cessation exposure to nicotine patch treatment in a sample of 240 high-dependent \& 240 low-dependent smokers; half of each group will wear two 21mg nicotine patches (42mg) daily, and half will wear one 21mg nicotine patch and one comparable placebo patch daily, resulting in the following four conditions (120 subjects each) during the 2-week pre-quit period: 1) Less Dependent/21mg nic., 2) Less Dependent/42mg nic., 3) More Dependent/21mg nic., and 4) More Dependent/42mg nic. After the quit date, subjects will continue with the same nicotine dosage for the 1st 4 weeks; after that the treatment will no longer be double-blind as only nicotine patches will be used: all subjects will wear one 21-mg patch daily for 2 weeks, one 14-mg patch daily for the following 2 weeks, and one 7-mg patch for the remaining 2 weeks. The four treatment groups will be distributed over 4 sites: Durham, Raleigh, Charlotte, and Winston-Salem. After the screening visit, subjects will have 7 lab visits: at 2 weeks, 1 week, and 1 day prior to the quit-smoking date, and at 1 week, 3 weeks, 6 weeks and 10 weeks after the quit-smoking date.	null	Cigarette Smoking	Cigarette Nicotine	null	2	arm 1: None arm 2: None	[ 0, 0 ]	1	[ 0 ]	intervention 1: Groups 1 \& 3 1-21mg Nicotine patch and 1-placebo for 2 wks pre quit day and 4 wks post quit day Groups 2 \& 4 2-21mg Nicotine Patches for 2 wks pre quit day and 4 wks post quit day	intervention 1: Nicotine Patch	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	479	NCT00734617	1COMPLETED	2009-05-01	2007-08-01	Duke University	7OTHER	false	false	false	null	0
[ 4 ]	2,694	RANDOMIZED	FACTORIAL	0TREATMENT	3TRIPLE	false	0ALL	false	Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in combination with amlodipine in patients with essential hypertension.	null	Hypertension	Hypertension, Aliskiren, Amlodipine	null	9	arm 1: Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 5 of the 5 pills taken were placebos. arm 2: Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. arm 3: Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. arm 4: Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. arm 5: Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg arm 6: Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. arm 7: 150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. arm 8: Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. arm 9: 300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.	[ 2, 0, 0, 0, 0, 0, 0, 0, 0 ]	9	[ 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None	intervention 1: Placebo intervention 2: Aliskiren 150 mg tablet intervention 3: Aliskiren 300 mg tablet intervention 4: Amlodipine 5 mg capsule intervention 5: Amlodipine 10 mg capsule intervention 6: Aliskiren/amlodipine 150/5 mg tablet intervention 7: Aliskiren/amlodipine 150/10 mg tablet intervention 8: Aliskiren/amlodipine 300/5 mg tablet intervention 9: Aliskiren/amlodipine 300/10 mg tablet	18	East Hanover \| New Jersey \| United States \| -74.36487 \| 40.8201 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Canberra \| N/A \| Australia \| 149.12807 \| -35.28346 Toronto \| N/A \| Canada \| -79.39864 \| 43.70643 Bogotá \| N/A \| Colombia \| -74.08175 \| 4.60971 Copenhagen \| N/A \| Denmark \| 12.56553 \| 55.67594 Oslo \| N/A \| Finland \| N/A \| N/A Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Rome \| N/A \| Italy \| 12.51133 \| 41.89193 Mexico City \| N/A \| Mexico \| -99.12766 \| 19.42847 Panama City \| N/A \| Panama \| -79.51973 \| 8.9936 Lima \| N/A \| Peru \| -77.02824 \| -12.04318 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Pretoria \| N/A \| South Africa \| 28.18783 \| -25.74486 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306	1,685	NCT00739973	1COMPLETED	2009-05-01	2008-09-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 2 ]	39	NA	PARALLEL	9OTHER	0NONE	false	0ALL	false	To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia	null	Pediatric Heterozygous Hypercholesterolemia	heterozygous familial hypercholesterolemia (HeFH); atorvastatin; pediatric	null	2	arm 1: 6-10 years will be administered with atorvastatin tablet formulation with initial doses based on age cohort. arm 2: 10-17 years will be administered 10-mg daily dose of atorvastatin tablet formulation.	[ 5, 5 ]	2	[ 0, 0 ]	intervention 1: 6-10 years Tanner Stage 1 will be administered 5-mg daily dose of an atorvastatin pediatric tablet formulation. Dose may be doubled if subjects have not attained target LDL (\<3.35 mmol/L) after 4-week treatment. intervention 2: 10-17 years Tanner Stage 2 will be administered 10-mg daily dose of atorvastatin tablet formulation. Dose may be doubled if subjects have not attained target LDL (\<3.35 mmol/L) after 4-week treatment.	intervention 1: Atorvastatin intervention 2: Atorvastatin	3	Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Oslo \| N/A \| Norway \| 10.74609 \| 59.91273	39	NCT00739999	1COMPLETED	2009-05-01	2008-12-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0
[ 0 ]	27	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	4QUADRUPLE	false	0ALL	false	This study will measure the effect of the agent tadalafil on glucose and insulin homeostasis in people with metabolic syndrome in the presence and absence of an ACE inhibitor.	null	Metabolic Syndrome		null	12	arm 1: placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, ramipril + tadalafil, washout, placebo+placebo for three weeks arm 2: placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks arm 3: ramipril+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks arm 4: placebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks, washout placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks arm 5: placebo+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+ramipril for three weeks, washout, ramipril+tadalafil for three weeks arm 6: placebo+ramipril for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo for three weeks arm 7: ramipril+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+placebo for three weeks, washout, placebo+tadalafil for three weeks arm 8: placebo+placebo for three weeks, washout, placebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+ramipril for three weeks arm 9: placebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+ramipril for three weeks arm 10: placebo+ramipril for three weeks, washout, placebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks arm 11: ramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+placebo for three weeks arm 12: placebo+placebo for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks	[ 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Ramipril 10 mg per day for three weeks intervention 2: tadalafil 10 mg every other day for three weeks intervention 3: placebo matching ramipril intervention 4: placebo matching tadalafil	intervention 1: Ramipril intervention 2: Tadalafil intervention 3: placebo intervention 4: placebo	0	null	95	NCT00750308	1COMPLETED	2009-05-01	2006-12-01	Vanderbilt University	7OTHER	false	false	false	null	0
[ 5 ]	20	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	true	Previous studies suggest that treadmill exercise may be a more relevant exercise stimulus than the cycle ergometer to demonstrate benefits with bronchodilator therapy in patients with COPD. The hypothesis of the study is that patients with COPD will exhibit greater improvements in exercise endurance and breathlessness with arformoterol compared with normal saline during treadmill walking than with cycle exercise.	The study is a randomized trial with crossover of consecutively recruited patients with symptomatic COPD. Each patient will participate in seven visits over a 3-4 week period. At the first visit patients will provide informed consent and then be familiarized with equipment and testing protocols. At visits 2 and 3 patients will inhale 2 puffs of albuterol HFA MDI, and then perform symptom limited incremental exercise on the treadmill or cycle ergometer (randomized order); after a one hour rest, the patient will perform constant work exercise at 80-85% of peak VO2 on the same exercise mode. At visits 4 - 7, patients will perform PFTs at baseline and at 30 and 120 minutes after inhaling arformoterol or normal saline (randomized order) and then constant work exercise on the treadmill or cycle ergometer (randomized order). Metabolic measurements will be made throughout exercise, and patients will provide continuous ratings of breathlessness and leg discomfort using a system consisting of a computer, monitor, and a mouse.	Chronic Obstructive Pulmonary Disease	exercise; treadmill; cycle ergometer; breathlessness; leg discomfort	null	2	arm 1: Bronchodilator therapy with arformoterol solution 15 mcg arm 2: Placebo using normal saline	[ 1, 2 ]	4	[ 0, 0, 10, 10 ]	intervention 1: 15 mcg in two ml solution administered via nebulizer intervention 2: Normal saline was nebulized. intervention 3: None intervention 4: None	intervention 1: Arformoterol tartrate intervention 2: Placebo: Normal Saline intervention 3: Treadmill Exercise intervention 4: Cycle Exercise	1	Lebanon \| New Hampshire \| United States \| -72.25176 \| 43.64229	80	NCT00754546	1COMPLETED	2009-05-01	2008-08-01	Dartmouth-Hitchcock Medical Center	7OTHER	false	false	false	null	0
[ 5 ]	299	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of the study is to explore the maintained efficacy, tolerability, and safety of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) previously unsuccessfully treated with other oral atypical antipsychotic medication.	This is an open-label (all people know the identity of the intervention), non-randomized (the study drug is not assigned by chance), single arm, multicenter (when more than one hospital or medical school team work on a medical research study), 24-week study. Participants can be transitioned to an effective dose of paliperidone ER from any oral antipsychotic medication without the need for titration due to lack of efficacy, lack of tolerability or safety, lack of compliance or other reason. A transition period of maximum 4 weeks will be allowed. Throughout the study, participants will receive flexible dose of 3 to 12 milligram (mg) of paliperidone once daily orally for 24 weeks. Dose adjustment will be done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug. Assessments of efficacy will be performed at screening and after 2, 4, 12 and 24 weeks. Efficacy will primarily be evaluated by means of Positive and Negative Syndrome Scale (PANSS). Participants' safety will also be monitored throughout the study.	Schizophrenia	Schizophrenia Paliperidone Extended-Release	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Participants will receive paliperidone ER tablet in dose range of 3 to12 milligram (mg) per day orally once daily for 24 weeks as per Investigator's discretion based on the individual participant's clinical response to and tolerability of the study drug.	intervention 1: Paliperidone ER	0	null	299	NCT00757705	1COMPLETED	2009-05-01	2008-03-01	Johnson & Johnson Taiwan Ltd	4INDUSTRY	false	false	false	null	0
[ 3 ]	55	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The primary aim of this study is to investigate the effects of AZD1236 compared with placebo ("inactive substance") in COPD patients by analysing biomarkers for inflammation and tissue degradation in blood, urine and sputum.	null	Chronic Obstructive Pulmonary Disease	COPD	null	2	arm 1: oral tablet, 75 mg, twice daily during 6 weeks arm 2: Dosing to match AZD1236	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: oral tablet, 75 mg, twice daily during 6 weeks intervention 2: Dosing to match AZD1236	intervention 1: AZD1236 intervention 2: Placebo	10	Aalborg \| N/A \| Denmark \| 9.9187 \| 57.048 Arhus C \| N/A \| Denmark \| N/A \| N/A København NV \| N/A \| Denmark \| 12.52343 \| 55.71258 Odense C \| N/A \| Denmark \| 10.39538 \| 55.40841 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Tampere \| N/A \| Finland \| 23.78712 \| 61.49911 Eindhoven \| N/A \| Netherlands \| 5.47778 \| 51.44083 Nieuwegein \| N/A \| Netherlands \| 5.08056 \| 52.02917 Oslo \| N/A \| Norway \| 10.74609 \| 59.91273 Trondheim \| N/A \| Norway \| 10.39506 \| 63.43049	55	NCT00758706	1COMPLETED	2009-05-01	2008-09-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 5 ]	34	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	false	The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram tablet.	null	Hypercholesterolemia	Hypercholesterolemia Statins Ezetimibe	null	2	arm 1: Vytorin 10/80 divided into 4 arm 2: Simvastatin 20 milligrams	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Vytorin 10/80 split into 4 intervention 2: Simvastatin 20 milligrams	intervention 1: Vytorin intervention 2: Simvastatin	1	The Bronx \| New York \| United States \| -73.86641 \| 40.84985	33	NCT00762164	1COMPLETED	2009-05-01	2007-03-01	Bronx VA Medical Center	1FED	false	false	false	null	0
[ 4 ]	305	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to compare pioglitazone and metformin combination therapy, twice daily (BID), to glimepiride and metformin combination therapy for treating diabetic subjects with dyslipidemia.	Insulin resistance is a major endocrinopathy preceding the development of hyperglycemia, diabetic dyslipidemia and cardiovascular disease in type 2 diabetes. The most common pattern of dyslipidemia in patients with type 2 diabetes are elevated triglyceride levels, decreased hih-density lipoprotein cholesterol and a predominance of small dense low-density lipoprotein particles. Each of these dyslipidemia features is associated with an increased risk of cardiovascular events. Pioglitazone and Metformin are established drugs which can be used for the treatment of type 2 diabetes. This study will investigate the effects of treatment with fixed Pioglitazone/Metformin combination therapy of Metformin and Glimepiride in Metformin-pretreated type 2 diabetic patients with dyslipidemia. Total participation time in this study is anticipated to be approximately 24 weeks.	Diabetes Mellitus Dyslipidemias	Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus, Lipoatrophic Dyslipidemia Hyperlipidemias Drug Therapy	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks. intervention 2: Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.	intervention 1: Pioglitazone and Metformin intervention 2: Glimepiride and Metformin	64	Bretten \| Baden-Wurttemberg \| Germany \| 8.70745 \| 49.03685 Deggingen \| Baden-Wurttemberg \| Germany \| 9.71891 \| 48.5971 Dettenheim \| Baden-Wurttemberg \| Germany \| N/A \| N/A Künzelsau \| Baden-Wurttemberg \| Germany \| 9.68352 \| 49.2818 Rottweil \| Baden-Wurttemberg \| Germany \| 8.62719 \| 48.16783 Spaichingen \| Baden-Wurttemberg \| Germany \| 8.73508 \| 48.07477 Stockach \| Baden-Wurttemberg \| Germany \| 9.0091 \| 47.85105 Wangen \| Baden-Wurttemberg \| Germany \| 9.83247 \| 47.6895 Augsburg \| Bavaria \| Germany \| 10.89851 \| 48.37154 Feldafing \| Bavaria \| Germany \| 11.29326 \| 47.94602 Furth im Wald \| Bavaria \| Germany \| 12.84156 \| 49.30955 Immenstadt im Allgäu \| Bavaria \| Germany \| 10.21394 \| 47.55996 Lichtenfels \| Bavaria \| Germany \| 11.05928 \| 50.14567 München \| Bavaria \| Germany \| 13.46314 \| 48.69668 Schweinfurt \| Bavaria \| Germany \| 10.22175 \| 50.04937 Waldkraiburg \| Bavaria \| Germany \| 12.39893 \| 48.20854 Wallerfing \| Bavaria \| Germany \| 12.88035 \| 48.68416 Weilersbach \| Bavaria \| Germany \| 11.11667 \| 49.75 Würzburg \| Bavaria \| Germany \| 9.95121 \| 49.79391 Ketzin \| Brandenburg \| Germany \| 12.8453 \| 52.47809 Rüdersdorf \| Brandenburg \| Germany \| 13.78631 \| 52.46927 Bermerhaven \| City state Bremen \| Germany \| N/A \| N/A Hamburg \| City state of Hamburg \| Germany \| 9.99302 \| 53.55073 Bensheim \| Hesse \| Germany \| 8.61839 \| 49.68369 Ehrenberg \| Hesse \| Germany \| N/A \| N/A Gersfeld \| Hesse \| Germany \| 9.91422 \| 50.45138 Kassel \| Hesse \| Germany \| 9.5 \| 51.31667 Kelkheim \| Hesse \| Germany \| 8.4502 \| 50.13703 Offenbach \| Hesse \| Germany \| 8.76647 \| 50.10061 Celle \| Lower Saxony \| Germany \| 10.08047 \| 52.62264 Einbeck \| Lower Saxony \| Germany \| 9.86961 \| 51.82018 Hanover \| Lower Saxony \| Germany \| 9.73322 \| 52.37052 Hildesheim \| Lower Saxony \| Germany \| 9.95112 \| 52.15077 Schwerin \| Mecklenburg-Vorpommern \| Germany \| 11.41316 \| 53.62937 Bad Berleburg \| North Rhine-Westphalia \| Germany \| 8.39227 \| 51.05224 Bad Laasphe \| North Rhine-Westphalia \| Germany \| 8.42502 \| 50.93139 Bad Oeynhausen \| North Rhine-Westphalia \| Germany \| 8.80365 \| 52.20699 Bocholt \| North Rhine-Westphalia \| Germany \| 6.61531 \| 51.83879 Cologne \| North Rhine-Westphalia \| Germany \| 6.95 \| 50.93333 Dinslaken \| North Rhine-Westphalia \| Germany \| 6.7434 \| 51.56227 Dorsten \| North Rhine-Westphalia \| Germany \| 6.96514 \| 51.66166 Duisburg \| North Rhine-Westphalia \| Germany \| 6.76516 \| 51.43247 Essen \| North Rhine-Westphalia \| Germany \| 7.01228 \| 51.45657 Frechen \| North Rhine-Westphalia \| Germany \| 6.8118 \| 50.91485 Isselburg \| North Rhine-Westphalia \| Germany \| 6.46428 \| 51.83232 Kamen \| North Rhine-Westphalia \| Germany \| 7.6638 \| 51.59231 Marl \| North Rhine-Westphalia \| Germany \| 7.09038 \| 51.65671 Menden \| North Rhine-Westphalia \| Germany \| 7.77825 \| 51.44337 Münster \| North Rhine-Westphalia \| Germany \| 7.62571 \| 51.96236 Siegen \| North Rhine-Westphalia \| Germany \| 8.02431 \| 50.87481 Diez \| Rhineland-Palatinate \| Germany \| 8.00735 \| 50.37419 Mainz \| Rhineland-Palatinate \| Germany \| 8.2791 \| 49.98419 Neuwied \| Rhineland-Palatinate \| Germany \| 7.47057 \| 50.4336 Rodenbach \| Rhineland-Palatinate \| Germany \| 8.10695 \| 49.57414 Simmern \| Rhineland-Palatinate \| Germany \| 7.52351 \| 49.98198 Borna \| Saxony \| Germany \| 12.49639 \| 51.12416 Dresden \| Saxony \| Germany \| 13.73832 \| 51.05089 Meissen \| Saxony \| Germany \| 13.4737 \| 51.16158 Mittweida \| Saxony \| Germany \| 12.97537 \| 50.98622 Magdeburg \| Saxony-Anhalt \| Germany \| 11.62916 \| 52.12773 Reinfeld \| Schleswig-Holstein \| Germany \| 10.49227 \| 53.8311 Berlin \| State of Berlin \| Germany \| 13.41053 \| 52.52437 Altenburg \| Thuringia \| Germany \| 12.43684 \| 50.98763 Blankenhain \| Thuringia \| Germany \| 11.3439 \| 50.85993	302	NCT00770653	1COMPLETED	2009-05-01	2007-04-01	Takeda	4INDUSTRY	false	false	false	null	0
[ 5 ]	20	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	false	This will be a double-blind crossover trial in 20 patient with stable COPD. Data from this study will provide proof-of-concept information on whether the (anticipated) additional bronchodilator effect of Brovana added to tiotropium will lead to a meaningful improvement in the patient-centered outcome, exercise capacity. This study will only evaluate the effects of short-term (1-week) administration of Brovana. If results are positive, it would provide preliminary data for further, multicenter investigations.	Hypotheses to be tested: Brovana nebulized twice daily added to maintenance inhaled tiotropium therapy in stable COPD patients increases: 1. Forced expiratory volume in 1 second (FEV1) at peak dose effect (approximately 2 hours after AM dosing in the laboratory) 2. Resting and exercise hyperinflation at peak dose effect (inspiratory capacity (IC) at baseline and at iso-time during exercise testing; these measurements will be approximately 2 ¼ hours after AM dosing of tiotropium plus test drug. 3. Exercise treadmill endurance time at peak dose effect (approximately 2 ¼ hours after AM dosing in the laboratory) Patients: Twenty patients will be studied Location: Section of Pulmonary and Critical Care, St. Francis Hospital \& Medical Center, Hartford, CT Excluded drugs: 1. Anticholinergic bronchodilators other than once-daily (AM) tiotropium at standard dose 2. Long acting beta agonist bronchodilators 3. Short acting beta agonist bronchodilators must be withheld within six hours of laboratory testing Allowed drugs: 1. Inhaled steroids 2. Oral steroids 10 mg/day or less, at stable dose for four weeks Removal of patients from study: 1. Withdrawal of consent 2. Documented oxygen desaturation \< 85% or clinically significant problems (such as angina, significant electrocardiogram (ECG) changes, etc) during any exercise testing 3. A significant adverse event 4. Protocol violation including lack of adherence COPD exacerbations during study: If the patient experiences a COPD exacerbation during the study which requires a change in medication or an addition of medication (such as oral steroids or antibiotics) the study will be held until stability is reached. At that time, the study will resume, beginning with new, 1-week treatment /testing corresponding to the study sequence when the exacerbation began. If the patient does not resume stability within four weeks or has a second exacerbation, the study will be terminated. Study design: This will be a double-blind, crossover, single-site study in COPD patients who are in stable condition. All patients in study randomized to test drug by Visit 2 will have been on steady-state tiotropium therapy, off commercial long-acting beta-agonists (LABA), and using prn short-acting beta-agonists (SABA). Only acute (i.e., 1-week) effects of Brovana will be studied. SABA will be withheld from midnight before testing on each day. Exercise testing and inspiratory capacity (IC) measurements Incremental and steady-state endurance testing will be performed on a treadmill in the Section of Pulmonary and Critical Care Medicine. The incremental test (Visit 1) will be performed to a symptom-limited maximum, with a goal to have the test duration over approximately 10 minutes. The protocol used for this will be from Porszasz et al using simultaneous increases in treadmill speed and incline, with settings based on estimated maximal workrate. Warm-up will be 1 mph at 1% grade. This will be followed at 30-second intervals by increases in speed and incline. Patients will have breath by breath measurements of expired air using our Sensormedics equipment, via a mouthpiece. IC measurements will also be measured at rest and at every minute into exercise. Endurance tests (Visit 2, 4, 5) will be at 75% of the maximal rate determined from the initial test. For exercise capacity, duration in exercise time will be the primary outcome variable. IC will be measured at rest and at every minute during exercise. An ECG will be performed before each exercise test, and continuous pulse oximetry will be monitored. A physician will be in attendance at each test. Primary Efficacy Variables: 1. Change in FEV1 near peak effect (\~ 2 hours of AM laboratory dosing of tiotropium plus test drug): 1. The primary comparison will be Δ FEV1 (@ 2-hours after Tiotropium + Brovana minus pre-dose FEV1) versus Δ FEV1 (@2-hours after Tiotropium + Placebo minus pre-dose FEV1) 2. The analysis will be performed using a repeated-measures design, PROC GLM Repeated, SAS: 2. Change in treadmill endurance time at \~75% of maximum (Δ endurance time) Brovana versus placebo: from baseline testing on tiotropium alone compared to testing on tiotropium + study drug. 1. The primary comparison will be Δ endurance time (@ 2 ¼ hours after Tiotropium + Brovana compared to tiotropium alone 2. The analysis will be performed using a repeated-measures design, PROC GLM Repeated, SAS 3. Change in static (resting), iso-time, and peak exercise IC measurements, which will be used as our estimates of hyperinflation; Brovana versus placebo: from baseline testing on tiotropium alone compared to testing on tiotropium + study drug. a. The primary co-comparisons will be: i. Δ IC at rest (static hyperinflation) (@ 2 ¼ hours after Tiotropium + Brovana compared to tiotropium alone ii. Δ IC at iso-time (static hyperinflation) (@ 2 ¼ hours after Tiotropium + Brovana compared to tiotropium alone. We are not sure what iso-time we will use, but if all patients go six minutes into exercise, we will use the six minute mark. b. The analyses will be performed using a repeated-measures design, PROC GLM Repeated, SAS Sample Size Estimation The van Noord sited earlier powered their study assuming a \~ 140 mL standard deviation for paired differences in FEV1 (determined from earlier trials), a difference of \~ 50 mL, and a power of 0.90. They achieved a 150 mL (0.150 L) difference in FEV1. For our study, using a difference of 150 mL, a standard deviation of 140 mL, and a power of 0.80, 16 patients would be sufficient. In a study by O'Donnell et al the combination of fluticasone 250 mcg / salmeterol 50 mcg was compared to salmeterol alone and placebo. Outcome variables included spirometry, lung volumes and exercise endurance time at 75% of maximal on a cycle ergometer. The average improvement (compared to placebo) in FEV1 at Day 1 (taken from graph) was about 200 mL with both the combination and salmeterol. The treatment-difference improvement in exercise endurance time with the combination was 131 ± 31 seconds (p. \< 0.004), representing a 22% improvement. For salmeterol alone it was 49 ± 37 seconds. Our study would use a treadmill rather than a cycle ergometer; this will probably lead to more dyspnea-limitation than leg fatigue limitation. We predict the Δ FEV1 at two hours post dosing (compared to tiotropium alone) with Brovana + tiotropium in our study will \~ 150 mL - a Δ not too dissimilar to the O'Donnell study Δ. To detect a 90 second difference in endurance time (1/2 way between 131 seconds and 49 seconds), and assuming a standard deviation (SD) of 35 seconds, our study would be amply powered. Study Sequence Visit 1: 1. Informed consent obtained 2. Inclusion/exclusion criteria met 3. History and physical examination performed 4. Post-bronchodilator spirometry for inclusion criteria 5. Patient started on tiotropium, if necessary; tiotropium dispensed, if necessary 6. If necessary: long acting bronchodilators (LABA) discontinued, ipratropium discontinued 7. Levalbuterol MDI dispensed for prn use 8. Appointment given for Visit 1 Visit 2: 1 day (for patients already on tiotropium) to 1 week (those starting tiotropium) after Visit 1: 1. Brief history and limited physical 2. Spirometry on maintenance tiotropium, before AM dosing and after having SABA withheld for \~ 6 hours 3. Incremental treadmill endurance test 4. Patient instructed to continue taking tiotropium once daily in the morning (qAM) and levalbuterol MDI prn 5. Appointment for 2-week follow-up Visit 3: 1 week after Visit 2, after maintenance tiotropium 1. Brief history and limited physical 2. Pre-bronchodilator spirometry (on maintenance tiotropium, levalbuterol withheld) 3. Tiotropium given (open label) 4. Spirometry 2 hours after tiotropium dosing 5. ECG 2 ¼ hour after tiotropium dosing 6. Endurance treadmill endurance test (including IC measurements) 2 ¼ hour after open-label tiotropium dosing 7. Nebulizer dispensed 8. Blinded Test drug # 1 dispensed (Brovana or placebo, 20 unit doses), instructions to take it via nebulizer bid, tiotropium continued qAM, levalbuterol MDI continued prn 9. Appointment for 1 week follow-up Visit 4: 1 weeks after Visit 3, after test drug # 1 1. Brief history and limited physical 2. Pre-dosing spirometry (on maintenance tiotropium and Test Drug #1, levalbuterol withheld) 3. Tiotropium and Test Drug # 1 given 4. Spirometry 2 hours after above dosing 5. ECG 2 ¼ hour after above dosing 6. Endurance treadmill endurance test 2 ¼ hour after above dosing 7. Begin wash-out period: Tiotropium open-label plus prn levalbuterol continued; placebo given via nebulizer, to be taken bid (this part is single-blinded) 8. Appointment for 1 week follow-up Visit 5: 1 week after Visit 4, after washout 1. Brief history and limited physical 2. Spirometry in AM 3. Blinded Test drug # 2 dispensed (Brovana or placebo, 20 unit doses), instructions to take it via nebulizer bid, tiotropium continued qAM, levalbuterol MDI continued prn 4. Appointment for 1 week follow-up Visit 6: 1 week after Visit 5, after test drug # 2 1. Brief history and limited physical 2. Pre-dosing spirometry (on maintenance tiotropium and Test Drug #2, levalbuterol withheld) 3. Tiotropium and Test Drug #2 given 4. Spirometry 2 hours after above dosing 5. ECG 2 ¼ hour after above dosing 6. Endurance treadmill endurance test and IC measurements 2 ¼ hour after above dosing 7. Study terminated	COPD	COPD Bronchodilator arformoterol tiotropium	null	2	arm 1: Arformoterol twice daily for 1 week via nebulizer arm 2: Placebo twice daily for 1 week	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: twice daily via nebulizer added to maintenance daily tiotropium intervention 2: Placebo twice daily for 1 week (added to maintenance tiotropium)	intervention 1: Arformoterol (Brovana) intervention 2: Placebo	1	Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371	40	NCT00773786	1COMPLETED	2009-05-01	2008-10-01	Trinity Health Of New England	7OTHER	false	false	false	null	0
[ 4 ]	381	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	false	NT 201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), is a Botulinum toxin type A preparation free of complexing proteins (150 kiloDalton). Injected into the muscle, NT201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is used for aesthetic treatment of mimic wrinkles and in the therapy of neurologic diseases. This study will investigate the safety and efficacy (non-inferiority) of NT 201 in comparison with OnabotulinumtoxinA (Vistabel®) in the treatment of glabellar frown lines.	null	Glabellar Frown Lines		null	2	arm 1: IncobotulinumtoxinA (Xeomin®/Bocouture®), 24 units; mode of administration: intramuscular injection. arm 2: OnabotulinumtoxinA (Vistabel®), 24 units; mode of administration: intramuscular injection.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: NT201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), active ingredient: Clostridium botulinum neurotoxin type A free from complexing proteins, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles. intervention 2: OnabotulinumtoxinA (Vistabel®), active ingredient: Clostridium botulinum neurotoxin type A, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.	intervention 1: NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®)) intervention 2: OnabotulinumtoxinA (Vistabel®)	17	Baden \| N/A \| Austria \| 16.23264 \| 48.00543 Krems \| N/A \| Austria \| 15.61415 \| 48.40921 Salzburg \| N/A \| Austria \| 13.04399 \| 47.79941 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Bad Soden \| N/A \| Germany \| 9.36404 \| 50.28857 Böblingen \| N/A \| Germany \| 9.01171 \| 48.68212 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Darmstadt \| N/A \| Germany \| 8.65027 \| 49.87167 Frankfurt \| N/A \| Germany \| 10.53333 \| 49.68333 Korschenbroich \| N/A \| Germany \| 6.51352 \| 51.19139 Ludwigshafen \| N/A \| Germany \| 9.06138 \| 47.81663 Munich \| N/A \| Germany \| 11.57549 \| 48.13743 Wuppertal \| N/A \| Germany \| 7.14816 \| 51.25627 Glasgow \| N/A \| United Kingdom \| -4.25763 \| 55.86515 Manchester \| N/A \| United Kingdom \| -2.23743 \| 53.48095 Suttion Coldfield \| N/A \| United Kingdom \| N/A \| N/A Winchester \| N/A \| United Kingdom \| -1.3187 \| 51.06513	381	NCT00777803	1COMPLETED	2009-05-01	2008-11-01	Merz Pharmaceuticals GmbH	4INDUSTRY	false	false	false	null	0
[ 4 ]	818	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone	null	Hypertension	Aliskiren, Amlodipine, Non-responder to aliskiren	null	3	arm 1: Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks. arm 2: Participants received 1 Aliskiren/Amlodipine 300/10 mg tablet + 1 Placebo to Aliskiren tablet orally once daily in the morning for 8 weeks. arm 3: Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.	[ 0, 0, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Aliskiren 300 mg tablet taken orally once a day with a glass of water. intervention 2: Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water. intervention 3: Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water. intervention 4: Placebo to Aliskiren tablet taken orally once a day. intervention 5: Placebo to Aliskiren/Amlodipine taken orally once a day.	intervention 1: Aliskiren 300 mg intervention 2: Aliskiren/Amlodipine 300/5 mg intervention 3: Aliskiren/Amlodipine 300/10 mg intervention 4: Placebo to Aliskiren intervention 5: Placebo to Aliskiren/Amlodipine	9	Estonia \| N/A \| Estonia \| N/A \| N/A France \| N/A \| France \| -0.84802 \| 45.60366 Iceland \| N/A \| Iceland \| N/A \| N/A India \| N/A \| India \| 75.36261 \| 23.01533 Italy \| N/A \| Italy \| N/A \| N/A Lithuania \| N/A \| Lithuania \| N/A \| N/A Republic of Korea \| N/A \| South Korea \| N/A \| N/A Spain \| N/A \| Spain \| N/A \| N/A Venezuela \| N/A \| Venezuela \| N/A \| N/A	818	NCT00777946	1COMPLETED	2009-05-01	2008-10-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 4 ]	55	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to assess the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) of itraconazole (ITCZ) oral solution in participants with Systemic Fungal Infection (SFI) and those with febrile (with fever) neutropenia (FN, decrease in white blood cells) suspected of fungal infection.	This is an open-label (all people know the identity of the intervention), multicenter (conducted in more than 1 center) and uncontrolled (no competitive drugs involved) study. Participants with SFI will receive treatment with ITCZ oral solution or switch treatment from intravenous (into a vein) infusion of itraconazole (ITCZ-intravenous) to ITCZ oral solution as per Investigator's discretion. All the participants with FN suspected of fungal infection will receive the switch treatment from ITCZ- intravenous to ITCZ oral solution. The study will include 3 periods: Pre-observation period (7 days), Treatment period (85 days for ITCZ oral solution monotherapy and 99 days for switch treatment) and Follow-up observation period (30 days). The participants who receive ITCZ oral solution monotherapy will receive ITCZ oral solution without ITCZ-intravenous in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks (85 days) and those on the switch treatment will receive 400 milligram (mg) per day ITCZ-intravenous twice for first 2 days followed by 200 mg per day ITCZ-intravenous up to 14 days and then they will be administered treatment as per ITCZ oral solution monotherapy. Efficacy will primarily be evaluated by assessing the pharmacokinetics. Participants' safety will be monitored throughout the study.	Mycoses Candidiasis Aspergillosis Cryptococcosis Blastomycosis Histoplasmosis Neutropenia	Mycoses Candidiasis Aspergillosis Cryptococcosis Blastomycosis Histoplasmosis Neutropenia Itraconazole JK1211	null	3	arm 1: Participants with deep-seated mycosis (Systemic Fungal Infection \[SFI\]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator's discretion. arm 2: Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous (into the vein) infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator's discretion. arm 3: Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator's discretion.	[ 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: ITCZ syrup product containing ITCZ 10 mg per ml in dose range of 20 ml to 40 ml daily for 7 days up to 12 weeks intervention 2: 200 mg IV twice daily for 2 days and once daily for the next 1 to 12 days	intervention 1: ITCZ Oral Solution intervention 2: ITCZ-IV	1	Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6	55	NCT00784368	1COMPLETED	2009-05-01	2008-01-01	Janssen Pharmaceutical K.K.	4INDUSTRY	false	false	false	null	0
[ 4 ]	366	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine whether AG-1749 (lansoprazole), once daily (QD), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with nonsteroid anti-inflammatory drug, compared to gefarnate, twice daily (BID).	In Japan, nonsteroid anti-inflammatory drug is one of common prescribed drugs for patients as an analgesic antipyretic, treating symptoms of cold, antiphlogistic and management of pain with rheumatoid arthritis, osteoarthrosis, lumbago. On the other hand, this nonsteroid anti-inflammatory drug sometimes causes gastric and duodenal ulcers and this ulcer leads to the gastrointestinal bleeding which may be cause of death. The purpose of this study is to assess the efficacy of lansoprazole versus gefarnate in patients with a history of gastric or duodenal ulcers receiving daily nonsteroid anti-inflammatory medication.	Stomach Ulcer Duodenal Ulcer	Curling Ulcer Gastric Ulcer Nonsteroid anti-inflammatory drug Drug Therapy	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months. intervention 2: Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.	intervention 1: Lansoprazole intervention 2: Gefarnate	68	Kasugai-shi \| Aichi-ken \| Japan \| N/A \| N/A Yotsukaido-shi \| Chiba \| Japan \| N/A \| N/A Matsuyama \| Ehime \| Japan \| 132.76574 \| 33.83916 Fukui-shi \| Fukui \| Japan \| 136.22257 \| 36.06443 Chikushi-gun \| Fukuoka \| Japan \| N/A \| N/A Fukuoka \| Fukuoka \| Japan \| 130.41667 \| 33.6 Kurume-shi \| Fukuoka \| Japan \| N/A \| N/A Munakata-shi \| Fukuoka \| Japan \| N/A \| N/A Onga-gun \| Fukuoka \| Japan \| N/A \| N/A Gifu \| Gifu \| Japan \| 136.76039 \| 35.42291 Maebashi \| Gunma \| Japan \| 139.08333 \| 36.4 Higashihiroshima-shi \| Hiroshima \| Japan \| N/A \| N/A Kure-shi \| Hiroshima \| Japan \| N/A \| N/A Asahikawa-shi \| Hokkaido \| Japan \| N/A \| N/A Chitose-shi \| Hokkaido \| Japan \| N/A \| N/A Sapporo \| Hokkaido \| Japan \| 141.35 \| 43.06667 Kato-shi \| Hyōgo \| Japan \| N/A \| N/A Nishinomiya-shi \| Hyōgo \| Japan \| N/A \| N/A Hitachi-Naka \| Ibaraki \| Japan \| 140.53479 \| 36.39659 Yuki-shi \| Ibaraki \| Japan \| N/A \| N/A Hakusan-shi \| Ishikawa-ken \| Japan \| N/A \| N/A Komatsu-shi \| Ishikawa-ken \| Japan \| N/A \| N/A Takamatsu \| Kagawa-ken \| Japan \| 134.05 \| 34.33333 Kagoshima \| Kagoshima-ken \| Japan \| 130.55 \| 31.56667 Kamakura-shi \| Kanagawa \| Japan \| N/A \| N/A Kawasaki-shi \| Kanagawa \| Japan \| N/A \| N/A Sagamihara-shi \| Kanagawa \| Japan \| N/A \| N/A Yamato-shi \| Kanagawa \| Japan \| N/A \| N/A Yokohama \| Kanagawa \| Japan \| 139.65 \| 35.43333 Kochi \| Kochi \| Japan \| 133.53333 \| 33.55 Susaki-shi \| Kochi \| Japan \| N/A \| N/A Kumamoto \| Kumamoto \| Japan \| 130.69181 \| 32.80589 Kyoto \| Kyoto \| Japan \| 135.75385 \| 35.02107 Ise-shi \| Mie-ken \| Japan \| N/A \| N/A Shima-shi \| Mie-ken \| Japan \| N/A \| N/A Yokkaichi-shi \| Mie-ken \| Japan \| N/A \| N/A Sendai \| Miyagi \| Japan \| 140.86667 \| 38.26667 Ebino-shi \| Miyazaki \| Japan \| N/A \| N/A Miyazaki \| Miyazaki \| Japan \| 131.41667 \| 31.91667 Miyazaki-gun \| Miyazaki \| Japan \| N/A \| N/A Matsumoto-shi \| Nagano \| Japan \| N/A \| N/A Omura-shi \| Nagasaki \| Japan \| N/A \| N/A Niigata \| Niigata \| Japan \| 139.04125 \| 37.92259 Beppu-shi \| Oita Prefecture \| Japan \| N/A \| N/A Okayama \| Okayama-ken \| Japan \| 133.93333 \| 34.65 Daito-shi \| Osaka \| Japan \| N/A \| N/A Osaka \| Osaka \| Japan \| 135.50107 \| 34.69379 Sakai-shi \| Osaka \| Japan \| N/A \| N/A Ogi-shi \| Saga-ken \| Japan \| N/A \| N/A Saga \| Saga-ken \| Japan \| 130.3 \| 33.23333 Hanyu-shi \| Saitama \| Japan \| N/A \| N/A Sunto-gun \| Shizuoka \| Japan \| N/A \| N/A Shimotsuke-shi \| Tochigi \| Japan \| N/A \| N/A Naruto-shi \| Tokushima \| Japan \| N/A \| N/A Tokushima \| Tokushima \| Japan \| 134.56667 \| 34.06667 Chuo-ku \| Tokyo \| Japan \| N/A \| N/A Hachioji-shi \| Tokyo \| Japan \| N/A \| N/A Kiyose-shi \| Tokyo \| Japan \| N/A \| N/A Machida-shi \| Tokyo \| Japan \| N/A \| N/A Meguro-ku \| Tokyo \| Japan \| N/A \| N/A Nishi-Tokyo-shi \| Tokyo \| Japan \| 139.5383 \| 35.72526 Shibuya-ku \| Tokyo \| Japan \| N/A \| N/A Shinjuku-ku \| Tokyo \| Japan \| N/A \| N/A Toshima-ku \| Tokyo \| Japan \| N/A \| N/A Tottori-shi \| Tottori \| Japan \| 134.23333 \| 35.5 Yonago-shi \| Tottori \| Japan \| N/A \| N/A Shimonoseki-shi \| Yamaguchi \| Japan \| N/A \| N/A Yanai-shi \| Yamaguchi \| Japan \| N/A \| N/A	364	NCT00787254	1COMPLETED	2009-05-01	2007-04-01	Takeda	4INDUSTRY	false	false	false	null	0
[ 3 ]	68	RANDOMIZED	PARALLEL	1PREVENTION	3TRIPLE	false	0ALL	null	Brief Summary: A randomized, single administration, double-blind, parallel- group Phase 2 dose finding study to assess the efficacy, tolerability, and safety of TRG in patients with chemotherapy-induced nausea and vomiting (CINV) associated with the administration of highly emetogenic chemotherapy. Primary Objective: To select a dose for Phase 3 by assessing the efficacy, safety, and tolerability of 3 doses of TRG in patients with CINV associated with the administration of highly emetogenic chemotherapy.	null	Chemotherapy-Induced Nausea and Vomiting	Highly emetogenic chemotherapy induced nausea and vomiting	null	3	arm 1: 0.5 mg dose, intranasal powder, single spray, administered once arm 2: 1.0 mg dose, intranasal powder, songle spray, administered once arm 3: 2.0 mg dose, intranasal powder, single spray, administered once	[ 0, 0, 0 ]	1	[ 0 ]	intervention 1: 0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen	intervention 1: Intranasal granisetron	1	The Study Is Managed by Kendle International, in Wilmington \| North Carolina \| United States \| N/A \| N/A	68	NCT00787566	1COMPLETED	2009-05-01	2008-10-01	Shin Nippon Biomedical Laboratories, Ltd.	4INDUSTRY	false	false	false	null	0
[ 5 ]	236	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.	null	Open-angle Glaucoma Ocular Hypertension	Open-angle glaucoma Ocular hypertension	null	2	arm 1: One drop self-administered in the study eye(s) once daily at night for 12 weeks arm 2: One drop self-administered in the study eye(s) once daily at night for 12 weeks	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as travoprost. intervention 2: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as latanoprost.	intervention 1: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) intervention 2: Latanoprost ophthalmic solution 0.005% (XALATAN®)	0	null	236	NCT00798759	1COMPLETED	2009-05-01	2008-12-01	Alcon Research	4INDUSTRY	false	false	false	null	0
[ 3 ]	3	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	This study is designed to assess the safety and efficacy of twice-daily oral dosing of 6R-BH4 to improve endothelial function, reduce systolic blood pressure and reduce arterial stiffness.	By comparing values measured at different timepoints, the study is expected to provide insight regarding the ability of 6R-BH4, administered along with their currently prescribed antihypertension medications, to improve endothelial function, reduce SBP, and reduce arterial stiffness in patients with ISH and endothelial dysfunction	Isolated Systolic Hypertension Endothelial Dysfunction	Isolated Systolic Hypertension with Endothelial Dysfunction	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period intervention 2: placebo given BID for entire length of study	intervention 1: 6R-BH4 intervention 2: Placebo	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	0	NCT00802893	6TERMINATED	2009-05-01	2008-12-01	Johns Hopkins University	7OTHER	false	false	false	null	0
[ 3 ]	120	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	0ALL	false	This is a Phase 2, multicenter, randomized, double-blind, placebo and active comparator-controlled study of LY2590443 in approximately 200 participants with migraines.	null	Migraine Headache	Migraine Headache	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 2, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 200 milligrams (mg) as four 50-mg capsules, oral, once intervention 2: saline solution, injection, once intervention 3: 6 milligrams (mg) injection (0.5 milliliter \[mL\] of 12 mg/mL solution), once intervention 4: 4 capsules, once	intervention 1: LY2590443 intervention 2: Placebo injection intervention 3: Sumatriptan intervention 4: Placebo capsule	19	Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 Chula Vista \| California \| United States \| -117.0842 \| 32.64005 Fresno \| California \| United States \| -119.77237 \| 36.74773 Garden Grove \| California \| United States \| -117.94145 \| 33.77391 Imperial \| California \| United States \| -115.56944 \| 32.84755 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Santa Monica \| California \| United States \| -118.49138 \| 34.01949 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Wellesley Hills \| Massachusetts \| United States \| -71.27867 \| 42.30843 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Mount Vernon \| New York \| United States \| -73.83708 \| 40.9126 West Chester \| Ohio \| United States \| -84.40716 \| 39.33172 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681	120	NCT00804973	6TERMINATED	2009-05-01	2008-11-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 3 ]	80	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	true	0ALL	false	The purpose of this study is to determine how VI-0521 affect speed and reaction time on specific tasks that require eye and hand coordination, compared to placebo.	null	Overweight Obesity	Overweight Obesity coordination psychomotor	null	4	arm 1: Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo arm 2: First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521 arm 3: First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521 arm 4: First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521	[ 0, 0, 0, 0 ]	4	[ 0, 0, 10, 10 ]	intervention 1: Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week intervention 2: Placebo daily for 4 weeks intervention 3: None intervention 4: fruit juice	intervention 1: VI-0521 intervention 2: Placebo intervention 3: Alcohol intervention 4: alcohol placebo	1	Lincoln \| Nebraska \| United States \| -96.66696 \| 40.8	161	NCT00806260	1COMPLETED	2009-05-01	2008-12-01	VIVUS LLC	4INDUSTRY	false	false	false	null	0
[ 3 ]	369	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder.	null	Anxiety Disorders	Generalized Anxiety Disorder GAD Anxiety	null	4	arm 1: AZD7325 5mg twice daily arm 2: AZD7325 15mg twice daily arm 3: Lorazepam 2mg twice daily arm 4: Placebo	[ 0, 0, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 4 tablets and 1 capsule taken twice a day for 28 days intervention 2: 4 tablets and 1 capsule taken twice a day for 28 days intervention 3: 4 tablets and 1 capsule taken twice a day for 28 days intervention 4: 4 tablets and 1 capsule taken twice a day for 28 days	intervention 1: AZD7325 intervention 2: AZD7325 intervention 3: Lorazepam intervention 4: Placebo	51	Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Carson \| California \| United States \| -118.28202 \| 33.83141 Escondido \| California \| United States \| -117.08642 \| 33.11921 Glendale \| California \| United States \| -118.25508 \| 34.14251 Irvine \| California \| United States \| -117.82311 \| 33.66946 Redlands \| California \| United States \| -117.18254 \| 34.05557 Riverside \| California \| United States \| -117.39616 \| 33.95335 Sherman Oaks \| California \| United States \| -118.44925 \| 34.15112 Fort Lauderdale \| Florida \| United States \| -80.14338 \| 26.12231 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Gainsville \| Florida \| United States \| N/A \| N/A Hallandale \| Florida \| United States \| -80.14838 \| 25.9812 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Maitland \| Florida \| United States \| -81.36312 \| 28.62778 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Hoffman Estates \| Illinois \| United States \| -88.0798 \| 42.04281 Oak Brook \| Illinois \| United States \| -87.92895 \| 41.83281 Schaumburg \| Illinois \| United States \| -88.08341 \| 42.03336 Lafayette \| Indiana \| United States \| -86.87529 \| 40.4167 Terre Haute \| Indiana \| United States \| -87.41391 \| 39.4667 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Glen Burnie \| Maryland \| United States \| -76.62469 \| 39.16261 Westminster \| Maryland \| United States \| -76.99581 \| 39.57538 Braintree \| Massachusetts \| United States \| -71.00215 \| 42.20384 Piscataway \| New Jersey \| United States \| -74.39904 \| 40.49927 Cedarhurst \| New York \| United States \| -73.7243 \| 40.62288 New York \| New York \| United States \| -74.00597 \| 40.71427 Staten Island \| New York \| United States \| -74.13986 \| 40.56233 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Willoughby \| Ohio \| United States \| -81.4065 \| 41.63977 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Salem \| Oregon \| United States \| -123.0351 \| 44.9429 Allentown \| Pennsylvania \| United States \| -75.49018 \| 40.60843 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Bartlett \| Tennessee \| United States \| -89.87398 \| 35.20453 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Wichita Falls \| Texas \| United States \| -98.49339 \| 33.91371 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Seattle \| Washington \| United States \| -122.33207 \| 47.60621	369	NCT00807937	1COMPLETED	2009-05-01	2008-12-01	AstraZeneca	4INDUSTRY	false	false	false	null	-0
[ 2, 3 ]	172	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks.	null	Ocular Hypertension Glaucoma		null	5	arm 1: AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks. arm 2: AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks. arm 3: AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks. arm 4: Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks. arm 5: AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.	[ 0, 0, 0, 1, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks. intervention 2: AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks. intervention 3: AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks. intervention 4: Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks. intervention 5: AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.	intervention 1: AGN-210669 ophthalmic solution, 0.075% intervention 2: AGN-210669 ophthalmic solution, 0.05% intervention 3: AGN-210669 ophthalmic solution, 0.025% intervention 4: bimatoprost ophthalmic solution 0.03% intervention 5: AGN-210669 vehicle ophthalmic solution	1	Artesia \| California \| United States \| -118.08312 \| 33.86585	172	NCT00809848	1COMPLETED	2009-05-01	2009-02-01	Allergan	4INDUSTRY	false	false	false	null	0
[ 5 ]	12	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	1FEMALE	false	The objective of this study is to compare the pharmacokinetics of lopinavir tablets administered to pediatric patients as either whole or crushed tablets. The study is a randomized,open-label, crossover study of pediatric subjects already taking lopinavir/ritonavir tablets as part of their clinical care. THe investigators hypothesize that lopinavir exposure in pediatric patients will be lower after taking a dose of the tablet formulation, crushed and mixed with pudding or yogurt, as compared to the exposure after taking a dose with tablets swallowed whole.	By the end of 2005, approximately 2.3 million children worldwide were living with HIV/AIDS.1 At least 660,000 children worldwide have advanced HIV/AIDS and are in dire need of antiretroviral treatment. While many barriers exist to scaling up HIV/AIDS care and treatment globally, access to life-saving treatments for children is increasing. The protease inhibitor, lopinavir/ritonavir (Kaletra®), is recommended as a first-line agent by the World Health Organization and by the US Department of Health and Human Services for the treatment of pediatric patients in resource-limited settings and in the United States. The prescribing information states that these tablets may not be crushed, broken or chewed, and the manufacturer does not plan to examine the pharmacokinetics of crushed tablets at this time. The company found that the crushed tablets were poorly absorbed in a small pharmacokinetic study in several dogs. While this information has spread through investigators by word-of-mouth, this information has not been published in any forum by the company, and no guidance as to the extent of the decrease in absorption has been provided. However, patients and caregivers are dosing pediatric patients with crushed tablets to overcome some of the limitations of the oral solution. If crushed tablet administration yields significantly lower systemic exposure to lopinavir than whole tablets, then patients using this administration technique will be at higher risk for development of viral resistance and treatment failure. This administration technique must be studied so that providers have evidence to support recommendations about this dose administration strategy.	HIV/AIDS Treatment HIV Infections	HIV/AIDS pediatrics resource-limited settings lopinavir ritonavir Kaletra® antiretroviral treatment crushed tablets treatment experienced	null	2	arm 1: These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2. arm 2: These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.	[ 0, 0 ]	1	[ 0 ]	intervention 1: The subject will bring their own prescription of lopinavir/ritonavir. The patient will take a witnessed dose of lopinavir/ritonavir with an 6 ounce glass of cool water (if taken whole) or mixed in 4 ounces of Jell-O brand pudding (if crushed).	intervention 1: lopinavir/ritonavir (Kaletra®) tablets	2	San Diego \| California \| United States \| -117.16472 \| 32.71571 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511	13	NCT00810108	1COMPLETED	2009-05-01	2006-06-01	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	0NIH	false	false	false	null	0
[ 2 ]	29	RANDOMIZED	PARALLEL	2DIAGNOSTIC	2DOUBLE	true	1FEMALE	false	The purpose of this study is to examine the effect of two different dose levels of estrogen or placebo in healthy postmenopausal women by measuring the changes in hormone levels and examining the changes in the uterine lining (endometrium).	null	Postmenopausal Symptoms		null	3	arm 1: Estrace 2.0 mg tablet arm 2: Estrace 0.5 mg tablet arm 3: Placebo	[ 1, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: 0.5 mg tablet taken once daily for 28 days intervention 2: 2 mg tablets taken once daily for 28 days. intervention 3: Placebo 0 mg capsule taken once daily for 28 days	intervention 1: Comparator: Estrace 0.5 mg intervention 2: Comparator: Estrace 2 mg intervention 3: Comparator: Placebo	0	null	29	NCT00820664	1COMPLETED	2009-05-01	2008-12-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 5 ]	30	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to determine whether cetirizine (zyrtec), levocetirizine (xyzal), and placebo differ in the degree of sedation they produce and their relief of allergy symptoms.	Levocetirizine, the R-enantiomer of cetirizine, has been found to be less sedating relative to placebo than was cetirizine in separate trials. We plan to examine whether patients who did not tolerate cetirizine due to sedation are able to tolerate levocetirizine. This study will utilize a randomized, double-blind, placebo controlled trial comparing levocetirizine, cetirizine, and placebo in regards to sedation and allergy symptom scores. Each patient will receive levocetirizine, cetirizine, and placebo in randomized order and thus serve as their own control.	Allergic Rhinitis	Allergic Rhinitis	null	3	arm 1: 5 mg daily x 7 days (note = cross over = all participants receive active comparators and placebo) arm 2: 10 mg daily x 7 days. Note = crossover study, so all participants recieve all active comparators and placebo. arm 3: one tablet daily x 7 days; note that this is a crossover study so all participants receive all active comparators and placebo	[ 1, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Cetirizine 10 mg tab daily x 7 days intervention 2: 5 mg tab daily x 7 days intervention 3: Placebo tablet daily x 7 days	intervention 1: Cetirizine intervention 2: Levocetirizine intervention 3: Placebo	1	Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589	90	NCT00826943	1COMPLETED	2009-05-01	2009-01-01	Vanderbilt University	7OTHER	false	false	false	null	0
[ 2 ]	425	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and to show superiority over vehicle in the treatment of AK. The secondary objective is to compare the adverse event (AE) profiles of the two creams.	null	Actinic Keratosis	Actinic Keratosis	null	3	arm 1: Imiquimod 5% manufactured by Taro applied for 16 weeks arm 2: Aldara, Imiquimod 5% applied for 16 weeks arm 3: Imiquimod vehicle applied for 16 weeks	[ 0, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks intervention 2: Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks intervention 3: Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks	intervention 1: Imiquimod 5% manufactured by Taro intervention 2: Aldara - Imiquimod 5% intervention 3: Imiquimod Vehicle manufactured by Taro	20	Gilbert \| Arizona \| United States \| -111.78903 \| 33.35283 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Tuscon \| Arizona \| United States \| N/A \| N/A Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Evansvill \| Indiana \| United States \| N/A \| N/A Plainfield \| Indiana \| United States \| -86.39944 \| 39.70421 Olathe \| Kansas \| United States \| -94.81913 \| 38.8814 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Henderson \| Nevada \| United States \| -114.98194 \| 36.0397 Cary \| North Carolina \| United States \| -78.78112 \| 35.79154 Hickory \| North Carolina \| United States \| -81.3412 \| 35.73319 High Point \| North Carolina \| United States \| -80.00532 \| 35.95569 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Simpsonville \| South Carolina \| United States \| -82.25428 \| 34.73706 Murfreesboro \| Tennessee \| United States \| -86.39027 \| 35.84562 College Station \| Texas \| United States \| -96.33441 \| 30.62798 Tyler \| Texas \| United States \| -95.30106 \| 32.35126	422	NCT00828568	1COMPLETED	2009-05-01	2008-06-01	Sun Pharmaceutical Industries, Inc.	4INDUSTRY	false	false	false	null	-0
[ 3 ]	65	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in subjects with type 1 diabetes mellitus.	null	Diabetes Diabetes Mellitus, Type 1		null	2	arm 1: None arm 2: None	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: The insulin NN1250 (insulin degludec) injected subcutaneously at bedtime intervention 2: Injection subcutaneously at bedtime intervention 3: Injection subcutaneously immediately before each meal.	intervention 1: insulin degludec intervention 2: insulin detemir intervention 3: insulin aspart	8	Chuo-ku, Tokyo \| N/A \| Japan \| N/A \| N/A Ebina-shi \| N/A \| Japan \| N/A \| N/A Koriyama-shi, Fukushima \| N/A \| Japan \| 140.46667 \| 37.75 Kumamoto-shi,Kumamoto \| N/A \| Japan \| N/A \| N/A Ōita \| N/A \| Japan \| 131.6 \| 33.23333 Sapporo-shi, Hokkaido \| N/A \| Japan \| 141.35 \| 43.06667 Sapporo-shi, Hokkaido \| N/A \| Japan \| 141.35 \| 43.06667 Yokohama \| N/A \| Japan \| 139.65 \| 35.43333	65	NCT00841087	1COMPLETED	2009-05-01	2009-01-01	Novo Nordisk A/S	4INDUSTRY	false	false	false	null	0
[ 5 ]	150	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal Spray for the treatment of seasonal allergic rhinitis.	null	Seasonal Allergic Rhinitis	Rhinitis Allergy Nasal Spray Antihistamine Intranasal Corticosteroid	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days intervention 2: 2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days	intervention 1: Olopatadine HCl Nasal Spray, 0.6% intervention 2: Azelastine HCl Nasal Spray, 0.1%	1	Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541	150	NCT00845195	1COMPLETED	2009-05-01	2009-03-01	Alcon Research	4INDUSTRY	false	false	false	null	0
[ 3 ]	24	RANDOMIZED	SINGLE_GROUP	9OTHER	1SINGLE	false	0ALL	false	The purpose of the study is to compare the anti-psoriatic effect of marketed products with Daivobet® ointment in a plaque test	null	Psoriasis Vulgaris		null	1	arm 1: None	[ 0 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Once daily application 6 days a week for 3 weeks intervention 2: Once daily application 6 days a week for 3 weeks intervention 3: Once daily application 6 days a week for 3 weeks intervention 4: Once daily application 6 days a week for 3 weeks intervention 5: Once daily application 6 days a week for 3 weeks intervention 6: Once daily application 6 days a week for 3 weeks	intervention 1: Daivobet® ointment intervention 2: Betnovat® ointment intervention 3: Diprosalic ointment intervention 4: Dermovat ointment intervention 5: Elocon ointment intervention 6: Daivobet® ointment vehicle	1	Saint Quentin Yvelines Cedex \| N/A \| France \| N/A \| N/A	24	NCT00845481	1COMPLETED	2009-05-01	2009-01-01	LEO Pharma	4INDUSTRY	false	false	false	null	0
[ 3 ]	487	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with SAR.	null	Seasonal Allergic Rhinitis Hayfever	Seasonal Allergic Rhinitis Hayfever	null	4	arm 1: During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 micrograms (µg) BDP HFA and two actuations of placebo HFA once daily. arm 2: During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily. arm 3: During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily. arm 4: During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.	[ 0, 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol intervention 2: HFA Vehicle Aerosol	intervention 1: Beclomethasone dipropionate HFA Nasal Aerosol intervention 2: Placebo	26	Mission Viejo \| California \| United States \| -117.672 \| 33.60002 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Gainesville \| Georgia \| United States \| -83.82407 \| 34.29788 Savannah \| Georgia \| United States \| -81.09983 \| 32.08354 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Brick \| New Jersey \| United States \| -74.13708 \| 40.05928 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Medford \| Oregon \| United States \| -122.87559 \| 42.32652 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Blue Bell \| Pennsylvania \| United States \| -75.26629 \| 40.15233 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Upland \| Pennsylvania \| United States \| -75.38269 \| 39.85261 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 New Braunfels \| Texas \| United States \| -98.12445 \| 29.703 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Draper \| Utah \| United States \| -111.86382 \| 40.52467 Burke \| Virginia \| United States \| -77.27165 \| 38.79345 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376	486	NCT00854360	1COMPLETED	2009-05-01	2009-03-01	Teva Branded Pharmaceutical Products R&D, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	33	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	null	This study was intended to assess how well inhaled NVA237 opens up the airways of patients with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period.	null	Chronic Obstructive Pulmonary Disease	COPD Bronchodilator	null	2	arm 1: Placebo 50 μg capsules followed by NVA237 50 μg capsules for inhalation once daily with Concept 1 device. arm 2: NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device.	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Matching placebo capsules were supplied for inhalation once daily with Concept 1 device. intervention 2: NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device.	intervention 1: Placebo intervention 2: NVA237	2	Spartanburg \| South Carolina \| United States \| -81.93205 \| 34.94957 Albrechtstrasse 14 \| Munich \| Germany \| N/A \| N/A	64	NCT00856193	1COMPLETED	2009-05-01	2009-02-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 4 ]	136	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.	null	Colonoscopy	colonoscopy bowel preparation	null	2	arm 1: Polyethylene glycol 3350 based bowel preparation arm 2: BLI800	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Solution for oral administration prior to colonoscopy intervention 2: Solution for oral administration prior to colonoscopy	intervention 1: BLI800 intervention 2: Polyethylene glycol 3350 based bowel preparation	5	Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Jupiter \| Florida \| United States \| -80.09421 \| 26.93422 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Great Neck \| New York \| United States \| -73.72846 \| 40.80066	130	NCT00856843	1COMPLETED	2009-05-01	2009-02-01	Braintree Laboratories	4INDUSTRY	false	false	false	null	0

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