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
[ 2, 3 ]	154	RANDOMIZED	FACTORIAL	9OTHER	3TRIPLE	true	0ALL	true	The aim of this study is to develop information about the acute and residual effects of a new product being targeted to young adults. Using a double placebo-controlled 2 X 2 factorial model study design, we will compare the acute and residual effects on driving impairment of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo. Under the alcohol conditions, participants will receive sufficient alcoholic beverage to attain a blood alcohol concentration (BAC) of .12 g%. Participants will be 144 undergraduate and graduate students, and recent college graduates.	Caffeinated alcoholic beverages target young adults with the promise that the caffeine will counteract the sedating effects of alcohol and thus let the consumer remain alert and active longer, while continuing to drink. It is likely that in the minds of some young people, this promise also translates into the idea that mixing caffeine with alcohol allows one to drive more safely than would be possible after having consumed an equivalent amount of non-caffeinated alcoholic beverage. These are dangerous assumptions because (1) alertness may not indicate the absence of impairment under intoxication and (2) next-day impairment from the residual effects of heavy drinking may be exacerbated by mixing caffeine and alcohol. We will compare the acute and residual effects of caffeinated and non-caffeinated beer in terms of a highly relevant outcome - the ability to drive safely. The long-term objectives of this program of research are to investigate factors that predict or contribute to performance decrements after alcohol ingestion, with a focus on behaviors most relevant to public health, such as driving. The primary specific aims of the proposed work are: AIM 1: To compare the acute effects of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo on driving-related impairment, as measured by performance on a driving simulator and the Psychomotor Vigilance Test (PVT), a test of sustained attention/reaction time. We hypothesize that caffeinated beverage will result in less impaired simulated driving ability and better PVT performance acutely, compared to non-caffeinated beverage, but that performance on these measures following both caffeinated and non-caffeinated beverage be impaired relative to placebo beverages. AIM 2: To compare the residual effects of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo on next-day driving-related impairment, as measured by a driving simulator and the PVT. We hypothesize that caffeinated beverage will result in greater impairment in next-day simulated driving and attention/reaction time, relative to non-caffeinated beverage, and that performance following both caffeinated and non-caffeinated alcoholic beverages will be impaired relative to corresponding placebo beverages. AIM 3: To compare the acute effects of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo on self-rated ability to drive, as measured by a self assessment of ability-to-drive questionnaire, and estimate of blood alcohol concentration (BAC). We hypothesize that caffeinated alcoholic beverages will result in greater confidence in ability to drive and lower estimates of BAC, compared to non-caffeinated alcoholic beverages, but that for both alcoholic beverages, confidence in driving ability will be lower and estimates of BAC will be greater, relative to placebos. AIM 4: To compare the residual effects of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo on self-rated ability to drive. We hypothesize that caffeinated alcoholic beverage will result in lower confidence in ability to drive and higher estimates of BAC, compared to non-caffeinated alcoholic beverage, but that for both alcoholic beverages, confidence in driving ability will be lower and estimates of BAC will be greater, relative to placebo.	Neurobehavioral Manifestations Drug Related Sleep Disturbance Alcohol Intoxication	Caffeine Alcohol Alcohol Consumption Residual Effects Family History Psychomotor Vigilance Test Driving Simulation Reaction Time	null	4	arm 1: Caffeinated Alcoholic beer arm 2: Non-Caffeinated Alcoholic beer arm 3: Caffeinated Non-Alcoholic Beer arm 4: Non-Caffeinated, Non-Alcoholic Beer	[ 0, 1, 1, 2 ]	4	[ 0, 10, 0, 10 ]	intervention 1: Alcoholic Beer plus Caffeine Citrate powder. intervention 2: Alcoholic Non-Caffeinated Beer intervention 3: Non-Alcoholic Beer plus Caffeine Citrate powder. intervention 4: Non-Alcoholic Beer	intervention 1: Caffeinated Alcoholic Beer intervention 2: Non-Caffeinated Alcoholic Beer intervention 3: Caffeinated Non-Alcoholic Beer intervention 4: Non-Caffeinated, Non-Alcoholic Beer	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	127	NCT00515294	1COMPLETED	2009-10-01	2006-10-01	Boston University	7OTHER	false	false	false	null	0
[ 4 ]	180	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that affects an individual's ability to breathe. This study will evaluate the effectiveness of sildenafil, a medication that increases blood flow to the lungs, at improving breathing function, exercise capacity, and quality of life in people with advanced IPF.	IPF is a disease in which fibrous tissue clogs the lungs. This eventually damages air sacs in the lungs and leads to widespread and permanent scarring of lung tissue. Individuals with IPF may experience breathing difficulties, cough, chest pain, and a decreased exercise capacity. Pulmonary hypertension, which is high blood pressure in the arteries of the lungs, affects half of all people with IPF. The fibrous tissue that clogs the lungs also blocks blood from flowing through the lungs effectively, reducing the amount of oxygen in the lungs. The fibrous tissue also reduces the lungs' ability to use what oxygen is available. These factors can cause breathing difficulties and may eventually lead to heart disease. Sildenafil is a medication that can increase blood supply to the lungs and reduce the heart's workload. The purpose of this study is to evaluate the effectiveness of sildenafil at improving breathing function, exercise capacity, and quality of life in people with advanced IPF. This study will enroll people with advanced IPF. Participants will be randomly assigned to receive sildenafil or placebo three times a day for 12 weeks. Study visits will occur at baseline and Weeks 1, 6, and 12. At Week 12, participants will have the option to continue in the study for an additional 12 weeks. All participants who agree to continue in the study will receive sildenafil three times a day for the second 12 weeks. Study visits will occur at Weeks 13, 18, and 24. At all study visits, a physical exam and blood collection will occur. At selected visits, the following study procedures will occur: lung function testing; urine collection; a 6-minute walk test, which will measure the distance walked in a 6-minute period; and questionnaires to assess health status, breathing, and quality of life. Participants will record medication usage and symptoms in a daily diary. Study researchers will review medical records and the Social Security death index 5 years following the end of the study to determine the incidence of death among study participants.	Pulmonary Fibrosis Hypertension, Pulmonary	Idiopathic Pulmonary Fibrosis Pulmonary Hypertension	null	2	arm 1: 20 mg of sildenafil 3 times a day (TID) for 12 weeks followed by 20 mg of sildenafil TID for an additional 12 weeks arm 2: 20 mg of placebo TID for 12 weeks followed by 20 mg of sildenafil citrate TID for an additional 12 weeks	[ 1, 2 ]	2	[ 0, 10 ]	intervention 1: Sildenafil citrate (20mg 3 times a day \[TID\] orally for 12 weeks followed by 20mg TID open-label sildenafil for an additional 12 weeks) intervention 2: Placebo (20mg TID orally for 12 weeks followed by 20mg open-label sildenafil for 12 weeks)	intervention 1: Sildenafil Citrate intervention 2: Placebo	13	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 New York \| New York \| United States \| -74.00597 \| 40.71427 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Seattle \| Washington \| United States \| -122.33207 \| 47.60621	180	NCT00517933	1COMPLETED	2009-10-01	2007-08-01	Duke University	7OTHER	false	false	false	null	0
[ 5 ]	11	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	false	The purpose of this pilot study is to determine the efficacy and safety of escitalopram administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe PMS in young women ages 15-19 years.	The medication in this study is a serotonin reuptake inhibitor (SSRI), a class that is considered the first-line treatment for severe PMS at this time. Although data indicate that young women who have PMS in their teen years report the same symptoms and symptom severity as adult women, clinical trials have not included this age group, and there is no information on the efficacy and safety of treatment with a serotonergic antidepressant for PMS in teens.	PMS	premenstrual syndrome PMS PMDD treatment SSRI	null	2	arm 1: Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects. arm 2: Placebo tablets matched to drug.	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects. intervention 2: Placebo tablets matched to drug	intervention 1: escitalopram intervention 2: placebo	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	11	NCT00523705	6TERMINATED	2009-10-01	2008-02-01	University of Pennsylvania	7OTHER	false	false	false	null	0
[ 5 ]	23	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this research study is to examine whether Methylphenidate (MPD) can result in improvement of gait (walking) in a population of Parkinson's Disease (PD) patients whose main disability is freezing of gait. MPD (Ritalin®) is a drug which can excite or stimulate certain systems of the body that control motor function. This drug is FDA approved for the treatment of attention hyperactivity disorder, a condition unrelated to PD. The researchers hypothesize that daily treatment with a tolerable daily oral dose of MPD will improve gait velocity, stride length, cadence, and decrease freezing of gait, 3 months from treatment initiation in patients with moderately advanced PD, whose gait impairment is an important source of disability despite optimized antiparkinsonian treatment.	There are a total of six clinic visits involved in this study. All study-related assessments will take place first during the practically defined off period, that is, in the morning after at least 12 hours from the last dose of any antiparkinsonian medication, followed by a repeat assessment once the "on" state is clearly identified by the patient and examiner (approximately 30 to 60 minutes after taking your Parkinson's medication). This "practically defined off period" state is considered the desired state on which to report motor changes for any currently available or experimental intervention in PD. Patients will be off his or her Parkinson's medication for no more than 14 hours for each of the assessments. Studying patients in the off-period is the most widely used manner in which the value of new therapies can be fully measured. During the first visit, patients will be "randomized" into one of the study groups described below. Neither the participant nor the researcher conducting this study will choose what group he or she will be in. Participants will receive either placebo or a dose of 1 mg/kg of Methylphenidate capsules divided into three doses (at 8 am, 12 noon, and 4 pm). An increase in medication over a four week period will be used until a target dosage is reached, which may range from 5 to 8 10-mg capsules per day. A measure of balance will be taken during both patient's "off" and "on" motor states during each of the study visits. Patients will be asked to stand on a force plate (a piece of equipment that measures your balance and is located in the floor) for thirty seconds in a total of four conditions. The four sessions will be carried out as follows: (1) with eyes open while standing on firm surface, (2) with eyes closed while standing on firm surface, (3) with eyes open while standing on foam surface, and (4) with eyes closed while standing on foam surface. These sessions will be in random order and will be repeated up to 4 times. During all the study visits, the physician will ask patients to perform some physical tests during which the Unified Parkinson's Disease Rating Scale (UPDRS) and the Hoehn and Yahr (H\&Y) will be used to assess the severity of the patient's Parkinson's disease. Each assessment will take place during both patient's "off" and "on" motor states. Instruments that will also be used are the self-administered Freezing of Gait Questionnaire (FOGQ), to evaluate walking difficulties, and the Gait-Falls diary, to document all indoor and outdoor freezing, tripping, and falls. To assess changes in mood, patients will also complete the following instruments: the Montgomery-Asberg Depression scale (MADRS), the 15-item Geriatric Depression Scale (GDS-15) and the 20-item Zung Self-Rating Depression scale (Zung). To assess quality of life and activities of daily living, patients will complete the EQ-5D Health Questionnaire. Finally, patients will be asked to complete the Epworth Sleepiness Scale (ESS) to document any changes in sleep patterns. After the first visit, patients will begin a four week increase in medication in order to reach a target dose. At the fourth visit, patients will receive the opposite treatment of what was received the first time and another four-week increase in medication will take place. If Methylphenidate was given at the first visit, patients will receive placebo on the third visit and vice versa. There will be a three week period where patients will not take the study medication (either Methylphenidate or placebo), between the third and fourth visit. At all study visits, during both patient's "off" and "on" motor states, patients will have balance testing. The physician will evaluate the severity of patient's disease using the UPDRS and the H\&Y. Patients will be asked to complete the FOGQ and the Gait-Falls diary.	Parkinson's Disease Gait Impairment	freezing gait festination shuffling balance	null	2	arm 1: Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo. arm 2: Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Participants will be given 1 mg/kg of MPD divided in three doses (at 8 am, 12 noon, and 4 pm). A four-week titration period will be used, using 0.25-mg/kg increments per week until achieving the weight-adjusted target dosage, which may range from five to eight 10-mg tablets per day. The maximum daily dose will be 80 mg/day. intervention 2: Participants will be given placebo instead of active MPD.	intervention 1: Methylphenidate (MPD) intervention 2: Placebo	1	Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711	43	NCT00526630	1COMPLETED	2009-10-01	2007-12-01	University of Cincinnati	7OTHER	false	false	false	null	0
[ 3 ]	170	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	null	A study to evaluate the safety, tolerability, and efficacy of MK-0773 in women with sarcopenia (loss of muscle mass).	null	Sarcopenia	Sarcopenia (loss of muscle mass)	null	2	arm 1: MK-0773 arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: MK-0773 50 mg tablets twice daily, 6 month treatment period intervention 2: Placebo tablets twice daily, 6 month treatment period	intervention 1: Comparator: MK-0773 intervention 2: Comparator: Placebo	0	null	170	NCT00529659	1COMPLETED	2009-10-01	2007-10-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 4 ]	120	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single-arm study will assess the long-term maintenance of hemoglobin levels, safety, and tolerability of once-monthly intravenous administration of Mircera in hemodialysis participants with chronic renal anemia. Those currently receiving darbepoetin alfa, epoetin alfa, or epoetin beta maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200, or 360 micrograms (mcg) per month (based on the erythropoiesis stimulating agent \[ESA\] dose administered on Week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the country-specific target range (11 to 13 grams per deciliter \[g/dL\] for Switzerland and 10 to 12 g/dL for Austria).	null	Anemia		null	1	arm 1: Participants will receive intravenous Mircera every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within a country-specific target range.	[ 0 ]	1	[ 0 ]	intervention 1: Mircera will be administered intravenously every 4 weeks for a total of 52 weeks. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within a country-specific target range.	intervention 1: Methoxy polyethylene glycol-epoetin beta	27	Bregenz \| N/A \| Austria \| 9.7471 \| 47.50311 Feldkirch \| N/A \| Austria \| 9.6 \| 47.23306 Graz \| N/A \| Austria \| 15.45 \| 47.06667 Kufstein \| N/A \| Austria \| 12.16667 \| 47.58333 Linz \| N/A \| Austria \| 14.28611 \| 48.30639 Salzburg \| N/A \| Austria \| 13.04399 \| 47.79941 Sankt Pölten \| N/A \| Austria \| 15.63333 \| 48.2 Steyr \| N/A \| Austria \| 14.42127 \| 48.04274 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Basel \| N/A \| Switzerland \| 7.57327 \| 47.55839 Bellinzona \| N/A \| Switzerland \| 9.01703 \| 46.19278 Burgdorf \| N/A \| Switzerland \| 7.62786 \| 47.05901 Geneva \| N/A \| Switzerland \| 6.14569 \| 46.20222 Lausanne \| N/A \| Switzerland \| 6.63282 \| 46.516 Liestal \| N/A \| Switzerland \| 7.73446 \| 47.48455 Locarno \| N/A \| Switzerland \| 8.79953 \| 46.17086 Lucerne \| N/A \| Switzerland \| 8.30635 \| 47.05048 Lugano \| N/A \| Switzerland \| 8.96004 \| 46.01008 Mendrisio \| N/A \| Switzerland \| 8.9816 \| 45.87019 Sankt Gallen \| N/A \| Switzerland \| 9.37477 \| 47.42391 Sion \| N/A \| Switzerland \| 7.35559 \| 46.22739 Zurich \| N/A \| Switzerland \| 8.55 \| 47.36667 Zurich \| N/A \| Switzerland \| 8.55 \| 47.36667	91	NCT00545571	1COMPLETED	2009-10-01	2007-10-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 3 ]	31	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer.	null	Non-Hodgkin's Lymphoma	Bortezomib Bendamustine Rituximab Relapsed Refractory Mantle Cell Indolent	null	1	arm 1: Subjects that met all eligibility criteria and were treated with Bendamustine, Rituxan and Bortezomib.	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: 1.3 mg/m\^2 on days 1, 4, 8, 11 intervention 2: 90 mg/m\^2 days 1 and 4 intervention 3: 375 mg/m\^2 day 1	intervention 1: bortezomib intervention 2: bendamustine intervention 3: rituximab	3	Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 New York \| New York \| United States \| -74.00597 \| 40.71427 Rochester \| New York \| United States \| -77.61556 \| 43.15478	30	NCT00547534	1COMPLETED	2009-10-01	2007-10-01	University of Rochester	7OTHER	false	false	false	null	0
[ 5 ]	54	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The primary objective is to estimate global response rate. Clinical, microbiological and global response rates and its 95% confidence intervals will be computed. No hypotheses will be tested.	null	Candidemia Invasive Candidiasis	Open-label non-comparative study to evaluate short course of IV anidulafungin followed by oral voriconazole for tx of candidemia/invasive candidiasis.	null	1	arm 1: None	[ 0 ]	2	[ 0, 0 ]	intervention 1: All patients will receive anidulafungin 200 mg IV dose on Day 1. On Day 2 and daily thereafter the patients will receive one daily IV dose of 100 mg of anidulafungin. intervention 2: Patients who complete a minimum of 5 days of IV treatment with anidulafungin may be switched to oral voriconazole 200 mg BID (or 100 mg BID if \<40 kg body weight) therapy on Day 5 and thereafter, starting with a loading dose of 400 mg BID (or 200 mg BID if \<40 kg body weight).	intervention 1: Anidulafungin intervention 2: Voriconazole	13	Brasília \| Federal District \| Brazil \| -47.92972 \| -15.77972 Curitiba \| Paraná \| Brazil \| -49.27306 \| -25.42778 Rio de Janeiro \| Rio de Janeiro \| Brazil \| -43.18223 \| -22.90642 Porto Alegre \| Rio Grande do Sul \| Brazil \| -51.23019 \| -30.03283 Porto Alegre \| Rio Grande do Sul \| Brazil \| -51.23019 \| -30.03283 São José do Rio Preto \| São Paulo \| Brazil \| -49.37944 \| -20.81972 Independencia \| Santiago, RM \| Chile \| -70.66647 \| -33.41167 Bogota DC \| Cundinamarca \| Colombia \| N/A \| N/A Santiago de Cali \| Valle del Cauca Department \| Colombia \| -76.5199 \| 3.43054 León \| Guanajuato \| Mexico \| -101.67374 \| 21.12908 Guadalajara \| Jalisco \| Mexico \| -103.34749 \| 20.67738 San Luis Potosí City \| San Luis Potosí \| Mexico \| -100.97135 \| 22.15234 Panama City \| N/A \| Panama \| -79.51973 \| 8.9936	54	NCT00548262	1COMPLETED	2009-10-01	2008-02-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 4 ]	215	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study is planned to objectively assess the efficacy and safety of lamotrigine maintenance therapy after symptoms of mood episode had been stabilised by open-label treatment with lamotrigine alone or in combination with other psychotropic medication in patients with bipolar I disorder.	null	Bipolar Disorder	Lamotrigine Prevention of relapse or recurrence of a mood episode Bipolar I disorder	null	2	arm 1: None arm 2: None	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: lamotrigine 100mg/day or 200mg/day intervention 2: placebo once daily	intervention 1: lamotrigine intervention 2: Placebo	60	Aichi \| N/A \| Japan \| 130.62158 \| 32.51879 Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Gunma \| N/A \| Japan \| N/A \| N/A Gunma \| N/A \| Japan \| N/A \| N/A Hiroshima \| N/A \| Japan \| 132.45 \| 34.4 Hiroshima \| N/A \| Japan \| 132.45 \| 34.4 Hokkaido \| N/A \| Japan \| N/A \| N/A Hokkaido \| N/A \| Japan \| N/A \| N/A Hokkaido \| N/A \| Japan \| N/A \| N/A Hokkaido \| N/A \| Japan \| N/A \| N/A Ibaraki \| N/A \| Japan \| 135.56828 \| 34.81641 Kanagawa \| N/A \| Japan \| 139.91667 \| 37.58333 Kanagawa \| N/A \| Japan \| 139.91667 \| 37.58333 Kanagawa \| N/A \| Japan \| 139.91667 \| 37.58333 Kanagawa \| N/A \| Japan \| 139.91667 \| 37.58333 Kanagawa \| N/A \| Japan \| 139.91667 \| 37.58333 Kanagawa \| N/A \| Japan \| 139.91667 \| 37.58333 Kumamoto \| N/A \| Japan \| 130.69181 \| 32.80589 Kyoto \| N/A \| Japan \| 135.75385 \| 35.02107 Mie \| N/A \| Japan \| 131.58333 \| 32.96667 Mie \| N/A \| Japan \| 131.58333 \| 32.96667 Nara \| N/A \| Japan \| 135.80485 \| 34.68505 Okayama \| N/A \| Japan \| 133.93333 \| 34.65 Osaka \| N/A \| Japan \| 135.50107 \| 34.69379 Osaka \| N/A \| Japan \| 135.50107 \| 34.69379 Osaka \| N/A \| Japan \| 135.50107 \| 34.69379 Osaka \| N/A \| Japan \| 135.50107 \| 34.69379 Osaka \| N/A \| Japan \| 135.50107 \| 34.69379 Ōita \| N/A \| Japan \| 131.6 \| 33.23333 Ōita \| N/A \| Japan \| 131.6 \| 33.23333 Ōita \| N/A \| Japan \| 131.6 \| 33.23333 Saga \| N/A \| Japan \| 130.3 \| 33.23333 Saitama \| N/A \| Japan \| 139.65657 \| 35.90807 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Tottori \| N/A \| Japan \| 134.67796 \| 34.24877 Tottori \| N/A \| Japan \| 134.67796 \| 34.24877 Yamagata \| N/A \| Japan \| 140.36667 \| 38.23333	318	NCT00550407	1COMPLETED	2009-10-01	2007-11-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 3, 4 ]	256	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	2MALE	false	The purpose of this study is to evaluate the effectiveness, safety and tolerability of the investigational drug, PSD502 in subjects with premature ejaculation (PE) The study drug, PSD02, is a metered dose (measured dose), topical (applied to the skin surface) anesthetic (numbing) spray containing a mixture of lidocaine and prilocaine. The study drug will be applied in a spray to the penis prior to intercourse in order to decrease sensitivity in an attempt to delay ejaculation.	Most studies evaluating treatments PE include intravaginal ejaculatory latency time (IELT) in the definition of PE. It has been estimated that PE affects 30-40% of the male population, but is paradoxically a condition for which they are least likely to seek help. Men with PE exhibit abnormal autonomic reflex pathways for the ejaculatory process. These include lower vibratory threshold to ejaculation, shorter bulbocavernous latency time and higher bulbocavernous evoked potentials. Reducing the heightened sensitivity of the glans penis with topical anesthetics might therefore be a way of improving IELT, without adversely affecting the sensation of ejaculation. Although IELT is an objective measure of ejaculatory function it does not address the impact of therapy on patients' well being and confidence in their sexual performance, which are important markers of treatment benefit. Therefore, if IELT is used as a sole efficacy measure it may not fully characterise the treatment benefit to the patient. For this reason, a patient reported outcome (PRO) known as the Index of Premature Ejaculation (IPE) will be used in this study in conjunction with IELT to evaluate efficacy. Thus the combination of the objective measure of ejaculatory latency with the PRO of IPE should be able to provide efficacy data which are representative of clinical benefit to the patient. The use of lidocaine, prilocaine and EMLA® cream as topical anesthetics is well established. Many years of experience of use in large numbers of patients, as well as comprehensive non-clinical safety testing programs for various formulations of lidocaine and prilocaine exist, to support their safety and tolerability. This information, together with the clinical data from 3 studies with PSD502 (ANAE-059-00, PSD502-PE-001, and PSD502-PE-003), suggest that PSD502 may have beneficial effects in reducing penile sensation and prolonging IELT, and its use is unlikely to be associated with significant clinical safety or tolerability concerns. The aim of this study is to provide additional placebo-controlled efficacy data to establish the clinical utility of PSD502 in the treatment of PE. In addition, long term open-label efficacy and safety data will be collected, to further support the registration package for PSD502 in the indication of treatment of PE.	Premature Ejaculation	Premature Ejaculation Lidocaine Prilocaine EMLA® cream topical anesthetics	null	3	arm 1: Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria. arm 2: Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria. arm 3: Subjects will all receive PSD502 if they wish to continue in the trial.	[ 1, 2, 1 ]	2	[ 0, 0 ]	intervention 1: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis. Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue. During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period. intervention 2: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine. Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue. During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing. During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period.	intervention 1: PSD502, contains a mixture of lidocaine and prilocaine intervention 2: Placebo	1	Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132	472	NCT00556478	1COMPLETED	2009-10-01	2007-10-01	Plethora Solutions Ltd	4INDUSTRY	false	false	false	null	0
[ 4 ]	307	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45 mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is 3-12 months.	null	Renal Anemia, Chronic		null	2	arm 1: Participants will receive Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks. arm 2: Participants will receive darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 1.2 mcg/kg SC monthly, starting dose intervention 2: 0.45 mcg/kg SC weekly or 0.75 mcg/kg every 2 weeks, starting dose	intervention 1: Methoxy polyethylene glycol-epoetin beta intervention 2: Darbepoetin alfa	76	Adelaide \| N/A \| Australia \| 138.59863 \| -34.92866 Clayton \| N/A \| Australia \| 145.11667 \| -37.91667 Gosford \| N/A \| Australia \| 151.34399 \| -33.4244 Parkville \| N/A \| Australia \| 144.95 \| -37.78333 Reservoir \| N/A \| Australia \| 145.0 \| -37.71667 Aalst \| N/A \| Belgium \| 4.0355 \| 50.93604 Roeselare \| N/A \| Belgium \| 3.12269 \| 50.94653 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Cahors \| N/A \| France \| 1.43663 \| 44.4491 Clermont-Ferrand \| N/A \| France \| 3.08682 \| 45.77969 Limoges \| N/A \| France \| 1.24759 \| 45.83362 Lyon \| N/A \| France \| 4.84671 \| 45.74846 Nice \| N/A \| France \| 7.26608 \| 43.70313 Paris \| N/A \| France \| 2.3488 \| 48.85341 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Bonn \| N/A \| Germany \| 7.09549 \| 50.73438 Heilbronn \| N/A \| Germany \| 9.22054 \| 49.13995 Homburg/saar \| N/A \| Germany \| N/A \| N/A Alexandroupoli \| N/A \| Greece \| 25.87644 \| 40.84995 Larissa \| N/A \| Greece \| 22.41761 \| 39.63689 Thessaloniki \| N/A \| Greece \| 22.93086 \| 40.64361 Volos \| N/A \| Greece \| 22.94769 \| 39.36923 Hong Kong \| N/A \| Hong Kong \| 114.17469 \| 22.27832 Baja \| N/A \| Hungary \| 18.95307 \| 46.18299 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Esztergom \| N/A \| Hungary \| 18.74148 \| 47.7928 Hatvan \| N/A \| Hungary \| 19.68333 \| 47.66667 Szigetvár \| N/A \| Hungary \| 17.80554 \| 46.04865 Haifa \| N/A \| Israel \| 34.99928 \| 32.81303 Kfar Saba \| N/A \| Israel \| 34.90694 \| 32.175 Petah Tikva \| N/A \| Israel \| 34.88747 \| 32.08707 Como \| N/A \| Italy \| 9.0832 \| 45.80819 Lecco \| N/A \| Italy \| 9.39704 \| 45.85589 Lodi \| N/A \| Italy \| 9.50085 \| 45.30989 Mestre \| N/A \| Italy \| 12.24538 \| 45.49167 Modena \| N/A \| Italy \| 10.92539 \| 44.64783 Pavia \| N/A \| Italy \| 9.15917 \| 45.19205 Gdansk \| N/A \| Poland \| 18.64912 \| 54.35227 Katowice \| N/A \| Poland \| 19.02754 \| 50.25841 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Radom \| N/A \| Poland \| 21.14714 \| 51.40253 Rzeszów \| N/A \| Poland \| 21.99901 \| 50.04132 Sieradz \| N/A \| Poland \| 18.73023 \| 51.59584 Szczecin \| N/A \| Poland \| 14.55302 \| 53.42894 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saratov \| N/A \| Russia \| 46.00861 \| 51.54056 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 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Palma de Mallorca \| N/A \| Spain \| 2.65024 \| 39.56939 Seville \| N/A \| Spain \| -5.97317 \| 37.38283 Seville \| N/A \| Spain \| -5.97317 \| 37.38283 Valencia \| N/A \| Spain \| -0.37966 \| 39.47391 Taichung \| N/A \| Taiwan \| 120.6839 \| 24.1469 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Bangkok \| N/A \| Thailand \| 100.50144 \| 13.75398 Bangkok \| N/A \| Thailand \| 100.50144 \| 13.75398 Bangkok \| N/A \| Thailand \| 100.50144 \| 13.75398 Nakhon Ratchasima \| N/A \| Thailand \| 102.10196 \| 14.97066 Pathum Thani \| N/A \| Thailand \| 100.53049 \| 14.01346	305	NCT00559273	1COMPLETED	2009-10-01	2007-12-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	36	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The goal of this clinical research study is to find the highest tolerable dose of Azacytidine (5-azacytidine) combined with cytosine arabinoside (ara-C) for the treatment of patients with relapsed and/or refractory Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS). The safety and effectiveness of this treatment combination will also be studied.	5-azacytidine is designed to "turn off" the growth of cancer cells. This may be increased by ara-C, which is designed to kills leukemia cells by helping to stop the cells from dividing. If you are found to be eligible to take part in this study, you will be assigned to a treatment group. You will be randomly assigned (as in the toss of a coin) to one of the 4 treatment groups. The first 3 to 6 patients will be assigned to Group 1. If no serious side effects are experienced, the next 3 to 6 patients will be assigned to Group 2. If no serious side effects are experienced, the next 3 to 6 patients will be assigned to Group 3. If no serious side effects are experienced, the next 3 to 6 patients will be assigned to Group 4. If you are in Group 1, you will receive low-dose 5-azacytidine as an infusion by vein over 20 to 30 minutes every day for 7 days. You will also receive low-dose ara-C as a continuous infusion by vein for 7 days. If you are in Group 2, you will receive high-dose 5-azacytidine as an infusion by vein over 20 to 30 minutes every day for 7 days. You will also receive low-dose ara-C as a continuous infusion by vein for 7 days. If you are in Group 3, you will receive low-dose 5-azacytidine as an infusion by vein over 20 to 30 minutes every day for 7 days. You will also receive high-dose ara-C as a continuous infusion by vein for 3 days (if you are 65 years of age or older) or for 4 days (if you are younger than 65 years of age). If you are in Group 4, you will receive high-dose 5-azacytidine as an infusion by vein over 20 to 30 minutes every day for 7 days. You will also receive high-dose ara-C as a continuous infusion by vein for 3 days (if you are 65 years of age or older) or for 4 days (if you are younger than 65 years of age). Each group's treatment will be repeated every 4 to 8 weeks (this is considered 1 cycle of treatment), depending on your blood counts and how well your bone marrow is recovering. You will receive at least 2 cycles of treatment. You will continue to receive treatment, unless your disease gets worse or if you experience intolerable side effects. If your disease gets worse or you experience intolerable side effects, you may be taken off this study. This is an investigational study. 5-azacytidine has been approved by the FDA for the treatment of MDS. Ara-C has been approved by the FDA for the treatment of AML. Up to 80 patients will take part in this study. All will be enrolled at M. D. Anderson.	Acute Myelogenous Leukemia Myelodysplastic Syndrome Leukemia	Acute Myelogenous Leukemia AML Myelodysplastic Syndrome MDS Leukemia	null	4	arm 1: Group 1 = Low-Dose Ara-C + Azacitidine-Level 0 Low-Dose Ara-C: 100 mg/m\^2 Daily continuous intravenous infusion (CIV) for 7 days Azacitidine (AZA): 37.5 mg/m\^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days arm 2: Group 2 = Low-Dose Ara-C + Azacitidine-Level 1 Low-Dose Ara-C: 100 mg/m\^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m\^2 IV Over 20-30 minutes Daily for 7 days arm 3: Group 3 = High-Dose Ara-C + Azacitidine-Level 0 High-dose Ara-C: 1 g/m\^2 Daily CIV for 4 days (age\<65years) or 3 days (age\>=65years) AZA: 37.5 mg/m\^2 IV Over 20-30 minutes Daily for 7 Days arm 4: Group 4 = High-Dose Ara-C + Azacitidine-Level 1 High-dose Ara-C: 1 g/m\^2 Daily CIV for 4 days (age\<65years) or 3 days (age\>=65 years) AZA:Level 1 = 75.0 mg/m\^2 IV Over 20-30 minutes Daily for 7 days	[ 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Group 1 and 3 at Level 0 = 37.5 mg/m\^2 IV Over 20-30 minutes Daily for 7 Days Group 2 and 4 at Level 1 = 75.0 mg/m\^2 IV Over 20-30 minutes Daily for 7 days intervention 2: Group 1 and 2 at Low-Dose = 100 mg/m\^2 Daily continuous intravenous infusion (CIV) for 7 days Arms 3 and 4 at High-dose = 1 g/m\^2 Daily CIV for 4 days (age\<65 years) or 3 days (age\>=65 years)	intervention 1: Azacitidine intervention 2: Ara-C	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	34	NCT00569010	1COMPLETED	2009-10-01	2005-12-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 3 ]	4	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	Primary objective is to determine the effectiveness of the combination of bortezomib and doxorubicin in patients with metastatic breast cancer. The trial format is a single arm Phase II design wherein patients are treated with bortezomib IV on days 1, 4, 8, and 11 and with doxorubicin IV on days 1 and 8 of a 21-day cycle.	null	Metastatic Breast Cancer		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: bortezomib:1.3 mg/m2 IVP over 3-5 sec. days 1, 4, 8, 11 of 21 day cycle doxorubicin: 20 mg/m2 IV over 3-5 min. days 1,8 (one hour after bortezomib) of 21 day cycle	intervention 1: PS-341, doxorubicin	1	Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	4	NCT00574236	6TERMINATED	2009-10-01	2006-08-01	University of Wisconsin, Madison	7OTHER	false	false	false	null	0
[ 4 ]	25	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	Primary objective was to determine efficacy of Alfuzosin in the treatment of children and adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to elevated detrusor Leak Point Pressure \[LPP\] of neuropathic etiology. Secondary objectives were: * To investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and adolescents, * To investigate the number of Urinary Tract Infection (UTI) episodes, * To investigate the pharmacokinetics of Alfuzosin (population kinetics).	The study consisted of 2 phases: * a 12-week efficacy phase then, * a 40-week safety extension phase. All eligible subjects received alfuzosin 0.2 mg/kg/day. The formulation and the frequency was assigned by Interactive Voice Response System (IVRS) according to age group and ability to swallow tablets. Patients who completed the 12-week open-label treatment period were offered to continue in the 40-week open-label safety extension study. The treatment was the same as in the 12-week efficacy phase. All patients had a one-week follow-up period after the last dose intake.	Hydronephrosis Neurogenic Bladder	child bladder neuropathic alpha blockers	null	3	arm 1: Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age. arm 2: Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow tablets or preferred to take the solution or had a body weight \< 30 kg. arm 3: Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow tablets and had a body weight ≥ 30 kg.	[ 0, 0, 0 ]	1	[ 0 ]	intervention 1: Dose: 0.2 mg/kg/day Route: oral	intervention 1: Alfuzosin	12	Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Laval \| N/A \| Canada \| -73.692 \| 45.56995 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 Kuala Lumpur \| N/A \| Malaysia \| 101.68653 \| 3.1412 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Belgrade \| N/A \| Serbia \| 20.46513 \| 44.80401 Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Bratislava \| N/A \| Slovakia \| 17.10674 \| 48.14816 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Istanbul \| N/A \| Turkey (Türkiye) \| 28.94966 \| 41.01384	25	NCT00576823	1COMPLETED	2009-10-01	2007-12-01	Sanofi	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	3	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study is to discover whether children with severe combined immunodeficiency disease (SCID) or other primary immunodeficiency disorder (PID) for which no satisfactory treatment other than stem cell transplantation (SCT) exists can be safely and effectively transplanted from HLA mismatched (up to one haplotype) related donors or unrelated matched or mismatched (up to one antigen) donors, when leukocytolytic monoclonal antibodies (MAb) and Fludarabine are the sole conditioning agents. Three monoclonal antibodies will be used in combination. Two of them are rat IgG1 (immunoglobulin G1) antibodies directed against two contiguous epitopes on the CD45 (common leucocyte) antigen. They have been safely administered as part of the conditioning regimen for 12 patients receiving allografts (HLA matched and mismatched) at this center. They produce a transient depletion of \>90% circulating leucocytes. The third MAb is Campath 1H, a humanized rat anti-CD52 MAb. Campath 1H, Alemtuzumab, has been licensed to treat B-cell chronic lymphocytic leukemia (B-CLL) and more recently has been safely given at this and other centers as part of a sub-ablative conditioning regimen to patients with malignant disease. Because these MAb produce both profound immunosuppression and significant, though transient, myelodestruction we believe they may be useful as the sole conditioning regimen in patients with SCID, in whom the use of conventional chemotherapeutic agents for conditioning may produce or aggravate unacceptable and even lethal short term toxicity. We anticipate MAb mediated subablative conditioning will permit engraftment in a high percentage of these patients with little or no immediate or long term toxicity. Campath IH persists in vivo for several days after administration and so will be present over the transplant period to deplete donor T cells as partial GvHD prophylaxis. Additional Graft versus Host Disease (GvHD) prophylaxis may be provided by administration of FK506.	Donor Stem Cell Processing for Mismatched Donors: Harvested peripheral blood stem cells will be enriched for CD34 cells using the CliniMACS CD34 Reagent system, according to Center for Cell and Gene Therapy (CAGT) SOPs. Stem Cell Transplant Conditioning Campath-1H will be given as 3 daily intravenous infusions and will be followed by Anti-CD45 which will be given as four daily intravenous infusions that will be completed two days prior to stem cell infusion. Diphenydramine will be administered i.v. q4h during the period of the course of the Campath and Anti-CD45 infusions. Day 8 Campath 1H as per CAGT SOP Fludarabine 10 kg or less: 1 mg/kg; \> 10 kg: 30 mg/m2 7 Campath 1H as per CAGT SOP Fludarabine 10 kg or less: 1 mg/kg; \> 10 kg: 30 mg/m2 6 Campath 1H as per CAGT SOP Fludarabine 10 kg or less: 1 mg/kg; \> 10 kg: 30 mg/m2 5 YTH 24/54 400ug/kg over 6 hr Fludarabine 10 kg or less: 1 mg/kg; \> 10 kg: 30 mg/m2 4 YTH 24/54 400ug/kg over 6 hr Fludarabine 10 kg or less: 1 mg/kg; \> 10 kg: 30 mg/m2 3 YTH 24/54 400ug/kg over 6 hr 2 YTH 24/54 400ug/kg over 6 hr 1 rest 0 Stem Cell Infusion Campath 1H Infusion- Campath dose is weight based: for patients less than 15 killograms (kg) administer Campath 3 mg; for patients \>15 kg to 30 kg administer Campath 5 mg; for patients \> 30 kg administer Campath 10 mg. Campath will be dosed and administered as per CAGT SOP. Anti-CD45- Infusion Anti-CD45 infusion will be administered according to CAGT SOPs. 3 ml of heparinized blood will be drawn 48 hr post Anti-CD45 to evaluate for free Anti-CD45 levels in the plasma. This estimation will be used to determine whether treatment with irradiated leukocytes is required before the bone marrow is infused. GVHD Prophylaxis- GVHD prophylaxis will be achieved through positive selection for CD34 resulting in \> 3 log T cell depletion. Previous reports have indicated that there is a low frequency of severe (Grade II/IV) GVHD after haploidentical transplants if recipients receive stem cell populations containing \<5 x 10 CD3 positive T cells. We hope to achieve such levels with our CD34 enrichment protocol. However, pharmacologic prophylaxis will be added if the CD34 selected product contains more than 5 x 10 CD3+ve T cells/kg recipient weight. In addition, Campath 1H persists in the recipient circulation through the immediate transplant period and will contribute anti-GVHD activity, in vivo. Patients who develop acute or chronic GVHD will be managed according to CAGT SOPs.	Severe Combined Immunodeficiency Disease Severe Primary Immunodeficiency Disorder Undefined T Cell Deficiency Disorder Wiskott-Aldrick Syndrome	Severe Combined Immunodeficiency Disease Severe Primary Immunodeficiency Disorder Undefined T cell Deficiency Disorder Wiskott-Aldrick Syndrome Allogeneic stem cell transplant Fludarabine monoclonal antibodies	null	1	arm 1: all patient will receive an allogeneic transplant with the following conditioning regimen Campath -1H, Fludarabine, Anti-CD45	[ 0 ]	4	[ 2, 0, 2, 3 ]	intervention 1: Given intravenous on Days -8,-7, and -6 Campath dose is weight based: for patients less than 15 kg the dose is 3 mg; for patients \>15 kg to 30 kg the dose 5 mg; for patients \> 30 kg the dose is 10 mg intervention 2: Given intravenous on Days -8,-7,-6,-5, and -4 Dose is 30 mg/m2 intervention 3: Given intravenous over 6 hours on Days -5,-4,-3, and -2 Dose is 400 microgram/kg intervention 4: stem cells are infused on day 0	intervention 1: Campath -1H intervention 2: Fludarabine intervention 3: Anti-CD45 intervention 4: Stem cell infusion	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	3	NCT00579137	6TERMINATED	2009-10-01	2007-10-01	Baylor College of Medicine	7OTHER	false	false	false	null	0
[ 5 ]	136	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate if Etanercept administered at a higher initial dose provides greater improvement in nail and skin psoriasis symptoms than a regimen with a lower initial dose.	This study will assess the effects of the 2 Etanercept regimens on fingernail psoriasis over 24 weeks among patients with both skin and fingernail symptoms who have previously failed at least one therapy for nail psoriasis. The endpoint of 24 weeks was chosen to allow sufficient time for normal nail growth.	Nail Psoriasis Plaque Psoriasis	Nail Psoriasis Plaque Psoriasis	null	2	arm 1: etanercept 50 mg SC injection twice weekly for 12 weeks reducing to etanercept 50 mg once weekly to week 24 arm 2: etanercept 50 mg SC once weekly for the complete 24 week treatment period	[ 1, 1 ]	1	[ 0 ]	intervention 1: Subjects randomized to Arm 1 shall be treated with ETN 50 mg twice weekly for 12 weeks reducing thereafter to ETN 50 mg once weekly to 24 weeks. Subjects randomized to Arm 2 shall be treated with ETN 50 mg once weekly for the entire 24 week treatment period.	intervention 1: etanercept	0	null	72	NCT00581100	1COMPLETED	2009-10-01	2007-09-01	Wyeth is now a wholly owned subsidiary of Pfizer	4INDUSTRY	false	false	false	null	0
[ 5 ]	34	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The primary objective of the study is to assess the efficacy and tolerability of a 12-week trial of memantine hydrochloride administered twice daily in 20 adults (ages 18-55) with ADHD and ADHD NOS. Improvement will be defined as: 1) changes from baseline on the investigator-rated DSM-IV based ADHD Rating Scale; 2) changes from baseline in a questionnaire aimed at assessing executive functions (BRIEF); and 3) changes from screening in a computerized neuropsychological battery (CANTAB). We hypothesize that memantine hydrochloride will be associated with improving ADHD symptoms and associated deficits in executive functions. We also expect that memantine will be well-tolerated with predictable adverse events.	Memantine (Namenda) is a low-affinity N-methyl-D-aspartate (NMDA) receptor antagonist believed to work by blocking prolonged low-level activation of the NMDA receptor and resultant neuronal damage caused by abnormal glutamatergic activity, yet also allowing normal physiological activity of the NMDA channel. Memantine (Namenda) was approved by the U.S. Food and Drug Administration in 2003 for the treatment of moderate to severe Alzheimer's disease. Memantine improves or delays the decline in cognition (attention, language, visuo-spatial ability), as well as functional and behavioral symptoms in adults with moderate Alzheimer's disease. Although the efficacy and safety of memantine has not been tested in people with ADHD, the spectrum of disorders possibly amenable to NMDA receptor antagonist treatment may include ADHD and associated executive function deficits (EFDs). To this end, we are proposing an open-label pilot study of memantine in adult subjects with ADHD and ADHD Not Otherwise Specified (NOS). This will be a 12-week, open-label pilot study to assess the efficacy and tolerability of memantine hydrochloride (Namenda) administered to 20 adults 18-55 years of age with ADHD and ADHD NOS. All subjects that enter the study will undergo standard screening and diagnostic procedures. After obtaining written informed consent from the subject, the diagnosis of ADHD will be established through clinical evaluation by an expert clinician. Only consenting subjects satisfying inclusion and exclusion criteria will be included in the study.	ADHD	ADHD Namenda	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: tablet, 5-20 mg, twice daily, by mouth, 12 weeks	intervention 1: memantine hydrochloride	1	Cambridge \| Massachusetts \| United States \| -71.10561 \| 42.3751	34	NCT00586573	1COMPLETED	2009-10-01	2007-03-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0
[ 0 ]	22	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.	The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. There are two arms in the study, one in which IVIG is administered to patients who have living donors with positive crossmatch results, and another in which intravenous immune globulin is administered to patients with no living donor and have a PRA greater than 30% for 3 consecutive months and a crossmatch with a cadaveric donor while on kidney transplant waiting list. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.	End Stage Renal Disease		null	2	arm 1: Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list arm 2: Intravenous immune globulin for patients who have living donors with positive crossmatch results.	[ 5, 5 ]	1	[ 0 ]	intervention 1: 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments	intervention 1: intravenous immune globulin	0	null	0	NCT00586716	6TERMINATED	2009-10-01	2004-11-01	Loma Linda University	7OTHER	false	false	false	null	0
[ 3 ]	311	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The primary objective of this study is to evaluate the efficacy of atacicept compared to placebo in the treatment of signs and symptoms in a subject population with active rheumatoid arthritis (RA), inadequate response to methotrexate (MTX) and no previous exposure to anti-tumor necrosis factor alpha (anti-TNFalpha) therapy.	null	Rheumatoid Arthritis	Rheumatoid arthritis Atacicept Adalimumab Humira®	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 1, 2 ]	4	[ 0, 0, 0, 2 ]	intervention 1: Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks. intervention 2: Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks. intervention 3: Atacicept will be administered subcutaneously at a dose of 150 mg once a week for 25 weeks. intervention 4: Adalimumab (Humira®) will be administered subcutaneously at a dose of 40 mg every other week for 25 weeks.	intervention 1: Placebo matched to atacicept intervention 2: Atacicept: with loading dose intervention 3: Atacicept intervention 4: Adalimumab	2	Rockland \| Massachusetts \| United States \| -70.91616 \| 42.13066 Darmstadt \| N/A \| Germany \| 8.65027 \| 49.87167	311	NCT00595413	1COMPLETED	2009-10-01	2007-09-01	EMD Serono	4INDUSTRY	false	false	false	null	0
[ 5 ]	80	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	0ALL	true	GenTeal gel is an artificial tear gel used to lubricate the surface of the eye. This study will evaluate the effect of GenTeal gel on comfort following LASIK surgery. Participants will be asked to come to the clinic for three regularly scheduled visits after LASIK surgery: Day 1 (one day after LASIK surgery), Day 7 (one week follow-up), and Day 30 (one month follow-up). Participants will be asked to complete a questionnaire regarding eye comfort during each follow up visit. Participants will be randomly assigned to one of two groups, one of which will receive Genteal Gel four times a day for five days prior to surgery. The other group will receive no preoperative gel or lubricant, which has been our standard approach for many years.	LASIK (Laser Keratomileusis in Situ) is a frequently performed procedure to reduce the refractive error of the eye so as to minimize the subsequent need for eyeglasses or contact lenses. The procedure requires the creation of a superficial corneal flap, usually with an instrument known as a microkeratome. During the creation of the flap with a microkeratome, the corneal epithelium is typically subjected to sliding stresses which occasionally cause disruption of the epithelial surface, a complication with potentially serious adverse effect on the post operative visual acuity. As well, shortly before the creation of the flap, the patient is often dilated and invariably treated with topical anesthetics. These agents, and their preservatives, can have a negative effect on corneal epithelial integrity, right before the epithelium must withstand the passage of the microkeratome. Therefore, it is imperative that the epithelium be in the best possible condition prior to the LASIK procedure. For this reason, ocular lubricants may be used for a period of time prior to surgery in order to maximize epithelial health. In the immediate post-operative period the bond between the newly created flap and the underlying corneal stroma is weak, and the epithelium has just been subjected to the pharmacologic and mechanical stresses noted above. It is imperative that the surface continuity of the epithelium between the edge of the flap and the surrounding surface be restored as rapidly as possible, as reestablishment of an intact epithelial surface minimizes the risks of flap shift, epithelial ingrowth, and infection. For all these reasons, it is a generally accepted standard of care to use aggressive ocular lubrication during the post-operative period in order to maximize the speed of epithelial recovery. GenTeal Lubricant Eye Drops and GenTeal Gel, (0.3% hypromellose, Novartis Ophthalmics, Basel, Switzerland) provide a natural alternative to preservative-free treatments, with a sodium perborate preservative system and long-lasting action due to the carbomer gelling agent. The perborate preservative, which breaks down to water and oxygen on the ocular surface, essentially delivers a preservative-free lubricant to the eye. This makes the GenTeal products attractive agents for use in the LASIK perioperative period.	Corneal Epithelium Defect	LASIK Ocular Lubricants Corneal Epithelium Wound Healing	null	2	arm 1: Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery. arm 2: Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery	[ 0, 4 ]	1	[ 0 ]	intervention 1: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery	intervention 1: 0.3% hypromellose	1	Augusta \| Georgia \| United States \| -81.97484 \| 33.47097	80	NCT00598689	1COMPLETED	2009-10-01	2007-10-01	Augusta University	7OTHER	false	false	false	null	0
[ 4 ]	798	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The trial is designed to assess the long term subjective well-being in schizophrenic outpatients treated with quetiapine XR (extended release) or oral risperidone at flexible dose in a naturalistic setting over a period of one year. Secondary outcome measures have been selected for helping in the differentiation of the compared atypical antipsychotics. The primary objective of this study is to demonstrate the non-inferiority of quetiapine XR to risperidone assessed at month 6 in terms of responder rate using the self-report instrument SWN-K	null	Schizophrenic Disorders	schizophrenia SWNK	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Oral, once daily, tablets of 400 mg to 800 mg intervention 2: Oral, once daily, tablets of 2 mg to 6 mg	intervention 1: Quetiapine XR intervention 2: Risperidone	116	Assebroek \| Belgium \| Belgium \| 3.2623 \| 51.19367 Hasselt \| Belgium \| Belgium \| 5.33781 \| 50.93106 Liège \| Belgium \| Belgium \| 5.56749 \| 50.63373 Montignies-sur-Sambre \| Belgium \| Belgium \| 4.49109 \| 50.41081 Roeselare \| Belgium \| Belgium \| 3.12269 \| 50.94653 Sint-Denijs-Westrem \| N/A \| Belgium \| 3.67202 \| 51.02135 Tournai \| N/A \| Belgium \| 3.38932 \| 50.60715 Fortaleza \| Ceará \| Brazil \| -38.54306 \| -3.71722 Salvador \| Estado de Bahia \| Brazil \| -38.49096 \| -12.97563 Aparecida de Goiânia \| Goiás \| Brazil \| -49.24389 \| -16.82333 Belo Horizonte \| Minas Gerais \| Brazil \| -43.93778 \| -19.92083 Curitiba \| Paraná \| Brazil \| -49.27306 \| -25.42778 Recife \| Pernambuco \| Brazil \| -34.88111 \| -8.05389 Rio de Janeiro \| Rio de Janeiro \| Brazil \| -43.18223 \| -22.90642 Porto Alegre \| Rio Grande do Sul \| Brazil \| -51.23019 \| -30.03283 Itapira \| São Paulo \| Brazil \| -46.82167 \| -22.43611 Ribeirão Preto \| São Paulo \| Brazil \| -47.81028 \| -21.1775 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 Sorocaba \| São Paulo \| Brazil \| -47.45806 \| -23.50167 Botucatu \| N/A \| Brazil \| -48.445 \| -22.88583 Cerova Koria Village \| Veliko Tarnovo \| Bulgaria \| N/A \| N/A Pazardzhik \| N/A \| Bulgaria \| 24.33333 \| 42.2 Pleven \| N/A \| Bulgaria \| 24.61667 \| 43.41667 Plovdiv \| N/A \| Bulgaria \| 24.75 \| 42.15 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Stara Zagora \| N/A \| Bulgaria \| 25.64194 \| 42.43278 Varna \| N/A \| Bulgaria \| 27.91667 \| 43.21667 Barrio Los Yoses \| Provincia de San José \| Costa Rica \| N/A \| N/A Curridabat \| Provincia de San José \| Costa Rica \| -84.03595 \| 9.9139 Guadalupe \| Provincia de San José \| Costa Rica \| -84.05665 \| 9.94805 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Kitee \| N/A \| Finland \| 30.15 \| 62.1 Kuopio \| N/A \| Finland \| 27.67703 \| 62.89238 Lapua \| N/A \| Finland \| 23.0088 \| 62.96927 Pori \| N/A \| Finland \| 21.78333 \| 61.48333 Raahe \| N/A \| Finland \| 24.48333 \| 64.68333 Rovaniemi \| N/A \| Finland \| 25.71667 \| 66.5 Tampere \| N/A \| Finland \| 23.78712 \| 61.49911 Turku \| N/A \| Finland \| 22.26869 \| 60.45148 Bad Saarow \| N/A \| Germany \| 14.06667 \| 52.28333 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Bielefeld \| N/A \| Germany \| 8.53333 \| 52.03333 Bochum \| N/A \| Germany \| 7.21648 \| 51.48165 Butzbach \| N/A \| Germany \| 8.67122 \| 50.43395 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Darmstadt \| N/A \| Germany \| 8.65027 \| 49.87167 Duisburg \| N/A \| Germany \| 6.76516 \| 51.43247 Gelsenkirchen \| N/A \| Germany \| 7.09654 \| 51.50508 Grevenbroich \| N/A \| Germany \| 6.5827 \| 51.09102 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Hattingen \| N/A \| Germany \| 7.18557 \| 51.39894 Hildesheim \| N/A \| Germany \| 9.95112 \| 52.15077 Königsbrück \| N/A \| Germany \| 13.9054 \| 51.26451 Mittweida \| N/A \| Germany \| 12.97537 \| 50.98622 München \| N/A \| Germany \| 13.31243 \| 51.60698 Oranienburg \| N/A \| Germany \| 13.24197 \| 52.75577 Siegen \| N/A \| Germany \| 8.02431 \| 50.87481 Stralsund \| N/A \| Germany \| 13.0818 \| 54.30911 Wismar \| N/A \| Germany \| 11.45563 \| 53.89218 Andria \| BA \| Italy \| 16.29797 \| 41.23117 Feltre \| BL \| Italy \| 11.90031 \| 46.02085 Maddaloni \| CE \| Italy \| 14.3823 \| 41.03578 Sora \| FR \| Italy \| 13.61356 \| 41.71829 Genova \| GE \| Italy \| 11.87211 \| 45.21604 Milan \| MI \| Italy \| 12.59836 \| 42.78235 Perugia \| PG \| Italy \| 12.38878 \| 43.1122 Fidenza \| PR \| Italy \| 10.06039 \| 44.86694 Parma \| PR \| Italy \| 10.32618 \| 44.79935 Palmi \| RC \| Italy \| 15.85155 \| 38.35943 Rimini \| RN \| Italy \| 12.56528 \| 44.05755 Salerno \| SA \| Italy \| 14.79328 \| 40.67545 Sassari \| SS \| Italy \| 8.55552 \| 40.72586 Chioggia \| VE \| Italy \| 12.27774 \| 45.21857 Ancona \| N/A \| Italy \| 13.5103 \| 43.60717 Pompei \| N/A \| Italy \| 14.49698 \| 40.74574 Mexico \| D.f. \| Mexico \| -98.43784 \| 18.88011 Mexico \| D.F \| Mexico \| -98.43784 \| 18.88011 Monterrey, Nuevo Leon \| Mexico \| Mexico \| N/A \| N/A San Luis Potosí City \| San Luis Potosí \| Mexico \| -100.97135 \| 22.15234 Guadalajara Jalisco \| N/A \| Mexico \| N/A \| N/A Mexico \| N/A \| Mexico \| -98.43784 \| 18.88011 Yucatán \| N/A \| Mexico \| -96.36167 \| 19.34472 Abraveses \| N/A \| Portugal \| -7.92102 \| 40.68137 Braga \| N/A \| Portugal \| -8.42005 \| 41.55032 Coimbra \| N/A \| Portugal \| -8.41955 \| 40.20564 Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 Porto \| N/A \| Portugal \| -8.61099 \| 41.14961 Santarém \| N/A \| Portugal \| -8.68333 \| 39.23333 Piteşti \| Argeş \| Romania \| 24.86667 \| 44.85 Galati \| Galați County \| Romania \| 28.05028 \| 45.43687 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Craiova \| N/A \| Romania \| 23.8 \| 44.31667 Sibiu \| N/A \| Romania \| 24.15 \| 45.8 Moscow \| Russia \| Russia \| 37.61556 \| 55.75222 Kazan' \| N/A \| Russia \| 49.12214 \| 55.78874 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Jaén \| Andalusia \| Spain \| -3.79028 \| 37.76922 Málaga \| Andalusia \| Spain \| -4.42034 \| 36.72016 Seville \| Andalusia \| Spain \| -5.97317 \| 37.38283 Zamudio (vizcaya) \| Basque Country \| Spain \| -2.87 \| 43.286 Salamanca \| Castille and León \| Spain \| -5.66388 \| 40.96882 Zamora \| Castille and León \| Spain \| -5.74456 \| 41.50633 Mataro (barcelona) \| Catalonia \| Spain \| 2.4445 \| 41.54211 Vigo \| Galicia \| Spain \| -8.72264 \| 42.23282 Madrid \| Madrid \| Spain \| -3.70256 \| 40.4165 Langreo \| Principality of Asturias \| Spain \| -5.68416 \| 43.29568 Elche (alicante) \| Valencia \| Spain \| -0.70107 \| 38.26218 Sant Joan d'Alacant \| Valencia \| Spain \| -0.43623 \| 38.40148 Prilly \| Canton of Vaud \| Switzerland \| 6.60456 \| 46.53698 Wil \| N/A \| Switzerland \| 9.04552 \| 47.46152 Istanbul \| Turkey \| Turkey (Türkiye) \| 28.94966 \| 41.01384 Manisa \| Turkey \| Turkey (Türkiye) \| 27.42647 \| 38.61202 Ankara \| N/A \| Turkey (Türkiye) \| 32.85427 \| 39.91987 Elâzığ \| N/A \| Turkey (Türkiye) \| 39.22321 \| 38.67431 Izmir \| N/A \| Turkey (Türkiye) \| 27.13838 \| 38.41273	793	NCT00600756	1COMPLETED	2009-10-01	2008-01-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 4 ]	480	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens	null	Sexual Dysfunctions, Psychological		null	1	arm 1: Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening. Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.	[ 0 ]	1	[ 0 ]	intervention 1: Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening. Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.	intervention 1: flibanserin flexible dose	68	Innsbruck \| N/A \| Austria \| 11.39454 \| 47.26266 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Wörgl \| N/A \| Austria \| 12.06174 \| 47.48906 Braine-l'Alleud \| N/A \| Belgium \| 4.36784 \| 50.68363 Edegem \| N/A \| Belgium \| 4.44504 \| 51.15662 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Hasselt \| N/A \| Belgium \| 5.33781 \| 50.93106 Yvoir \| N/A \| Belgium \| 4.88059 \| 50.3279 Olomouc \| N/A \| Czechia \| 17.25175 \| 49.59552 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Vřesina \| N/A \| Czechia \| 18.12569 \| 49.82418 Espoo \| N/A \| Finland \| 24.6522 \| 60.2052 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Oulu \| N/A \| Finland \| 25.46816 \| 65.01236 Seinäjoki \| N/A \| Finland \| 22.82822 \| 62.79446 Tampere \| N/A \| Finland \| 23.78712 \| 61.49911 Blanquefort \| N/A \| France \| -0.63758 \| 44.91065 Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 La Rochelle \| N/A \| France \| -1.15222 \| 46.16308 Lille \| N/A \| France \| 3.05858 \| 50.63297 Lille \| N/A \| France \| 3.05858 \| 50.63297 Marseille \| N/A \| France \| 5.38107 \| 43.29695 Marseille \| N/A \| France \| 5.38107 \| 43.29695 Marseille \| N/A \| France \| 5.38107 \| 43.29695 Rennes \| N/A \| France \| -1.67429 \| 48.11198 Saint-Émilion \| N/A \| France \| -0.15609 \| 44.89258 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Bonn \| N/A \| Germany \| 7.09549 \| 50.73438 Dresden \| N/A \| Germany \| 13.73832 \| 51.05089 Frankfurt \| N/A \| Germany \| 10.53333 \| 49.68333 Freiburg im Breisgau \| N/A \| Germany \| 7.85222 \| 47.9959 Hanover \| N/A \| Germany \| 9.73322 \| 52.37052 Leipzig \| N/A \| Germany \| 12.37129 \| 51.33962 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Kecskemét \| N/A \| Hungary \| 19.69128 \| 46.90618 Szeged \| N/A \| Hungary \| 20.14824 \| 46.253 Szentes \| N/A \| Hungary \| 20.2608 \| 46.65834 Catania \| N/A \| Italy \| 15.07041 \| 37.49223 Pavia \| N/A \| Italy \| 9.15917 \| 45.19205 Torino \| N/A \| Italy \| 11.99138 \| 44.88856 Almere Stad \| N/A \| Netherlands \| 5.21413 \| 52.37025 Amsterdam \| N/A \| Netherlands \| 4.88969 \| 52.37403 Apeldoorn \| N/A \| Netherlands \| 5.96944 \| 52.21 Bilthoven \| N/A \| Netherlands \| 5.20139 \| 52.13 Den Helder \| N/A \| Netherlands \| 4.75933 \| 52.95988 Enschede \| N/A \| Netherlands \| 6.89583 \| 52.21833 Nieuwegein \| N/A \| Netherlands \| 5.08056 \| 52.02917 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Manresa (Barcelona) \| N/A \| Spain \| 1.82399 \| 41.72815 Mataró-Barcelona \| N/A \| Spain \| N/A \| N/A Ourense \| N/A \| Spain \| -7.86407 \| 42.33669 Kungsbacka \| N/A \| Sweden \| 12.07612 \| 57.48719 Lund \| N/A \| Sweden \| 13.19321 \| 55.70584 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Uppsala \| N/A \| Sweden \| 17.63889 \| 59.85882 Västerås \| N/A \| Sweden \| 16.55276 \| 59.61617 Chorley \| N/A \| United Kingdom \| -2.61667 \| 53.65 Fisherwick, Lichfield \| N/A \| United Kingdom \| N/A \| N/A Glasgow \| N/A \| United Kingdom \| -4.25763 \| 55.86515 Headington, Oxford \| N/A \| United Kingdom \| N/A \| N/A London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 South Brent \| N/A \| United Kingdom \| -3.83426 \| 50.42654 Waterloo, Liverpool \| N/A \| United Kingdom \| N/A \| N/A	480	NCT00601367	1COMPLETED	2009-10-01	2008-01-01	Sprout Pharmaceuticals, Inc	4INDUSTRY	false	false	false	null	0
[ 5 ]	40	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this research study is to test the safety of duloxetine and see what effects (good and bad) it has on the subject's binge eating disorder and comorbid depressive disorder (depression occurring with binge eating disorder) compared to placebo (inactive pill).	This is a 12-week, double blind, randomized, placebo-controlled, parallel-group, flexible-dose study of duloxetine 60-120 mg/day in patients with BED and comorbid depressive disorders. Patients will be randomly assigned to either duloxetine 30 mg capsules or matching placebo at the baseline visit. The initial dose of study medication will be one 30 mg duloxetine capsule/day or placebo with a planned increase to 60 mg/day (2 X 30 mg) or matching placebo at the end of week 1. Further dose increases of 30 mg up to 120 mg/day will be allowed after the end of week two based on the investigators' assessment of efficacy and tolerability. Dosing will be either once per day or twice a day depending on tolerability. Patient visits will occur at screening and baseline and at the end of weeks 1, 2, 4, 6, 8, 10, and 12. Study drug will be tapered by 30 mg every 3 days at the end of the study.	Binge Eating Depression		null	2	arm 1: Start with 30 mg duloxetine hydrochloride capsule/day to be increased up to 120 mg per day. arm 2: Sugar pill with matching dosage as Duloxetine	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 30 mg/day - 120 mg/day intervention 2: identical to study drug	intervention 1: Duloxetine intervention 2: Placebo	1	Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711	40	NCT00607789	1COMPLETED	2009-10-01	2006-10-01	University of Cincinnati	7OTHER	false	false	false	null	0
[ 4 ]	2,417	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder	null	Overactive Bladder	Treatment of overactive bladder	null	3	arm 1: None arm 2: None arm 3: None	[ 1, 2, 0 ]	3	[ 0, 0, 0 ]	intervention 1: The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks. intervention 2: Placebo treatment will be once daily(QD) for 12 weeks. intervention 3: The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.	intervention 1: Tolterodine ER intervention 2: Placebo intervention 3: Fesoterodine	227	Enterprise \| Alabama \| United States \| -85.85522 \| 31.31517 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Clovis \| California \| United States \| -119.70292 \| 36.82523 Fresno \| California \| United States \| -119.77237 \| 36.74773 Fresno \| California \| United States \| -119.77237 \| 36.74773 San Diego \| California \| United States \| -117.16472 \| 32.71571 Torrance \| California \| United States \| -118.34063 \| 33.83585 Upland \| California \| United States \| -117.64839 \| 34.09751 Vista \| California \| United States \| -117.24254 \| 33.20004 Westlake Village \| California \| United States \| -118.80565 \| 34.14584 Englewood \| Colorado \| United States \| -104.98776 \| 39.64777 New London \| Connecticut \| United States \| -72.09952 \| 41.35565 Bonita Spring \| Florida \| United States \| N/A \| N/A Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Lake Worth \| Florida \| United States \| -80.07231 \| 26.61708 Leesburg \| Florida \| United States \| -81.87786 \| 28.81082 Longwood \| Florida \| United States \| -81.3384 \| 28.70305 Loxahatchee Groves \| Florida \| United States \| -80.27977 \| 26.68368 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Naples \| Florida \| United States \| -81.79596 \| 26.14234 Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 Stuart \| Florida \| United States \| -80.25283 \| 27.19755 Tallahassee \| Florida \| United States \| -84.28073 \| 30.43826 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Meridian \| Idaho \| United States \| -116.39151 \| 43.61211 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Peoria \| Illinois \| United States \| -89.58899 \| 40.69365 Avon \| Indiana \| United States \| -86.39972 \| 39.76282 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Noblesville \| Indiana \| United States \| -86.0086 \| 40.04559 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Metairie \| Louisiana \| United States \| -90.15285 \| 29.98409 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Bel Air \| Maryland \| United States \| -76.34829 \| 39.53594 North Dartmouth \| Massachusetts \| United States \| -70.97032 \| 41.63899 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Royal Oak \| Michigan \| United States \| -83.14465 \| 42.48948 Troy \| Michigan \| United States \| -83.14993 \| 42.60559 Edina \| Minnesota \| United States \| -93.34995 \| 44.88969 Sartell \| Minnesota \| United States \| -94.20694 \| 45.62163 Olive Branch \| Mississippi \| United States \| -89.82953 \| 34.96176 Picayune \| Mississippi \| United States \| -89.67788 \| 30.52556 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Lincoln \| Nebraska \| United States \| -96.66696 \| 40.8 Lincoln \| Nebraska \| United States \| -96.66696 \| 40.8 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Hamilton \| New Jersey \| United States \| -74.08125 \| 40.20706 Williamsville \| New York \| United States \| -78.73781 \| 42.96395 Cary \| North Carolina \| United States \| -78.78112 \| 35.79154 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Bensalem \| Pennsylvania \| United States \| -74.95128 \| 40.10455 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Uniontown \| Pennsylvania \| United States \| -79.71643 \| 39.90008 Cumberland \| Rhode Island \| United States \| -71.43284 \| 41.96677 Pawtucket \| Rhode Island \| United States \| -71.38256 \| 41.87871 Anderson \| South Carolina \| United States \| -82.65013 \| 34.50344 Greer \| South Carolina \| United States \| -82.22706 \| 34.93873 Summerville \| South Carolina \| United States \| -80.17565 \| 33.0185 Johnson City \| Tennessee \| United States \| -82.35347 \| 36.31344 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 New Tazewell \| Tennessee \| United States \| -83.59963 \| 36.44258 Beaumont \| Texas \| United States \| -94.10185 \| 30.08605 Beaumont \| Texas \| United States \| -94.10185 \| 30.08605 Bryan \| Texas \| United States \| -96.36996 \| 30.67436 Plano \| Texas \| United States \| -96.69889 \| 33.01984 Plano \| Texas \| United States \| -96.69889 \| 33.01984 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Sugar Land \| Texas \| United States \| -95.63495 \| 29.61968 Midvale \| Utah \| United States \| -111.89994 \| 40.61106 West Jordan \| Utah \| United States \| -111.9391 \| 40.60967 Arlington \| Virginia \| United States \| -77.10428 \| 38.88101 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Virginia Beach \| Virginia \| United States \| -75.97799 \| 36.85293 Virginia Beach \| Virginia \| United States \| -75.97799 \| 36.85293 Weber City \| Virginia \| United States \| -78.28389 \| 37.75514 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Salvador \| Estado de Bahia \| Brazil \| -38.49096 \| -12.97563 Goiânia \| Goiás \| Brazil \| -49.25389 \| -16.67861 Curitiba \| Paraná \| Brazil \| -49.27306 \| -25.42778 Rio de Janeiro \| Rio de Janeiro \| Brazil \| -43.18223 \| -22.90642 Porto Alegre \| Rio Grande do Sul \| Brazil \| -51.23019 \| -30.03283 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 Pernik \| N/A \| Bulgaria \| 23.03333 \| 42.6 Pleven \| N/A \| Bulgaria \| 24.61667 \| 43.41667 Plovdiv \| N/A \| Bulgaria \| 24.75 \| 42.15 Plovdiv \| N/A \| Bulgaria \| 24.75 \| 42.15 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Veliko Tarnovo \| N/A \| Bulgaria \| 25.62904 \| 43.08124 Surrey \| British Columbia \| Canada \| -122.82509 \| 49.10635 Winnipeg \| Manitoba \| Canada \| -97.14704 \| 49.8844 Halifax \| Nova Scotia \| Canada \| -63.57688 \| 44.64269 Oshawa \| Ontario \| Canada \| -78.84957 \| 43.90012 Chicoutimi \| Quebec \| Canada \| -71.06369 \| 48.41963 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Trois-Rivières \| Quebec \| Canada \| -72.5477 \| 46.34515 Saskatoon \| Saskatchewan \| Canada \| -106.66892 \| 52.13238 Barranquilla \| Atlántico \| Colombia \| -74.78132 \| 10.96854 Bogotá \| Colombia \| Colombia \| -74.08175 \| 4.60971 Alajuela \| Alajuela Province \| Costa Rica \| -84.21275 \| 10.01723 Cartago \| Cartago Province \| Costa Rica \| -83.9195 \| 9.86371 San José \| Provincia de San José \| Costa Rica \| -84.08489 \| 9.93388 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Tartu \| N/A \| Estonia \| 26.72509 \| 58.38062 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Grünstadt \| N/A \| Germany \| 8.16279 \| 49.56302 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Krumbach \| N/A \| Germany \| 10.3632 \| 48.24182 Leipzig \| N/A \| Germany \| 12.37129 \| 51.33962 Marburg \| N/A \| Germany \| 8.77069 \| 50.80904 Muelheim A.d. Ruhr \| N/A \| Germany \| N/A \| N/A München \| N/A \| Germany \| 13.31243 \| 51.60698 München \| N/A \| Germany \| 13.31243 \| 51.60698 Heraklion/Voutes \| Crete \| Greece \| N/A \| N/A Alexandroupoli \| N/A \| Greece \| 25.87644 \| 40.84995 Athens, Maroussi \| N/A \| Greece \| N/A \| N/A Larissa \| N/A \| Greece \| 22.41761 \| 39.63689 Thessaloniki \| N/A \| Greece \| 22.93086 \| 40.64361 Debrecen \| N/A \| Hungary \| 21.62444 \| 47.53167 Győr \| N/A \| Hungary \| 17.63512 \| 47.68333 Nyíregyháza \| N/A \| Hungary \| 21.71671 \| 47.95539 Salgótarján \| N/A \| Hungary \| 19.80303 \| 48.09872 Szentes \| N/A \| Hungary \| 20.2608 \| 46.65834 Hyderabad \| Andhra Pradesh \| India \| N/A \| N/A Ahmedabad \| Gujarat \| India \| 72.58727 \| 23.02579 Nadiād \| Gujarat \| India \| 72.86157 \| 22.69385 Bengaluru \| Karnataka \| India \| 77.59369 \| 12.97194 Pune \| Maharashtra \| India \| 73.85535 \| 18.51957 New Delhi \| N/A \| India \| 77.2148 \| 28.62137 Beaumont \| Dublin \| Ireland \| -6.22713 \| 53.38721 Dublin \| N/A \| Ireland \| -6.24889 \| 53.33306 Riga \| N/A \| Latvia \| 24.10589 \| 56.946 Kaunas \| N/A \| Lithuania \| 23.90961 \| 54.90272 Kaunas \| N/A \| Lithuania \| 23.90961 \| 54.90272 Klaipėda \| N/A \| Lithuania \| 21.13912 \| 55.7068 Vilnius \| N/A \| Lithuania \| 25.2798 \| 54.68916 Vilnius \| N/A \| Lithuania \| 25.2798 \| 54.68916 Kuala Lumpur \| N/A \| Malaysia \| 101.68653 \| 3.1412 Kuala Lumpur \| N/A \| Malaysia \| 101.68653 \| 3.1412 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Bydgoszcz \| N/A \| Poland \| 18.00762 \| 53.1235 Gdynia \| N/A \| Poland \| 18.53188 \| 54.51889 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Lublin \| N/A \| Poland \| 22.56667 \| 51.25 Poznan \| N/A \| Poland \| 16.92993 \| 52.40692 Słupsk \| N/A \| Poland \| 17.02872 \| 54.46405 Bucharest \| București \| Romania \| 26.10626 \| 44.43225 Bucharest \| Sector 5, \| Romania \| 26.10626 \| 44.43225 Sibiu \| Sibiu County \| Romania \| 24.15 \| 45.8 Arad \| N/A \| Romania \| 21.31667 \| 46.18333 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 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 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Singapore \| Singapore \| Singapore \| 103.85007 \| 1.28967 Nitra \| N/A \| Slovakia \| 18.08453 \| 48.30763 Považská Bystrica \| N/A \| Slovakia \| 18.42169 \| 49.12153 Prešov \| N/A \| Slovakia \| 21.23393 \| 48.99839 Trenčín \| N/A \| Slovakia \| 18.04436 \| 48.89452 Zvolen \| N/A \| Slovakia \| 19.15324 \| 48.57442 Claremont \| Cape Town \| South Africa \| 18.46528 \| -33.98056 Bloemfontein \| Free State \| South Africa \| 26.214 \| -29.12107 Vosloorus \| Gauteng \| South Africa \| 28.20756 \| -26.35745 Durban \| KwaZulu-Natal \| South Africa \| 31.0292 \| -29.8579 Durban \| KwaZulu-Natal \| South Africa \| 31.0292 \| -29.8579 Pietermaritzburg \| KwaZulu-Natal \| South Africa \| 30.39278 \| -29.61679 Pretoria \| N/A \| South Africa \| 28.18783 \| -25.74486 Roodepoort \| N/A \| South Africa \| 27.8725 \| -26.1625 Jeonju \| Jeollabuk-do \| South Korea \| 127.14889 \| 35.82194 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 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Suwon \| N/A \| South Korea \| 127.00889 \| 37.29111 Santander \| Cantabria \| Spain \| -3.80444 \| 43.46472 Las Palmas de Gran Canaria \| Las Palmas de Gran Canaria \| Spain \| -15.41343 \| 28.09973 Madrid \| Madrid \| Spain \| -3.70256 \| 40.4165 San Cristóbal de La Laguna \| Santa Cruz de Tenerife \| Spain \| -16.32014 \| 28.4853 Valencia \| Valencia \| Spain \| -0.37966 \| 39.47391 Valencia \| Valencia \| Spain \| -0.37966 \| 39.47391 Karlskoga \| N/A \| Sweden \| 14.52386 \| 59.32667 Malmo \| N/A \| Sweden \| 13.00073 \| 55.60587 Norrköping \| N/A \| Sweden \| 16.1826 \| 58.59419 Örebro \| N/A \| Sweden \| 15.2066 \| 59.27412 Skövde \| N/A \| Sweden \| 13.84506 \| 58.39118 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Chernivtsi \| N/A \| Ukraine \| 25.93241 \| 48.29045 Dnipropetrovsk \| N/A \| Ukraine \| 35.04066 \| 48.46664 Kyiv \| N/A \| Ukraine \| 30.5238 \| 50.45466 Uzhhorod \| N/A \| Ukraine \| 22.2947 \| 48.6242 Zaporizhzhia \| N/A \| Ukraine \| 36.76605 \| 48.03327	2,411	NCT00611026	1COMPLETED	2009-10-01	2008-02-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 3 ]	139	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one of the dose levels to be tested will be more effective than placebo (inactive drug).	null	Crohn's Disease		null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: administration via oral route twice daily intervention 2: administration via oral route twice daily intervention 3: administration via oral route twice daily intervention 4: administration via oral route twice daily	intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: Placebo	72	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Boulder \| Colorado \| United States \| -105.27055 \| 40.01499 Lakewood \| Colorado \| United States \| -105.08137 \| 39.70471 Wheat Ridge \| Colorado \| United States \| -105.07721 \| 39.7661 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Boca Raton \| Florida \| United States \| -80.0831 \| 26.35869 Boca Raton \| Florida \| United States \| -80.0831 \| 26.35869 Boca Raton \| Florida \| United States \| -80.0831 \| 26.35869 Boca Raton \| Florida \| United States \| -80.0831 \| 26.35869 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Chevy Chase \| Maryland \| United States \| -77.07115 \| 39.00287 Towson \| Maryland \| United States \| -76.60191 \| 39.4015 Troy \| Michigan \| United States \| -83.14993 \| 42.60559 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 Mexico \| Missouri \| United States \| -91.88295 \| 39.16976 Great Neck \| New York \| United States \| -73.72846 \| 40.80066 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Salisbury \| North Carolina \| United States \| -80.47423 \| 35.67097 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Duncansville \| Pennsylvania \| United States \| -78.4339 \| 40.42341 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Upper Saint Clair \| Pennsylvania \| United States \| -80.08339 \| 40.3359 Bristol \| Tennessee \| United States \| -82.18874 \| 36.59511 Kingsport \| Tennessee \| United States \| -82.56182 \| 36.54843 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Charleston \| West Virginia \| United States \| -81.63262 \| 38.34982 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Hradec Králové \| N/A \| Czechia \| 15.83277 \| 50.20923 Ústí nad Labem \| N/A \| Czechia \| 14.03227 \| 50.6607 Vandœuvre-lès-Nancy \| France \| France \| 6.17114 \| 48.66115 Lille \| N/A \| France \| 3.05858 \| 50.63297 Pessac \| N/A \| France \| -0.6324 \| 44.80565 Békéscsaba \| N/A \| Hungary \| 21.1 \| 46.68333 Debrecen \| N/A \| Hungary \| 21.62444 \| 47.53167 Győr \| N/A \| Hungary \| 17.63512 \| 47.68333 Gyula \| N/A \| Hungary \| 21.28333 \| 46.65 Kaposvár \| N/A \| Hungary \| 17.8 \| 46.36667 Szekszárd \| N/A \| Hungary \| 18.70905 \| 46.35014 Bologna \| N/A \| Italy \| 11.33875 \| 44.49381 Roma \| N/A \| Italy \| 11.10642 \| 44.99364 Amsterdam \| N/A \| Netherlands \| 4.88969 \| 52.37403 Lublin \| N/A \| Poland \| 22.56667 \| 51.25 Olsztyn \| N/A \| Poland \| 20.49416 \| 53.77995 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1 Bratislava \| Slovakia \| Slovakia \| 17.10674 \| 48.14816 Bratislava \| N/A \| Slovakia \| 17.10674 \| 48.14816 Nitra \| N/A \| Slovakia \| 18.08453 \| 48.30763 Durbanvilee \| Cape Town \| South Africa \| N/A \| N/A Johannesburg \| Gauteng \| South Africa \| 28.04363 \| -26.20227 Durban \| KwaZulu-Natal \| South Africa \| 31.0292 \| -29.8579 Durban \| South Africa \| South Africa \| 31.0292 \| -29.8579 Cape Town \| Western Cape \| South Africa \| 18.42322 \| -33.92584 Barcelona \| Barcelona \| Spain \| 2.15899 \| 41.38879 L'Hospitalet de Llobregat \| Barcelona \| Spain \| 2.10028 \| 41.35967 Majadahonda \| Madrid \| Spain \| -3.87182 \| 40.47353 Bristol \| N/A \| United Kingdom \| -2.59665 \| 51.45523 Salford \| N/A \| United Kingdom \| -2.29042 \| 53.48771	139	NCT00615199	1COMPLETED	2009-10-01	2008-01-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 4 ]	259	null	PARALLEL	0TREATMENT	null	false	0ALL	null	To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy	null	Hypertension		null	0	null	null	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: telmisartan40/amlodipine5 intervention 2: telmisartan80/amlodipine5	7	Chofu, Tokyo \| N/A \| Japan \| N/A \| N/A Nishi-ku, Hiroshima, Hiroshima \| N/A \| Japan \| N/A \| N/A Osaka, Osaka \| N/A \| Japan \| N/A \| N/A Osaka, Osaka \| N/A \| Japan \| N/A \| N/A Shinjuku-ku, Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Shinjyuku-ku,Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Suita, Osaka \| N/A \| Japan \| N/A \| N/A	259	NCT00618774	1COMPLETED	2009-10-01	2008-01-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	200	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Meropenem is an antibiotic that is commonly used to treat serious infections. Although it is used in premature and young infants, the correct dose is not known. The purpose of this study is to determine the correct dose and the safety of meropenem for the treatment of complicated intra-abdominal infections in these young babies.	This study will evaluate the safety, tolerability and Pharmacokinetics - Pharmacodynamics (PK-PD) of meropenem in infants \<91 days of age with suspected and complicated intra-abdominal infections. The specific aims of this trial are: 1. To characterize meropenem single-dose and multiple-dose PK in subjects with suspected and complicated intra-abdominal infections. 2. To characterize the safety profile of meropenem in the treatment of suspected and complicated intra-abdominal infections. 3. To assess collected efficacy data for meropenem for the treatment of suspected and complicated intra-abdominal infections.	Necrotizing Enterocolitis Intra-abdominal Infection	meropenem infants intra-abdominal infection pharmacokinetics safety	null	1	arm 1: These Participants were subdivided into the following four groups based on Gestational Age (GA) and Postnatal Age (PNA): Group 1: GA at birth below 32 weeks - PNA \<2 weeks; Group 2: GA at birth below 32 weeks - PNA ≥2 weeks and \<91 days; Group 3: GA at birth 32 weeks or older - PNA \<2 weeks; Group 4: GA at birth 32 weeks or older - PNA ≥2 weeks and \<91 days.	[ 0 ]	1	[ 0 ]	intervention 1: Meropenem was administered concomitantly with compatible medications. Because an in-line filter is not appropriate due to drug binding, the 30 minute infusion was rate controlled by using appropriate infusion (syringe) pumps. Dosing and administration of other antimicrobial therapy (e.g., an aminoglycoside) was administered per local standard of care at the discretion of the infant's neonatologist. If there was a delay in the study drug shipment, sites were to use open-label meropenem to protect the safety of the participant. 20 mg/kg every 12 hours in infants \<32 weeks GA and PNA \< 2 weeks 20 mg/kg every 8 hours in infants \<32 weeks GA and PNA ≥ 2 weeks 20 mg/kg every 8 hours in infants ≥32 weeks GA and PNA \< 2 weeks 30 mg/kg every 8 hours in infants ≥32 weeks GA and PNA ≥ 2 weeks	intervention 1: meropenem	26	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Oakland \| California \| United States \| -122.2708 \| 37.80437 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 New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Honolulu \| Hawaii \| United States \| -157.85833 \| 21.30694 Evanston \| Illinois \| United States \| -87.69006 \| 42.04114 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Albany \| New York \| United States \| -73.75623 \| 42.65258 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Akron \| Ohio \| United States \| -81.51901 \| 41.08144 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078	200	NCT00621192	1COMPLETED	2009-10-01	2008-06-01	The Emmes Company, LLC	4INDUSTRY	false	false	false	null	0
[ 3 ]	1,878	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily, compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascular events.	null	Coronary Disease		null	5	arm 1: twice daily dosing, arm 2: twice daily dosing, patients with moderate renal impairment allocated 50mg bid arm 3: twice daily dosing, patients with moderate renal impairment allocated 75mg bid arm 4: twice daily dosing, patients with moderate renal impairment allocated 110mg bid arm 5: matched placebo	[ 0, 0, 0, 0, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: matched placebo intervention 2: capsules, twice daily, 26 weeks treatment intervention 3: capsules, twice daily, 26 weeks treatment intervention 4: capsules, twice daily, 26 weeks treatment intervention 5: capsules, twice daily, 26 weeks treatment	intervention 1: placebo intervention 2: dabigatran etexilate intervention 3: dabigatran etexilate intervention 4: dabigatran etexilate intervention 5: dabigatran etexilate	167	Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Bouge/Namur \| N/A \| Belgium \| N/A \| N/A Brasschaat \| N/A \| Belgium \| 4.49182 \| 51.2912 Edegem \| N/A \| Belgium \| 4.44504 \| 51.15662 Genk \| N/A \| Belgium \| 5.50082 \| 50.965 Gilly \| N/A \| Belgium \| 4.4789 \| 50.42449 Hasselt \| N/A \| Belgium \| 5.33781 \| 50.93106 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Tienen \| N/A \| Belgium \| 4.9378 \| 50.80745 Burgas \| N/A \| Bulgaria \| 27.46781 \| 42.50606 Dimitrovgrad \| N/A \| Bulgaria \| 25.6 \| 42.05 Pleven \| N/A \| Bulgaria \| 24.61667 \| 43.41667 Pleven \| N/A \| Bulgaria \| 24.61667 \| 43.41667 Rousse \| N/A \| Bulgaria \| 25.9534 \| 43.84872 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Cambridge \| Ontario \| Canada \| -80.31269 \| 43.3601 Greater Sudbury \| Ontario \| Canada \| -80.99001 \| 46.49 Greater Sudbury \| Ontario \| Canada \| -80.99001 \| 46.49 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Mississauga \| Ontario \| Canada \| -79.6583 \| 43.5789 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 Terrebonne \| Quebec \| Canada \| -73.64732 \| 45.70004 Hradec Králové \| N/A \| Czechia \| 15.83277 \| 50.20923 Litoměřice \| N/A \| Czechia \| 14.1318 \| 50.53348 Ostrava \| N/A \| Czechia \| 18.28204 \| 49.83465 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Teplice \| N/A \| Czechia \| 13.82451 \| 50.6404 Zlín \| N/A \| Czechia \| 17.67065 \| 49.22645 Aarhus C \| N/A \| Denmark \| 10.21231 \| 56.16558 Hvidovre \| N/A \| Denmark \| 12.47708 \| 55.64297 Odense \| N/A \| Denmark \| 10.38831 \| 55.39594 Roskilde \| N/A \| Denmark \| 12.08035 \| 55.64152 HUS \| N/A \| Finland \| N/A \| N/A Jyväskylä \| N/A \| Finland \| 25.72088 \| 62.24147 Kuopio \| N/A \| Finland \| 27.67703 \| 62.89238 Pori \| N/A \| Finland \| 21.78333 \| 61.48333 Brest \| N/A \| France \| -4.48628 \| 48.39029 Brest \| N/A \| France \| -4.48628 \| 48.39029 Dijon \| N/A \| France \| 5.01667 \| 47.31667 Dijon \| N/A \| France \| 5.01667 \| 47.31667 Dijon \| N/A \| France \| 5.01667 \| 47.31667 Dijon \| N/A \| France \| 5.01667 \| 47.31667 Paris \| N/A \| France \| 2.3488 \| 48.85341 Tbilisi \| N/A \| Georgia \| 44.83412 \| 41.69143 Tbilisi \| N/A \| Georgia \| 44.83412 \| 41.69143 Tbilisi \| N/A \| Georgia \| 44.83412 \| 41.69143 Tbilisi \| N/A \| Georgia \| 44.83412 \| 41.69143 Tbilisi \| N/A \| Georgia \| 44.83412 \| 41.69143 Tbilisi \| N/A \| Georgia \| 44.83412 \| 41.69143 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Dresden \| N/A \| Germany \| 13.73832 \| 51.05089 Hanover \| N/A \| Germany \| 9.73322 \| 52.37052 Homburg/Saar \| N/A \| Germany \| N/A \| N/A Ludwigshafen am Rhein \| N/A \| Germany \| 8.44641 \| 49.48121 Neuss \| N/A \| Germany \| 6.68504 \| 51.19807 Rostock \| N/A \| Germany \| 12.14049 \| 54.0887 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Debrecen \| N/A \| Hungary \| 21.62444 \| 47.53167 Kecskemét \| N/A \| Hungary \| 19.69128 \| 46.90618 Komárom \| N/A \| Hungary \| 18.11913 \| 47.74318 Miskolc \| N/A \| Hungary \| 20.77806 \| 48.10306 Mosonmagyaróvár \| N/A \| Hungary \| 17.26994 \| 47.86789 Zalaegerszeg \| N/A \| Hungary \| 16.84389 \| 46.84 Amedabad \| N/A \| India \| N/A \| N/A Chennai \| N/A \| India \| 80.27847 \| 13.08784 Hyderabad \| N/A \| India \| 78.45636 \| 17.38405 Lucknow \| N/A \| India \| 80.92313 \| 26.83928 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 Pune \| N/A \| India \| 73.85535 \| 18.51957 Pune \| N/A \| India \| 73.85535 \| 18.51957 Dublin \| N/A \| Ireland \| -6.24889 \| 53.33306 Dublin \| N/A \| Ireland \| -6.24889 \| 53.33306 Ascoli Piceno \| N/A \| Italy \| 13.57395 \| 42.85351 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Parma \| N/A \| Italy \| 10.32618 \| 44.79935 S. Maria Capua Vetere (CE) \| N/A \| Italy \| N/A \| N/A Torino \| N/A \| Italy \| 11.99138 \| 44.88856 's-Hertogenbosch \| N/A \| Netherlands \| 5.30417 \| 51.69917 Amsterdam \| N/A \| Netherlands \| 4.88969 \| 52.37403 Ede \| N/A \| Netherlands \| 5.65833 \| 52.03333 Groningen \| N/A \| Netherlands \| 6.56667 \| 53.21917 Helmond \| N/A \| Netherlands \| 5.66111 \| 51.48167 Hoogeveen \| N/A \| Netherlands \| 6.47639 \| 52.7225 Rotterdam \| N/A \| Netherlands \| 4.47917 \| 51.9225 Spijkenisse \| N/A \| Netherlands \| 4.32917 \| 51.845 The Hague \| N/A \| Netherlands \| 4.29861 \| 52.07667 Tilburg \| N/A \| Netherlands \| 5.0913 \| 51.55551 Drammen \| N/A \| Norway \| 10.20449 \| 59.74389 Hamar \| N/A \| Norway \| 11.06798 \| 60.7945 Haugesund \| N/A \| Norway \| 5.268 \| 59.41378 Hønefoss \| N/A \| Norway \| 10.25647 \| 60.16804 Oslo \| N/A \| Norway \| 10.74609 \| 59.91273 Bydgoszcz \| N/A \| Poland \| 18.00762 \| 53.1235 Bydgoszcz \| N/A \| Poland \| 18.00762 \| 53.1235 Gdynia \| N/A \| Poland \| 18.53188 \| 54.51889 Inowrocław \| N/A \| Poland \| 18.26387 \| 52.79886 Sopot \| N/A \| Poland \| 18.56003 \| 54.4418 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Baia Mare \| N/A \| Romania \| 23.56808 \| 47.65729 Brăila \| N/A \| Romania \| 27.97429 \| 45.27152 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Oradea \| N/A \| Romania \| 21.91833 \| 47.0458 Tg. Mures \| N/A \| Romania \| N/A \| N/A Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saratov \| N/A \| Russia \| 46.00861 \| 51.54056 Saratov \| N/A \| Russia \| 46.00861 \| 51.54056 Busan \| N/A \| South Korea \| 129.03004 \| 35.10168 Daegu \| N/A \| South Korea \| 128.59111 \| 35.87028 Daegu \| N/A \| South Korea \| 128.59111 \| 35.87028 Daejeon \| N/A \| South Korea \| 127.38493 \| 36.34913 Daejoen \| N/A \| South Korea \| N/A \| N/A Incheon \| N/A \| South Korea \| 126.70515 \| 37.45646 Jeonju \| N/A \| South Korea \| 127.14889 \| 35.82194 Kwangju \| N/A \| South Korea \| 127.1279 \| 36.9122 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 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Sabadell (Barcelona) \| N/A \| Spain \| 2.10942 \| 41.54329 Tarragona \| N/A \| Spain \| 1.24544 \| 41.11905 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Malmo \| N/A \| Sweden \| 13.00073 \| 55.60587 Motala \| N/A \| Sweden \| 15.03649 \| 58.53706 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Uppsala \| N/A \| Sweden \| 17.63889 \| 59.85882 Vaesteraas \| N/A \| Sweden \| N/A \| N/A Ivano-Frankivsk \| N/A \| Ukraine \| 24.71248 \| 48.92312 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 Nikolayev \| N/A \| Ukraine \| 36.12778 \| 50.20889 Odesa \| N/A \| Ukraine \| 30.74383 \| 46.48572 Brighton \| N/A \| United Kingdom \| -0.13947 \| 50.82838 Exeter \| N/A \| United Kingdom \| -3.52751 \| 50.7236 Middlesbrough \| N/A \| United Kingdom \| -1.23483 \| 54.57623	1,861	NCT00621855	1COMPLETED	2009-10-01	2008-03-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 3 ]	53	NON_RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to determine the safety and efficacy of AKR-501 (avatrombopag) administered in participants with chronic Idiopathic Thrombocytopenic Purpura (ITP) who were enrolled into and completed 28 days of study treatment in Protocol 501-CL-003 (NCT00441090).	Participants eligible to enroll into this rollover protocol will begin study treatment within 2-5 days of their Day 28 study termination visit in Protocol 501-CL-003 (NCT00441090). Participants who met the primary efficacy response criterion in Protocol 501-CL-003 will continue receiving the same study treatment to which they were assigned in the previous protocol in a double-blinded manner, these being one of the following 5 treatments: * avatrombopag 2.5 mg daily * avatrombopag 5 mg daily * avatrombopag 10 mg daily * avatrombopag 20 mg daily * placebo Participants who did not meet the primary efficacy response criterion in Protocol 501-CL-003 who otherwise meet the eligibility criteria for this rollover protocol will be offered open label avatrombopag 10 mg daily. This is a parallel group, rollover study.	Idiopathic Thrombocytopenic Purpura	Idiopathic Thrombocytopenic Purpura ITP Chronic Idiopathic Thrombocytopenic Purpura	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Placebo Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack) Duration - 6 months intervention 2: Dose 10 mg Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack) Duration - 6 months intervention 3: Dose: 2.5, 5, 10, or 20 mg Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack) Duration - 6 months	intervention 1: Blinded (placebo) intervention 2: Open Label (Avatrombopag tablets) intervention 3: Blinded (Avatrombopoag tablets)	12	Anaheim \| California \| United States \| -117.9145 \| 33.83529 Bakersfield \| California \| United States \| -119.01871 \| 35.37329 Manchester \| Connecticut \| United States \| -72.52148 \| 41.77593 New Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 New Albany \| Indiana \| United States \| -85.82413 \| 38.28562 Jefferson City \| Missouri \| United States \| -92.17352 \| 38.5767 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 High Point \| North Carolina \| United States \| -80.00532 \| 35.95569 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118	53	NCT00625443	1COMPLETED	2009-10-01	2007-05-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0
[ 0 ]	34	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	true	Reducing tobacco use by adolescents is a national health priority. In recent polls, most adolescent smokers reported having tried unsuccessfully to quit. Smoking cessation treatment during adolescence has the potential to interrupt the progression to nicotine dependence, which is attended by a wide range of negative health consequences. Given the need for effective smoking cessation programs aimed at youth, scientifically rigorous research is warranted to reduce adolescent smoking. This project will address gaps in the scientific treatment literature. The goal of this project is to develop a tailored, practical, and efficacious smoking cessation intervention. Combined with other efforts in the field, this work can provide an initial guide to an evidence-based treatment for smoking cessation in youth. In keeping with developments in other fields of medicine, we believe that further advances in smoking cessation will move towards a goal of personalized treatment. Such an individualized approach for adolescent smoking cessation will be informed by further investigation of the relationships between outcomes in this trial. To serve these goals, we propose the following program: Youths who smoke regularly will receive a 6 week intervention using "cognitive-behavioral motivational enhancement" (CBME) supplemented by nicotine replacement therapy (NRT), if youth and parents desire this option. Furthermore, youth has to smoke more than 5 cigarettes a day in order to qualify for nicotine replacement therapy. This approach is consistent with treatment guidelines for smoking cessation (Fiore 2000). Compared with participants who fail to achieve smoking cessation, those who successfully achieve smoking abstinence during intervention, will have lower baseline rates of comorbid ADHD, lower depressive symptom scores, enhanced readiness to quit, more negative attitudes towards smoking, fewer friends who smoke, and fewer family members who smoke. The investigators predict that the intervention will help youth to quit smoking and will examine predictions of successful quitting.	Tobacco use is the leading preventable cause of death in the United States, and current estimates project that 6.4 million of our nation's youth will die prematurely from a smoking-related disease (Fellows et al., 2002). Extant data suggest that three of every five adolescent smokers are nicotine-dependent, and that some subgroups of adolescents are at higher risk for dependence (e.g., daily or heavy smokers, incarcerated youth, youth in vocational schools, depressed youth, youth with Attention Deficit Hyperactivity Disorder (ADHD)). Adolescent tobacco smoking increases risk for a wide range of negative health consequences (Abrantes et al., 2005; Anda et al., 1990; Biederman et al., 2006; Escobedo et al., 1998; Kandel et al., 1986; Kollins et al., 2005; Wilens \& Dodson 2004). For example, smoking-related cancer risk is increased with early age of initiating smoking and longer time of smoking, underscoring the importance of addressing this health risk behavior in youth (Centers for Disease Control and Prevention, 1994). Reducing tobacco use by adolescents is a national health priority (see Healthy People 2010, Objective, 27.2 (Office of Disease Prevention and Health Promotion 2000)). Approximately 4% of 8th graders, 7.5% of 10th graders, and 13.6% of 12th graders smoke daily and almost half of these youths smoke ≥ half a pack per day (Johnston \& O'Coner 2005). In recent polls, most adolescent smokers reported having tried unsuccessfully to quit (Grimshaw et al., 2003; Hollis et al., 2003). Smoking cessation treatment during adolescence has the potential to interrupt the progression to nicotine dependence, which is attended by a wide range of negative health consequences (Anda et al., 1990; Escobedo et al., 1998; Kandel \& Davies 1986). Given the need for effective smoking cessation programs aimed at youth, scientifically rigorous research is warranted to reduce adolescent smoking (Backinger et al., 2003). This project will address gaps in the scientific treatment literature. In keeping with developments in other fields of medicine, we believe that further advances in smoking cessation will move towards a goal of personalized treatment. In order to optimize the aim for personalized treatment we will include genetic testing. For some smoking cessation treatments, evidence has begun to accumulate that the inter-individual variability in response to treatment benefits and side effects may be influenced by inheritance. In the smoking cessation treatment literature, some observations have already been made suggesting that common gene variants may be associated with different treatment outcomes. The association between depression and smoking has led to interest in whether the short allele of the serotonin transporter gene may be associated with increased vulnerability to smoking and nicotine dependence, although to our knowledge this has yet to be demonstrated (Brody, et al. 2005). Such findings suggest that individual vulnerability to the reinforcing effects of smoking, and most important to this study differences in quitting success, could be partially predicted by individual genotype. Additionally, motivational and psychosocial factors have also been identified as likely predictors of treatment response. We are seeking predictors that would allow us to reach the ultimate objective: to contribute to an algorithm to better match youth and effective smoking cessation treatment. Specific Aims of the study are as follows: 1. To evaluate an intervention for adolescent smoking cessation. 2. To examine moderators and mediators of successful smoking cessation.	Smoking	Youth Smoking Tobacco Adolescent Dependence Teen smoking Smoking and youth Youth and tobacco	null	1	arm 1: 6 weeks CBME with optional 4 weeks NRT	[ 0 ]	2	[ 5, 0 ]	intervention 1: 6 weeks of once a week one-on-one CBME intervention 2: NicoDerm CQ nicotine transdermal patch	intervention 1: CBME intervention 2: Optional NRT	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	34	NCT00631020	1COMPLETED	2009-10-01	2007-12-01	University of California, Los Angeles	7OTHER	false	false	false	null	0
[ 0 ]	5	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study is being conducted to evaluate the safety and effectiveness of lenalidomide (Revlimid®) in subjects with Cutaneous Lupus Erythematosus (CLE). The study drug will be used in an off-label indication to treat 6 subjects for 12 months each. Men and women over the age of 18, who have a biopsy proven diagnosis of CLE and who have failed standard treatment, will be included in the study.	Cutaneous lupus erythematosus (CLE) is a chronic and often disabling disease which affects the skin. Many patients experience scarring and inflammation of the skin, which often occur on the face. Moderate to severe CLE is most frequently treated with antimalarial drugs such as hydroxychloroquine, quinacrine or chloroquine. Up to 70% of CLE patients treated with antimalarials experience a beneficial clinical response, while the remainder of patients show no response or continue to experience progression of the disease. Thalidomide has been used successfully in such patients, with up to 75% clinical response rate in refractory CLE patients. However, thalidomide is a known teratogen and can cause severe birth defects, including short, malformed limbs and damage to peripheral nerves in the extremities, requiring patients to be monitored for pregnancy. In addition, up to 25% of patients on thalidomide develop peripheral neuropathy. A new drug, lenalidomide (REVLIMID®), an analogue of thalidomide, has been developed to treat neoplastic and inflammatory conditions, including various oncologic conditions such as multiple myeloma, myelodysplastic syndrome and solid tumors. Unlike thalidomide, lenalidomide (REVLIMID®) is not known to cause the extent of serious side effects caused by thalidomide; however, it must also be monitored for side effects and be distributed under the RevAssist program authorized by the drug manufacturer, Celgene Corporation. The primary goal of this investigator-initiated, small pilot study is to evaluate the safety and effectiveness of lenalidomide (REVLIMID®) in CLE subjects using measurements such as the CLASI (Cutaneous Lupus Activity and Severity Index). The study drug will be used in an off-label indication to treat 6 subjects, for whom lenalidomide (REVLIMID®) will be provided at no cost by the drug manufacturer. Men and women over the age of 18, who have a biopsy proven diagnosis of refractory CLE and who have failed standard treatment with hydroxychloroquine for up to three months, will be included in the study. Secondarily, the study will evaluate the biologic effects of lenalidomide on pathogenic and immunologic mechanisms of the CLE disease process during the treatment period by collecting skin specimens (biopsies) and blood samples.	Cutaneous Lupus Erythematosus (CLE)	Cutaneous Lupus Erythematosus CLE lenalidomide revlimid thalidomide derivative drug lupus	null	2	arm 1: Open label lenalidomide received. arm 2: Open label lenalidomide received.	[ 0, 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: Lenalidomide	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	5	NCT00633945	1COMPLETED	2009-10-01	2007-11-01	University of Pennsylvania	7OTHER	false	false	false	null	0
[ 0 ]	60	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	This study will apply polysomnography (PSG) to evaluate the effect of quetiapine fumarate on sleep architecture. Most of previous studies evaluated sleep by self-reported questionnaires during the antipsychotic treatment (clozapine, risperidone, olanzapine, et al), while only a few studies with PSG evaluation had some limitation, such as: small sample size, respective or cross-sectional, potential sleep disorders, et al. In this study, we will investigate both subjective and objective effect of quetiapine fumarate in improving sleep quality in schizophrenic patients by PSG as well as psychiatric scales. The control drug in this study is the typical antipsychotic - haloperidol. It could increase sleep duration and efficiency by mostly increasing the S2 without effect on rapid eye movement (REM) sleep and slow wave sleep (SWS). The patients will be randomised into two groups as a parallel design. This study is designed as rater blinded to reduce the bias in evaluation. It is suggested that the sedative effect of quetiapine fumarate could diminish in 2 weeks, therefore, we use 4 weeks to ensure the change of sleep quality in this study, which could be helpful for the evaluation of relative short and middle term effect of quetiapine fumarate on sleep quality.	1. The objective sleep structures of quetiapine fumarate and haloperidol being used as mono-therapy respectively in the treatment of patients with acute schizophrenia are measured by the change of composite variables for PSG test (sleep stages, time in bed, total sleep time, sleep efficiency, sleep latency) from baseline to Week 4 (LOCF). 2. The subjective sleep qualities of quetiapine fumarate and haloperidol being used as mono-therapy respectively in the treatment of patients with acute schizophrenia are measured by the change of Pittsburgh Sleep Quality Inventory (PSQI) and Epworth Sleepiness Scale(ESS) from baseline to Week 4 (LOCF). 3. The clinical efficacy of quetiapine fumarate and haloperidol being used as mono-therapy respectively in the treatment of patients with acute schizophrenia are measured by the change of Positive and Negative Syndrome Scale (PANSS) and Clinical Globe Impression (CGI),and Calgary Depression Scale for Schizophrenia (CDSS) from baseline to Week 4 (LOCF). 4. The clinical safety and tolerance quetiapine fumarate and haloperidol being used as mono-therapy respectively in the treatment of patients with acute schizophrenia are measured by Treatment Emergent Symptom Scale (TESS) in day 14 and day 28.	Schizophrenia	Polysomnograph	null	2	arm 1: quetiapine fumarate was administered 25mg on the 1st day,738±41mg/day on the 14th day, and 738±48mg/day on the 28th day. arm 2: haloperidol was administered 2mg on the 1st day,16±7mg/day on the 14th day, and 18±6mg/day on the 28th day.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 600-750mg/day intervention 2: 6-40mg/day	intervention 1: quetiapine fumarate intervention 2: haloperidol	1	Guangzhou \| Guangdong \| China \| 113.25 \| 23.11667	60	NCT00642369	1COMPLETED	2009-10-01	2008-03-01	Guang Dong Provincial Mental Health Institute	7OTHER	false	false	false	null	0
[ 5 ]	40	RANDOMIZED	SINGLE_GROUP	7BASIC_SCIENCE	0NONE	true	0ALL	false	The purpose of this research is to study how people respond differently to capsaicin in different racial groups and the effect it has on your pain levels. Capsaicin is a natural product made from hot chili peppers that is useful for treating the itch symptoms of skin disease.	To comprehensively evaluate the ethnic differences in response to topical capsaicin and its effect on thermal sensory thresholds.	Healthy	Healthy volunteers	null	2	arm 1: Capsaicin 0.1% cream application to the volar side of forearm. arm 2: Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) to the opposite forearm.	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Topical application, 0.1%, Capzasin HP; Chattem Inc., Chattanooga, TN, U.S.A intervention 2: Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.)	intervention 1: Capsaicin intervention 2: Placebo moisturizing cream	1	Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986	80	NCT00655811	1COMPLETED	2009-10-01	2008-02-01	Wake Forest University	7OTHER	false	false	false	null	0
[ 3 ]	40	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	true	It is hypothesized that the opioid antagonist naltrexone will improve inflammation of the bowel and quality of life in subjects with active Crohn's disease compared to placebo. In order to test this hypothesis the following specific aims are proposed: 1. Evaluate the effects of low dose naltrexone compared to placebo on the activity of Crohn's disease by the following end points: Crohn's Disease Activity Index (CDAI), pain assessment, laboratory values (CRP and ESR), endoscopic appearance, histology, and quality of life surveys; 2. Examine the effects of naltrexone given over 3 months compared to 6 months for durability of response; 3. Determine the safety and toxicity of low dose naltrexone in subjects with active Crohn's disease, and 4. Study the mechanism by which naltrexone exerts its effect by measuring plasma enkephalin levels of subjects on therapy. Purpose statement: The purpose of this study is to evaluate the effects of low dose naltrexone in a blinded placebo controlled study to determine the safety and efficacy of this compound in those with active Crohn's disease.	Study design : The study is designed as a double-blind placebo controlled study for 3 months followed by a pseudo cross-over such that all subjects receiving placebo the first 3 months will receive active drug the second 3 months and all receiving naltrexone the first 3 months remain on the drug the last 3 months of this 6 month study.	Inflammation Crohn's Disease	naltrexone LDN IBD Inflammatory bowel disease	null	2	arm 1: placebo for 3 months blinded then followed by an open-labelled study and all are treated with naltrexone 4.5 mg for 3 additional months arm 2: Subjects are treated in a blinded fashion for 3 months with naltrexone 4.5 mg po for active Crohn's disease followed an open-labelled study where naltrexone is given an additional 3 months at 4.5 mg po; hence the total treatment interval in this arm is 6 months. The response to the intervention administered is measured in the activity index and mucosal healing by colonoscopy.	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: naltrexone 4.5 mg intervention 2: Placebo	intervention 1: Naltrexone-HCl intervention 2: Placebo	1	Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592	60	NCT00663117	1COMPLETED	2009-10-01	2006-09-01	Milton S. Hershey Medical Center	7OTHER	false	false	false	null	0
[ 3 ]	6	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.	null	Arthritis, Gouty	Arthritis Gouty ACZ885 IL1B protein Pain	null	2	arm 1: Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1. arm 2: Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.	[ 0, 1 ]	4	[ 2, 0, 10, 10 ]	intervention 1: 10 mg/kg intravenous infusion 250 mL over 2 hours. intervention 2: 12 mg intravenous infusion 50 mL over 30 minutes. intervention 3: 5% glucose in water intravenous infusion. intervention 4: Placebo intravenous infusion.	intervention 1: canakinumab intervention 2: dexamethasone intervention 3: placebo matching canakinumab intervention 4: placebo matching dexamethasone	4	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 New Brunswick \| New Jersey \| United States \| -74.45182 \| 40.48622 Lausanne \| N/A \| Switzerland \| 6.63282 \| 46.516 Glasgow \| N/A \| United Kingdom \| -4.25763 \| 55.86515	6	NCT00663169	1COMPLETED	2009-10-01	2008-04-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 3 ]	636	RANDOMIZED	FACTORIAL	0TREATMENT	2DOUBLE	false	0ALL	false	A randomized, double-blind, placebo-controlled, dose-ranging study to examine the safety, tolerability and effect on body weight of a range of doses of metreleptin and pramlintide, each administered by a separate subcutaneous (SC) injection in obese and overweight subjects.	null	Overweight Obesity	overweight obesity pramlintide metreleptin Amylin	null	8	arm 1: Placebo matched to pramlintide BID plus placebo matched to metreleptin BID arm 2: 360 mcg pramlintide given twice per day (BID) plus Placebo matched to Metreleptin given BID arm 3: Placebo matched to pramlintide BID plus metreleptin 5.0 mg BID arm 4: Pramlintide 180 mcg BID plus Metreleptin 2.5 mg BID arm 5: Pramlintide 180 mcg BID plus Metreleptin 5.0 mg BID arm 6: Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID arm 7: Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID arm 8: Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID	[ 2, 0, 0, 0, 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: subcutaneous injection, twice a day intervention 2: subcutaneous injection, twice a day intervention 3: subcutaneous injection, twice a day intervention 4: subcutaneous injection, twice a day	intervention 1: pramlintide acetate intervention 2: metreleptin intervention 3: placebo-P intervention 4: placebo-M	36	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Santa Rosa \| California \| United States \| -122.71443 \| 38.44047 Walnut Creek \| California \| United States \| -122.06496 \| 37.90631 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Pembrook Pines \| Florida \| United States \| N/A \| N/A Plantation \| Florida \| United States \| -80.23184 \| 26.13421 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Springfield \| Illinois \| United States \| -89.64371 \| 39.80172 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 Auburn \| Maine \| United States \| -70.23117 \| 44.09785 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Edina \| Minnesota \| United States \| -93.34995 \| 44.88969 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Butte \| Montana \| United States \| -112.53474 \| 46.00382 New York \| New York \| United States \| -74.00597 \| 40.71427 Statesville \| North Carolina \| United States \| -80.8873 \| 35.78264 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Medford \| Oregon \| United States \| -122.87559 \| 42.32652 Anderson \| South Carolina \| United States \| -82.65013 \| 34.50344 Greer \| South Carolina \| United States \| -82.22706 \| 34.93873 Mt. Pleasant \| South Carolina \| United States \| -79.86259 \| 32.79407 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 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 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Belingham \| Washington \| United States \| N/A \| N/A Olympia \| Washington \| United States \| -122.90169 \| 47.04491	608	NCT00673387	1COMPLETED	2009-10-01	2008-04-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 3 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to investigate if the combination of gemcitabine and oxaliplatin is effective for triple negative breast cancer.	In this study, participants will receive gemcitabine and oxaliplatin, drugs that have been in use for a long time. Gemcitabine is a treatment that is an effective therapy currently available to patients with this type and stage of breast cancer. Frequently, in cancer therapy, combinations of drugs prove more effective as treatment than the same drugs used alone. The combination of gemcitabine and oxaliplatin has not been tested in patients with triple negative breast cancer. It is hoped that the addition of oxaliplatin may cause your tumor to stop growing or possible your tumor may shrink. This assessment will be basd on measuring changes in the size of your tumor.	Breast Cancer	Metastatic breast cancer	null	1	arm 1: All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m\^2 on Day 1 and Oxaliplatin 100 mg/m\^2 intravenously over 2 hours on Day 2.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Gemcitabine 1000mg/m\^2 on day 1 every 14 days Cycles of treatment will be repeated every 2 weeks until disease progression, intolerable toxicity, or the development of any of the criteria for study removal intervention 2: Oxaliplatin 100mg/m\^2 on day 2 every 14 days Cycles of treatment will be repeated every 2 weeks until disease progression, intolerable toxicity, or the development of any of the criteria for study removal	intervention 1: Gemcitabine intervention 2: Oxaliplatin	1	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749	6	NCT00674206	6TERMINATED	2009-10-01	2008-10-01	Emory University	7OTHER	false	false	false	null	0
[ 4 ]	292	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive procedures. The clinical benefit of eltrombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an invasive procedure. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events and medical resource utilisation will be monitored during this time and for up to 30 days after undergoing an invasive procedure to help further evaluate clinical benefit.	null	Non-alcoholic Steatohepatitis Chronic Liver Disease HCV NASH - Nonalcoholic Steatohepatitis HIV Infection Thrombocytopenia Hepatitis C Virus HBV Human Immunodeficiency Virus Liver Diseases Hepatitis B Virus	elective invasive procedure. platelet transfusion chronic liver disease-related thrombocytopenia platelets thrombopoietin	null	2	arm 1: placebo, once daily, oral arm 2: 75 mg, once daily, oral	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: 75 mg, once daily, oral intervention 2: placebo, once daily, oral	intervention 1: Eltrombopag intervention 2: Placebo	107	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Burlington \| Massachusetts \| United States \| -71.19561 \| 42.50482 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 New York \| New York \| United States \| -74.00597 \| 40.71427 Valhalla \| New York \| United States \| -73.77513 \| 41.07482 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931 Falls Church \| Virginia \| United States \| -77.17109 \| 38.88233 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Capital Fefderal \| Buenos Aires \| Argentina \| N/A \| N/A Ciudad Autonoma de Buenos Aires \| Buenos Aires \| Argentina \| N/A \| N/A Derqui, Pilar \| Buenos Aires \| Argentina \| N/A \| N/A Rosario \| Santa Fe Province \| Argentina \| -60.63932 \| -32.94682 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Edegem \| N/A \| Belgium \| 4.44504 \| 51.15662 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Clermont Ferrand Cédex 1 \| N/A \| France \| N/A \| N/A Lyon \| N/A \| France \| 4.84671 \| 45.74846 Lyon \| N/A \| France \| 4.84671 \| 45.74846 Marseille \| N/A \| France \| 5.38107 \| 43.29695 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Nice \| N/A \| France \| 7.26608 \| 43.70313 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| France \| 2.3488 \| 48.85341 Villejuif \| N/A \| France \| 2.35992 \| 48.7939 Jaipur \| N/A \| India \| 75.78781 \| 26.91962 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 Bari \| Apulia \| Italy \| 16.86982 \| 41.12066 San Giovanni Rotondo (FG) \| Apulia \| Italy \| 15.7277 \| 41.70643 Avellino \| Campania \| Italy \| 14.79103 \| 40.91494 Napoli \| Campania \| Italy \| 14.5195 \| 40.87618 Bologna \| Emilia-Romagna \| Italy \| 11.33875 \| 44.49381 Rome \| Lazio \| Italy \| 12.51133 \| 41.89193 Rome \| Lazio \| Italy \| 12.51133 \| 41.89193 Genoa \| Liguria \| Italy \| 8.94439 \| 44.40478 Milan \| Lombardy \| Italy \| 9.18951 \| 45.46427 Milan \| Lombardy \| Italy \| 9.18951 \| 45.46427 Milan \| Lombardy \| Italy \| 9.18951 \| 45.46427 Turin \| Piedmont \| Italy \| 7.68682 \| 45.07049 Palermo \| Sicily \| Italy \| 13.3636 \| 38.1166 Padua \| Veneto \| Italy \| 11.88586 \| 45.40797 Lahore \| N/A \| Pakistan \| 74.35071 \| 31.558 Lahore \| N/A \| Pakistan \| 74.35071 \| 31.558 Chorzów \| N/A \| Poland \| 18.9742 \| 50.30582 Lubin \| N/A \| Poland \| 16.20149 \| 51.40089 Słupsk \| N/A \| Poland \| 17.02872 \| 54.46405 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Samara \| N/A \| Russia \| 50.15 \| 53.20007 Smolensk \| N/A \| Russia \| 32.04371 \| 54.77944 Yekaterinburg \| N/A \| Russia \| 60.6122 \| 56.8519 Busan \| N/A \| South Korea \| 129.03004 \| 35.10168 Incheon \| N/A \| South Korea \| 126.70515 \| 37.45646 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 Barakaldo \| N/A \| Spain \| -2.98813 \| 43.29639 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 L'Hospitalet de Llobregat \| N/A \| Spain \| 2.10028 \| 41.35967 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Málaga \| N/A \| Spain \| -4.42034 \| 36.72016 Oviedo \| N/A \| Spain \| -5.84476 \| 43.36029 Seville \| N/A \| Spain \| -5.97317 \| 37.38283 Valencia \| N/A \| Spain \| -0.37966 \| 39.47391 Valencia \| N/A \| Spain \| -0.37966 \| 39.47391 Valladolid \| N/A \| Spain \| -4.72372 \| 41.65518 Douliu \| N/A \| Taiwan \| 120.54333 \| 23.70944 Kaohsiung City \| N/A \| Taiwan \| 120.31333 \| 22.61626 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	288	NCT00678587	6TERMINATED	2009-10-01	2008-06-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 4 ]	45	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The primary objective of this open-label, flexible dose study is to assess the safety and efficacy of pramipexole over a 24-week period in children and adolescents (age 6-17 years inclusive) diagnosed with Tourette Syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria and who have completed either Study 248.641 (NCT 00681863) or 248.644 (NCT 00558467).	null	Tourette Syndrome		null	5	arm 1: all patients to receive one tablet of pramipexole 0.0625 mg BID for first 4 weeks (flexible dosing for all other arms) arm 2: patients to receive one tablet of pramipexole 0.0625 mg QD arm 3: patients to receive one tablet of pramipexole 0.125 mg BID arm 4: patients to receive one tablet of pramipexole 0.125 mg TID arm 5: patients to receive one tablet of pramipexole 0.25 mg BID	[ 1, 1, 1, 1, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: titrated dose for those patients whose symptoms were not controlled on the 0.0625 mg BID dose intervention 2: dose down titrated for those patients unable to tolerate the 0.0625 mg BID dosing intervention 3: titrated up for those patients whose symptoms were not adequately controlled on 0.125 mg BID dose intervention 4: titrated for those patients whose symptoms were not adequately controlled on 0.125 mg TID dose intervention 5: 0.0625 mg BID given for first 4 wks of treatment	intervention 1: pramipexole 0.125 mg BID intervention 2: pramipexole 0.0625 mg QD intervention 3: pramipexole 0.125 mg TID intervention 4: pramipexole 0.25 mg BID intervention 5: pramipexole 0.0625 mg BID	14	Bradenton \| Florida \| United States \| -82.57482 \| 27.49893 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Columbus \| Georgia \| United States \| -84.98771 \| 32.46098 Cambridge \| Massachusetts \| United States \| -71.10561 \| 42.3751 Manhasset \| New York \| United States \| -73.69957 \| 40.79788 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 Orangeburg \| New York \| United States \| -73.94958 \| 41.04649 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Ulm \| N/A \| Germany \| 9.99155 \| 48.39841	45	NCT00681863	6TERMINATED	2009-10-01	2008-05-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 4 ]	508	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of Study TOC110977 is to demonstrate clinical superiority of Retapamulin ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions, which includes secondarily-infected lacerations, abrasions and sutured wounds. Subjects 2 months of age and older will be treated with topical retapamulin or placebo ointment twice daily for 5 days. The primary endpoint of this study is the clinical response at follow-up (Day 12-14; 7-9 days after the end of therapy) in the intent-to-treat clinical population.	This is a prospective, multicenter, double-blind, placebo-controlled parallel group study in subjects aged 2 months and older with SITL, including secondarily-infected lacerations, sutured wounds or abrasions. A laceration or sutured wound cannot exceed 10 cm in length with surrounding erythema not extending more than 2 cm from the edge of the lesion. Abrasions cannot exceed 100 cm2 in total area, or up to a maximum of 2% total body surface area for subjects \<18 years of age, with surrounding erythema not extending more than 2 cm from the edge of the abrasion. There are four study visits occurring over a 12-14 day period. At the Baseline visit (Visit 1, Day 1), subjects will be randomized to receive retapamulin or placebo ointment in a 2:1 (retapamulin:placebo) ratio. The 2:1 randomization is included to minimize the number of subjects exposed to treatment with placebo. Both active treatment and placebo will be dosed topically twice daily (BID) for 5 days. All subjects will receive a telephone call from the investigator or appropriate designee appointed by the investigator on Day 2. The subject will be interviewed to determine if there is any evidence of worsening infection. Subjects who are thought to be worsening will be instructed to come in to the clinic for an assessment. Subjects will be monitored and clinically evaluated at the On-therapy (Days 3-4), End of Therapy (Days 7-9), and Follow-up (Days 12-14) visits. Randomization will be center-based and performed using an appropriate Interactive Voice Response System (IVRS), an automated telephone system. The block size will remain confidential. Subjects are considered to have completed the study if they meet all inclusion/exclusion criteria, are considered compliant with study medication, and attend all study visits as defined by the protocol.	Skin Infections, Bacterial	infection retapamulin secondarily-infected traumatic lesions placebo	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps. intervention 2: Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps.	intervention 1: Retapamulin Ointment, 1% intervention 2: Placebo ointment	54	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Fresno \| California \| United States \| -119.77237 \| 36.74773 Irvine \| California \| United States \| -117.82311 \| 33.66946 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Sacramento \| California \| United States \| -121.4944 \| 38.58157 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Deerfield Beach \| Florida \| United States \| -80.09977 \| 26.31841 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Panama City \| Florida \| United States \| -85.65983 \| 30.15946 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Vero Beach \| Florida \| United States \| -80.39727 \| 27.63864 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Arlington Heights \| Illinois \| United States \| -87.98063 \| 42.08836 Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Butte \| Montana \| United States \| -112.53474 \| 46.00382 Teaneck \| New Jersey \| United States \| -74.01597 \| 40.8976 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 East Syracuse \| New York \| United States \| -76.07853 \| 43.06534 Johnson City \| New York \| United States \| -75.95881 \| 42.11563 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Norristown \| Pennsylvania \| United States \| -75.3399 \| 40.1215 Uniontown \| Pennsylvania \| United States \| -79.71643 \| 39.90008 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Bountiful \| Utah \| United States \| -111.88077 \| 40.88939 Vienna \| Virginia \| United States \| -77.26526 \| 38.90122 Buenos Aires \| Buenos Aires \| Argentina \| N/A \| N/A Chivilocoy \| Buenos Aires \| Argentina \| N/A \| N/A Loma Hermosa \| Buenos Aires \| Argentina \| -58.60214 \| -34.56867 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Curitiba \| Paraná \| Brazil \| -49.27306 \| -25.42778 Curitiba/Paraná \| Paraná \| Brazil \| N/A \| N/A Passo Fundo \| Rio Grande do Sul \| Brazil \| -52.40667 \| -28.26278 Bangalore \| N/A \| India \| 77.59369 \| 12.97194 Lucknow \| N/A \| India \| 80.92313 \| 26.83928 Pune \| N/A \| India \| 73.85535 \| 18.51957 Vadodara \| N/A \| India \| 73.20812 \| 22.29941 Wardha \| N/A \| India \| 78.59784 \| 20.73933 Belville \| N/A \| South Africa \| 18.63486 \| -33.89404 Benoni \| N/A \| South Africa \| 28.32078 \| -26.18848 Cape Town \| N/A \| South Africa \| 18.42322 \| -33.92584 Cape Town \| N/A \| South Africa \| 18.42322 \| -33.92584 Hatfield \| N/A \| South Africa \| 28.24314 \| -25.74973 Lynnwood \| N/A \| South Africa \| 28.26506 \| -25.75974 Midrand \| N/A \| South Africa \| 28.118 \| -25.976 Newton \| N/A \| South Africa \| N/A \| N/A Welkom \| N/A \| South Africa \| 26.73506 \| -27.97742 Worcester \| N/A \| South Africa \| 19.44852 \| -33.64651	507	NCT00684177	1COMPLETED	2009-10-01	2008-05-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 5 ]	61	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	The primary objective of this study is to investigate potential differences between four treatment intervention groups in the adherence to treatment with Differin® Gel, 0.1%. Differin is approved by the Food and Drug Administration (FDA) to treat acne.	Subjects will be enrolled and randomized in a 1:1:1:1 ratio to one of four treatment intervention groups. All Subjects will be treated once-daily for 12 weeks with Differin® Gel, 0.1%. The four intervention groups were designated according to follow-up strategies as follows: * More frequent than normal office visits * Electronic reminders (voice, e-mail, text messages) * Parental involvement/intervention reminders * No intervention or reminders	Acne Vulgaris		null	4	arm 1: This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12. arm 2: This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12. arm 3: In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12. arm 4: This group is considered to be the "standard of care" arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits.	[ 0, 0, 0, 0 ]	5	[ 0, 5, 5, 5, 5 ]	intervention 1: All Subjects will treat the face once daily in the evening. intervention 2: This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12. intervention 3: This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12. intervention 4: In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12. intervention 5: This group is considered to be the "standard of care" arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits.	intervention 1: Adapalene intervention 2: frequent visits intervention 3: electronic reminder intervention 4: Parent reminder intervention 5: Standard of care	1	Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986	61	NCT00696449	1COMPLETED	2009-10-01	2006-06-01	Wake Forest University	7OTHER	false	false	false	null	0
[ 4 ]	568	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients with inadequate glycaemic control with diet and exercise.	null	Type 2 Diabetes	DPP-4 inhibitors HBA1c Incretins	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 5mg, oral tablet, once daily for 24 weeks intervention 2: oral tablet, once daily for 24 weeks	intervention 1: Saxagliptin intervention 2: Placebo	30	Hefei \| Anhui \| China \| 117.28083 \| 31.86389 Beijing \| China \| China \| 116.39723 \| 39.9075 Chongqing \| China \| China \| 106.55771 \| 29.56026 Fuzhou \| Fujian \| China \| 119.30611 \| 26.06139 Guangzhou \| Guangdong \| China \| 113.25 \| 23.11667 Shijiazhuang \| Hebei \| China \| 114.47861 \| 38.04139 Changsha \| Hunan \| China \| 112.97087 \| 28.19874 Nanjing \| Jiangsu \| China \| 118.77778 \| 32.06167 Changchun \| Jilin \| China \| 125.32278 \| 43.88 Dalian \| Liaoning \| China \| 121.60222 \| 38.91222 Shenyang \| Liaoning \| China \| 123.43278 \| 41.79222 Shanghai \| Shanghai Municipality \| China \| 121.45806 \| 31.22222 Chengdu \| Sichuan \| China \| 104.06667 \| 30.66667 Hangzhou \| Zhejiang \| China \| 120.16142 \| 30.29365 Tianjin \| N/A \| China \| 117.17667 \| 39.14222 Hyderabaad \| Andhra Pradesh \| India \| N/A \| N/A Bangalore \| Karnataka \| India \| 77.59369 \| 12.97194 Mangalore \| Karnataka \| India \| 74.85603 \| 12.91723 Mumbai \| Maharashtra \| India \| 72.88261 \| 19.07283 Nagpur \| Maharashtra \| India \| 79.08491 \| 21.14631 Pune \| Maharashtra \| India \| 73.85535 \| 18.51957 Coimbatore \| N/A \| India \| 76.96612 \| 11.00555 Cebu City \| N/A \| Philippines \| 123.89071 \| 10.31672 Makati City \| N/A \| Philippines \| 121.03269 \| 14.55027 Manila \| N/A \| Philippines \| 120.9822 \| 14.6042 Marikina City \| N/A \| Philippines \| 121.1133 \| 14.6481 Quezon City \| N/A \| Philippines \| 121.0509 \| 14.6488 Jeonju \| Jeollabuk-do \| South Korea \| 127.14889 \| 35.82194 Daegu \| N/A \| South Korea \| 128.59111 \| 35.87028 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	568	NCT00698932	1COMPLETED	2009-10-01	2008-06-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 3 ]	405	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.	null	Acute, Uncomplicated Human Influenza		null	2	arm 1: 600 mg peramivir administered as bilateral 2-mL intramuscular injection. arm 2: Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 600 mg peramivir administered as bilateral 2-mL intramuscular injection intervention 2: Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.	intervention 1: Peramivir intervention 2: Placebo	123	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Jonesboro \| Arkansas \| United States \| -90.70428 \| 35.8423 Jonesboro \| Arkansas \| United States \| -90.70428 \| 35.8423 Mountain Home \| Arkansas \| United States \| -92.38516 \| 36.33534 Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 Carmichael \| California \| United States \| -121.32828 \| 38.61713 Paramount \| California \| United States \| -118.15979 \| 33.88946 San Luis Obispo \| California \| United States \| -120.65962 \| 35.28275 Boulder \| Colorado \| United States \| -105.27055 \| 40.01499 Centennial \| Colorado \| United States \| -104.87692 \| 39.57916 Coral Gables \| Florida \| United States \| -80.26838 \| 25.72149 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 Pinellas Park \| Florida \| United States \| -82.69954 \| 27.8428 Saint Cloud \| Florida \| United States \| -81.28118 \| 28.2489 Columbus \| Georgia \| United States \| -84.98771 \| 32.46098 Savannah \| Georgia \| United States \| -81.09983 \| 32.08354 Woodstock \| Georgia \| United States \| -84.51938 \| 34.10149 Idaho Falls \| Idaho \| United States \| -112.03414 \| 43.46658 Bloomingdale \| Illinois \| United States \| -88.0809 \| 41.95753 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Dubuque \| Iowa \| United States \| -90.66457 \| 42.50056 Shawnee \| Kansas \| United States \| -94.72024 \| 39.04167 Hazard \| Kentucky \| United States \| -83.19323 \| 37.24954 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 Bangor \| Maine \| United States \| -68.77265 \| 44.79884 Clarksburg \| Maryland \| United States \| -77.27943 \| 39.23872 Brockton \| Massachusetts \| United States \| -71.01838 \| 42.08343 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Royal Oak \| Michigan \| United States \| -83.14465 \| 42.48948 Saint Claire Shores \| Michigan \| United States \| N/A \| N/A Olive Branch \| Mississippi \| United States \| -89.82953 \| 34.96176 Bozeman \| Montana \| United States \| -111.03856 \| 45.67965 Butte \| Montana \| United States \| -112.53474 \| 46.00382 Fremont \| Nebraska \| United States \| -96.49808 \| 41.43333 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Johnson City \| New York \| United States \| -75.95881 \| 42.11563 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Greensboro \| North Carolina \| United States \| -79.79198 \| 36.07264 Canfield \| Ohio \| United States \| -80.76091 \| 41.02506 Thornville \| Ohio \| United States \| -82.42015 \| 39.89645 Owasso \| Oklahoma \| United States \| -95.85471 \| 36.26954 Ashland \| Oregon \| United States \| -122.70948 \| 42.19458 Souderton \| Pennsylvania \| United States \| -75.32518 \| 40.31177 Cranston \| Rhode Island \| United States \| -71.43728 \| 41.77982 Cumberland \| Rhode Island \| United States \| -71.43284 \| 41.96677 Johnston \| Rhode Island \| United States \| -71.50675 \| 41.82186 Warwick \| Rhode Island \| United States \| -71.41617 \| 41.7001 Simpsonville \| South Carolina \| United States \| -82.25428 \| 34.73706 Rapid City \| South Dakota \| United States \| -103.23101 \| 44.08054 Bristol \| Tennessee \| United States \| -82.18874 \| 36.59511 Bryan \| Texas \| United States \| -96.36996 \| 30.67436 Corpus Christi \| Texas \| United States \| -97.39638 \| 27.80058 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Garland \| Texas \| United States \| -96.63888 \| 32.91262 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Tomball \| Texas \| United States \| -95.61605 \| 30.09716 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Bellevue \| Washington \| United States \| -122.20068 \| 47.61038 Oregon \| Wisconsin \| United States \| -89.38456 \| 42.92611 Blacktown \| New South Wales \| Australia \| 150.91667 \| -33.76667 Darlinghurst \| New South Wales \| Australia \| 151.21925 \| -33.87939 Hurtsville \| New South Wales \| Australia \| N/A \| N/A Umina \| New South Wales \| Australia \| N/A \| N/A Auchenflower \| Queensland \| Australia \| 152.99213 \| -27.47443 Caboolture \| Queensland \| Australia \| 152.9511 \| -27.08465 Kpparing \| Queensland \| Australia \| N/A \| N/A Carlton \| Victoria \| Australia \| 144.96667 \| -37.8 Adelaide \| N/A \| Australia \| 138.59863 \| -34.92866 Brisbane \| N/A \| Australia \| 153.02809 \| -27.46794 Burwood \| N/A \| Australia \| 151.1 \| -33.88333 Darlinghurst \| N/A \| Australia \| 151.21925 \| -33.87939 Melbourne \| N/A \| Australia \| 144.96332 \| -37.814 Nedlands \| N/A \| Australia \| 115.8073 \| -31.98184 Sydney \| N/A \| Australia \| 151.20732 \| -33.86785 Christchurch \| Christchurch \| New Zealand \| 172.63333 \| -43.53333 Rotorua \| Rotorua \| New Zealand \| 176.24516 \| -38.13874 Auckland \| N/A \| New Zealand \| 174.76349 \| -36.84853 Christchurch \| N/A \| New Zealand \| 172.63333 \| -43.53333 Dunedin \| N/A \| New Zealand \| 170.50361 \| -45.87416 Rotorua \| N/A \| New Zealand \| 176.24516 \| -38.13874 Rotorua \| N/A \| New Zealand \| 176.24516 \| -38.13874 Bloemfontein \| Bloemfontein \| South Africa \| 26.214 \| -29.12107 Goodwood \| Capetown \| South Africa \| 24.25963 \| -26.4533 Greenbury \| Durban \| South Africa \| N/A \| N/A Silverglen \| Durban \| South Africa \| N/A \| N/A Bloemfontein \| Free State \| South Africa \| 26.214 \| -29.12107 Reigerpark \| Gauteg \| South Africa \| N/A \| N/A Bryanston \| Gauteng \| South Africa \| 28.02805 \| -26.05211 Klipspruit West \| Gauteng \| South Africa \| N/A \| N/A Noordheuwel \| Krugersdorp \| South Africa \| 27.79223 \| -26.08639 Verulam \| KwaZulu-Natal \| South Africa \| 31.04709 \| -29.6434 Durban \| KZ-Natal \| South Africa \| 31.0292 \| -29.8579 Kempton Park \| Pretoria \| South Africa \| 28.2377 \| -26.10859 Sunnyside Pretoria \| Pretoria \| South Africa \| N/A \| N/A Cape Town \| W. Cape \| South Africa \| 18.42322 \| -33.92584 Cape Town \| W. Cape \| South Africa \| 18.42322 \| -33.92584 Worcester \| W. Cape \| South Africa \| 19.44852 \| -33.64651 Benoni \| N/A \| South Africa \| 28.32078 \| -26.18848 Brits \| N/A \| South Africa \| 27.78022 \| -25.63473 Cape Town \| N/A \| South Africa \| 18.42322 \| -33.92584 Cape Town \| N/A \| South Africa \| 18.42322 \| -33.92584 Durban \| N/A \| South Africa \| 31.0292 \| -29.8579 Durban \| N/A \| South Africa \| 31.0292 \| -29.8579 eManzimtoti \| N/A \| South Africa \| 30.88527 \| -30.05219 Johannesburg \| N/A \| South Africa \| 28.04363 \| -26.20227 Johannesburg \| N/A \| South Africa \| 28.04363 \| -26.20227 Port Elizabeth \| N/A \| South Africa \| 25.61494 \| -33.96109 Pretoria \| N/A \| South Africa \| 28.18783 \| -25.74486 Pretoria \| N/A \| South Africa \| 28.18783 \| -25.74486 Pretoria \| N/A \| South Africa \| 28.18783 \| -25.74486 Pretoria \| N/A \| South Africa \| 28.18783 \| -25.74486 Roodepoort \| N/A \| South Africa \| 27.8725 \| -26.1625 Scottburgh \| N/A \| South Africa \| 30.75316 \| -30.28666 Soweto \| N/A \| South Africa \| 27.85849 \| -26.26781 Worcester \| N/A \| South Africa \| 19.44852 \| -33.64651	402	NCT00705406	1COMPLETED	2009-10-01	2008-07-01	BioCryst Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 5 ]	40	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive Sleep Apnea/Hypopnea Syndrome) who have residual sleepiness despite receiving nCPAP therapy.	null	Excessive Sleepiness		null	2	arm 1: Armodafinil treatment (200 mg/day) - Study drug was supplied as 50 mg tablets and the dose was titrated from a starting dose of 50 mg taken once daily in the morning (before 0800), increasing to 100 mg/day on Day 2, 150 mg/day on day 5, and then 200 mg/day beginning Day 8 and continuing through the end of the two week double-blind treatment period. arm 2: Placebo comparator - Placebo tablets matching the armodafinil 50 mg tablets drug were supplied and the dose was titrated from a starting dose of one tablet taken once daily in the morning (before 0800), increasing to two tablets/day on Day 2, three tablets/day on day 5, and then four tablets/day beginning Day 8 and continuing through the end of the two week double-blind treatment period.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Armodafinil once-daily (50 mg/day (1 tablet) on Day 1; increased to 100 mg/day (2 tablets) starting on Day 2; increased to 150 mg/day (3 tablets) starting on Day 5; increased to 200 mg/day (4 tablets) starting on Day 8). Then continue 200 mg/day dosage through Day 14. intervention 2: Matching Placebo dosed once-daily (50 mg/day (1 tablet) on Day 1; increased to 100 mg/day (2 tablets) starting on Day 2; increased to 150 mg/day (3 tablets) starting on Day 5; increased to 200 mg/day (4 tablets) starting on Day 8). Then continue 200 mg/day dosage through Day 14.	intervention 1: Armodafinil intervention 2: Placebo	9	Burlingame \| California \| United States \| -122.36608 \| 37.5841 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 Stanford \| California \| United States \| -122.16608 \| 37.42411 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Newton \| Massachusetts \| United States \| -71.20922 \| 42.33704 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721	40	NCT00711516	1COMPLETED	2009-10-01	2008-09-01	Cephalon	4INDUSTRY	false	false	false	null	0
[ 0 ]	4	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	true	This pilot study will help us to determine the success of using a special technique called microarray technology to examine cancer genes in order to predict how individual women will respond to one of two therapies, liposomal doxorubicin or topotecan, and which will be more effective in treating ovarian cancer that has returned (recurrent ovarian cancer). We believe that this study may lead to a means by which microarray technology can predict the most effective treatment decision, based on the genetic characteristics of her tumor tissue, for a woman with recurrent ovarian cancer. Another purpose of this study is to determine how quickly a woman with recurrent ovarian cancer will respond to treatment (treatment response rate) and to evaluate the accuracy of the genomic predictions. Recent data suggest that microarray technology can predict a patient's response to chemotherapy; this has not yet been proven in a forward-looking study which is why we are conducting this research.	Patients who take part in the study will have an initial visit and undergo a CT guided core biopsy. Using tissue from a CT guided core biopsy, microarray analysis will be performed to help predict which of the two drugs appears to be better suited to individual genomic factors. The results will result in being assigned to treatment with either liposomal doxorubicin or topotecan. Patients who receive liposomal doxorubicin - IV chemotherapeutic treatment will occur 3 times, 28 days apart, weeks 1,5,and 9. At each of these visits patients will be evaluated and have blood work to check their liver tests and electrolytes. Every 8 weeks patients will have a radiologic evaluation of their tumor. Patients who receive topotecan - IV chemotherapeutic treatment will occur 4 times, 21 days apart, weeks 1,4,7, and 10. At each of these visits patients will be evaluated and have blood work to check levels of liver tests and electrolytes. Every 8 weeks patients will have a radiologic evaluation of their tumor.	Ovarian Cancer	Persistent Ovarian Cancer Genomic directed salvage chemotherapy Genomic Microarray	null	2	arm 1: Liposomal Doxorubicin - Chemotherapy single agent systemic. arm 2: Topotecan - Chemotherapy single agent systemic.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Liposomal Doxorubicin 40 mg/m2 q 28 days intervention 2: 1. Topotecan (daily x 5 days of a 21 day cycle) 2. Per amendment #15: Topotecan (days 1, 8, 15 of a 28 day cycle)	intervention 1: Liposomal Doxorubicin intervention 2: Topotecan	1	Tampa \| Florida \| United States \| -82.45843 \| 27.94752	4	NCT00720096	6TERMINATED	2009-10-01	2008-07-01	H. Lee Moffitt Cancer Center and Research Institute	7OTHER	false	false	false	null	0
[ 5 ]	83	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione \[TZD\]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.	null	Type 2 Diabetes Mellitus	diabetes exenatide sitagliptin Amylin Lilly metformin thiazolidinedione	null	2	arm 1: None arm 2: None	[ 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: subcutaneous injection (5mcg or 10mcg), twice a day intervention 2: oral administration (100mg), once a day in the morning intervention 3: subcutaneous injection (5mcg or 10mcg), twice a day intervention 4: oral administration (100mg), once a day in the morning	intervention 1: exenatide intervention 2: sitagliptin intervention 3: placebo intervention 4: placebo	1	San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	146	NCT00729326	1COMPLETED	2009-10-01	2008-08-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 4 ]	643	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each dosing group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder.	null	Chronic Constipation		null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Oral, once daily intervention 2: Oral, once daily	intervention 1: Matching Placebo intervention 2: Linaclotide	105	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tuscon \| Arizona \| United States \| N/A \| N/A Sherwood \| Arkansas \| United States \| -92.22432 \| 34.81509 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Chula Vista \| California \| United States \| -117.0842 \| 32.64005 Encinitas \| California \| United States \| -117.29198 \| 33.03699 Garden Grove \| California \| United States \| -117.94145 \| 33.77391 Laguna Hills \| California \| United States \| -117.71283 \| 33.61252 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Orange \| California \| United States \| -117.85311 \| 33.78779 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Carlos \| California \| United States \| -122.26052 \| 37.50716 San Diego \| California \| United States \| -117.16472 \| 32.71571 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 Bristol \| Connecticut \| United States \| -72.94927 \| 41.67176 Boynton Beach \| Florida \| United States \| -80.06643 \| 26.52535 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 Inverness \| Florida \| United States \| -82.33037 \| 28.83582 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Port Orange \| Florida \| United States \| -80.99561 \| 29.13832 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Newnan \| Georgia \| United States \| -84.79966 \| 33.38067 Peoria \| Illinois \| United States \| -89.58899 \| 40.69365 Anderson \| Indiana \| United States \| -85.68025 \| 40.10532 Clive \| Iowa \| United States \| -93.72411 \| 41.60304 Davenport \| Iowa \| United States \| -90.57764 \| 41.52364 Mission \| Kansas \| United States \| -94.65579 \| 39.02778 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Topeka \| Kansas \| United States \| -95.67804 \| 39.04833 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 Monroe \| Louisiana \| United States \| -92.1193 \| 32.50931 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Annapolis \| Maryland \| United States \| -76.49184 \| 38.97859 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Hollywood \| Maryland \| United States \| -76.5858 \| 39.07511 Laurel \| Maryland \| United States \| -76.84831 \| 39.09928 Chesterfield \| Michigan \| United States \| -82.84242 \| 42.66281 Traverse City \| Michigan \| United States \| -85.62063 \| 44.76306 Troy \| Michigan \| United States \| -83.14993 \| 42.60559 Jackson \| Mississippi \| United States \| -90.18481 \| 32.29876 Tupelo \| Mississippi \| United States \| -88.70464 \| 34.25807 Jefferson City \| Missouri \| United States \| -92.17352 \| 38.5767 Henderson \| Nevada \| United States \| -114.98194 \| 36.0397 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Cedar Knolls \| New Jersey \| United States \| -74.44876 \| 40.82204 Marlton \| New Jersey \| United States \| -74.92183 \| 39.89122 Ocean City \| New Jersey \| United States \| -74.5746 \| 39.27762 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Mineola \| New York \| United States \| -73.64068 \| 40.74927 Pittsford \| New York \| United States \| -77.515 \| 43.09062 Asheboro \| North Carolina \| United States \| -79.81364 \| 35.70791 Asheville \| North Carolina \| United States \| -82.55402 \| 35.60095 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Greensboro \| North Carolina \| United States \| -79.79198 \| 36.07264 Harrisburg \| North Carolina \| United States \| -80.65784 \| 35.32395 Hickory \| North Carolina \| United States \| -81.3412 \| 35.73319 Jacksonville \| North Carolina \| United States \| -77.43024 \| 34.75405 New Bern \| North Carolina \| United States \| -77.04411 \| 35.10849 Statesville \| North Carolina \| United States \| -80.8873 \| 35.78264 Summerville \| North Carolina \| United States \| N/A \| N/A Wilmington \| North Carolina \| United States \| -77.94604 \| 34.23556 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Beachwood \| Ohio \| United States \| -81.50873 \| 41.4645 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Sylvania \| Ohio \| United States \| -83.71299 \| 41.71894 Wadsworth \| Ohio \| United States \| -81.72985 \| 41.02561 Zanesville \| Ohio \| United States \| -82.01319 \| 39.94035 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Yukon \| Oklahoma \| United States \| -97.76254 \| 35.50672 Lancaster \| Pennsylvania \| United States \| -76.30551 \| 40.03788 Lancaster \| Pennsylvania \| United States \| -76.30551 \| 40.03788 Levittown \| Pennsylvania \| United States \| -74.82877 \| 40.15511 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Sellersville \| Pennsylvania \| United States \| -75.3049 \| 40.35399 Anderson \| South Carolina \| United States \| -82.65013 \| 34.50344 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Simpsonville \| South Carolina \| United States \| -82.25428 \| 34.73706 Bristol \| Tennessee \| United States \| -82.18874 \| 36.59511 Chattanooga \| Tennessee \| United States \| -85.30968 \| 35.04563 Germantown \| Tennessee \| United States \| -89.81009 \| 35.08676 Kingsport \| Tennessee \| United States \| -82.56182 \| 36.54843 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Beaumont \| Texas \| United States \| -94.10185 \| 30.08605 El Paso \| Texas \| United States \| -106.48693 \| 31.75872 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Irving \| Texas \| United States \| -96.94889 \| 32.81402 Longview \| Texas \| United States \| -94.74049 \| 32.5007 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Ogden \| Utah \| United States \| -111.97383 \| 41.223 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Chesapeake \| Virginia \| United States \| -76.27494 \| 36.81904 Lynchburg \| Virginia \| United States \| -79.14225 \| 37.41375 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Vancouver \| Washington \| United States \| -122.66149 \| 45.63873 La Crosse \| Wisconsin \| United States \| -91.23958 \| 43.80136 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389	1,181	NCT00730015	1COMPLETED	2009-10-01	2008-08-01	Ironwood Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	1,039	NA	SINGLE_GROUP	null	0NONE	false	0ALL	true	This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.	null	Echocardiography	Surveillance Optison Perflutren Echocardiography Subjects receive Optison during enhanced echocardiography	null	1	arm 1: Open Label	[ 5 ]	1	[ 0 ]	intervention 1: The recommended dose of Optison is 0.5mL injected into a peripheral vein. This may be repeated for further contrast enhancement as needed. The injection rate should not exceed 1mL per second. Follow the Optison injection with a flush of 0.9% sodium chloride injection, USP or 5% dextrose in water injection, United States Pharmacopeia (USP) . The maximum total dose should not exceed 5.0mL in any 10 minutes period. The maximum total dose should not exceed 8.7mL in any one patient study.	intervention 1: Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)	1	Princeton \| New Jersey \| United States \| -74.65905 \| 40.34872	1,039	NCT00730964	1COMPLETED	2009-10-01	2008-05-01	GE Healthcare	4INDUSTRY	false	false	false	null	0
[ 5 ]	189	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.	null	Anemia		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: iv 0.6 micrograms/kg every 2 weeks	intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]	16	Ahmedabad \| N/A \| India \| 72.58727 \| 23.02579 Bangalore \| N/A \| India \| 77.59369 \| 12.97194 Chennai \| N/A \| India \| 80.27847 \| 13.08784 Coimbatore \| N/A \| India \| 76.96612 \| 11.00555 Gujarat \| N/A \| India \| N/A \| N/A Hyderabad \| N/A \| India \| 78.45636 \| 17.38405 Kerala \| N/A \| India \| N/A \| N/A Kolkata \| N/A \| India \| 88.36304 \| 22.56263 Ludhiana \| N/A \| India \| 75.85379 \| 30.91204 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 New Delhi \| N/A \| India \| 77.2148 \| 28.62137 New Delhi \| N/A \| India \| 77.2148 \| 28.62137 New Delhi \| N/A \| India \| 77.2148 \| 28.62137 Vellore \| N/A \| India \| 79.13255 \| 12.9184 Vishakpatnam \| N/A \| India \| N/A \| N/A	189	NCT00737711	1COMPLETED	2009-10-01	2008-07-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 5 ]	150	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	2MALE	false	This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. This study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re nata)	null	Erectile Dysfunction Metabolic Syndrome	Vardenafil Erectile Dysfunction Double-blind study	null	2	arm 1: Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks arm 2: Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks intervention 2: Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks	intervention 1: Vardenafil (Levitra, BAY38-9456) intervention 2: Placebo	19	Cham \| Bavaria \| Germany \| 12.65501 \| 49.22565 Regensburg \| Bavaria \| Germany \| 12.10161 \| 49.01513 Hamburg \| City state of Hamburg \| Germany \| 9.99302 \| 53.55073 Frankfurt am Main \| Hesse \| Germany \| 8.68417 \| 50.11552 Marburg \| Hesse \| Germany \| 8.77069 \| 50.80904 Stuhr \| Lower Saxony \| Germany \| 8.75 \| 53.03333 Bonn \| North Rhine-Westphalia \| Germany \| 7.09549 \| 50.73438 Grevenbroich \| North Rhine-Westphalia \| Germany \| 6.5827 \| 51.09102 Leverkusen \| North Rhine-Westphalia \| Germany \| 6.98432 \| 51.0303 Mülheim \| North Rhine-Westphalia \| Germany \| 6.87967 \| 51.43218 Wuppertal \| North Rhine-Westphalia \| Germany \| 7.14816 \| 51.25627 Dierdorf \| Rhineland-Palatinate \| Germany \| 7.65271 \| 50.54647 Koblenz \| Rhineland-Palatinate \| Germany \| 7.57883 \| 50.35357 Trier \| Rhineland-Palatinate \| Germany \| 6.63935 \| 49.75565 Homburg \| Saarland \| Germany \| 7.33867 \| 49.32637 Dresden \| Saxony \| Germany \| 13.73832 \| 51.05089 Leipzig \| Saxony \| Germany \| 12.37129 \| 51.33962 Berlin \| State of Berlin \| Germany \| 13.41053 \| 52.52437 Berlin \| State of Berlin \| Germany \| 13.41053 \| 52.52437	147	NCT00738400	1COMPLETED	2009-10-01	2008-11-01	Bayer	4INDUSTRY	false	false	false	null	0
[ 3 ]	153	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	2MALE	false	The primary objective is to compare the efficacy of silodosin 4 and 8 mg once daily with placebo in the treatment of subjects with moderate to severe abacterial chronic prostatitis/chronic pelvic pain syndrome during a 12 week treatment period. The secondary objective is to compare the safety of silodosin 4 and 8 mg once daily with placebo.	A Multi-Center, Double-Blind, Placebo-Controlled Investigation of Silodosin in the Treatment of Subjects With Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.	Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome	prostatitis, chronic pelvic pain	null	3	arm 1: 4 mg daily arm 2: Silodosin 8 mg daily arm 3: 1 placebo capsule daily	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Silodosin 8 mg daily intervention 2: Placebo intervention 3: Silodosin 4 mg daily	intervention 1: Silodosin 8 mg intervention 2: Placebo intervention 3: Silodosin 4 mg	22	San Diego \| California \| United States \| -117.16472 \| 32.71571 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Columbus \| Georgia \| United States \| -84.98771 \| 32.46098 Roswell \| Georgia \| United States \| -84.36159 \| 34.02316 Jeffersonville \| Indiana \| United States \| -85.73718 \| 38.27757 West Des Moines \| Iowa \| United States \| -93.71133 \| 41.57721 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Watertown \| Massachusetts \| United States \| -71.18283 \| 42.37093 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Voorhees Township \| New Jersey \| United States \| -74.49062 \| 40.4795 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Garden City \| New York \| United States \| -73.6343 \| 40.72677 Kingston \| New York \| United States \| -73.99736 \| 41.92704 New York \| New York \| United States \| -74.00597 \| 40.71427 Poughkeepsie \| New York \| United States \| -73.92097 \| 41.70037 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Bethany \| Oklahoma \| United States \| -97.63226 \| 35.51867 Edmond \| Oklahoma \| United States \| -97.4781 \| 35.65283 State College \| Pennsylvania \| United States \| -77.86 \| 40.79339 Mountlake Terrace \| Washington \| United States \| -122.30874 \| 47.78815 Spokane \| Washington \| United States \| -117.42908 \| 47.65966	151	NCT00740779	1COMPLETED	2009-10-01	2008-09-01	Watson Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	495	null	PARALLEL	0TREATMENT	null	false	0ALL	null	The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.	null	Diabetes Mellitus, Type 2		null	0	null	null	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: BI 10773 intervention 2: placebo intervention 3: sitagliptin	116	Chula Vista \| California \| United States \| -117.0842 \| 32.64005 Mission Viejo \| California \| United States \| -117.672 \| 33.60002 Pasadena \| California \| United States \| -118.14452 \| 34.14778 Spring Valley \| California \| United States \| -116.99892 \| 32.74477 Walnut Creek \| California \| United States \| -122.06496 \| 37.90631 Clearwarter \| Florida \| United States \| N/A \| N/A Melbourne \| Florida \| United States \| -80.60811 \| 28.08363 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Saint Cloud \| Florida \| United States \| -81.28118 \| 28.2489 Roswell \| Georgia \| United States \| -84.36159 \| 34.02316 Staten Island \| New York \| United States \| -74.13986 \| 40.56233 Shelby \| North Carolina \| United States \| -81.53565 \| 35.29235 Wadsworth \| Ohio \| United States \| -81.72985 \| 41.02561 Norristown \| Pennsylvania \| United States \| -75.3399 \| 40.1215 Clemson \| South Carolina \| United States \| -82.83737 \| 34.68344 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Temple \| Texas \| United States \| -97.34278 \| 31.09823 Federal Way \| Washington \| United States \| -122.31262 \| 47.32232 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 Mar del Plata \| N/A \| Argentina \| -57.5562 \| -38.00042 Mendoza \| N/A \| Argentina \| -68.84582 \| -32.88946 Graz \| N/A \| Austria \| 15.45 \| 47.06667 Innsbruck \| N/A \| Austria \| 11.39454 \| 47.26266 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 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 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Tartu \| N/A \| Estonia \| 26.72509 \| 58.38062 Kerava \| N/A \| Finland \| 25.105 \| 60.40338 Oulu \| N/A \| Finland \| 25.46816 \| 65.01236 Tampere \| N/A \| Finland \| 23.78712 \| 61.49911 Turku \| N/A \| Finland \| 22.26869 \| 60.45148 Bondy \| N/A \| France \| 2.48931 \| 48.9018 Bondy \| N/A \| France \| 2.48931 \| 48.9018 Caen \| N/A \| France \| -0.35912 \| 49.18585 Caen \| N/A \| France \| -0.35912 \| 49.18585 Caen \| N/A \| France \| -0.35912 \| 49.18585 Corbeil-Essonnes \| N/A \| France \| 2.48757 \| 48.60603 Corbeil-Essonnes \| N/A \| France \| 2.48757 \| 48.60603 La Rochelle \| N/A \| France \| -1.15222 \| 46.16308 La Rochelle \| N/A \| France \| -1.15222 \| 46.16308 La Rochelle \| N/A \| France \| -1.15222 \| 46.16308 La Rochelle \| N/A \| France \| -1.15222 \| 46.16308 Le Grau-du-Roi \| N/A \| France \| 4.13559 \| 43.53881 Le Grau-du-Roi \| N/A \| France \| 4.13559 \| 43.53881 Nanterre \| N/A \| France \| 2.20675 \| 48.89198 Narbonne \| N/A \| France \| 3.00141 \| 43.18396 Narbonne \| N/A \| France \| 3.00141 \| 43.18396 Quimper \| N/A \| France \| -4.09795 \| 47.99597 Reims \| N/A \| France \| 4.02853 \| 49.26526 Reims \| N/A \| France \| 4.02853 \| 49.26526 Reims \| N/A \| France \| 4.02853 \| 49.26526 Saint-Mandé \| N/A \| France \| 2.41579 \| 48.83864 Saint-Mandé \| N/A \| France \| 2.41579 \| 48.83864 Saint-Mandé \| N/A \| France \| 2.41579 \| 48.83864 Saint-Mandé \| N/A \| France \| 2.41579 \| 48.83864 Valenciennes \| N/A \| France \| 3.52506 \| 50.35909 Valenciennes \| N/A \| France \| 3.52506 \| 50.35909 Valenciennes \| N/A \| France \| 3.52506 \| 50.35909 Valenciennes \| N/A \| France \| 3.52506 \| 50.35909 Erlangen \| N/A \| Germany \| 11.00783 \| 49.59099 Frankfurt \| N/A \| Germany \| 10.53333 \| 49.68333 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Rehlingen-Siersburg \| N/A \| Germany \| 6.68439 \| 49.37565 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Győr \| N/A \| Hungary \| 17.63512 \| 47.68333 Szombathely \| N/A \| Hungary \| 16.62155 \| 47.23088 Daugavpils \| N/A \| Latvia \| 26.53333 \| 55.88333 Kuldīga \| N/A \| Latvia \| 21.95721 \| 56.97399 Ogre \| N/A \| Latvia \| 24.61401 \| 56.8162 Riga \| N/A \| Latvia \| 24.10589 \| 56.946 Riga \| N/A \| Latvia \| 24.10589 \| 56.946 Talsi \| N/A \| Latvia \| 22.58137 \| 57.24562 Valmiera \| N/A \| Latvia \| 25.42751 \| 57.54108 Ålesund \| N/A \| Norway \| 6.15492 \| 62.47225 Hamar \| N/A \| Norway \| 11.06798 \| 60.7945 Oslo \| N/A \| Norway \| 10.74609 \| 59.91273 Stavanger \| N/A \| Norway \| 5.73332 \| 58.97005 Alba Iulia \| N/A \| Romania \| 23.58333 \| 46.06667 Baia Mare Maramures \| N/A \| Romania \| N/A \| N/A Brasov \| N/A \| Romania \| 25.60613 \| 45.64861 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Galati \| N/A \| Romania \| 28.05028 \| 45.43687 Satu Mare \| N/A \| Romania \| 22.86255 \| 47.79926 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saratov \| N/A \| Russia \| 46.00861 \| 51.54056 Bratislava \| N/A \| Slovakia \| 17.10674 \| 48.14816 Nitra \| N/A \| Slovakia \| 18.08453 \| 48.30763 Nitra \| N/A \| Slovakia \| 18.08453 \| 48.30763 Prešov \| N/A \| Slovakia \| 21.23393 \| 48.99839 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Girona \| N/A \| Spain \| 2.82493 \| 41.98311 L'Hospitalet de Llobregat (Barcelona) \| N/A \| Spain \| 2.10028 \| 41.35967 Málaga \| N/A \| Spain \| -4.42034 \| 36.72016 Palma (Mallorca) \| N/A \| Spain \| 2.65024 \| 39.56939 Palma de Mallorca \| N/A \| Spain \| 2.65024 \| 39.56939 Santander \| N/A \| Spain \| -3.80444 \| 43.46472 Dnipro \| N/A \| Ukraine \| 35.04066 \| 48.46664 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Vinnitsa \| N/A \| Ukraine \| 37.71861 \| 49.84639	495	NCT00749190	1COMPLETED	2009-10-01	2008-08-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 4 ]	541	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	1FEMALE	false	Depomed's Gabapentin Extended Release (G-ER) is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women.	The primary study objective is to assess the efficacy of G-ER dosed in either of the following regimens: * G-ER 1200 mg daily (single evening dose) * G-ER 1800 mg daily (dosed asymmetrically; 600 mg in AM/1200 mg in PM) compared to placebo in reducing the average daily frequency and severity score of moderate to severe hot flashes in postmenopausal women after 4 weeks and 12 weeks of treatment with a stable dose, compared with the baseline week.	Hot Flashes	Hot flashes Hot flushes Postmenopausal symptoms Vasomotor symptoms	null	3	arm 1: Gabapentin extended-release (G-ER) 1200 mg arm 2: Gabapentin extended-release (G-ER) 1800 mg arm 3: Placebo 1200 mg or 1800 mg	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: G-ER 1200 mg daily dosage given as two 600-mg tablets. intervention 2: G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening. intervention 3: Matching placebo dosages of 1200 mg daily (two 600-mg tablets) and 1800 mg daily (one 600-mg tablet in the morning and two 600-mg tablets in the evening).	intervention 1: Gabapentin Extended-Release (G-ER) 1200 mg intervention 2: Gabapentin Extended-Release (G-ER) 1800 mg intervention 3: Placebo	45	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Berkely \| California \| United States \| N/A \| N/A La Mesa \| California \| United States \| -117.02308 \| 32.76783 San Diego \| California \| United States \| -117.16472 \| 32.71571 Santa Rosa \| California \| United States \| -122.71443 \| 38.44047 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Lakewood \| Colorado \| United States \| -105.08137 \| 39.70471 Waterbury \| Connecticut \| United States \| -73.0515 \| 41.55815 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 New Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 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 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Sandy Springs \| Georgia \| United States \| -84.37854 \| 33.92427 Savannah \| Georgia \| United States \| -81.09983 \| 32.08354 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Madisonville \| Kentucky \| United States \| -87.49889 \| 37.3281 Fall River \| Massachusetts \| United States \| -71.15505 \| 41.70149 Edina \| Minnesota \| United States \| -93.34995 \| 44.88969 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Moorestown \| New Jersey \| United States \| -74.94267 \| 39.96706 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Wilmington \| North Carolina \| United States \| -77.94604 \| 34.23556 Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 West Reading \| Pennsylvania \| United States \| -75.94743 \| 40.3337 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Hilton Head Island \| South Carolina \| United States \| -80.73816 \| 32.19382 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 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 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Bellevue \| Washington \| United States \| -122.20068 \| 47.61038 Renton \| Washington \| United States \| -122.21707 \| 47.48288 Spokane \| Washington \| United States \| -117.42908 \| 47.65966	532	NCT00755417	1COMPLETED	2009-10-01	2008-09-01	Depomed	4INDUSTRY	false	false	false	null	0
[ 5 ]	39	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The overall purpose of this research is to determine if there is a relationship between your symptoms of Dementia of the Alzheimers type and changes in the size and shape of certain brain structures during combined Donepezil (Aricept®) and Memantine (Namenda®) treatment.	In this study we will be using Memantine (Namenda®) in an investigational fashion with individuals with very mild to mild dementia. Donepezil (Aricept®) is approved by the Food and Drug Administration for the treatment of Alzheimers disease. Memantine (Namenda®) is currently approved by the Food and Drug Administration for moderate and severe dementia only. This study may be instrumental in the development of a new therapy for others with similar conditions, and to determine whether Memantine (Namenda®) will be helpful to individuals with very mild to mild dementia. Specific Aim 1. To determine what neuroanatomical measures are most strongly correlated with the progression of clinical and cognitive deficits in patients with dementia of the Alzheimer type (DAT). To accomplish this aim, we will use high-resolution magnetic resonance (MR) imaging and the tools of computational anatomy to assess changes in the structure of selected subcortical (e.g., hippocampus) and cortical (e.g., parahippocampal gyrus and cingulate gyrus) structure along with clinical and cognitive measures of dementia severity in subjects with very mild-to-mild DAT. Specific Aim 2 - To determine whether cholinesterase inhibitors and memantine can slow disease progression in DAT subjects. To accomplish this aim, we will use MR imaging and the tools of computational anatomy to compare the rate of change in the neuroanatomical measures listed above in 1) untreated DAT subjects, 2) DAT subjects treated with donepezil alone, and 3) DAT subjects treated with the combination of donepezil and memantine.	Dementia	Dementia of the Alzheimer type	Prot_SAP_000.pdf: RESEARCH PROTOCOL CORTICOLIMBIC DEGENERATION AND TREATMENT OF DEMENTIA AUGUST 26, 2008 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 PRINCIPAL INVESTIGATOR John G. Csernansky, M.D. Gilman Professor and Chairman Department of Psychiatry and Behavioral Sciences Northwestern Feinberg School of Medicine 446 E. Ontario St., Suite 7-200 Chicago, Illinois 60611 Phone: (312) 926-2323 Fax: (312) 695-6276 E-mail: jgc@northwestern.edu STUDY SITES Data Collection Washington University School of Medicine Alzheimer’s Disease Research Center (ADRC) 4488 Forest Park Ave #130 St. Louis, MO 63108 Data Analysis of De-identified Data Northwestern University Department of Psychiatry and Behavioral Sciences 446 E. Ontario, Suite 7-200 Chicago, IL 60611 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 TABLE OF CONTENTS PURPOSE AND OBJECTIVES 1 BACKGROUND 2 CHOLINESTERASE INHIBITORS AS TREATMENTS FOR DAT 2 NMDA ANTAGONISTS AS TREATMENTS FOR DAT 3 NEUROANATOMICAL MEASURES AS MARKERS OF DISEASE PROGRESSION 3 CLINICAL SIGNIFICANCE OF THE PROPOSED STUDIES PRELIMINARY STUDIES 4 DISCRIMINATION OF SUBJECTS WITH VERY MILD DAT AND CONTROLS USING NEUROANATOMICAL MARKERS 4 ASSESSMENT OF DISEASE PROGRESSION USING NEUROANATOMICAL MARKERS 5 HIPPOCAMPAL SHAPE PREDICTS RESPONSE TO DONEPEZIL 6 STUDY DESIGN 7 SPECIFIC AIMS 1&2 – CORRELATIONS BETWEEN CG LEVELS AND DISEASE PROGRESSION IN DAT SUBJECTS 7 OVERALL DESIGN AND SOURCE OF SUBJECTS 7 INCLUSION CRITERIA 9 EXCLUSION CRITERIA 9 SELECTION OF INSTRUMENTS FOR CLINICAL EVALUATION 10 NEUROANATOMICAL RULES FOR BRAIN STRUCTURE BOUNDARIES 10 MR SCANNING PROTOCOLS AND IMAGE PREPROCESSING 10 LARGE DEFORMATION HIGH DIMENSIONAL BRAIN MAPPING (HDBM-LD) TO ASSESS THE VOLUME AND SHAPE OF THE HIPPOCAMUS 12 METHODS FOR LABELED CORTICAL DEPTH MAPPING (LCDM) OF THE PARAHIPPOCAMPAL AND CINGULATE GYRI 14 ASSESSMENT OF TOTAL INTRACRANIAL AND CEREBRAL VOLUMES 15 DATA ANALYSIS 15 SAMPLE SIZE AND POWER CONSIDERATIONS 16 HUMAN SUBJECTS 16 DATA MANAGEMENT 18 REFERENCES 19 1 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 PURPOSE AND OBJECTIVES Amyloid plaques, neurofibrillary tangles and other indications of neuronal degeneration in the hippocampus and cortical structures that are functionally related to it, such as the parahippocampal and cingulate gyri, are among the neuropathological hallmarks of AD (Hyman, et al, 1984 and 1987; Arnold, et al, 1991; Gomez-Isla, et al, 1996; Berg, et al, 1998). Since these corticolimbic structures have been shown in humans to play a critical role in declarative memory (Squire and Zola-Morgan, 1991), neurodegeneration within them has been hypothesized to be the basis for memory losses in patients with dementia of the Alzheimer type (DAT). Moreover, progressive structural degeneration of the hippocampus occurs in parallel with clinical worsening of the disease (Jobst, et al, 1994; Fox, et al, 1996; Jack, et al, 1998). Treatment with cholinesterase inhibitors is now considered routine for patients with very mild-to-mild DAT (Knopman and Morris, 1997; Samuels and Davis, 1998). A number of cholinesterase inhibitors (e.g., tacrine, donepezil, rivastigmine, and galantamine) are commercially available, and there is ample evidence of their capacity to ameliorate cognitive deficits associated with AD (Corey-Bloom, et al, 1998; Davis, et al, 1992; Farlow, et al, 1992; Knapp,et al, 1994; Morris, et al, 1998; Rogers, et al, 1998; Rogers and Friedhoff, 1996; Thal, et al, 1996; Wilcock and Wilkinson, 1996). However, these studies provide little evidence that cholinesterase inhibitors have the capacity to alter the progression of the disease. Recently, the first drug treatment for DAT other than a cholinesterase inhibitor was approved for use in the U.S. Memantine, a voltage dependent, uncompetitive NMDA antagonist, has also been shown to ameliorate the cognitive deficits associated with AD (Reisberg, et al, 2003), and in a trial comparing combined memantine/donepezil treatment to donepezil alone, the combination of memantine and donepezil was demonstrated to have superior efficacy (Tariot, et al, 2004). Because the mechanism of action of this drug involves modulation of the potentially excitotoxic neurotransmitter, glutamate, it has been hypothesized that this drug may slow progression of the disease process in AD (Jarvis and Figgitt, 2003). However, there is no direct evidence of memantine’s capacity to slow the progression of neurodegeneration in DAT patients. During the initial funding period of this grant, we tested the hypothesis that the volume and shape of the hippocampus could predict the outcome of treatment with donepezil in patients with very mild-to-mild DAT. The rationale for this experiment was that hippocampal neurons receive cholinergic afferent projections (Umbriaco, et al, 1995), and so became the indirect targets of cholinomimetic treatments. We now propose to extend this investigation of the relationships between neuroanatomical structure and treatment response in patients with DAT by 1) determining what neuroanatomical changes are most strongly correlated with the progression of cognitive deficits in patients with DAT (Specific Aim 1), and 2) determining whether treatment with cholinesterase inhibitors and/or adjunctive memantine can slow progression of the neuroanatomical and cognitive/behavioral changes associated with AD (Specific Aim 2). The specific aims and hypotheses of the project are as follows: Specific Aim 1: To determine what neuroanatomical measures are most strongly correlated with the progression of cognitive deficits in patients with DAT, we propose to use high resolution magnetic resonance (MR) imaging and the tools of computational anatomy to assess changes in the structure of the hippocampus, parahippocampal gyrus and cingulate gyrus in subjects with very mild-to-mild DAT over two years. During the first funding period of this project, we collected data using MR imaging and large-deformation high dimensional brain mapping (HDBM-LD) that shows that progressive hippocampal volume loss and shape change discriminates subjects with very mild DAT from nondemented controls (see Progress Report). The volume, thickness, and surface area of the parahippocampal and cingulate gyri will be assessed in the proposed work using labeled cortical depth mapping (LCDM), a new computational tool that was developed during the last funding period (see Progress Report). (Hypothesis 1: Over two years, decreases in hippocampal and cortical volumes, thinning of the cingulate and parahippocampal cortices, and changes in hippocampal shape will be correlated with the rate of cognitive decline in subjects with very mild-to-mild DAT. Moreover, in a stepwise regression 2 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 model, each of these variables will predict the rate of cognitive decline in DAT subjects independently of each other and independently of the effects of age, gender and apoE allelic status.) Specific Aim 2: To determine whether cholinesterase inhibitors and memantine can slow the progression of disease in DAT subjects, we will use HDBM-LD and LCDM to compare the rate of change in the neuroanatomical measures listed above in three groups – 1) untreated DAT subjects, 2) DAT subjects treated with donepezil alone, and 3) DAT subjects treated with the combination of donepezil and memantine. Past, present and future subjects recruited from the ADRC as well as the Memory Diagnostic Center (MDC) at Washington University will be used for this study, and the period of treatment will be two years. Due to ethical considerations (see Research Design and Methods), drug treatment will be naturalistic and open label. (Hypothesis 2: The rate of decreasing hippocampal and cortical volumes, thinning of the cingulate and parahippocampal cortices, and changing hippocampal shape will be equal in DAT subjects that are untreated and in DAT subjects that are treated with donepezil alone, but greater than the rate of volume loss, thinning and hippocampal shape change in DAT subjects that are treated with the combination of donepezil and memantine.) BACKGROUND Cholinesterase Inhibitors as Treatments for DAT Several cholinesterase inhibitors are now commercially available for the treatment of DAT, and have been shown to have at least ameliorative effects on the symptoms of DAT, including memory loss (Corey-Bloom, et al, 1998; Davis, et al. 1992; Farlow, et al, 1992; Knapp,et al, 1994; Morris, et al, 1998; Rogers, et al., 1998; Rogers and Friedhoff, 1996; Thal, et al, 1996; Wilcock and Wilkinson, 1996). Cholinergic projections from the nucleus basalis are dispersed widely throughout the brain, and include the hippocampus, parahippocampal gyrus, cingulate gyrus and other neocortical areas. However, because of the central role played by the hippocampus and structures related to it in memory (Zola-Morgan and Squire, 1993), and the high frequency with which these structures are affected early in the course of Alzheimer’s disease (Hyman, et al, 1984 and 1987; Arnold, et al, 1991; Gomez-Isla, et al, 1996; Berg, et al, 1998), these structures may be especially involved in symptom production and treatment response in subjects with DAT. The precise mechanism of action of cholinesterase inhibitors for the treatment of DAT remains under investigation. Terminals for acetylcholine are found throughout the CA1 subfield of the hippocampus (Umbriaco, et al, 1995), and studies of neurotransmitter receptors show that the hippocampus contains a variety of receptors for acetylcholine. Receptors for both muscarinic (M1) and nicotinic ACh receptors are expressed throughout the CA1 subfield of the hippocampus. In particular, M1 receptors are found on the terminals of pyramidal neurons where they suppress excitatory activity (Dutar and Nicoll, 1988; Sheridan and Sutor, 1990), and on the terminals of inhibitory/GABA interneurons where they suppress GABA release (Behrends and Ten Bruggencate, 1993). However, while acetylcholine has various sites of action within the hippocampus, the net result of these effects appears to be the excitation of hippocampal pyramidal neurons (Steckler and Sahgal, 1995). In rats, injection of the prototypical cholinesterase inhibitor, physostigmine, directly into the hippocampus reverses the memory deficits induced by scopolamine (Ohno, et al, 1996). RU47213, another cholinesterase inhibitor, similarly reverses the working memory deficits of rats in the radial arm maze induced by scopolamine (M’Harzi, et al, 1997). These studies suggest that cholinomimetic drugs are effective in reversing cognitive deficits due to experimentally-induced cholinergic deficits. Relatively few studies have addressed the question of whether treatment with cholinesterase inhibitors can slow the progression of the AD process. In many clinical studies of cholinesterase inhibitors in patients with DAT, improvements in cognition are only temporary and when declines in cognition resume, they proceed similarly in patients that have received active treatment and placebo (Burns, et al, 1999; Feldman, et al, 2001; Raskind, et al, 2000; Rogers, et al, 1998). Moreover, there is no obvious neural mechanism by which acetylcholine might exert neuroprotective effects. Instead, acetylcholine is generally considered to be an 3 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 excitatory neurotransmitter (Steckler and Sahgal, 1995), and elevations in the release of acetylcholine have even been reported to have neurotoxic effects (Kim, et al, 1999). NMDA Antagonists as Treatments for DAT Hippocampal pyramidal neurons are glutamatergic and are interconnected via a trisynaptic excitatory circuit (Wyss and van Groen, 1989). When experimentally-induced increases in the release of glutamate occur, ongoing destruction of the hippocampus can proceed through a cascade of excitotoxicity (Choi, et al, 1988; Lipton and Rosenberg, 1994). Of particular importance to the pathogenesis of AD and to the mechanism of action of memantine, Aβ may also initiate the excitotoxic cascade. For example, Harkany, et al (2000), reported that Aβ depolarizes astroglial membranes and blocks glutamate uptake by such cells. Increases in the resultant levels of glutamate then trigger neuronal damage, which is blocked by the non-competitive NMDA antagonist, MK-801. Barger and Basile (2001) have also suggested that glial cells may be a source of the glutamate released by Aβ. Excitotoxic stimulation, in turn, promotes the processing of APP so that more pathogenic forms of Aβ, such as Aβ42, accumulate (Mattson, et al, 1993). Finally, Parks, et al (2001) and Ikezu, et al (2003) have shown that the NMDA antagonist, MK-801, blocks the release of reactive oxygen species triggered by Aβ. Memantine is a voltage-dependent, uncompetitive antagonist at NMDA-type glutamate receptors that does not interfere with the physiological actions of glutamate required for learning and memory (see Kilpatrick and Tillbrook, 2002 and Jarvis and Figgitt, 2003 for review). Because of this unusual pharmacology, it is devoid of the anesthestic and psychotogenic effects that characterize non-competitive NMDA antagonists, such as phencyclidine and MK-801 (Frankiewicz, et al, 1996). Twenty years ago, memantine was observed to have alerting effects in comatose patients (Miltner, 1982), and more than 10 years ago, memantine was first investigated for use in patients with AD (Ditzler, 1991). Memantine’s hypothesized mechanism of action as an anti-dementia drug is the use-dependent (i.e., voltage-dependent) blockade of NMDA receptors that mediate excitotoxicity (Erdo and Schafer, 1991; Weller, et al, 1993) and neuronal degeneration triggered by Aβ (Miguel-Hidelgo, et al, 2002). Also, memantine increases the expression of brain-derived neuroprotective factor (BDNF) and trkB in the mammalian brain (Marvanova, et al, 2001). The efficacy of memantine in patients with DAT has been recently been demonstrated in a major multi- center study in the US (Reisberg, et al, 2003), and in the fall of 2003, memantine was approved for use in the U.S. as a treatment for DAT. Also, combination therapy of memantine and donepezil has been shown to be superior to treatment with donepezil alone (Farlow, et al, 2003; Tariot, et al, 2004). However, while reports of memantine’s efficacy have been impressive, it remains uncertain as to whether the drug can alter the progression of AD (Reisberg, et al, 2003). The potential of memantine to alter the course of AD rests on its capacity to block excitotoxicity (Jarvis and Figgitt, 2003). However, clinical trials alone cannot provide conclusive evidence of its ability to block excitotoxic neurodegeneration and so alter the underlying disease process of AD (see Areosa and Sherriff, 2003 for review). Neuroanatomical Measures as Markers of Disease Progression Substantial volume losses in medial temporal lobe brain structures, such as the hippocampus, have been reported using manual analysis of MR scans in DAT subjects (Jack, et al, 1992; Pearlson, et al, 1992; Scheltens, et al, 1992; Ikeda, et al, 1994). These studies are consistent with the results of post-mortem studies, which demonstrate substantial neuronal loss in the same brain areas (Gomez-Isla, et al, 1996). Substantial volume losses in the hippocampus and parahippocampal gyrus are seen in people with even mild DAT, and the progression of such volume losses correlates with symptomatic worsening (Jobst, et al, 1994; Fox, et al, 1996; Killiany, et al, 1993; Jack, et al, 1998; Laakso, et al, 1996; Murphy, et al, 1993; Mungas, et al, 2002; Wang, et al, 2003). In fact, progression of hippocampal volume loss over time has been suggested as a method of discriminating patients with DAT from patients with normal aging and other brain diseases (Fox, et al, 1996; 4 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 Jack, et al, 1998). However, to date, there have been no studies that have answered the question of whether drug treatment alters the progression of neuroanatomical changes in patients with DAT. Computerized methods for MR image analysis are being increasingly applied to the problem of identifying early forms of AD and other neuropsychiatric diseases (Iosifescu, et al, 1997; Thompson, et al, 1997; Ashburner, et al, 2003). We have recently completed several studies of the hippocampus using one of these methods (i.e., HDBM-LD) in subjects with very mild DAT, showing that hippocampal shape and volume can be used to discriminate DAT and control subjects (Csernansky, et al, 2000; Wang, et al, 2003) and that antemortem hippocampal volume predicted post-mortem tangle density in the hippocampus (Csernansky, et al, 2004). The results of these studies indicate that subjects with very mild DAT symptoms have highly characteristic shape deformations of the hippocampus as well as substantial hippocampal volume losses. These methods also hold promise for improving our capacity to study disease progression in DAT patients during drug treatment. In drug treatment studies, one is chiefly interested in assessing the degree of change within individuals. This problem is ideally addressed by methods that can transform one MR scan (i.e., at baseline) onto another (i.e., after drug treatment), thus quantifying subtle changes in neuroanatomical volumes and shapes. Fox and colleagues have performed a number of studies of this kind in subjects with and without DAT using a methodology called voxel compression mapping (VBM) (Fox, et al, 1996 and 2001; Fox and Freeborough, 1997; Freeborough and Fox, 1998). Also, this group has shown compelling evidence that VBM as compared to conventional manual volumetry significantly reduces the sample size required to detect the effects of drug treatment in patients with DAT (Fox, et al, 2000). During the first funding period of this project, we used HDBM-LD to compare patterns of change in hippocampal volume and shape in untreated patients with very mild DAT and non-demented controls (Wang, et al, 2003). In this study, we demonstrated that hippocampal shape change and the rate of volume loss provided complementary information for distinguishing subjects with DAT from the non-demented controls. Clinical Significance of the Proposed Studies There are two major areas of clinical significance to the proposed studies. First, the human study proposed in this application represent direct tests of the capacity of memantine and donepezil to slow the progression of DAT in patients. Second, we will be able to identify neuroanatomical measures that are most highly correlated for assessing the clinical progression of the AD process. By identifying neuroanatomical measures that are most sensitive to disease progression and to the potential effects of drug treatment, we will be identifying measures likely to be sensitive to the disease-altering effects of other therapeutic approaches to be developed in the future. PRELIMINARY STUDIES Discrimination of Subjects with Very Mild DAT and Controls Using Neuroanatomical Markers To select neuroanatomical markers optimal for tracking the progression of disease in patients with DAT, one can first determine which neuroanatomical markers discriminate patients with early forms of DAT from controls. In our first study of this kind, we compared 18 subjects with very mild DAT and 18 elderly controls matched for age and gender using measures of hippocampal volume and shape generated by HDBM-LD (Csernansky, et al, 2000). The elderly subjects were categorized as having either very mild DAT (i.e. CDR 0.5) or no dementia (i.e., CDR 0) using the Clinical Dementia Rating Scale (CDR) (Morris, 1993). MR scans from a younger control group previously recruited for a study of schizophrenia (Csernansky, et al, 1998) were included so that we could also assess the effects of aging alone on hippocampal structure. Measures of hippocampal volume and shape both discriminated the CDR 0.5 and CDR 0 subjects. There was no significant difference in hippocampal volume between the elder non-demented subjects and the younger control subjects; however, the shape of the hippocampus also discriminated these two groups. Interestingly, the patterns of hippocampal shape deformation that discriminated CDR 0.5 and CDR 0 subjects and the CDR 0 subjects from younger controls were markedly different, indicating that the neurobiological effects of early DAT and healthy aging on hippocampal structure were distinct. 5 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 Figure 1. Visualizing the pattern of hippocampal surface deformation associated with DAT. The left and right hippocampi are viewed from above and to the right of the paired structures. The structure seen represents the com- posite hippocampus of the non-demented subjects and the shading indicates the degree of displacement of the hippocam- pal surface that was present in the DAT subjects (cooler colors (e.g. blue) represent inward deformation and warmer colors represent outward deformation). Areas of blue shading indicate regions of the hippocampal surface where there is localized volume loss (i.e., inward deformation) in the DAT subjects. R L We have recently replicated the results of our first study of hippocampal structure in DAT in a larger, non- overlapping group of 46 subjects with DAT and 65 non-demented controls (Csernansky, et al, in preparation). The DAT and non-demented subjects were again matched with regard to gender (20/26 [m/f] for the DAT subjects and 19/46 [m/f] for the non-demented subjects) and age (mean (SD) 74.6 (7.9) years for the DAT subjects and 78.2 (7.7) years for the non-demented subjects). The mean (SD) sum-of-box score derived from the CDR was 4.05 (2.04) for the DAT subjects, indicating that the subjects had very mild-to-mild dementia. The non-demented subjects had a mean (SD) hippocampal volume of 2142 mm3 (344) on the left and 2588 mm3 (416) on the right, while the DAT subjects had a mean (SD) hippocampal volume of 1833 mm3 (359) on the left and 2242 mm3 (462) on the right. Analysis of variance (ANOVA) showed that the difference in hippocampal volumes between these two subject groups was highly significant (F = 21.38, df = 1,109, p < .0001). As in our first study (Csernansky, et al, 2000), the difference in hippocampal shape between the two groups was evaluated using eigenvectors derived from the HDBM-LD transformations (see Research Design and Methods for further explanation). The first 20 eigenvectors explained 87.5% of the variance in hippocampal shape, and a MANOVA using these variables revealed a significant group difference (F = 3.34, df = 20,90, p < .0001). Moreover, in a "leave-one-out" (jackknife) discriminant function analysis, 56 of the 65 non-demented subjects (86% sensitivity) and 36 of 46 DAT subjects could be correctly classified (78% specificity). In this study, the group discrimination achieved by hippo-campal shape information alone was equivalent to the discrimination achieved when both hippocampal volume and shape information was used. Not surprisingly, eigenvector 1 was correlated with both left (rho = .69, p < .0001) and right (rho = .69, p < .0001) hippocampal volumes. The pattern of hippocampal shape abnormality found in these DAT subjects (see Figure 1) was highly similar to the pattern of deformity we observed in our first study (Csernansky, et al, 2000), and again showed inward deformation of the head and lateral prominence of the hippocampus. This pattern of hippocampal deformation is highly consistent with patterns of plaque and tangle deposition in the CA1 hippocampal subfield observed in post-mortem studies of AD (Arnold, et al, 1991; Price and Morris, 1999). Assessment of Disease Progression Using Neuroanatomical Markers During the first funding period, we completed a longitudinal study comparing changes in hippocampal structure in CDR 0.5 and CDR 0 subjects matched for age and gender over approximately two years (mean interval in years (range) - CDR 0.5 – 2.0 (1.0-2.6) and CDR 0 subjects– 2.2 (1.4-4.1) (Wang, et al, 2003). The results of this study are critical for this application, as they demonstrate that our approach to assessing disease progression can discriminate between subjects with and without DAT, and so may also be sensitive to differences between groups of DAT patients treated with different drugs. This study included 18 CDR 0.5 subjects and 26 CDR 0 subjects that were partially overlapping with the subjects included in our previously published cross-sectional study (Csernansky, et al, 2000). The 18 CDR 0.5 subjects were not treated with cholinesterase inhibitors or memantine during the period of study. Measures of hippocampal shape and 6 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 R L CDR 0.5 CDR 0 Figure 2. Comparisons from Baseline to Follow-up (two years) in CDR 0.5 and CDR 0 Elder Subjects. Displacement maps were used to visualize the across-time difference in hippo- campal structure in the two sub- ject groups. Cooler colors (blue to purple) signify areas of inward deformation over time. In the CDR 0.5 subjects, areas of inward deformation were more wide- spread and included more of the lateral edge of the hippocampus, while in the CDR 0 subjects, areas of inward deformation were smaller and confined to the head f h hi volume were generated across both groups and time as in the cross-sectional study. At baseline, the CDR 0 subjects had a mean (SD) hippocampal volume of 2081(354) mm3 on the left side and 2600 (481) mm3 on the right side, while the CDR 0.5 subjects had a mean hippocampal volume of 1717 (224 mm3) on the left side and 2186 (370 mm3) on the right side. At follow-up, the CDR 0 subjects showed a hippocampal volume reduction of 82 mm3 on the left side and 142 mm3 on the right side, while the CDR 0.5 subjects showed a hippocampal volume reduction of 164 mm3 on the left side and 236 mm3 on the right side. ANOVA indicated a significant group effect on the rate of hippocampal volume loss (F = 7.81, df = 1,42, p = 0.008). This difference persisted after covarying hippocampal volumes for total cerebral brain volume (p = 0.007), total intra-cranial volume (p = 0.008) and scan interval (p = 0.015). There was also a group difference in the rate of progression of hippocampal shape deformity. The first 12 eigenvectors explained 75% of the variance in hippocampal shape, and using these 12 eigenvectors as variables in a MANOVA, we found a significant group effect (F = 2.66, df = 12,31, p = 0.014; effect size = 2.0). In a follow-up logistic regression analysis, the combination of eigenvectors 1, 2, 4, and 11 were found to be optimally useful for discriminating the patterns of hippocampal shape change in the two groups of subjects (χ2 = 19.4). Using these four eigenvectors, a significant group x time interaction was found (F = 7.81, df = 4,39, p < 0.008), and in a “take-one- out'' discriminant function analysis, 22 out of 26 (84.6%) CDR 0 subjects and 15 out of 18 (83.3%) CDR 0.5 subjects were correctly classified. When hippocampal volume change was included in this logistic regression analysis, only eigenvectors 2, 4, and 11 were selected (χ2=20.1) (eigenvector 1 was again correlated with the change in hippocampal volume across subject groups - r = - 0.75, p < 0.0001). Visualization of the changes in the shape of the hippocampus in the two groups revealed that areas of inward deformities over time were more widespread in the CDR 0.5 than in the CDR 0 subjects (see Figure 2). Hippocampal Shape Predicts Response to Donepezil A major objective during the first funding period was to test the hypothesis that an assessment of hippocampal structure could be used to predict the outcome of donepezil treatment in DAT patients. As proposed in our original application, estimates of cognitive decline over time were generated using CDR sum of-boxes scores, ADAS-Cog total scores, MMSE total scores and Neuropsychiatric Inventory (NPI) total scores (see Research Design and Methods section below for more description of these measures). Fifty-one subjects with DAT were included in this analysis and, to date, data were available for a minimum of 48 weeks in 38 subjects (this trial will be completed in the final year of the present funding period). In almost all cases, the subjects had been treated with donepezil, 10 mg/day, for the period of study – in rare subjects that could not tolerate this dose of donepezil, 5 mg/ day, was used. In addition, we included data from 65 non-demented subjects (CDR 0) in the analysis, so that we could evaluate variation in hippocampal shape related to drug response in the context of normative structure. To estimate the rate of annual change in the selected clinical measures, a slope value was calculated for each subject using a growth curve model (Laird and Ware, 1982). The mean (SD) annual rate of change for the sum-of-boxes scores was 0.13 (± 0.11, range -0.06 to +0.41) per year. Other mean (SD) annual rates of change were as follows: ADAS-Cog total score - 0.15 (± 0.29, range -0.29 to +1.32); MMSE total score - -0.084 (± 0.17, range - -0.61 to +0.16); the NPI total score - +0.027 (± 0.06, range -0.03 to +0.37). Thus, in general, mild deterioration was observed in the DAT subjects 7 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 Figure 3. Pattern of Hippo- campal Shape Variation Correlated with the Outcome of Donepezil Treatment. The two panels illustrate the extremes of hippocampal shape variation in eigenvector 3, that were characteristic of DAT subjects who showed clinical worsening (top panel) and improvement (bottom panel) during donepezil treatment. Cooler colors (blue to purple) signify areas of inward deformation and warmer colors signify areas of outward deformation relative to the mean shape of all subjects. R L R treated with donepezil (i.e., slopes for sum-of-boxes scores, ADAS-Cog and NPI scores were positive, while MMSE slopes were negative). Hippocampal volumes, total cerebral volumes and total intracranial volumes were not significantly correlated with any of the measures of cognitive decline. However, among the first 10 eigenvectors (which explained > 80% of the variance in hippocampal shape), eigenvector 3 coefficients were correlated with two measures of the rate of cognitive decline. More negative eigenvector 3 coefficient values were significantly correlated with increasing sum-of-boxes slope values (r = -0.34, p = 0.03, two-tailed) and with increasing NPI slope values (r = -0.31, p = 0.05, two-tailed). A trend correlation was observed between more negative eigenvector 3 coefficient values and decreasing MMSE total scores (r = 0.29, p = 0.07, two-tailed), but no correlation was observed between eigenvector 3 coefficient values and ADAS-Cog total scores (r = -0.11, p = .50, two-tailed). These correlations were unchanged after taking into account total cerebral brain volume, total intracranial volume, and age. The pattern of hippocampal shape variation represented by eigenvector 3 is shown in Figure 3. The pattern of shape variation associated with greater cognitive decline during donepezil treatment was similar to the pattern of shape deformation previously shown to discriminate CDR 0.5 and CDR 0 subjects (see Figure 1), and to be associated with disease progression changes CDR 0.5 subjects over time (see Figure 2) (i.e., inward deformation of the lateral prominence of the hippocampus). In turn, the relative absence of this pattern of deformation in hippocampal shape was associated a more favorable outcome during donepezil treatment. These results suggest that hippocampal shape may be a predictor of the capacity of DAT patients to respond to donepezil. STUDY DESIGN Clinical data and digital MR scans from the Specific Aims of this study will be de-identified and obtained for analysis from the clinical database maintained by the Alzheimer’s Disease Research Center (ADRC) at Washington University via an electronically secure file transfer protocol (ftp). At Northwestern University, the data will be downloaded to a Pentium D based PC managed by Dr. Lei Wang. The data will be physically secure and will have continuous power via a UPS and connection to an emergency power supply. The NMFF’s internet security system secures its network from the Internet via firewalls and a network intrusion detection system. Analysis of the data will be conducted by the Principle and Co-investigator. The confidentiality of the participants at Washington University will be protected as indicated in the “Code Access Agreement” signed by the PI and Washington University personnel such that Northwestern University personnel will not have access to subject identifiers or a master code list under any circumstances (see attached code access agreement). Specific Aims 1& 2 - Monitoring Disease Progression During Treatment with Donepezil and Memantine in Subjects with Very Mild-to-Mild DAT a. Overall Design and Source of Subjects. Changes in specific neuroanatomical markers will be compared over a two year period in four groups of subjects – Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine, Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with donepezil, Group 3) subjects with R L 8 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with the combination of donepezil and memantine, and Group 4) nondemented comparison subjects. MR scans and clinical data from Group 1 and Group 4 subjects will be obtained from the clinical database and MR image archive maintained by the ADRC at Washington University. The ADRC is directed by Dr. John Morris, who is also a Co-Investigator on this project. At present, repeat MR scans and clinical data are available for 21 Group 1 subjects and 44 Group 4 subjects. MR scans and clinical data from Group 2 subjects will be obtained from data collected during the initial funding period of this project. At present, complete sets of clinical data and repeat MR scans are available for 38 such subjects; however, 9 additional subjects are still completing the protocol – thus, the total number of Group 2 subjects could be as high as 47. Finally, repeat MR scans and clinical data from Group 3 subjects will be obtained during the proposed funding period of the project. Specifically, we propose to treat 50 new DAT subjects with the combination of memantine and donepezil during the proposed funding period, and again projecting an attrition rate of approximately 20% (see Data Analysis section below), this plan should yield approximately 40 Group 3 subjects for data analysis. New subjects to be studied during the proposed funding period will be recruited from DAT patients enrolled at the Memory Diagnostic Center (MDC) at Washington University School of Medicine, also directed by Drs. John C. Morris and James Galvin. These subjects are referred to the MDC from community neurologists and from the ADRC at Washington University. Presently, MDC patients are prescribed donepezil as the cholinesterase inhibitor of first choice, because of its tolerability and ease of use (single daily dosing). Other cholinesterase inhibitors are offered only if the patient cannot tolerate donepezil or has a strong personal preference. A New Drug Application for memantine was submitted to the FDA in January of 2003, and memantine was approved for use in October, 2003. In February, 2003, the drug was distributed to U.S. pharmacies, and launch occurred in March, 2003. Thus, memantine will be clinically available in advance of the beginning of the proposed study. The MDC has evaluated the data available for memantine and plans to use this new drug almost exclusively as an adjunctive agent to donepezil (John Morris, M.D., personal communication). Clinical diagnostic criteria for DAT at the ADRC and MDC at Washington University correspond to those established by the NINCDS-ADRDA Work Group (McKhann, et al, 1984), and have a 93% accuracy for the histopathological presence of AD at autopsy (Morris, et al, 1996; Berg, et al, 1998). All subjects are assessed annually using clinical, psychometric, and behavioral measures that are valid for the detection of very mild stages of DAT (Berg, et al, 1998). The clinical measures include staging of dementia severity using the CDR (Morris, 1993). Treatment will be administered in this study in an open-label fashion. All DAT subjects selected for this study will already have been selected for donepezil therapy alone or the combination of donepezil and memantine, regardless of their participation in the proposed study. Therefore, randomization to a lesser form of drug therapy or placebo would be below the standard of care and therefore unethical (Kawas, et al, 1999; Knopman, et al, 1998). Also, by selecting subjects for this study who have already been identified as candidates for drug therapy, our sample should be representative of clinical populations prescribed such treatments. All clinical evaluations will be performed blind to the results of neuroanatomical assessments. Therefore, no systematic bias will be introduced related to our main hypotheses involving correlations between the results of these biological assessments and treatment response. Subjects will be excluded from this study if they have already had a substantial period of treatment (i.e., more than 8 weeks) with a cholinesterase inhibitor. Vitamin E treatment (400-800 U/day), non-steroidal drugs and Cox-2 inhibitor drugs will be permitted during the treatment period, since this situation is typical of clinical settings in which cholinesterase inhibitors and memantine are administered, so long as the doses of these treatments remain constant throughout the treatment period. However, other drug treatments under investigation for their efficacy in DAT will not be permitted during the treatment period. Prior to initiation of treatment, all subjects will undergo a comprehensive diagnostic evaluation using NINCDS-ADRDA criteria (McKhann, et al, 1984), as well as the CDR (Morris, 1993), the Alzheimer Disease Assessment Scale (ADAS; Rosen, et al, 1984), which includes a concise battery of cognitive tests (i.e., the ADAS-Cog), the Mini-Mental State Examination (MMSE; Folstein, et al, 1975), and the Neuropsychiatric Inventory (NPI), to assess the severity of dementia and behavioral symptoms related to dementia. Emergent 9 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 side-effects of donepezil and memantine treatment will be recorded using an instrument standard to clinical trials (Treatment Emergent Side-effect Scale [TESS]). Drug treatment will begin with 5 mg/day of donepezil for six weeks. After six weeks of such treatment, the subjects’ symptoms will be re-evaluated and any side-effects of treatment assessed and recorded. If no serious side-effects of donepezil are encountered, the dose of donepezil will be increased to 10 mg/day. For subjects prescribed the combination of donepezil and memantine, memantine (20 mg/day) will be added to the drug treatment regimen after the dose of donepezil has been established (i.e., at six weeks). Again, memantine will be initially started at 10 mg/day and increased to its full dose only if no serious side-effects are encountered. Subsequent evaluations will then be performed every 12 weeks for two years. All evaluations after 6 weeks will include the complete set of clinical and cognitive (i.e., ADAS-Cog) assessments, and a full diagnostic evaluation will be repeated annually (see Flowchart below). MR scans will be collected at baseline and after two years of treatment for all subjects who complete the entire period of treatment. For any subject that discontinues their participation in the study prematurely, the second MR scan will be collected at that time. _______________________________________________________________________________________________ Clinical Trial Flowchart Baseline Six Weeks 12 Weeks Every 12 Weeks For Two Years Donepezil     Donepezil                      (5 mg/d) (5 to 10 mg/d) Memantine                      (10 to 20 mg/d) Diagnosis Repeat Diagnosis at 1 and 2 Yrs CDR CDR CDR CDR ADAS-Cog ADAS-Cog ADAS-Cog ADAS-Cog MMSE MMSE MMSE MMSE NPI NPI NPI NPI TESS TESS TESS MRI Repeat MRI at 2 Yrs _______________________________________________________________________________________________ Subjects will be selected for this study if they meet NINCDS-ADRDA criteria for DAT at baseline (McKhann, et al, 1984), and have a score of 0.5 or 1 on the CDR (Morris, 1993). Subjects who no longer meet diagnostic criteria for DAT after one or two years of treatment, or who are diagnosed with another dementing illness, will still be followed for the remainder of the study, but their data will be evaluated separately from those subjects who continue to meet all inclusion and exclusion criteria. Based upon our prior experience with this population of subjects in the ADRC (Berg, et al, 1992), we expect such changes in diagnosis to be rare. The great majority of DAT subjects rated as 0.5 or 1 using the CDR are proven at autopsy to show the neuropathological signs of AD (Morris, et al, 1996; Berg, et al, 1998). Although it is possible that there will be subjects whose symptoms progress to the point where they can no longer be evaluated, this again should be rare given the demonstrated reliability and validity of the CDR across a wide range of severity of dementia symptoms (Berg, et al, 1992; Morris, et al, 1993). Inclusion Criteria: 1) meets NINCDS-ADRDA criteria for DAT, 2) CDR score of 0.5 or 1, 3) 50-80 years of age, 4) able to give informed consent or has a primary caregiver or legal guardian, who can give informed consent. Exclusion Criteria: 1) other psychiatric (e.g., depression) or neurological (e.g., CVA) disorders that would confound the assessment of dementia symptoms, 2) history of loss of consciousness, and 3) unstable or severe 10 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 medical illness (e.g., hepatotoxicity) that would make donepezil or memantine treatment or participation in other aspects of the study unsafe. b. Selection of Instruments for Clinical Evaluation Total sum-of-box scores from the CDR (Morris, 1993) will be used as the primary outcome measure. In our prior long-term studies (i.e., 4 to 10 years) of DAT subjects with very mild-to-mild DAT (i.e., CDR 0.5 to CDR 1), sum-of-boxes scores have been shown to be highly sensitive to disease progression and to have minimal ceiling or floor effects (Berg, et al, 1988; Berg, et al, 1992). In addition, so that the results of this study can be compared with large clinical treatment trials of DAT subjects, ADAS-Cog scores, total MMSE scores and total NPI scores will be used as secondary outcome measures (see below). To perform the CDR, a clinician trained in its use rates the subject’s cognitive abilities and function in six categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Impairment is rated 0-5 in the direction of increasing severity in each of these categories or boxes. The sum of these box scores is then compiled to yield CDR scores as follows: CDR 0 (no dementia); CDR 0.5 (very mild dementia); CDR 1 (mild dementia); CDR 2 (moderate dementia); and CDR 3 (severe dementia). Interrater reliability for the CDR is very high (Burke, et al, 1988), and subjects categorized with DAT over time using the CDR, including the CDR 0.5 category, are confirmed at autopsy as having AD with 96% accuracy (Morris, et al, 1988; Morris, et al, 1991; Berg and Morris, 1994). Clinicians at our Center all routinely receive extensive training in the use of the CDR, and interrater reliability is routinely monitored. Finally, sum-of-boxes scores have been shown to be a highly useful an index of dementia severity over time (Berg, et al, 1988; Berg, et al, 1992). In a study of 68 DAT subjects with beginning CDR scores of 0.5 or 1 followed for 4 to 10 years, sum-of-boxes scores declined in a relatively linear fashion and had very few ceiling or floor effects (i.e., all 68 DAT subjects could be rated using this measure at baseline and 24 months later) (Berg, et al, 1992). As mentioned above, the ADAS-Cog (Rosen, et al, 1984), the MMSE total score (Folstein, et al, 1975), and the NPI will be used as secondary outcome measures. These measures have been previously used in treatment trials of DAT subjects as both primary and secondary measures of symptom severity, and have been demonstrated to be sensitive to the effects of cholinesterase inhibitors (Farlow, et al, 1998; Rogers, et al, 1996) and memantine (Reisberg, et al, 2003). c. Neuroanatomical Rules for Brain Structure Boundaries The hippocampus, parahippocampal gyrus and cingulate gyrus have been selected as the neuroanatomical variables to be assessed during the proposed funding period based on a review of the literature and our own prior results. Explicit neuroanatomical rules were used to define the boundaries of these brain structures. To generate templates, structural boundaries were outlined using semiautomated routines that combine autotracing and manual tracing techniques available in AnalyzeTM. AnalyzeTM permits the simultaneous viewing of any point in the scan from three orthogonal planes. Autotracing functions encircle a selected region of uniform density by enclosing all contiguous pixels of similar density. The selection of tissue of a particular density is then achieved by setting thresholds that define the brightness of the pixels in the area of interest. Surrounding tissue of a different density (threshold) is deleted from the picture, leaving only the tissue of interest. When autotracing fails to segment tissues of similar density, the tissue is manually traced. d. MR Scanning Protocols and Image Preprocessing MR scans will be collected at the baseline assessment and after two years using a 1.5T VISION system (Siemens Medical Systems) with a UNIX based host computer (Sun Microsystems), actively shielded gradients, and echo-planar capability. Subjects will be positioned on the table with their canthomeatal line perpendicular to the table; head position stability is facilitated with adjustable cushioned head supports. A standardization object is placed in the field of view on the left side of the head for each MR scan. Prior to the scan, the 11 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 procedure is explained in detail to each subject, and techniques to tolerate small spaces and avoid claustrophobia are described. The MRI scans do not involve the administration of any contrast agent. All MR scans will be acquired using a turbo-FLASH sequence (TR=20, TE=5.4, Flip angle=30o ACQ-1, Matrix=256X256, Scanning time=13.5 minutes), that 3D datasets with 1 mm x 1 mm x 1 mm isotropic resolution across the entire cranium (Venkatesan and Haacke, 1997). A 2D set of proton density and T2 weighted images with standard 5-mm thicknesses will also be acquired for clinical interpretation of any unsuspected disease conditions, and to assess the number of white matter hyperintensities in each subject. Dr. Tom Conturo, Associate Professor of Radiology, oversees MR scan acquisition at Washington University School of Medicine, and together with his team, monitors scanner drift on a daily basis. Frequency, receiver gain, reference transmitter voltage, and signal-to-noise are examined. Phantoms of known dimensions are imaged and the gradient calibration is checked to make certain the correct size is registered. Protocols are also employed to check for ghosting artifacts. Further tests and calibration adjustments are performed when needed. Shims are used when needed to correct for field inhomogeneities. For image analysis, the raw MR data are transferred to a SGI workstation at Washington University where 3D reconstructions of brains are obtained using AnalyzeTM software (Rochester, MN). MR data files are identified by number only to maintain blind conditions for image analysis. Because the turbo-FLASH MR sequence yields 1 mm isotropic voxels, rescaling to correct discrepancies due to voxel isotropy is not necessary. Signed 16 bit MR datasets are compressed to unsigned 8 bit MR datasets by linearly rescaling the voxel intensities, such that voxels with intensity levels at two standard deviations above the white matter mean (corpus callosum) are mapped to 255, and voxels with intensity levels at two standard deviations below the CSF mean (third ventricle) are mapped to 0. As a final step in the preprocessing of MR images, neuroanatomical landmarks are placed by Dr. Lei Wang. In each scan, twelve landmarks are placed at the external boundaries of the brain, and at the points where the anterior and posterior commissures intersect the midsagittal plane (Haller, et al, 1997). Additional landmarks are also placed at selected points along the principal axis of the hippocampus (Csernansky, et al, 1998). i) Hippocampus. The most posterior slice containing the hippocampus is defined when the hippocampus first appears adjacent to the trigone of the lateral ventricle. A narrow band of gray matter along the medial aspect of the trigone opens to a thicker complex of gray matter and is separated from the trigone by a strip of white matter, i.e., the junction of the fimbria and fornix. The coronal slice shows an elongated gray matter shape because of the transverse orientation of the hippocampal tail. This complex is the cornu ammonis (CA), dentate gyrus and subiculum. It is difficult to select a point of separation between the CA and the subiculum because the superior component of the CA does not extend medially far enough to be the landmark of the medial border of the hippocampus, the inferior component of CA is continuous with the subiculum, and there is no gross anatomical separation of the subiculum, presubiculum, and parasubiculum, the lattermost being part of the parahippocampal gyrus. For these reasons, the subiculum and CA are combined in the volume called hippocampus, as has been done by others (Shenton, et al, 1992), and the inferior border of the CA-subiculum is continued medially with a straight horizontal line across the cortex of the parahippocampal gyrus. The cortex below this line is thus considered the parahippocampal gyrus, and the cortex above this line the hippocampus. Progressing anteriorly from the tail, the orientation of the hippocampus changes from the medial-to-lateral alignment of the tail to the posterior-to-anterior alignment of the body. Thus, the body is cross-sectioned in the coronal slices perpendicular to its long axis, and appears to be divided by the white matter of the fimbria into a lower part that is the CA-subiculum and an upper part formed by the tail of the caudate nucleus. The thalamus appears medial and superior to the CA-subiculum complex. The thalamus and caudate nucleus form the superior borders of the hippocampus in its posterior aspect. The white matter boundary (alveus and fimbria) between the hippocampus and caudate nucleus as well as any CSF lateral to the hippocampus is not included. The superior and lateral borders of the hippocampal body and head are identified by the contrast against the white matter or CSF. Vessels at the medial aspect of the hippocampus are excluded from the hippocampus. Where the amygdala appears at the superior boundary of the hippocampal head, it as well as the white matter boundary are excluded. However, the vertical digitation of the hippocampal 12 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 head which curves up and medial to the amygdala in coronal sections is included. The separation of the amygdala and hippocampus is best achieved by viewing sagittal and transverse sections. ii) Parahippocampal Gyrus (including entorhinal cortex). Delineation of the structure is made primarily using MR slices oriented in the coronal plane, perpendicular to the AC-PC line. Posteriorly, the parahippocampal gyrus blends imperceptibly with the lingual gyrus of the occipital lobe. It is well known that temporo-occipital separation is not definable. Therefore, the posterior limit of the parahippocampal gyrus is defined as the anterior end of the calcarine sulcus. The same coronal section also defines the posterior limit of the cingulate gyrus, and the parahippocampal gyrus is situated between the notch of the calcarine sulcus below and the cingulate gyrus above. Moving anteriorly, in coronal sections, the parahippocampal gyrus is limited by the subiculum medially and the collateral sulcus laterally. The anterior limit is defined by the rhinal sulcus which runs from lateral to medial, separating the parahippocampal gyrus from the temporal pole. The rhinal sulcus is identified in the axial section that shows the amygdala, head of hippocampus and uncal recess of the temporal horn. The sweep of the ambient gyrus over the medial aspect of amygdala in the axial section ends at a notch where the temporal pole begins. This notch is the rhinal sulcus. In coronal sections anterior to the amygdala, the superior limit of the parahippocampal gyrus is defined as the inflection point of the white matter at the inferior border of the gray matter of the amygdala. iii) Cingulate Gyrus. The cingulate gyrus is delimited at its ventral aspect by the callosal sulcus, which separates it from the corpus callosum. Dorsally, it is delimited by the cingulate sulcus. Delineation of the structure is made primarily from MR slices oriented in the coronal plane, perpendicular to the AC-PC line. The cingulate gyrus can be separated into anterior and posterior segments. The posterior limit of the anterior cingulate gyrus is taken to be in the coronal section perpendicular to the midpoint of the AC-PC line. As the cingulate gyrus extends anteriorly and wraps around the genu and rostrum of the corpus callosum, it tapers off gradually. Therefore, the anterior limit of the anterior cingulate gyrus is defined as the most rostral coronal section through the septum pellucidum, and the medial limit of the cingulate gyrus is the cortical surface in the interhemispheric fissure. The superior limit of the cingulate gyrus is the cortical surface forming the inferior bank of the cingulate sulcus (the superior bank being the superior frontal gyrus). This surface extends horizontally in a lateral direction to the fundus of the cingulate gyrus. At this point, a straight horizontal line is drawn through the thickness of the cortex to indicate the separation of the cingulate gyrus and superior frontal gyrus. From the lateral end of this horizontal line in the deep limit of the cortex, a straight line is drawn to the lateral limit of the cortex abutting the superior surface of the corpus callosum and separated from it by the callosal sulcus. The inferior limit of the cingulate gyrus is the inferior surface of the cortex forming the superior bank of the callosal surface (the inferior bank being the corpus callosum). The posterior cingulate gyrus wraps around the splenium of the corpus callosum. In the coronal sections which run through the posterior end of thalamus, the anterior limit of the sub-splenium segment of the cingulate gyrus is defined as the most rostral extent through the anterior end of the calcarine sulcus. Indeed, the same coronal section also defines the posterior limit of the parahippocampal gyrus (see above). The posterior cingulate gyrus then starts at the anterior end of the calcarine sulcus, moving posteriorly, follow its bank until reaching the bifurcation point where the calcarine sulcus branches into the posterior calcarine sulcus and the parietal-occipital sulcus. A straight line is then drawn from this point upwards to the nearest point on the sub- parietal sulcus. The cortex below this line is also delineated as the cingulate gyrus. The posterior cingulate gyrus follows the bank of sub-parietal sulcus as it traces out a curve parallel to the corpus callosum (and the brain derma). The lateral extent of the posterior cingulate follows the upper bank of the calcarine sulcus. e. Large Deformation High Dimensional Brain Mapping (HDBM-LD) to Assess the Volume and Shape of the Hippocampus MR scans from different subject groups or from the same subject group at different points in time will be used to construct and compare composite volumes and shape representations. In statistical terms, these representations reflect the coordinate systems of the scans for the subject groups or time points that are associated with the smallest average squared error. In practical terms, these representations allow us to generate 13 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 automatic volume measurements of selected brain structures and to quantify neuroanatomical shapes. Composite representations for the subject groups are first created by forming the MR scans from the subject groups or time points into sets. Composite coordinate systems for the various sets of scans are then calculated by finding the correspondence of the coordinate system of each of the members of each group with a standard coordinate system. The composite coordinate system most representative of each population is then constructed from the average of these correspondences. This approach relies fundamentally on our ability to calculate the correspondence of highly variable MR images with a common coordinate system. Since the earliest introduction of our brain mapping methods (Miller, et al, 1993; Christensen, et al, 1994; Grenander and Miller, 1994), we have studied the variability of mammalian brain anatomy by generating smooth correspondences (i.e. maps) from a single template onto families of target images. In our approach, the template represents the typical structure. Anatomical variation is then accommodated by performing transformations of the coordinate system of the template. The translation of every point in the template allows us to change the coordinate system in as many ways as there are points in the coordinate system (i.e. the number of voxels in the MR image). It is the high dimensionality of these transformations that differentiates our method from other mapping algorithms, and allows for the analysis of subtle characteristics of shape in small brain structures. Our method uses a coarse-to-fine approach that fuses the elegant landmark work of Bookstein (Bookstein and Green, 1992; Bookstein, 1978) with the pioneering volume-based deformation work of Bajcsy and colleagues (Bajcsy, et al, 1983; Dann, et al, 1989), but extends these methods to accommodate local deformations so that the precise shape of brain structures can be studied. The importance of this innovation is that it allows neuroanatomists to embed information into brain maps that is optimally meaningful with regard to subtle anatomical variation. To help ensure that the transformations preserve key features of brain geometry (e.g. unbroken gyral surfaces), we force the transformations to obey physical laws of elasticity and fluidity. The continuum mechanics-based mathematical derivations that correspond to these constraints may be found in several previously published works (Grenander, et al, 1992; Miller, et al, 1993; Christensen, et al, 1994 and 1995; Grenander and Miller, 1994; Joshi, et al, 1997; Miller, et al, 1997). There are limitations to any method, including HDBM-LD. First, our methods depend heavily on the quality of the gray scale image data. Currently, we are using the state-of-the-art high resolution MR images; however, as better resolution scanning sequences become available, we will employ them and very likely increase the precision of our assessments. Also, non-uniformities in the MR image data due to poor calibration and field inhomogeneities may result in mismatches of gray and white matter, because our current tools are not driven solely by information about geometric structure. We have worked hard to control these sources of error using conventional strategies. In addition, we have recently begun to develop transformation tools, which are driven solely by geometry and will therefore be invariant to non-uniformities in the MR images. Second, our methods are not entirely automatic, and the expertise of the expert neuroanatomist continues to play a key role. The expert creates the information in the template, and landmarks placed by experts may bias the initial manifold transformations. However, as regards the hippocampus, we have shown (see Haller, et al, 1997) that the transformations are robust to this potential source of error (i.e. the automatic results were more repeatable than the results obtained from manual outlining). Another potential limitation of our methods is that we make the assumption that the anatomies in the template and targets are diffeomorphic. Diffeomorphism can be roughly defined as the requirement that an analogous anatomical features can be found in every target and in the template. Moreover, as the transformations occur, the movements of contours and surfaces in the template never intersect. Thus, our mapping algorithms would currently fail if the template or the targets contained non- analogous features (e.g., tumor). The quantification of hippocampal volume and shape using HDBM-LD begins with superimposing a triangulated graph of points onto the gray matter surface of the hippocampus within the template using a computer aided design program for fitting closed surfaces to connected subvolumes. This surface is then treated as a two-dimensional closed manifold and carried along as the template is transformed onto the target MR scans. When the transformations are completed, a vector field and the surface that it represents are generated for each selected brain structure in each of the target scans. Composite surfaces for each structure in each group of subjects are then produced by averaging the individual vector fields generated by the 14 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 transformations. Brain structure volumes are measured in the subject groups by calculating the gray matter volumes enclosed by the transformation-generated surfaces. Quantification of hippocampal shape is performed using the deformation vector fields produced by the transformations. A pooled covariance matrix is first computed using the vector fields from the transformed surfaces in all subjects. This covariance matrix is then reduced in its dimensionality by computing the complete orthonormal set of eigenvectors, and a subset of eigenvectors that accounts for ~75 % of the variance in hippocampal shape is used in group comparisons. Recently, we have adapted these methods to specifically assess the rate of change in hippocampal shape over time (Wang, et al, 2003). From the pairs of MR images collected at different time points, the assessment of a change in the shape of the hippocampus over time is accomplished by mapping the transformations from the first time point onto the second time point via rigid-motion registration (rotation and translation). If no change in the shape of the hippocampus has occurred, the result of this transformation is an identity map (modulo rotation and translation). Conversely, any shape change that has occurred is defined as the deviation of the result of the transformation away from this identity map. To compare shape change in different groups of subjects, the covariance of the resulting transformation vector fields across all subjects is used, and shape change is assessed in each group by 1) obtaining a set of eigenvectors via the singular value decomposition of the covariance matrix, 2) computing coefficients associated with these eigenvectors for each subject, and 3) performing a MANOVA using the eigenvectors across all subjects. A post-hoc logistic regression is used to determine which of the eigenvectors are most discriminating of the groups being compared. Since the covariance of the shape change vector fields is empirical, repeat neuroanatomical data from nondemented (CDR 0) subjects are required in order to account for “normal” shape change during the analysis of shape change associated with DAT and its treatment. f. Methods for Labeled Cortical Depth Mapping (LCDM) of the Parahippocampal and Cingulate Gyri When the brain structure of interest is a subregion of the cerebral cortex (e.g., cingulate or parahippocampal gyrus), it is first necessary to create a segmentation of the various tissues (i.e., gray matter, white matter, and CSF) within that portion of the MR dataset, and in relationship to the geometry of the neocortex. We have recently developed specific algorithms for this purpose (see Figure 5). Construction of the surface between gray and white matter then places us in a position to determine the probabilities of CSF, gray matter and white matter voxels within the segmented subvolume as a function of the closest distance from the voxel to this surface (see embedded surface represented by the yellow line in Figure 5, panel C). Specific algorithms to compute these distances were first developed in Miller, et al (2000), for several types of cortical subvolumes, and then refined by Ratnanather, et al (2003), for specific cortical regions. Figure 5, panel D shows an example of a profile that shows the probabilities of encountering CSF, gray matter and white matter voxels as a function of the distance to the gray matter/white matter surface in a single subject. Figure 5. Computational Algorithms for Assessing the Neuroanatomical Structure of Cortical Subregions. The first step in the assessment of a subregion of the cerebral cortex is tissue segmentation (panel A) followed by identification of the iso-surface between gray and white matter (panel B). The probabilities of voxels at every distance from this surface (yellow line in panel C) is then determined, along with the cumulative probability of accounting for all voxels (panel D). The distance at A C D B 15 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 which a predetermined percentage of voxels are accounted for (e.g., 80%, 90%, etc.) can then be used as an estimate of cortical thickness across the region. Cortical metrics such as gray matter volume and thickness are then generated from the probability profiles. The gray matter volume is equivalent to the cumulative sum of gray matter data in the profile. In turn, graymatter thickness is based on the distances from the gray matter/white matter surface where pre-assigned percentiles of voxels (e.g., 85%, 90% or 95%) are reached. Finally, gray matter surface area is computed by summing up all the triangles of the triangulated graph of the surface within the selected subvolume. g. Assessment of Total Intracranial and Cerebral Volumes Assessment of total intracranial and brain volumes is needed to control for generalized brain volume reduction, as has been reported by some investigators. Mathalon, et al (1993), have examined the issue of correction for head size and brain volume in such circumstances and shown that such corrections decrease unwanted variance while improving the ability to detect meaningful biological variation (e.g. correlations between brain structure volumes and age). A template image is prepared by an expert using manual outlining techniques, and includes, in this case, segmentation data for the total intracranial and brain volumes. The entire MR image of the template is first globally registered with the MR image of each target using a landmark-based transformation and scalar points at the boundaries of the brain and in the midline. An elastic transformation (with eight basis vectors having 2187 basis coefficients) is then performed, which matches the templates for the total intracranial space and total brain to the target. As with the transformations developed to study the hippocampus, the manifold and the elastic transformations used for this measurement are concatenated together and all the anatomical features of the segmented template brain are carried through the transformation. h. Data Analysis To test hypothesis 1 (Decreases in hippocampal and cortical volumes, thinning of the cingulate and parahippocampal cortices, and changes in hippocampal shape will be correlated with the rate of cognitive decline in subjects with very mild-to-mild DAT.), growth curve models will be developed to assess the rate of cognitive decline for the principal (i.e., CDR sum-of-boxes scores) and secondary (i.e., ADAS-cog total scores, MMSE total scores, and NPI total scores) outcome variables (Laird and Ware, 1982). The underlying framework for the Laird and Ware model is essentially the same as for a traditional univariate repeated measures analysis of variance (ANOVA). However, the traditional ANOVA framework is difficult to apply when assessments are not available for all subjects at all time points. We have previously examined the advantages and disadvantages of this statistical model in characterizing rates of cognitive decline in a group of CDR 0.5 and CDR 1 DAT subjects highly similar to the one recruited for this project (Berg, et al, 1992). The CDR sum-of-boxes score was found to be entirely adequate as an outcome variable in that analysis (Berg, et al, 1992), because of its minimal ceiling and floor effects. The Laird and Ware model generates a slope value and intercept (i.e., estimate of baseline severity) for each subject. Variables to assess changes in structural volume, thickness, and shape (for the hippocampus) will be generated as described above. Bivariate correlations between changes in clinical and neuroanatomical variables will be estimated using non-parametric statistics (Spearman’s rho). To assess whether observed bivariate relationships are independent of each other, a stepwise multiple regression model will be developed including all independent neuroanatomical variables and slope values for the CDR sum-of-boxes scores as the dependent variable. To test hypothesis 2 (The rate of decreasing hippocampal and cortical volumes, thinning of the cingulate and parahippocampal cortices, and changing hippocampal shape will be equal in DAT subjects that are untreated and in DAT subjects that are treated with donepezil alone, but greater than the rate of volume loss, thinning and hippocampal shape change in DAT subjects that are treated with the combination of donepezil and 16 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 memantine.), rates of change for the various neuroanatomical variables will be compared in DAT subjects that are untreated, that are treated with donepezil alone, that are treated with the combination of donepezil and memantine, and in nondemented comparison subjects. These analyses will be performed using simple difference scores (follow-up minus baseline) for volume and thickness variables. To compare rates of change in hippocampal shape across groups, a MANOVA using eigenvectors derived from the time 1-to-time 2 transformation covariance will be performed (see above). The distributional characteristics of each of these variables will be examined prior to hypothesis testing. Finally, non-parametric (Wilcoxon rank sum tests) statistics will be used to compare the groups. i. Sample Size and Power Considerations Based upon previous work by our group in similar groups of CDR 0.5 and CDR 1 DAT subjects (Berg, et al, 1988; Berg, et al, 1992), and on our experience with the subjects recruited and studied during the initial funding period, we estimate that the attrition rate of subjects who cannot continue in the study for the full two years due to pronounced deterioration, drug side-effects, or refusal to participate will be approximately 20% or less, leaving at least 40 subjects who would provide data for the entire two-year period. However, the number of subjects entered into the analysis may exceed this somewhat, since a slope value can be estimated for each subject who remains in the treatment trial for at least five assessments (one year). Estimating 40 subjects are used in the analysis used to test Hypothesis 1, we will have a power of .80 to detect a correlation (or partial correlation) of .44 or more with a 2-tailed significance level of .05 (Borenstein and Cohen, 1988; Kraemer and Thiemann, 1987). For the testing of Hypothesis 2, we will be measuring the rate of change of neuroanatomical variables over time; therefore, the test-retest reliability for these variables must be high. To estimate the normative test-retest reliability of the neuroanatomical measures proposed in this application, we scanned eight healthy control subjects on two separate occasions approximately one month apart, and then estimated differences between volumes and surface contours of the hippocampus. At the first time point, the mean left hippocampal volume was 2,233 mm3 and the mean right hippocampal volume was 2,699 mm3; at the second time point, these volumes were 2,209 and 2,686 mm3, respectively. Using repeated measures ANOVA, there were no significant test-retest differences in these volumes (on the left F = .14, p = .72; on the right F = .07, p = .80) and the intraclass correlation coefficient between these two datasets was very high (ICC = 0.93). To compare the similarity of surface contours at the two time points, we then registered all the scans with respect to the template and then calculated the percent overlap of voxels. The average percent overlap in the eight subjects was 87.4%, which is comparable to the overlap achieved by a single expert performing repeated manual segmentations of the hippocampus from the same MR scan (Haller, et al, 1997). To the test the reliability of shape assessment for the hippocampus, we generated the eigenvectors associated with this brain structure based on the eight control subjects at time point 1. The coefficients associated with these eigenvectors were then computed for each subject at both time 1 and time 2. The mean ICC for all eigenvector coefficients was very high - 0.89 (range of 0.83 to 0.94), suggesting very high repeatability. Finally, the standard deviation for the estimation of hippocampal volumes on the two occasions was 225 mm3, and an annual rate of decrease in hippocampal volumes was 2 mm3. Assuming that the between-group effect size for comparisons of the rate of change of neuroanatomical variables is moderate (i.e., 0.5 or higher), and if the correlations in neuromorphometric measures within our proposed sample sizes at the different time points continue to be high (i.e., > .75), changes in brain structure shapes of the magnitude observed to date (see Progress Report and Wang, et al, 2003), and volume decreases of 50 mm3 or greater over two years, would be detectable with greater than 85% power (Borenstein and Cohen, 1988; Kraemer and Thiemann, 1987). HUMAN SUBJECTS 50 new subjects who meet NINDS-ADRDA criteria for probable AD (i.e. DAT), and who have been registered with the MDC for treatment will be recruited for participation in the project during the proposed 17 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 funding period. The age range of the subjects will be 50 to 80 years. Any subjects will be excluded if they have medical problems that would contraindicate treatment with donepezil or memantine or make administration of a MR scan or any other aspect of the protocol hazardous. With regard to the inclusion of both genders and various minorities, the samples will be equally balanced for gender and include approximately 15% African-American subjects. This percentage is similar to the distribution of African-Americans who present to the ADRC and MDC. This distribution of subjects should also allow inclusion of gender as a covariate in data analyses. 2. Collected clinical data will include information about demographics, dementia symptoms, other behavioral disturbances, and performance on tests of cognition (i.e., the ADAS-Cog). In all cases, verbal or written information obtained directly from the patients and involved caregivers will be used. These evaluations will take place in an ordinary office setting. MR scan data will be collected according to established protocols at the Mallinckrodt Institute of Radiology at Washington University. 3. Patients will be recruited for participation in this project as they present to the MDC for assessment and treatment. Several neurologists work together to assess and treat patients at the MDC - Drs. Morris, Galvin, Holtzman, and Snider. As Director of the MDC and Co-Investigator on this project, Dr. Morris will work with the other treating neurologists to select possible subjects for this project. However, the consent of the individual treating neurologist, who has been informed of the goals and procedures of the project, and of the patients’ families will always be obtained before any patient is approached to obtain their informed consent. For those patients who are incompetent to give informed consent, legal guardians will be approached to seek their informed consent for the subject’s participation. All subjects shall give their ongoing assent for participation in the project, regardless of whether they have provided written informed consent as well. 4. The potential risks of this project include those associated with routine clinical interviews. The clinical interview and cognitive testing instruments to be used for the project could produce boredom and fatigue. However, breaks in interview sessions will be given whenever the subject requests or obvious fatigue is observed. There are also risks in obtaining MRI scans. However, so long as subjects are properly screened to exclude individuals with metal embedded within their bodies, these risks are minimal and include feelings of claustrophobic fear while being scanned, and minor physical discomfort because of remaining still throughout the scanning procedure. Subjects will also be warned that should they have unremembered metal objects within their bodies, these objects could become heated by the radiofrequency energy of the scanner. The risks of donepezil therapy include increased bowel movements, diarrhea, nausea, vomiting, dyspepsia, diminished appetite, and weight loss in approximately 10% of subjects. Less commonly, slight decreases in heart rate, insomnia, and psychomotor agitation have occurred. These side-effects can generally be managed by reducing the dose of donepezil from 10 to 5 mg/day. The side effects of memantine include diarrhea, insomnia, dizziness, headache, and rarely hallucinations. Also, as with any drug, idiocyncratic hypersensitivity reactions can rarely occur. Again, subjects will be warned about these risks, and excluded when they have a history of serious or unstable medical disorders. 5. To minimize these risks, clinical interviews and scanning sessions will be interrupted or discontinued if necessary. Subjects and their caregivers will also be carefully interviewed to exclude the possibility of including anyone with metal embedded in their body. Finally, all drug treatment will be performed in the context of an expert clinic. The DAT subjects will be closely monitored for any drug side-effects, and in subjects who experience such side-effects, the protocol will be discontinued. Personnel trained by the ADRC at Washington University in interviewing and testing DAT subjects will conduct all research-related procedures. 6. The risks of this project are relatively small, and not appreciably greater than the risks of ordinary inpatient assessment and non-invasive radiologic procedures. The drug treatment will be administered to these subjects in the context of ordinary clinical care in the MDC. If successful, knowledge may be gained about neuromorphometric predictors of treatment response in patients with DAT, and perhaps about the pathophysiology of AD in general. In consideration of the small risks and substantial scientific benefit of this work, we consider that risk/benefit ratio to be favorable. 7. All key personnel involved in the design or conduct of the research involving the human subjects will receive the required education on the protection of human research participants prior to funding of this project. 18 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 DATA MANAGEMENT All data will be de-identified and then entered at Washington University. The Northwestern University research team will not have access to any identified data – all subjects in this study are given a random study number that will be used. All identifying data will be kept at Washington University. A distributed data entry system for this project will be used, with computers for data entry at all Washington University clinical data collection sites. Brain structure measures are entered into datasets using PC-type workstations. All computers currently use Excel data entry screens, formatted to simulate the hard copy data entry forms. All data are double-entered, and error checking programs are used to identify and correct errors. Once entered into these spreadsheets and checked, the data files are consolidated into the main SAS project database, which is maintained on a PC microcomputer under the direct supervision of Dr. Paul Thompson from Washington University, the project biostatistician. Back-ups are routinely performed to assure the preservation of the database. Data are checked for range, consistency, missing values, etc. Whenever errors are detected, reports are sent to the data entry sites, where the data are checked again. Data entry system at Washington University is transitioning to a web-based data entry system for easier data management. This system uses SAS/IntrNet methods for data entry and formulates data entry tools using HTML screens (Thompson, 2003a, 2003b). This system integrates data entry with data analysis when necessary, and includes programs to check for completeness of data entry and other data monitoring tools to be run as data are entered, so that data evaluations and comparisons can be synchronous with data entry. This system is used on several other projects in which Dr. Thompson has management responsibilities, and is thus well tested and highly reliable. The project database is maintained using SAS. Data from individual clinical or cognitive instruments are maintained in separate datasets, indexed by subject ID number, date and originating clinic. During data analysis, combined datasets are created as needed. Data are maintained in the master system datasets using a source/derived data approach, where source datasets are maintained unmodified, while the derived datasets are modified as needed. Thus, alterations that prove to be incorrect are easily rectified. The confidentiality of all data is maintained using the HIPPA compliance standards of Washington University. These standards involve retaining confidential information (name, address, telephone numbers, and social security number) in encrypted datasets or on removable media. No confidential information is posted to the web under any circumstances. All possible efforts are made to retain only the necessary information in all cases; that is, ID numbers are used in all possible cases, and actual identification information are used only when necessary and will not be included in the data that is transferred to Northwestern University. Neuroimaging data produced by high dimensional transformations of the neuroanatomical template consists of volumes (in mm 3), symmetry metrics (no units), and shape metrics (e.g., individual eigenvector coefficient values). These data are also collected into Excel datasets, checked, and then merged into the project database. As a first step in the data analysis process, exploratory data analyses will be undertaken for all neuroanatomical variables to assess their distributional properties and to identify outliers. Variables intended for use in MANOVA and other parametric analyses will be tested for deviations from distributional assumptions of the tests. If deviations are identified, we will attempt to find appropriate transformations, such as power or log transformations, which give the variables the required distributional properties. If no simple transformation can be used, alternative analyses with less rigid distributional requirements will be used. For example, rank-ordered group comparisons (e.g., Mann-Whitney U and Wilcoxon tests) and correlations (i.e. Spearman rho) may be used for ordered data for which we cannot demonstrate normality. 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Arch Gen Psych 49:402-408. 23 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 Phillps RG, LeDoux JE (1992) Differential contribution of amygdala and hippocampus to cued and contextual fear conditioning. Behav Neurosci, 106:274-285. Price JL, Morris JC. (1999) Tangles and plaques in nondemented aging and preclinical Alzheimer’s disease. Ann Neurol 45:358-368. Raskind SL, Peskind ER, et al. (2000) Galantamine in AD: A 6-month, randomized, placebo-controlled trial with a 6-month extension. Neurology 54:2261-2268. Ratnanather JT, Priebe CE, Miller MI (2003) Semi-automated segmentation of cortical subvolumes via hierarchical mixture modeling. In: Medical Imaging 2003: Image Processing (eds. Sonka M and Fitzpatrick JM). Proc SPIE 5032:1602-1612. Reisberg B, Doody R, Stoffler A, Schmitt F, Ferris S, Mobius HJ and the Memantine Study Group (2003) Memantine in moderate-to-severe Alzheimer’s disease. New England J Medicine 348:1333-1341. Rogers SL, Farlow MR, et al. 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(1991) Unbiased stereological estimation of the total number of neurons in the subdivisions of the rat hippocampus using the optical fractionator. Anat Record 231:482- 497. 24 Corticolimbic Degeneration and Treatment of Dementia 8-26-2008 Wilcock G, Wilkinson D. (1996) Galanthamine hydrobromide: Interim results of a group comparative, placebo controlled study of efficacy and safety in patients with a diagnosis of senile dementia of the Alzheimer type. Neurobiol Aging 17:S144. Wyss JM, van Groen R. (1989) Development of the hippocampus. In: The Hippocampus - New Vistas (Eds: V. Chan-Palay, C. Kohler) Neurology and Neurobiology, Vol. 52, Alan R. Liss, Inc. pp. 1-17. Zola-Morgan S, Squire L. (1993) Neuroanatomy of memory. Annual Rev Neurosci 16:547-563.	4	arm 1: Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine arm 2: Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with Donepezil (Aricept®). arm 3: Group 3) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with the combination of Donepezil (Aricept®) and Memantine (Namenda®) arm 4: Group 4) nondemented comparison subjects.	[ 4, 1, 1, 4 ]	2	[ 0, 0 ]	intervention 1: Drug treatment will begin with 5 mg/day of donepezil for six weeks. After six weeks of such treatment, the subjects symptoms will be re-evaluated and any side-effects of treatment assessed and recorded. If no serious side-effects of donepezil are encountered, the dose of donepezil will be increased to 10 mg/day. For subjects prescribed the combination of donepezil and memantine, memantine (20 mg/day) will be added to the drug treatment regimen after the dose of donepezil has been established (i.e., at six weeks). Again, memantine will be initially started at 10 mg/day and increased to its full dose only if no serious side-effects are encountered. intervention 2: 5mg/day for six weeks and if no serious side-effects increased to 10mg/dy.	intervention 1: Memantine (Namenda®) intervention 2: Donepezil (Aricept®)	0	null	102	NCT00768261	1COMPLETED	2009-10-01	2004-11-01	Washington University School of Medicine	7OTHER	true	true	false	https://cdn.clinicaltrials.gov/large-docs/61/NCT00768261/Prot_SAP_000.pdf	0
[ 5 ]	27	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Glycemic control can be safely achieved in surgical and medical intensive care unit settings and has been shown to improve short and long-term clinical outcomes. As such, insulin infusion protocols are routinely used in the ICU setting. The investigators plan to establish the use of strict glycemic control in a heterogenous group of acutely ill patients in the ED setting. The investigators propose to study the aspects of implementing a strict glycemic control protocol in the ED.	null	Hyperglycemia	Hyperglycemia Glycemic control	null	1	arm 1: All subjects placed on insulin infusion.	[ 5 ]	1	[ 0 ]	intervention 1: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL	intervention 1: Insulin	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	27	NCT00779701	1COMPLETED	2009-10-01	2007-03-01	Temple University	7OTHER	false	false	false	null	0
[ 5 ]	29	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This proposal is to fund a pilot study to assess feasibility and refine methodology for an intended large Scotland wide study on Response to Oral Agents in Diabetes (ROAD). The study will collect cohorts of patients who have carefully controlled standardised dose titration and monitoring with an assessment of drug response and side effects over a 6 month period. The primary aim will be to use these cohorts to investigate phenotypic and genotypic (pharmacogenetic) determinants of response. Drug naïve patients will be treated with Metformin. Patients who have failed on Metformin or are intolerant of Metformin will be randomised to gliclazide, pioglitazone or sitagliptin. With the ability to capture patient data beyond 6 months via data linkage we will monitor time to treatment failure and therefore compare which of the 3 oral agents is the best therapy to use after Metformin in a cost efficient and "real world" RCT.	The Response to Oral Agents in Diabetes (ROAD) study aims to address the limitations of observational data by creating a prospective study of incident users of oral agents. For the first six months the research team will ensure a protocol driven dose titration, standardised monitoring of adherence, response and side effects and standardised deviations from therapy. Thereafter patients will receive 6 monthly monitoring and further protocol led dose titration by the GP. Biochemistry, prescribing data, morbidity and mortality data will be captured for up to 10 years from drug initiation. The ROAD study will provide a highly powered prospective cohort to investigate phenotypic and genotypic determinants of response in its own right. However, this cohort will be used synergistically with ongoing observational pharmacogenetics studies, allowing for crucial replication of 'positive' signals. Furthermore, by randomisation at drug initiation, long term community follow up will allow a comparison of time to treatment failure in patients treated with gliclazide, pioglitazone and sitagliptin in a much more cost effective and 'real-world' setting than traditional prospective randomised trials This pilot study is to assess the feasibility of the larger complex intervention. The primary outcome of the pilot is HbA1c change. Other measures regarding recruitment and dose titration will be assessed. With knowledge from this pilot, an application will be made for a large region or Scotland wide study to collect 2000 patients incident to oral diabetes treatment.	Diabetes Mellitus, Type 2	Diabetes therapies Pharmacogenetics	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 1, 1, 1, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 30mg daily increased to 60mg if HbA1c \> 7% at 3 months intervention 2: Sitagliptin 100mg daily for 6 months intervention 3: Pioglitazone 30mg daily , increased to 45mg daily if HbA1c \>7% at 3 months. 6 months duration intervention 4: Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment	intervention 1: Gliclazide MR intervention 2: Sitagliptin intervention 3: Pioglitazone intervention 4: Metformin	1	Dundee \| N/A \| United Kingdom \| -2.97489 \| 56.46913	29	NCT00780715	1COMPLETED	2009-10-01	2008-12-01	University of Dundee	7OTHER	false	false	false	null	0
[ 3 ]	13	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is a phase II study of Nilotinib for patients with advanced GIST that cannot be surgically removed. Patients are candidates for the study if their tumors have progressed on imatinib and sunitinib or if they were intolerant to these drugs. Patients may have received other investigational therapies as well. We are testing the benefit of nilotinib in advanced GIST looking at the length of time disease is controlled as well as the response of the disease to the drug.	Nilotinib is an oral drug. The dose is 400 mg twice daily Patients are evaluated every 8 weeks for disease response. Blood work is assessed for safety initially weekly, then every 4 weeks. Physical exams are performed initially weekly and then decreased to every 4 weeks after the first month.	Gastrointestinal Stromal Tumors	GIST Nilotinib	null	0	null	null	1	[ 0 ]	intervention 1: 400 mg orally twice daily until disease progression, intolerability or withdrawal of consent	intervention 1: Nilotinib	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	13	NCT00782834	6TERMINATED	2009-10-01	2008-07-01	Fox Chase Cancer Center	7OTHER	false	false	false	null	0
[ 2, 3 ]	327	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in subjects with dry eye.	null	Dry Eye Syndromes	Dry eye	null	6	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None	[ 0, 0, 0, 0, 1, 2 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks intervention 2: Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks intervention 3: Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks intervention 4: Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks intervention 5: Ophthalmic topical solution, 0.05%, dosed at least once/day, 8 weeks intervention 6: Ophthalmic topical solution, dosed at least once/day, 8 weeks	intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550 intervention 5: Cyclosporine intervention 6: CP-690,550 Vehicle	27	Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Artesia \| California \| United States \| -118.08312 \| 33.86585 Centennial \| Colorado \| United States \| -104.87692 \| 39.57916 Ormond Beach \| Florida \| United States \| -81.05589 \| 29.28581 Stuart \| Florida \| United States \| -80.25283 \| 27.19755 Tamarac \| Florida \| United States \| -80.24977 \| 26.21286 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Morrow \| Georgia \| United States \| -84.33937 \| 33.58317 Roswell \| Georgia \| United States \| -84.36159 \| 34.02316 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Lynbrook \| New York \| United States \| -73.6718 \| 40.65483 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 High Point \| North Carolina \| United States \| -80.00532 \| 35.95569 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Austin \| Texas \| United States \| -97.74306 \| 30.26715 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	327	NCT00784719	1COMPLETED	2009-10-01	2008-11-01	Pfizer	4INDUSTRY	false	false	false	null	-0
[ 3 ]	408	null	PARALLEL	0TREATMENT	null	false	0ALL	null	The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed	null	Diabetes Mellitus, Type 2		null	0	null	null	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: BI 10773 intervention 2: placebo intervention 3: metformin	74	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 Capital Federal \| N/A \| Argentina \| N/A \| N/A Mar del Plata \| N/A \| Argentina \| -57.5562 \| -38.00042 Mendoza \| N/A \| Argentina \| -68.84582 \| -32.88946 Salta \| N/A \| Argentina \| -65.41999 \| -24.80645 Salta \| N/A \| Argentina \| -65.41999 \| -24.80645 Karlovac \| N/A \| Croatia \| 15.55 \| 45.49167 Krapinske Toplice \| N/A \| Croatia \| 15.84333 \| 46.09333 Osijek \| N/A \| Croatia \| 18.69389 \| 45.55111 Varaždin \| N/A \| Croatia \| 16.33778 \| 46.30444 Zagreb \| N/A \| Croatia \| 15.97798 \| 45.81444 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Aschaffenburg \| N/A \| Germany \| 9.15214 \| 49.97704 Erlangen \| N/A \| Germany \| 11.00783 \| 49.59099 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Melsungen \| N/A \| Germany \| 9.55236 \| 51.13029 Nuremberg \| N/A \| Germany \| 11.07752 \| 49.45421 Saint Ingbert/Oberwürzbach \| N/A \| Germany \| N/A \| N/A Sulzbach-Rosenberg \| N/A \| Germany \| 11.74598 \| 49.50126 Genova \| N/A \| Italy \| 11.87211 \| 45.21604 Pisa \| N/A \| Italy \| 10.4036 \| 43.70853 Pisa \| N/A \| Italy \| 10.4036 \| 43.70853 Siena \| N/A \| Italy \| 11.33064 \| 43.31822 Treviso \| N/A \| Italy \| 12.2416 \| 45.66673 Klaipėda \| N/A \| Lithuania \| 21.13912 \| 55.7068 Vilnius \| N/A \| Lithuania \| 25.2798 \| 54.68916 Brasov \| N/A \| Romania \| 25.60613 \| 45.64861 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Galati \| N/A \| Romania \| 28.05028 \| 45.43687 Târgu Mureş \| N/A \| Romania \| 24.55747 \| 46.54245 Kazan' \| N/A \| Russia \| 49.12214 \| 55.78874 Nizhny Novgorod \| N/A \| Russia \| 44.00205 \| 56.32867 Petrozavodsk \| N/A \| Russia \| 34.34691 \| 61.78491 Smolensk \| N/A \| Russia \| 32.04371 \| 54.77944 Yaroslavl \| N/A \| Russia \| 39.87368 \| 57.62987 Yaroslavl \| N/A \| Russia \| 39.87368 \| 57.62987 Yekaterinburg \| N/A \| Russia \| 60.6122 \| 56.8519 Bratislava \| N/A \| Slovakia \| 17.10674 \| 48.14816 Lučenec \| N/A \| Slovakia \| 19.66708 \| 48.33249 Nové Mesto nad Váhom \| N/A \| Slovakia \| 17.8309 \| 48.75763 Prievidza \| N/A \| Slovakia \| 18.6275 \| 48.77446 Goyang \| N/A \| South Korea \| 127.19731 \| 36.21689 Goyang \| N/A \| South Korea \| 127.19731 \| 36.21689 Incheon \| N/A \| South Korea \| 126.70515 \| 37.45646 Pucheon \| N/A \| South Korea \| N/A \| N/A 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 Uijeongbu-si \| N/A \| South Korea \| 127.0474 \| 37.7415 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Härnösand \| N/A \| Sweden \| 17.93794 \| 62.63228 Lund \| N/A \| Sweden \| 13.19321 \| 55.70584 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Västerås \| N/A \| Sweden \| 16.55276 \| 59.61617 Changhua \| N/A \| Taiwan \| 120.5512 \| 24.0692 Kaohsiung City \| N/A \| Taiwan \| 120.31333 \| 22.61626 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 Taoyuan District \| N/A \| Taiwan \| 121.3187 \| 24.9896 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Odesa \| N/A \| Ukraine \| 30.74383 \| 46.48572 Vinnytsia \| N/A \| Ukraine \| 28.46871 \| 49.2322 Vinnytsia \| N/A \| Ukraine \| 28.46871 \| 49.2322	406	NCT00789035	1COMPLETED	2009-10-01	2008-10-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 3 ]	1	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	Primary objective: To determine whether aspirin (ASA) can lower the incidence of Venous Thromboembolism(VTE) in patients with Glioblastoma (GBM). Secondary objectives: To determine clinical and laboratory factors which are associated with increased risk of VTE If it is determined that ASA reduces the incidence of VTE in patients with GBM, then to determine the clinical and laboratory factors which are associated with an increased benefit from the drug.	Study Drug: Aspirin is designed to make blood less "sticky" and reduce its chances of clotting. By making blood less sticky, it may be less likely to allow a clot to form. Study Groups: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 study groups. If you are assigned to Group 1, you will take aspirin. If you are in Group 2, you will take a placebo. A placebo is a substance that looks like the study drug but has no active ingredients. You will have an equal chance of being placed in either group. Neither you nor your study doctor will know what group you are in. In case of an emergency, the study staff will be able to find out which group you are in. Study Drug Administration: If you are assigned to Group 1, you will take 1 aspirin tablet, once a day, by mouth. Aspirin should be taken with food and may be taken at any time during the day. If you are assigned to Group 2, you will take 1 placebo tablet once a day, by mouth. The placebo should be taken with food and may be taken at any time during the day. Study Visits: While on study you will have tests and procedures performed at the same time as each routine clinical visit and when the study doctor thinks it may be necessary. The following tests and procedures will be performed: * You will have a physical exam. * You will be checked for VTE at each visit. * Blood (2 teaspoons) will be drawn for routine tests at least once every 8 weeks. Blood samples will not be routinely collected if you are not receiving any chemotherapy. * Blood (about 1 teaspoon) will be drawn to see how well your blood clots about 4 months after you begin treatment. If you show signs of VTE, this test will be done on the first visit after the signs are shown. Length of Study: You may remain on-study for as long as you are benefiting. If the disease gets worse or intolerable side effects occur, you may be taken off of the study. End of Study Visit: Once you are off-study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed: * Your complete medical history will be recorded. * You will have a physical exam. * You will have performance status evaluation. * You will be asked about any medications you may be taking. * You will be checked for VTE. * Blood (about 1 teaspoon) will be drawn to see how well your blood clots. * If you have symptoms of VTE, you will have a Doppler ultrasound test of your legs. Follow-up: The study staff will call you or a member of your family every 3 months, after your last clinic visit, to follow your health status. This is an investigational study. Aspirin is approved by the FDA and commercially available. Its use in lowering the risk of VTE is investigational. Aspirin, and the study-related tests/procedures will be provided free of charge to you while on this study. Up to 224 patients will take part in this study. All will be enrolled at M. D. Anderson.	Glioblastoma	Brain Hematologic Disorder Venous Thromboembolism Glioblastoma Aspirin Placebo VTE ASA DVT	null	2	arm 1: Aspirin 325 mg/day orally arm 2: Tablet/day orally	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 325 mg daily by mouth intervention 2: Tablet daily by mouth	intervention 1: Aspirin intervention 2: Placebo	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	1	NCT00790452	6TERMINATED	2009-10-01	2008-11-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 3 ]	215	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	2MALE	false	Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH	This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia and nocturia. The following procedures are utilized; physical exams, electrocardiograms, clinical laboratory tests, vital signs, urinary diary, Pittsburgh Quality of Sleep Index, Nocturia Quality of Life	Nocturia Prostatic Hyperplasia	nocturia BPH benign prostate hyperplasia nocturia in men with benign prostate hyperplasia	null	2	arm 1: None arm 2: None	[ 0, 2 ]	1	[ 0 ]	intervention 1: α1-adrenergic antagonist	intervention 1: silodosin	27	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Laguna Hills \| California \| United States \| -117.71283 \| 33.61252 San Diego \| California \| United States \| -117.16472 \| 32.71571 Aventura \| Florida \| United States \| -80.13921 \| 25.95648 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Sandy Springs \| Georgia \| United States \| -84.37854 \| 33.92427 Coeur d'Alene \| Idaho \| United States \| -116.78047 \| 47.67768 West Des Moines \| Iowa \| United States \| -93.71133 \| 41.57721 Paducah \| Kentucky \| United States \| -88.60005 \| 37.08339 Greenbelt \| Maryland \| United States \| -76.87553 \| 39.00455 Troy \| Michigan \| United States \| -83.14993 \| 42.60559 Missoula \| Montana \| United States \| -113.994 \| 46.87215 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Lawrenceville \| New Jersey \| United States \| -74.7296 \| 40.29733 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Bay Shore \| New York \| United States \| -73.24539 \| 40.7251 New York \| New York \| United States \| -74.00597 \| 40.71427 Williamsville \| New York \| United States \| -78.73781 \| 42.96395 Concord \| North Carolina \| United States \| -80.58158 \| 35.40888 Salisbury \| North Carolina \| United States \| -80.47423 \| 35.67097 Bethany \| Oklahoma \| United States \| -97.63226 \| 35.51867 Bala-Cynwyd \| Pennsylvania \| United States \| -75.23407 \| 40.00761 Myrtle Beach \| South Carolina \| United States \| -78.88669 \| 33.68906 Burien \| Washington \| United States \| -122.34679 \| 47.47038	209	NCT00793819	1COMPLETED	2009-10-01	2009-01-01	Watson Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 4 ]	347	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily \[od\]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.	null	Chronic Obstructive Pulmonary Disease (COPD)	COPD chronic obstructive pulmonary disease indacaterol long acting β2-agonist	null	3	arm 1: Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 2: Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 3: Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI). intervention 2: Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI). intervention 3: Placebo was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).	intervention 1: Indacaterol 150 μg capsules intervention 2: Indacaterol 300 μg capsules intervention 3: Placebo capsules	60	Hong Kong \| N/A \| Hong Kong \| 114.17469 \| 22.27832 New Territories \| N/A \| Hong Kong \| 114.11095 \| 22.42441 Ahmedabad \| N/A \| India \| 72.58727 \| 23.02579 Bangalore \| N/A \| India \| 77.59369 \| 12.97194 Coimbatore \| N/A \| India \| 76.96612 \| 11.00555 Coimbatore \| N/A \| India \| 76.96612 \| 11.00555 India \| N/A \| India \| 75.36261 \| 23.01533 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 Panjim \| N/A \| India \| 73.82624 \| 15.49574 Asahikawa \| N/A \| Japan \| 142.36489 \| 43.77063 Bunkyō City \| N/A \| Japan \| 139.4217 \| 35.5331 Gifu \| N/A \| Japan \| 136.76039 \| 35.42291 Himeji \| N/A \| Japan \| 134.7 \| 34.81667 Hiroshima \| N/A \| Japan \| 132.45 \| 34.4 Iwata \| N/A \| Japan \| 137.85 \| 34.7 Kanazawa \| N/A \| Japan \| 136.61667 \| 36.6 Kawasaki \| N/A \| Japan \| 139.71722 \| 35.52056 Kishiwada \| N/A \| Japan \| 135.36667 \| 34.46667 Kitakyushu \| N/A \| Japan \| 130.85034 \| 33.85181 Kochi \| N/A \| Japan \| 133.53333 \| 33.55 Koga \| N/A \| Japan \| 139.71667 \| 36.18333 Kurume \| N/A \| Japan \| 130.51667 \| 33.31667 Kyoto \| N/A \| Japan \| 135.75385 \| 35.02107 Maebashi \| N/A \| Japan \| 139.08333 \| 36.4 Matsusaka \| N/A \| Japan \| 136.53706 \| 34.57895 Morioka \| N/A \| Japan \| 141.15 \| 39.7 Nagaoka \| N/A \| Japan \| 138.85 \| 37.45 Nagoya \| N/A \| Japan \| 136.90641 \| 35.18147 Noda \| N/A \| Japan \| 139.86793 \| 35.94897 Obihiro \| N/A \| Japan \| 143.20444 \| 42.91722 Sakai \| N/A \| Japan \| 135.46653 \| 34.58216 Sapporo \| N/A \| Japan \| 141.35 \| 43.06667 Sendai \| N/A \| Japan \| 140.86667 \| 38.26667 Seto \| N/A \| Japan \| 137.1 \| 35.23333 Tenri \| N/A \| Japan \| 135.83333 \| 34.58333 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Toyonaka \| N/A \| Japan \| 135.46932 \| 34.78244 Ube \| N/A \| Japan \| 131.25111 \| 33.94306 Wakayama \| N/A \| Japan \| 135.16667 \| 34.23333 Yabu \| N/A \| Japan \| 134.77118 \| 35.40304 Yanagawa \| N/A \| Japan \| 130.4 \| 33.16667 Yokkaichi \| N/A \| Japan \| 136.61667 \| 34.96667 Yokohama \| N/A \| Japan \| 139.65 \| 35.43333 Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Daegu \| N/A \| South Korea \| 128.59111 \| 35.87028 Junggu \| N/A \| South Korea \| 126.60024 \| 37.69175 Kangwon-Do \| N/A \| South Korea \| N/A \| N/A 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 Chiayi City \| N/A \| Taiwan \| 120.44889 \| 23.47917 Kaohsiung City \| N/A \| Taiwan \| 120.31333 \| 22.61626 Keelung \| N/A \| Taiwan \| 121.74094 \| 25.13089 Linkou District \| N/A \| Taiwan \| 121.39348 \| 25.07777 Taichung \| N/A \| Taiwan \| 120.6839 \| 24.1469 Taichung \| N/A \| Taiwan \| 120.6839 \| 24.1469 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Taipei County \| N/A \| Taiwan \| N/A \| N/A Xindian District \| N/A \| Taiwan \| 121.53892 \| 24.96005	347	NCT00794157	1COMPLETED	2009-10-01	2008-11-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	30	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of blood pressure in cardiac surgery patients, as well as to evaluate the efficacy, safety and pharmacokinetics of clevidipine after bolus administration.	Study participants were screened up to 14 days prior to their elective cardiac surgery. For the purpose of this study, hypertension was defined as systolic blood pressure (SBP) ≥140 mm Hg immediately prior to initiation of study drug. On the day of surgery, an IV bolus dose of clevidipine (Bolus 1 - pre-anesthesia) was administered to each eligible study participant during Treatment Period 1 to decrease BP before induction of general anesthesia. The dose (either 125 μg, 250 μg or 500 μg) given was based on the assigned cohort for each participant, listed in the 'Arms' section below. At the discretion of the investigator, a second IV bolus dose of clevidipine (Bolus 2 - with anesthesia) could have been administered during Treatment Period 2 at either 125 μg, 250 μg or 500 μg, based upon the earlier observed response to Bolus 1. This dose was administered after the induction of anesthesia, to decrease BP prior to cannulation of the ascending aorta for initiation of cardiopulmonary bypass. Assessment of safety was performed throughout Treatment Periods 1 and 2 with Adverse Events (AEs) followed 6 hours post final bolus dose and Serious Adverse Events (SAEs) followed 24 hours post final bolus dose.	Hypertension	Hypertension Antihypertensive Agent Calcium Channel Blocker	null	1	arm 1: Patients were sequentially assigned to one of following three planned dose cohorts for Bolus 1 within the clevidipine arm: * Cohort 1: clevidipine 250 µg (0.5 mL) * Cohort 2: clevidipine 500 µg (1 mL) * Cohort 3: clevidipine 125 µg (0.25 mL or 0.5 mL of a 1:1 solution)	[ 0 ]	1	[ 0 ]	intervention 1: Clevidipine (0.5mg/mL in 20% lipid emulsion) was administered as an IV bolus (\<5 sec) by rapid injection for Bolus 1 and for Bolus 2, if second bolus dose was administered, directly into a peripheral venous catheter followed by a normal saline flush (10mL).	intervention 1: clevidipine	2	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	30	NCT00799604	1COMPLETED	2009-10-01	2008-11-01	The Medicines Company	4INDUSTRY	false	false	false	null	0
[ 2 ]	66	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	0ALL	null	This two-part study is designed to select the subcutaneous (SC) dose of Herceptin that results in comparable exposure to intravenous (IV) Herceptin in healthy male participants and in HER2-positive female participants. The study will also assess the safety and tolerability of the SC and IV formulations. In Part 1 of the study, four cohorts will be treated with a single dose of Herceptin as follows: Cohort 1 (6 milligrams per kilogram \[mg/kg\] IV in healthy male participants); Cohort 2 (6 mg/kg IV in HER2-positive female participants); Cohort 3 (6 mg/kg SC in healthy male participants); Cohort 4 (10 mg/kg SC in healthy male participants). An additional cohort of healthy volunteers (Cohort 5) will be opened if both SC dose levels from Cohorts 3 and 4 result in Herceptin exposures different from the target concentration produced by a single IV dose, or if the variability in pharmacokinetic (PK) parameter values cannot be used to define the target SC dose level. In Part 2 of the study, HER2-positive female participants will receive a single dose of SC Herceptin at the dose level defined in Part 1. Participants from Part 1 are eligible to enter Part 2 provided they receive the second (Part 2) study dose of Herceptin a minimum of 22 days after their first (Part 1) dose.	null	Breast Cancer		null	7	arm 1: Healthy male participants will receive Herceptin 6 mg/kg IV on Day 1. arm 2: Female participants with HER2-positive breast cancer will receive Herceptin 6 mg/kg IV on Day 1. arm 3: Healthy male participants will receive Herceptin 6 mg/kg SC on Day 1. arm 4: Healthy male participants will receive Herceptin 10 mg/kg SC on Day 1. arm 5: Healthy male participants will receive Herceptin SC at an adjusted dose level based on preliminary PK analysis of Cohorts 1, 2, 3, and 4. arm 6: Female participants with HER2-positive breast cancer will receive Herceptin SC at the dose level determined in Part 1. arm 7: Female participants with HER2-positive breast cancer will receive Herceptin SC at an adjusted dose level based on preliminary PK analysis of Cohort A.	[ 0, 0, 0, 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: Herceptin will be administered IV or SC at various dosages (depending upon the cohort to which the participant is assigned) on Day 1.	intervention 1: Herceptin	3	East Bentleigh \| N/A \| Australia \| N/A \| N/A Christchurch \| N/A \| New Zealand \| 172.63333 \| -43.53333 Grafton \| N/A \| New Zealand \| 174.76566 \| -36.86029	70	NCT00800436	1COMPLETED	2009-10-01	2008-11-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 5 ]	21	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	true	This study will compare the safety and effectiveness of three different antipsychotic medications, as well as the use of other medications to limit treatment side effects, in adults with schizophrenia.	Schizophrenia is a chronic brain disease affecting approximately 1% of Americans. Antipsychotic medications can treat some of the most severe symptoms of schizophrenia, but they are not a cure, are often taken for long periods of time, and can have severe side effects. Other, secondary medications can provide relief from some of the most common severe side effects. This study will compare the safety and effectiveness of three different antipsychotic medications, as well as the use of additional medications to limit treatment side effects, in adults with schizophrenia. Participation in this study will last 28 to 30 weeks and include 11 visits to a study clinic. Each visit will last 2 to 3 hours. The first 2 visits will include screening and baseline measurements. The screening visit will take place at study entry, and the baseline visit will take place 3 to 14 days later. Study visits will then occur 1, 2, and 4 weeks after the baseline visit, followed by monthly visits. At the baseline visit participants will be randomly assigned to receive olanzapine, perphenazine, or aripiprazole for 28 weeks. Dosage for all three antipsychotic medications will start at low levels and be increased to full strength over 2 weeks. If participants are taking another antipsychotic when they enter the study, this 2-week period will also be used to slowly reduce and then end treatment with the non-study antipsychotic. Side effects to all three antipsychotics will be monitored, and, depending on the side effect, one of three different medications will be added to the treatment regimen. If increased cholesterol levels are experienced with any antipsychotic, simvastatin will be added; if weight gain is experienced, metformin will be added; if involuntary movements, inner restlessness, or muscle stiffness are experienced, benztropine will be added. Because of already known side effects, participants assigned to olanzapine or perphenazine will automatically add metformin or benztropine, respectively, to their regimens. Starting on the third study visit, participants will also undergo a behavioral treatment aimed at reducing cardiovascular risk factors. This behavioral treatment will involve nine 20-minute sessions, with phone calls being made to participants between sessions. During each study visit, assessments will be made of schizophrenia symptoms, side effects, adherence to medication regimen, vital signs, waist circumference, and weight. Participants will also complete a questionnaire on use of health care services and undergo instructions on exercise and eating right. On visits 1, 5, 7, and 11, blood will be drawn for standard lab tests. Additional measures at the screening visit will include questions about medical and psychiatric history, a urine test for drugs, and a questionnaire about physical and social activities.	Schizophrenia	Schizoaffective Disorder	null	3	arm 1: Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects. arm 2: Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects. arm 3: Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.	[ 0, 0, 0 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Daily tablets of 10 to 30 mg intervention 2: Daily tablets of 8 to 24 mg intervention 3: Daily tablets of 10 to 30 mg intervention 4: Daily tablets of 850 to 2550 mg intervention 5: Daily tablets of 20 to 40 mg intervention 6: Daily tablets of 1 to 2 mg	intervention 1: Olanzapine intervention 2: Perphenazine intervention 3: Aripiprazole intervention 4: Metformin intervention 5: Simvastatin intervention 6: Benztropine	13	Colton \| California \| United States \| -117.31365 \| 34.0739 Palo Alto \| California \| United States \| -122.14302 \| 37.44188 New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Glen Burnie \| Maryland \| United States \| -76.62469 \| 39.16261 Worcester \| Massachusetts \| United States \| -71.80229 \| 42.26259 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 New York \| New York \| United States \| -74.00597 \| 40.71427 Butner \| North Carolina \| United States \| -78.75667 \| 36.13209 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328	21	NCT00802100	1COMPLETED	2009-10-01	2008-12-01	National Institute of Mental Health (NIMH)	0NIH	false	false	false	null	0
[ 3 ]	89	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Over the 70-day study period, eligible patients visited the study clinic every 2 weeks (total of 6 visits) and received a 28-day course of aztreonam for inhalation solution (AZLI). The Quality of Life-Bronchiectasis (QOL-B) questionnaire was completed at several time points during the study, in additional to pulmonary function testing and other standard procedures.	null	Bronchiectasis		null	1	arm 1: Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.	[ 0 ]	1	[ 0 ]	intervention 1: 75 mg aztreonam for inhalation solution (AZLI), administered 3 times daily using the PARI Investigational eFlow® Nebulizer System (with a minimum of 4 hours between doses) following administration of a short-acting bronchodilator	intervention 1: AZLI	24	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Orange \| California \| United States \| -117.85311 \| 33.78779 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Farmington \| Connecticut \| United States \| -72.83204 \| 41.71982 New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Olathe \| Kansas \| United States \| -94.81913 \| 38.8814 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Chesterfield \| Missouri \| United States \| -90.57707 \| 38.66311 Mineola \| New York \| United States \| -73.64068 \| 40.74927 New York \| New York \| United States \| -74.00597 \| 40.71427 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Tyler \| Texas \| United States \| -95.30106 \| 32.35126 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	89	NCT00805025	1COMPLETED	2009-10-01	2008-12-01	Gilead Sciences	4INDUSTRY	false	false	false	null	0
[ 5 ]	145	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to biphasic human insulin 30, both in combination with metformin in Chinese insulin-naive subjects with type 2 diabetes when failing on oral antidiabetic drug (OAD) therapy.	null	Diabetes Diabetes Mellitus, Type 2		null	2	arm 1: BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred. arm 2: BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.	[ 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: The initial doses for BIAsp 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 U/kg body weight and to be equally divided (1/2:1/2) between pre-breakfast and pre-dinner intervention 2: The initial doses for BHI 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 IU/kg body weight and to be divided in the ratio of 2/3:1/3 between pre-breakfast and pre-dinner intervention 3: Metformin dose must remain the same as that used prior to the trial.	intervention 1: biphasic insulin aspart 30 intervention 2: biphasic human insulin 30 intervention 3: metformin	1	Beijing \| Beijing Municipality \| China \| 116.39723 \| 39.9075	144	NCT00807092	1COMPLETED	2009-10-01	2008-12-01	Novo Nordisk A/S	4INDUSTRY	false	false	false	null	0
[ 5 ]	22	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to evaluate the combination of galantamine with nimodipine in patients with mixed dementia on cognition and quality of life.	A double-blind (neither the patient nor the physician know the name of the study drug), 6-month, multicenter, placebo-controlled trial to evaluate the combination of galantamine with nimodipine in patients with mixed dementia on cognition and quality of life. The target dose of galantamine is 24 mg/day and nimodipine will be taken in fixed doses of 90 mg/day. Primary outcomes will be measured by a computerized battery of neuropsychological tests and Quality of Life (QoL) scores. Secondary outcomes will be measured by ADAS-cog, Clinical Global Impression (CGI) and Neuropsychiatric Inventory (NPI). Mixed dementia (Alzheimer's Disease (AD) associated with cerebrovascular disease) is one of the most common causes of dementia, which remain largely underdiagnosed. Little is known about specific treatments for this condition. Ischemic lesions by themselves seem to play an important role in cognitive impairment, even in the presence of AD pathology. Hypotheses: - Galantamine 16-24 mg/day in combination with nimodipine 90 mg/day is superior to galantamine monotherapy (16-24 mg/day) in improving or stabilizing cognition in patients with AD associated with cerebrovascular disease (mixed dementia), as measured by the CNTB at 6 months. - Galantamine 16-24 mg/day in combination with nimodipine 90 mg/day is superior to galantamine monotherapy (16-24 mg/day) on QoL measures in this population as measured by QoL - AD at 6 months. Group 1: galantamine oral 8mg/day for a month, 16mg/day for 4 weeks and after 24mg/day until end of study plus nimodipine oral 30mg tid during all study. Group 2: Group 1: galantamine oral 8mg/day for a month, 16mg/day for 4 weeks and after 24mg/day until end of study plus placebo oral 30mg tid during all study.	Dementia	Dementia Mixed Dementia Galantamine Reminyl ER Nimodipine	null	2	arm 1: None arm 2: None	[ 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Galantamine 8 mg/day for one month, followed by 4 weeks of galantamine 16 mg/day. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day. intervention 2: Nimodipine 30 mg 3 times a day (tid). intervention 3: Matching placebo three times a day (tid).	intervention 1: Galantamine intervention 2: Nimodipine intervention 3: Placebo	0	null	21	NCT00814658	1COMPLETED	2009-10-01	2008-06-01	Janssen-Cilag Farmaceutica Ltda.	4INDUSTRY	false	false	false	null	0
[ 3 ]	60	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. The purpose of this study is to investigate safety (if there are any side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following shoulder surgery.	null	Postoperative Pain	Postoperative pain shoulder surgery opioid	null	2	arm 1: 5.0 mL SABER-Bupivacaine/Once arm 2: 5.0 mL SABER-Placebo/Once	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once intervention 2: Injectable Solution; 5.0 mL SABER-Placebo/Once	intervention 1: SABER-Bupivacaine intervention 2: SABER-Placebo	9	Westmead \| New South Wales \| Australia \| 150.98768 \| -33.80383 Kippa-Ring \| Queensland \| Australia \| 153.0835 \| -27.22586 Adelaide \| South Australia \| Australia \| 138.59863 \| -34.92866 Toorak Gardens \| South Australia \| Australia \| 138.63639 \| -34.93478 Geelong \| Victoria \| Australia \| 144.36069 \| -38.14711 Hampton \| Victoria \| Australia \| 145.0 \| -37.95 Ringwood East \| Victoria \| Australia \| 145.25 \| -37.81667 Christchurch \| N/A \| New Zealand \| 172.63333 \| -43.53333 Hamilton \| N/A \| New Zealand \| 175.28333 \| -37.78333	60	NCT00818363	1COMPLETED	2009-10-01	2008-12-01	Durect	4INDUSTRY	false	false	false	null	0
[ 3, 4 ]	84	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to compare the effectiveness of lithium combined with riluzole to riluzole combined with placebo in people with amyotrophic lateral sclerosis.	Amyotrophic lateral sclerosis (ALS) is a rare, neurodegenerative disorder that results in progressive wasting and paralysis of voluntary muscles. In this double blind, randomized, placebo-controlled clinical trial, researchers will evaluate the safety and effectiveness of the drug lithium given in combination with riluzole, a drug commonly used to treat ALS, compared to a placebo given in combination with riluzole. Approximately 250 participants will be recruited from multiple centers, in the US and Canada, that belong to the Northeast ALS Consortium (NEALS) and the Canadian ALS Clinical Trials and Research Network (CALS). Enrollment will occur in stages. Initially 84 participants will be enrolled in the trial. An interim analysis using available data will occur after the 84th participant is enrolled. During this time, the Data and Safety Monitoring Board (DSMB) appointed by the National Institutes of Health (NIH) may decide to stop the trial for efficacy or futility reasons or to stop enrollment and request that follow-up continue with the 84 participants already enrolled in the trial, or the DSMB may decide to continue enrollment. Participants will be randomized to one of two arms of the study. Arm one will receive lithium and riluzole. Arm two will receive riluzole and placebo (an inactive substance). All participants will be receiving riluzole. After screening and randomization, participants will be followed every 4 weeks for the first 12 weeks. Subsequent in-person visits will occur every 8 weeks with a final visit at week 52. Between in-person visits, telephone interviews will take place every 4 weeks to administer the Amyotropic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) questionnaire. A follow-up telephone interview will occur at week 56 (off study medication) to review adverse events. The primary outcome measure is disease progression as measured by the ALSFRS-R questionnaire. Participants randomized to placebo whose disease progresses will be crossed over to lithium for the remaining period of the study (up to 52 weeks total). Duration of the study for participants is 56 weeks which includes 52 weeks of treatment and a followup telephone interview at week 56.	Amyotrophic Lateral Sclerosis	Amyotrophic lateral sclerosis ALS Lou Gehrig's disease riluzole lithium neurodegeneration	null	2	arm 1: Participants randomized to lithium/riluzole (randomization is 1:1 lithium/riluzole to placebo/riluzole, i.e., participants have an equal chance of getting randomized to lithium vs. placebo). arm 2: Participants randomized to placebo/riluzole (randomization is 1:1 lithium/riluzole to placebo/riluzole, i.e., participants have an equal chance of getting randomized to lithium vs. placebo).	[ 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Participants will receive capsules that contain 150 milligrams (mg) lithium carbonate. Participants will be randomized to lithium/riluzole or placebo/riluzole and treated for 52 weeks. Participants originally randomized to placebo who fail (progress) will crossover to lithium for the remainder of the trial. intervention 2: All participants enrolled in this study will be taking a stable dose of riluzole 50 milligrams (mg) by mouth (PO) twice per day (BID) for at least 30 days prior to screening. intervention 3: an inactive substance	intervention 1: Lithium Carbonate intervention 2: Riluzole intervention 3: placebo	37	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Charlestown \| Massachusetts \| United States \| -71.062 \| 42.37787 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 New York \| New York \| United States \| -74.00597 \| 40.71427 Syracuse \| New York \| United States \| -76.14742 \| 43.04812 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Burlington \| Vermont \| United States \| -73.21207 \| 44.47588 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931 Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Winnipeg \| Manitoba \| Canada \| -97.14704 \| 49.8844 Fredericton \| New Brunswick \| Canada \| -66.66558 \| 45.94541 Halifax \| Nova Scotia \| Canada \| -63.57688 \| 44.64269 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Kingston \| Ontario \| Canada \| -76.48098 \| 44.22976 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 Saskatoon \| Saskatchewan \| Canada \| -106.66892 \| 52.13238	84	NCT00818389	6TERMINATED	2009-10-01	2009-01-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0
[ 3 ]	68	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study compared the blunting effect of aliskiren and valsartan monotherapies on exercise-induced rises in systolic blood pressure in patients with mild to moderate essential hypertension.	null	Hypertension	hypertension systolic blood pressure exercise test cardiovascular disease aliskiren valsartan	null	2	arm 1: For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days). arm 2: For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).	[ 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Aliskiren was supplied in 150 mg tablets. intervention 2: Valsartan was supplied in 160 mg capsules. intervention 3: Placebo to aliskiren was supplied in tablets matching aliskiren 150 mg. intervention 4: Placebo to valsartan was supplied in capsules matching valsartan 160 mg.	intervention 1: Aliskiren intervention 2: Valsartan intervention 3: Placebo to aliskiren intervention 4: Placebo to valsartan	8	Pardubice \| N/A \| Czechia \| 15.77659 \| 50.04075 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Nyíregyháza \| N/A \| Hungary \| 21.71671 \| 47.95539 Pilisvörösvár \| N/A \| Hungary \| 18.90893 \| 47.61386 Szentendre \| N/A \| Hungary \| 19.07561 \| 47.66943 Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Leicester \| N/A \| United Kingdom \| -1.13169 \| 52.6386	68	NCT00819767	1COMPLETED	2009-10-01	2009-02-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 4 ]	1,123	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.	null	Chronic Obstructive Pulmonary Disease (COPD)	respiratory dyspnea breathlessness COPD indacaterol long-acting β2-agonist	null	2	arm 1: Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 2: Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	[ 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Indacaterol 150 μg was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI). intervention 2: Salmeterol 50 μg was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]). intervention 3: Placebo to indacaterol was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI). intervention 4: Placebo to salmeterol was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]).	intervention 1: Indacaterol 150 µg intervention 2: Salmeterol 50 µg intervention 3: Placebo to indacaterol intervention 4: Placebo to salmeterol	144	Anniston \| Alabama \| United States \| -85.83163 \| 33.65983 Fairhope \| Alabama \| United States \| -87.90333 \| 30.52297 Jasper \| Alabama \| United States \| -87.27751 \| 33.83122 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Glendale \| Arizona \| United States \| -112.18599 \| 33.53865 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Buena Park \| California \| United States \| -117.99812 \| 33.86751 Encinitas \| California \| United States \| -117.29198 \| 33.03699 Fullerton \| California \| United States \| -117.92534 \| 33.87029 Rancho Mirage \| California \| United States \| -116.41279 \| 33.73974 Riverside \| California \| United States \| -117.39616 \| 33.95335 San Diego \| California \| United States \| -117.16472 \| 32.71571 Torrance \| California \| United States \| -118.34063 \| 33.83585 Walnut Creek \| California \| United States \| -122.06496 \| 37.90631 Fort Collins \| Colorado \| United States \| -105.08442 \| 40.58526 Wheat Ridge \| Colorado \| United States \| -105.07721 \| 39.7661 Stamford \| Connecticut \| United States \| -73.53873 \| 41.05343 Newark \| Delaware \| United States \| -75.74966 \| 39.68372 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Pensacola \| Florida \| United States \| -87.21691 \| 30.42131 Pensacola \| Florida \| United States \| -87.21691 \| 30.42131 South Miami \| Florida \| United States \| -80.29338 \| 25.7076 Tamarac \| Florida \| United States \| -80.24977 \| 26.21286 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Normal \| Illinois \| United States \| -88.99063 \| 40.5142 River Forest \| Illinois \| United States \| -87.81395 \| 41.89781 Skokie \| Illinois \| United States \| -87.73339 \| 42.03336 Olathe \| Kansas \| United States \| -94.81913 \| 38.8814 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Madisonville \| Kentucky \| United States \| -87.49889 \| 37.3281 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Opelousas \| Louisiana \| United States \| -92.08151 \| 30.53353 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Livonia \| Michigan \| United States \| -83.35271 \| 42.36837 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Saint Charles \| Missouri \| United States \| -90.48123 \| 38.78394 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Lincoln \| Nebraska \| United States \| -96.66696 \| 40.8 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Henderson \| Nevada \| United States \| -114.98194 \| 36.0397 Reno \| Nevada \| United States \| -119.8138 \| 39.52963 Cherry Hill \| New Jersey \| United States \| -75.03073 \| 39.93484 Summit \| New Jersey \| United States \| -74.36468 \| 40.71562 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Larchmont \| New York \| United States \| -73.7518 \| 40.92788 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Hickory \| North Carolina \| United States \| -81.3412 \| 35.73319 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Shelby \| North Carolina \| United States \| -81.53565 \| 35.29235 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Willoughby Hills \| Ohio \| United States \| -81.41845 \| 41.59838 Tulsa \| Oklahoma \| United States \| -95.99277 \| 36.15398 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Medford \| Oregon \| United States \| -122.87559 \| 42.32652 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Erie \| Pennsylvania \| United States \| -80.08506 \| 42.12922 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 North Charleston \| South Carolina \| United States \| -79.97481 \| 32.85462 Spartanburg \| South Carolina \| United States \| -81.93205 \| 34.94957 Union \| South Carolina \| United States \| -81.62371 \| 34.71541 El Paso \| Texas \| United States \| -106.48693 \| 31.75872 Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Abingdon \| Virginia \| United States \| -81.97735 \| 36.70983 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389 Cvikov \| N/A \| Czechia \| 14.63298 \| 50.77668 Kyjov \| N/A \| Czechia \| 17.12253 \| 49.01018 Lovosice \| N/A \| Czechia \| 14.05103 \| 50.51504 Neratovice \| N/A \| Czechia \| 14.51759 \| 50.25926 Ostrava \| N/A \| Czechia \| 18.28204 \| 49.83465 Pardubice \| N/A \| Czechia \| 15.77659 \| 50.04075 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Teplice \| N/A \| Czechia \| 13.82451 \| 50.6404 Aschaffenburg \| N/A \| Germany \| 9.15214 \| 49.97704 Augsburg \| N/A \| Germany \| 10.89851 \| 48.37154 Backnang \| N/A \| Germany \| 9.43718 \| 48.94743 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Bielefeld \| N/A \| Germany \| 8.53333 \| 52.03333 Borstel \| N/A \| Germany \| 8.96896 \| 52.67034 Dortmund \| N/A \| Germany \| 7.466 \| 51.51494 Duisburg \| N/A \| Germany \| 6.76516 \| 51.43247 Frankfurt \| N/A \| Germany \| 10.53333 \| 49.68333 Geesthacht \| N/A \| Germany \| 10.3779 \| 53.43575 Hagen \| N/A \| Germany \| 7.47168 \| 51.36081 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Karlsruhe \| N/A \| Germany \| 8.40444 \| 49.00937 Kiel \| N/A \| Germany \| 10.13489 \| 54.32133 Leipzig \| N/A \| Germany \| 12.37129 \| 51.33962 Lübeck \| N/A \| Germany \| 10.68729 \| 53.86893 Mainz \| N/A \| Germany \| 8.2791 \| 49.98419 Marburg \| N/A \| Germany \| 8.77069 \| 50.80904 Neumünster \| N/A \| Germany \| 9.98456 \| 54.07399 Oschersleben \| N/A \| Germany \| 11.22898 \| 52.03039 Rüdersdorf \| N/A \| Germany \| 13.78631 \| 52.46927 Weyhe \| N/A \| Germany \| 8.66667 \| 52.96667 Wiesloch \| N/A \| Germany \| 8.69846 \| 49.29504 Witten \| N/A \| Germany \| 7.35258 \| 51.44362 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Debrecen \| N/A \| Hungary \| 21.62444 \| 47.53167 Deszk \| N/A \| Hungary \| 20.24322 \| 46.21802 Mosonmagyaróvár \| N/A \| Hungary \| 17.26994 \| 47.86789 Nyíregyháza \| N/A \| Hungary \| 21.71671 \| 47.95539 Tatabánya \| N/A \| Hungary \| 18.39325 \| 47.58494 Törökbálint \| N/A \| Hungary \| 18.91356 \| 47.42931 Chennai \| N/A \| India \| 80.27847 \| 13.08784 Hyderabad \| N/A \| India \| 78.45636 \| 17.38405 Jaipur \| N/A \| India \| 75.78781 \| 26.91962 Mangalore \| N/A \| India \| 74.85603 \| 12.91723 Panjim \| N/A \| India \| 73.82624 \| 15.49574 Pune \| N/A \| India \| 73.85535 \| 18.51957 Trivandrum \| N/A \| India \| 76.94924 \| 8.4855 Vellore \| N/A \| India \| 79.13255 \| 12.9184 Bojnice \| N/A \| Slovakia \| 18.5864 \| 48.78511 Bratislava \| N/A \| Slovakia \| 17.10674 \| 48.14816 Humenné \| N/A \| Slovakia \| 21.91625 \| 48.93707 Košice \| N/A \| Slovakia \| 21.25808 \| 48.71395 Liptovský Hrádok \| N/A \| Slovakia \| 19.72335 \| 49.03962 Partizánske \| N/A \| Slovakia \| 18.38455 \| 48.62861 Spišská Nová Ves \| N/A \| Slovakia \| 20.56153 \| 48.94464 A Coruña \| N/A \| Spain \| -8.396 \| 43.37135 Alicante \| N/A \| Spain \| -0.48149 \| 38.34517 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Cáceres \| N/A \| Spain \| -6.37224 \| 39.47649 Córdoba \| N/A \| Spain \| -4.77275 \| 37.89155 Mérida \| N/A \| Spain \| -6.34366 \| 38.91611 Ourense \| N/A \| Spain \| -7.86407 \| 42.33669 Valencia \| N/A \| Spain \| -0.37966 \| 39.47391 Altunizade \| N/A \| Turkey (Türkiye) \| 29.04794 \| 41.01779 Istanbul \| N/A \| Turkey (Türkiye) \| 28.94966 \| 41.01384 Izmir \| N/A \| Turkey (Türkiye) \| 27.13838 \| 38.41273 Kartal/Istanbul \| N/A \| Turkey (Türkiye) \| N/A \| N/A Kinikli / Denizli \| N/A \| Turkey (Türkiye) \| N/A \| N/A Mersin \| N/A \| Turkey (Türkiye) \| 34.63886 \| 36.81196 Yenisehir/Izmir \| N/A \| Turkey (Türkiye) \| N/A \| N/A	1,121	NCT00821093	1COMPLETED	2009-10-01	2009-01-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 5 ]	5	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study will assess the safety, tolerability, and efficacy of Alefacept in patient with moderate to severe atopic dermatitis who could not be adequately controlled with topical therapies.	Atopic dermatitis is a chronic inflammatory skin disease associated with cutaneous hyper-reactivity to environmental triggers that are generally innocuous to healthy, nonatopic individuals (Leung et al. 2004). Acute eczematous skin lesions in atopic dermatitis are characterized by marked epidermal intercellular edema (spongiosis). Chronic lesions are characterized by an acanthotic epidermis with elongation of the rete ridges, parakeratosis, and minimal spongiosis (Leung and Bieber 2003). A significant mixed inflammatory cell infiltrate is present in both acute and chronic skin lesions, consisting of lymphocytes, immunoglobulin E (IgE)-bearing Langerhans cells, inflammatory dendritic epidermal cells, and macrophages. Eosinophils are also present in varying levels (Leung and Bieber 2003). Activation and skin-selective homing of peripheral blood T lymphocytes and their subsequent effector functions in the skin represent sequential immunologic events in the pathogenesis of atopic dermatitis (Akdis et al. 2000). More than 90% of skin-infiltrating T lymphocytes in inflammatory skin diseases such as atopic dermatitis express CD44- and the oligosaccharide determinant cutaneous lymphocyte-associated antigen (CLA) (Berg et al. 1991). The migration of CD4+, CLA-positive T lymphocytes across cytokine-activated endothelial cell layers has 2 been shown to be dependent on the interaction of lymphocyte function-associated antigen (LFA)-1 and intercellular adhesion molecule (ICAM)-1 (Santamaria Babi et al. 1995). The activation of T lymphocytes plays an important role in atopic dermatitis pathogenesis. In acute atopic dermatitis, a T-helper (TH)2 cytokine profile is predominantly seen, with increased expression of interleukin (IL)-4, lL-5, and IL-13 (Stone 2003). In chronic atopic dermatitis, the cytokine profile changes to a TH1 predominant profile, with increased expression of interferon y (IFN-y) (Leung et al. 2004). Activated T lymphocytes also are responsible for direct cell-mediated keratinocyte apoptosis, which contributes to the spongiosis pattern of epidermal injury characteristic of acute atopic dermatitis (Trautmann et al. 2001), The interaction of T lymphocytes with antigen-presenting cells (APCs) is one of the initial steps in T lymphocyte activation of an immunologic response to what is perceived by the immune system to be a foreign antigen. Although much attention has been focused on the primary interaction of the T lymphocyte receptor with the major histocompatability complex (MHC)-antigen complex on the APC, several other cell surface components are also involved in, and necessary for, T lymphocyte activation. Ligand pairs necessary for T lymphocyte activation, located on the cell surface of the T lymphocytes and the APC, respectively, include CD2/LFA-3, LFA-1/ICAM-1 (also ICAM-2 and ICAM-3), CD281B7, CD4/MHC Class II, and CD8/MHC Class I. CD2 interaction with LFA.-3 is necessary for T lymphocyte activation, binding, and T-helper cell responses. (Fischer et al. 1986; Springer et al. 1987) Anievive® (Alefacept) is a dimeric fusion protein that consists of the extracellular CD2 binding portion of the human leukocyte function antigen -3 (LFA-3) linked to the Fc portion of IgG1. Amevive® interferes with lymphocyte activation by specifically binding to CD2 on lymphocytes thereby inhibiting LFA-3/CD2 interaction. Amevive® causes a reduction in CD4+ lymphocytes which play a role in atopic dermatitis. Currently, Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other "biologics" for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. (1-Lodak and David, 2004) Ten atopic patients who meet the inclusion/exclusion criteria will be enrolled in the study.	Atopic Dermatitis	Atopic Dermatitis chronic skin	null	1	arm 1: Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis at a dose of 15mg IM every week for 12 weeks. Unlike other "biologics" for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes.	[ 0 ]	1	[ 0 ]	intervention 1: Alefacept 15mg IM every week for 12 weeks	intervention 1: Alefacept	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	5	NCT00832585	1COMPLETED	2009-10-01	2008-01-01	Rush University Medical Center	7OTHER	false	false	false	null	0
[ 0 ]	18	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	1FEMALE	null	The primary objective of this study is to determine the efficacy of phosphatidylcholine and deoxycholate subcutaneous injections for localized fat removal. Subcutaneous injections of the study drug will be efficacious in decreasing localized fat deposits due to the known fat necrosis effects on fat tissue after study drug tissue incubation.	This study is a randomized, double-blind study of 21 subjects. Participants in this study will be healthy, non-obese (BMI \<30) subjects over 25 with two localized, symmetrical, and contralateral areas of fat deposition on the abdomen or flanks and on the buttocks or thighs that have proven resistant to diet and exercise. Each participant will be randomized to one of three groups and will receive 4 series of injections two weeks apart. Multiple injections will be placed in the subdermal fat layer from 1-1.5 cm apart depending on the size of the treatment area. Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections. The study sites will include a symmetric, contralateral area of localized fat deposit on both the upper and lower torso. Clinical evaluations will be performed at each visit. Hematologic and ultrasonographic evaluations will be performed at baseline, at the 3rd treatment (Week 4), and at 6 month follow-up. Histologic evaluations will be performed on select individuals at baseline and at the 3rd treatment (Week 4) visit.	Obesity		null	3	arm 1: Phosphatidylcholine Deoxycholate Injections. Group C will receive only study drug injections arm 2: Group A will serve as a control and will receive only injections of saline as a placebo. arm 3: Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side.	[ 0, 2, 1 ]	2	[ 0, 0 ]	intervention 1: Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections intervention 2: Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections	intervention 1: Phosphatidylcholine Deoxycholate intervention 2: Saline	1	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	18	NCT00851747	6TERMINATED	2009-10-01	2009-02-01	The Cleveland Clinic	7OTHER	false	false	false	null	0
[ 5 ]	1,009	RANDOMIZED	PARALLEL	2DIAGNOSTIC	2DOUBLE	false	0ALL	false	This study is intended to determine the safety and tolerance of regadenoson in subjects with asthma or chronic obstructive pulmonary disease.	null	Asthma Coronary Artery Disease Pulmonary Disease, Chronic Obstructive	regadenoson CVT 3146 asthma coronary artery disease pulmonary disease, chronic obstructive	null	4	arm 1: Matching intravenous (IV) bolus injection, subjects with Asthma arm 2: 0.4mg / 5mL intravenous bolus injection, subjects with Asthma arm 3: Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD) arm 4: 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	[ 2, 0, 2, 0 ]	2	[ 0, 0 ]	intervention 1: IV intervention 2: IV	intervention 1: Regadenoson intervention 2: Placebo	48	Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Encinitas \| California \| United States \| -117.29198 \| 33.03699 Fullerton \| California \| United States \| -117.92534 \| 33.87029 Huntington Beach \| California \| United States \| -117.99923 \| 33.6603 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Mission Viejo \| California \| United States \| -117.672 \| 33.60002 Roseville \| California \| United States \| -121.28801 \| 38.75212 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 Santa Ana \| California \| United States \| -117.86783 \| 33.74557 Waterbury \| Connecticut \| United States \| -73.0515 \| 41.55815 Newark \| Delaware \| United States \| -75.74966 \| 39.68372 Wilmington \| Delaware \| United States \| -75.54659 \| 39.74595 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 DeLand \| Florida \| United States \| -81.30312 \| 29.02832 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Trinity \| Florida \| United States \| -82.68177 \| 28.18085 Winter Park \| Florida \| United States \| -81.33924 \| 28.6 Stockbridge \| Georgia \| United States \| -84.23381 \| 33.54428 Aurora \| Illinois \| United States \| -88.32007 \| 41.76058 Topeka \| Kansas \| United States \| -95.67804 \| 39.04833 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Auburn \| Maine \| United States \| -70.23117 \| 44.09785 No. Dartmouth \| Massachusetts \| United States \| N/A \| N/A Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Plymouth \| Minnesota \| United States \| -93.45551 \| 45.01052 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Papillion \| Nebraska \| United States \| -96.04224 \| 41.15444 Brick \| New Jersey \| United States \| -74.13708 \| 40.05928 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Chardon \| Ohio \| United States \| -81.14899 \| 41.61422 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Medford \| Oregon \| United States \| -122.87559 \| 42.32652 Upland \| Pennsylvania \| United States \| -75.38269 \| 39.85261 Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Easley \| South Carolina \| United States \| -82.60152 \| 34.82984 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Spartanburg \| South Carolina \| United States \| -81.93205 \| 34.94957 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 New Braunfels \| Texas \| United States \| -98.12445 \| 29.703 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Seattle \| Washington \| United States \| -122.33207 \| 47.60621	999	NCT00862641	1COMPLETED	2009-10-01	2009-04-01	Astellas Pharma Inc	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	9	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Cystinosis is an inheritable disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. RP103 is a formulation of cysteamine bitartrate that is being studied to see if it may be able to be given less frequently, once every 12 hours, and have similar results.	This is a single-dose, open-labeled, non-randomized, two-period study of Cysteamine Bitartrate Delayed-release Capsules (RP103) and Cystagon® in up to 10 patients (male or female) with nephropathic cystinosis under fasting conditions. It will involve a 4 night check-in to a clinical research center. Study with completed results acquired from Horizon in 2024	Cystinosis	cystinosis cysteamine inheritable disease orphan disease CTNS protein, human nephropathic cystinosis	null	2	arm 1: Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg arm 2: Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg. Duration of Treatment and Dose: Reference Period up to four doses Q6H. intervention 2: Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg. Duration of treatment and Dose: Single dose of Test Product at dose equivalent to Reference Product.	intervention 1: Cystagon® intervention 2: RP103	1	San Diego \| California \| United States \| -117.16472 \| 32.71571	18	NCT00872729	1COMPLETED	2009-10-01	2009-05-01	Amgen	4INDUSTRY	false	false	false	null	0
[ 5 ]	66	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	1SINGLE	true	0ALL	null	The purpose of this study is to assess if the presence of BAK in a fluoroquinolone in the study eye affects the development of resistant bacteria on the conjunctiva based upon changes in the surface flora over the course of 2 weeks of topical treatment in healthy adult subjects.	null	Anti-biotic Resistance		null	2	arm 1: moxifloxacin 0.5% (m mg/mL), boric acid, sodium chloride, and purified water arm 2: gatifloxacin 0.3% (3 mg/mL), benzalkonium chloride 0.005%, edetate disodium; purified water and sodium chloride	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: 1 drop in study eye three times a day for 14 days intervention 2: 1 drop in study eye four times a day for 14 days	intervention 1: moxifloxacin 0.5% HCI ophthalmic solution intervention 2: gatifloxacin ophthalmic solution 0.3%	2	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Saskatoon \| Saskatchewan \| Canada \| -106.66892 \| 52.13238	66	NCT00874887	1COMPLETED	2009-10-01	2009-03-01	Allergan	4INDUSTRY	false	false	false	null	0
[ 3 ]	100	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.	null	Diabetes Mellitus, Type 2		null	5	arm 1: patient to receive a BI 10773 low dose tablet and a placebo tablet once daily arm 2: patient to receive a BI 10773 middle dose tablet and a placebo tablet once daily arm 3: patient to receive two tablets of BI 10773 middle dose once daily arm 4: patient to receive a BI 10773 high dose tablet and a placebo tablet once daily arm 5: patient to receive two tablets of placebo once daily	[ 0, 0, 0, 0, 2 ]	8	[ 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: Placebo tablets once a day intervention 2: Placebo tablets once a day intervention 3: BI 10773 middle dose tablets once a day intervention 4: BI 10773 high dose tablets once a day intervention 5: BI 10773 middle dose tablets once a day intervention 6: Placebo tablets once a day intervention 7: BI 10773 low dose tablets once a day intervention 8: Placebo tablets once a day	intervention 1: Placebo (middle dose) intervention 2: Placebo intervention 3: BI 10773 intervention 4: BI 10773 intervention 5: BI 10773 intervention 6: Placebo (high dose) intervention 7: BI 10773 intervention 8: Placebo (low dose)	5	Hachioji, Tokyo \| N/A \| Japan \| N/A \| N/A Koganei, Tokyo \| N/A \| Japan \| N/A \| N/A Nakano-ku, Tokyo \| N/A \| Japan \| N/A \| N/A Suita, Osaka \| N/A \| Japan \| N/A \| N/A Yokohama, Kanagawa \| N/A \| Japan \| N/A \| N/A	100	NCT00885118	1COMPLETED	2009-10-01	2009-04-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 5 ]	1,421	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The objective of this study is to assess the effectiveness, safety, subject satisfaction and quality of life with Oracea® when used as monotherapy or as add-on therapy to existing topical regimens for the treatment of rosacea.	null	Rosacea		null	2	arm 1: Oracea as monotherapy arm 2: Oracea® as add-on Therapy (Oracea® + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides	[ 5, 5 ]	2	[ 0, 0 ]	intervention 1: Take once daily in the morning intervention 2: Take once daily in the morning	intervention 1: doxycycline (Oracea®) 40 mg modified release as monotherapy intervention 2: doxycycline (Oracea®) 40 mg modified release as add-on therapy	1	Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869	1,420	NCT00892281	1COMPLETED	2009-10-01	2009-04-01	Galderma R&D	4INDUSTRY	false	false	false	null	0
[ 4 ]	305	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to compare the efficacy, safety and tolerability of rabeprazole extended release (ER) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux disease (sGERD).	null	Symptomatic Gastroesophageal Reflux Disease (sGERD)	Gastroesophageal Reflux Disease GERD	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: One rabeprazole extended release (ER) 50 mg capsule daily; rescue medication will be provided to subjects to take as needed. intervention 2: One rabeprazole placebo capsule daily; rescue medication will be provided to subjects to take as needed.	intervention 1: rabeprazole sodium intervention 2: Placebo	98	Athens \| Alabama \| United States \| -86.97219 \| 34.80243 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Encinitas \| California \| United States \| -117.29198 \| 33.03699 Irvine \| California \| United States \| -117.82311 \| 33.66946 Lancaster \| California \| United States \| -118.13674 \| 34.69804 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Merced \| California \| United States \| -120.48297 \| 37.30216 Oceanside \| California \| United States \| -117.37948 \| 33.19587 Orange \| California \| United States \| -117.85311 \| 33.78779 Pasadena \| California \| United States \| -118.14452 \| 34.14778 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 Wheat Ridge \| Colorado \| United States \| -105.07721 \| 39.7661 Bridgeport \| Connecticut \| United States \| -73.18945 \| 41.17923 Altamonte Springs \| Florida \| United States \| -81.36562 \| 28.66111 Boynton Beach \| Florida \| United States \| -80.06643 \| 26.52535 Cape Coral \| Florida \| United States \| -81.94953 \| 26.56285 Hialeah \| Florida \| United States \| -80.27811 \| 25.8576 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami \| Florida \| United States \| -80.19366 \| 25.77427 New Smyrna Beach \| Florida \| United States \| -80.927 \| 29.02582 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Wellington \| Florida \| United States \| -80.24144 \| 26.65868 Zephyrhills \| Florida \| United States \| -82.18119 \| 28.23362 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Newnam \| Georgia \| United States \| N/A \| N/A Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Lake Charles \| Louisiana \| United States \| -93.2044 \| 30.21309 Metairie \| Louisiana \| United States \| -90.15285 \| 29.98409 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Hagerstown \| Maryland \| United States \| -77.71999 \| 39.64176 Hollywood \| Maryland \| United States \| -76.5858 \| 39.07511 Chesterfield \| Michigan \| United States \| -82.84242 \| 42.66281 Troy \| Michigan \| United States \| -83.14993 \| 42.60559 Chaska \| Minnesota \| United States \| -93.60218 \| 44.78941 Mexico \| Missouri \| United States \| -91.88295 \| 39.16976 Butte \| Montana \| United States \| -112.53474 \| 46.00382 Haddon Heights \| New Jersey \| United States \| -75.06462 \| 39.87734 Ocean City \| New Jersey \| United States \| -74.5746 \| 39.27762 Vineland \| New Jersey \| United States \| -75.02573 \| 39.48623 Voorhees Township \| New Jersey \| United States \| -74.49062 \| 40.4795 Great Neck \| New York \| United States \| -73.72846 \| 40.80066 Great Neck \| New York \| United States \| -73.72846 \| 40.80066 Lake Success \| New York \| United States \| -73.71763 \| 40.77066 Pittsford \| New York \| United States \| -77.515 \| 43.09062 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Asheville \| North Carolina \| United States \| -82.55402 \| 35.60095 Boone \| North Carolina \| United States \| -81.67455 \| 36.21679 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Fayetteville \| North Carolina \| United States \| -78.87836 \| 35.05266 Greesnboro \| North Carolina \| United States \| N/A \| N/A High Point \| North Carolina \| United States \| -80.00532 \| 35.95569 Jacksonville \| North Carolina \| United States \| -77.43024 \| 34.75405 Kinston \| North Carolina \| United States \| -77.58164 \| 35.26266 New Bern \| North Carolina \| United States \| -77.04411 \| 35.10849 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Rutherford College \| North Carolina \| United States \| -81.52259 \| 35.74846 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Gallipolis \| Ohio \| United States \| -82.20237 \| 38.8098 Mentor \| Ohio \| United States \| -81.33955 \| 41.66616 Perrysburg \| Ohio \| United States \| -83.62716 \| 41.557 Norman \| Oklahoma \| United States \| -97.43948 \| 35.22257 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Simpsonville \| South Carolina \| United States \| -82.25428 \| 34.73706 Franklin \| Tennessee \| United States \| -86.86889 \| 35.92506 Jackson \| Tennessee \| United States \| -88.81395 \| 35.61452 Johnson City \| Tennessee \| United States \| -82.35347 \| 36.31344 Joshson City \| Tennessee \| United States \| N/A \| N/A Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Corsicana \| Texas \| United States \| -96.46887 \| 32.09543 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Laredo \| Texas \| United States \| -99.50754 \| 27.50641 Odessa \| Texas \| United States \| -102.36764 \| 31.84568 Overland Park \| Texas \| United States \| N/A \| N/A San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Sugar Land \| Texas \| United States \| -95.63495 \| 29.61968 Bountiful \| Utah \| United States \| -111.88077 \| 40.88939 Ogden \| Utah \| United States \| -111.97383 \| 41.223 West Valley City \| Utah \| United States \| -112.00105 \| 40.69161 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931 Christiansburg \| Virginia \| United States \| -80.40894 \| 37.12985 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389 Monroe \| Wisconsin \| United States \| -89.63845 \| 42.60112	299	NCT00911534	1COMPLETED	2009-10-01	2009-01-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	205	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	1FEMALE	false	Randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study in approximately 201 postmenopausal women. A subset of subjects (approximately 102) will also participate in a pharmacokinetic (PK) component of the study. Each subject will be randomized to 1 of 3 treatment regimens for 3 months.	null	Postmenopausal Osteoporosis		null	3	arm 1: 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast. arm 2: 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast arm 3: 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast	[ 1, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast. intervention 2: 75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast intervention 3: 100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast	intervention 1: 150 mg intervention 2: 75 mg intervention 3: 100 mg	6	Daytona Beach \| Florida \| United States \| -81.02283 \| 29.21081 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Honolulu \| Hawaii \| United States \| -157.85833 \| 21.30694 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Dallas \| Texas \| United States \| -96.80667 \| 32.78306	204	NCT00918749	1COMPLETED	2009-10-01	2009-05-01	Warner Chilcott	4INDUSTRY	false	false	false	null	0
[ 3 ]	102	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This was a multi-center, randomized, double-blind, parallel group study. Efficacy Objectives: To evaluate the efficacy of CD2027 ointment 3 mcg/g applied twice daily over 4 weeks versus its vehicle in adult participants with at least moderate atopic dermatitis. Safety objective: To evaluate safety of CD2027 ointment 3 mcg/g when applied twice daily over 4 weeks versus its vehicle on 5 percent (%) - 20% involved Body Surface Area (BSA) (excluding Head/Neck) in adult participants with at least moderate atopic dermatitis.	null	Atopic Dermatitis	Dermatitis, Atopic	null	2	arm 1: Participants applied 3 mcg/g CD2027 Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions. arm 2: Participants applied Vehicle Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Topical Ointment intervention 2: Topical Ointment	intervention 1: CD2027 Ointment 3 mcg/g, twice daily intervention 2: Vehicle Ointment, twice daily	14	Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 San Diego \| California \| United States \| -117.16472 \| 32.71571 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Longmont \| Colorado \| United States \| -105.10193 \| 40.16721 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Fridley \| Minnesota \| United States \| -93.26328 \| 45.08608 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Arlington \| Texas \| United States \| -97.10807 \| 32.73569 Austin \| Texas \| United States \| -97.74306 \| 30.26715 College Station \| Texas \| United States \| -96.33441 \| 30.62798	102	NCT00919763	1COMPLETED	2009-10-01	2009-05-21	Galderma R&D	4INDUSTRY	false	false	false	null	0
[ 0 ]	20	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	false	To evaluate which of the two de-airing methods (CO2 insufflation vs. Lund de-airing technique) can shorten the left heart de-airing time and prevent or minimize cerebral air emboli during open surgery involving exposure of the left heart to the ambient air. To evaluate the cost effectiveness and possible side effects of CO2 de-airing technique compared to Lund de-airing technique.	Study design: Prospective, randomized and controlled study involving 20 patients, 10 in each group. The de-airing time and the efficiency of the techniques will be assessed by trans-esophageal echocardiography (TEE) and trans-cranial echo-doppler monitoring (TCD). The cardiologists analyzing the TEE recordings will be blinded to the de-airing technique used (the recorded videos will be analyzed at the end of the study). The TCD monitoring will be done by on-line automatic recording of the micro embolic signals (MES) from the right and or left middle cerebral arteries and performed by single surgeon. The CO2 insufflation of the operating field will be performed according to manufacturer's guide lines. During entire study course one type of extracorporeal perfusion system will be used.The study will be registered in the international database. A prior approval will be sought from the hospital ethical committee for the study. Patient selection: Patients planned for aortic valve/root replacement or repair will be selected for the study Exclusion criteria: Patients with known: a) chronic obstructive pulmonary disease, b) emphysema, c) previous thoracic or cardiac surgery, d) history of CVA or stroke and e) evidence of intraoperative pleural adhesions will be excluded from the study. Patients requiring internal mammary artery coronary bypass will also be excluded. Patient consent: A written consent previously approved by the hospital ethical committee will be obtained from all patients before they are enrolled in the study (enclosure 3). De-airing procedure: Enrolled patients will be assigned randomly to one of the two following groups: Control group ( newly developed de-airing technique in Lund ) : In these patients (n=10) the pleura will be opened on both sides and the ventilator will be disconnected before aorta is cross-clamped and cardioplegia administered. At the end of the cardioplegic arrest, the aortic root and the LV will be actively vented and aortic cross clamp released. The time will be noted down (T1). The heart will be defibrillated to sinus or pacemaker induced rhythm. The heart will be kept empty by the LV vent and ejection avoided as monitored by continual intraoperative TEE and systemic arterial pressure tracing. At 35 Celsius body temperature, as measured from the thermistor in the urinary bladder, and with apparently good cardiac contraction the de-airing will begin. Inotropic drugs or systemic arterial vasodilators will be used as and when necessary to achieve good cardiac contraction. The time will be noted down (T2) (T2 - T1 = Pre ejection de-airing time). The LV preload will first now be successively increased by reducing the venous return from the heart-lung machine to raise CVP between 5-10 cm water. LV vent will be continuously regulated depending upon the amount of residual air showing in the left heart. When no air is seen on TEE monitoring in the left heart (LA, LV \& Aorta), half the calculated minute ventilation with 100% oxygen and a PEEP of 5 cm H2O will be started. De-airing will be continued and when the TEE shows no or minimal air in left heart, full ventilation with unchanged PEEP will be restored. The patient will be weaned successively from the CPB thereby ensuring that entire cardiac output is diverted through the native fully ventilated lungs. When TEE will show no air in the left heart, the de-airing will be considered complete and the time noted again (T3) (T3 - T2 = Post ejection de-airing time). All cardiac cannulae including the LV vent will be left in situ but clamped, patient weaned completely from the cardiopulmonary bypass and monitored for residual air by TEE \& TCD for 10 minutes continually. The LV vent will be re-opened whenever the residual air in the left heart exceeds grade II. The frequency of theses measures will be noted in the protocol. If the patient has by now achieved 36 Celsius core temperature, the heart will be decannulated and CPB removed. Otherwise CPB will be restarted and patient warmed to 36 Celsius before final weaning and decannulation. Study group ( CO2 insufflation ): In these patients (n=10) the pleurae will not be opened. During aortic cross-clamp period the ventilator will be adjusted to provide dead space ventilation only i.e. 5cm PEEP, ventilator frequency 5/min and the minute ventilation = 1,5 liter. Fio2 = 50%. The operating field will be insufflated with CO2 at a flow rate of 10 L / minute starting 2 minutes before cardiac cannulation and continued until 10 minutes after termination of the CPB. At the end of the cardioplegic arrest, the aortic root and the LV will be actively vented and the time noted down (T1). The LV preload will be successively increased by reducing the venous return from the heart-lung machine to raise CVP between 5-10 cm water. LV venting will be continued and when no air bubbles are seen in the left heart (LA, LV \& Aorta) under TEE monitoring, the calculated minute ventilation with 100% oxygen and PEEP of 5 cm H2O will be restored. De-airing will be continued and when no or minimal air is seen in the left heart the time will be noted down (T2) (T2 - T1 = Pre ejection de-airing time). Aortic cross-clamp will be released now and heart defibrillated to sinus or pacemaker induced rhythm and de-airing continued. At 35 Celsius body temperature, as measured from the thermistor in the urinary bladder, and with apparently good cardiac contraction the patient will be weaned successively from the CPB ensuring thereby that the entire cardiac output is diverted through the native fully ventilated lungs. Inotropic drugs or systemic arterial vasodilators will be used as and when necessary to achieve good cardiac contraction. When TEE will show no air in the left heart, the de-airing will be considered complete and the time noted again (T3) (T3 - T2 = Post ejection de-airing time). The patient will be weaned completely from the cardiopulmonary bypass and all cardiac cannulae including the LV vent will be left in situ but clamped. The patient will be monitored now for residual air by TEE \& TCD for 10 minutes continually. The LV vent will be re-opened whenever the residual air showing on TEE in the left heart exceeds grade II. The frequency of theses measures will be noted in the protocol. The C02 insufflations will continue until the 10- minute post CPB monitoring interval is completed. If patient by now has achieved 36 Celsius core temperature, the heart will be decannulated and CPB removed. Otherwise CPB will be restarted and patient warmed to 36 Celsius before final weaning and decannulation. Trans-esophageal echocardiographic study (TEE): After completion of the cardioplegic arrest and for 10 minutes after termination of the CPB, all the patients will be monitored by TEE for air in the left heart. The residual air showing on TEE after the termination of CPB will be quantified in 4 grades depending upon presence of air in LA, LV and aortic root during one cardiac cycle (grade 0 = no or occasional air in LA, grade 1 = air showing in LA only, grade 2 = air showing simultaneously in LA and LV, grade 3 = air showing simultaneously in LA, LV and the aortic root). The 10-minute post CPB TEE recording will be saved on a video-tape. Trans-cranial echo-doppler study (TCD): After release of the aortic cross clamp and for 10 minutes after the patient has been weaned off from the CPB, the patient will be continuously monitored for micro embolic signals by on-line automatic TCD placed on middle cerebral arteries. Blood gases will be monitored in all patients as following: Blood gas analysis from arterial \& venous blood of the patient every 15 minutes in the operating room in both groups until 15 minutes post CPB) - following attached tables (Anesthesia, Perfusion and TCD \& Invous monitoring) Measurement of end-tidal PCO2 and volume of expired CO2 every 15 minutes after the patient is intubated and till the time patient leaves the operating room in both groups. (No measurements possible in the control group during cardioplegic arrest) Blood gas analysis from arterial \& venous blood lines of the oxygenator and from the LV vent line every 15 minutes while the patient is on CPB in both groups. Continuous on-line monitoring of CO2 content and PCO2 in the blood at the inflow and outflow ports of the oxygenator in both groups using CDI \& new machine. Variations in gas flow and the FiO2 needed to adjust PaCO2 to within a fixed desirable range will be recorded and extra blood gas sample will be taken whenever any such adjustment is made. Alfa stat will be employed for blood gas analysis. A core temperature at 30 C will be used for all patients unless positively indicted.	Aortic Valve Disorder	Cardiac de-airing CO2 insufflation Air emboli Trans cranial doppler Intraoperative echocardiography	null	2	arm 1: Lund de-airing technique arm 2: carbon-dioxide insufflation will be provided to the open mediastinal wound in a standardized manner	[ 0, 1 ]	2	[ 3, 0 ]	intervention 1: In these patients the pleura will be opened on both sides and the ventilator will be disconnected before aorta is cross-clamped and cardioplegia administered. At the conclusion of the surgical procedure, the LV preload will first now be successively increased. When no air is seen on TEE monitoring in the left heart (LA, LV \& Aorta), half the calculated minute ventilation with 100% oxygen and a PEEP of 5 cm H2O will be started. Deairing will be continued and when the TEE shows no or minimal air in left heart, full ventilation with unchanged PEEP will be restored. The patient will be weaned successively from the CPB. When TEE will show no air in the left heart, the de-airing will be considered complete. intervention 2: In these patients (n=10) the pleurae will not be opened. During aortic cross-clamp period the ventilator will be adjusted to provide dead space ventilation only i.e. 5cm PEEP, ventilator frequency 5/min and the minute ventilation = 1,5 liter. Fio2 = 50%. The operating field will be insufflated with Co2 at a flow rate of 10 L / minute starting 2 minutes before cardiac cannulation and continued until 10 minutes after termination of the CPB.At the end of the cardioplegic arrest, the de-airing procedure is similar to that in the Lund de-airing group.	intervention 1: Lund de-airing technique intervention 2: carbon-dioxide insufflation	0	null	20	NCT00934596	1COMPLETED	2009-10-01	2009-06-01	Lund University	7OTHER	false	false	false	null	0
[ 2 ]	31	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	2MALE	false	The purpose of this study was to provide human lipidomics standards with simvastatin treatment that were to be used for comparison with similar preclinical studies.	null	Hypercholesterolemia, Dyslipidemia	Hypercholesterolemia, Dyslipidemia, simvastatin, Zocor	null	2	arm 1: Simvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks arm 2: Placebo for 2 weeks followed by simvastatin 40 mg once daily for 2 weeks	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 40 mg once daily for 2 weeks intervention 2: Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks	intervention 1: Simvastatin intervention 2: Placebo	0	null	60	NCT00935259	1COMPLETED	2009-10-01	2009-07-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 3 ]	35	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study is designed to understand the pharmacokinetics of different oral formulations of CK-1827452 being considered for future studies in patients with heart failure. This study will compare the pharmacokinetics and safety and tolerability of both modified-release (MR) and immediate-release (IR) oral formulations of CK-1827452.	null	Heart Failure	omecamtiv mecarbil	null	3	arm 1: Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days. arm 2: Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days. arm 3: Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 50 mg MR CK-1827452 BID for 10 days intervention 2: 37.5 mg IR CK-1827452 TID for 10 days intervention 3: 100 mg MR CK-1827452 BID for 10 days	intervention 1: CK-1827452 intervention 2: CK-1827452 intervention 3: CK-1827452	3	Tbilisi \| N/A \| Georgia \| 44.83412 \| 41.69143 Tbilisi \| N/A \| Georgia \| 44.83412 \| 41.69143 Tbilisi \| N/A \| Georgia \| 44.83412 \| 41.69143	35	NCT00941681	1COMPLETED	2009-10-01	2009-04-01	Cytokinetics	4INDUSTRY	false	false	false	null	0
[ 4 ]	203	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.	null	Actinic Keratoses	Peplin Actinic keratosis PEP005	null	2	arm 1: PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days arm 2: Vehicle gel once daily for 2 consecutive days	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: two day treatment intervention 2: two day treatment	intervention 1: PEP005 (ingenol mebutate) Gel intervention 2: Vehicle gel	17	Hot Springs \| Arizona \| United States \| N/A \| N/A San Diego \| California \| United States \| -117.16472 \| 32.71571 Alpharetta \| Georgia \| United States \| -84.29409 \| 34.07538 Arlington Heights \| Illinois \| United States \| -87.98063 \| 42.08836 Buffalo Grove \| Illinois \| United States \| -87.95979 \| 42.15141 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Henderson \| Nevada \| United States \| -114.98194 \| 36.0397 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Tyler \| Texas \| United States \| -95.30106 \| 32.35126 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Lynchburg \| Virginia \| United States \| -79.14225 \| 37.41375 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681	203	NCT00942604	1COMPLETED	2009-10-01	2009-07-01	Peplin	4INDUSTRY	false	false	false	null	0
[ 5 ]	1	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of this study is to determine whether a single intravenous administration of an N-methyl-D-aspartate antagonist is safe and effective for the acute treatment of bipolar depression.	Bipolar disorder (BPD) is a common, recurrent, and disabling medical condition. Although mania is the defining feature of BPD, depression represents the majority of illness burden in patients with this devastating condition. Despite the high degree of morbidity and mortality associated with bipolar depression, currently available treatments are few and often inadequate. Recently, a single intravenous (IV) dose of the N-methyl-D-aspartate (NMDA) glutamate receptor antagonist ketamine has demonstrated rapid antidepressant effects in severe unipolar depression. Therefore, the objective of the current study is to investigate the safety and efficacy of a single IV dose of ketamine in treatment-resistant bipolar depression (TRBD).	Bipolar Disorder	Bipolar Disorder Depression Treatment-Resistant ketamine antidepressant glutamate	null	2	arm 1: Patients receive both treatment conditions (ketamine and midazolam) in a single arm, crossover design. Patients are randomized to ketamine-midazolam. Each treatment occurs as a single intravenous infusion on one treatment day. The two treatment conditions occur 2 weeks apart. arm 2: Patients receive both treatment conditions (ketamine and midazolam) in a single arm, crossover design. Patients are randomized to midazolam-ketamine. Each treatment occurs as a single intravenous infusion on one treatment day. The two treatment conditions occur 2 weeks apart.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: a single IV infusion of ketamine, IV 0.5 mg/kg intervention 2: a single IV infusion of midazolam, 0.045 mg/kg	intervention 1: ketamine intervention 2: midazolam	1	New York \| New York \| United States \| -74.00597 \| 40.71427	0	NCT00947791	6TERMINATED	2009-10-01	2009-07-01	Icahn School of Medicine at Mount Sinai	7OTHER	false	false	false	null	0
[ 5 ]	162	RANDOMIZED	SINGLE_GROUP	0TREATMENT	1SINGLE	true	0ALL	false	A study to compare the skin irritation potential of two marketed gels for acne treatment, each applied to half of the face of healthy volunteers.	At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all subjects will be applying two products to their faces, each on one side only. The side of the face receiving each product is randomly assigned. One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash. Subjects will return to the study center every weekday morning for evaluation and application of both study products. Applications done on the weekends, will be done at home by the subject. At each visit the subject will be scored for cutaneous treatment effects by a blinded evaluator. At baseline and at the end of each week, subjects will be photographed and have chromometer readings.	Acne Vulgaris	acne irritation objective sensory methods	null	1	arm 1: Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model	[ 0 ]	2	[ 0, 0 ]	intervention 1: A marketed facial gel containing Tretinoin 0.04% is applied to one side of the face daily for three weeks. intervention 2: A marketed facial gel containing Adapalene .1% and Benzoyl peroxide 2.5% is applied to the other side of the face daily for three weeks	intervention 1: Tretinoin Facial Gel intervention 2: Adapalene/Benzoyl Peroxide Facial Gel	1	Broomall \| Pennsylvania \| United States \| -75.35658 \| 39.9815	324	NCT00952523	1COMPLETED	2009-10-01	2009-07-01	Bausch Health Americas, Inc.	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	10	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain arteries) is a known complication after SAH and significantly increases disability and death after SAH. Vasospasm is difficult to treat and can lead to stroke. Animal studies have shown that the muscles in the artery wall play a role in cVSP. Dantrolene has been FDA approved and extensively used in clinical practice as a muscle relaxant for more than 30 years. It has been shown to provide some benefit in animal studies of cVSP, as well as in a small number of humans. Therefore, we plan to undertake this study to evaluate the safety and tolerability of treatment with dantrolene in patients with cVSP after SAH, and to determine the maximal tolerated dose to be used in future studies to determine if treatment with Dantrolene can improve the outcome of patients with cVSP after SAH.	Our main objectives are: 1) to evaluate the safety and tolerability of varying doses of dantrolene, by determining the treatment related adverse events, in participants with cVSP after SAH; and 2) to determine the maximal tolerated dose to be adopted in subsequent studies and 3) to determine efficacy trends of dantrolene on brain vessels as assessed by ultrasound of brain vessels (transcranial Doppler). We hypothesize that dantrolene is well-tolerated and has minimal serious adverse effects in patients with cVSP after SAH. The results can potentially bring a new treatment to patients with SAH. cVPS after SAH is a frequent cause of disability and death. A successful study demonstrating the safety of dantrolene in would be of considerable public health significance.	Cerebral Vasospasm After Subarachnoid Hemorrhage	vasospasm subarachnoid hemorrhage neurocritical care dantrolene vasorelaxation	null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 1.25 mg/kg IV once over 60 min intervention 2: 2.5 mg/kg IV once over 60 min	intervention 1: Dantrolene intervention 2: Dantrolene	2	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Worcester \| Massachusetts \| United States \| -71.80229 \| 42.26259	10	NCT00964548	1COMPLETED	2009-10-01	2007-07-01	University of Massachusetts, Worcester	7OTHER	false	false	false	null	0
[ 2, 3 ]	34	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	true	0ALL	true	The purpose of this study is to determine the single-dose pharmacokinetics of the investigational drug PL 3100 following oral administration to healthy volunteers and to compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose.	null	Healthy Volunteers		null	2	arm 1: Active experimental drug arm 2: Active comparator	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Single orally administered dose of 500 mg naproxen intervention 2: Single orally administered dose of PL 3100 (500 mg naproxen)	intervention 1: Naproxen intervention 2: PL 3100	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	68	NCT00966641	1COMPLETED	2009-10-01	2009-08-01	PLx Pharma	4INDUSTRY	false	false	false	null	0
[ 4 ]	108	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this exploratory sub-study was to evaluate from a clinical perspective the impact on disease activity of lowering the dose of abatacept from 10 mg/kg to 5 mg/kg in subjects who had achieved remission (Disease Activity Score 28 \[DAS 28\]-erythrocyte sedimentation rate \[ESR\] \< 2.6) at Day 701 of study IM101023.	null	Rheumatoid Arthritis	NOS	null	2	arm 1: None arm 2: None	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: IV solution, IV, 10 mg/Kg, Once monthly, 1 year intervention 2: IV solution, IV, 5 mg/Kg, Once monthly, 1 year	intervention 1: Abatacept intervention 2: Abatacept	0	null	116	NCT00989235	1COMPLETED	2009-10-01	2007-04-01	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	0
[ 5 ]	100	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This study is a clinical trial of moderate sedation with propofol versus moderate sedation with ketamine for procedural sedation in the Emergency Department.	null	Sedation	ketamine propofol procedural sedation moderate procedural sedation in the ED	null	2	arm 1: propofol 1 milligram per kilogram intravenous bolus followed by 0.5 millligrams per kilogram as needed for mooderate procedural sedation arm 2: ketamine 1 milligram per kilogram followed by 0.5 millgram per kilogram as needed for moderate procedural sedation	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: propofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation intervention 2: ketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation	intervention 1: propofol intervention 2: Ketamine	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	97	NCT00997321	1COMPLETED	2009-10-01	2007-07-01	Hennepin Healthcare Research Institute	7OTHER	false	false	false	null	0
[ 2 ]	38	NON_RANDOMIZED	SINGLE_GROUP	7BASIC_SCIENCE	0NONE	true	0ALL	false	The purpose of this study is to evaluate and compare the relative bioavailability of a single dose of Colcrys™ (colchicine) 0.6 mg when administered to a group of young , healthy subjects 18-30 years of age compared to a group of older, generally healthy subjects 60 years of age or older following an overnight fast.	The purpose of this study is to evaluate and compare the relative bioavailability of a single dose of Colcrys™ (colchicine) 0.6 mg when administered to a group of young, healthy subjects 18-30 years of age compared to a group of older, generally healthy subjects 60 years of age or older following an overnight fast. On study Day 1 following an overnight fast, twenty healthy, non-smoking, non-obese male and female subjects between the ages of 18 and 30 and twenty generally healthy, non-smoking, non-obese male and female subjects over 60 years of age will be administered one single dose of Colcrys™ (1 x 0.6 mg tablet). Fasting will continue for 4 hours after the dose. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of Colcrys. Blood sampling will continue on a non-confined basis at 36, 48, 60 and 72 hours post-dose. Subjects will be monitored throughout participation in the study for adverse reactions to the study drug and/or procedures. Vitals signs (temperature, respiratory rate, pulse rate and blood pressure) will be measured in the sitting position prior to dosing. Seated blood pressure and pulse will be measured at approximately 1, 3, 6 and 12 hours after dosing and prior to release from the facility. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.	Healthy	Healthy bioavailability	null	2	arm 1: One single dose of Colcrys™ 0.6mg taken by mouth on day 1 arm 2: One single dose of Colcrys™ 0.6mg taken by mouth on day 1	[ 0, 0 ]	1	[ 0 ]	intervention 1: 0.6 mg taken by mouth on day 1	intervention 1: Colcrys™ (colchicine)	0	null	38	NCT01001052	1COMPLETED	2009-10-01	2009-10-01	Mutual Pharmaceutical Company, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	55	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	RATIONALE * Fractionated radiotherapy uses high-energy photons to kill, or damage tumor cells. High daily dose temozolomide combined with fractionated radiotherapy may make tumor cells more sensible to treatment. PURPOSE * This randomized phase II trial, assess in patients with brain metastases from solid tumors, whether the whole brain radiotherapy (WBRT) plus temozolomide is able to improve the results obtained with WBRT.	Primary Outcome Measures * Objective Response Rates Secondary Outcome Measures * Survival Free of Brain Metastases progression * Overall Survival * Systemic Side effects Objectives Primary * Compare objective response rates in both arms of treatment Secondary * Compare survival free of progression in both arms of treatment * Compare Overall Survival in both arms of treatment * Compare side effects	Brain Neoplasms	Brain metastases Temozolomide Whole-brain radiotherapy Phase II trial	null	2	arm 1: Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide. arm 2: Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks	[ 0, 1 ]	2	[ 0, 4 ]	intervention 1: None intervention 2: None	intervention 1: Temozolomide intervention 2: Whole brain irradiation	1	México \| D.F \| Mexico \| -103.57339 \| 22.76088	55	NCT01015534	1COMPLETED	2009-10-01	2006-01-01	Instituto Nacional de Cancerologia de Mexico	7OTHER	false	false	false	null	0
[ 5 ]	26	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	The purpose of this research study is to evaluate the effectiveness of two different types of topical acne medication. This study will help to determine if one combined medication results in better acne improvement than two separate medications for acne.	null	Acne Vulgaris	Mild to moderate acne vulgaris	null	2	arm 1: Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks arm 2: Generic clindamycin 1% gel plus tretinoin 0.025% cream	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: applied once daily for 12 weeks intervention 2: Topical clindamycin applied each morning for 12 weeks intervention 3: Tretinoin 0.025% cream each evening for 12 weeks	intervention 1: clindamycin phosphate 1.2% and tretinoin 0.025% intervention 2: clindamycin 1% gel intervention 3: tretinoin 0.025% cream	1	Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986	26	NCT01047189	1COMPLETED	2009-10-01	2009-03-01	Wake Forest University	7OTHER	false	false	false	null	0
[ 5 ]	20	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this research study is to better understand how fluocinonide cream 0.1% (Vanos®) works when people use it to treat atopic dermatitis for just a few days.	This is a single center study. This is an open label study of fluocinonide cream 0.1% (Vanos™) for subjects with mild to severe atopic dermatitis with an assessment of 2 to 4 on the Investigator Global Assessment scale (Appendix B). Up to 20 subjects age 12 and above will be enrolled after providing informed consent. All subjects will receive the study medication, fluocinonide cream 0.1% (Vanos™). Each subject will be instructed to use fluocinonide cream 0.1% (Vanos™) twice daily for three consecutive days (for a total of 6 doses). The study period will last for approximately 2 weeks. Subjects will be evaluated at baseline and Day 2 or 3 (as needed to achieve 6 doses), day 7 and day 14 (or end of study). Subjects will not apply any study drug after the 6 doses.	Atopic Dermatitis	Atopic Dermatitis Open-Label Topical Cream Eczema Vanos	null	1	arm 1: Fluocinonide Cream 0.1% open label	[ 5 ]	1	[ 0 ]	intervention 1: 0.1% Cream, One Application, Twice Daily, 14 Days	intervention 1: Fluocinonide Cream 0.1%	1	Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986	20	NCT01049243	1COMPLETED	2009-10-01	2009-03-01	Wake Forest University Health Sciences	7OTHER	false	false	false	null	0
[ 4 ]	248	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to evaluate the efficacy and safety of extended release (ER) tramadol hydrochloride (HCl)/acetaminophen compared with placebo in participants with chronic (lasting a long time) low-back pain.	This is a double blind (a medical research study in which neither the researchers nor the participants know what treatment the participants is receiving), randomized (study drug is assigned by chance), placebo-controlled, parallel group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions \[treatments\]) and up-titration study in participants with chronic low back pain. The study will consist of 6 visits (Day -7 to Day -1 \[Visit 1\], Day 1 \[Visit 2\], Day 3 \[telephone visit\], Day 8 \[Visit 3\], Day 15 \[Visit 4\] and Day 29 \[Visit 5\]) and 2 phases: a screening phase and treatment phase. Screening phase will be of 7 days during which, participants will receive stable dose of non-steroidal anti-inflammatory drugs (NSAIDS) or COX-2 selective inhibitors (NSAID that specifically inhibits an enzyme known as cyclooxygenase-2) for pain therapy. On the basis of average pain intensity over the last 48 hours which will be measured at baseline (at the end of screening period), participants will enter the treatment phase. Treatment phase will be of 28 days which includes 7-days of dose titration period. In treatment phase all participants will be randomly assigned to 1 of 2 possible treatments: tramadol HCl 75 milligram (mg)/acetaminophen 650 mg ER tablet treatment or the equivalent placebo (an inactive substance) treatment until study completion, Day 29. Participants will receive 1 tablet of tramadol HCl/acetaminophen ER or its equivalent placebo, once daily for 3 days. After the first 3 days, the participants will receive a telephone inquiry monitoring the occurrence of adverse events and will be given additional administration instructions for the next 4 days (1 tablet twice daily for 4 days). From Day 7, participants will receive 1 or 2 tablets twice a day depending on the degree of pain relief required. Participants will visit the center on the Day 8 (Visit 3), Day 15 (Visit 4), and Day 29 (Visit 5) after starting study drug. The efficacy will be assessed by measuring extent of reduction in pain intensity on a Visual Analog Scale (VAS). Participants' safety will be monitored throughout the study.	Low Back Pain	Chronic low back pain Tramadol Hydrochloride (HCl) acetaminophen	null	2	arm 1: Participants will receive 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. arm 2: Prticipants will receive 1 tablet matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.	[ 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Participants will receive 1 tablet containing 75 mg of tramadol HCl and 650 mg of acetaminophen, once daily on Days 1to 3, then 1 tablet twice daily on Days 4 to 7 intervention 2: Participants will receive 1 matching placebo tablet once daily on Days 1 to 3, then 1 tablet twice daily on Days 4 to 7 intervention 3: Participants will receive 1 or 2 tablets containing 75 mg of tramadol HCl and 650 mg of acetaminophen, twice daily on Days 8 to 28 intervention 4: Prticipants will receive 1 or 2 matching placebo tablet once daily on Days 1 to 3, then 1 tablet twice daily on Days 8 to 28	intervention 1: Tramadol HCl/acetaminophen Extended Release intervention 2: Placebo intervention 3: Tramadol HCl/acetaminophen Extended Release intervention 4: Placebo	0	null	245	NCT01112267	1COMPLETED	2009-10-01	2009-05-01	Janssen Korea, Ltd., Korea	4INDUSTRY	false	false	false	null	0
[ 3 ]	32	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	An exploratory study investigating the direct application of potassium nitrate (KNO3) solutions of different concentrations in reducing dentine hypersensitivity.	null	Dentine Hypersensitivity	potassium nitrate tooth sensitivity dentin sensitivity	null	3	arm 1: Participants to apply 5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period. arm 2: Participants to apply 2.5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period. arm 3: Participants to apply sterile water to a single sensitive tooth for two minutes, in each of the five day treatment period.	[ 0, 0, 2 ]	3	[ 0, 0, 10 ]	intervention 1: 5% potassium nitrate solution intervention 2: 2.5% potassium nitrate solution intervention 3: Sterile water	intervention 1: 5% Potassium nitrate intervention 2: 2.5% Potassium nitrate intervention 3: Sterile water	1	Fort Wayne \| Indiana \| United States \| -85.12886 \| 41.1306	32	NCT01115452	1COMPLETED	2009-10-01	2009-09-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 3 ]	36	RANDOMIZED	CROSSOVER	0TREATMENT	1SINGLE	true	0ALL	false	An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.	null	Tooth Erosion	enamel erosion tooth remineralization tooth erosion	null	5	arm 1: Test fluoride dentifrice and test fluoride MR arm 2: Test fluoride dentifrice and sterile water rinse arm 3: Placebo dentifrice and test fluoride rinse arm 4: Marketed fluoride dentifrice with sterile water rinse arm 5: Placebo dentifrice and sterile water rinse	[ 0, 0, 0, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Test fluoride toothpaste and test fluoride mouth rinse intervention 2: United Kingdom marketed fluoride toothpaste intervention 3: Sterile water rinse	intervention 1: Sodium fluoride intervention 2: Sodium monoflurophosphate intervention 3: Sterile water	1	Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838	180	NCT01128972	1COMPLETED	2009-10-01	2009-08-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 4 ]	143	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	2MALE	false	The primary purpose of this project is to evaluate the effectiveness of behavioral treatment compared to standard drug therapy for symptoms of OAB in male veterans.	Overactive bladder (OAB) is a very common and bothersome condition manifested by urgency, frequent urination, urge urinary incontinence, and nocturia. Drug therapy with oxybutynin or tolterodine is the most common approach to treatment of OAB in VA Medical Center clinics and is the standard of care nationally. Although it improves symptoms of OAB for many patients, drug therapy often has side effects, which cause a significant number of patients to discontinue therapy. Further, many symptoms are not completely controlled, even while patients are on the medication. Therefore, there is a need to improve interventions for this common problem. Although behavioral treatment is a well-established treatment for urge urinary incontinence and frequency in women, there are no controlled trials of behavioral treatment for symptoms of OAB in men. The primary purpose of this project is to evaluate the effectiveness of behavioral treatment for symptoms of OAB in male veterans. The study is a two-site (Birmingham and Atlanta) randomized clinical trial to evaluate the effects of behavioral training compared to a standard (drug) treatment control condition. Subjects are 143 men with OAB as manifested by urgency and frequent urination (\>8 voids per day), with or without incontinence, and without significant bladder outlet obstruction. Following a run-in period in which all patients are treated with an alpha blocker to empirically treat any undetected obstruction, they are stratified on severity and presence of urge incontinence and randomized to 8 weeks of behavioral treatment or drug therapy. The behavioral treatment is a comprehensive, behavioral training program, which includes pelvic floor muscle rehabilitation, self monitoring with bladder diaries, and teaching urge suppression and other skills to inhibit detrusor contraction, thus reducing urgency, frequency, incontinence, and nocturia. Patients in the control group receive standard therapy consisting of individually titrated, extended-release oxybutynin, a well-established pharmacologic agent with a state of the art drug delivery system that has the lowest rates of side effects. Bladder diaries completed by subjects prior to randomization and following the last treatment session are used to calculate changes in frequency of urination, as well as other symptoms of overactive bladder, including reports of urgency, incontinence, and nocturia. Secondary outcome measures include patient global ratings of satisfaction and improvement, impact of incontinence, and the American Urological Association (AUA) Symptom Index. The second purpose of the study is to examine combined behavioral and drug therapy. Following post-treatment assessment, patients who do not achieve satisfactory outcomes with either behavioral or drug therapy alone are crossed over into a second phase, in which they receive combined treatment to improve outcome as much as possible. This study will yield important information related to alternative treatment of OAB in male veterans. Though many clinicians use drug therapy routinely in the treatment of OAB, most do not offer behavioral treatments such as pelvic floor muscle training for this problem. Thus, this study has potential to alter standards of care for OAB in men.	Overactive Bladder	Overactive bladder Behavioral treatment Drug therapy Lower urinary tract symptoms Urinary incontinence Clinical trial	null	2	arm 1: Behavioral training using delayed voiding, urge suppression techniques, and pelvic floor muscle training arm 2: Oxybutynin chloride, extended-release, individually-titrated, 5-30 mg	[ 0, 1 ]	2	[ 5, 0 ]	intervention 1: Comprehensive behavioral training program using delayed voiding, urge suppression techniques, pelvic floor muscle training, and monitoring with bladder diaries. Treatment is implemented by a nurse practitioner in 4 clinic visits over 8 weeks. intervention 2: Individually titrated, extended-release oxybutynin chloride, initiated at 10 mg, fluid management handout, and monitoring with bladder diaries. Treatment is implemented by a nurse practitioner in 4 clinic visits over 8 weeks.	intervention 1: Behavioral training intervention 2: Oxybutynin chloride, extended-release	2	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483	143	NCT01187498	1COMPLETED	2009-10-01	2005-01-01	US Department of Veterans Affairs	1FED	false	false	false	null	0

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