Split (3)

train · 29.5k rows

FEATURE_phases list	FEATURE_enrollmentCount int64	FEATURE_allocation string	FEATURE_interventionModel string	FEATURE_primaryPurpose class label	FEATURE_masking class label	FEATURE_healthyVolunteers bool	FEATURE_sex class label	FEATURE_oversightHasDmc bool	FEATURE_briefSummary string	FEATURE_detailedDescription string	FEATURE_conditions string	FEATURE_conditionsKeywords string	FEATURE_protocolPdfText string	FEATURE_numArms int64	FEATURE_armDescriptions string	FEATURE_armGroupTypes list	FEATURE_numInterventions int64	FEATURE_interventionTypes list	FEATURE_interventionDescriptions string	FEATURE_interventionNames string	FEATURE_numLocations int64	FEATURE_locationDetails string	LABEL_ct_level_ade_population int64	METADATA_nctId string	METADATA_overallStatus class label	METADATA_completionDate date32	METADATA_startDate date32	METADATA_leadSponsorName string	METADATA_leadSponsorClass class label	METADATA_hasProtocol bool	METADATA_hasSap bool	METADATA_hasIcf bool	METADATA_protocolPdfLinks string	METADATA_wilson_lower_bound float32
[ 3 ]	76	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This study will test the hypothesis that CF101, which is under development to treat other immune-mediated inflammatory diseases, will provide clinical benefits in the treatment of chronic plaque psoriasis. Patients with psoriasis who qualify for the study will be treated every 12 hours (q12h) with CF101 capsules, or placebo capsules, for 12 weeks. The safety of treatment will be carefully assessed through clinical and laboratory monitoring. The effect of treatment on psoriasis will be evaluated through standard techniques of examination and measurement of the severity of skin involvement.	This is a Phase 2, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study in adult males and females, ages 18 to 70 years, inclusive, with a diagnosis of moderate-to-severe chronic plaque psoriasis. At the Screening Visit, patients who provide written informed consent will have screening procedures performed, including a complete medical history, medication history, physical examination, including height, weight, blood pressure, pulse rate and temperature, and clinical laboratory tests. Eligible patients will be those who have not received systemic retinoids, corticosteroids, or immunosuppressants (e.g., methotrexate, cyclosporine) within 6 weeks prior to initiation of study; or high potency topical corticosteroids (Class I-III), keratolytics, or coal tar (other than on the scalp, palms, groin, and/or soles); and UV or Dead Sea therapy within 4 weeks prior to initiation of study treatment. Eligible patients will be sequentially assigned to 1 of 3 dosing cohorts: Cohort 1: CF101 1 mg (15 patients) or Placebo (5 patients); Cohort 2: CF101 2 mg (15 patients) or Placebo (5 patients); Cohort 3: CF101 4 mg (15 patients) or Placebo (5 patients). Medication will be taken orally q12h for 12 weeks. Disease activity will be assessed using the Psoriasis Area and Severity Index (PASI) and the Physician Global Assessment (PGA). Patients will return for assessments at Weeks 2, 4, 8, 12 and 14.	Plaque Psoriasis	Psoriasis	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: CF101 1 mg q12 hours for 12 weeks intervention 2: CF101 2 mg q12 hours for 12 weeks intervention 3: CF101 4 mg q12 hours for 12 weeks intervention 4: Placebo tablets q12 hours for 12 weeks	intervention 1: CF101 1mg intervention 2: CF101 2mg intervention 3: CF101 4mg intervention 4: Placebo	4	Afula \| N/A \| Israel \| 35.2892 \| 32.60907 Holon \| N/A \| Israel \| 34.77918 \| 32.01034 Petah Tikva \| N/A \| Israel \| 34.88747 \| 32.08707 Tel Litwinsky \| N/A \| Israel \| 34.84588 \| 32.05096	75	NCT00428974	1COMPLETED	2009-09-01	2007-06-01	Can-Fite BioPharma	4INDUSTRY	false	false	false	null	0
[ 3 ]	256	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid arthritis who had failed a three month therapeutic trial with a tumor necrosis factor alpha (TNFa) antagonist due to lack of efficacy.	null	Rheumatoid Arthritis	atacicept arthritis	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: Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks. intervention 2: Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks. intervention 3: Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks. intervention 4: Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.	intervention 1: Atacicept intervention 2: Atacicept intervention 3: Atacicept intervention 4: Placebo matched to atacicept	2	Rockland \| Massachusetts \| United States \| -70.91616 \| 42.13066 Canada \| N/A \| Canada \| N/A \| N/A	254	NCT00430495	1COMPLETED	2009-09-01	2006-12-01	EMD Serono	4INDUSTRY	false	false	false	null	0
[ 4 ]	207	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine	null	Osteoporosis		null	2	arm 1: 20 micrograms for 104 weeks arm 2: Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: daily, subcutaneous intervention 2: daily, subcutaneous	intervention 1: Teriparatide intervention 2: Placebo	16	Aichi \| N/A \| Japan \| 130.62158 \| 32.51879 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Hokkaido \| N/A \| Japan \| N/A \| N/A Hyōgo \| N/A \| Japan \| 144.43333 \| 43.36667 Kagoshima \| N/A \| Japan \| 130.55 \| 31.56667 Kanagawa \| N/A \| Japan \| 139.91667 \| 37.58333 Nagano \| N/A \| Japan \| 138.18333 \| 36.65 Nagasaki \| N/A \| Japan \| 129.88333 \| 32.75 Numakunai \| N/A \| Japan \| 141.21667 \| 39.96667 Osaka \| N/A \| Japan \| 135.50107 \| 34.69379 Ōita \| N/A \| Japan \| 131.6 \| 33.23333 Saitama \| N/A \| Japan \| 139.65657 \| 35.90807 Shimane \| N/A \| Japan \| 139.79727 \| 35.78334 Tokushima \| N/A \| Japan \| 134.56667 \| 34.06667 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Tottori \| N/A \| Japan \| 134.67796 \| 34.24877	609	NCT00433160	1COMPLETED	2009-09-01	2007-01-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	-0
[ 4 ]	1,197	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	false	This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).	Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor. The treatment period was followed by an observational period of 30 days starting the day after the last intake of study medication, regardless of the actual duration of study drug administration. Participants who did not complete the treatment period also entered the observational period. It was also possible that participants did not enter the observational period, e.g. due to withdrawal of consent or termination of study participation.	Venous Thromboembolism		null	2	arm 1: Participants were to receive rivaroxaban 20 mg oral tablet once daily arm 2: Participants were to receive matching placebo oral tablet once daily	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Patients randomized to rivaroxaban will receive rivaroxaban 20 mg once-daily. intervention 2: Patients allocated to placebo will receive a matching placebo tablet once daily.	intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Placebo	322	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Redlands \| California \| United States \| -117.18254 \| 34.05557 Bay Pines \| Florida \| United States \| -82.77816 \| 27.81419 Melbourne \| Florida \| United States \| -80.60811 \| 28.08363 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Idaho Falls \| Idaho \| United States \| -112.03414 \| 43.46658 Covington \| Louisiana \| United States \| -90.10042 \| 30.47549 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Greensboro \| North Carolina \| United States \| -79.79198 \| 36.07264 Greensboro \| North Carolina \| United States \| -79.79198 \| 36.07264 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Corsicana \| Texas \| United States \| -96.46887 \| 32.09543 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Murray \| Utah \| United States \| -111.88799 \| 40.66689 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Burlington \| Vermont \| United States \| -73.21207 \| 44.47588 Fredericksburg \| Virginia \| United States \| -77.46054 \| 38.30318 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Garran \| Australian Capital Territory \| Australia \| 149.10846 \| -35.34206 Gosford \| New South Wales \| Australia \| 151.34399 \| -33.4244 Kogarah \| New South Wales \| Australia \| 151.13564 \| -33.9681 Lismore \| New South Wales \| Australia \| 153.2773 \| -28.81354 St Leonards \| New South Wales \| Australia \| 151.19836 \| -33.82344 Sydney \| New South Wales \| Australia \| 151.20732 \| -33.86785 Sydney \| New South Wales \| Australia \| 151.20732 \| -33.86785 Sydney \| New South Wales \| Australia \| 151.20732 \| -33.86785 Sydney \| New South Wales \| Australia \| 151.20732 \| -33.86785 Brisbane \| Queensland \| Australia \| 153.02809 \| -27.46794 Redcliffe \| Queensland \| Australia \| 153.10648 \| -27.22649 Southport \| Queensland \| Australia \| 153.39796 \| -27.96724 Woolloongabba \| Queensland \| Australia \| 153.03655 \| -27.48855 Adelaide \| South Australia \| Australia \| 138.59863 \| -34.92866 Adelaide \| South Australia \| Australia \| 138.59863 \| -34.92866 Box Hill \| Victoria \| Australia \| 145.12545 \| -37.81887 Clayton \| Victoria \| Australia \| 145.11667 \| -37.91667 Geelong \| Victoria \| Australia \| 144.36069 \| -38.14711 Melbourne \| Victoria \| Australia \| 144.96332 \| -37.814 Melbourne \| Victoria \| Australia \| 144.96332 \| -37.814 Prahran \| Victoria \| Australia \| 144.99318 \| -37.85114 Fremantle \| Western Australia \| Australia \| 115.74557 \| -32.05632 Perth \| Western Australia \| Australia \| 115.8614 \| -31.95224 Salzburg \| Salzburg \| Austria \| 13.04399 \| 47.79941 Graz \| Styria \| Austria \| 15.45 \| 47.06667 Innsbruck \| Tyrol \| Austria \| 11.39454 \| 47.26266 Vienna \| Vienna \| Austria \| 16.37208 \| 48.20849 Vienna \| Vienna \| Austria \| 16.37208 \| 48.20849 Feldkirch \| Vorarlberg \| Austria \| 9.6 \| 47.23306 Bruxelles - Brussel \| N/A \| Belgium \| N/A \| N/A Bruxelles - Brussel \| N/A \| Belgium \| N/A \| N/A Duffel \| N/A \| Belgium \| 4.50903 \| 51.09554 Genk \| N/A \| Belgium \| 5.50082 \| 50.965 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Hasselt \| N/A \| Belgium \| 5.33781 \| 50.93106 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Lier \| N/A \| Belgium \| 4.57041 \| 51.13128 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Namur \| N/A \| Belgium \| 4.86746 \| 50.4669 Sint-Truiden \| N/A \| Belgium \| 5.18647 \| 50.81679 Yvoir \| N/A \| Belgium \| 4.88059 \| 50.3279 Zottegem \| N/A \| Belgium \| 3.81052 \| 50.86955 Uberaba \| Minas Gerais \| Brazil \| -47.93194 \| -19.74833 Curitiba \| Paraná \| Brazil \| -49.27306 \| -25.42778 Londrina \| Paraná \| Brazil \| -51.16278 \| -23.31028 Porto Alegre \| Rio Grande do Sul \| Brazil \| -51.23019 \| -30.03283 Botucatu \| São Paulo \| Brazil \| -48.445 \| -22.88583 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 Sorocaba \| São Paulo \| Brazil \| -47.45806 \| -23.50167 Rio de Janeiro \| N/A \| Brazil \| -43.18223 \| -22.90642 Winnipeg \| Manitoba \| Canada \| -97.14704 \| 49.8844 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Guangzhou \| Guangdong \| China \| 113.25 \| 23.11667 Harbin \| Heilongjiang \| China \| 126.65 \| 45.75 Wuhan \| Hubei \| China \| 114.26667 \| 30.58333 Suzhou \| Jiangsu \| China \| 120.59538 \| 31.30408 Shenyang \| Liaoning \| China \| 123.43278 \| 41.79222 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Karlovy Vary \| N/A \| Czechia \| 12.87117 \| 50.23271 Kladno \| N/A \| Czechia \| 14.10285 \| 50.14734 Ostrava \| N/A \| Czechia \| 18.28204 \| 49.83465 Ostrava-Poruba \| N/A \| Czechia \| N/A \| N/A Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Usti Nad Lebem \| N/A \| Czechia \| N/A \| N/A Aarhus C \| N/A \| Denmark \| 10.21231 \| 56.16558 Brædstrup \| N/A \| Denmark \| 9.61129 \| 55.97153 Frederiksberg \| N/A \| Denmark \| 12.53463 \| 55.67938 Hellerup \| N/A \| Denmark \| 12.57093 \| 55.73204 Seinäjoki \| N/A \| Finland \| 22.82822 \| 62.79446 Agen \| N/A \| France \| 0.62055 \| 44.20199 Amiens \| N/A \| France \| 2.3 \| 49.9 Angers \| N/A \| France \| -0.55202 \| 47.47156 Arras \| N/A \| France \| 2.78186 \| 50.29301 Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 Brest \| N/A \| France \| -4.48628 \| 48.39029 Castelnau-le-Lez \| N/A \| France \| 3.90137 \| 43.63605 Clamart \| N/A \| France \| 2.26692 \| 48.80299 Clermont-Ferrand \| N/A \| France \| 3.08682 \| 45.77969 Colombes \| N/A \| France \| 2.25404 \| 48.91882 Créteil \| N/A \| France \| 2.46569 \| 48.79266 Dijon \| N/A \| France \| 5.01667 \| 47.31667 Grenoble \| N/A \| France \| 5.71479 \| 45.17869 Grenoble \| N/A \| France \| 5.71479 \| 45.17869 Lille \| N/A \| France \| 3.05858 \| 50.63297 Limoges \| N/A \| France \| 1.24759 \| 45.83362 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Nantes \| N/A \| France \| -1.55336 \| 47.21725 Nîmes \| N/A \| France \| 4.35788 \| 43.83665 Orthez \| N/A \| France \| -0.77266 \| 43.48834 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| France \| 2.3488 \| 48.85341 Pierre-Bénite \| N/A \| France \| 4.82424 \| 45.70359 Roanne \| N/A \| France \| 4.06802 \| 46.03624 Rouen \| N/A \| France \| 1.09932 \| 49.44313 Saint-Etienne \| N/A \| France \| 4.39 \| 45.43389 Strasbourg \| N/A \| France \| 7.74553 \| 48.58392 Toulon \| N/A \| France \| 5.92836 \| 43.12442 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Tours \| N/A \| France \| 0.70398 \| 47.39484 Valenciennes \| N/A \| France \| 3.52506 \| 50.35909 Vandœuvre-lès-Nancy \| N/A \| France \| 6.17114 \| 48.66115 Vernon \| N/A \| France \| 1.46332 \| 49.09292 Bruchsal \| Baden-Wurttemberg \| Germany \| 8.59804 \| 49.12426 Heidelberg \| Baden-Wurttemberg \| Germany \| 8.69079 \| 49.40768 Karlsbad \| Baden-Wurttemberg \| Germany \| N/A \| N/A Mannheim \| Baden-Wurttemberg \| Germany \| 8.46694 \| 49.4891 Neckargemünd \| Baden-Wurttemberg \| Germany \| 8.7959 \| 49.38899 Tübingen \| Baden-Wurttemberg \| Germany \| 9.05222 \| 48.52266 Augsburg \| Bavaria \| Germany \| 10.89851 \| 48.37154 München \| Bavaria \| Germany \| 13.46314 \| 48.69668 München \| Bavaria \| Germany \| 13.46314 \| 48.69668 Würzburg \| Bavaria \| Germany \| 9.95121 \| 49.79391 Hamburg \| City state of Hamburg \| Germany \| 9.99302 \| 53.55073 Darmstadt \| Hesse \| Germany \| 8.65027 \| 49.87167 Frankfurt am Main \| Hesse \| Germany \| 8.68417 \| 50.11552 Giessen \| Hesse \| Germany \| 8.67554 \| 50.58727 Wiesbaden \| Hesse \| Germany \| 8.24932 \| 50.08258 Hanover \| Lower Saxony \| Germany \| 9.73322 \| 52.37052 Rotenburg (Wümme) \| Lower Saxony \| Germany \| 9.41082 \| 53.11125 Greifswald \| Mecklenburg-Vorpommern \| Germany \| 13.40244 \| 54.08905 Düsseldorf \| North Rhine-Westphalia \| Germany \| 6.77616 \| 51.22172 Essen \| North Rhine-Westphalia \| Germany \| 7.01228 \| 51.45657 Paderborn \| North Rhine-Westphalia \| Germany \| 8.75439 \| 51.71905 Soest \| North Rhine-Westphalia \| Germany \| 8.10619 \| 51.57558 Witten \| North Rhine-Westphalia \| Germany \| 7.35258 \| 51.44362 Mainz \| Rhineland-Palatinate \| Germany \| 8.2791 \| 49.98419 Homburg \| Saarland \| Germany \| 7.33867 \| 49.32637 Homburg \| Saarland \| Germany \| 7.33867 \| 49.32637 Dresden \| Saxony \| Germany \| 13.73832 \| 51.05089 Leipzig \| Saxony \| Germany \| 12.37129 \| 51.33962 Halle \| Saxony-Anhalt \| Germany \| 11.97947 \| 51.48158 Magdeburg \| Saxony-Anhalt \| Germany \| 11.62916 \| 52.12773 Berlin \| State of Berlin \| Germany \| 13.41053 \| 52.52437 Berlin \| State of Berlin \| Germany \| 13.41053 \| 52.52437 Hong Kong \| N/A \| Hong Kong \| 114.17469 \| 22.27832 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 Kistarcsa \| N/A \| Hungary \| 19.26247 \| 47.54757 Miskolc \| N/A \| Hungary \| 20.77806 \| 48.10306 Nyíregyháza \| N/A \| Hungary \| 21.71671 \| 47.95539 Szentes \| N/A \| Hungary \| 20.2608 \| 46.65834 Szombathely \| N/A \| Hungary \| 16.62155 \| 47.23088 Kochi \| Kerala \| India \| 76.26022 \| 9.93988 Vellore \| Kerala \| India \| N/A \| N/A Mumbai \| Maharashtra \| India \| 72.88261 \| 19.07283 Mumbai \| Maharashtra \| India \| 72.88261 \| 19.07283 Mumbai \| Maharashtra \| India \| 72.88261 \| 19.07283 Hyderabad \| N/A \| India \| 78.45636 \| 17.38405 Kolkata \| N/A \| India \| 88.36304 \| 22.56263 New Delhi \| N/A \| India \| 77.2148 \| 28.62137 Pune \| N/A \| India \| 73.85535 \| 18.51957 Bandung \| N/A \| Indonesia \| 107.60694 \| -6.92222 Jakarta \| N/A \| Indonesia \| 106.84513 \| -6.21462 Medan \| N/A \| Indonesia \| 98.66667 \| 3.58333 Semarang \| N/A \| Indonesia \| 110.42083 \| -6.99306 Haifa \| Israel \| Israel \| 34.99928 \| 32.81303 Petah Tikva \| Israel \| Israel \| 34.88747 \| 32.08707 Afula \| N/A \| Israel \| 35.2892 \| 32.60907 Ashkelon \| N/A \| Israel \| 34.57149 \| 31.66926 Beersheba \| N/A \| Israel \| 34.7913 \| 31.25181 Haifa \| N/A \| Israel \| 34.99928 \| 32.81303 Haifa \| N/A \| Israel \| 34.99928 \| 32.81303 Holon \| N/A \| Israel \| 34.77918 \| 32.01034 Jerusalem \| N/A \| Israel \| 35.21633 \| 31.76904 Kfar Saba \| N/A \| Israel \| 34.90694 \| 32.175 Rehovot \| N/A \| Israel \| 34.81199 \| 31.89421 Safed \| N/A \| Israel \| 35.496 \| 32.96465 Tel Aviv \| N/A \| Israel \| 34.78057 \| 32.08088 Bologna \| N/A \| Italy \| 11.33875 \| 44.49381 Chieti \| N/A \| Italy \| 14.16494 \| 42.34827 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Napoli \| N/A \| Italy \| 14.5195 \| 40.87618 Padua \| N/A \| Italy \| 11.88586 \| 45.40797 Palermo \| N/A \| Italy \| 13.3636 \| 38.1166 Parma \| N/A \| Italy \| 10.32618 \| 44.79935 Pavia \| N/A \| Italy \| 9.15917 \| 45.19205 Piacenza \| N/A \| Italy \| 9.69342 \| 45.05242 Venezia \| N/A \| Italy \| 11.17365 \| 44.42329 Kuala Selangor \| N/A \| Malaysia \| 101.25 \| 3.35 's-Hertogenbosch \| N/A \| Netherlands \| 5.30417 \| 51.69917 Amsterdam \| N/A \| Netherlands \| 4.88969 \| 52.37403 Arnhem \| N/A \| Netherlands \| 5.91111 \| 51.98 Dordrecht \| N/A \| Netherlands \| 4.67361 \| 51.81 Enschede \| N/A \| Netherlands \| 6.89583 \| 52.21833 Groningen \| N/A \| Netherlands \| 6.56667 \| 53.21917 Hoofddorp \| N/A \| Netherlands \| 4.68889 \| 52.3025 Maastricht \| N/A \| Netherlands \| 5.68889 \| 50.84833 Rotterdam \| N/A \| Netherlands \| 4.47917 \| 51.9225 Zwijndrecht \| N/A \| Netherlands \| 4.63333 \| 51.8175 Zwolle \| N/A \| Netherlands \| 6.09444 \| 52.5125 Auckland \| N/A \| New Zealand \| 174.76349 \| -36.84853 Auckland \| N/A \| New Zealand \| 174.76349 \| -36.84853 Christchurch \| N/A \| New Zealand \| 172.63333 \| -43.53333 Palmerston North \| N/A \| New Zealand \| 175.61113 \| -40.35636 Wellington South \| N/A \| New Zealand \| N/A \| N/A Fredrikstad \| N/A \| Norway \| 10.9298 \| 59.2181 Oslo \| N/A \| Norway \| 10.74609 \| 59.91273 Oslo \| N/A \| Norway \| 10.74609 \| 59.91273 Rud \| N/A \| Norway \| 11.63333 \| 60.43333 Quezon City \| N/A \| Philippines \| 121.0509 \| 14.6488 Quezon City \| N/A \| Philippines \| 121.0509 \| 14.6488 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Bydgoszcz \| N/A \| Poland \| 18.00762 \| 53.1235 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 Lublin \| N/A \| Poland \| 22.56667 \| 51.25 Poznan \| N/A \| Poland \| 16.92993 \| 52.40692 Poznan \| N/A \| Poland \| 16.92993 \| 52.40692 Torun \| N/A \| Poland \| 18.59814 \| 53.01375 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1 Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Cape Town \| Cape \| South Africa \| 18.42322 \| -33.92584 Johannesburg \| Gauteng \| South Africa \| 28.04363 \| -26.20227 Johannesburg \| Gauteng \| South Africa \| 28.04363 \| -26.20227 Johannesburg \| Gauteng \| South Africa \| 28.04363 \| -26.20227 Johannesburg \| Gauteng \| South Africa \| 28.04363 \| -26.20227 Pretoria \| Gauteng \| South Africa \| 28.18783 \| -25.74486 Pretoria \| Gauteng \| South Africa \| 28.18783 \| -25.74486 Pretoria \| Gauteng \| South Africa \| 28.18783 \| -25.74486 Roodepoort \| Gauteng \| South Africa \| 27.8725 \| -26.1625 Cape Town \| Western Cape \| South Africa \| 18.42322 \| -33.92584 Somerset West \| Western Cape \| South Africa \| 18.82113 \| -34.08401 Worcester \| Western Cape \| South Africa \| 19.44852 \| -33.64651 Daegu \| Daegu Gwang'yeogsi \| South Korea \| 128.59111 \| 35.87028 Seoul \| Seoul Teugbyeolsi \| South Korea \| 126.9784 \| 37.566 Daegu \| N/A \| South Korea \| 128.59111 \| 35.87028 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Taegu \| N/A \| South Korea \| 128.07278 \| 34.88889 Barcelona \| Barcelona \| Spain \| 2.15899 \| 41.38879 Barcelona \| Barcelona \| Spain \| 2.15899 \| 41.38879 Terrassa \| Barcelona \| Spain \| 2.01667 \| 41.56667 Girona \| Girona \| Spain \| 2.82493 \| 41.98311 Alcorcón \| Madrid \| Spain \| -3.82487 \| 40.34582 Fuenlabrada \| Madrid \| Spain \| -3.79415 \| 40.28419 Madrid \| Madrid \| Spain \| -3.70256 \| 40.4165 Pamplona \| Pamplona \| Spain \| -1.64323 \| 42.81687 Xàtiva \| Valencia \| Spain \| -0.51852 \| 38.99042 Borås \| N/A \| Sweden \| 12.9401 \| 57.72101 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Jönköping \| N/A \| Sweden \| 14.15618 \| 57.78145 Sundsvall \| N/A \| Sweden \| 17.3063 \| 62.39129 Västervik \| N/A \| Sweden \| 16.63733 \| 57.7584 Bruderholz \| Basel-Landschaft \| Switzerland \| N/A \| N/A Zurich \| Canton of Zurich \| Switzerland \| 8.55 \| 47.36667 Genéve 14 \| Genève 14 \| Switzerland \| N/A \| N/A Chur \| Kanton Graubünden \| Switzerland \| 9.53287 \| 46.84986 Brig \| Valais \| Switzerland \| 7.98333 \| 46.31667 Lucerne \| N/A \| Switzerland \| 8.30635 \| 47.05048 Lugano \| N/A \| Switzerland \| 8.96004 \| 46.01008 Kaohsiung City \| N/A \| Taiwan \| 120.31333 \| 22.61626 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 Bangkok \| Bangkok \| Thailand \| 100.50144 \| 13.75398 Pathumwan, Bangkok \| Thailand \| Thailand \| 100.50144 \| 13.75398 Bangkok \| N/A \| Thailand \| 100.50144 \| 13.75398 Plymouth \| Devon \| United Kingdom \| -4.14305 \| 50.37153 Chelmsford \| Essex \| United Kingdom \| 0.46958 \| 51.73575 Romford \| Essex \| United Kingdom \| 0.18582 \| 51.57515 Isleworth \| London \| United Kingdom \| -0.34246 \| 51.47518 London \| London \| United Kingdom \| -0.12574 \| 51.50853 London \| London \| United Kingdom \| -0.12574 \| 51.50853 Edinburgh \| Lothian \| United Kingdom \| -3.19648 \| 55.95206 Liverpool \| Merseyside \| United Kingdom \| -2.97794 \| 53.41058 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	1,188	NCT00439725	1COMPLETED	2009-09-01	2007-02-01	Bayer	4INDUSTRY	false	false	false	null	-0
[ 0 ]	74	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	We are testing the hypothesis that subjects in the treatment group will experience fewer fasting induced headaches as compared to those in the placebo group.In our clinical experience, we estimate that approximately 25% of our headache population experiences fasting-induced migraine or hunger-induced migraine. With a given migraine incidence of 28 million in the United States alone, we estimate that approximately 7 million will experience hunger as a migraine trigger. If an individual has a known migraine trigger, then there are a variety of ways to modify care in order to address that trigger. The simplest is to avoid that trigger or preemptively treat that trigger. Frovatriptan has good evidence for daily use for a short time to help prevent menstrually related migraines. A short course of treatment can often avoid the initiation of the migraine and improve quality of life. Knowing that a longer acting triptan, such as frovatriptan, has demonstrated capability at suppressing headache through a known trigger, suggests the need to study this with fasting induced migraines, as well.	null	Migraine		null	2	arm 1: 5.0 mg of Frovatriptan given as single dose arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Frovatriptan 5.0 mg orally one time at the start of the 20 hour fast intervention 2: Inert tab identical in appearance to Frovatriptan	intervention 1: Frovatriptan intervention 2: Placebo	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	71	NCT00440232	1COMPLETED	2009-09-01	2007-07-01	Thomas Jefferson University	7OTHER	false	false	false	null	0
[ 3 ]	32	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	This study will examine the efficacy and safety of lapatinib in patients with ErbB2 positive ovarian, gastric/esophageal adenocarcinoma, uterine serous papillary, or bladder cancers.	null	Cancer	Ovarian Cancer Bladder Cancer ErbB2 positive Lapatinib Gastric/Esophageal Cancer Uterine Serous Papillary Cancer	null	2	arm 1: None arm 2: None	[ 0, 2 ]	1	[ 0 ]	intervention 1: Subjects administered open label lapatinib, 1500 mg to be taken orally once a day, for 12 weeks. After 12 weeks, subjects with a partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST) will continue to receive open label lapatinib (1500 mg/day orally) until disease progression. Subjects who maintain stable disease will be randomized in a 1:1 ratio to enter stage 2 of the study and receive double blind therapy of either lapatinib 1500 mg/day orally or placebo. Subjects who progress on placebo will have the option to receive lapatinib 1500 mg/day orally until further progression. Those who progress on lapatinib will be withdrawn from the study.	intervention 1: Oral lapatinib tablets or placebo tablets	20	Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Albany \| New York \| United States \| -73.75623 \| 42.65258 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Bedford \| Texas \| United States \| -97.14307 \| 32.84402 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 El Paso \| Texas \| United States \| -106.48693 \| 31.75872 Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541 Tyler \| Texas \| United States \| -95.30106 \| 32.35126 Webster \| Texas \| United States \| -95.11826 \| 29.53773 Leesburg \| Virginia \| United States \| -77.5636 \| 39.11566 Newport News \| Virginia \| United States \| -76.42975 \| 36.98038 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Vancouver \| Washington \| United States \| -122.66149 \| 45.63873	32	NCT00447226	6TERMINATED	2009-09-01	2007-05-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 3 ]	114	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study was to evaluate the long term safety and tolerability of peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease (CKD) who had received at least 24 weeks of peginesatide treatment in an earlier study.	Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The presence and severity of anemia are related to the duration and extent of kidney failure. Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function, and increased left ventricular hypertrophy and heart failure. Erythropoiesis stimulating agents (ESAs) have been established as a treatment for anemia in subjects with chronic kidney disease, and have improved the management of anemia over alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of anemia associated with chronic kidney disease. Peginesatide binds to and activates the human erythropoietin receptor, and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents. Study participants had received at least 24 weeks of peginesatide dosing in a previous Affymax-sponsored study and were to receive doses of peginesatide for up to 54 months. However, the Sponsor ended the study early.	Chronic Renal Failure Chronic Kidney Disease Anemia	anemia chronic kidney disease CKD chronic renal failure CRF dialysis erythropoietin EPO erythropoiesis stimulating agent ESA Hematide™ hemodialysis hemoglobin Hb Hgb Omontys peginesatide red blood cell red blood cell production	null	2	arm 1: Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). This group is categorized as "Maintenance Switch in Dialysis Participants" regardless of dialysis status at the start of or during this study. arm 2: Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). This group is categorized as "Initiation of Treatment in Non-Dialysis Participants" regardless of dialysis status at the start of or during this study.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Participants received the same initial peginesatide dose via the same route, intravenously or subcutaneously, as was administered at the end of the previous peginesatide treatment study in which the participant was enrolled. The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. Each participant was to receive peginesatide as an injection administered once every 4 weeks for approximately 54 months in this trial. intervention 2: Participants received the same initial peginesatide dose via the same route, intravenously or subcutaneously, as was administered at the end of the previous peginesatide treatment study in which the participant was enrolled. The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. Each participant was to receive peginesatide as an injection administered once every 4 weeks for approximately 54 months in this trial.	intervention 1: peginesatide intervention 2: peginesatide	20	Burgas \| N/A \| Bulgaria \| 27.46781 \| 42.50606 Pleven \| N/A \| Bulgaria \| 24.61667 \| 43.41667 Plovdiv \| N/A \| Bulgaria \| 24.75 \| 42.15 Rousse \| N/A \| Bulgaria \| 25.9534 \| 43.84872 Varna \| N/A \| Bulgaria \| 27.91667 \| 43.21667 Veliko Tarnovo \| N/A \| Bulgaria \| 25.62904 \| 43.08124 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Katowice \| N/A \| Poland \| 19.02754 \| 50.25841 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Arad \| N/A \| Romania \| 21.31667 \| 46.18333 Bacau \| N/A \| Romania \| 26.91384 \| 46.56718 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Iași \| N/A \| Romania \| 27.6 \| 47.16667 Timișoara \| N/A \| Romania \| 21.22571 \| 45.75372 Croydon \| N/A \| United Kingdom \| -0.1 \| 51.38333 Derby \| N/A \| United Kingdom \| -1.47663 \| 52.92277 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 Swansea \| N/A \| United Kingdom \| -3.94323 \| 51.62079	114	NCT00453973	6TERMINATED	2009-09-01	2006-11-01	Affymax	4INDUSTRY	false	false	false	null	0
[ 5 ]	40	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	false	This study will evaluate changes in brain gamma-aminobutyric acid (GABA) levels due to treatment with escitalopram in people with major depressive disorder.	Major depressive disorder (MDD) is a severe form of depression. MDD can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be unable to cope with problems in their life. In addition, they often experience sleep disruption, loss of appetite, and chronic pain. The purpose of the study is to compare images taken of the brains of people who are depressed and the brains of healthy volunteers. Specifically, we want to see if symptoms of depression are related to a decrease in a brain chemical called GABA. We measure the concentration of GABA using a brain-scanning device called "magnetic resonance spectroscopy" (or "MRS"), which is a type of MRI. The study lasts for 14 weeks and involves 8 visits to our MGH clinic in Boston. The first visit is the screening visit, which can last up to 3 hours. The rest of the visits are about a half hour long and take place every other week. In addition to these 8 visits, there are also 2 visits to McLean Hospital Brain Imaging Center for the MRS scans. The first scan takes place within a few days after the screening visit, and the second scan will be at the end of the 14 weeks. Each scan visit lasts between an hour and a half and two hours. Subjects are reimbursed $50 per MRS scan and $25 per visit to McLean to cover travel costs. All subjects in this study will receive escitalopram (or Lexapro), which is an antidepressant medication approved by the Food and Drug Administration. Subjects start at 10 mg daily of the escitalopram, but may be increased up to 30 mg if the study doctor thinks it is appropriate.	Major Depressive Disorder	depression biology	null	1	arm 1: single arm	[ 5 ]	1	[ 0 ]	intervention 1: Dose determined per clinical discretion. All participants begin on 10mg po qd of escitalopram, and can increase the dose to 30mg po qd over the 12 weeks of the study.	intervention 1: Escitalopram	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	40	NCT00464711	1COMPLETED	2009-09-01	2006-09-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0
[ 4 ]	147	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	true	This study is designed to test whether treatment of depressive symptoms using escitalopram improves adherence to Buprenorphine and reduces symptoms of depression for individuals receiving Buprenorphine through their medical provider.	Participants interested in receiving Buprenorphine will be offered the opportunity to enroll in this study. Enrolled study participants will complete interviews at baseline and again every two weeks for a total of 8 interviews over 3 months. In this double-blind randomized controlled trial, participants will either receive a placebo or escitalopram (10mg). All participants will also be followed by their Buprenorphine clinic medical provider. Questions during the face-to-face interviews will assess mood, drug craving, pain, sleep, medication adherence and drug-related experiences. Comparison(s): Participants randomized into the medication component of the study as compared to participants randomized into the placebo component of the study.	Opiate Dependence Depression	opiate use depression buprenorphine escitalopram	null	2	arm 1: None arm 2: None	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: 10mg escitalopram/day for 3 months intervention 2: placebo capsule/day for 3 months	intervention 1: escitalopram intervention 2: placebo	1	Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399	147	NCT00475878	1COMPLETED	2009-09-01	2006-12-01	Butler Hospital	7OTHER	false	false	false	null	0
[ 3 ]	59	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	To determine the pharmacokinetic profile and to evaluate the safety and tolerability of ascending multiple doses of tigecycline in patients aged 8 to 11 years with selected serious infections; complicated intra-abdominal infections (cIAI), complicated skin and skin structure infections (cSSSI), or community-acquired pneumonia (CAP).	null	Bacterial Infections Intra-Abdominal Infection Pneumonia, Bacterial Skin Diseases, Bacterial Skin Diseases, Infectious	cIAI cSSSI CAP Child	null	3	arm 1: 0.75 mg/kg (up to a maximum dose of 50 mg for each dose) of tigecycline every 12 hours infused over approximately 30 minutes. Escalation to next dose cohort will occur only after safety and tolerability at preceding dose have been established by sponsor (after tigecycline LDOT data are received) and if at least 5 of 6 PK samples per patient have been received by central laboratory in acceptable condition for 10 to 12 patients in cohort. Treatment period of tigecycline will be a minimum of 3 days (unless patient is considered a treatment failure before this time) and a maximum of 14 days. On or after Day 4, based on investigator's decision, patients can switch to oral antibiotic therapy (to be chosen and provided by the investigator) and discharged after collection of planned PK samples. arm 2: 1 mg/kg (up to a maximum dose of 50 mg for each dose) of tigecycline every 12 hours infused over approximately 30 minutes. Escalation to next dose cohort will occur only after safety and tolerability at preceding dose have been established by sponsor (after tigecycline LDOT data are received) and if at least 5 of 6 PK samples per patient have been received by the central laboratory in acceptable condition for 10 to 12 patients in the cohort. Treatment period of tigecycline will be a minimum of 3 days (unless the patient is considered a treatment failure before this time) and a maximum of 14 days. On or after Day 4, based on investigator's decision, patients can switch to oral antibiotic therapy (to be chosen and provided by the investigator) and discharged after collection of planned PK samples. arm 3: 1.25 mg/kg (up to maximum dose of 50 mg for each dose) of tigecycline every 12 hours infused over approximately 30 minutes. Treatment period of tigecycline will be a minimum of 3 days (unless patient is considered a treatment failure before this time) and a maximum of 14 days. On or after Day 4, based on investigator's decision, patients can switch to oral antibiotic therapy (to be chosen and provided by the investigator) and discharged after collection of planned PK samples.	[ 0, 0, 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: Tygacil	36	Long Beach \| California \| United States \| -118.18923 \| 33.76696 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 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Flint \| Michigan \| United States \| -83.68746 \| 43.01253 Jackson \| Mississippi \| United States \| -90.18481 \| 32.29876 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 New York \| New York \| United States \| -74.00597 \| 40.71427 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Akron \| Ohio \| United States \| -81.51901 \| 41.08144 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Guadalarajara Jalisco \| N/A \| Mexico \| N/A \| N/A Parow \| N/A \| South Africa \| 18.59992 \| -33.89723 Pretoria \| N/A \| South Africa \| 28.18783 \| -25.74486 Pretoria \| N/A \| South Africa \| 28.18783 \| -25.74486 Themba \| N/A \| South Africa \| 28.26438 \| -25.38171 Worcester \| N/A \| South Africa \| 19.44852 \| -33.64651 Taipei \| Taipei \| Taiwan \| N/A \| N/A Kyiv \| Kyiv Oblast \| Ukraine \| N/A \| N/A Lviv \| Lviv Oblast \| Ukraine \| 24.02324 \| 49.83826 Uzhhorod \| Uzhorod \| Ukraine \| 22.2947 \| 48.6242 Vinnitsa \| Vynnitsa \| Ukraine \| 37.71861 \| 49.84639 Dnipropetrovsk \| N/A \| Ukraine \| 35.04066 \| 48.46664 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Kyiv \| N/A \| Ukraine \| 30.5238 \| 50.45466 Kyiv \| N/A \| Ukraine \| 30.5238 \| 50.45466 Vinnitsa \| N/A \| Ukraine \| 37.71861 \| 49.84639	58	NCT00488345	1COMPLETED	2009-09-01	2007-12-01	Wyeth is now a wholly owned subsidiary of Pfizer	4INDUSTRY	false	false	false	null	0
[ 3 ]	63	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	Patients with schizophrenia are characterized by a broad range of neurocognitive abnormalities. These include impairments in attention, including abnormalities in sensory gating; executive function; visual and verbal learning and memory; working memory; processing speed; and social cognition (Nuechterlein et al, 2004). These impairments are major determinants of poor functional outcome in patients with schizophrenia (Green, 1996; Green et al, 2004). Conventional antipsychotics have limited effects on these impairments. Second generation antipsychotics may have modest benefits for cognitive function, but whether this represents a direct cognitive enhancing effect has not been established. Regardless, patients continue to exhibit pronounced cognitive impairments despite adequate second generation antipsychotic treatment. Adjunctive pharmacotherapy may offer a viable approach for the treatment of cognitive impairments. Adjunctive agents can be used to modulate specific neurotransmitter systems that are hypothesized to be involved in the pharmacology of cognitive functions. The standard of care for schizophrenia is antipsychotic medications to treat psychotic symptoms. However, cognitive impairments remain and these impairments have been found to be significantly associated with the poor psychosocial function observed in patients with schizophrenia. There is a considerable preclinical rationale for the use of drugs that act at the Gamma-amino-buyric acid (GABA) α2 subunit as adjunctive treatments to target cognitive impairments. MK-0777 GEM (Merck-0777 Gel Extrusion Module) formulation provides an opportunity to directly test this mechanism. The purpose of the proposed study is to examine the efficacy and safety of two doses of MK (Merck) -0777 GEM, 3 mg BID (twice daily) and 8 mg BID (twice daily), in the treatment of cognitive impairments in patients with schizophrenia. Secondary goals are to determine whether MK-0777 has beneficial effects on measures of functional capacity and patient self-report of cognitive function.	The proposed study is a multicenter, randomized, double blind comparison of MK-0777 GEM 3 mg BID, MK-0777 GEM 8 mg BID, and placebo. The total sample will consist of 90 clinically stable patients with DSM IV TR schizophrenia, with 30 subjects randomized to each group. A best estimate diagnostic approach will be utilized, in which information from the Structured Clinical Interview for DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) (First et al, 1997) is supplemented by information from family informants, previous psychiatrists, and medical records to generate a diagnosis. The projected number of subjects to be recruited from each site is 12-13. There will be a 2 week, placebo lead-in evaluation phase, in which subjects will undergo baseline diagnostic; medical, including a physical examination, EKG (electrocardiogram), CBC (Complete Blood Count), complete metabolic panel, urine toxicology, and UA (urinalysis); psychiatric; and neurocognitive, symptom level and functional capacity and patient self-report of cognitive function assessments. In addition, all subjects will receive a slit-lamp eye examination. At the end of the evaluation phase, subjects will be randomized to one of two MK-0777 doses or placebo. The double-blind treatment phase will be 4 weeks. Subjects will receive bi-weekly symptom assessments and weekly side effect and vital sign assessments. At week 4, subjects will undergo repeat administration of the neuropsychological test battery and the functional capacity and patient self-report of cognitive function measures. These assessments will be done over a two-day period. Subjects will have blood samples collected for antipsychotic and MK-0777 levels at week 4. An EKG (electrocardiogram) will be obtained at the end of the double-blind study. Slit-lamp eye examinations will be conducted at study completion, 6 months and 12 months after study completion. After the completion of the 4-week double-blind phase, there will be a 4-day follow-up phase during which subjects will be tapered off study medication. Study Locations: The study will be conducted in the Treatment Units for Research on Neurocognition and Schizophrenia (TURNS) study network, which is comprised of seven sites: Columbia University School of Medicine (P.I.: Jeffrey Lieberman, M.D.); Duke University School of Medicine (P.I.: Joseph McEvoy, M.D.); Harvard University School of Medicine (P.I.: Donald Goff, M.D.); Maryland Psychiatric Research Center (MPRC) (P.I.: Robert W. Buchanan, M.D.); Nathan Kline Institute (P.I.: Daniel Javitt, M.D.) University of California Los Angeles School of Medicine (P.I.: Steve Marder, M.D.); and Washington University School of Medicine (P.I.: John Csernansky, M.D.). The TURNS is a NIMH-funded contract for the evaluation of new compounds for the treatment of cognitive impairments in schizophrenia (HHSN 27820044 1003C; P.I.: Steve Marder, M.D.). Data management will be performed by the Clinical Trials Data Management Unit of the Nathan Kline Institute under the direction of Jim Robinson, M.S., and statistical analysis will be performed by Dr. Robert McMahon of the Maryland Psychiatric Research Center. Laboratory assays will be performed by Quest Diagnostics. Procedures: Clinical Assessments: The symptom assessments will include the Brief Psychiatric Rating Scale; Scale for the Assessment of Negative Symptoms (SANS); Calgary Depression Scale (CDS); and Clinical Global Impression Scale (CGI). i) BPRS(Brief Psychiatric Rating Scale): the four positive symptom items (conceptual disorganization, suspiciousness, hallucinatory behavior, and unusual thought content) will be used to measure positive psychotic symptoms. ii) SANS (Scale for Assessment of Negative Symptoms): the SANS total score, minus the global items, inappropriate affect, poverty of content of speech, and attention items, will be used to measure negative symptoms. The inappropriate affect, poverty of content of speech, and attention items are excluded as lacking construct validity and because factor analytic study results suggest that these items are not closely related to negative symptoms. iii) CDS (Calgary Depression Scale): the CDS total score will be used to measure depressive symptoms. iv) CGI (Clinical Global Impressions): the CGI severity of illness item will be used to assess global changes Safety Assessments: The safety assessments will include the Simpson Angus Extrapyramidal Symptom Rating Scale (SAS); Abnormal Involuntary Movement Scale (AIMS); and Side Effect Checklist (SEC). i) SAS: a modified 11 item version of the SAS will be used to assess EPS. ii) AIMS: is a 12 item scale, with 7 items designed to assess abnormal facial, oral, extremity, and trunk movements; 3 global judgment items; and 2 current dental status items. iii) SEC: is designed to assess vital signs, commonly occurring antipsychotic side effects, and side effects indicative of uveitis or cataracts. Subjects will be asked about adverse events at each visit, and instructed to call the study site should they experience adverse events at any point in the study. Any serious adverse event, including death due to any cause, which occurs to any subject entered into this study or within 14 days following cessation of treatment, whether or not related to the investigational product, will be reported to Merck \& Co., Inc. within 24 hours. Functional Assessments: The functional assessments will include the UCSD Performance-Based Skills Assessment (UPSA) and the Schizophrenia Cognition Rating Scale (SCoRS). i) UPSA: is designed to assess skills in five areas: household chores, communication, finance, transportation, and planning recreational activities. Subjects are asked to perform tasks in each of these areas and scored according to their ability to complete the task. The UPSA takes 25 - 30 minutes to administer. ii) SCoRS: is a rating scale designed to elicit information from the subject and informant on the level of cognitive function of the subject. The subject and informant versions both have 20 items. Subject and informant interviews take from 10 - 15 minutes to complete. Neurocognitive Assessments: The NIMH MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia Research) Neuropsychological Battery, the Wechsler Test of Adult Reading (WTAR), the N-Back test; and the Continuous Performance Test (CPT-AX) will be used to assess cognitive function. The NIMH MATRICS Neuropsychological Battery is comprised of measures of: a) working memory; b) attention/vigilance; c) verbal memory; d) visual memory; e) processing speed; f) problem solving; and g) social cognition. The N-Back and CPT-AX are both computerized measures of prefrontal cortex dependent cognitive behavior. Screening: The diagnosis of schizophrenia will be confirmed by a research psychiatrist using a modified version of the Structured Clinical Interview for DSM IV (SCID). The BPRS, SANS, CDRS and SAS will be administered to verify that inclusionary criteria are met. Subjects will have a slit-lamp eye examination. 2 Week, Lead-in Evaluation Phase: In the 2 week lead-in evaluation phase, subjects will receive placebo. They will undergo baseline symptom, medical, safety, and neurocognitive assessments. The subjects will undergo a physical examination; including neurological exam, an EKG; and laboratory tests of major organ functions (i.e., CBC (complete blood count), liver function tests, electrolytes, glucose, BUN/Creatinine, Urinalysis (UA), urine toxicology, and thyroid functions). Baseline antipsychotic levels will be collected. All women will have a pregnancy test, unless they are either surgically or hormonally post menopausal. 4-Week Double Blind Treatment Phase: The study is a 4-week, placebo controlled, double blind study. Subjects will be randomized to either: MK-0777 GEM 3mg BID; MK-0777 GEM 8mg BID; or placebo. The unblinded site pharmacist will be notified of the treatment assignment, and will dispense study medication. Subjects will receive biweekly symptom assessments and weekly side effect and vital sign assessments. At week 4, subjects will undergo repeat administration of the neuropsychological test battery and the functional capacity and patient self-report of cognitive function measures. These assessments will be done over a two-day period. At week 4, subjects will also undergo a repeat slit lamp eye examination. We will also attempt to contact and schedule subjects who dropped out of the study prior to week 4 for the week 4 slit lamp eye examination. Finally, subjects will have blood samples collected for antipsychotic and MK-0777 levels at week 4. 6-Month and 12-Month Follow-up Evaluations: All subjects, regardless if they completed the 4-week double-blind treatment phase, will be contacted and scheduled for follow-up slit lamp eye examinations. Randomization: Subjects will be randomly assigned to placebo or one of two doses of experimental treatment within strata defined by site. Recruitment: Recruitment for potential subjects will be performed by reviewing subject records to determine eligibility based on the inclusion and exclusion criteria. Once qualifying records have been identified, potential subjects will be informed individually and/or in a group setting about the study.	Schizophrenia	Cognition Schizophrenia	null	3	arm 1: MK-0777 8 mg tablet by mouth twice daily for 4 weeks arm 2: MK-0777 3 mg tablet by mouth twice daily for 4 weeks arm 3: Placebo tablet by mouth twice daily for 4 weeks	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: MK-0777 GEM, 8 mg BID intervention 2: MK-0777 GEM, 3 mg BID intervention 3: 2 tablets placebo BID	intervention 1: MK-0777 intervention 2: MK-0777 intervention 3: placebo	8	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Catonsville \| Maryland \| United States \| -76.73192 \| 39.27205 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 New York \| New York \| United States \| -74.00597 \| 40.71427 Orangeburg \| New York \| United States \| -73.94958 \| 41.04649 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	60	NCT00505076	1COMPLETED	2009-09-01	2007-07-01	University of California, Los Angeles	7OTHER	false	false	false	null	0
[ 4 ]	245	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.	null	Chronic Kidney Disease Dialysis Hyperphosphatemia	Chronic Kidney Disease Dialysis Hyperphosphatemia Phosphate binder	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind intervention 2: 3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind	intervention 1: MCI-196 intervention 2: Placebo	39	Glendale \| Arizona \| United States \| -112.18599 \| 33.53865 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Paragould \| Arkansas \| United States \| -90.49733 \| 36.0584 Pine Bluff \| Arkansas \| United States \| -92.0032 \| 34.22843 Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 La Mesa \| California \| United States \| -117.02308 \| 32.76783 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Lynwood \| California \| United States \| -118.21146 \| 33.93029 Orange \| California \| United States \| -117.85311 \| 33.78779 San Diego \| California \| United States \| -117.16472 \| 32.71571 Whittier \| California \| United States \| -118.03284 \| 33.97918 Brandon \| Florida \| United States \| -82.28592 \| 27.9378 Hudson \| Florida \| United States \| -82.69343 \| 28.36445 Lauderdale Lakes \| Florida \| United States \| -80.20838 \| 26.16647 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Macon \| Georgia \| United States \| -83.6324 \| 32.84069 Evanston \| Illinois \| United States \| -87.69006 \| 42.04114 Evergreen Park \| Illinois \| United States \| -87.70172 \| 41.72059 Fort Wayne \| Indiana \| United States \| -85.12886 \| 41.1306 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Springfield \| Massachusetts \| United States \| -72.58981 \| 42.10148 Eatontown \| New Jersey \| United States \| -74.05097 \| 40.29622 Flushing \| New York \| United States \| -73.81736 \| 40.76538 Springfield Gardens \| New York \| United States \| -73.76221 \| 40.66312 Allentown \| Pennsylvania \| United States \| -75.49018 \| 40.60843 Lewistown \| Pennsylvania \| United States \| -77.57138 \| 40.59924 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Orangeburg \| South Carolina \| United States \| -80.85565 \| 33.49182 Sumter \| South Carolina \| United States \| -80.34147 \| 33.92044 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Alexandria \| Virginia \| United States \| -77.04692 \| 38.80484 Portsmouth \| Virginia \| United States \| -76.29827 \| 36.83543 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 West Allis \| Wisconsin \| United States \| -88.00703 \| 43.01668 San Juan \| N/A \| Puerto Rico \| -66.10572 \| 18.46633	414	NCT00506441	1COMPLETED	2009-09-01	2007-09-01	Mitsubishi Tanabe Pharma Corporation	4INDUSTRY	false	false	false	null	0
[ 4 ]	55	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This study is designed to evaluate the effectiveness of treatment of residual amblyopia in children ages 3 to \< 10 years with visual acuity of 20/32 to 20/63 in the amblyopic eye. The study is a randomized clinical trial comparing intensive treatment (42 hours per week of patching plus daily atropine) with a control group that will have rapid weaning of existing treatment followed by spectacle correction only (if needed). The primary objective is to determine if this intensive treatment will improve visual acuity in patients with residual amblyopia. The primary outcome assessment is amblyopic eye visual acuity at 10 weeks. The primary analytic approach for the amblyopic eye acuity will be a treatment group comparison of the proportion of patients with at least two lines of visual acuity improvement.	Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children. Despite best efforts with conventional treatment, some patients fail to achieve normal visual acuity in the amblyopic eye. In a randomized trial conducted by PEDIG comparing atropine versus patching in 3 to 6 year olds with moderate amblyopia (ATS1), 261 of 402 patients (65%) had amblyopic eye visual acuity of 20/32 or worse after 6 months of treatment with patching or atropine. Beyond 6 months, treatment was at investigator discretion, and two years after randomization, 181 of 363 children (50%) still had amblyopic eye visual acuity of 20/32 or worse. In a randomized trial conducted by PEDIG comparing patching regimens, 129 of 181 patients with moderate amblyopia (71%) and 145 of 157 patients with severe amblyopia (92%) had amblyopic eye visual acuity of 20/32 or worse after 4 months of occlusion therapy. Many patients receive treatment beyond 6 months but still fail to achieve normal visual acuity in the amblyopic eye. It is unknown whether an intensive "final push" of combined treatment with daily patching and atropine will improve visual acuity in these patients. Although some clinicians prescribe simultaneous patching and atropine for selected patients, there are no published reports of its effectiveness. Also, we are not aware of reports of response to treatment of residual amblyopia. The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. Patients will be randomized to one of two treatment regimens: * Intensive treatment: 42 hours per week of patching combined with daily atropine (1%) * Control group: Weaning of the current treatment (two hours of daily patching for patients currently using patching and once weekly atropine for patients currently using atropine) for 4 weeks, then no treatment other than spectacles (if needed).	Amblyopia	Amblyopia Atropine Patching	null	2	arm 1: 42 hours per week of patching combined with atropine (1%) once daily in the sound eye, with spectacle correction (if needed) arm 2: For patients currently patching, reduce patching to two hours daily for four weeks, then no treatment thereafter except spectacle correction (if needed). For patients currently using atropine, reduce atropine to once weekly for 4 weeks, then no treatment thereafter except spectacle correction (if needed)	[ 1, 1 ]	4	[ 1, 0, 1, 0 ]	intervention 1: 42 hours per week of patching intervention 2: daily atropine (1%) intervention 3: two hours of daily patching for 4 weeks, then no treatment intervention 4: once weekly atropine for 4 weeks, then no treatment	intervention 1: Patching intervention 2: Atropine intervention 3: Patching intervention 4: Atropine	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	55	NCT00506675	6TERMINATED	2009-09-01	2007-10-01	Jaeb Center for Health Research	7OTHER	false	false	false	null	0
[ 3 ]	6	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	false	The purpose of this study is to investigate the prevention of Restenosis following Revascularization of the superficial Femoral Artery (SFA)	null	Vascular Disease, Peripheral	Restenosis Superficial Femoral Artery Prevention of restenosis Revascularization of the superficial Femoral Artery	null	4	arm 1: Following revascularization, participants did not receive any study drug treatment. arm 2: Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m\^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m\^2 at 7 days. arm 3: Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m\^2 nanoparticle paclitaxel immediately following revascularization. arm 4: Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m\^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m\^2 at 7 days.	[ 4, 0, 0, 0 ]	1	[ 0 ]	intervention 1: Nanoparticle albumin-bound paclitaxel, 45 mg/m\^2.	intervention 1: Nanoparticle Paclitaxel	7	Sacramento \| California \| United States \| -121.4944 \| 38.58157 Gainsville \| Florida \| United States \| N/A \| N/A Davenport \| Iowa \| United States \| -90.57764 \| 41.52364 Flint \| Michigan \| United States \| -83.68746 \| 43.01253 Teaneck \| New Jersey \| United States \| -74.01597 \| 40.8976 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399	6	NCT00518284	6TERMINATED	2009-09-01	2008-01-01	Celgene Corporation	4INDUSTRY	false	false	false	null	0
[ 0 ]	1	RANDOMIZED	PARALLEL	1PREVENTION	3TRIPLE	false	0ALL	true	A total of 50 patients \>40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer will be enrolled. The patient and study team will be blinded to which drug they are receiving (either Arixtra or Lovenox). Subjects will be examined for any bleeding complications. Subjects will receive drug for a total of 6-14 days while in the hospital. A follow up phone call will be performed by the study team approximately 30 days after discharge from the hospital.	A total of 50 patients will be enrolled in this double-blinded, randomized, controlled trial. Inclusion criteria: subjects\>40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer (4 days bedridden) will be enrolled. Total drug treatment will be 6-14 days while in the hospital. A follow up phone call will be performed by the study team approximately 30 days after hospital discharge. Primary endpoint: bleeding rate (minor vs major) between study days 1-14. Secondary endpoint: DVT study days 1-14 (confirmed with LE duplex ultrasonogram).	Venous Thrombosis	Bleeding rates Prophylaxis for deep vein thrombosis	null	2	arm 1: Arixtra (Fondaparinox) 2.5 mg SC Daily arm 2: Lovenox 40mg SC Daily	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Patients will be randomized to receive Arixtra 2.5mg once a day if randomized to this arm intervention 2: Patients will be randomized to receive Lovenox 40mg SC Daily if randomized to this arm	intervention 1: Arixtra (Fondaparinox) 2.5 mg SC Daily intervention 2: Lovenox 40mg SC Daily	1	Bethlehem \| Pennsylvania \| United States \| -75.37046 \| 40.62593	0	NCT00521885	6TERMINATED	2009-09-01	2007-09-01	Lehigh Valley Hospital	7OTHER	false	false	false	null	0
[ 4 ]	52	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The primary objective of this study is: To assess the virologic effect of changing enfuvirtide to MK-0518(raltegravir) in human immunodeficiency virus type 1(HIV-1) infected patients who have an undetectable level of serum human immunodeficiency virus(HIV) (\< 75 copies/ml by branch deoxyribonucleic acid (bDNA) assay, \< 50 copies/ml by Ultrasensitive Polymerase Chain Reaction(PCR) assay) on their current HIV medication regimen. Hypothesis: HIV-1 infected individuals well controlled on an enfuvirtide containing regimen with HIV RNA levels below limits of quantification can safely have the investigational integrase inhibitor, MK-0518 substituted for enfuvirtide without loss of virologic suppression.	Human immunodeficiency virus type 1(HIV-1) infected patients who have had an undetectable viral load on an enfuvirtide containing regimen at the Kaiser Permanente Hayward, Los Angeles, San Francisco, and Santa Clara Medical Centers will be enrolled. Patients will receive open label MK-0518 (raltegravir) 400mg orally twice a day as substitution for enfuvirtide for 24 weeks.	HIV Infections	Treatment Experience On enfuvirtide	null	1	arm 1: Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.	[ 0 ]	1	[ 0 ]	intervention 1: This is a single-arm, open-label, non-randomized pilot study in human immunodeficiency virus type 1 (HIV-1) positive patients who have an undetectable viral load on their current enfuvirtide containing medication regimen. The treatment regimen will consist of replacing enfuvirtide with MK-0518 400 mg twice a day given as part of the patient's HIV medication regimen. The study regimen will be administered for 24 weeks, with patients given the option of continuing on the study medication past that time if they wish to. Patients serve as their own control as they have viral control (HIV ribonucleic acid (RNA) below limits of quantification) for at least 6 months with enfuvirtide prior to switch to raltegravir.	intervention 1: raltegravir	8	Anaheim \| California \| United States \| -117.9145 \| 33.83529 Hayward \| California \| United States \| -122.0808 \| 37.66882 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Panorama City \| California \| United States \| -118.44981 \| 34.22473 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Santa Clara \| California \| United States \| -121.95524 \| 37.35411 Santa Clarita \| California \| United States \| -118.54259 \| 34.39166	52	NCT00529243	1COMPLETED	2009-09-01	2007-09-01	Kaiser Permanente	7OTHER	false	false	false	null	0
[ 4 ]	345	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of the study is to investigate the efficacy and safety of a grass sublingual tablet in children and adolescents with a history of grass-pollen induced rhinoconjunctivitis with or without asthma.	This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in participants aged 5 to \<18 years of either sex, and of any race with a history of grass pollen induced rhinoconjunctivitis with or without asthma. While receiving treatment, participants will receive either grass sublingual tablet or placebo. Open-label rescue medications for the rhinoconjunctivitis and asthma symptoms will be provided. Participants will visit the study site for at least 12 visits. A total of 10 allergic symptoms, 6 rhinoconjunctivitis and 4 lung symptoms, will be recorded daily on an electronic diary by the participant/parent/guardian. The start and end of the grass pollen season (GPS) was determined based on the regional grass pollen count, and lasted up to 162 days. For each region, the GPS is defined as the first day of 3 consecutive recorded days with a grass pollen count of ≥ 10 grains/m\^3, to the last day of the last occurrence of 3 consecutive recorded days with a grass pollen count ≥ 10 grains/m\^3, inclusively.	Rhinoconjunctivitis Rhinitis Conjunctivitis Allergy	rhinoconjunctivitis rhinitis conjunctivitis allergy allergen immunotherapy	null	2	arm 1: Matching Placebo arm 2: Grass Sublingual Tablet (Phleum pratense extract)	[ 2, 0 ]	9	[ 0, 2, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: Placebo sublingual tablet, once daily intervention 2: Grass sublingual tablet, once daily intervention 3: Loratadine Syrup 1 mg/mL was dosed orally once daily at a dose of 5 mg for children aged 5 to \<6 years of age and at a dose of 10 mg for children aged 6 to \<18 years of age as rescue medication for symptoms of rhinoconjunctivitis among participants with a total symptom score ≥4. intervention 4: Loratadine 10 mg RediTabs tablets were dosed orally once daily at a dose of 10 mg for children aged 6 to \<18 years of age as rescue medication for symptoms of rhinoconjunctivitis among participants with a total symptom score ≥4. intervention 5: Olopatadine hydrochloride 0.1% ophthalmic solution was dosed intraocularly at a dose of 1 drop in each affected eye twice daily, in addition to loratadine, as rescue medication for participants with persistent eye symptoms due to rhinoconjunctivitis. intervention 6: Mometasone furoate monohydrate nasal spray 50 mcg was dosed intranasally at a dose of one spray in each nostril once daily for participants aged 5 to \<12 years and a dose of 2 sprays in each nostril once daily for participants aged 12 to \<18 years as rescue medication for nasal symptoms of rhinoconjunctivitis among participants with a total symptom score of ≥4 despite loratadine and mometasone furoate nasal spray. intervention 7: Albuterol sulfate inhalation aerosol 108 mcg/inhalation was administered via inhalation at a dose of 2 inhalations every 4 to 6 hours as rescue medication among participants aged 5 to \<18 years with asthma symptoms . intervention 8: Fluticasone propionate inhalation aerosol 44 mcg/inhalation was administered via inhalation at a dose of 2 inhalations twice daily among participants aged 12 to \<18 years up to a maximum dose of 10 inhalations twice daily, in combination with albuterol, among participants with ≥4 albuterol sulfate inhalations/day for 2 days as rescue medication for nocturnal asthma or shortness of breath. intervention 9: Prednisone tablet 5 mg was administered orally at a dose of 1 mg/kg/day once daily up to a maximum of 50 mg/day on Day 1, and at a dose of 0.5 mg/kg/day once daily up to a maximum of 25 mg/day on Days 2, 3, 5, and 7 as rescue medication for asthma exacerbation at the discretion of the investigator.	intervention 1: Placebo intervention 2: SCH 697243 intervention 3: Loratadine Syrup 1 mg/mL Rescue Treatment intervention 4: Loratadine 10 mg Rescue Treatment intervention 5: Olopatadine 0.1% Rescue Treatment intervention 6: Mometasone furoate 50 mcg Rescue Treatment intervention 7: Albuterol 108 mcg Rescue Treatment intervention 8: Fluticasone 44 mcg Rescue Treatment intervention 9: Prednisone 5 mg Rescue Treatment	0	null	345	NCT00550550	1COMPLETED	2009-09-01	2007-11-01	ALK-Abelló A/S	4INDUSTRY	false	false	false	null	0
[ 4 ]	208	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal anemia. Individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200, or 360 micrograms \[mcg\] IV injection) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving in the week preceding study start.	null	Chronic Renal Anemia		null	1	arm 1: Participants with chronic renal anemia who have been previously treated with erythropoiesis-stimulating agent (ESA) therapy will receive IV Mircera every 4 weeks for a total of 24 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. Subsequent doses will be adjusted to maintain Hb concentrations within target of 10.5 and 12.5 grams per deciliter (g/dL).	[ 0 ]	1	[ 0 ]	intervention 1: Participants will receive a starting dose of 120, 200, or 360 mcg via IV injection. Thereafter, the once-monthly dose will be titrated to achieve target Hb concentrations.	intervention 1: Methoxy polyethylene glycol-epoetin beta	24	Aigáleo \| N/A \| Greece \| 23.68333 \| 37.98333 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Corinthos \| N/A \| Greece \| N/A \| N/A Daphni-athens \| N/A \| Greece \| N/A \| N/A Ioannina \| N/A \| Greece \| 20.85189 \| 39.66486 Kalamata \| N/A \| Greece \| 22.11265 \| 37.03913 Kyparissía \| N/A \| Greece \| 21.67361 \| 37.25111 Lamia \| N/A \| Greece \| 22.43333 \| 38.9 Larissa \| N/A \| Greece \| 22.41761 \| 39.63689 Larissa \| N/A \| Greece \| 22.41761 \| 39.63689 Livadeia \| N/A \| Greece \| 22.87665 \| 38.43616 Mytilene \| N/A \| Greece \| 26.55529 \| 39.10772 Pátrai \| N/A \| Greece \| 21.73444 \| 38.24444 Rhodes \| N/A \| Greece \| 28.22199 \| 36.43556 Thessaloniki \| N/A \| Greece \| 22.93086 \| 40.64361 Thessaloniki \| N/A \| Greece \| 22.93086 \| 40.64361 Thessaloniki \| N/A \| Greece \| 22.93086 \| 40.64361 Thessaloniki \| N/A \| Greece \| 22.93086 \| 40.64361	188	NCT00550680	1COMPLETED	2009-09-01	2008-01-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 4 ]	425	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	2MALE	false	The purpose of this study is to test whether pregabalin added to the standard of care with dosing starting preoperatively and continuing for 1 week post surgery will decrease the intensity of acute post-operative pain following inguinal hernia repair.	null	Pain, Postoperative Hernia, Inguinal	postoperative pain chronic pain	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 2, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 150 mg BID intervention 2: Placebo intervention 3: 75 mg BID intervention 4: 25 mg BID	intervention 1: Pregabalin intervention 2: placebo intervention 3: Pregabalin intervention 4: Pregabalin	42	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Glendale \| California \| United States \| -118.25508 \| 34.14251 Laguna Hills \| California \| United States \| -117.71283 \| 33.61252 Pasadena \| California \| United States \| -118.14452 \| 34.14778 Lake Worth \| Florida \| United States \| -80.07231 \| 26.61708 Pensacola \| Florida \| United States \| -87.21691 \| 30.42131 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Stony Brook \| New York \| United States \| -73.14094 \| 40.92565 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Hermitage \| Tennessee \| United States \| -86.6225 \| 36.19617 Hermitage \| Tennessee \| United States \| -86.6225 \| 36.19617 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Humble \| Texas \| United States \| -95.26216 \| 29.99883 Kingwood \| Texas \| United States \| -95.18349 \| 30.05691 Randwick \| New South Wales \| Australia \| 151.24895 \| -33.91439 London \| Ontario \| Canada \| -81.23304 \| 42.98339 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Charlottetown \| Prince Edward Island \| Canada \| -63.1256 \| 46.23459 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 Vadodara \| Gujarat \| India \| 73.20812 \| 22.29941 Pune \| Maharashtra \| India \| 73.85535 \| 18.51957 Madurai \| Tamil Nadu \| India \| 78.11953 \| 9.919 Delhi \| N/A \| India \| 77.23149 \| 28.65195 Alcorcón \| Madrid \| Spain \| -3.82487 \| 40.34582 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Gävle \| N/A \| Sweden \| 17.14174 \| 60.67452 Landskrona \| N/A \| Sweden \| 12.83016 \| 55.8708 Mora \| N/A \| Sweden \| 14.54316 \| 61.00704 Örebro \| N/A \| Sweden \| 15.2066 \| 59.27412 Skellefteå \| N/A \| Sweden \| 20.95279 \| 64.75067	425	NCT00551135	1COMPLETED	2009-09-01	2008-01-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	2	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Src expression has been identified in a majority of Non-Small Cell Lung Cancer (NSCLC) cell lines and there is preclinical evidence that Src family kinases may be important in hypoxic growth and angiogenesis in NSCLC. We hypothesize that the inhibition of Src pathway with dasatinib will demonstrate anti-tumor activity in early stage NSCLC, with a tolerable safety profile. Patients will receive dasatinib, a Src inhibitor, for 3 weeks prior to surgical resection for early stage NSCLC. Fresh frozen tumor tissue is needed for genomic analysis. If fresh frozen tumor tissue is not available from the initial diagnosis, a biopsy will be required to participate in this trial. A second tumor sample will be obtained at time of surgical resection to evaluate for changes in genomic expression profiles. Patients will be eligible to receive 3 months of adjuvant dasatinib therapy after completion of standard adjuvant therapy or after recovery from surgery if no standard adjuvant therapy is given, if there is evidence of neoadjuvant tumor response (radiologic and/or pathologic) to dasatinib. Many patients who present with NSCLC are active smokers. Patients who are smoking up until the time of their surgery experience increased peri-operative complications compared to patients who have not smoked cigarettes immediately prior to surgery. While this trial will not be limited to active smokers, the period of smoking cessation prior to surgery is an attractive window of opportunity during which the potentially active novel anticancer therapy dasatinib can be offered to the patient.	This is a phase II study of dasatinib, a targeted biologic agent, known to inhibit Src. It is difficult to assess outcome in phase II adjuvant trials because there is no measurable disease to evaluate efficacy and there are many variables that could confound comparing survival of subjects on trial to historical controls. Therefore, after a fresh frozen tumor tissue sample is obtained for genomic analysis, we plan to treat subjects with neoadjuvant dasatinib and then measure tumor response to therapy prior to surgery. Resected tumor will also be assessed for pathologic response as well as for changes in genomic expression patterns. Subjects will be treated with neoadjuvant dasatinib 70 mg PO twice daily for 3 weeks, with a mandatory minimum of 3 days (72 hours) off of study drug prior to surgical resection. Imaging studies will be done pre-treatment and pre-surgery to assess radiologic response to therapy. The surgical specimen will be evaluated for pathologic response. A tumor tissue sample will be obtained from the surgical specimen for genomic analysis and will be evaluated for changes in genomic expression profiles. Patients whose tumors have a response to neoadjuvant dasatinib therapy might benefit with better cancer control if they receive a potentially therapeutic course of adjuvant dasatinib. Patients that have at least a 15% decrease or better objective response, without evidence of progression to neoadjuvant dasatinib (per tumor evaluation pre-surgery) or pathologic response (as defined as ≥30% tumor necrosis or cell death) to neoadjuvant dasatinib therapy will be eligible to receive dasatinib 70 mg twice daily for 90 days after the completion of standard adjuvant therapy or after recovery from surgery if no standard adjuvant therapy is given. Patients will be followed for approximately 30 days after the last dose of dasatinib to assess toxicity. Response will be evaluated in Src regulated and Src deregulated cohorts of tumors. If responses to neoadjuvant dasatinib occur, then accrual to either or both cohorts will be expanded. If there are no responses to neoadjuvant dasatinib in the cohort groups, then accrual to either or both cohorts will be stopped. The results of this study may be useful in designing future studies in early stage NSCLC using dasatinib alone or in combination with chemotherapy.	Carcinoma, Non-Small-Cell Lung	Non Small Cell Lung Cancer (NSCLC) carcinoma dasatinib neoadjuvant adjuvant resection genomic signature predictor microarray	null	1	arm 1: Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.	[ 0 ]	1	[ 0 ]	intervention 1: Fresh frozen tumor tissue must be available prior to initiating dasatinib. Eligible patients will receive neoadjuvant dasatinib 70 mg PO twice daily for 3 weeks followed by surgery. The surgical specimen will be evaluated for pathologic response. The second tumor sample will be obtained after 3 weeks of dasatinib therapy at the time of definitive surgical resection which will be evaluated for changes in genomic expression profiles. Patients with at least a 15% decrease or better objective response, without evidence of progression (per tumor evaluation pre-surgery) or pathologic response (as defined as ≥30% tumor necrosis or cell death) to neoadjuvant dasatinib therapy will be eligible to receive dasatinib 70 mg twice daily for 90 days after the completion of standard adjuvant therapy.	intervention 1: Dasatinib	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	2	NCT00564876	6TERMINATED	2009-09-01	2007-11-01	Duke University	7OTHER	false	false	false	null	0
[ 3 ]	37	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine whether varenicline (Chantix), is effective for the treatment of cocaine dependence.	The purpose of study is to determine if Varenicline (Chantix™) promotes cocaine abstinence in cocaine dependent individuals. Varenicline (Chantix™) (2.0 mg/day) or placebo will be administered in a 9-week double-blind trial to patients meeting diagnostic criteria for cocaine dependence.	Cocaine Dependence	cocaine crack cocaine cocaine-related disorders substance-related disorders alpha4beta2 nicotinic acetylcholine receptor	null	2	arm 1: Varenicline (Chantix) arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 1.0 mg BID for 8 weeks intervention 2: placebo BID for 8 weeks	intervention 1: varenicline intervention 2: placebo	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	35	NCT00567008	1COMPLETED	2009-09-01	2007-12-01	University of Pennsylvania	7OTHER	false	false	false	null	0
[ 4 ]	94	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	false	Prior studies in animal models have established that the pathogenesis of alcoholic liver disease (ALD) is regulated in part by the effects of chronic alcohol abuse on hepatic methionine metabolism. The hypothesis of the clinical study was that provision of the methionine metabolite S-adenosylmethionine (SAM) would correct abnormal hepatic methionine metabolism thereby effectively treating ALD. The two goals of the clinical research were a)to determine the clinical relationship of aberrant hepatic methionine metabolism to ALD by comparisons of patterns of serum methionine metabolites in groups of ALD patients, alcoholics without liver disease, and normal healthy subjects, and b) to determine the treatment effects of SAM on patterns of serum methionine metabolites and on the histopathology and biochemical features of liver injury in ALD patients.	We assessed a total of 297 potential ALD candidates, from whom 40 were enrolled in the study. In addition, we enrolled 26 gender matched active alcohol drinkers without liver disease (AD) and 28 age and gender matched healthy control subjects (HS). Of the original 40 ALD subjects who provided initial enrollment data, 3 declined to proceed with the trial. Therefore, 37 ALD patients were randomized to receive SAM at a dose of 400 mg or placebo three times daily for 24 weeks. However 11 of these dropped out after initial evaluation, leaving 26 ALD patients, 13 in each arm, who completed the 24 week trial.	Liver Disease, Alcoholic	Alcoholic Liver Disease (ALD) S-adenosylmethionine SAMe	null	2	arm 1: Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks arm 2: ALD subjects receiving Placebo three times daily for 24 weeks.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Alcoholic liver disease patients received drug at dose of 400 mg three times daily for 24 weeks. intervention 2: Alcoholic liver disease patients received identical size and shape sugar pill placebo three times daily for 24 weeks.	intervention 1: S-adenosylmethionine intervention 2: Placebo	1	Sacramento \| California \| United States \| -121.4944 \| 38.58157	37	NCT00573313	1COMPLETED	2009-09-01	2005-09-01	University of California, Davis	7OTHER	false	false	false	null	0
[ 2, 3 ]	5	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to discover whether children and adults with Fanconi anemia (FA) can be safely and effectively transplanted with Human Leukocyte Antigen (HLA) mismatched (up to one haplotype), HLA-matched sibling, or unrelated donor stem cells, when leukocytolytic monoclonal antibodies are the sole conditioning agents (patients receiving an HLA mismatched transplant will receive Fludarabine as part of the conditioning regimen). Three monoclonal antibodies (MAb) will be used in combination. Two of them, YTH 24 and YTH 54 are rat 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. This MAb has been widely used 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 Fanconi anemia, in whom the use of conventional chemotherapeutic agents for conditioning produces a high rate of short and long 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 graft versus host disease (GvHD) prophylaxis. Additional GvHD prophylaxis will be provided by administration of the medication FK506.	If clinically feasible (no aplasia, no active malignancy), the recipients marrow will be harvested and cryopreserved as a back up for use if non-engraftment/rejection is followed by failure to undergo autologous reconstitution. For HLA Mismatched donors, harvested peripheral blood stem cells will be enriched for CD34 cells using the Clinimacs CD34 Reagent system. Fludarabine will be given as 5 daily intravenous infusions. 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 intravenously every 4 hours during the period of the course of each infusion. Day -8 Campath 1H as per CAGT SOP Fludarabine 30 mg/m2 -7 Campath 1H as per CAGT SOP Fludarabine 30 mg/m2 -6 Campath 1H as per CAGT SOP Fludarabine 30 mg/m2 -5 YTH 24/54 400ug/kg over 6 hr Fludarabine 30 mg/m2 -4 YTH 24/54 400ug/kg over 6 hr Fludarabine 30 mg/m2 -3 YTH 24/54 400ug/kg over 6 hr -2 YTH 24/54 400ug/kg over 6 hr -1 -0 Stem Cell Infusion 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 10e4 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 10e4 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.	Fanconi Anemia Severe Aplastic Anemia	Allogeneic Stem Cell Transplant Fanconi Anemia Severe Aplastic Anemia fludarabine campath anti-CD45	null	1	arm 1: CAMPATH-1H Anti-CD45 Fludarabine Stem Cell Infusion	[ 0 ]	4	[ 2, 2, 0, 3 ]	intervention 1: Given intravenous on days -8, -7, and -6 intervention 2: Given intravenous on days -5, -4, -3 and -2 dose is 400 micrograms/kg intervention 3: Given intravenous on days -8, -7, -6, -5 and -4 Dose is 30 mg/m2 intervention 4: Stem cells are infused on day 0	intervention 1: CAMPATH-1H intervention 2: Anti-CD45 intervention 3: Fludarabine intervention 4: Stem cell infusion	2	Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328	5	NCT00590460	6TERMINATED	2009-09-01	2001-07-01	Baylor College of Medicine	7OTHER	false	false	false	null	0
[ 2, 3 ]	13	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	false	This placebo-controlled study investigates acetyl-L-carnitine in the treatment of septic shock requiring vasopressors.	This is a cross-over study which infuses ALC for 12 out of 18 hours (and placebo the other 6). Patients must have vasopressor-dependent septic shock and be free from renal failure, hepatic failure, and seizures to be eligible.	Septic Shock	Septic shock Acetyl-L-carnitine	null	2	arm 1: Placebo for first 6 hours then Acetyl-L-Carnitine (ALC) for 12 hours arm 2: Acetyl-L-Carnitine (ALC) for first 12 hours then placebo for next 6 hours	[ 5, 5 ]	1	[ 0 ]	intervention 1: Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours	intervention 1: Acetyl-L-Carnitine	1	Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589	13	NCT00592488	1COMPLETED	2009-09-01	2006-08-01	Vanderbilt University	7OTHER	false	false	false	null	0
[ 4 ]	395	NON_RANDOMIZED	SINGLE_GROUP	1PREVENTION	0NONE	false	0ALL	false	The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.	null	Gastric Ulcer Duodenal Ulcer Rheumatoid Arthritis Osteoarthritis Lumbago	gastrointestinal GI NSAID Japan Japanese Gastric ulcer duodenal ulcer	null	1	arm 1: Esomeprazole 20 mg once daily	[ 0 ]	1	[ 0 ]	intervention 1: Esomeprazole 20 mg once daily	intervention 1: Esomeprazole 20 mg	3	Ōita \| N/A \| Japan \| 131.6 \| 33.23333 Saitama \| N/A \| Japan \| 139.65657 \| 35.90807 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895	130	NCT00595517	1COMPLETED	2009-09-01	2007-10-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 0 ]	6	NA	SINGLE_GROUP	null	0NONE	false	0ALL	true	Short-daily hemodialysis is increasingly becoming a preferred alternative to the conventional intermittent (three times per week) hemodialysis schedule. Studies have shown that short-daily dialysis improves a patient's quality of life, high blood pressure, anemia and calcium-phosphorus balance. Infection, however, will likely remain a persistent problem for dialysis patients regardless of the frequency of treatments. There is currently a wealth of information to guide doctors on how much and how frequently to give an antibiotic for patients who receive intermittent (thrice weekly) hemodialysis. However, there is very little information on how to prescribe antibiotics for patient's receiving short-daily hemodialysis. This study will develop drug dose guidelines for patients receiving short-daily hemodialysis for three frequently used antibiotics, vancomycin, levofloxacin and gentamicin. These guidelines will assist doctors so that patients receive the most effective dose and frequency of an antibiotic to treat their infection. The following is the study hypothesis which will be tested with two-sided, one sample t-tests comparing the AUC observed to historical measures8. 1\) Vancomycin, levofloxacin and gentamicin are removed to a greater extent by short-daily hemodialysis than intermittent hemodialysis. The following are the specific aims: 1. Determine the interdialytic pharmacokinetics of vancomycin, gentamicin, and levofloxacin by short-daily HD. 2. Determine the extent of vancomycin removal when administered during the last hour of short-daily HD. 3. Develop drug-dosing guidelines for vancomycin, gentamicin and levofloxacin for patients receiving short-daily HD.	Despite improvements in dialysis machine and filter technology and refinements in providing an adequate "dose" of HD, patients receiving thrice-weekly hemodialysis (HD) have an alarming 20% annual mortality rate. Concomitant with this high mortality rate, patients with end stage renal disease (ESRD) also endure poorer qualities of life and medical complications such as anemia, infection, accelerated cardiovascular disease and bone disease associated with calcium-phosphorus disequilibrium. Recently, quotidian dialysis regimens, which include both the short-daily and nocturnal modalities, have emerged as dialytic approaches that appear to improve the patient's quality of life and attenuate the medical complications associated with ESRD1- 4. Specifically, recent studies have documented improvements in a patient's quality of life as measured by both general instruments (SF-36) and by renal disease specific tools. Short-daily HD regimens have also led to improvements in anemia allowing reductions in doses of erythropoietin. Similarly, in one study blood pressure control was improved with short-daily HD to such an extent that the majority of the study patients were eventually off of all antihypertensive medications. Phosphorus control has also improved with hemeral and especially nocturnal short-daily regimens. In one study of patients receiving nocturnal HD, all of the patients were completely weaned of their phosphorus binders and actually required intradialytic phosphorus supplementation. Finally, nutritional status also appears to be enhanced in studies of short-daily HD with increases in both appetite and weight gain observed. The medical benefits observed in these studies are believed to be secondary to the enhanced solute clearance and better extra-cellular volume management that short-daily HD affords as compared to intermittent HD. In particular, the nocturnal regimen appears especially effective since it provides a higher "dose" of HD than its hemeral counterpart. According to the most recent United States Renal Data Service (USRDS) compilation, infection continues to exact a heavy toll among dialysis patients. The most recent USRDS mortality rate attributable to sepsis for dialysis patients was 27.0%. Despite the reported improvements in quality of life and medical complications provided by short-daily HD, infection will likely remain a persistent medical issue for dialysis patients. As a result, the appropriate provision of antibiotic therapy to patients receiving hemodialysis will remain paramount. Currently, there are no studies that have evaluated the pharmacokinetics of the commonly used antibiotics in the growing short-daily HD population. With no specific guidelines, pharmaco-kinetic estimations and frequent drug levels have been utilized to direct antibiotic dosing. This is likely not the best therapeutic approach and may not be the most cost-effective. This study will attempt to address this deficit in the clinical knowledge for three commonly used antibiotics, vancomycin, levofloxacin and gentamicin. The drug dosing guidelines developed from this study will ensure that this patient population receives the optimum antibiotic therapy to treat their infection in the most cost-effective manner. Utilizing drug level data from an as yet unpublished study on the removal of gentamicin by thrice weekly dialysis, we configured the pharmacokinetic modeling software ADAPT to compare the serum levels of gentamicin during intermittent and short-daily HD. For the short-daily HD simulation, the ADAPT software demonstrated two periods of increased removal of gentamicin corresponding to the two sessions of short-daily HD (Figure 1). The purpose of the present study is to demonstrate in vivo that this is indeed true for gentamicin, as well as for vancomycin and levofloxacin.	End Stage Renal Disease Infection	Short-daily hemodialysis pharmacokinetics levofloxacin gentamicin vancomycin	null	1	arm 1: Intervention: administer intravenous vancomycin, gentamicin and levofloxacin. This study will determine the pharmacokinetics of intravenous vancomycin, gentamicin and levofloxacin in subjects receiving short-daily hemodialysis. There will not be a control arm for this study. The intervention for this arm will be to administer intravenous vancomycin, gentamicin and levofloxacin and draw blood samples at periodic intervals. The blood samples will be tested for these medications and pharmacokinetic analysis will be performed.	[ 0 ]	1	[ 0 ]	intervention 1: Each subject will receive a single dose of 15 mg/kg vancomycin; 2 mg/kg gentamicin and 250 mg levofloxacin administered intravenously over a one-hour infusion period through the venous limb of their HD access (or tunneled catheter) via an IV pump.	intervention 1: Intravenous antibiotics	1	Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838	6	NCT00596167	1COMPLETED	2009-09-01	2007-09-01	Indiana University School of Medicine	7OTHER	false	false	false	null	0
[ 2, 3 ]	6	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this study is to determine if nikkomycin Z is safe when administered at different dose levels for 14 days. The study will also determine blood levels and urinary excretion of nikkomycin Z in relation to dose administered. Patients with mild forms of Valley Fever pneumonia will be eligible to participate and will be allocated to receive treatment with nikkomycin Z (various doses) or a placebo. A secondary goal of this study is to evaluate the effectiveness and dose response of nikkomycin Z in an exploratory analysis.	Every year there are 50,000 new U.S. cases of coccidioidomycosis (Valley Fever). The majority of these illnesses occur as a result of endemic exposure in Arizona and California. The benefits of antifungal therapy for uncomplicated disease are not currently established. Current therapies for serious and complicated forms of coccidioidomycosis are only partially effective and in themselves are unable to eradicate the fungus from sites of infection, commonly resulting in breakthrough infection and/or relapse. Nikkomycin Z is effective in the mouse model and results in improved microbiological response over fluconazole. The goals of this study include: 1) Evaluating the safety and tolerance of nikkomycin Z following administration of multiple doses (50 mg Q 12 h to 750 mg Q 8 h) for two week and 2) Evaluating the pharmacokinetics of nikkomycin Z after single and multiple doses in relationship to dose. The study will include patients with uncomplicated Coccidioides pneumonia (mild illness) which will allow exploratory analysis of efficacy and dose response based on biomarkers.	Coccidioidomycosis	coccidioidomycosis Valley Fever nikkomycin Z	null	5	arm 1: nikkomycin Z 50 mg BID x 14 days arm 2: nikkomycin Z nikkomycin Z 250 mg BID x 14 days arm 3: nikkomycin Z 500 mg BID x 14 days arm 4: nikkomycin Z 750 BID x 14 days arm 5: placebo BID x 14 days	[ 0, 0, 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses. * 50 mg BID (n=4) vs placebo capsule BID (n=1) * 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2) * 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2) * 500 mg BID (n=4) vs Placebo capsule BID (n=1) At least 4 subjects complete lower dose before randomization includes next higher dose. Stage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization. intervention 2: Placebo comparator	intervention 1: nikkomycin Z intervention 2: Placebo	1	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174	6	NCT00614666	6TERMINATED	2009-09-01	2007-09-01	University of Arizona	7OTHER	false	false	false	null	0
[ 3 ]	218	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection.	null	De Novo Kidney Transplantation	kidney transplant alefacept	null	2	arm 1: Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment. arm 2: Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.	[ 2, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: IV and subcutaneous injection intervention 2: IV and subcutaneous injection intervention 3: The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery. intervention 4: Mycophenolic mofetil was administered as 750 mg twice per day orally intervention 5: Methylprednisolone or equivalent: Day 0: 500 - 1000 mg IV bolus Day 1: 125 - 250 mg IV bolus Prednisone or equivalent: Days 2 - 14: 20 - 30 mg orally Days 15 - 28: 10 - 20 mg orally Days 29 - 60: 10 - 15 mg orally Days 61 onwards: 5 - 10 mg orally	intervention 1: Alefacept intervention 2: placebo intervention 3: Tacrolimus intervention 4: Mycophenolate Mofetil intervention 5: Steroids	33	Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Créteil \| N/A \| France \| 2.46569 \| 48.79266 Le Kremlin-Bicêtre \| N/A \| France \| 2.36073 \| 48.81471 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Nantes \| N/A \| France \| -1.55336 \| 47.21725 Nice \| N/A \| France \| 7.26608 \| 43.70313 Paris \| N/A \| France \| 2.3488 \| 48.85341 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Bochum \| N/A \| Germany \| 7.21648 \| 51.48165 Regensburg \| N/A \| Germany \| 12.10161 \| 49.01513 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Bologna \| N/A \| Italy \| 11.33875 \| 44.49381 Padua \| N/A \| Italy \| 11.88586 \| 45.40797 Rome \| N/A \| Italy \| 12.51133 \| 41.89193 Siena \| N/A \| Italy \| 11.33064 \| 43.31822 Maastricht \| N/A \| Netherlands \| 5.68889 \| 50.84833 Bydgoszcz \| N/A \| Poland \| 18.00762 \| 53.1235 Poznan \| N/A \| Poland \| 16.92993 \| 52.40692 Szczecin \| N/A \| Poland \| 14.55302 \| 53.42894 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Llobregat \| N/A \| Spain \| N/A \| N/A Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Málaga \| N/A \| Spain \| -4.42034 \| 36.72016 Santander \| N/A \| Spain \| -3.80444 \| 43.46472 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Uppsala \| N/A \| Sweden \| 17.63889 \| 59.85882 Manchester \| N/A \| United Kingdom \| -2.23743 \| 53.48095	212	NCT00617604	1COMPLETED	2009-09-01	2007-12-01	Astellas Pharma Inc	4INDUSTRY	false	false	false	null	0
[ 5 ]	52	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	true	To show that the use of intravenous levetiracetam(LEV;Keppra)for seizure prevention in patients in the Neuroscience Intensive Care Unit will result in fewer side effects compared to the current standard of care anticonvulsant and will be at least as effective as the current standard of care in preventing clinical and sub-clinical seizure activity.	To show that the use of intravenous levetiracetam(LEV;Keppra)for seizure prophylaxis in the Neuroscience Intensive Care Unit will result in fewer adverse effects compared to the current standard of care anticonvulsant(phenytoin) and will be at least as effective as phenytoin in preventing clinical and sub-clinical seizure activity.	Traumatic Brain Injury Subarachnoid Hemorrhage	Seizures Traumatic Brain Injury Subarachnoid Hemorrhage	null	2	arm 1: Group 1 - The levetiracetam (Keppra®) group will receive a loading dose of 20 mg/kg IV over 15 minutes (rounded to the nearest 250mg) up to a maximum of 2000 mg, then started on maintenance dose (1000 mg, IV BID)as prophylaxis for 7 days. arm 2: Group 2-The phenytoin group will receive a loading dose of 20 mg/kg IV to a maximum of 2000mg, then started on maintenance dose at 5 mg/kg/day (rounded to nearest 100mg dose, IV, divided into three doses a day) as prophylaxis for 7 days. Phenytoin levels are to be checked daily and dose adjusted as needed to maintain therapeutic levels of 10-20 µg/dL.	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Levetiracetam group will receive a loading dose of 20 mg/kg IV(rounded to nearest 250mg) to a maximum of 2000mg, then started on maintenance dose (1000 mg,IV q 12h) as prophylaxis for seven days. intervention 2: The group will receive a loading dose of fosphenytoin 20 mg/kg IV to a maximum of 2000 mg, then started on maintenance dose of 5mg/kg/day, rounded to nearest 100mg dose, IV, q 12h for seven days.	intervention 1: Levetiracetam intervention 2: Phenytoin	1	Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711	52	NCT00618436	1COMPLETED	2009-09-01	2007-08-01	University of Cincinnati	7OTHER	false	false	false	null	0
[ 0 ]	3	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	To determine whether sorafenib is able to change pre-cancerous cells in a way that we believe is important in the progression of cancer.	To characterize the effects of sorafenib on specific molecular markers in patients with Barrett's esophagus and high grade intraepithelial neoplasia (HGIN) or carcinoma in situ (CIS).	Esophageal Cancer	Esophageal cancer	null	1	arm 1: sorafenib 2 tablets by mouth	[ 0 ]	1	[ 0 ]	intervention 1: 2 tablets with water by mouth twice a day for two weeks.	intervention 1: sorafenib	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	3	NCT00619242	6TERMINATED	2009-09-01	2006-06-01	University of Chicago	7OTHER	false	false	false	null	0
[ 4 ]	439	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.	null	Opioid-Induced Bowel Dysfunction		null	1	arm 1: Lubiprostone: 24 mcg capsule twice daily (BID) for 36 weeks	[ 0 ]	1	[ 0 ]	intervention 1: 24 mcg capsules for oral administration	intervention 1: Lubiprostone 24	123	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Hueytown \| Alabama \| United States \| -86.99666 \| 33.45122 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Arcadia \| California \| United States \| -118.03534 \| 34.13973 Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 Garden Grove \| California \| United States \| -117.94145 \| 33.77391 Garden Grove \| California \| United States \| -117.94145 \| 33.77391 Loma Linda \| California \| United States \| -117.26115 \| 34.04835 Pasadena \| California \| United States \| -118.14452 \| 34.14778 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Yorba Linda \| California \| United States \| -117.81311 \| 33.88863 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Brooksville \| Florida \| United States \| -82.38991 \| 28.55554 Daytona Beach \| Florida \| United States \| -81.02283 \| 29.21081 Daytona Beach \| Florida \| United States \| -81.02283 \| 29.21081 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Holly Hill \| Florida \| United States \| -81.03756 \| 29.24359 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Jupiter \| Florida \| United States \| -80.09421 \| 26.93422 Lauderdale Lakes \| Florida \| United States \| -80.20838 \| 26.16647 Niceville \| Florida \| United States \| -86.48217 \| 30.51686 North Miami \| Florida \| United States \| -80.18671 \| 25.89009 Pinellas Park \| Florida \| United States \| -82.69954 \| 27.8428 Port Orange \| Florida \| United States \| -80.99561 \| 29.13832 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Dawsonville \| Georgia \| United States \| -84.11908 \| 34.42121 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Bloomington \| Illinois \| United States \| -88.99369 \| 40.4842 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Peoria \| Illinois \| United States \| -89.58899 \| 40.69365 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 West Des Moines \| Iowa \| United States \| -93.71133 \| 41.57721 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067 Columbia \| Maryland \| United States \| -76.83942 \| 39.24038 Chestnut Hill \| Massachusetts \| United States \| -71.16616 \| 42.33065 Wellesley Hills \| Massachusetts \| United States \| -71.27867 \| 42.30843 Dearborn \| Michigan \| United States \| -83.17631 \| 42.32226 Flint \| Michigan \| United States \| -83.68746 \| 43.01253 Interlochen \| Michigan \| United States \| -85.7673 \| 44.64472 Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Traverse City \| Michigan \| United States \| -85.62063 \| 44.76306 Troy \| Michigan \| United States \| -83.14993 \| 42.60559 Edina \| Minnesota \| United States \| -93.34995 \| 44.88969 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Missoula \| Montana \| United States \| -113.994 \| 46.87215 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Cedar Knolls \| New Jersey \| United States \| -74.44876 \| 40.82204 Elizabeth \| New Jersey \| United States \| -74.2107 \| 40.66399 Lumberton \| New Jersey \| United States \| -74.80516 \| 39.96595 Teaneck \| New Jersey \| United States \| -74.01597 \| 40.8976 Great Neck \| New York \| United States \| -73.72846 \| 40.80066 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Williamsville \| New York \| United States \| -78.73781 \| 42.96395 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Greenville \| North Carolina \| United States \| -77.36635 \| 35.61266 High Point \| North Carolina \| United States \| -80.00532 \| 35.95569 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Marion \| Ohio \| United States \| -83.12852 \| 40.58867 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Medford \| Oregon \| United States \| -122.87559 \| 42.32652 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Allentown \| Pennsylvania \| United States \| -75.49018 \| 40.60843 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Yardley \| Pennsylvania \| United States \| -74.846 \| 40.24566 North Charleston \| South Carolina \| United States \| -79.97481 \| 32.85462 Chattanooga \| Tennessee \| United States \| -85.30968 \| 35.04563 Hendersonville \| Tennessee \| United States \| -86.62 \| 36.30477 Milan \| Tennessee \| United States \| -88.75895 \| 35.91979 Hurst \| Texas \| United States \| -97.17057 \| 32.82346 Longview \| Texas \| United States \| -94.74049 \| 32.5007 Ogden \| Utah \| United States \| -111.97383 \| 41.223 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Christiansburg \| Virginia \| United States \| -80.40894 \| 37.12985 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Portsmouth \| Virginia \| United States \| -76.29827 \| 36.83543 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Bellevue \| Washington \| United States \| -122.20068 \| 47.61038 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389 Winnipeg \| Manitoba \| Canada \| -97.14704 \| 49.8844 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	439	NCT00620061	1COMPLETED	2009-09-01	2007-12-01	Sucampo Pharma Americas, LLC	4INDUSTRY	false	false	false	null	0
[ 4 ]	146	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This trial is conducted in Europe. The aim of this research is to assess the safety of continuous treatment with insulin detemir following participation in trial NN304-1689 (NCT00435019) on antibody development.	null	Diabetes Diabetes Mellitus, Type 1		null	1	arm 1: Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)	[ 0 ]	2	[ 0, 0 ]	intervention 1: Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily. intervention 2: Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals.	intervention 1: insulin detemir intervention 2: insulin aspart	32	Pleven \| N/A \| Bulgaria \| 24.61667 \| 43.41667 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Varna \| N/A \| Bulgaria \| 27.91667 \| 43.21667 Olomouc \| N/A \| Czechia \| 17.25175 \| 49.59552 Pardubice \| N/A \| Czechia \| 15.77659 \| 50.04075 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Glostrup Municipality \| N/A \| Denmark \| 12.40377 \| 55.6666 Kolding \| N/A \| Denmark \| 9.47216 \| 55.4904 Odense \| N/A \| Denmark \| 10.38831 \| 55.39594 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Oulu \| N/A \| Finland \| 25.46816 \| 65.01236 Seinäjoki \| N/A \| Finland \| 22.82822 \| 62.79446 Turku \| N/A \| Finland \| 22.26869 \| 60.45148 Paris \| N/A \| France \| 2.3488 \| 48.85341 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Miskolc \| N/A \| Hungary \| 20.77806 \| 48.10306 Skopje \| N/A \| North Macedonia \| 21.43141 \| 41.99646 Gdansk \| N/A \| Poland \| 18.64912 \| 54.35227 Kielce \| N/A \| Poland \| 20.62752 \| 50.87033 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 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 Altunizade-Istanbul \| N/A \| Turkey (Türkiye) \| N/A \| N/A Antalya \| N/A \| Turkey (Türkiye) \| 30.69556 \| 36.90812 Istanbul \| N/A \| Turkey (Türkiye) \| 28.94966 \| 41.01384 Izmir \| N/A \| Turkey (Türkiye) \| 27.13838 \| 38.41273 Aberdeen \| N/A \| United Kingdom \| -2.09814 \| 57.14369 Dundee \| N/A \| United Kingdom \| -2.97489 \| 56.46913 Norfolk \| N/A \| United Kingdom \| N/A \| N/A	146	NCT00623194	1COMPLETED	2009-09-01	2008-02-01	Novo Nordisk A/S	4INDUSTRY	false	false	false	null	0
[ 4 ]	310	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A formulation will be deemed successful if the percentage of subjects with suppression of testosterone to \<= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of the 2-sided 90% confidence interval), a protocol-specified criterion.	A total of 300 male subjects were planned to be enrolled. Subjects were to receive a total of 2 intramuscular (IM) injections of the same formulation, either Formulation A or Formulation B, administered 24 weeks apart. The first 150 subjects were to receive Formulation A for both injections and the next 150 subjects were to receive Formulation B for both injections. The sponsor was to conduct an ongoing review of the primary endpoint data (suppression of testosterone \<= 50 ng/dL) and planned to stop enrollment of Formulation A or Formulation B, or not to administer the second injection of Formulation A or Formulation B, if 15 or more subjects did not achieve testosterone suppression by Week 4 or failed to maintain testosterone suppression during the treatment period. All analyses and summaries were to be conducted separately for subjects who received Formulation A or Formulation B. This study was to be conducted at approximately 60-80 investigative sites. Subjects participated in the trial for approximately 14 months. This trial was to include a Screening Period (up to 4 weeks), a 12-month Treatment Period (two 6-month treatment cycles), and a Follow-Up Period (30 days).	Prostate Cancer	Lupron Depot prostate cancer leuprolide acetate	null	2	arm 1: Leuprolide acetate 45 mg, 6-month depot arm 2: Leuprolide acetate, 45 mg, 6-month depot	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation A, 45 mg 6 month depot, 24 weeks apart. intervention 2: Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation B, 45 mg 6 month depot, 24 weeks apart.	intervention 1: Leuprolide acetate - Formulation A intervention 2: Leuprolide acetate - Formulation B	63	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Homewood \| Alabama \| United States \| -86.80082 \| 33.47177 Anchorage \| Alaska \| United States \| -149.90028 \| 61.21806 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Sierra Vista \| Arizona \| United States \| -110.30369 \| 31.55454 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 Atherton \| California \| United States \| -122.19774 \| 37.46133 Fresno \| California \| United States \| -119.77237 \| 36.74773 Laguna Hills \| California \| United States \| -117.71283 \| 33.61252 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Tarzana \| California \| United States \| -118.55397 \| 34.17334 Torrance \| California \| United States \| -118.34063 \| 33.83585 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Englewood \| Colorado \| United States \| -104.98776 \| 39.64777 Middlebury \| Connecticut \| United States \| -73.12761 \| 41.52787 New Britain \| Connecticut \| United States \| -72.77954 \| 41.66121 Aventura \| Florida \| United States \| -80.13921 \| 25.95648 Daytona Beach \| Florida \| United States \| -81.02283 \| 29.21081 New Smyrna Beach \| Florida \| United States \| -80.927 \| 29.02582 Orange City \| Florida \| United States \| -81.29867 \| 28.94888 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Saint Augustine \| Florida \| United States \| -81.31452 \| 29.89469 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Tallahassee \| Florida \| United States \| -84.28073 \| 30.43826 Wellington \| Florida \| United States \| -80.24144 \| 26.65868 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Roswell \| Georgia \| United States \| -84.36159 \| 34.02316 Thomasville \| Georgia \| United States \| -83.97878 \| 30.83658 Fort Wayne \| Indiana \| United States \| -85.12886 \| 41.1306 Newburgh \| Indiana \| United States \| -87.40529 \| 37.94449 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Greenbelt \| Maryland \| United States \| -76.87553 \| 39.00455 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Lawrenceville \| New Jersey \| United States \| -74.7296 \| 40.29733 New York \| New York \| United States \| -74.00597 \| 40.71427 Poughkeepsie \| New York \| United States \| -73.92097 \| 41.70037 The Bronx \| New York \| United States \| -73.86641 \| 40.84985 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Concord \| North Carolina \| United States \| -80.58158 \| 35.40888 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Salisbury \| North Carolina \| United States \| -80.47423 \| 35.67097 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Bethany \| Oklahoma \| United States \| -97.63226 \| 35.51867 Bala-Cynwyd \| Pennsylvania \| United States \| -75.23407 \| 40.00761 Lancaster \| Pennsylvania \| United States \| -76.30551 \| 40.03788 Myrtle Beach \| South Carolina \| United States \| -78.88669 \| 33.68906 Germantown \| Tennessee \| United States \| -89.81009 \| 35.08676 Germantown \| Tennessee \| United States \| -89.81009 \| 35.08676 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 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 Tyler \| Texas \| United States \| -95.30106 \| 32.35126 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376	310	NCT00626431	1COMPLETED	2009-09-01	2008-02-01	Abbott	4INDUSTRY	false	false	false	null	0
[ 3 ]	5	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to test the hypothesis that the combination of gemcitabine and doxil will have clinical activity in patients with metastatic renal cell carcinoma.	Patients with metastatic renal cell carcinoma who have received prior therapy with sorafenib, sunitinib or temsirolimus and have progressive disease may participate in this study if all eligibility criteria are met. Doxil will be administered on day 1 and gemcitabine on day 1 and 8 of a 21 day cycle. Tumor responses will be evaluated by RECIST. Up to six cycles of study treatment may be administered. Cardiac ejection fraction will be monitored.	Metastatic Renal Cell Carcinoma	Renal cell carcinoma Kidney Cancer Gemcitabine Doxil Chemotherapy	null	1	arm 1: Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.	[ 0 ]	2	[ 0, 0 ]	intervention 1: 800 mg IV day 1 and 8 intervention 2: 24 mg/m2 every 21 days IV	intervention 1: Gemcitabine intervention 2: Doxil	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	5	NCT00630409	1COMPLETED	2009-09-01	2004-09-01	University of Pittsburgh	7OTHER	false	false	false	null	0
[ 3 ]	367	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This is a 24 week study comparing the efficacy of four dose levels of INT131 besylate with pioglitazone HCl in patients with type 2 diabetes. Eligible patients will be men and women (of non-childbearing potential or using dual barrier methods of contraception) between 30 and 75 years of age who are minimally responsive to treatment with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy.	null	Type 2 Diabetes Mellitus	Type 2 diabetes diabetes diabetes mellitus diabetes mellitus, type 2 non-TZD thiazolidinedione selective peroxisome proliferator-activated receptor gamma modulator SPPARM peroxisome proliferator-activated receptor gamma PPAR gamma insulin sensitizer glucose control endocrinopathy hypoglycemic agent sulfonylurea metformin pioglitazone nutritional and metabolic diseases	null	6	arm 1: INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone HCl. arm 2: INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone HCl arm 3: INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone HCl arm 4: INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone HCl arm 5: pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate arm 6: placebo administered once-daily, matching placebo to INT131 besylate and matching placebo to pioglitazone HCl	[ 0, 0, 0, 0, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Once-daily, oral intervention 2: Once-daily, oral intervention 3: Once-daily, oral	intervention 1: INT131 besylate intervention 2: Pioglitazone HCl intervention 3: Placebo	66	Carmichael \| California \| United States \| -121.32828 \| 38.61713 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Diego \| California \| United States \| -117.16472 \| 32.71571 Santa Ana \| California \| United States \| -117.86783 \| 33.74557 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Milford \| Connecticut \| United States \| -73.0565 \| 41.22232 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Coral Gables \| Florida \| United States \| -80.26838 \| 25.72149 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 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 Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 Palm Harbor \| Florida \| United States \| -82.76371 \| 28.07807 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Winter Haven \| Florida \| United States \| -81.73286 \| 28.02224 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Roswell \| Georgia \| United States \| -84.36159 \| 34.02316 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Olive Branch \| Mississippi \| United States \| -89.82953 \| 34.96176 Chesterfield \| Missouri \| United States \| -90.57707 \| 38.66311 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Bozeman \| Montana \| United States \| -111.03856 \| 45.67965 Berlin \| New Jersey \| United States \| -74.92905 \| 39.79123 Buffalo \| New York \| United States \| -78.87837 \| 42.88645 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Hickory \| North Carolina \| United States \| -81.3412 \| 35.73319 Morehead City \| North Carolina \| United States \| -76.72604 \| 34.72294 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Cuyahoga Falls \| Ohio \| United States \| -81.48456 \| 41.13394 Delaware \| Ohio \| United States \| -83.06797 \| 40.29867 Franklin \| Ohio \| United States \| -84.30411 \| 39.55895 Kettering \| Ohio \| United States \| -84.16883 \| 39.6895 Marion \| Ohio \| United States \| -83.12852 \| 40.58867 Mentor \| Ohio \| United States \| -81.33955 \| 41.66616 Perrysburg \| Ohio \| United States \| -83.62716 \| 41.557 Beaver \| Pennsylvania \| United States \| -80.30478 \| 40.69534 Jersey Shore \| Pennsylvania \| United States \| -77.26442 \| 41.20202 Cranston \| Rhode Island \| United States \| -71.43728 \| 41.77982 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 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Midland \| Texas \| United States \| -102.07791 \| 31.99735 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Salem \| Virginia \| United States \| -80.05476 \| 37.29347 Guadalajara \| Jalisco \| Mexico \| -103.34749 \| 20.67738 Mexico City \| Mexico DF \| Mexico \| -99.12766 \| 19.42847 Mexico City \| Mexico DF \| Mexico \| -99.12766 \| 19.42847 Mexico City \| Mexico DF \| Mexico \| -99.12766 \| 19.42847 Mexico City \| Mexico DF \| Mexico \| -99.12766 \| 19.42847 Cuernavaca \| Morelos \| Mexico \| -99.23075 \| 18.9261 Monterrey \| Nuevo León \| Mexico \| -100.31721 \| 25.68435	366	NCT00631007	1COMPLETED	2009-09-01	2008-02-01	InteKrin Therapeutics, Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	774	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren (300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.	null	Hypertension	Hypertension, aliskiren, ramipril, colonoscopy	null	2	arm 1: For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration. arm 2: For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.	[ 0, 1 ]	4	[ 0, 0, 10, 10 ]	intervention 1: Aliskiren 300 mg once a day intervention 2: Ramipril 10 mg once a day intervention 3: Placebo capsules to match ramipril. intervention 4: Placebo tablets to match aliskiren.	intervention 1: Aliskiren intervention 2: Ramipril intervention 3: Placebo to Ramipril intervention 4: Placebo to Aliskiren	7	Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Investigative Site \| N/A \| Argentina \| N/A \| N/A Investigative Site \| Colombia \| Colombia \| N/A \| N/A Investigative Site \| N/A \| France \| N/A \| N/A Investigative Site \| N/A \| Germany \| N/A \| N/A Investigative Site \| N/A \| India \| N/A \| N/A Investigative Site \| N/A \| Spain \| N/A \| N/A	774	NCT00631917	1COMPLETED	2009-09-01	2008-02-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 5 ]	32	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	2MALE	false	A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.	null	Hemophilia A	Kogenate, Children, Factor VIII, Hemophilia A, Prophylactic	null	3	arm 1: rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection once per week \[qw\] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week) arm 2: rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection twice per week \[biw\] (30 IU/kg \[day 1\] + 40 IU/kg \[day 4\]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week) arm 3: rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 75 IU/kg, dosing by injection three times per week \[tiw\] (3 x 25 IU/kg \[day 1, 3, 5\]) for 9 months. No escalation opportunity for participants in this group	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection once per week (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week) intervention 2: rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection twice per week (30 IU/kg \[day 1\] + 40 IU/kg \[day 4\]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week) intervention 3: rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 75 IU/kg, dosing by injection three times per week (3 x 25 IU/kg \[day 1, 3, 5\]) for 9 months. No escalation opportunity for patients in this group	intervention 1: rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week intervention 2: rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg) intervention 3: rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)	4	Kirov \| N/A \| Russia \| 49.66007 \| 58.59665 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Yekaterinburg \| N/A \| Russia \| 60.6122 \| 56.8519	32	NCT00632814	1COMPLETED	2009-09-01	2007-06-01	Bayer	4INDUSTRY	false	false	false	null	0
[ 4 ]	181	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to see whether droxidopa is effective in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta Hydroxylase deficiency.	Systolic blood pressure is transiently and minimally decreased in healthy individuals upon standing. Normal physiologic feedback mechanisms work through neurally-mediated pathways to maintain the standing blood pressure, and thus maintain adequate cerebral perfusion. The compensatory mechanisms that regulate blood pressure upon standing are dysfunctional in subjects with orthostatic hypotension (OH), a condition that may lead to inadequate cerebral perfusion with accompanying symptoms of syncope, dizziness or lightheadedness, unsteadiness and blurred or impaired vision, among other symptoms. The autonomic nervous system has a central role in the regulation of blood pressure. Primary Autonomic Failure is manifested in a variety of syndromes. Orthostatic hypotension is a usual presenting symptom. Primary Autonomic Failure may be the primary diagnosis, and classifications include pure autonomic failure (PAF), also called idiopathic orthostatic hypotension (Bradbury-Eggleston syndrome) autonomic failure with multiple system atrophy (Shy-Drager syndrome) and also Parkinson's disease. Regardless of the primary condition, autonomic dysfunction underlies orthostatic hypotension. Orthostatic hypotension may be a severely disabling condition which can seriously interfere with the quality of life of afflicted subjects. Currently available therapeutic options provide some symptomatic relief in a subset of subjects, but are relatively ineffective and are often accompanied by severe side effects that limit their usefulness. Support garments (tight-fitting leotard) may prove useful in some subjects, but is difficult to don without family or nursing assistance, especially for older subjects. Midodrine, fludrocortisone, methylphenidate, ephedrine, indomethacin and dihydroergotamine are among some of the pharmacological interventions that have been used to treat orthostatic hypotension, although only midodrine is specifically approved for this indication. The limitations of these currently available therapeutic options, and the incapacitating nature and often progressive downhill course of disease, point to the need for an improved therapeutic alternative. The current withdrawal design study will measure the efficacy of droxidopa on symptoms of neurogenic orthostatic hypotension in patients randomized to continued droxidopa treatment versus placebo, following 14 days of double-blind treatment. droxidopa droxidopa \[also, known as L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPS\] is the International non-proprietary name (INN) for a synthetic amino acid precursor of norepinephrine (NE), which was originally developed by Sumitomo Pharmaceuticals Co., Limited, Japan. It has been approved for use in Japan since 1989. Droxidopa has been shown to improve symptoms of orthostatic hypotension that result from a variety of conditions including Shy Drager syndrome (Multiple System Atrophy), Pure Autonomic Failure, and Parkinson's disease. There are four stereoisomers of DOPS; however, only the L-threo-enantiomer (droxidopa) is biologically active. The exact mechanism of action of droxidopa in the treatment of symptomatic NOH has not been precisely defined; however, its NE replenishing properties with concomitant recovery of decreased noradrenergic activity are considered to be of major importance. Droxidopa has been marketed in Japan since 1989. Data from clinical studies and post-marketing surveillance programs conducted in Japan show that the most commonly reported adverse drug reactions with droxidopa are increased blood pressure, nausea, and headache. In clinical studies, the prevalence and severity of droxidopa adverse effects appear to be similar to those reported by the placebo control arm.	Symptomatic Neurogenic Orthostatic Hypotension (NOH) Non-diabetic Neuropathy Primary Autonomic Failure Dopamine Beta Hydroxylase Deficiency	NOH Neurogenic Orthostatic Hypotension Orthostatic hypotension PAF Pure Autonomic Failure MSA Multiple System Atrophy Neuropathy Autonomic Failure Parkinson Dopamine Deficiency Dopamine Droxidopa	null	2	arm 1: Double-blind arm 2: Double-blind	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day intervention 2: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day	intervention 1: Placebo intervention 2: Droxidopa	54	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Litchfield Park \| Arizona \| United States \| -112.35794 \| 33.49337 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Sun City \| Arizona \| United States \| -112.27182 \| 33.59754 Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 Oxnard \| California \| United States \| -119.17705 \| 34.1975 Sunnyvale \| California \| United States \| -122.03635 \| 37.36883 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Boca Raton \| Florida \| United States \| -80.0831 \| 26.35869 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Canton \| Georgia \| United States \| -84.49076 \| 34.23676 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 North Chicago \| Illinois \| United States \| -87.84118 \| 42.32558 Elkhart \| Indiana \| United States \| -85.97667 \| 41.68199 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Worcester \| Massachusetts \| United States \| -71.80229 \| 42.26259 Southfield \| Michigan \| United States \| -83.22187 \| 42.47337 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Edison \| New Jersey \| United States \| -74.4121 \| 40.51872 Kingston \| New York \| United States \| -73.99736 \| 41.92704 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Baytown \| Texas \| United States \| -94.97743 \| 29.7355 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Round Rock \| Texas \| United States \| -97.6789 \| 30.50826 Temple \| Texas \| United States \| -97.34278 \| 31.09823 Tyler \| Texas \| United States \| -95.30106 \| 32.35126 Adelaide \| South Australia \| Australia \| 138.59863 \| -34.92866 Melbourne \| Victoria \| Australia \| 144.96332 \| -37.814 Heidelburg \| N/A \| Australia \| N/A \| N/A Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Markham \| Ontario \| Canada \| -79.2663 \| 43.86682 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 Grafton Auckland \| Private Bag \| New Zealand \| N/A \| N/A Christchurch \| N/A \| New Zealand \| 172.63333 \| -43.53333	282	NCT00633880	1COMPLETED	2009-09-01	2008-01-01	Chelsea Therapeutics	4INDUSTRY	false	false	false	null	0
[ 4 ]	452	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	Gabapentin and pregabalin are treatments for some types of neuropathic pain, including postherpetic neuralgia (PHN). However, these treatments usually need to be taken 3 times a day for effective pain control. The purpose of this study is to determine whether a new gabapentin tablet, which only needs to be taken once a day, is safe and effective for the treatment of postherpetic neuralgia.	The primary study objective is to assess the relative efficacy of G-ER dosed once daily (1800 mg following the evening meal), versus placebo in reducing the mean daily pain score from the baseline week to the end of the efficacy treatment period (Treatment Week 10) in patients with PHN. Secondary efficacy measures will include changes from baseline in mean weekly sleep interference scores, Short-Form McGill Pain Questionnaire (SF-MPQ), the Neuropathic Pain Scale (NPS), Brief Pain Inventory (BPI), Patient Global Impression of Change (PGIC), and Investigator-Rated Clinical Global Impression of Change (CGIC).	Neuralgia,Postherpetic	Postherpetic Neuralgia (PHN), shingles	null	2	arm 1: Gabapentin - Extended Release arm 2: Sugar pill	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Once-Daily; 300 mg and 600 mg tablets intervention 2: Once daily; 300 mg and 600 mg tablets	intervention 1: Gabapentin Extended Release tablets intervention 2: Placebo	39	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Tuscaloosa \| Alabama \| United States \| -87.56917 \| 33.20984 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Lancaster \| California \| United States \| -118.13674 \| 34.69804 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Pismo Beach \| California \| United States \| -120.64128 \| 35.14275 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Pueblo \| Colorado \| United States \| -104.60914 \| 38.25445 Daytona Beach \| Florida \| United States \| -81.02283 \| 29.21081 Naples \| Florida \| United States \| -81.79596 \| 26.14234 New Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Honolulu \| Hawaii \| United States \| -157.85833 \| 21.30694 Elk Grove Village \| Illinois \| United States \| -87.97035 \| 42.00392 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 West Yarmouth \| Massachusetts \| United States \| -70.24113 \| 41.65011 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Florissant \| Missouri \| United States \| -90.32261 \| 38.78922 Jefferson City \| Missouri \| United States \| -92.17352 \| 38.5767 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 High Point \| North Carolina \| United States \| -80.00532 \| 35.95569 Bismarck \| North Dakota \| United States \| -100.78374 \| 46.80833 Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719 Canton \| Ohio \| United States \| -81.37845 \| 40.79895 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Kettering \| Ohio \| United States \| -84.16883 \| 39.6895 Warwick \| Rhode Island \| United States \| -71.41617 \| 41.7001 Murrells Inlet \| South Carolina \| United States \| -79.04143 \| 33.551 Pelzer \| South Carolina \| United States \| -82.45596 \| 34.64234 Tullahoma \| Tennessee \| United States \| -86.20943 \| 35.36202 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Longview \| Texas \| United States \| -94.74049 \| 32.5007 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 All Over Russia \| N/A \| Russia \| N/A \| N/A Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863	452	NCT00636636	1COMPLETED	2009-09-01	2008-03-01	Depomed	4INDUSTRY	false	false	false	null	-0
[ 3 ]	32	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.	null	Eosinophilic Esophagitis	Eosinophils Esophagitis Microscopy	null	2	arm 1: oral viscous budesonide plus Prevacid arm 2: placebo plus Prevacid	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months. intervention 2: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.	intervention 1: Budesonide plus Prevacid intervention 2: placebo plus Prevacid	1	San Diego \| California \| United States \| -117.16472 \| 32.71571	32	NCT00638456	1COMPLETED	2009-09-01	2008-02-01	Ranjan Dohil	7OTHER	false	false	false	null	0
[ 2 ]	23	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of a single oral dose of BAY63-2521 in patients with pulmonary hypertension due to chronic obstructive pulmonary disease (COPD).	In addition to the pharmacodynamic and pharmacokinetic variables, the following laboratory variables were assessed: * Hematology: Leucocytes, erythrocytes, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets, white blood cell (WBC), partial thromboplastin time (PTT), prothrombin time (Quick), international normalized ratio (INR) (prothrombin time expressed in relation to normal value) ; * Clinical chemistry: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP), gamma glutamyl transpeptidase (GGT), creatine phosphokinase (CK), lipase, cholinesterase (CHE), glucose, creatinine, urea, uric acid, bilirubin, total protein, serum albumin, sodium, potassium, calcium, chloride. And due to the small number of subjects analyzed at several local labs, no summary statistics were provided.	Hypertension, Pulmonary Pulmonary Disease, Chronic Obstructive	Chronic obstructive pulmonary disease COPD Pulmonary hypertension	null	2	arm 1: Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3. arm 2: Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 1.0 mg BAY63-2521 will be given twice per subject, as single dose administration during the hemodynamic investigation (on study day 1) and during the lung function testing (on study day 3). intervention 2: 2.5 mg BAY63-2521 will be given twice per subject, as single dose administration during the hemodynamic investigation (on study day 1) and during the lung function testing (on study day 3).	intervention 1: Riociguat (Adempas, BAY63-2521) 1.0 mg intervention 2: Riociguat (Adempas, BAY63-2521) 2.5 mg	7	Heidelberg \| Baden-Wurttemberg \| Germany \| 8.69079 \| 49.40768 Löwenstein \| Baden-Wurttemberg \| Germany \| 9.38 \| 49.09558 München \| Bavaria \| Germany \| 13.46314 \| 48.69668 Bad Nauheim \| Hesse \| Germany \| 8.73859 \| 50.36463 Giessen \| Hesse \| Germany \| 8.67554 \| 50.58727 Greifswald \| Mecklenburg-Vorpommern \| Germany \| 13.40244 \| 54.08905 Dresden \| Saxony \| Germany \| 13.73832 \| 51.05089	23	NCT00640315	1COMPLETED	2009-09-01	2008-08-01	Bayer	4INDUSTRY	false	false	false	null	0
[ 3 ]	255	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.	null	Relapsing Multiple Sclerosis	Relapsing Multiple Sclerosis Atacicept	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: Atacicept will be administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks. intervention 2: Atacicept will be administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks. intervention 3: Atacicept will be administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks. intervention 4: Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.	intervention 1: Atacicept intervention 2: Atacicept intervention 3: Atacicept intervention 4: Placebo matched to atacicept	50	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Northbrook \| Illinois \| United States \| -87.82895 \| 42.12753 East Lansing \| Michigan \| United States \| -84.48387 \| 42.73698 Jefferson \| New Hampshire \| United States \| -71.47453 \| 44.41895 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Box Hill \| N/A \| Australia \| 145.12545 \| -37.81887 Fitzroy \| N/A \| Australia \| 144.97833 \| -37.79839 New Lambton \| N/A \| Australia \| 151.7085 \| -32.92838 Woodville \| N/A \| Australia \| 138.54291 \| -34.877 Innsbruck \| N/A \| Austria \| 11.39454 \| 47.26266 Diepenbeek \| N/A \| Belgium \| 5.41875 \| 50.90769 Sijsele \| N/A \| Belgium \| 3.31714 \| 51.20846 Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Ontario \| N/A \| Canada \| N/A \| N/A Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Hradec Králové \| N/A \| Czechia \| 15.83277 \| 50.20923 Olomouc \| N/A \| Czechia \| 17.25175 \| 49.59552 Caen \| N/A \| France \| -0.35912 \| 49.18585 Saint-Herblain \| N/A \| France \| -1.651 \| 47.21154 Bochum \| N/A \| Germany \| 7.21648 \| 51.48165 Düsseldorf \| N/A \| Germany \| 6.77616 \| 51.22172 Beirut \| N/A \| Lebanon \| 35.50157 \| 33.89332 Kaunas \| N/A \| Lithuania \| 23.90961 \| 54.90272 Breda \| N/A \| Netherlands \| 4.77596 \| 51.58656 Nieuwegein \| N/A \| Netherlands \| 5.08056 \| 52.02917 Rotterdam \| N/A \| Netherlands \| 4.47917 \| 51.9225 Dnipropetrovsk \| N/A \| Russia \| N/A \| N/A Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Novosibirsk \| N/A \| Russia \| 82.94339 \| 55.03442 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Samara \| N/A \| Russia \| 50.15 \| 53.20007 Vladimir \| N/A \| Russia \| 40.39658 \| 56.13655 Yaroslavl \| N/A \| Russia \| 39.87368 \| 57.62987 Yekaterinburg \| N/A \| Russia \| 60.6122 \| 56.8519 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Málaga \| N/A \| Spain \| -4.42034 \| 36.72016 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Basel \| N/A \| Switzerland \| 7.57327 \| 47.55839 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Kyiv \| N/A \| Ukraine \| 30.5238 \| 50.45466 Odesa \| N/A \| Ukraine \| 30.74383 \| 46.48572 Uzhhorod \| N/A \| Ukraine \| 22.2947 \| 48.6242 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 Sheffield \| N/A \| United Kingdom \| -1.4659 \| 53.38297 Stoke-on-Trent \| N/A \| United Kingdom \| -2.18538 \| 53.00415	254	NCT00642902	6TERMINATED	2009-09-01	2008-04-01	EMD Serono	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	15	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine whether control of inflammatory pathways mediated by IL-1 beta using the IL-1 receptor antagonist anakinra will yield measurable decreases in expression of genes that are otherwise overexpressed as a consequence of IL-1 beta effects in children with newly diagnosed type 1 diabetes. Ultimately, we believe that control of IL-1 beta pathways will be associated with preserved insulin secretory capacity.	Type 1 diabetes mellitus (T1D) is caused by autoimmune and autoinflammatory destruction of the insulin-producing beta cells in the pancreatic islets of Langerhans. Historically, treatment for this condition has consisted of insulin replacement therapy and dietary modification. Recent studies have demonstrated the potential benefits of immunomodulatory therapy in patients with newly diagnosed T1D to prevent further immune-mediated damage. Thus far, there has been a paucity of completed research using agents that target pro-inflammatory cytokines dysregulated in T1D. IL1B, the gene encoding the proinflammatory cytokine interleukin-1β (IL-1β) is significantly overexpressed in peripheral blood mononuclear cells (PBMC) in patients with newly diagnosed T1D compared to healthy controls. There is ample precedent to support the involvement of IL-1β in the pathogenesis of diabetes. In particular, incubation of human or animal islets or insulinoma cell lines with IL-1β inhibits insulin secretion and leads to apoptosis of beta cells. Additionally, the IL-1 receptor antagonist protein, anakinra, improves glycemic control and insulin secretory capacity in patients with type 2 diabetes.However, no data have been published regarding efficacy of agents targeting IL-1β in modifying the course of the disease in patients with T1D. Anti-Interleukin-1 in Diabetes Action (AIDA) is a randomized, placebo controlled clinical trial of anakinra in 160 adults with newly diagnosed type 1 diabetes. This trial is currently recruiting subjects. Review of clinicaltrials.gov demonstrates two other planned trials of IL-1 agents in newly diagnosed T1D, one using canakinumab, a monoclonal antibody directed at IL-1β, and another using rilonacept, a cytokine trap targeting IL-1β. To assess the effectiveness of these drugs in future studies and in clinical practice, it will be valuable to identify biomarkers that allow us to monitor their therapeutic effects. However, to the best of our knowledge, the pattern of changes in gene expression induced by IL-1β in normal PBMC has not been systematically studied, making it difficult to identify candidate biomarkers for validation studies. In this exploratory study, we aimed to determine which of the characteristic changes in gene expression from patients with newly diagnosed T1D are IL-1β-mediated, using both in vitro and in vivo approaches. We also determined the effect size of a short course of anakinra therapy on glycemic control, insulin dosing, and C-peptide area under the curve during mixed-meal tolerance testing (MMTT). Finally, we evaluated the tolerability of anakinra in children and adolescents with newly diagnosed T1D. Methods In vitro studies To determine the effects of IL-1β on gene expression in peripheral blood mononuclear cells (PBMC), blood samples were collected from 7 healthy adult volunteers under an IRB-approved protocol. Isolating serum. Blood was collected in EDTA tubes (BD, Franklin Lakes, NJ) and centrifuged at 2500 rpm for 15 minutes. The plasma layer was treated with topical thrombin (5000 U/ml, King Pharmaceuticals, Bristol, TN) equaling 5% total volume and incubated at 38° for 20 minutes. The resulting clot was removed from the serum and discarded. Cell culture. PBMC were isolated from the cellular fraction by centrifugation using Lymphocyte Separation Medium (Mediatech, Manassas, VA) and washed with PBS (Mediatech, Manassas, VA). Cells were plated at 3 x 106 per well in 6 well plates in RPMI 1640 (Mediatech) supplemented with 10% fetal bovine serum (Atlanta Biologicals, Lawrenceville, GA), 10% autologous human serum, 5.5 mM glucose, 100 U penicillin, 100 µg/ml streptomycin, 50 µmol/l 2-mercaptoethanol and 5% HEPES. IL-1β (15 ng/ml final concentration, Abcam, Cambridge, MA), or 9.3 µg/ml S100b (Sigma, St. Louis, MO) were added to some wells, All experimental conditions were plated in triplicate. Cells were collected after 24 hours of incubation at 37°C in a 5% CO2 atmosphere. Validation by RT-PCR. Total RNA was isolated using RNA-Stat 60 (Tel-Test, Friendswood, TX). The High Capacity cDNA Reverse Transcription Kit (Applied Biosystems, Carlsbad, CA) was used with 750 ng RNA to create cDNA. Real time PCR was performed on the Roche LightCycler 480 system using 5 ul of the cDNA sample, the Roche LightCycler Probes Master kit and human IL1B primers (Applied Biosystems). RNA was quantitated by delta Ct values using GADPH as the internal control (Applied Biosystems). Microarray analysis. Triplicate samples for each experimental condition were pooled for further analysis. From 2-5 µg of total RNA, double-stranded cDNA containing the T7-dT(24) promoter sequence were generated using GeneChip® One-Cycle cDNA Synthesis Kits (Invitrogen, Santa Clara, CA). Synthesis of cRNA used 200ng of cDNA for in vitro transcription, amplification and labeling steps according to the manufacturer's instructions using the Illumina RNA amplification kit (Ambion Inc, Austin, TX). 1.5 µg of amplified biotin-labeled cRNA was subsequently hybridized to Illumina Human HT-12 v3.0 Beadchip microarrays according to standard protocols. at the Baylor Institute for Immunology Research, Dallas, TX. Slides were scanned on an Illumina Beadstation 500 and data processed with Beadstudio software. For each chip, raw intensity data were normalized to the mean intensity of all measurements on that chip. Data were imported into Genespring GX11 (Agilent) for further analysis. Probe sets were selected if "Present" or "Marginal" in at least 50% of samples in any group. Principal component analysis was performed to detect outliers. Class comparisons were performed using t-tests after log transformation with the Type 1 error rate controlled using Benjamini-Hochberg false discovery rates (FDR). In vivo studies Subjects. The study was approved by the Institutional Review Board of the University of Texas Southwestern Medical Center. Written informed consent was obtained from parents or legal guardians, and assent for participation was obtained from subjects aged 10 years and older. Patients at Children's Medical Center Dallas between ages 6 and 18 years with Type 1 diabetes within one week of diagnosis were eligible. Exclusion criteria included treatment with systemic or inhaled corticosteroids or any other immunomodulatory drug, active infection, history of mycobacterial disease, pregnancy or lactation, use of a live vaccine within 90 days of study enrollment, and severe comorbidities (such as chronic kidney disease, heart failure, or uncontrolled hypertension). Patients were excluded if it was unclear whether they had Type 1 or Type 2 diabetes. Data collected from the medical charts included age, gender, race/ethnicity, weight, height, hemoglobin A1c (HbA1c) and beta-hydroxybutyrate at diagnosis. A blood sample was obtained at study entry; a portion was analyzed for screening labs including alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), creatinine, complete blood count (CBC) with differential, and serum pregnancy test for all menstruating females and any female over age 10 years. Additionally, 20 mL was processed for microarray analysis. Diabetes care At diagnosis, all subjects were placed on a basal-bolus insulin regimen with glargine and either lispro or aspart. For the duration of the study, insulin doses were adjusted per standard clinic protocol with target glucose of 80-140 mg/dL fasting and 80-180 mg/dL before meals. At each study visit, we recorded the subject's current insulin doses and weight to allow calculation of the total daily dose (units/kg/day). Anakinra After study enrollment, all subjects started anakinra (Kineret; Amgen, Thousand Oaks, CA) as a subcutaneous daily injection. Subjects weighing more than 25 kg at the time of enrollment received 100 mg daily whereas those weighing 25 kg or less received 50 mg daily. Anakinra was continued for a total of 28 days with no dose adjustment. Diabetes autoantibodies Per standard protocol, all patients were tested for antibodies to insulin, protein tyrosine phosphatase receptor type N (insulinoma-associated antigen (IA-2)), and glutamic acid decarboxylase (ARUP Laboratories, Salt Lake City, UT). The results of these studies were typically not available at the time of study enrollment and therefore were not used as criteria for study entry. However, we excluded patients with negative results for all three antibodies from further analysis. Surveillance laboratory tests Upon completion of anakinra therapy (4-5 weeks after diagnosis), a blood sample was collected and sent for ALT, AST, BUN, creatinine, and CBC with differential. Per standard protocol, all subjects had point-of-care hemoglobin A1c (DCA Vantage Analyzer, Siemens Healthcare Diagnostics, Deerfield, IL) and capillary glucose tested at clinic visits 4-5 weeks after diagnosis, 4 months after diagnosis, and 7 months after diagnosis. Adverse event monitoring During the 28 days of anakinra therapy, study personnel called subjects weekly to document frequency of hypoglycemia and presence of rash, injection site reactions (swelling, erythema, and pain at the site of anakinra administration), headaches, fevers, and any other adverse events. After the completion of anakinra therapy, patients were assessed for adverse events at each subsequent study visit. Mixed meal tolerance tests (MMTTs) MMTTs were conducted at the University of Texas Southwestern Medical Center Clinical Translational Research Center (CTRC). Subjects underwent MMTTs essentially as described (8) at 3-4 weeks after diagnosis and again at 7 months after diagnosis. C-peptide analyses were performed in the laboratory of Dr. Philip Raskin (UT Southwestern Medical Center, Dallas, TX). Microarray blood sample processing Microarray blood samples were collected in EDTA tubes (BD Vacutainer) at study enrollment, 3-4 weeks after diagnosis, and upon completion of anakinra therapy. PBMC were isolated and stored at -80°C within 4 hours of the blood draw. Cells were lysed in RLT lysis buffer containing β-mercaptoethanol (Qiagen, Valencia, CA). Total RNA was extracted using the RNeasy® Mini Kit according to the manufacturer-recommended protocol (Qiagen, Valencia, CA) and analyzed as described above. Control groups Because subjects in the anakinra study were not randomized, we used two different pre-existing control groups. Subjects in control group A were previously enrolled at our institution under a separate, IRB-approved protocol in a randomized, controlled trial examining the effect of the initial choice of longer-acting insulin on the rate of loss of beta cell function. Subjects were enrolled during their hospitalization for diabetes diagnosis and randomized to receive either NPH or basal insulin (glargine or detemir). Diabetes care and routine clinic visits, schedule and procedures for mixed meal tolerance testing and microarray analysis were the same as for our anakinra-treated subjects.. Control group A includes all patients in that study randomized to receive basal insulin, except those with negative autoantibody results. Subjects in control group B were identified in a chart review of all new diabetes diagnoses from April 2008 through November 2009 in patients aged 9-18 years (to match date range of recruitment and age of anakinra-treated subjects). Subjects were included in this control group if they had at least one positive autoantibody and were not enrolled in the anakinra study. We collected age, gender, race/ethnicity, weight, height, and beta-hydroxybutyrate at diagnosis. We also collected HbA1c and total daily insulin dose (expressed as units/kg/day) at diagnosis and for clinic visits at 1 month, 4 months, and 7 months after diagnosis. A subset of 10 of these subjects consented to enroll in an IRB-approved study in which blood was drawn for microarray analysis at diagnosis and again 1 month after diagnosis. Microarray procedures were the same as described above for the anakinra-treated subjects. Statistical analysis Descriptive statistics were compiled and all comparative analyses performed using SAS version 9.2 (Cary, NC). C-peptide area under the curve (AUC) was calculated for each MMTT using the trapezoidal method.. Insulin-dose adjusted A1c (IDAA1c) was calculated as outlined by Mortensen, et. al. (9), IDAA1c = hemoglobin A1C (percent) + \[4 × insulin dose (units per kilogram per 24 h)\]. Hemoglobin A1c and IDAA1c between groups were compared using Wilcoxon rank-sum tests. Since total daily insulin dose was normally distributed, between groups comparisons were performed by standard t-test.	Type 1 Diabetes Mellitus	Type 1 diabetes mellitus IL1 beta Anakinra	null	1	arm 1: After study enrollment, all subjects started anakinra (Kineret™; Amgen, Thousand Oaks, CA, USA) as a subcutaneous daily injection. Subjects weighing \>25 kg at the time of enrollment received 100 mg daily, whereas those weighing \<25 kg received 50 mg daily. Anakinra was continued for 28 d with no dose adjustment.	[ 0 ]	1	[ 0 ]	intervention 1: Patients will receive daily anakinra therapy for 28 days	intervention 1: Anakinra	1	Dallas \| Texas \| United States \| -96.80667 \| 32.78306	12	NCT00645840	1COMPLETED	2009-09-01	2008-03-01	University of Texas Southwestern Medical Center	7OTHER	false	false	false	null	0
[ 5 ]	12	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will evaluate the effectiveness of propranolol in reducing symptoms of distress in people with post-traumatic stress disorder.	Post-traumatic stress disorder (PTSD) is a common and disabling condition, with about 10% of people having experienced PTSD at some point during their lives. The diagnosis of PTSD requires certain criteria: exposure to a severe psychological trauma and the persistent presence of three symptom clusters that include re-experiencing the traumatic event, physiologic hyperarousal, and emotional numbing paired with avoidance of stimuli associated with the event. Stimuli and cues associated with the trauma, such as features of an assailant or accident site, can cause a person to re-experience the traumatic memory and associated feelings of helplessness and fear. When re-experiencing a traumatic memory, people with PTSD usually undergo a heightened stress-related hormonal response that further solidifies new stimulating associations with the traumatic memory. Treatment with propranolol, a blood pressure-lowering drug that reduces stress-related hormonal responses, may be an effective means of preventing the formation of traumatic memories and of improving PTSD symptoms. This study will evaluate the effectiveness of propranolol in reducing symptoms of distress associated with traumatic memories in people with PTSD. Participation in this study will last 14 weeks. All potential participants will undergo a 4-hour initial visit that will begin with a medical and psychiatric history review, a psychiatric interview, and symptom questionnaires. Participants will then be assigned randomly to take a test dose of either propranolol or placebo. Upon completion of the test dose, participants will begin 14 weeks of treatment with their assigned test dose medication. Participants will be asked to take the study medication each time they have a traumatic memory associated with hyperarousal symptoms, but no more than two times a day. Using a cognitive behavioral therapy based-workbook, participants will track their symptoms daily and when they use cognitive techniques to relieve symptoms. Participants will attend study visits every 2 weeks for the 14 weeks of treatment. During these visits, participants will describe any side effects experienced, complete interviews and questionnaires about PTSD symptom severity, review with study officials their daily workbook entries, and pick up medication. Study participation will end upon completion of the Week 14 study visit. For information on a related study, please follow this link: http://clinicaltrials.gov/show/NCT00391430	Post-Traumatic Stress Disorder	Propanolol Beta Blockers Reconsolidation Cognitive Therapy PTSD	null	2	arm 1: Participants will take propranolol for 14 weeks. Medication will be self-administered times they experience acute onset of hyperarousal symptoms, not more than twice per day. arm 2: Participants will take placebo for 14 weeks. Medication will be self-administered times they experience acute onset of hyperarousal symptoms, not more than twice per day.	[ 0, 2 ]	3	[ 0, 0, 5 ]	intervention 1: Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours. intervention 2: Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours. intervention 3: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.	intervention 1: Propanolol intervention 2: Placebo intervention 3: Cognitive therapy workbook	1	New York \| New York \| United States \| -74.00597 \| 40.71427	3	NCT00648375	6TERMINATED	2009-09-01	2003-12-01	Weill Medical College of Cornell University	7OTHER	false	false	false	null	0
[ 5 ]	30	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this research study is to better understand how the study drug works when people use it to treat atopic dermatitis.	To evaluate adherence to topical therapy using adherence data collected by the MEMS cap (Medication Electronic Monitoring System) in pediatric patients with atopic dermatitis (AD) and the impact of a return visit.	Atopic Dermatitis	atopic dermatitis eczema	null	1	arm 1: tacrolimus ointment	[ 0 ]	1	[ 0 ]	intervention 1: tacrolimus ointment to be applied twice daily to affected areas during duration of study	intervention 1: tacrolimus ointment	1	Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986	30	NCT00654355	1COMPLETED	2009-09-01	2008-04-01	Wake Forest University	7OTHER	false	false	false	null	0
[ 4 ]	100	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of the trial is to evaluate the safety of intravenous (iv) lacosamide delivered in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with partial-onset seizures.	This multicenter, open-label trial examined safety and tolerability of rapid initiation of adjunctive lacosamide via a single intravenous loading dose followed by oral maintenance treatment in subjects 16 - 60 years of age with partial-onset seizures. Three consecutive 25-subject cohorts were given a progressively increasing dose of lacosamide (200, 300, 400 mg) administered as a single 15-minute intravenous (iv) loading dose followed by the equivalent daily dose administered orally twice daily for 6.5 days with the first oral dose 12 hours after the iv dose. A fourth cohort of 25 subjects repeated the 300 mg dose to provide safety data on a total of 50 subjects at the highest well-tolerated dose.	Partial Epilepsies Partial Onset Seizures	epilepsy seizures Lacosamide Vimpat intravenous	null	3	arm 1: Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily arm 2: Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily arm 3: Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Single loading intravenous (iv) lacosamide 200 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 200 mg/day (100 mg twice daily) for 6.5 days intervention 2: Single loading intravenous (iv) lacosamide 300 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 300 mg/day (150 mg twice daily) for 6.5 days intervention 3: Single loading intravenous (iv) lacosamide 400 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 400 mg/day (200 mg twice daily) for 6.5 days	intervention 1: lacosamide intervention 2: lacosamide intervention 3: lacosamide	7	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Chesterfield \| Missouri \| United States \| -90.57707 \| 38.66311 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931	100	NCT00655551	1COMPLETED	2009-09-01	2008-04-01	UCB BIOSCIENCES, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	2,055	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	false	0ALL	null	The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and efficacy will be compared between the treatment groups.	null	Venous Thromboembolism		null	2	arm 1: 220 mg once daily arm 2: 40 mg once daily	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 40 mg once daily intervention 2: 220 mg once daily	intervention 1: Enoxaparin intervention 2: Dabigatran etexilate	108	La Jolla \| California \| United States \| -117.2742 \| 32.84727 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Englewood \| Colorado \| United States \| -104.98776 \| 39.64777 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Missoula \| Montana \| United States \| -113.994 \| 46.87215 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Conway \| South Carolina \| United States \| -79.04781 \| 33.836 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Daws Park \| South Australia \| Australia \| N/A \| N/A Box Hill \| Victoria \| Australia \| 145.12545 \| -37.81887 Windsor \| Victoria \| Australia \| 144.99241 \| -37.85344 Nedlands \| Western Australia \| Australia \| 115.8073 \| -31.98184 Graz \| N/A \| Austria \| 15.45 \| 47.06667 Linz \| N/A \| Austria \| 14.28611 \| 48.30639 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Wels \| N/A \| Austria \| 14.03333 \| 48.16667 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Deurne \| N/A \| Belgium \| 4.46595 \| 51.22134 Lanaken \| N/A \| Belgium \| 5.6468 \| 50.89318 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Red Deer \| Alberta \| Canada \| -113.802 \| 52.26682 Ajax \| Ontario \| Canada \| -79.03288 \| 43.85012 Belleville \| Ontario \| Canada \| -77.38277 \| 44.16682 Cambridge \| Ontario \| Canada \| -80.31269 \| 43.3601 Kitchener \| Ontario \| Canada \| -80.5112 \| 43.42537 Oshawa \| Ontario \| Canada \| -78.84957 \| 43.90012 Sarnia \| Ontario \| Canada \| -82.40407 \| 42.97866 Stratford \| Ontario \| Canada \| -80.94972 \| 43.36679 Windsor \| Ontario \| Canada \| -83.01654 \| 42.30008 Chomutov \| N/A \| Czechia \| 13.41779 \| 50.46048 Jihlava \| N/A \| Czechia \| 15.59124 \| 49.3961 Kolín \| N/A \| Czechia \| 15.1998 \| 50.02806 Pilsen \| N/A \| Czechia \| 13.37759 \| 49.74747 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Frederiksberg \| N/A \| Denmark \| 12.53463 \| 55.67938 Herlev \| N/A \| Denmark \| 12.43998 \| 55.72366 Hørsholm \| N/A \| Denmark \| 12.50111 \| 55.88098 Silkeborg \| N/A \| Denmark \| 9.54508 \| 56.1697 Jyväskylä \| N/A \| Finland \| 25.72088 \| 62.24147 Oulu \| N/A \| Finland \| 25.46816 \| 65.01236 Tampere \| N/A \| Finland \| 23.78712 \| 61.49911 Garmisch-Partenkirchen \| N/A \| Germany \| 11.09576 \| 47.49209 Mainz \| N/A \| Germany \| 8.2791 \| 49.98419 Markgröningen \| N/A \| Germany \| 9.08059 \| 48.90493 Rheinfelden \| N/A \| Germany \| 7.78715 \| 47.56013 Gyula \| N/A \| Hungary \| 21.28333 \| 46.65 Kecskemét \| N/A \| Hungary \| 19.69128 \| 46.90618 Szeged \| N/A \| Hungary \| 20.14824 \| 46.253 Székesfehérvár \| N/A \| Hungary \| 18.41034 \| 47.18995 Ahmedabad \| N/A \| India \| 72.58727 \| 23.02579 Andhra Pradesh \| N/A \| India \| N/A \| N/A Andhra Predesh \| N/A \| India \| N/A \| N/A Bangalore \| N/A \| India \| 77.59369 \| 12.97194 Bangalore \| N/A \| India \| 77.59369 \| 12.97194 Baroda \| N/A \| India \| 76.65 \| 25.5 Mangalore \| N/A \| India \| 74.85603 \| 12.91723 Mohali \| N/A \| India \| 76.72211 \| 30.67995 New Delhi \| N/A \| India \| 77.2148 \| 28.62137 Pune \| N/A \| India \| 73.85535 \| 18.51957 Ramdaspeth Nagpur \| N/A \| India \| N/A \| N/A Secunderabad \| N/A \| India \| 78.54263 \| 17.50427 Vadodara \| N/A \| India \| 73.20812 \| 22.29941 Bologna \| N/A \| Italy \| 11.33875 \| 44.49381 Parma \| N/A \| Italy \| 10.32618 \| 44.79935 Pavia \| N/A \| Italy \| 9.15917 \| 45.19205 Reggio Emilia \| N/A \| Italy \| 10.63125 \| 44.69825 Roma \| N/A \| Italy \| 11.10642 \| 44.99364 Torino \| N/A \| Italy \| 11.99138 \| 44.88856 Amsterdam \| N/A \| Netherlands \| 4.88969 \| 52.37403 Amsterdam \| N/A \| Netherlands \| 4.88969 \| 52.37403 Hilversum \| N/A \| Netherlands \| 5.17639 \| 52.22333 Hoofddorp \| N/A \| Netherlands \| 4.68889 \| 52.3025 Leiden \| N/A \| Netherlands \| 4.49306 \| 52.15833 Sittard \| N/A \| Netherlands \| 5.86944 \| 50.99833 Zwolle \| N/A \| Netherlands \| 6.09444 \| 52.5125 Takapuna Auckland \| N/A \| New Zealand \| N/A \| N/A Ålesund \| N/A \| Norway \| 6.15492 \| 62.47225 Bodø \| N/A \| Norway \| 14.37513 \| 67.28267 Elverum \| N/A \| Norway \| 11.56231 \| 60.88191 Lillehammer \| N/A \| Norway \| 10.46628 \| 61.11514 Tynset \| N/A \| Norway \| 10.78241 \| 62.27594 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Piekary Śląskie \| N/A \| Poland \| 18.92653 \| 50.38017 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Bryanston \| N/A \| South Africa \| 28.02805 \| -26.05211 Cape Western Province \| N/A \| South Africa \| N/A \| N/A Plumstead \| N/A \| South Africa \| 18.47835 \| -34.01909 Alcorcón (Madrid) \| N/A \| Spain \| -3.82487 \| 40.34582 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Fuenlabrada \| N/A \| Spain \| -3.79415 \| 40.28419 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Valencia \| N/A \| Spain \| -0.37966 \| 39.47391 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Halmstad \| N/A \| Sweden \| 12.85676 \| 56.67446 Hässleholm \| N/A \| Sweden \| 13.76638 \| 56.15905 Kalmar \| N/A \| Sweden \| 16.36163 \| 56.66157 Kungälv \| N/A \| Sweden \| 11.98054 \| 57.87096 Lidköping \| N/A \| Sweden \| 13.15765 \| 58.50517 Motala \| N/A \| Sweden \| 15.03649 \| 58.53706 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Uppsala \| N/A \| Sweden \| 17.63889 \| 59.85882 Varberg \| N/A \| Sweden \| 12.25078 \| 57.10557	2,013	NCT00657150	1COMPLETED	2009-09-01	2008-03-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 4 ]	1,397	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to investigate the efficacy and safety of Rabeprazole (RAB) Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with erosive gastroesophageal reflux disease (eGERD).	This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the treatment of mild to moderate erosive Gastroesophageal Reflux Disease (GERD).	Gastroesophageal Reflux Disease (GERD)	GERD erosive GERD erosive esophagitis	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks. intervention 2: Esomeprazole 40 mg capsule, once daily for 4-8 weeks.	intervention 1: Rabeprazole sodium intervention 2: Esomeprazole	85	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 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 Fullerton \| California \| United States \| -117.92534 \| 33.87029 Irvine \| California \| United States \| -117.82311 \| 33.66946 Laguna Hills \| California \| United States \| -117.71283 \| 33.61252 Mission Hills \| California \| United States \| -120.43683 \| 34.68609 Redwood City \| California \| United States \| -122.23635 \| 37.48522 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Louis Obispo \| California \| United States \| N/A \| N/A West Covina \| California \| United States \| -117.93895 \| 34.06862 Pueblo \| Colorado \| United States \| -104.60914 \| 38.25445 Wheat Ridge \| Colorado \| United States \| -105.07721 \| 39.7661 Bristol \| Connecticut \| United States \| -72.94927 \| 41.67176 Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 Boynton Beach \| Florida \| United States \| -80.06643 \| 26.52535 Hialeah \| Florida \| United States \| -80.27811 \| 25.8576 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Jupiter \| Florida \| United States \| -80.09421 \| 26.93422 Largo \| Florida \| United States \| -82.78842 \| 27.90979 Lauderdale Lakes \| Florida \| United States \| -80.20838 \| 26.16647 Naples \| Florida \| United States \| -81.79596 \| 26.14234 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Newnan \| Georgia \| United States \| -84.79966 \| 33.38067 Rockford \| Illinois \| United States \| -89.094 \| 42.27113 Clive \| Iowa \| United States \| -93.72411 \| 41.60304 Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417 Topeka \| Kansas \| United States \| -95.67804 \| 39.04833 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 Slidell \| Louisiana \| United States \| -89.78117 \| 30.27519 Annapolis \| Maryland \| United States \| -76.49184 \| 38.97859 Hagerstown \| Maryland \| United States \| -77.71999 \| 39.64176 Mexico \| Missouri \| United States \| -91.88295 \| 39.16976 Washington \| Missouri \| United States \| -91.01209 \| 38.55811 Vineland \| New Jersey \| United States \| -75.02573 \| 39.48623 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Bay Shore \| New York \| United States \| -73.24539 \| 40.7251 Hartsdale \| New York \| United States \| -73.79819 \| 41.01899 Mineola \| New York \| United States \| -73.64068 \| 40.74927 New York \| New York \| United States \| -74.00597 \| 40.71427 Pittsford \| New York \| United States \| -77.515 \| 43.09062 Boone \| North Carolina \| United States \| -81.67455 \| 36.21679 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Jacksonville \| North Carolina \| United States \| -77.43024 \| 34.75405 New Bern \| North Carolina \| United States \| -77.04411 \| 35.10849 Wilmington \| North Carolina \| United States \| -77.94604 \| 34.23556 Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Anderson \| South Carolina \| United States \| -82.65013 \| 34.50344 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Franklin \| Tennessee \| United States \| -86.86889 \| 35.92506 Germantown \| Tennessee \| United States \| -89.81009 \| 35.08676 Jackson \| Tennessee \| United States \| -88.81395 \| 35.61452 Johnson City \| Tennessee \| United States \| -82.35347 \| 36.31344 Kingsport \| Tennessee \| United States \| -82.56182 \| 36.54843 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Beaumont \| Texas \| United States \| -94.10185 \| 30.08605 Bryan \| Texas \| United States \| -96.36996 \| 30.67436 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 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 Chesapeake \| Virginia \| United States \| -76.27494 \| 36.81904 Bellevue \| Washington \| United States \| -122.20068 \| 47.61038 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389	1,361	NCT00658632	1COMPLETED	2009-09-01	2008-02-01	Eisai Inc.	4INDUSTRY	false	false	false	null	-0
[ 4 ]	570	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 who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.	null	Type 2 Diabetes	DPP-4 inhibitors HbA1c Incretins	null	2	arm 1: Metformin + Saxagliptin arm 2: Metformin + Placebo	[ 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Oral tablet, once daily for 24 weeks intervention 2: oral tablet, once daily for 24 weeks intervention 3: oral tablet, once daily for 24 weeks	intervention 1: Saxagliptin intervention 2: Placebo intervention 3: Metformin	30	Hefei \| Anhui \| China \| 117.28083 \| 31.86389 Beijing \| China \| China \| 116.39723 \| 39.9075 Chongqing \| China \| China \| 106.55771 \| 29.56026 Guangzhou \| Guangdong \| China \| 113.25 \| 23.11667 Shijiazhuang \| Hebei \| China \| 114.47861 \| 38.04139 Ha'er Bing \| Hei Longjiang \| China \| N/A \| N/A Wuhan \| Hubei \| China \| 114.26667 \| 30.58333 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 Hyderabad \| Andhra Pradesh \| India \| N/A \| N/A Bangalore \| Karnataka \| India \| 77.59369 \| 12.97194 Mangalore \| Karnataka \| India \| 74.85603 \| 12.91723 Nagpur \| Maharashtra \| India \| 79.08491 \| 21.14631 Bangalore \| N/A \| India \| 77.59369 \| 12.97194 Seongnam-si \| Gyeonggi-do \| South Korea \| 127.13778 \| 37.43861 Bucheon-si \| N/A \| South Korea \| 126.78306 \| 37.49889 Daegu \| N/A \| South Korea \| 128.59111 \| 35.87028 Goyang \| N/A \| South Korea \| 127.19731 \| 36.21689 Gwangju \| N/A \| South Korea \| 126.91556 \| 35.15472 Incheon \| N/A \| South Korea \| 126.70515 \| 37.45646 Pusan \| N/A \| South Korea \| 128.3681 \| 36.3809 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Uijeongbu-si \| N/A \| South Korea \| 127.0474 \| 37.7415	570	NCT00661362	1COMPLETED	2009-09-01	2008-06-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 5 ]	32	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to find out how an anti-anxiety drug or placebo affects the activity of your brain when you are at rest and when you are viewing emotional material, such as, emotional faces and pictures.	This is an exploratory study to evaluate the usefulness of fMRI as a biomarker to measure the response to a known, FDA approved marketed anxiolytic. As such, this is not a study testing safety and efficacy of an approved medicine; it is a study to evaluate the usefulness of fMRI (a non-significant risk device procedure) to correlate the clinical/behavioral effects of a marketed anxiolytic with brain activity assessed by magnetic resonance imaging. fMRI is a more direct measure of brain function than behavior, outcomes are quantitative and objective. As such, it may be more specific, i.e., may be more sensitive to drug effects or show them earlier than clinical endpoints and enable determination of efficacy in smaller or shorter studies than those required to show effects on clinical endpoints. Finally, imaging may allow differentiation of placebo responders from true drug responders.	Generalized Anxiety Disorder	Anxiety disorders Generalized anxiety	null	2	arm 1: Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder. arm 2: A placebo comparator will be administered to 12 patients with generalized anxiety disorder	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks). intervention 2: Placebo, bid, p.o. for 28 +/- 2 days.	intervention 1: Alprazolam (Xanax) intervention 2: Placebo	1	San Diego \| California \| United States \| -117.16472 \| 32.71571	32	NCT00662259	1COMPLETED	2009-09-01	2008-04-01	University of California, San Diego	7OTHER	false	false	false	null	0
[ 5 ]	39	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study is being done to see if the blood pressure lowering effect of an approved drug nebivolol is comparable to that of another approved drug carvedilol for the treatment of hypertension in patients who have coronary artery disease.	null	Hypertension Coronary Artery Disease	carvedilol Coreg (TM) hypertension blood pressure coronary artery disease Nebivolol BYSTOLIC (TM)	null	2	arm 1: Encapsulated Nebivolol arm 2: Encapsulated Carvedilol	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily intervention 2: Encapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily	intervention 1: Nebivolol intervention 2: Carvedilol	34	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Buena Park \| California \| United States \| -117.99812 \| 33.86751 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Orange \| California \| United States \| -117.85311 \| 33.78779 Santa Ana \| California \| United States \| -117.86783 \| 33.74557 Guilford \| Connecticut \| United States \| -72.68176 \| 41.28899 Coral Gables \| Florida \| United States \| -80.26838 \| 25.72149 Daytona Beach \| Florida \| United States \| -81.02283 \| 29.21081 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 New Smyrna Beach \| Florida \| United States \| -80.927 \| 29.02582 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Winter Haven \| Florida \| United States \| -81.73286 \| 28.02224 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Lafayette \| Louisiana \| United States \| -92.01984 \| 30.22409 Auburn \| Maine \| United States \| -70.23117 \| 44.09785 Pittsfield \| Massachusetts \| United States \| -73.24538 \| 42.45008 Worcester \| Massachusetts \| United States \| -71.80229 \| 42.26259 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Lansing \| Michigan \| United States \| -84.55553 \| 42.73253 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Northport \| New York \| United States \| -73.34317 \| 40.90093 The Bronx \| New York \| United States \| -73.86641 \| 40.84985 The Bronx \| New York \| United States \| -73.86641 \| 40.84985 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Lenoir \| North Carolina \| United States \| -81.53898 \| 35.91402 Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Lancaster \| Pennsylvania \| United States \| -76.30551 \| 40.03788 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Florence \| South Carolina \| United States \| -79.76256 \| 34.19543 Cleveland \| Tennessee \| United States \| -84.87661 \| 35.15952 Carrollton \| Texas \| United States \| -96.89028 \| 32.95373	62	NCT00673075	1COMPLETED	2009-09-01	2008-05-01	Forest Laboratories	4INDUSTRY	false	false	false	null	0
[ 5 ]	17	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The primary objective of this trial is to assess the continued efficacy of Omacor co-administered with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HCL-C) levels.	The present trial is an open-label, uncontrolled extension to the previous trial (PRV-06009) which utilized a randomized,double-blind, two-period crossover design with eight clinic visits. The current trial consists of nine clinic visits over 104 weeks. There will be two treatment periods in this study: * Phase I: All subjects will receive simvastatin 80 md/d plus Omacor 4 g/d for the first six weeks of the trial. * Phase II: All subjects will receive simvastatin (at a dose to be determined at the discretion of the Investigator) plus Omacor 4 g/d for the remainder of the treatment period.	Dyslipidemias	cholesterol dyslipidemia omega 3	null	1	arm 1: Subjects who had successfully completed a 12-wk double-blind crossover study of P-OM3 plus simvastatin 20 mg/d were eligible for the open-label extension study. Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.	[ 5 ]	1	[ 0 ]	intervention 1: Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.	intervention 1: Omacor + simvastatin	0	null	16	NCT00678743	1COMPLETED	2009-09-01	2007-08-01	Provident Clinical Research	7OTHER	false	false	false	null	0
[ 4 ]	225	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine whether a reduced dose of aripiprazole is effective in treating patients with major depressive disorder	This is a 60-day, multi-center, double-blind, placebo-controlled study on the efficacy of aripiprazole (Abilify) augmentation of selective serotonin reuptake inhibitors (SSRIs) or selective serotonin norepinephrine uptake inhibitors (SNRIs) venlafaxine in patients with MDD who have responded inadequately to treatment with ADTs. The purpose of our study is to evaluate the efficacy and tolerability of low-dose (2 mg/day) aripiprazole (Abilify) as an augmentation strategy in MDD non-responding to ADT with SSRIs or the SNRI venlafaxine.	Major Depressive Disorder	Depression	null	3	arm 1: patients randomly assigned to the drug/drug sequence, the dose of aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase. arm 2: For patients randomly assigned to the placebo/drug sequence, the dose of aripiprazole will be 2 mg/day during the second phase of the study. arm 3: for patients randomly assigned to the placebo/placebo sequence, study medication will be placebo during both phases of the study.	[ 1, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Tablet dose of aripiprazole will be 2 mg/day during the first phase (30 days) of the study, and 5 mg/day in the second phase (30 days) intervention 2: For patients randomly assigned to the placebo/drug sequence, the dose of aripiprazole will be 2 mg/day during the second phase of the study (30 days) intervention 3: for patients randomly assigned to the placebo/placebo sequence, study medication will be placebo during both phases of the study (60 days)	intervention 1: Aripiprazole 5mg intervention 2: Aripiprazole 2mg intervention 3: Placebo	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	222	NCT00683852	1COMPLETED	2009-09-01	2008-09-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0
[ 2 ]	12	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine the maximum tolerated dose, dose-limiting toxicity, and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with non-small cell lung cancer.	null	Non-small Cell Lung Cancer (NSCLC)		null	2	arm 1: None arm 2: None	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m\^2, intravenous (IV) solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 5 mg/min/mL, intravenous IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles. intervention 2: After all participants in Dose Level 1 (ixabepilone, 32 mg/m\^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2(ixabepilone, 32 mg/m\^2 + carboplatin, 6 mg/min/mL) opened. On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m\^2, IV solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 6 mg/min/mL, IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.	intervention 1: Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL intervention 2: Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL	1	Chuo-Ku \| Tokyo \| Japan \| N/A \| N/A	12	NCT00683904	1COMPLETED	2009-09-01	2008-06-01	R-Pharm	4INDUSTRY	false	false	false	null	0
[ 5 ]	385	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Open label, 12-week clinical trial to assess efficacy, safety, treatment adherence and Quality of Life impact of Mometasone Furoate dry powder 400 mcg once-daily in persistent mild-moderate asthmatic patients at least 12 years old. Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.	null	Asthma		null	1	arm 1: Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.	[ 0 ]	1	[ 0 ]	intervention 1: Mometasone Furoate 400 mcg once daily, in the evening through 12 weeks.	intervention 1: Mometasone Furoate	0	null	281	NCT00687531	6TERMINATED	2009-09-01	2006-11-01	Organon and Co	4INDUSTRY	false	false	false	null	0
[ 4 ]	35	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The HIP study is designed to follow the clinical experience of young hypertensive children receiving candesartan cilexetil (Atacand) who are between the ages of 1 and less than 11 years old. The study is open label with no concurrent control group. To be eligible for HIP, children must have completed Study 328 without discontinuation due to a study drug-related AE and in the investigator's opinion, have an on-going clinical indication for an orally administered suspension of candesartan cilexetil to control blood pressure. Children will return to clinic every 3 months (more frequently at the investigator's discretion) for safety and efficacy evaluations. Safety will be monitored by serum chemistries, urinalyses, echocardiograms and by physical examinations at specified clinic visits. Blood pressure and heart rate will be measured at each clinic visit. Study drug is administered orally once a day. Investigators determine the efficacious dose ( 0.05 mg/kg; 0.2 mg/kg; 0.4 mg/kg) on a vist-by-vist basis depending on the child's BP response. It is anticipated that study dose will align closely with the effective anti-hypertensive dose determined in Study 328. If the child's hypertension is not well-controlled, dose adjustments up to a maximum of 0.4mg/kg/day and/or the addition of other antihypertensive medications are permitted, with the exception of other angiotensin receptor blockers. The HIP study offers eligible children up to two additional years of treatment with the liquid formulation of Atacand.	null	Hypertension	pediatric renal disease high blood pressure	null	1	arm 1: investigator determines efficacious dose based on child's BP response.	[ 0 ]	1	[ 0 ]	intervention 1: 0.05, 0.2, 0.4 mg/kg, oral solution, single daily dose	intervention 1: candesartan cilexetil	13	Edegem \| Belgium \| Belgium \| 4.44504 \| 51.15662 Ghent \| Belgium \| Belgium \| 3.71667 \| 51.05 Strasbourg \| N/A \| France \| 7.74553 \| 48.58392 Erlangen \| N/A \| Germany \| 11.00783 \| 49.59099 Heidelberg \| N/A \| Germany \| 8.69079 \| 49.40768 Marburg \| N/A \| Germany \| 8.77069 \| 50.80904 Rostock \| N/A \| Germany \| 12.14049 \| 54.0887 Genova \| GE \| Italy \| 11.87211 \| 45.21604 Padua \| PD \| Italy \| 11.88586 \| 45.40797 Gda�sk \| N/A \| Poland \| N/A \| N/A Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Crimea \| N/A \| Ukraine \| N/A \| N/A Kyiv \| N/A \| Ukraine \| 30.5238 \| 50.45466	35	NCT00690612	1COMPLETED	2009-09-01	2007-09-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 3 ]	56	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this research study is to find out how well cetuximab works in treating NSCLC in patients who have been previously treated with a class of drug called tyrosine kinase inhibitor (TKI). Cetuximab is a protein that is designed to block a substance in cancer cells called "epidermal growth factor receptor" or EGFR. EGFR helps cancer cells grow.	* Participants on this study will receive cetuximab by infusion intravenously once per week and may continue to receive weekly cetuximab infusions until their disease progresses or they experience unacceptable side effects. * The following will be performed every 4 weeks while they are receiving study treatments: Physical examination; performance status; and blood work. A CT scan of the chest and upper abdomen will be performed every 8 weeks.	Non-small Cell Lung Cancer	cetuximab tyrosine kinase inhibitor	null	1	arm 1: 400mg/m2 IV x 1 and then 250mg/m2 IV weekly	[ 0 ]	1	[ 0 ]	intervention 1: Given intravenously once per week.	intervention 1: Cetuximab	3	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	18	NCT00694603	6TERMINATED	2009-09-01	2006-09-01	Lecia V. Sequist	7OTHER	false	false	false	null	0
[ 3 ]	60	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy variable of SREs (Skeletal Related Events) and to assess the safety in nasopharyngeal patients with bone metastases randomized to receive either zometa 4 mg or anti-neoplastic treatment alone.	null	Nasopharyngeal Cancer		null	2	arm 1: Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy. arm 2: Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.	[ 0, 4 ]	1	[ 0 ]	intervention 1: Zometa 4 mg IV infusion every 4 weeks for 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily	intervention 1: Zometa (zoledronic acid)	1	Guangzhou \| Guangdong \| China \| 113.25 \| 23.11667	59	NCT00697619	1COMPLETED	2009-09-01	2005-09-01	Sun Yat-sen University	7OTHER	false	false	false	null	0
[ 5 ]	42	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	Generalized anxiety disorder (GAD) is a very common disorder in the geriatric population with prevalence rates reaching 7% and even higher rates of 8% among elderly veterans. However, despite such high prevalence treating clinicians are presently forced to address treatment issues in this population without the guidance of scientific data. This proposal aims to begin to address this void. In light of emerging information regarding efficacy of the newer anti anxiety agents, specifically the selective serotonin reuptake inhibitors (SSRIs), in the treatment of young adult GAD patients it is time to prospectively evaluate the safety and efficacy of these medications in the treatment of elderly GAD patients. Therefore, this study will examine the effects and safety of the SSRI sertraline at different doses (50mg and 100mg per day) for older patients with GAD.	Generalized anxiety disorder (GAD) is a serious and distinct illness that occurs in significant numbers, affecting at least 7 million people in the United States alone. The prevalence of GAD is higher in the primary care setting with rates twice as high as the rates reported in community samples. GAD is a life-long disorder with low remission rates, resulting in high disability and morbidity. Of significance are emerging epidemiological data suggesting that GAD is highly prevalent in the geriatric population with prevalence rates ranging from 1.9% to 7.1% and accounting for the majority of anxiety disorder cases in this age group. More alarming is the fact that the presence of anxiety symptoms leads to considerable functional impairment, increased morbidity, and mortality among the affected elderly population, thus leading to increases in the costs of their care. However, despite advances made in GAD treatment in the adult population, no prospective data are presently available on the treatment of GAD in the elderly population, forcing clinicians to provide treatment without the guidance of scientific data. These findings are of particular relevance to the Veterans Affairs Health Care System where the average age of patients treated in primary care clinics is currently 60-64 years. The present application focuses on this target subpopulation of elderly veterans. This proposal aims to provide evidence-based guidelines for pharmacological management of elderly veterans suffering from generalized anxiety disorder. This will be accomplished by conducting a clinical trial in elderly veterans suffering from GAD by evaluating the efficacy and safety of sertraline - a proven anxiolytic compound widely used in the young adult population. We believe that this proposed study will be one of the first studies in this area. Thus, it may also serve as a first step in a future line of research aimed at developing comprehensive pharmacological and psychosocial interventions in the treatment of anxiety in the elderly. (b) HYPOTHESIS/RESEARCH QUESTIONS Study Hypothesis In a double-blind, placebo-controlled trial in elderly veterans diagnosed with GAD, sertraline will be more effective and equally safe as placebo in reducing symptoms of generalized anxiety disorder. Research Question Will the presence of differences in pharmacokinetics (PK) (i.e., mean population values of steady state plasma concentrations) and plasma levels of sertraline explain differences in efficacy and side effect profile between and within the two fixed sertraline doses studied, if detected? (c) SPECIFIC OBJECTIVE The objective of the proposed study is to conduct a multi-site, double-blind, placebo-controlled trial evaluating the efficacy and safety of sertraline at fixed doses vs. placebo in the treatment of GAD among elderly primary care outpatient veterans.	Generalized Anxiety Disorder	sertraline pharmacotherapy geriatric	null	3	arm 1: sertraline 50 mg daily arm 2: sertraline 100mg daily arm 3: placebo 50 or 100mg	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: 50 mg daily intervention 2: 100 mg daily intervention 3: 50mg or 100mg matching placebo	intervention 1: sertraline 50 mg daily intervention 2: sertraline 100 mg daily intervention 3: Placebo 50 or 100 mg	3	Tuscaloosa \| Alabama \| United States \| -87.56917 \| 33.20984 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632	42	NCT00701675	1COMPLETED	2009-09-01	2005-10-01	VA Office of Research and Development	1FED	false	false	false	null	0
[ 5 ]	311	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.	null	Asthma	Asthma	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 160/4.5 μg x 2 actuations twice daily (bid) intervention 2: inhalation powder 180 μg x 2 inhalations bid (PULMICORT)	intervention 1: Budesonide / formoterol fumarate (SYMBICORT) intervention 2: Budesonide	57	Pell City \| Alabama \| United States \| -86.28609 \| 33.58621 Bentonville \| Arkansas \| United States \| -94.20882 \| 36.37285 Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Malvern \| Arkansas \| United States \| -92.81295 \| 34.36231 Huntington Park \| California \| United States \| -118.22507 \| 33.98168 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angles \| California \| United States \| N/A \| N/A Orange \| California \| United States \| -117.85311 \| 33.78779 Rolling Hills Estates \| California \| United States \| -118.35813 \| 33.78779 Centennial \| Colorado \| United States \| -104.87692 \| 39.57916 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Waterbury \| Connecticut \| United States \| -73.0515 \| 41.55815 Inverness \| Florida \| United States \| -82.33037 \| 28.83582 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Ocala \| Florida \| United States \| -82.14009 \| 29.1872 Tallahassee \| Florida \| United States \| -84.28073 \| 30.43826 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Alpharetta \| Georgia \| United States \| -84.29409 \| 34.07538 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Lawrenceville \| Georgia \| United States \| -83.98796 \| 33.95621 Lithia Springs \| Georgia \| United States \| -84.66049 \| 33.794 Lovejoy \| Georgia \| United States \| -84.31437 \| 33.43622 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Hagerstown \| Maryland \| United States \| -77.71999 \| 39.64176 Lanham \| Maryland \| United States \| -76.8634 \| 38.96875 Largo \| Maryland \| United States \| -76.83025 \| 38.89761 Towson \| Maryland \| United States \| -76.60191 \| 39.4015 Flint \| Michigan \| United States \| -83.68746 \| 43.01253 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Skillman \| New Jersey \| United States \| -74.7146 \| 40.42011 New York \| New York \| United States \| -74.00597 \| 40.71427 North Syracuse \| New York \| United States \| -76.12992 \| 43.13479 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Greenville \| North Carolina \| United States \| -77.36635 \| 35.61266 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Blue Bell \| Pennsylvania \| United States \| -75.26629 \| 40.15233 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Spartanburg \| South Carolina \| United States \| -81.93205 \| 34.94957 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Arlington \| Texas \| United States \| -97.10807 \| 32.73569 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541 Houston \| Texas \| United States \| -95.36327 \| 29.76328 McKinney \| Texas \| United States \| -96.61527 \| 33.19762 Plano \| Texas \| United States \| -96.69889 \| 33.01984 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Waco \| Texas \| United States \| -97.14667 \| 31.54933 Emporia \| Virginia \| United States \| -77.54248 \| 36.68598 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Virginia Beach \| Virginia \| United States \| -75.97799 \| 36.85293 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389	311	NCT00702325	1COMPLETED	2009-09-01	2008-06-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 4 ]	34	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a decongestant, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue.	The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a decongestant, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue. We studied patients treated with placebo compared to FDA approved dose of pseudoephedrine and assessed sleep, QOL and daytime sleepiness.	Rhinitis Sleep	Sleep, Pseudoephedrine	null	2	arm 1: Placebo arm 2: Pseudoephedrine is a 240 mg PO per day	[ 2, 1 ]	1	[ 0 ]	intervention 1: Pseudoephedrine is a 240 mg PO per day	intervention 1: Pseudoephedrine	1	Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592	0	NCT00704496	1COMPLETED	2009-09-01	2007-06-01	Milton S. Hershey Medical Center	7OTHER	false	false	false	null	0
[ 5 ]	50	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	false	This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.	This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.	Constipation	constipation laxative lactulose Kristalose®	null	2	arm 1: Kristalose®, as prescribed, for 7 days. arm 2: Liquid lactulose, as prescribed, for 7 days.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Crystals to be dissolved in water and taken as prescribed. intervention 2: Liquid to be taken as prescribed.	intervention 1: lactulose (Kristalose®) intervention 2: liquid lactulose	3	Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	100	NCT00712543	1COMPLETED	2009-09-01	2009-06-01	Cumberland Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 2 ]	8	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	true	More people worldwide use amphetamine-type stimulants than any illicit drug besides cannabis, and methamphetamine (MA) abuse and dependence is the fastest growing drug problem in the United States. Much work remains in identifying an effective pharmacotherapy for MA dependence. The neurobiological actions produced by MA involve dopamine (DA), serotonin, and norepinephrine, but also include alterations to cholinergic neurotransmitter systems. Candidate compounds that target acetylcholine (ACh) are attractive options for development that have not received adequate attention. Varenicline is a drug that increases the release of DA in the brain and it is logical to assume that it would to some extent compensate for the reduction in these neurotransmitters that occurs in MA withdrawal. Current research has linked certain genes that are related to neurotransmitters with drug abuse and memory impairment (e.g., A1 allele for the D2 dopamine receptor and catechol-O-methyltransferase). We will take blood samples and test for these genes in order to relate the findings to brain function. This is a double-blind, placebo-controlled, within-subjects study to determine the safety and tolerability of MA in MA-dependent volunteers treated with varenicline and placebo.	Study Procedures: Study participants are those who meet criteria for MA dependence, who are not seeking treatment, and who also meet criteria for nicotine dependence. Participants will be asked to wear a telemetry device during screening and throughout the study that records heart rate and body temperature. Participants will be required to refrain from smoking at certain times, illicit and prescription drug use for the duration of the study and this will be confirmed with daily urine testing. The study consists of 30 days or less of outpatient screening. The 2-component inpatient portion of the study lasts a total of 18 days. Participants will be admitted to the GCRC at UCLA for Days 1-10. After the first study day, participants will be randomized to varenicline or matched placebo for 9-days and then discharged from the GCRC. Then, after 2-4 weeks, the same subjects return to the GCRC to be switched to the alternate condition (placebo or varenicline) for the second component of the study, which lasts another 8-days. Each subject is randomized to both varenicline and placebo, so total time commitment is 18 inpatient study days. One follow-up visit is scheduled 2 weeks after completion of both study phases for assessment of delayed adverse events and for final payment. On the first day of the inpatient procedure, subjects received 10 3mg infusions of methamphetamine over 2.5 hours for assessment of drug tolerability. On day 9 of the first component and day 7 of the second component, subjects received either 10 3mg infusions of saline OR methamphetamine over 2.5 hours. In the afternoon, the infusion was the opposite of the morning condition.	Methamphetamine Addiction Crystal Meth Addiction Amphetamine Addiction	methamphetamine varenicline Chantix stimulant crystal meth	null	2	arm 1: Sugar pill (placebo) drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition. arm 2: Varenicline dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: Subjects receive MA infusions on certain days first under varenicline (10 days) then under placebo (8 days) after a 14-24 day washout in order to determine study medication safety and tolerability intervention 2: Subjects receive MA infusions on certain days first under placebo (10 days) then under varenicline(8 days) after a 14-28 day washout in order to determine study medication safety and tolerability	intervention 1: Varenicline, then placebo intervention 2: Placebo, then varenicline	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	16	NCT00713479	1COMPLETED	2009-09-01	2008-07-01	University of California, Los Angeles	7OTHER	false	false	false	null	0
[ 2 ]	41	null	null	0TREATMENT	null	false	0ALL	null	The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters. Secondary objectives are the collection of further safety data (vital signs), efficacy data and the determination of pharmacokinetic characteristics during long-term therapy with BIBF 1120.	null	Neoplasms		null	0	null	null	1	[ 0 ]	intervention 1: None	intervention 1: BIBF 1120	11	Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 Clichy \| N/A \| France \| 2.30952 \| 48.90018 Clichy \| N/A \| France \| 2.30952 \| 48.90018 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| France \| 2.3488 \| 48.85341 Freiburg/Breisgau \| N/A \| Germany \| N/A \| N/A Großhansdorf \| N/A \| Germany \| 10.28333 \| 53.66667 Tübingen \| N/A \| Germany \| 9.05222 \| 48.52266 Wiesbaden \| N/A \| Germany \| 8.24932 \| 50.08258	41	NCT00715403	1COMPLETED	2009-09-01	2004-10-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 0 ]	1,931	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	true	0ALL	false	Background: In developing countries, many babies are born at home and the umbilical cord commonly becomes infected during the first week after birth, and can be deadly. Cleansing of the cord with a low-cost antiseptic like chlorhexidine may reduce the risk of these infections. Little is known, however, about the frequency of chlorhexidine cleansing needed to impact upon the overall presence of bacteria on the stump, or regarding the changes in bacteria during the first week of life when most cord infections occur. Objectives: We will describe the profile of bacteria colonizing the umbilical cord stump of infants in rural Bangladesh and examine the role of topical chlorhexidine in altering colonization and progress of infection. We will compare the overall and bacteria-specific rate of colonization of the cord stump between infants receiving chlorhexidine cleansing of their cord through the first day or first week of life. We will also quantify the relationship between colonization of the cord stump with specific pathogens and the presence and severity of signs of umbilical cord infection (pus, redness, swelling) among these newborns. Potential Impact: More information is needed on the impact of single versus repeated applications of chlorhexidine to the cord stump, as the number of cleansing may substantially influence the feasibility of widespread scale-up in many populations. The data generated from this proposed study will guide the most appropriate design of this simple intervention and will help inform specific treatment protocols for effective management of infants with signs of umbilical cord infections.	null	Infection	chlorhexidine umbilical cord	null	3	arm 1: Chlorhexidine cleansing of the cord for seven days arm 2: Chlorhexidine cleansing of the cord for 1 day arm 3: Dry cord care, as recommended by WHO	[ 0, 0, 2 ]	2	[ 0, 5 ]	intervention 1: Solution (4.0%, 7.1% CHX-D) intervention 2: Educational messages regarding clean cord care	intervention 1: Chlorhexidine 4.0% intervention 2: Dry Cord Care	3	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Sylhet \| Sylhet Division \| Bangladesh \| 91.87198 \| 24.89904 Dhaka \| N/A \| Bangladesh \| 90.40744 \| 23.7104	1,923	NCT00719329	1COMPLETED	2009-09-01	2008-08-01	Johns Hopkins Bloomberg School of Public Health	7OTHER	false	false	false	null	0
[ 4 ]	637	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms.	null	Non-Constipation Irritable Bowel Syndrome	Diarrhea Rifaximin IBS Abdominal pain Bloating	null	2	arm 1: Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period. arm 2: Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Rifaximin intervention 2: Placebo	88	Anniston \| Alabama \| United States \| -85.83163 \| 33.65983 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Carmichael \| California \| United States \| -121.32828 \| 38.61713 Chula Vista \| California \| United States \| -117.0842 \| 32.64005 Concord \| California \| United States \| -122.03107 \| 37.97798 Garden Grove \| California \| United States \| -117.94145 \| 33.77391 Laguna Hills \| California \| United States \| -117.71283 \| 33.61252 Lakewood \| California \| United States \| -118.13396 \| 33.85363 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Monterey \| California \| United States \| -121.89468 \| 36.60024 Orange \| California \| United States \| -117.85311 \| 33.78779 Roseville \| California \| United States \| -121.28801 \| 38.75212 San Carlos \| California \| United States \| -122.26052 \| 37.50716 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Bristol \| Connecticut \| United States \| -72.94927 \| 41.67176 Hamden \| Connecticut \| United States \| -72.89677 \| 41.39593 Newark \| Delaware \| United States \| -75.74966 \| 39.68372 Boca Raton \| Florida \| United States \| -80.0831 \| 26.35869 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 Largo \| Florida \| United States \| -82.78842 \| 27.90979 New Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 New Smyrna Beach \| Florida \| United States \| -80.927 \| 29.02582 Port Orange \| Florida \| United States \| -80.99561 \| 29.13832 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Zephyrhills \| Florida \| United States \| -82.18119 \| 28.23362 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Macon \| Georgia \| United States \| -83.6324 \| 32.84069 Elkhart \| Indiana \| United States \| -85.97667 \| 41.68199 Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417 Topeka \| Kansas \| United States \| -95.67804 \| 39.04833 Bowling Green \| Kentucky \| United States \| -86.4436 \| 36.99032 Metairie \| Louisiana \| United States \| -90.15285 \| 29.98409 Monroe \| Louisiana \| United States \| -92.1193 \| 32.50931 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Elkridge \| Maryland \| United States \| -76.71358 \| 39.21261 Wellesley \| Massachusetts \| United States \| -71.29256 \| 42.29649 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Troy \| Michigan \| United States \| -83.14993 \| 42.60559 Wyoming \| Michigan \| United States \| -85.70531 \| 42.91336 Mexico \| Missouri \| United States \| -91.88295 \| 39.16976 Sicklerville \| New Jersey \| United States \| -74.96933 \| 39.71734 Voorhees Township \| New Jersey \| United States \| -74.49062 \| 40.4795 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Great Neck \| New York \| United States \| -73.72846 \| 40.80066 Mineola \| New York \| United States \| -73.64068 \| 40.74927 New York \| New York \| United States \| -74.00597 \| 40.71427 North Massapequa \| New York \| United States \| -73.46207 \| 40.70093 Pomona \| New York \| United States \| -74.0432 \| 41.16704 Stony Brook \| New York \| United States \| -73.14094 \| 40.92565 Boone \| North Carolina \| United States \| -81.67455 \| 36.21679 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 Greensboro \| North Carolina \| United States \| -79.79198 \| 36.07264 New Bern \| North Carolina \| United States \| -77.04411 \| 35.10849 Wilmington \| North Carolina \| United States \| -77.94604 \| 34.23556 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Canton \| Ohio \| United States \| -81.37845 \| 40.79895 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Downingtown \| Pennsylvania \| United States \| -75.70327 \| 40.0065 Newtown \| Pennsylvania \| United States \| -74.93683 \| 40.22928 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Sayre \| Pennsylvania \| United States \| -76.5155 \| 41.97896 Anderson \| South Carolina \| United States \| -82.65013 \| 34.50344 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Bristol \| Tennessee \| United States \| -82.18874 \| 36.59511 Chattanooga \| Tennessee \| United States \| -85.30968 \| 35.04563 Franklin \| Tennessee \| United States \| -86.86889 \| 35.92506 Germantown \| Tennessee \| United States \| -89.81009 \| 35.08676 Jackson \| Tennessee \| United States \| -88.81395 \| 35.61452 Kingsport \| Tennessee \| United States \| -82.56182 \| 36.54843 El Paso \| Texas \| United States \| -106.48693 \| 31.75872 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Lewisville \| Texas \| United States \| -96.99417 \| 33.04623 Plano \| Texas \| United States \| -96.69889 \| 33.01984 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Burlington \| Vermont \| United States \| -73.21207 \| 44.47588 Chesapeake \| Virginia \| United States \| -76.27494 \| 36.81904 Fairfax \| Virginia \| United States \| -77.30637 \| 38.84622 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389	635	NCT00724126	1COMPLETED	2009-09-01	2008-07-01	Bausch Health Americas, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	623	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms.	null	Non-Constipation Irritable Bowel Syndrome	IBS Abdominal pain Bloating Diarrhea Rifaximin	null	2	arm 1: Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period. arm 2: Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Rifaximin intervention 2: Placebo	96	Hueytown \| Alabama \| United States \| -86.99666 \| 33.45122 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Sierra Vista \| Arizona \| United States \| -110.30369 \| 31.55454 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Sherwood \| Arkansas \| United States \| -92.22432 \| 34.81509 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Lancaster \| California \| United States \| -118.13674 \| 34.69804 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Murrieta \| California \| United States \| -117.21392 \| 33.55391 San Diego \| California \| United States \| -117.16472 \| 32.71571 Lakewood \| Colorado \| United States \| -105.08137 \| 39.70471 Bridgeport \| Connecticut \| United States \| -73.18945 \| 41.17923 Torrington \| Connecticut \| United States \| -73.12122 \| 41.80065 Altamonte Springs \| Florida \| United States \| -81.36562 \| 28.66111 Boynton Beach \| Florida \| United States \| -80.06643 \| 26.52535 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 Jupiter \| Florida \| United States \| -80.09421 \| 26.93422 Lauderdale Lakes \| Florida \| United States \| -80.20838 \| 26.16647 Maitland \| Florida \| United States \| -81.36312 \| 28.62778 Naples \| Florida \| United States \| -81.79596 \| 26.14234 New Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Winter Garden \| Florida \| United States \| -81.58618 \| 28.56528 Winter Park \| Florida \| United States \| -81.33924 \| 28.6 Topeka \| Kansas \| United States \| -95.67804 \| 39.04833 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Hagerstown \| Maryland \| United States \| -77.71999 \| 39.64176 Silver Spring \| Maryland \| United States \| -77.02609 \| 38.99067 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Paw Paw \| Michigan \| United States \| -85.89112 \| 42.21782 Jackson \| Mississippi \| United States \| -90.18481 \| 32.29876 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Lebanon \| New Hampshire \| United States \| -72.25176 \| 43.64229 Elizabeth \| New Jersey \| United States \| -74.2107 \| 40.66399 Lumberton \| New Jersey \| United States \| -74.80516 \| 39.96595 Bayside \| New York \| United States \| -73.77708 \| 40.76844 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 New York \| New York \| United States \| -74.00597 \| 40.71427 Troy \| New York \| United States \| -73.69179 \| 42.72841 Asheboro \| North Carolina \| United States \| -79.81364 \| 35.70791 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 Greensboro \| North Carolina \| United States \| -79.79198 \| 36.07264 High Point \| North Carolina \| United States \| -80.00532 \| 35.95569 Mooresville \| North Carolina \| United States \| -80.81007 \| 35.58486 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Salisbury \| North Carolina \| United States \| -80.47423 \| 35.67097 Wilmington \| North Carolina \| United States \| -77.94604 \| 34.23556 Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Zanesville \| Ohio \| United States \| -82.01319 \| 39.94035 Tulsa \| Oklahoma \| United States \| -95.99277 \| 36.15398 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Lancaster \| Pennsylvania \| United States \| -76.30551 \| 40.03788 Germantown \| Tennessee \| United States \| -89.81009 \| 35.08676 Jackson \| Tennessee \| United States \| -88.81395 \| 35.61452 Johnson City \| Tennessee \| United States \| -82.35347 \| 36.31344 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Pasadena \| Texas \| United States \| -95.2091 \| 29.69106 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Tyler \| Texas \| United States \| -95.30106 \| 32.35126 Ogden \| Utah \| United States \| -111.97383 \| 41.223 West Jordan \| Utah \| United States \| -111.9391 \| 40.60967 Chesapeake \| Virginia \| United States \| -76.27494 \| 36.81904 Lynchburg \| Virginia \| United States \| -79.14225 \| 37.41375 Bellevue \| Washington \| United States \| -122.20068 \| 47.61038 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 West Bend \| Wisconsin \| United States \| -88.18343 \| 43.42528 St. John's \| Newfoundland and Labrador \| Canada \| -52.70931 \| 47.56494 Corunna \| Ontario \| Canada \| -82.43313 \| 42.88338 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 London \| Ontario \| Canada \| -81.23304 \| 42.98339 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Newmarket \| Ontario \| Canada \| -79.46631 \| 44.05011 Niagara Falls \| Ontario \| Canada \| -79.06627 \| 43.10012 Sarnia \| Ontario \| Canada \| -82.40407 \| 42.97866	623	NCT00731679	1COMPLETED	2009-09-01	2008-07-01	Bausch Health Americas, Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	42	NA	SINGLE_GROUP	7BASIC_SCIENCE	1SINGLE	false	0ALL	true	This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension, over a period of approximately 6-8 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.	This is a single-blind study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension over a period of approximately 6 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study. The study will consist of periods detailed below: Screening and Washout. Subjects will be screened up to four weeks prior to baseline. The washout period will be 3 days for most ADHD stimulant medication (the half life is around 3-5 hours and the washout is at least 5 half-lives in duration). Other medication will be discussed during the visit. The Screening Visit will occur at the UCI Child Development Center and will allow for the determination of appropriateness of each subject's inclusion into the study. The Principal Investigator or his/her designee must obtain written signed and dated consent for the subject to participate in the study from the subject's parent(s)/legally authorized representative and assent must be given by the subject, prior to any study related procedures being performed. This visit is expected to last 3-4 hours and may take place across more than one day. The following procedures will be conducted during the Screening Visit: * Informed Consent/Assent obtained * Psychiatric evaluation that utilizes the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL) and according to DSM-IV-TR™ criteria * Inclusion/Exclusion criteria confirmed * Demographics collected * Medical and Medication History * Physical Examination including height (using a calibrated stadiometer), weight (using a calibrated scale) * Sitting Vital Signs after 5 minutes of rest (oral or tympanic temperature, pulse, blood pressure, and respiratory rate) * 12-Lead ECG after 5 minutes of rest * Kaufman Brief Intelligence Test 2 (KBIT2): used to assess both verbal and non-verbal cognitive ability. * Concomitant Medications reviewed * Adverse Events reviewed In addition, the subject will be asked to give a small blood sample, for safety screening purposes, for laboratory procedures (approximately 2 teaspoons).The following lab procedures will be performed: * Hematology with complete blood count (CBC) * Serum Chemistry * Urinalysis and microscopic examination (if protein and/or blood are detected during urinalysis) * Serum Pregnancy Test for all FOCP - A negative serum pregnancy test must be documented for inclusion into this study * Urine drug test Baseline Procedures. After all Screening and washout procedures have been completed, subjects will return to the site for the Baseline Visit, which will last approximately 5-6 hours. Subjects will be provided with a one-week supply of VyvanseTM 30mg/day. Subjects will begin treatment the morning of the baseline visit and continue on the same dose for the next week. The first dose of medication will be administered on site and subsequent dosing will be given to the subject's parent(s)/legally authorized representative who will be required to administer study drug to the subject upon awakening. During the visit subjects will perform the Attention Task while the NIRS is recording and they will also be given the Gray's Oral Reading Test before the medication is administered. After the medication is administered the subject will stay on site until the second NIRS measurement can be taken a second time. They will be provided food and activities during the waiting period. The following procedures will be conducted during the Baseline Visit: * Confirmation of continued eligibility (i.e., with respect to inclusion/exclusion criteria and medication history) * Sitting Vital Signs (oral or tympanic temperature, pulse, blood pressure and respiratory rate) * Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv): The primary efficacy measure, used to assess the 18 symptoms of ADHD. * Clinical Global Impressions Severity scale (CGI-S): This measure is used to assess the severity of the subject's symptoms. * Concomitant Medications will be reviewed with the subject. * Adverse Events * Medication administered on-site * Near Infrared Spectroscopy and Attention Task performed twice, once at before medication and again 3-4 hours after first exposure to medication. * Administer the Gray Oral Reading Test-4 (GORT-4), which used to test oral reading rate, accuracy, fluency, and comprehension, before exposure to medication. * Distribute Open-Label Study Drug - A one-week supply of VyvanseTM 30mg capsules will be dispensed, including the dose administered on site. Dose Optimization. During the dose optimization period, subjects will visit the office once per week so that the study doctor can determine if the subject is tolerating the study medication and if she/he is seeing any benefit. These visits will last approximately 45 minutes. The Investigator will review AEs, ADHD-RS-IV, and CGI-I scores, and use clinical judgment to ensure that subjects are titrated to an acceptable dose of VyvanseTM for evaluation. The following procedures will be conducted at each dose optimization visit: * Sitting Vital Signs (oral or tympanic temperature, pulse, blood pressure and respiratory rate) * Subject Weight (using a calibrated scale) * Investigator Dose Assessment * ADHD-RS-IV * Clinical Global Impressions Improvement Scale (CGI-I). * Study Drug Accountability and Compliance Assessment Performed * Distribute Open-Label Study Drug * Concomitant Medications * Adverse Events Dose Optimized NIRS and GORT Testing This visit will be similar to the baseline visit. Subjects will arrive early in the morning and medication will be administered on-site. They will remain on site for the next 4 hours so that the dose will be at peak effect before administering the GORT or NIRS. The following procedures will happen during this visit: * Sitting Vital Signs after 5 minutes of rest (oral and tympanic temperature, pulse, blood pressure and respiratory rate) * Subject weight (using a calibrated scale) * An electrocardiogram will be performed. * Serum Pregnancy Test for all FOCP - A negative serum pregnancy test must be documented for the end of the study. * ADHD-RS-IV * CGI-I * Study Drug Accountability and Compliance Assessment Performed * Concomitant Medications * Adverse Events * Medication administered on-site * Near Infrared Spectroscopy and Attention Task performed once. * Administer the Gray's Oral Reading Test. * Physical examination including height (using a calibrated stadiometer) * 12 Lead ECG 30-day Follow-up Phone Call	Attention Deficit/Hyperactivity Disorder	Attention Deficit Hyperactivity Disorder ADHD ADD reading brain hemodynamics brain imaging attention Near-Infrared Spectroscopy NIRS MSIT	null	1	arm 1: All subjects were tested at baseline before medication and then titrated to best dose and retested on Vyvanse Medication.	[ 0 ]	1	[ 0 ]	intervention 1: Subjects will participate in an open-label dose optimization period and successful titration to an optimal dose of Vyvanse™, subjects will take their optimized dose of Vyvanse™ (30, 50 or 70 mg/day) during the week leading up to their final visit. During the study subjects will take their prescribed dose once a day in the morning with breakfast.	intervention 1: Vyvanse	1	Irvine \| California \| United States \| -117.82311 \| 33.66946	26	NCT00733356	1COMPLETED	2009-09-01	2008-07-01	Kimberley Lakes	7OTHER	false	false	false	null	0
[ 4 ]	378	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	2MALE	false	The primary purpose of the study is to help answer whether tadalafil taken once a day can help improve the psychological outcomes (such as sexual self confidence, spontaneity and time concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).	null	Erectile Dysfunction		null	6	arm 1: Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks arm 2: Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks arm 3: Sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks arm 4: Sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks arm 5: Tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks arm 6: Tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks	[ 0, 0, 0, 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 5 mg tablet taken once a day (OaD) by mouth for 8 weeks intervention 2: 100 mg tablet taken as needed (PRN) by mouth for 8 weeks intervention 3: 20 mg tablet taken as needed (PRN) by mouth for 8 weeks	intervention 1: tadalafil once a day [T(OaD)] intervention 2: sildenafil citrate as needed [S(PRN)] intervention 3: tadalafil as needed [T(PRN)]	37	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Newport Beach \| California \| United States \| -117.92895 \| 33.61891 Middlebury \| Connecticut \| United States \| -73.12761 \| 41.52787 Plantation \| Florida \| United States \| -80.23184 \| 26.13421 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Federal Way \| Washington \| United States \| -122.31262 \| 47.32232 Adelaide \| South Australia \| Australia \| 138.59863 \| -34.92866 Malvern \| Victoria \| Australia \| 145.02811 \| -37.86259 Nedlands \| Western Australia \| Australia \| 115.8073 \| -31.98184 Goiânia \| N/A \| Brazil \| -49.25389 \| -16.67861 Rio Claro \| N/A \| Brazil \| -47.56139 \| -22.41139 Rio de Janeiro \| N/A \| Brazil \| -43.18223 \| -22.90642 Sao Jose Rio Preto \| N/A \| Brazil \| N/A \| N/A São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 Augsburg \| N/A \| Germany \| 10.89851 \| 48.37154 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Milan \| N/A \| Italy \| 9.18951 \| 45.46427 Sassari \| N/A \| Italy \| 8.55552 \| 40.72586 Torino \| N/A \| Italy \| 11.99138 \| 44.88856 La Joya \| N/A \| Mexico \| -117.00371 \| 32.44363 Mexico City \| N/A \| Mexico \| -99.12766 \| 19.42847 Monterrey \| N/A \| Mexico \| -100.31721 \| 25.68435 San Juan \| N/A \| Puerto Rico \| -66.10572 \| 18.46633 Santurce \| N/A \| Puerto Rico \| -67.14018 \| 18.19523 A Coruña \| N/A \| Spain \| -8.396 \| 43.37135 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Málaga \| N/A \| Spain \| -4.42034 \| 36.72016 Seville \| N/A \| Spain \| -5.97317 \| 37.38283 Vigo \| N/A \| Spain \| -8.72264 \| 42.23282 Durham \| County Durham \| United Kingdom \| -1.57566 \| 54.77676 Plymouth \| Devonshire \| United Kingdom \| -4.14305 \| 50.37153 Lichfield \| Staffordshire \| United Kingdom \| -1.82549 \| 52.68154 Leeds \| West Yorkshire \| United Kingdom \| -1.54785 \| 53.79648 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	1,134	NCT00734604	1COMPLETED	2009-09-01	2008-08-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 3 ]	23	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	2DOUBLE	true	0ALL	false	In heavy marijuana smokers, opioid receptor blockade increases the subjective and cardiovascular effects of marijuana. The current study was designed to clarify opioid-cannabinoid interactions by assessing how naltrexone shifts the dose-response function for marijuana-elicited effects in heavy marijuana smokers. For this within-subject, double-blind study, a marijuana smoking procedure was designed to characterize a dose-response relationship for marijuana's subjective and cardiovascular effects under blinded conditions.	null	Marijuana Smoking	naltrexone smoked marijuana marijuana use	null	6	arm 1: Placebo naltrexone capsules (0mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order. arm 2: Placebo naltrexone capsules (0mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order. arm 3: Placebo naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order. arm 4: Naltrexone capsules (12mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order. arm 5: Naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order. arm 6: Naltrexone capsules (12mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.	[ 2, 2, 2, 0, 0, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Marijuana cigarette containing 0% THC intervention 2: Marijuana cigarette containing 5.5% THC intervention 3: Marijuana cigarette containing 6.2% THC intervention 4: Naltrexone (12mg/70kg) intervention 5: Naltrexone (0mg)	intervention 1: Inactive Marijuana (0% THC) intervention 2: Active Marijuana (5.5% THC) intervention 3: Active Marijuana (6.2% THC) intervention 4: Naltrexone intervention 5: Placebo naltrexone	1	New York \| New York \| United States \| -74.00597 \| 40.71427	138	NCT00743145	1COMPLETED	2009-09-01	2008-05-01	New York State Psychiatric Institute	7OTHER	false	false	false	null	0
[ 4 ]	115	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	1FEMALE	true	The purpose of this study is to determine whether combination oral contraceptive pill of norethindrone and ethinyl estradiol is effective in the treatment of primary dysmenorrhea.	null	Dysmenorrhea		null	2	arm 1: ethinyl estradiol 0.035mg and norethisterone 1mg arm 2: Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: ethinyl estradiol 0.035mg and norethisterone 1mg intervention 2: Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg	intervention 1: IKH-01 intervention 2: Placebo	0	null	112	NCT00746096	1COMPLETED	2009-09-01	2008-09-01	Nobelpharma	4INDUSTRY	false	false	false	null	0
[ 0 ]	42	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	false	There are many ways to perform a suprapubic approach pubovaginal sling. Some surgeons inject local pain medical into the retropubic space before placing the sling, others do not. This study is to determine if injection of local pain medication into the retropubic space before placing a mid-urethral sling for urinary stress incontinence results in lower postoperative pain scores, lower use of postoperative narcotic medication and lower rates of urinary retention.	To evaluate if an injection in the retropubic space with a local acting anesthetic, Marcaine, (bupivacaine) at the time of mid-urethral sling placement will improve patients' reported post operative pain and decrease the use of narcotic pain medication. This study will include all female patients age 18 and older who will undergo a mid-urethral sling with or without anterior repair for the treatment of urinary stress incontinence by a member of the Division of Urogynecology and Reconstructive Pelvic Surgery who consent to be in the study. Once patients have consented to participate in the study they will be randomized into two groups. One group will have the mid-urethral sling placed in the usual fashion with no injection of local anesthetic. The other group will have the mid-urethral sling placed after the retropubic space has been infiltrated with local anesthetic as previously described in the literature. Pain will be assessed with the use of a Visual Analog Scale during the hospitalization and the use of narcotic pain medication will be assessed during recovery and overnight in the hospital. Patients will be asked to record how often and what type of pain medication they use. Patients will also be asked to keep a log of their urination if they are discharged home with self catheterization. They will be asked to mail in their pain medication log and voiding diary (if needed) at a two-week post-operative. Outcomes will then be compared.	Stress Urinary Incontinence	mid-urethral sling pubovaginal sling postoperative pain visual analog scale suprapubic approach SPARC sling	null	2	arm 1: Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach. arm 2: Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.	[ 0, 4 ]	1	[ 0 ]	intervention 1: Patients randomized to the intervention arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.	intervention 1: 0.125% Marcaine	1	Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132	42	NCT00746863	1COMPLETED	2009-09-01	2007-01-01	University of North Carolina, Chapel Hill	7OTHER	false	false	false	null	0
[ 3, 4 ]	15	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	4QUADRUPLE	true	0ALL	false	The purpose of this study is to figure out how decreasing the activity of 11-beta hydroxysteroid dehydrogenase (11-beta HSD) will affect your blood vessel function. 11-beta HSD, which is found in the kidneys and blood vessels, is a natural protein that when active helps to keep your blood pressure under control.	This study intends to determine whether activation of mineralocorticoid receptors affects vascular function. Vascular function relies on two components of the blood vessel: the inner lining (endothelium) and the vascular smooth muscle. In specific aim 1, we seek to determine if that inhibition of the enzyme 11-beta hydroxysteroid dehydrogenase (11-beta-HSD) will impair endothelium-dependent vasodilation and/or vascular smooth muscle function. The syndrome of apparent mineralocorticoid excess (AME) is a rare disorder identified in approximately 50 individuals characterized by low-aldosterone hypertension, associated with low renin and hypokalemia These subjects avidly retain salt and water, have suppression of both plasma renin and aldosterone levels, but clinically appear as though they have a state of mineralocorticoid excess. A detailed series of investigations has elucidated the cause of this syndrome: severe attenuation of the enzyme 11 beta-hydroxysteroid dehydrogenase (11-beta-HSD). 11-beta-HSD converts cortisol, able to activate mineralocorticoid receptors to cortisone, which cannot. This abnormality can be identified by measuring an abnormal ratio of urinary breakdown products of cortisol and cortisone. Subjects with AME have a high ratio indicative of elevated cortisol concentrations. Although classical AME is a rare syndrome with a specific recessive inheritance, several other mutations have been identified which cause a varying severity of disease. Recent evidence has suggested mild abnormalities in this pathway may be much more common. In fact two studies have demonstrated that subjects with essential hypertension had greater levels of cortisol/cortisone urinary levels than matched controls. Thus, mild abnormalities of this enzyme may be an important contributor to a segment of patients with high blood pressure. Further, this is the pathway by which consumption of excess black licorice causes hypertension. Black licorice contains glycyrrhizic acid that selectively inhibits 11 beta-HSD. Glycyrrhizic acid is used as a dietary sweetener and sold in "health-food" stores and may also play a epidemiological role in hypertension. Analogous to the renin-angiotensin system, 11-beta-HSD is not only found in the kidneys, but is found in both vascular endothelial (inner lining) and smooth muscle cells. Hypertension, similar to other risk factors for cardiovascular disease impairs vascular function. One of its major effects is decreasing the bioavailability of endothelium-derived nitric oxide. Nitric oxide contributes importantly to vascular homeostasis by modulating vascular tone, inhibiting both platelet aggregation and coagulation, and inhibition translocation of leukocytes into the vascular wall. Further, patients with hypertension have increased endothelin-1 production and receptor activation. Endothelin-1 antagonizes the beneficial activities of nitric oxide. Experimentally, inactivation of 11 beta-HSD in a rat model has been demonstrated to cause hypertension, increase endothelin receptor A activation and decrease bioavailability of endothelium-derived nitric oxide. Inhibition of mineralocorticoid receptors in this model prevents impairment of vascular function. Thus, in animal models, abnormalities in this pathway may not only cause hypertension, but create an environment favorable to the development and progression of atherosclerosis. Further, recent evidence suggests that activation of this pathway contributes importantly to the morbidity and mortality in patients with congestive heart failure. A large, randomized study demonstrated that a small dose of a mineralocorticoid inhibitor, spironolactone, substantially reduced morbidity and mortality in patients with severe heart failure. Experimentally, spironolactone improved vascular function in patients with congestive heart failure. Therefore, we seek to characterize the vascular effects of this pathway in humans. This submission involves one protocol: 1) to determine if reversible inhibition of 11 beta-HSD decreases the bioavailability of endothelium-derived nitric oxide and impairs vascular smooth muscle function.	Apparent Mineralocorticoid Excess (AME)		null	2	arm 1: Glycyrrhetic Acid arm 2: Placebo	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 130 mg daily for fourteen days intervention 2: Placebo daily for fourteen days	intervention 1: Glycyrrhetic Acid intervention 2: Placebo	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	15	NCT00759525	1COMPLETED	2009-09-01	2002-02-01	Brigham and Women's Hospital	7OTHER	false	false	false	null	0
[ 4 ]	705	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.	null	Open-angle Glaucoma Ocular Hypertension	Open-angle glaucoma ocular hypertension	null	2	arm 1: One drop self-administered in the study eye(s) once daily for 90 days arm 2: One drop self-administered in the study eye(s) once daily for 90 days	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as travoprost. intervention 2: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as latanoprost.	intervention 1: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) intervention 2: Latanoprost ophthalmic solution 0.005% (XALATAN®)	0	null	701	NCT00761319	1COMPLETED	2009-09-01	2008-10-01	Alcon Research	4INDUSTRY	false	false	false	null	0
[ 4 ]	1,315	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris	A multicenter, randomized, double-blind, comparator and vehicle-controlled study in subjects with acne vulgaris. Approximately 1320 subjects will be enrolled. Subjects will be randomized to 1 of 4 parallel study groups in a 1:1:1:1 ratio (clindamycin / benzoyl peroxide gel:clindamycin gel:BPO gel:vehicle gel).	Acne Vulgaris	Acne Vulgaris Acne	null	4	arm 1: clindamycin / benzoyl peroxide gel arm 2: Clindamycin gel arm 3: BPO gel arm 4: vehicle gel	[ 0, 1, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Once a day application to the face intervention 2: Once a day application to the face intervention 3: Once a day application to the face intervention 4: Once a day application to the face	intervention 1: clindamycin / benzoyl peroxide gel intervention 2: clindamycin gel intervention 3: BPO gel intervention 4: vehicle gel	24	San Diego \| California \| United States \| -117.16472 \| 32.71571 Santa Monica \| California \| United States \| -118.49138 \| 34.01949 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Boca Raton \| Florida \| United States \| -80.0831 \| 26.35869 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami Beach \| Florida \| United States \| -80.13005 \| 25.79065 Alpharetta \| Georgia \| United States \| -84.29409 \| 34.07538 Lincolnshire \| Illinois \| United States \| -87.9084 \| 42.19002 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Troy \| Michigan \| United States \| -83.14993 \| 42.60559 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Stony Brook \| New York \| United States \| -73.14094 \| 40.92565 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Arlington \| Texas \| United States \| -97.10807 \| 32.73569 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Belize City \| N/A \| Belize \| -88.19756 \| 17.49952 Belize City \| N/A \| Belize \| -88.19756 \| 17.49952 Surrey \| British Columbia \| Canada \| -122.82509 \| 49.10635 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Markham \| Ontario \| Canada \| -79.2663 \| 43.86682 North Bay \| Ontario \| Canada \| -79.46633 \| 46.3168 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 St. John's \| N/A \| Canada \| -52.70931 \| 47.56494	1,315	NCT00776919	1COMPLETED	2009-09-01	2008-10-01	Stiefel, a GSK Company	4INDUSTRY	false	false	false	null	0
[ 5 ]	100	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	0NONE	false	0ALL	false	The goal of the proposed study is to evaluate the effectiveness of intraoperative, strict glycemic control to improve survival and infection rates following liver transplantation in a randomized, prospective trial.Primary objective: To determine if strict intraoperative blood glucose control, when compared to standard intraoperative glycemic control, improves 1-year recipient survival and decreases surgical complications, including infections, following liver transplantation.	Approximately 2.1 million patients in the United States acquire infections during medical care every year. For example, 9%-30% patients who undergo surgery acquire nosocomial infections, which increase mortality and morbidity over that expected normally expected and increase the cost of care by several billion dollars. Studies have shown that controlling high blood glucose levels dramatically improves the recovery of critically ill patients after surgery, most notably decreasing the risk of infection. The advantage of strict glycemic control in the critically ill patient is now well accepted, and the Institute for Healthcare Improvement and Surviving Sepsis Campaign set glycemic control as part of the post-operative sepsis management bundle. Few studies have investigated the role of strict glycemic control during surgery itself. Liver transplantation is a good model for studying glucose control as hyperglycemia almost always occurs and the incidence of infection is higher than with other surgical procedures. We performed a retrospective review of 184 consecutive adult liver recipients in which intra-operative blood glucose levels were measured and treated with insulin. Recipients with strict glycemic control were compared to those with poor control for differences in donor and recipient demographics, intra-operative blood glucose concentrations, intra-operative insulin administered, immunosuppression, post-operative complications, and mortality. Poor glycemic control was associated with a significantly increased rate of infection during the first 30 days post-operatively (48% vs. 33%, P=0.05) and 1-year mortality was significantly increased for those recipients with poor intra-operative glucose control (21.9% vs. 8.8%; P = 0.05). These data along with the post-operative studies, suggest that the post-transplant mortality rate may potentially be decreased by nearly 50% at 1 year and underscore the need for this to be confirmed in a prospective trial. The goal of this study is to prospectively evaluate the outcomes of liver transplant recipients to either strict glucose control (goal of 80-110 mg/dl) or the current standard of care (goal of between 180 and 200 mg/dl). The specific aim of this study is to determine if strict intra-operative blood glucose control, improves 1-year recipient survival and decreases surgical complications, including infections, following liver transplantation. The rates of infection at 30 days after surgery and health at one year post- surgery will be compared. The frequency of other common post-operation complications will also be studied. The proposed study has the potential to have an impact on the intra-operative management of all liver transplant recipients.	Liver Transplant	liver transplant blood sugar	null	2	arm 1: strict glycemic control (80 to 110 mg/dl) arm 2: standard of care insulin dosing	[ 0, 4 ]	1	[ 0 ]	intervention 1: bolus or infusion 80 to 110 mg/dl	intervention 1: insulin	1	Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756	100	NCT00780026	1COMPLETED	2009-09-01	2008-07-01	University of Michigan	7OTHER	false	false	false	null	0
[ 5 ]	4	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Studying the effectiveness of a functional rehabilitation protocol (FRP) in early Relapsing Remitting Multiple Sclerosis (RRMS) patients treated with Betaferon by comparing the physical ability of patients with and without FRP.	null	Multiple Sclerosis, Relapsing-Remitting	KineSEP Rehabilitation Betaferon	null	2	arm 1: Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization arm 2: Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program starting within 6 weeks after randomization intervention 2: Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program about 6 weeks after randomization.	intervention 1: Interferon beta-1b, FRP within 15 days after randomization intervention 2: Interferon beta-1b, FRP about 6 weeks after randomization	10	Rennes \| Brittany Region \| France \| -1.67429 \| 48.11198 Avignon \| N/A \| France \| 4.80892 \| 43.94834 Lille \| N/A \| France \| 3.05858 \| 50.63297 Lomme \| N/A \| France \| 2.98715 \| 50.64358 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Mulhouse \| N/A \| France \| 7.32866 \| 47.75205 Nîmes \| N/A \| France \| 4.35788 \| 43.83665 Quimper \| N/A \| France \| -4.09795 \| 47.99597 Reims \| N/A \| France \| 4.02853 \| 49.26526 Toulouse \| N/A \| France \| 1.44367 \| 43.60426	4	NCT00780455	6TERMINATED	2009-09-01	2008-10-01	Bayer	4INDUSTRY	false	false	false	null	0
[ 5 ]	23	RANDOMIZED	PARALLEL	2DIAGNOSTIC	3TRIPLE	false	0ALL	false	The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) in patients with moderate-to-severe chronic kidney disease and diabetes mellitus undergoing cardiac angiography.	This was a Phase IV, multicenter, randomized, double-blind, parallel-group comparison of iopamidol-370 and iodixanol-320 in patients at high risk for CIN, i.e., patients with: * Stage 3 or 4 CKD (SCr level of ≥ 1.5 mg/dL for men and ≥1.3 mg/dL for women or eGFR between 15 and 50 mL/min, and * Diabetes mellitus who would undergo clinically indicated cardiac angiography procedures. Approximately 10 investigative centers were to participate in this study. This study was to enroll approximately 220 patients to ensure that 200 evaluable patients were able to complete the study according to this protocol. Patients were to be randomized to receive either iopamidol-370 or iodixanol-320. Each patient was to be evaluated for the occurrence of CIN within 48 to 72 hours postdose.	Chronic Renal Impairment Diabetes Mellitus		null	2	arm 1: None arm 2: None	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Iopamiro-370 (Iopamidol injection 76%) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution intervention 2: Visipaque 320 (iodixanol) injection is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution	intervention 1: Iopamidol injection 76% intervention 2: iodixanol	1	Princeton \| New Jersey \| United States \| -74.65905 \| 40.34872	23	NCT00782639	6TERMINATED	2009-09-01	2009-03-01	Bracco Diagnostics, Inc	4INDUSTRY	false	false	false	null	0
[ 5 ]	500	RANDOMIZED	PARALLEL	6HEALTH_SERVICES_RESEARCH	0NONE	false	0ALL	false	With the advances of flexible bronchoscopy, like metallic stent, electrocautery and real time endobronchial ultrasound, the complexity and duration of procedures are increasing. So, adequate sedation and analgesia is important for both patients and bronchoscopist. Clinical-judged midazolam administration is the current standard. However, midazolam is difficult to titrated and the clinical observations are not reliable sedative indices. Propofol is titrated easily because of its unique pharmacokinetics. Bispectral index (BIS), a real time monitor of depth-of-sedation, has been applied in general anesthesia. We design a BIS-guided propofol sedation for bronchoscopy. Through the combination of advantages of propofol and BIS, we hope to provide patients a more tolerable and safety sedation for bronchoscopy.	It is well known that patients undergoing bronchoscopy could be less suffering and the procedures could be carried on more smoothly if the patients have adequate sedation and analgesia. The preferred sedative and analgesic drugs are Midazolam and opioid, like Alfentanil or Morphine, which were titrated according to physicians' judgment on patients' clinical responsiveness. However, due to the pharmacokinetic characteristic of midazolam while used in intravenous injection (onset time 4-6 minutes, effective time 2-4 hours), the effective onset time may be too slow for repeated injection while patients already suffered from the bronchoscopic procedure. It is also noted that when over-sedation occurred the side effects like apnea/hypopnea, hypoxemia, and hypotension could last from dozen minutes to few hours. Although events mentioned above could be handled properly under experienced medical staff, it is still very difficult to predict the oncoming events as the pharmacokinetic effect is variant individually. Ideally, it will be more safe and efficient, during invasive procedure like bronchoscope, if the sedative drug could be onset or vanish fast and the drug effect could be titrated with an objective device directly monitoring the depth of sedation or anesthesia. Propofol is a short-acting intravenous sedative agent used for the induction of general anesthesia for children and adults; maintenance of general anesthesia; and sedation in medical contexts, such as intensive care unit (ICU) sedation for intubated, mechanically ventilated adults, and in procedures such as colonoscopy. Its mechanism of action is uncertain, but it is postulated that its primary effect may be potentiation of the Gamma-Amino Butyric Acid-A receptor, possibly by slowing the channel closing time. It has a fast onset time (1\~2 minutes) but a short working duration (8\~10 minutes), which vanished fast after stop administration. Bispectral Index (BIS), an non-invasive neurophysiologic monitor instrument, can transform the electroencephalogram (EEG) and electromyography of the patient to a continual numeral, ranging from 0 to 99, which provides a direct and real-time sedative depth monitor. A BIS value of 0 equals EEG silence, near 100 is the expected value in a fully awake adult, and below70 indicated the patient lose explicit memory recall but still has the ability to maintain his own vital signs. In this study, we design a sedative technique for bronchoscopy, a BIS-guided propofol administration, to compare with the traditional sedative technique, clinical-judged midazolam administration. Through the combination of the advantages of unique pharmacokinetics of propofol and real time monitor of sedative level from BIS, we hope to provide patients undergoing bronchoscopy a more satisfied and safety sedative procedure.	Flexible Bronchoscopy	flexible bronchoscopy sedation bispectral index	null	2	arm 1: In the study group, induction was started using alfentanil 4\~5μg/kg bolus following repeated propofol boluses (0.5\~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3\~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75. arm 2: In the control group, induction was started using alfentanil 4\~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/2min until conscious sedation was achieved	[ 1, 1 ]	2	[ 1, 0 ]	intervention 1: Induction: Alfentanil: 5μg/kg slowly push. Propofol: 0.5-1.5mg/kg slowly push till BIS value 70. Maintenance: Propofol infusion (3\~12 mg/kg/hour) to maintain BIS around 65\~75. Alfentanil: 5μg/kg slowly push Q15min prn if severe cough. intervention 2: Induction: Alfentanil: 5μg/kg slowly push. Midazolam: 2 mg slowly push followed by increments of 2 mg/ 2min till OAA/S\* 2\~3. Maintenance: Midazolam: 2 mg/ 2min prn to keep OAA/S\* 2\~3 or if intolerance of procedure. Alfentanil as study arm. \*Observer's assessment of alertness/sedation (OAA/S): Class 5: Responds readily to name spoken in normal tone. Class 4: Lethargic response to name called in normal tone. Class 3: Responds only to name called loudly. Class 2: Responds only to shaking. Class 1: No response to shaking.	intervention 1: Bispectral index guide propofol infusion intervention 2: Clinical-judged midazolam administration	1	Taoyuan \| N/A \| Taiwan \| 121.29696 \| 24.99368	500	NCT00789815	1COMPLETED	2009-09-01	2008-04-01	Chang Gung Memorial Hospital	7OTHER	false	false	false	null	0
[ 2 ]	14	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	null	A 2-period crossover study to assess the safety, tolerability and glucose-lowering effects of MK8245.	Hypothesis: Multiple doses of MK-8245 are sufficiently safe and well tolerated in patients with Type 2 diabetes based on an assessment of clinical and laboratory adverse experiences (AEs), to permit continued clinical investigation.	Type 2 Diabetes		null	2	arm 1: MK8245 arm 2: Placebo Comparator	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken. intervention 2: MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken.	intervention 1: MK8245 intervention 2: Comparator: Placebo	0	null	28	NCT00790556	1COMPLETED	2009-09-01	2008-10-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 5 ]	999	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.	null	Hypertension		null	1	arm 1: Azor tablets and hydrochlorothiazide tablets (if necessary) will be administered for up to 20 weeks	[ 0 ]	2	[ 0, 0 ]	intervention 1: amlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks intervention 2: hydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks	intervention 1: amlodipine and olmesartan medoxomil tablets intervention 2: hydrochlorothiazide tablets	72	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Green Valley \| Arizona \| United States \| -110.9937 \| 31.85425 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Sierra Vista \| Arizona \| United States \| -110.30369 \| 31.55454 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Harbor City \| California \| United States \| -118.29785 \| 33.79002 National City \| California \| United States \| -117.0992 \| 32.67811 Tustin \| California \| United States \| -117.82617 \| 33.74585 Westlake Village \| California \| United States \| -118.80565 \| 34.14584 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Pueblo \| Colorado \| United States \| -104.60914 \| 38.25445 Milford \| Connecticut \| United States \| -73.0565 \| 41.22232 Boynton Beach \| Florida \| United States \| -80.06643 \| 26.52535 Brooksville \| Florida \| United States \| -82.38991 \| 28.55554 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Deerfield Beach \| Florida \| United States \| -80.09977 \| 26.31841 DeLand \| Florida \| United States \| -81.30312 \| 29.02832 Fort Lauderdale \| Florida \| United States \| -80.14338 \| 26.12231 Kissimmee \| Florida \| United States \| -81.41667 \| 28.30468 Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Addison \| Illinois \| United States \| -87.98896 \| 41.9317 Orland Park \| Illinois \| United States \| -87.85394 \| 41.63031 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Columbia \| Maryland \| United States \| -76.83942 \| 39.24038 Elkridge \| Maryland \| United States \| -76.71358 \| 39.21261 Oxon Hill \| Maryland \| United States \| -76.9897 \| 38.80345 Reisterstown \| Maryland \| United States \| -76.8319 \| 39.46976 Stevensville \| Michigan \| United States \| -86.51947 \| 42.01449 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Edison \| New Jersey \| United States \| -74.4121 \| 40.51872 Sewell \| New Jersey \| United States \| -75.14434 \| 39.7665 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Binghamton \| New York \| United States \| -75.91797 \| 42.09869 Cary \| North Carolina \| United States \| -78.78112 \| 35.79154 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Harrisburg \| North Carolina \| United States \| -80.65784 \| 35.32395 Hickory \| North Carolina \| United States \| -81.3412 \| 35.73319 High Point \| North Carolina \| United States \| -80.00532 \| 35.95569 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Wilmington \| North Carolina \| United States \| -77.94604 \| 34.23556 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Norman \| Oklahoma \| United States \| -97.43948 \| 35.22257 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Tulsa \| Oklahoma \| United States \| -95.99277 \| 36.15398 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Havertown \| Pennsylvania \| United States \| -75.30852 \| 39.98095 Jenkintown \| Pennsylvania \| United States \| -75.12517 \| 40.09594 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Mt. Pleasant \| South Carolina \| United States \| -79.86259 \| 32.79407 New Tazewell \| Tennessee \| United States \| -83.59963 \| 36.44258 Amarillo \| Texas \| United States \| -101.8313 \| 35.222 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Carrollton \| Texas \| United States \| -96.89028 \| 32.95373 Corpus Christi \| Texas \| United States \| -97.39638 \| 27.80058 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Longview \| Texas \| United States \| -94.74049 \| 32.5007 West Jordan \| Utah \| United States \| -111.9391 \| 40.60967 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Walla Walla \| Washington \| United States \| -118.34302 \| 46.06458 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	999	NCT00791258	1COMPLETED	2009-09-01	2008-11-01	Daiichi Sankyo	4INDUSTRY	false	false	false	null	0
[ 3 ]	14	RANDOMIZED	CROSSOVER	0TREATMENT	1SINGLE	false	0ALL	false	This study aims to test an insulin and glucagon delivery algorithm designed to be used in conjunction with a continuous glucose monitoring system. This combined glucose sensing/hormone delivery approach is a step on the way to eventual development of an artificial (or automated) pancreas. The insulin and glucagon delivery algorithm is based on the difference between the current blood glucose and the target glucose (proportional error) and the rate of change in blood glucose (derivative error), both adjusted for the recent glucose history. This algorithm is called the Fading Memory Proportional-Derivative (FMPD) Algorithm. The principal investigator of this study has published previous research regarding the use of this algorithm and found it to be well-suited to control blood glucose in type 1 diabetic animals. The addition of glucagon was helpful; better glycemic control with fewer glucose excursions were observed when small intermittent infusions of subcutaneous glucagon were given during times of impending low blood sugar (Ward et al. 2008).	The objective of the current human study is to compare glycemic control in persons with Type 1 Diabetes using the FMPD Insulin plus Glucagon Delivery Algorithm vs. the FMPD Insulin-Alone Algorithm. Subjects will undergo two 28-hour sensor-augmented glycemic control studies. Each subject will be fitted with two short term continuous glucose monitoring systems and two subcutaneous (SC) infusion catheters. These catheters will allow for SC delivery of insulin and glucagon (or insulin plus a glucagon placebo). The accuracy of the wire sensors will be verified every 10 minutes with a venous blood glucose test. For the first 4 hours, the insulin and glucagon delivery will be controlled by venous blood in order to assess and compare the accuracy of the two sensors, after which the more accurate sensor (if it remains accurate) will control the FMPD algorithm. The main outcomes of our study are time spent in the target range (70 - 180 mg/dl) and the percentage of studies requiring intervention due to hypoglycemia (glucose \< 70 mg/dl). The accuracy of the sensors over the life of the study will also be evaluated. The specific system used in this study of frequent blood testing and the use of two separate infusion pumps is not feasible for every day use for individuals with diabetes. However, if the glucose control algorithm (with or without the use of glucagon) provides effective blood glucose management over long time periods the calculation program may be integrated into a continuous blood glucose monitoring system with an insulin and glucagon pump.	Type 1 Diabetes	diabetes pancreas beta cell glucagon insulin hypoglycemia	null	3	arm 1: Glycemic control of subject participants was managed by the closed-loop system which delivered insulin and normal saline (instead of glucagon) as a placebo, based upon algorithm calculations. arm 2: Glycemic control of subject participants was managed by the system which delivered insulin and glucagon based upon algorithm calculations. arm 3: Pilot studies designed to assess safety of the system. Includes 6 participants undergoing 7 studies.	[ 2, 1, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Insulin dosing and frequency calculated by Fading Memory Proportional Derivative algorithm intervention 2: During incipient hypoglycemia, glucagon was given in an attempt to prevent overt hypoglycemia. Dosing and frequency was calculated by the Fading Memory Proportional Derivative algorithm intervention 3: Saline solution 0.9%	intervention 1: Insulin, Asp(B28)- intervention 2: Glucagon intervention 3: Placebo	1	Portland \| Oregon \| United States \| -122.67621 \| 45.52345	14	NCT00797823	1COMPLETED	2009-09-01	2008-11-01	Legacy Health System	7OTHER	false	false	false	null	0
[ 5 ]	336	NA	SINGLE_GROUP	1PREVENTION	0NONE	true	0ALL	false	We hypothesize that when offered influenza vaccine at little or no cost, in a setting where the value of the vaccine is connected to one's high risk child, vaccination rates for parents will approach 90-95%, similar to rates obtained in the Neonatal Intensive Care Unit environment.	null	Influenza	Influenza prevention	null	0	null	null	1	[ 0 ]	intervention 1: 0.5 mL Deltoid Intramuscular Injection X 1	intervention 1: Influenzae vaccine	1	Akron \| Ohio \| United States \| -81.51901 \| 41.08144	292	NCT00812110	1COMPLETED	2009-09-01	2008-12-01	Akron Children's Hospital	7OTHER	false	false	false	null	0
[ 3 ]	226	null	CROSSOVER	0TREATMENT	null	false	0ALL	null	The primary goal of this trial is to compare the efficacy and safety of COMBIVENT CFC MDI with albuterol HFA MDI, the current standard reliever medication in asthma. In the first cross-over part of the study (Treatment Phases 1 and 2) the marketed product, COMBIVENT CFC MDI will be used. In the second, parallel group part of the trial (Treatment Phase 3) COMBIVENT RESPIMAT will be tested for acute bronchodilator efficacy in a blinded manner at the clinic visits. During the third 4-week treatment phase open label COMBIVENT RESPIMAT will be used for symptom relief as needed.	null	Asthma		null	0	null	null	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: Combivent CFC MDI intervention 2: Albuterol HFA MDI intervention 3: Respimat Combivent	41	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Palmdale \| California \| United States \| -118.11646 \| 34.57943 San Diego \| California \| United States \| -117.16472 \| 32.71571 Stockton \| California \| United States \| -121.29078 \| 37.9577 Centennial \| Colorado \| United States \| -104.87692 \| 39.57916 Wheat Ridge \| Colorado \| United States \| -105.07721 \| 39.7661 Panama City \| Florida \| United States \| -85.65983 \| 30.15946 Winter Park \| Florida \| United States \| -81.33924 \| 28.6 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Coeur d'Alene \| Idaho \| United States \| -116.78047 \| 47.67768 Normal \| Illinois \| United States \| -88.99063 \| 40.5142 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 North Dartmouth \| Massachusetts \| United States \| -70.97032 \| 41.63899 North Dartmouth \| Massachusetts \| United States \| -70.97032 \| 41.63899 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 Bozeman \| Montana \| United States \| -111.03856 \| 45.67965 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Skillman \| New Jersey \| United States \| -74.7146 \| 40.42011 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 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 Lake Oswego \| Oregon \| United States \| -122.67065 \| 45.42067 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Upland \| Pennsylvania \| United States \| -75.38269 \| 39.85261 Easley \| South Carolina \| United States \| -82.60152 \| 34.82984 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Union \| South Carolina \| United States \| -81.62371 \| 34.71541 El Paso \| Texas \| United States \| -106.48693 \| 31.75872 Killeen \| Texas \| United States \| -97.7278 \| 31.11712 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	606	NCT00818454	1COMPLETED	2009-09-01	2008-12-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 2 ]	32	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study will assess the pharmacokinetics of MK-0941 in participants with varying degrees of renal insufficiency.	null	Type 2 Diabetes		null	5	arm 1: MK-0941 20 mg administered to participants with mild renal insufficiency and type 2 diabetes. arm 2: MK-0941 20 mg administered to participants with moderate renal insufficiency and type 2 diabetes. arm 3: MK-0941 5 mg administered to participants with severe renal insufficiency and type 2 diabetes. arm 4: MK-0941 20 mg administered to age-, gender-, race-, body mass index (BMI)-, and hemoglobin A1C (HbAIc)-matched control subjects with normal renal function and type 2 diabetes. arm 5: MK-0941 5 mg administered to age-, gender-, race-, body mass index (BMI)-, and HbAIc-matched control subjects with normal renal function and type 2 diabetes.	[ 0, 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Two 10-mg tablets of MK-0941 administered as a single oral dose. intervention 2: MK-0941 administered as one single 5-mg tablet.	intervention 1: MK-0941 20 mg intervention 2: MK-0941 5 mg	0	null	32	NCT00830791	6TERMINATED	2009-09-01	2009-01-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 5 ]	171	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	null	A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tazarotene cream 0.1% compared with tazarotene cream 0.1% monotherapy in treating moderate to severe facial acne vulgaris	null	Acne Vulgaris		null	2	arm 1: Dapsone Gel 5% and Tazarotene Cream 0.1% arm 2: Tazarotene Cream 0.1%	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks intervention 2: Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks	intervention 1: Dapsone intervention 2: Tazarotene	1	Fremont \| California \| United States \| -121.98857 \| 37.54827	171	NCT00834210	1COMPLETED	2009-09-01	2008-12-01	Allergan	4INDUSTRY	false	false	false	null	0
[ 4 ]	485	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.	null	Moderate to Severe Hypertension	Hypertension systolic blood pressure cardiovascular disease aliskiren amlodipine	null	2	arm 1: Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg. arm 2: Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study. intervention 2: Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.	intervention 1: Aliskiren/amlodipine 300/10 mg tablet intervention 2: Amlodipine 10 mg capsule	6	Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Manila \| N/A \| Philippines \| 120.9822 \| 14.6042 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165	484	NCT00841672	1COMPLETED	2009-09-01	2009-01-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 3 ]	191	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will evaluate the lipid-modifying effect and tolerability of MK1903 when compared to placebo in patients with dyslipidemia who are not on a statin or other lipid-modifying therapy.	null	Dyslipidemia		null	2	arm 1: MK1903 arm 2: Placebo to MK1903	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period. intervention 2: Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.	intervention 1: MK1903 intervention 2: Comparator: Placebo	0	null	191	NCT00847197	1COMPLETED	2009-09-01	2008-06-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 2 ]	36	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole modified release (MR), once daily (QD), in adolescent subjects (age 12-17 years old) with Symptomatic Gastroesophageal Reflux Disease.	Gastroesophageal reflux disease is a condition of multifactorial etiology resulting in the reflux of gastric contents into the esophagus through the lower esophageal sphincter. The prevalence of Gastroesophageal reflux disease in the pediatric population is becoming increasingly recognized and documented. It is a chronic disease that can persist through adulthood with symptoms in older children and adolescents being similar to those seen in adults. The prevalence of gastroesophageal reflux disease increases with age, from 2.5% of children between the ages of 3 and 9 years, to 8.5% of those between the ages of 10 and 17 years. Younger children generally present with extra-esophageal manifestations, regurgitation, and epigastric pain, while older children and adolescents typically present with adult-type gastroesophageal reflux disease symptoms of heartburn and regurgitation. Treatment for gastroesophageal reflux disease is aimed at alleviating symptoms and healing the esophageal inflammation. This study evaluated the pharmacokinetics and safety of dexlansoprazole MR in the pediatric population (ages 12-17) and determined if the pharmacokinetic profile is similar to that in adults given the same dose.	Gastroesophageal Reflux	Esophageal Reflux Gastro-Esophageal Reflux Gastroesophageal Reflux Disease GERD Regurgitation, Gastric Heartburn Drug Therapy Adolescent	null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days. intervention 2: Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.	intervention 1: Dexlansoprazole MR intervention 2: Dexlansoprazole MR	3	Anaheim \| California \| United States \| -117.9145 \| 33.83529 Cypress \| California \| United States \| -118.03729 \| 33.81696 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223	36	NCT00847210	1COMPLETED	2009-09-01	2009-05-01	Takeda	4INDUSTRY	false	false	false	null	0
[ 5 ]	18	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	1FEMALE	null	The primary objective of this study is to determine the efficacy and longevity of the use of Restylane® and Perlane® in combination for the rejuvenation of the infraorbital hollows and to measure patient satisfaction with this treatment	This study will examine the effectiveness of using Restylane® and Perlane® together in the treatment of the hollows in the under eye area. The combination of these treatments for use in the under eye area is considered investigational. An investigational therapy is a therapy that is not approved by the US Food and Drug Administration (FDA). Restylane® and Perlane® has been approved for treatment of moderate to severe facial wrinkles and folds, such as nasolabial folds by the FDA.	Infraorbital Hollows		null	1	arm 1: One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.	[ 0 ]	2	[ 0, 0 ]	intervention 1: one syringe of Restylane® (1.0cc) will be used total for both tear trough areas. intervention 2: One syringe of Perlane® (1.0cc) will be used total for both tear trough areas.	intervention 1: Restalyne intervention 2: Perlane	1	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	18	NCT00852241	1COMPLETED	2009-09-01	2009-02-01	The Cleveland Clinic	7OTHER	false	false	false	null	0
[ 2 ]	46	NON_RANDOMIZED	PARALLEL	null	0NONE	true	0ALL	false	The purpose of this study is to assess the effects of hepatic impairment on the single dose pharmacokinetics of BMS-790052.	null	Hepatic Insufficiency		null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 1, 1, 1, 1 ]	1	[ 0 ]	intervention 1: Capsules, Oral, 30 mg, single dose, one day	intervention 1: BMS-790052	2	Anaheim \| California \| United States \| -117.9145 \| 33.83529 Orlando \| Florida \| United States \| -81.37924 \| 28.53834	30	NCT00859053	1COMPLETED	2009-09-01	2009-03-01	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	0
[ 3 ]	34	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed doses of MP-214 orally administered once daily to patients with schizophrenia. MP-214 tablets will be administered to patients starting at an initial dose, followed by up-titration to a fixed dose (low, medium or high) for 14 days.	null	Schizophrenia	schizophrenia antipsychotics dopamine D3/D2 antagonist	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: Cariprazine 3 mg intervention 2: Cariprazine 6 mg intervention 3: Cariprazine 12.5 mg	1	Kure \| Hiroshima \| Japan \| 132.56658 \| 34.23222	34	NCT00862992	1COMPLETED	2009-09-01	2008-04-01	Mitsubishi Tanabe Pharma Corporation	4INDUSTRY	false	false	false	null	0
[ 2 ]	84	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	0ALL	false	This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose.	This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).	Psoriasis		null	4	arm 1: Placebo treatment arm 2: 140 mg SC PsO arm 3: 350 mg SC PsO arm 4: 700 mg IV PsO	[ 2, 0, 1, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). intervention 2: single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). intervention 3: single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). intervention 4: single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).	intervention 1: 700 mg IV intervention 2: 350 mg SC intervention 3: Placebo intervention 4: 140 mg SC	0	null	82	NCT00867100	1COMPLETED	2009-09-01	2007-12-01	Bausch Health Americas, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	100	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of this study was to assess the safety and efficacy of CNS 7056 as a procedural sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.	This was a randomized, double-blind, parallel-group, dose-finding study assessing the safety and efficacy of three dose levels of CNS 7056 compared with midazolam in patients undergoing diagnostic upper GI endoscopy. Patients who met all study entry criteria and completed screening procedures were randomly assigned to 1 of 4 treatment groups: CNS 7056 0.10 mg/kg,0.15 mg/kg, or 0.20 mg/kg; or midazolam 0.075 mg/kg. Patients received their assigned treatment administered as a single intravenous injection by a syringe driver over 1 minute. The endoscopy started when a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of ≤3 has been reached, but no earlier than 90 seconds after Time 0 (the start of study drug injection). Rescue with sedative medication (midazolam 1-2 mg) was be permitted at the discretion of the administering physician. Efficacy assessments consisted of the MOAA/S scores, Aldrete scores, and drowsiness measures using a Visual Analogue Scale (VAS). Cognitive function was assessed by the Hopkins Verbal Learning Test-Revised™ (HVLT-R™) and memory for the procedure by the Brice Questionnaire. Safety assessments included adverse events, physical examinations, vital signs, ECGs, pulse oximetry measurements, clinical laboratory tests, and pain on injection using a VAS.	Procedural Sedation Endoscopy	CNS 7056 Procedural Sedation Sedation Endoscopy	null	4	arm 1: Remimazolam (CNS 7056) 0.10 mg/kg iv arm 2: Remimazolam (CNS 7056) 0.15 mg/kg iv arm 3: Remimazolam (CNS 7056) 0.20 mg/kg iv arm 4: Midazolam 0.075 mg/kg iv	[ 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Administered as a single intravenous injection by a syringe driver over 1 minute intervention 2: Administered as a single intravenous injection by a syringe driver over 1 minute	intervention 1: CNS 7056 intervention 2: Midazolam	7	Sheffield \| Alabama \| United States \| -87.69864 \| 34.76509 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Anaheim \| California \| United States \| -117.9145 \| 33.83529 South Miami \| Florida \| United States \| -80.29338 \| 25.7076 Stony Brook \| New York \| United States \| -73.14094 \| 40.92565 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931	100	NCT00869440	1COMPLETED	2009-09-01	2009-03-01	Paion UK Ltd.	4INDUSTRY	false	false	false	null	0
[ 3 ]	41	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	4QUADRUPLE	false	0ALL	false	Pain is a most common symptom and it has a high impact on quality of life in cancer patients. Many cancer patients have received opioid therapy, but also many of them have suffered from side effects of opioids. Drowsiness and confusion are common side effects of opioids. Caffeine is a well known psychostimulant,and it is widely used as an analgesics. Thus, the investigators aimed to prove the efficacy of intravenous caffeine administration as an adjuvant analgesics to opioids. At the same time, the investigators tried to find that the side effects of opioids could be ameliorated by caffeine.	Previous studies on cancer pain lacked assessment of quality of life. And most of previous studies on cancer pain did not give attention to symptoms accompanied with pain. We include such variables as outcome measures, and aimed to evaluate the efficacy and the safety of intravenous caffeine in advanced cancer inpatients.	Cancer Pain	Pain Cancer patients Caffeine Adjuvant analgesics Sedation Confusion Quality of life Fatigue	null	2	arm 1: Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour arm 2: Intravenous injections of 100ml of normal saline over 1 hour	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Intravenous injection of caffeine 200mg with 100ml of normal saline over 1 hour, once a day, for two days. intervention 2: Intravenous injections of 100ml of normal saline over 1 hour, once a day, for two days	intervention 1: Caffeine intervention 2: Normal saline	2	Goyang-si \| Gyeonggi-do \| South Korea \| 126.835 \| 37.65639 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	38	NCT00879775	1COMPLETED	2009-09-01	2009-04-01	Korea Research Foundation	7OTHER	false	false	false	null	0
[ 4 ]	123	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens will also be evaluated.	null	Acne	Acne	null	4	arm 1: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks arm 2: Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks arm 3: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks arm 4: Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week	[ 0, 0, 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week intervention 2: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks intervention 3: Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks intervention 4: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks	intervention 1: Adapalene BPO Gel standard daily overnight application intervention 2: Adapalene-BPO 3-hour daily application before bedtime intervention 3: Adapalene-BPO Gel every other day application intervention 4: Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion	2	Windsor \| Ontario \| Canada \| -83.01654 \| 42.30008 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884	123	NCT00883233	1COMPLETED	2009-09-01	2009-04-01	Galderma R&D	4INDUSTRY	false	false	false	null	0
[ 3 ]	40	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to evaluate the safety and effectiveness of a study medication that contains a combination of a pain medication, sufentanil, and a sedative, triazolam. This drug is being designed to provide mild sedation as well as reduce anxiety and pain before and during a procedure (in this case elective abdominal liposuction).	null	Sedation Anxiety Pain	procedural sedation	null	2	arm 1: single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ arm 2: single dose of sublingual Placebo NanoTab™	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ intervention 2: Single dose of sublingual placebo NanoTab™	intervention 1: Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03) intervention 2: Placebo NanoTab™	1	Pasadena \| California \| United States \| -118.14452 \| 34.14778	40	NCT00894699	1COMPLETED	2009-09-01	2009-06-01	Talphera, Inc	4INDUSTRY	false	false	false	null	0
[ 5 ]	99	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following robot-assisted endoscopic thyroidectomy compared to placebo. The primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome will be the incidence of chronic pain and hypoesthesia in the anterior chest at 3 months after operation.	null	Pain, Postoperative	thyroidectomy pain, postoperative pregabalin	null	2	arm 1: Patients receive oral Placebo 150 mg 1 hour prior to surgery, and 12 hours later arm 2: Patients receive oral pregabalin 150 mg 1 hour prior to surgery, and 12 hours later	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Pregabalin 150 mg orally intervention 2: Vitamin Complex 150 mg orally	intervention 1: Pregabalin intervention 2: Vitamin Complex (placebo)	1	Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	94	NCT00905580	1COMPLETED	2009-09-01	2009-05-01	Severance Hospital	7OTHER	false	false	false	null	0
[ 5 ]	247	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	A study to determine if using 2 acne products in the morning is as safe and efficacious as using one product in the morning and one product in the evening.	Approximately 240 subjects will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, all subjects will receive RETIN-A MICRO PUMP 0.04% and a 5% Benzoyl Peroxide wash (OTC) for the entire 12-week treatment period. Subjects will be randomized to either both morning treatments (test) or to the morning/evening treatment (active control). Subjects will be assessed at baseline, at week 3, week 6 and again at the end of therapy, week 12 for number and type of individual lesions and safety. At selected sites, photographs will be taken at the same time points. At Week 12 subjects will be assessed for Investigator's Global Assessment of Acne Severity. The investigator will conduct all of the lesion counts, global assessments and safety assessments.	Acne Vulgaris	acne irritation objective sensory methods	null	2	arm 1: 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day arm 2: 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 5% benzoyl peroxide wash intervention 2: 0.04% tretinoin gel	intervention 1: benzoyl peroxide wash intervention 2: Tretinoin gel	12	Boca Raton \| Florida \| United States \| -80.0831 \| 26.35869 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Snellville \| Georgia \| United States \| -84.01991 \| 33.85733 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 Stony Brook \| New York \| United States \| -73.14094 \| 40.92565 Cincinnatti \| Ohio \| United States \| N/A \| N/A Yardley \| Pennsylvania \| United States \| -74.846 \| 40.24566 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Lynchburg \| Virginia \| United States \| -79.14225 \| 37.41375 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681	247	NCT00907257	1COMPLETED	2009-09-01	2009-02-01	Bausch Health Americas, Inc.	4INDUSTRY	false	false	false	null	-0
[ 4 ]	278	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.	null	Actinic Keratosis	Peplin Actinic keratosis PEP005	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: once daily for 3 consecutive days intervention 2: once daily for 3 consecutive days	intervention 1: PEP005 (Ingenol Mebutate) gel, 0.015% intervention 2: Vehicle Gel	21	Hot Springs \| Arizona \| United States \| N/A \| N/A Fremont \| California \| United States \| -121.98857 \| 37.54827 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Arlington Heights \| Illinois \| United States \| -87.98063 \| 42.08836 Carmel \| Indiana \| United States \| -86.11804 \| 39.97837 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Plainfield \| Indiana \| United States \| -86.39944 \| 39.70421 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Henderson \| Nevada \| United States \| -114.98194 \| 36.0397 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 New York \| New York \| United States \| -74.00597 \| 40.71427 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 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 Lynchburg \| Virginia \| United States \| -79.14225 \| 37.41375 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Benowa \| Queensland \| Australia \| 153.38583 \| -28.0077 Carina Heights \| Queensland \| Australia \| 153.09126 \| -27.50721	278	NCT00915551	1COMPLETED	2009-09-01	2009-06-01	Peplin	4INDUSTRY	false	false	false	null	0

Subsets and Splits

No community queries yet

The top public SQL queries from the community will appear here once available.