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 ]	10	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	true	The purpose of the study is to evaluate the safety and tolerability of pegylated interferon alpha-2b (PEG-Intron) in patients with severe complications related to Hereditary hemorrhagic telangiectasia (HHT). Funding Source - FDA Office of Orphan Products Development (OOPD)	The objective of this study is to evaluate the safety and tolerability of pegylated interferon alpha-2b (PEG-Intron) in patients with severe complications related to Hereditary Hemorrhagic Telangiectasia (HHT). Participants will be randomized to the treatment arm or control arm and then crossed over to the alternate ar...	Anemia Liver Disease Hypoxemia	anemia HHT Liver disease Hypoxemia Iron deficiency anemia Liver disease with high cardiac output Diffuse pulmonary AVMs with hypoxemia	null	2	arm 1: Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months, then standard care for 6 months. arm 2: Standard care for 6 months, then weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months.	[ 0, 0 ]	2	[ 0, 10 ]	intervention 1: Weekly subcutaneous injection of 1 microgram/kg/week intervention 2: Standard care	intervention 1: Pegylated Interferon Alpha2b intervention 2: Standard care	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	20	NCT00588146	6TERMINATED	2011-09-01	2007-01-01	Mayo Clinic	7OTHER	false	false	false	null	0
[ 2, 3 ]	50	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to: Phase I Objectives: * Find the most tolerated dose to use for Phase II * Collect information on how the body responds to this combination of study drug Phase II Objectives: * To determine the overall response of participants using this combination of study drug The expression of pr...	Patient will receive Dacarbazine intravenously (IV), which means it is given through a needle in a vein in the arm or through a venous port (if patient already has one). Dasatinib will be given orally starting day 2 for 17 days straight (days 2 through 19) starting the day after patient receives their first dose of Dac...	Metastatic Melanoma	Dasatinib Dacarbazine	null	2	arm 1: Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established. arm 2: Dasatinib and Dacarbazine...	[ 0, 0 ]	1	[ 0 ]	intervention 1: Arm A/ Phase I Potential Dose Levels. Dose Level -1: Dasatinib 40 mg; DTIC 600 mg/m\^2. Dose Level 1: Dasatinib 50 mg; DTIC 800 mg/m\^2. Dose Level 2: Dasatinib 70 mg; DTIC 800 mg/m\^2. Dose Level 3: Dasatinib 70 mg; DTIC 1000 mg/m\^2. Arm B/Phase II Potential Dose Levels. MTD1: Dasatinib 70 mg; DTIC...	intervention 1: Dasatinib and Dacarbazine (DTIC)	2	San Francisco \| California \| United States \| -122.41942 \| 37.77493 Tampa \| Florida \| United States \| -82.45843 \| 27.94752	50	NCT00597038	1COMPLETED	2011-09-01	2007-11-01	H. Lee Moffitt Cancer Center and Research Institute	7OTHER	false	false	false	null	0
[ 4 ]	25	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	true	Idiopathic Pulmonary Fibrosis (IPF) is a rapidly progressive lung disorder that is often associated with a chronic, intractable cough. The etiology of the cough associated with IPF is unclear but it is often so severe that it adversely effects the patient's quality of life. We propose that thalidomide specifically supp...	This study is a Phase III, double blinded, randomized, placebo controlled, crossover trial testing the efficacy of thalidomide in suppressing the chronic cough of IPF. All subjects will be randomized to either begin the study receiving the active study drug - (thalidomide) or inactive drug (placebo). Study drug will be...	Idiopathic Pulmonary Fibrosis Cough	idiopathic pulmonary fibrosis cough	null	2	arm 1: Participants first received Thalidomide tablet for 12 weeks. After a washout period of two weeks, they then received placebo tablet for 12 weeks. arm 2: Participants first received Placebo tablet for 12 weeks. After a washout period of two weeks, they then received Thalidomide tablet for 12 weeks.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Thalidomide 50 - 100 mg by mouth daily intervention 2: Placebo 50-100 mg by mouth per day	intervention 1: Thalidomide intervention 2: Placebo	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	46	NCT00600028	1COMPLETED	2011-09-01	2007-12-01	Johns Hopkins University	7OTHER	false	false	false	null	0
[ 0 ]	73	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study will assess whether adding cognitive behavioral therapy to the antidepressant escitalopram is effective in reducing anxiety in older adults with generalized anxiety disorder.	Generalized anxiety disorder (GAD) affects nearly 6.8 million adults in the United States. GAD is diagnosed when a person spends at least 6 months excessively worrying over everyday problems to the point that carrying out normal life becomes difficult. People with GAD face each day with intense anxiety and tension and ...	Generalized Anxiety Disorder		null	4	arm 1: 12 weeks open-label escitalopram (10-20mg/day as tolerated), followed by 16 weeks individual cognitive behavioral therapy plus continuation escitalopram at same dose as end of first 12 weeks, followed by 28 weeks maintenance escitalopram at same dose as at end of first 12 weeks. Up to 3 booster sessions of CBT a...	[ 0, 1, 2, 2 ]	3	[ 0, 0, 5 ]	intervention 1: 20 mg daily oral escitalopram intervention 2: Placebo pill of daily oral escitalopram intervention 3: 16 weekly 1-hour sessions	intervention 1: Escitalopram intervention 2: Placebo intervention 3: Cognitive behavioral therapy (CBT)	3	San Diego \| California \| United States \| -117.16472 \| 32.71571 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	73	NCT00601965	1COMPLETED	2011-09-01	2007-10-01	Veterans Medical Research Foundation	7OTHER	false	false	false	null	0
[ 2, 3 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study will test whether valproic acid (Depakote\[Registered Trademark\]) can shrink enlarged lymph glands and spleen in patients with autoimmune lymphoproliferative syndrome (ALPS). Depakote has been used for more than 30 years for treating various medical disorders in adults and children, including migraine heada...	The Autoimmune Lymphoproliferative Syndrome (ALPS) is an inherited disease associated with a defect of lymphocyte apoptosis that leads to lymphoproliferation and autoimmunity. Although, there are immunosuppressive treatments for many of its complications, there currently is no safe and effective therapy for this syndro...	ALPS Hypersplenism Lymphadenopathy	ALPS Valproic Acid Lymphadenopathy Splenomegaly Histone Deacytelase (HDAC) Inhibitor Autoimmune Lymphoproliferative Syndrome	null	1	arm 1: Single arm study involving oral administration of valproic acid and monitoring of its efficacy by CT scans done before and after the intervention. Blood samples were also obtained to monitor safety labs and biomarkers.	[ 0 ]	3	[ 0, 3, 3 ]	intervention 1: Oral administration of valproic acid intervention 2: CT scans were done before and after treating the patient with valproic acid intervention 3: Blood samples were collected before and after the intervention to monitor blood counts and biomarkers of ALPS	intervention 1: Valproic Acid intervention 2: CT Scan intervention 3: Blood Sample	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	5	NCT00605657	1COMPLETED	2011-09-01	2008-01-01	Koneti Rao	0NIH	false	false	false	null	0
[ 3 ]	59	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Primary Objective to estimate 6-month progression free survival probability of patients with recurrent malignant glioma treated with Etoposide + Bevacizumab. Secondary Objectives To evaluate safety \& tolerability of Etoposide + Bevacizumab among patients with recurrent malignant glioma (RMG). To evaluate radiographi...	Exploratory, single-arm, ph II study designed to assess anti-tumor activity of combinatorial regimen consisting of Etoposide + Bevacizumab among patients with RMG. Primary endpoint of study is probability of progression-free survival at 6 months. Important secondary objective is to further assess safety of Etoposide \&...	Glioblastoma Gliosarcoma	Glioblastoma Gliosarcoma GBM MG Brain tumor Bevacizumab Avastin Etoposide VP-16 Etopophos Toposar VePesid Glioblastoma multiforme Recurrent GBM Anaplastic astrocytoma Malignant glioma	null	1	arm 1: Grade III and IV patients will receive: Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1st bevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days ...	[ 0 ]	1	[ 0 ]	intervention 1: 32 pts w recurrent WHO grade III MG \& 27 pts w recurrent WHO grade IV MG will be enrolled in this study. Estimated rate of accrual is 10 pts per month. The estimated date of study completion is 6-9 months from study initiation. Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If...	intervention 1: Bevacizumab and Etoposide	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	59	NCT00612430	1COMPLETED	2011-09-01	2007-03-01	Duke University	7OTHER	false	false	false	null	0
[ 0 ]	68	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This study will evaluate the effectiveness of an integrative group psychosocial therapy combined with stimulant medication in treating children with attention deficit hyperactivity disorder plus impairments in mood.	There has been increasing recognition that many children with attention deficit hyperactivity disorder (ADHD) exhibit depressive and manic-like symptoms suggestive of major depressive disorder (MDD) and bipolar disorder (BP). Many children with ADHD plus impairments in mood display symptoms of irritability, affective i...	Attention Deficit Disorder With Hyperactivity	Subthreshold Manic States in Children ADHD	null	2	arm 1: Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments. arm 2: Participants will receive stimulant medication therapy and group-based behavior therapy.	[ 1, 0 ]	3	[ 5, 0, 5 ]	intervention 1: Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Pare...	intervention 1: Group-based behavior therapy intervention 2: Stimulant medication therapy intervention 3: Community-based psychosocial treatment	1	Miami \| Florida \| United States \| -80.19366 \| 25.77427	65	NCT00632619	1COMPLETED	2011-09-01	2009-03-01	Florida International University	7OTHER	false	false	false	null	0
[ 0 ]	23	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	true	The goal of this clinical research study is to learn the effect of combining aprepitant with CHOP or R-CHOP in patients with Non-Hodgkin's Lymphoma (NHL) that is either newly diagnosed or has come back. Researchers also want to see if aprepitant can help to prevent nausea and/or vomiting that may be caused by chemother...	The Study Drugs: Aprepitant is designed to block the natural substance in the brain that causes nausea and vomiting. This may help to prevent and/or control nausea and vomiting caused by cancer chemotherapy treatment. CHOP and R-CHOP are commonly used chemotherapy regimens for treating NHL. In the blood, aprepitant ...	Lymphoma	Non-Hodgkin's Lymphoma Lymphoma Nausea Cyclophosphamide Cytoxan Neosar Doxorubicin AD Hydroxydaunomycin hydrochloride Vincristine Prednisone Rituximab Rituxan Aprepitant Emend L754030 MK869 Drug Metabolism CHOP R-CHOP NHL	null	2	arm 1: Aprepitant 125 mg oral (PO) Day 1 of Cycle 1 followed by 80 mg PO Daily Days 2-3 with CHOP (steroid in CHOP) or R-CHOP plus Rituximab 375 mg/m\^2 intravenous Day 1. CHOP or R-CHOP chemotherapy: (1) bolus or 48-hour infusion CHOP \[cyclophosphamide 750 mg/m\^2 IV Day 1, doxorubicin 25 mg/m\^2/day IV given bolus o...	[ 0, 0 ]	7	[ 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: 125 mg By Mouth (PO) On Day 1, followed by 80 mg PO Daily On Days 2-3. intervention 2: 750 mg/m\^2 By Vein On Day 1 intervention 3: 25 mg/m\^2 By Vein Over 48 Hours On Days 1-2 intervention 4: 2 mg By Vein On Day 1 intervention 5: 100 mg PO for 5 Days intervention 6: 375 mg/m\^2 By Vein On Day 1. interv...	intervention 1: Aprepitant intervention 2: Cyclophosphamide intervention 3: Doxorubicin intervention 4: Vincristine intervention 5: Prednisone intervention 6: Rituximab intervention 7: Ondansetron	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	40	NCT00651755	1COMPLETED	2011-09-01	2008-03-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 2, 3 ]	5	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This phase I/II trial studies the side effects and best dose of vorinostat when given together with paclitaxel and radiation therapy and to see how well it works in treating patients unable to tolerate cisplatin with stage III non-small cell lung cancer (NSCLC) that cannot be removed by surgery. Vorinostat may stop the...	PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of vorinostat when administered in combination with paclitaxel and thoracic radiation therapy in patients with locally advanced NSCLC. SECONDARY OBJECTIVES: I. To assess the safety and toxicity of vorinostat when administered in combination with pa...	Stage IIIA Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer		null	1	arm 1: Patients receive vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.	[ 0 ]	3	[ 0, 0, 4 ]	intervention 1: Given PO intervention 2: Given IV intervention 3: Undergo radiation therapy	intervention 1: vorinostat intervention 2: paclitaxel intervention 3: radiation therapy	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	5	NCT00662311	6TERMINATED	2011-09-01	2008-03-01	University of Washington	7OTHER	false	false	false	null	0
[ 2, 3 ]	1	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	true	1FEMALE	true	Congenital cystic adenomatoid malformations (CCAMs) are theorized to be growing immature lung tissue. Administration of maternal steroids in the mid-trimester may stop the growth or decrease the size of the CCAM, thus increasing normal lung tissue and improving survival in fetuses with large CCAMs. This is a prospectiv...	null	Congenital Cystic Adenomatoid Malformation	prenatal steroids hydrops congenital cystic adenomatoid malformation of the lung prenatal intervention betamethasone prenatal diagnosis	null	2	arm 1: STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart arm 2: PLACEBO: IM x 2 doses 24 hours apart	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 12 mg intramuscularly x 2 doses 24 hours apart intervention 2: PLACEBO: IM x 2 doses 24 hours apart	intervention 1: Betamethasone intervention 2: Placebo	3	San Francisco \| California \| United States \| -122.41942 \| 37.77493 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	1	NCT00670956	6TERMINATED	2011-09-01	2008-04-01	University of California, San Francisco	7OTHER	false	false	false	null	0
[ 3 ]	3	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine how safe and effective fondaparinux is in treating patients with suspected or confirmed heparin-induced thrombocytopenia (HIT).	Currently, standard treatment of HIT involves the transition from a direct thrombin inhibitor (a type of anticoagulant or "blood thinner") to warfarin, a different type of anticoagulant. Direct thrombin inhibitors (DTIs) require IV administration and frequent blood draws for dose adjustments, which can lead to prolonge...	Heparin-Induced Thrombocytopenia	heparin-induced thrombocytopenia thrombocytopenia HIT thrombosis blood clot blood thinner anticoagulant heparin warfarin fondaparinux Arixtra	null	1	arm 1: daily subcutaneous injection of fondaparinux (7.5-10 mg)	[ 0 ]	2	[ 0, 0 ]	intervention 1: Dosage form: subcutaneous injection; dosage: 7.5 to 10.0 mg; frequency and duration: daily until blood test results rule out confirmed HIT - for patients with confirmed HIT, continue daily until INR (blood clotting) measurement rises to at least 2 intervention 2: Dosage form: oral; dosage: 2.5 to 5.0 mg...	intervention 1: fondaparinux intervention 2: warfarin	1	Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424	3	NCT00673439	6TERMINATED	2011-09-01	2007-11-01	University of Louisville	7OTHER	false	false	false	null	0
[ 3 ]	250	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This is an outpatient clinical trial of topiramate for addressing cocaine dependence and reduction of cocaine associated behaviors in opiate dependent drug users maintained on methadone treatment. The study aims to answer whether topiramate 1. is safe and acceptable to methadone patients 2. reduces cocaine use 3. hel...	This is an outpatient clinical trial of topiramate treatment for cocaine dependence and reduction of cocaine-associated HIV risk behavior. Topiramate is of high current interest in this regard, having been identified my National Institute on Drud Abuse (NIDA) leadership as among only a small number of tested candidates...	Cocaine Dependence	addiction drug dependence stimulant	null	4	arm 1: topiramate and contingency reinforcement for urine sample confirming cocaine abstinence arm 2: Topiramate and random reinforcement irrespective of cocaine use arm 3: None arm 4: Placebo and contingency reinforcement for urine sample confirming cocaine abstinence	[ 0, 0, 2, 1 ]	3	[ 0, 5, 0 ]	intervention 1: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day. capsules are adminis...	intervention 1: topiramate intervention 2: Contingency Reinforcement intervention 3: placebo + NonCR	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	171	NCT00685178	1COMPLETED	2011-09-01	2007-02-01	Johns Hopkins University	7OTHER	false	false	false	null	0
[ 0 ]	74	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study aimed to test whether escitalopram would slow the brain atrophy in patients with mild to moderate AD over the 52-week period.	* Study institutions: Four university hospitals in Korea * Design: Multi-center, randomized, placebo-controlled, double-blind clinical trial * Subjects: 74 probable Alzheimer's disease patients who have been taking donepezil at stable dose within 2 months (Escitalopram 37 : Placebo 37)	Alzheimer's Disease	Alzheimer's disease escitalopram MRI	null	2	arm 1: Escitalopram 20mg tablet by mouth once a day arm 2: Placebo 20mg tablet by mouth once a day	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 5 mg/day for 2 weeks, 10 mg/day for 2 weeks and 20 mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period) intervention 2: 5mg/day for 2 weeks, 10mg/day for 2 weeks and 20mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole...	intervention 1: escitalopram intervention 2: placebo	4	Chuncheon \| N/A \| South Korea \| 127.73417 \| 37.87472 Seongnam \| N/A \| South Korea \| 127.39683 \| 35.54127 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	74	NCT00702780	1COMPLETED	2011-09-01	2008-11-01	Seoul National University Hospital	7OTHER	false	false	false	null	0
[ 2 ]	172	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study will aims to determine the maximum tolerated dose of CGC-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047 will be escalated until the maximum tolerated dose is e...	This study will use a dose escalation design to determine the MTD of CGC-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047 will be escalated in cohorts of 3 patients and dos...	Cancer	cancer advanced cancer solid tumors lymphoma CGC-11047	null	7	arm 1: CGC-11047 in combination with Gemcitabine arm 2: CGC-11047 in combination with Docetaxel arm 3: CGC-11047 in combination with Bevacizumab arm 4: CGC-11047 in combination with Erlotinib arm 5: Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. CGC-11047 will be administered on Days 1, 8 and 15 of...	[ 0, 0, 0, 0, 0, 0, 0 ]	7	[ 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: Gemcitabine: (Closed to enrollment) 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle. CGC-11047 will only be given on days 1 and 15 of each cycle and will start at dose level -1 (50 mg). intervention 2: Docetaxel: (Closed to enrollment) 75 mg/m2 administered IV over 60 m...	intervention 1: CGC-11047 and gemcitabine intervention 2: CGC-11047 and docetaxel intervention 3: CGC-11047 and bevacizumab intervention 4: CGC-11047 and erlotinib intervention 5: CGC-11047 and cisplatin intervention 6: CGC-11047 and 5-flurouracil / leucovorin intervention 7: CGC-11047 and sunitinib	12	Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Ocoee \| Florida \| United States \| -81.54396 \| 28.56917 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Albany \| New York \| United States \| -73.75623 \| 42.65258 Kettering \| Ohio \| United Stat...	172	NCT00705874	1COMPLETED	2011-09-01	2006-05-01	Progen Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 0 ]	255	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study is looking at the effects of certain long-acting bronchodilators on patients with asthma who have specific genetic variations. The investigators are interested in a certain common genetic variation in the receptor for beta-agonists, which is found in as many of one-sixth of the population. There is evidence ...	Asthma affects 7% of the population in the United States. Asthma morbidity and mortality has increased over the past decade. Long-acting β-agonists (LABAs) combined with inhaled corticosteroids are the most rapidly growing form of asthma therapy in the USA. The only currently USA licensed pharmaceutical that combines a...	Asthma	Asthma Pharmacogenetics Beta agonists salmeterol formoterol tiotropium beta adrenergic receptor single nucleotide polymorphism	null	6	arm 1: Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 m...	[ 0, 0, 0, 1, 1, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: tiotropium bromide one inhalation a day for one year, along with inhaled steroids at variable dosing based on patient's prior inhaled steroid dosing and treating physician's judgement. intervention 2: salmeterol diskus 1 puff twice a day for 1 year, depending on which medication the patient was on befor...	intervention 1: tiotropium bromide intervention 2: Salmeterol intervention 3: Formoterol intervention 4: Fluticasone propionate intervention 5: budesonide	2	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	0	NCT00706446	6TERMINATED	2011-09-01	2008-06-01	Brigham and Women's Hospital	7OTHER	false	false	false	null	0
[ 3 ]	30	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of advanced or metastatic bladder cancer. The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this patient population. Additionally, this study i...	null	Carcinoma, Transitional Cell Bladder Cancer Bladder Neoplasm	Transitional Cell Carcinoma of the Urinary Bladder Transitional Cell Carcinoma Bladder Cancer Urinary Bladder Cancer Bladder Carcinoma Urinary Metastatic Relapsed	null	1	arm 1: Vitamin B12 : 1 mg intramuscular injection Administered within 10 weeks of enrollment, every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate. Folic Acid: 1-1.25 mg orally Administered daily for at least 7 days prior to enrollment, throughout the study and for at least 30...	[ 5 ]	3	[ 0, 7, 7 ]	intervention 1: Intravenous (IV) push administration over 3-5 minutes via a peripheral IV line containing normal saline (0.9% sodium chloride). Initial dose: 190 mg/m2 Dose reductions per protocol: 150 mg/m2, 120 mg/m2 and 100 mg/m2 will be allowed for defined toxicity. Administered on days 1 and 15 of a 4-week cycl...	intervention 1: Pralatrexate Injection intervention 2: Vitamin B12 intervention 3: Folic Acid	19	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Rosario \| Santa Fe Province \| Argentina \| -60.63932 \| -32.94682 Córdoba \| N/A \| Argent...	30	NCT00722553	1COMPLETED	2011-09-01	2008-07-01	Acrotech Biopharma Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	48	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	false	We propose to study the episode rate, duration, and quantity of HSV-2 genital shedding in patients taking standard, FDA approved, CDC recommended doses of acyclovir (400 mg PO BID) for HSV-2 suppression compared to taking no medication to better define the effect of acyclovir on short bursts of rapidly cleared HSV-2 sh...	We propose to study the episode rate, duration, and quantity of HSV-2 genital shedding in patients taking standard, FDA approved, CDC recommended doses of acyclovir (400 mg PO BID) for HSV-2 suppression compared to taking no medication to better define the effect of acyclovir on short bursts of rapidly cleared HSV-2 sh...	Genital Herpes		null	2	arm 1: None arm 2: None	[ 1, 4 ]	1	[ 0 ]	intervention 1: Acyclovir 400 mg PO BID for 28 days	intervention 1: acyclovir	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	76	NCT00723229	1COMPLETED	2011-09-01	2008-08-01	University of Washington	7OTHER	false	false	false	null	0
[ 4 ]	304	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	Craving for alcohol has been related to loss of control drinking and is a major target of biological and behavioral interventions for alcohol dependence. Our previous research has demonstrated that olanzapine (a dopamine antagonist) attenuates craving for alcohol, that a variant in the gene that expresses D4 receptors ...	The first goal of the study is to determine whether olanzapine is effective at reducing cue-elicited craving (i.e., subjective craving as well as activation of the midbrain and prefrontal cortex after exposure to alcohol cues) for alcohol and reducing alcohol use in a sample of alcohol dependent subjects. The second go...	Alcohol Dependence	Olanzapine	null	3	arm 1: 2.5 mg Olanzapine 1x per day for 12 weeks. arm 2: 5 mg Olanzapine 1x per day for 12 weeks. arm 3: Placebo 1x per day for 12 weeks.	[ 0, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: 2.5 mg intervention 2: 5 mg intervention 3: placebo	intervention 1: 2.5 mg Olanzapine intervention 2: 5mg Olanzapine intervention 3: placebo	1	Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449	129	NCT00746785	1COMPLETED	2011-09-01	2002-09-01	The Mind Research Network	7OTHER	false	false	false	null	0
[ 5 ]	109	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain inadequately controlled despite GINA (2006) step 4 or 5 therapy.	null	Asthma	Inadequately controlled severe asthma	null	2	arm 1: Azithromycin 250 mg 1x/day during 5 days 3x/week afterwards arm 2: Placebo 1x/day during 5 days 3x/week afterwards	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Azithromycin 250 mg three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks intervention 2: Placebo three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks	intervention 1: Azithromycin 250 mg intervention 2: Placebo	7	Aalst \| N/A \| Belgium \| 4.0355 \| 50.93604 Antwerp \| N/A \| Belgium \| 4.40026 \| 51.22047 Bruges \| N/A \| Belgium \| 3.22424 \| 51.20892 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Kortrijk \| N/A \| Belgium \| 3.26487 \| 50.82803 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Roeselare \| N/A \| Belgium \| 3.12269 \| 50.94653	109	NCT00760838	1COMPLETED	2011-09-01	2009-03-01	University Hospital, Ghent	7OTHER	false	false	false	null	0
[ 0 ]	23	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	S-adenosyl-L-methionine (SAMe) is a dietary supplement with antidepressant properties. SAMe's mechanism of action remains unclear, but it appears to be distinct from that of conventional antidepressants. The purpose of this study is to examine the effect of these properties on the mood of bipolar subjects with persiste...	Depression in bipolar disorder is a significant source of disease-related debility; with bipolar individuals typically spending three fold as much time depressed as manic or hypomanic. Clinicians treating bipolar disorder often struggle to provide relief from depressive symptoms that are more often treatment resistant ...	Bipolar Disorder Depression Bipolar Depression	SAMe alternative treatments bipolar disorder depression bipolar depression treatment-resistant depression	null	2	arm 1: SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day "rest-period", before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-w...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day "rest-period", before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a ...	intervention 1: SAMe intervention 2: Placebo	1	Belmont \| Massachusetts \| United States \| -71.17867 \| 42.39593	17	NCT00762268	1COMPLETED	2011-09-01	2008-09-01	Mclean Hospital	7OTHER	false	false	false	null	0
[ 1 ]	35	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	true	0ALL	false	The burden of chronic gingivitis and periodontitis in the US is disproportionately high among Non-Hispanic Blacks compared to Non-Hispanic Whites. Chronic gingivitis is a highly prevalent chronic inflammatory disease that may progress into periodontitis, a major cause of tooth loss, Data from in-vitro and animal studie...	Vitamin D is important for healthy bones. More recently, anti-inflammatory effects of vitamin D have been found in laboratory and animal studies and vitamin D may be beneficial for inflammatory diseases. Gingivitis is a common inflammatory disease of the gums that develops in response to bacterial components in dental ...	Gingivitis	vitamin D gingivitis periodontal disease inflammation	null	4	arm 1: placebo capsule once per day arm 2: vitamin D3, 500 IU capsule once per day arm 3: vitamin D3, 2500 IU capsule once per day arm 4: vitamin D3, 5000 IU capsule once per day	[ 2, 0, 0, 0 ]	2	[ 0, 10 ]	intervention 1: oral supplementation once per day for 12 weeks of different daily doses: 500 IU, 2500 IU, or 5000 IU after abstaining from oral hygiene measures (brushing, flossing or antiseptic mouth rinses) for a period of 4 weeks to allow accumulation of plaque and development of experimental gingivitis. interventio...	intervention 1: vitamin D3 intervention 2: Placebo	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	32	NCT00779909	1COMPLETED	2011-09-01	2008-12-01	Boston University	7OTHER	false	false	false	null	0
[ 2, 3 ]	17	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The study will be a dose-finding, phase I study of the combination of vorinostat and PLD in patients with advanced lymphoma refractory to at least one prior systemic therapy.	The study will also be a dose-escalating study of vorinostat 200mg to 400 mg twice daily for 7 days with PLD 30mg/m2 on day 3 every 21 days, with intrapatient dose escalation. Primary endpoint is progression. All endpoints are observational	Relapsed Lymphomas Refractory Lymphomas	Relapsed Lymphomas Refractory Lymphomas	null	1	arm 1: Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle	[ 0 ]	2	[ 0, 0 ]	intervention 1: 200mg to 400 mg twice daily on days 1-7 intervention 2: IV 30mg/m2 on day 3 of a 21-day cycle	intervention 1: Vorinostat intervention 2: Pegylated Liposomal Doxorubicin (PLD), Doxil	1	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815	17	NCT00785798	6TERMINATED	2011-09-01	2009-01-01	Yale University	7OTHER	false	false	false	null	0
[ 2, 3 ]	37	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study was to assess the safety, tolerability and preliminary efficacy of FP-1201 (Interferon Beta) in patients with Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).	This was a phase I/II open-label study to assess the safety, tolerability and preliminary efficacy of FP-1201 (IFN β-1a) in the treatment of patients with ALI and ARDS. The primary objective in the study was to evaluate the safety and tolerability of FP-1201 in patients with ALI/ARDS and to assess the safety, tolerabi...	Acute Lung Injury Acute Respiratory Distress Syndrome	Open label	null	1	arm 1: Interferon Beta	[ 0 ]	1	[ 0 ]	intervention 1: Interferon Beta administered intravenously daily for 6 days. Doses of 0.12 MIU, 1.2 MIU, 2.7 MIU or 6.0 MIU (dose escalation phase) or 2.7 MIU (dose expansion phase) were administered.	intervention 1: Interferon Beta	8	Cardiff \| N/A \| United Kingdom \| -3.18 \| 51.48 Edinburgh \| N/A \| United Kingdom \| -3.19648 \| 55.95206 Glasgow \| N/A \| United Kingdom \| -4.25763 \| 55.86515 Glasgow \| N/A \| United Kingdom \| -4.25763 \| 55.86515 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 London \|...	37	NCT00789685	1COMPLETED	2011-09-01	2009-02-01	Faron Pharmaceuticals Ltd	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	39	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The goal of this study is to evaluate the safety of melphalan and autologous PBSCT (peripheral blood stem cell transplantation - stem cells that come from your own body) in combination with bortezomib, a new FDA approved drug used to treat myeloma.	null	Cancer Multiple Myeloma	Cancer Multiple Myeloma Peripheral Blood Stem Cell Transplant	null	2	arm 1: Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours before melphalan. arm 2: Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours after melphalan.	[ 1, 1 ]	3	[ 0, 0, 3 ]	intervention 1: Escalating doses of bortezomib 1.0, 1.3, or 1.6 mg/m2 in Arm A and Arm B. intervention 2: All patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. intervention 3: Day 0 consists of the stem cell infusion.	intervention 1: Bortezomib intervention 2: Melphalan intervention 3: Autologous PBSC Transplant	1	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749	39	NCT00793650	6TERMINATED	2011-09-01	2005-05-01	Emory University	7OTHER	false	false	false	null	0
[ 4 ]	15,526	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.	Acute coronary syndrome (ACS) is a serious and life threatening condition. Following an acute coronary syndrome event patients are at risk of important additional clinical events such as death, myocardial infarction, and stroke. Six months after patients present with an index event of ST-segment myocardial infarction, ...	Acute Coronary Syndrome Myocardial Infarction Myocardial Ischemia Unstable Angina	Rivaroxaban Acute Coronary Syndrome ACS Aspirin Thienopyridine Unstable Angina Myocardial Infarction Anticoagulation Clopidogrel (Plavix)	null	3	arm 1: One 2.5 mg rivaroxaban tablet twice daily for up to 6 months arm 2: One 5 mg rivaroxaban tablet twice daily for up to 6 months arm 3: One placebo tablet twice daily for up to 6 months	[ 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: One tablet twice daily intervention 2: One tablet twice daily intervention 3: One placebo tablet twice daily intervention 4: None	intervention 1: Rivaroxaban 2.5 mg intervention 2: Rivaroxaban 5 mg intervention 3: Placebo intervention 4: Standard of care	556	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Geneva \| Alabama \| United States \| -85.86382 \| 31.03296 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Burbank \| California \| United States \| -118.30897 \| 34.18084 Los Angeles \| California \| ...	15,350	NCT00809965	1COMPLETED	2011-09-01	2008-11-01	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	4INDUSTRY	false	false	false	null	0
[ 3 ]	200	RANDOMIZED	PARALLEL	1PREVENTION	1SINGLE	false	0ALL	false	The purpose of this trial is to study the effects of preoperative antithrombin supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order to maintain antithrombin levels in a range greater than 58% of functional activity and, eventually, to decrease negative clinical outcomes during the...	null	Acquired Antithrombin III Deficiency Coronary Artery Bypass	antithrombin ATIII acquired deficiency anticoagulants cardiopulmonary bypass surgery complications postoperative outcomes	null	2	arm 1: Preoperative ATIII supplementation administered immediately after anesthesia induction arm 2: No preoperative ATIII supplementation administered	[ 0, 4 ]	1	[ 0 ]	intervention 1: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%	intervention 1: Antithrombin III	1	Milan \| Lombardy \| Italy \| 9.18951 \| 45.46427	199	NCT00823082	1COMPLETED	2011-09-01	2009-06-01	Instituto Grifols, S.A.	4INDUSTRY	false	false	false	null	0
[ 3 ]	61	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the safety and efficacy of ofatumumab used in combination with ifosfamide, carboplatin, etoposide (ICE) or dexamethasone, cytarabine, cisplatin (DHAP) salvage chemotherapy regimens in subjects with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who are eligible for...	Rituximab combined with anthracycline based chemotherapy is the most common first-line treatment for subjects with diffuse large B cell lymphoma (DLBCL). Subjects requiring second-line therapy will most often receive rituximab in combination with salvage chemotherapy as an induction therapy prior to autologous stem cel...	Lymphoma, Large-Cell, Diffuse	Salvage chemotherapy relapsed grade 3B follicular lymphoma efficacy safety DHAP ofatumumab refractory Non-Hodgkin's Lymphoma Diffuse Large B Cell Lymphoma (DLBCL) Oncology ICE Transformed follicular lymphoma	null	1	arm 1: This study is a single arm study, but the Investigators are required to prospectively choose to treat all of their subjects with either ICE or DHAP chemotherapy regimens in combination with ofatumumab. Regardless of whether the subject receives ICE or DHAP chemotherapy, all subjects will receive the same ofatumu...	[ 0 ]	2	[ 0, 0 ]	intervention 1: 3 cycles of treatment will be administered. Each cycle will last 21 days. ofatumumab dose: cycle 1, day 1 - 1000 milligrams (mg); cycle 1, day 8 - 1000 mg; cycle 2, day 1 and cycle 3, day 1 - 1000 mg ICE regimen: ifosfamide + mesna - 5 grams (g)/meters squared (m\^2)/24 hours (hrs) continuous on day 2...	intervention 1: ofatumumab + ICE intervention 2: ofatumumab + DHAP	0	null	122	NCT00823719	1COMPLETED	2011-09-01	2009-05-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 4 ]	246	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	2MALE	false	The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that...	null	Prostate Cancer		null	2	arm 1: The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 an...	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on D...	intervention 1: Degarelix intervention 2: Goserelin intervention 3: Bicalutamide	66	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Homewood \| Alabama \| United States \| -86.80082 \| 33.47177 Anchorage \| Alaska \| United States \| -149.90028 \| 61.21806 Tuscon \| Arizona \| United States \| N/A \| N/A Lagua Hills \| California \| United States \| N/A \| N/A Murrieta \| California \| United States \| -117....	245	NCT00833248	1COMPLETED	2011-09-01	2009-04-01	Ferring Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	115	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects with SSc and digital ulcers.	null	Systemic Sclerosis	systemic sclerosis scleroderma digital ulcers vasculopathy	null	1	arm 1: Treprostinil diethanolamine sustained release tablet initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).	[ 0 ]	1	[ 0 ]	intervention 1: sustained release tablet; BID dosing; up to 16 mg BID	intervention 1: treprostinil diethanolamine	26	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Farmington \| Connecticut \| United States \| -72.83204 \| 41.71982 Washington D...	115	NCT00848107	6TERMINATED	2011-09-01	2009-09-01	United Therapeutics	4INDUSTRY	false	false	false	null	0
[ 3 ]	9	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by ...	OBJECTIVES: Primary * To determine the overall objective response rate (i.e., complete and partial response) in patients with relapsed or refractory, CD20-positive, diffuse large B-cell lymphoma treated with bortezomib, pegylated liposomal doxorubicin hydrochloride, and rituximab. Secondary * To assess the toxicity...	Lymphoma	recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma anaplastic large cell lymphoma	null	0	null	null	9	[ 2, 0, 0, 6, 6, 6, 6, 10, 10 ]	intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Correlative Study intervention 5: Correlative Study intervention 6: Correlative Study intervention 7: Correlative Study intervention 8: Correlative Study intervention 9: Correlative Study	intervention 1: rituximab intervention 2: bortezomib intervention 3: pegylated liposomal doxorubicin hydrochloride intervention 4: gene expression analysis intervention 5: polymerase chain reaction intervention 6: polymorphism analysis intervention 7: proteomic profiling intervention 8: flow cytometry intervention 9: l...	1	Buffalo \| New York \| United States \| -78.87837 \| 42.88645	9	NCT00851552	6TERMINATED	2011-09-01	2009-01-01	Roswell Park Cancer Institute	7OTHER	false	false	false	null	0
[ 4 ]	112	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This study was the extension of the LANTU\_C\_02761 study named EASIE and identified as NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve patients treated with metformin and not adequately controlled). All patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the cor...	null	Diabetes Mellitus, Type 2		null	1	arm 1: Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration...	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: Subcutaneous injection. 100 Units/mL solution for injection in a prefilled SoloStar® pen (3 mL). intervention 2: Oral administration. 100mg film-coated tablets. intervention 3: Patients continued with metformin as usual oral anti-diabetic treatment.	intervention 1: Insulin Glargine intervention 2: Sitagliptin intervention 3: Metformin	16	Bridgewater \| New Jersey \| United States \| -74.64815 \| 40.60079 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 Bogotá \| N/A \| Colombia \| -74.08175 \| 4.60971 Cairo \| N/A \| Egypt \| 31.24967 \| 30.06263 Kallithea \| N/A \| Greece \| 23.7 \| 37.95 Hong Kong \| N/A \| Hong Kong \| 114.1...	112	NCT00851903	1COMPLETED	2011-09-01	2009-06-01	Sanofi	4INDUSTRY	false	false	false	null	0
[ 5 ]	60	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine wether ketorolac is effective in the treatment of postoperative pain after total knee arthroplasty	null	Postoperative Pain	Total Knee Arthroplasty	null	2	arm 1: None arm 2: None	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: 30 mg (1 ml) infiltration combined with Intraarticular bolus injection of 120 mg (4 ml) ketorolac intervention 2: 1 ml infiltration 4 ml intraarticular bolus injection of placebo	intervention 1: Ketorolac intervention 2: Saline	1	Aarhus \| N/A \| Denmark \| 10.21076 \| 56.15674	60	NCT00868348	1COMPLETED	2011-09-01	2009-05-01	University of Aarhus	7OTHER	false	false	false	null	0
[ 2 ]	2	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is a study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity to continue treatment with study drug. Participants who have not progressed while receiving CS-7017 will continue to benefit from longer ...	This is an open-label non-randomized study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity to continue treatment with study drug.	Advanced Cancer	CS-7017 Advanced Cancer	null	1	arm 1: CS-7017 tablets twice daily at strength ranging from 0.5 mg to 0.75 mg	[ 0 ]	1	[ 0 ]	intervention 1: CS-7017 administered orally, twice daily continuously for 6 weeks	intervention 1: CS-7017	1	Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511	2	NCT00881569	1COMPLETED	2011-09-01	2009-03-01	Daiichi Sankyo	4INDUSTRY	false	false	false	null	0
[ 4 ]	177	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	This two-part study assessed the sustained efficacy of canakinumab in the double-blind Part II and the ability to taper steroids in the open label Part I.	null	Systemic Juvenile Idiopathic Arthritis With Active Flare	Flare arthritis IL-1beta antagonist systemic juvenile idiopathic arthritis Juvenile rheumatoid	null	2	arm 1: In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and th...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Canakinumab 4 mg/kg dose subcutaneous injection supplied as 6 mL glass vials each containing 150 mg canakinumab as a lyophilized cake. intervention 2: Placebo powder matching canakinumab supplied as 6 mL glass vials containing a lyophilized cake for subcutaneous injection every 4 weeks in Part II.	intervention 1: canakinumab intervention 2: placebo	73	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843...	277	NCT00889863	1COMPLETED	2011-09-01	2009-07-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	19	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	This study is a phase II clinical and pharmacokinetic trial of PM00104 (Zalypsis®) in patients with advanced and/or metastatic endometrial or cervical cancer previously treated with one line of systemic chemotherapy to evaluate the antitumor activity and to determine the safety profile, the pharmacokinetic profile and ...	null	Uterine Cervical Cancer Endometrial Cancer	Zalypsis Cancer Endometrial Uterine Cervical PharmaMar	Prot_000.pdf: SPONSOR Pharma Mar, S.A. Avda de los Reyes, 1 Polígono Industrial “La Mina” 28770 Colmenar Viejo (Madrid), Spain Phone: + 34 918 466 000 Fax: + 34 918 466 003 Pharma Mar USA, Inc. One Liberty Plaza, 23rd floor, suite 2335 New York, NY 10006, USA Phone: +1 212 201 6770 Fax: +...	1	arm 1: Zalypsis (PM00104)	[ 0 ]	1	[ 0 ]	intervention 1: Zalypsis (PM00104) (2.5 mg/vial) is provided as a powder for concentrate for solution for infusion	intervention 1: Zalypsis ( PM00104)	4	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	19	NCT00900562	6TERMINATED	2011-09-01	2009-08-01	PharmaMar	4INDUSTRY	true	true	false	https://cdn.clinicaltrials.gov/large-docs/62/NCT00900562/Prot_000.pdf https://cdn.clinicaltrials.gov/large-docs/62/NCT00900562/SAP_001.pdf	0
[ 5 ]	23	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to determine whether botulinum toxin helps patients with bruxism.	Bruxism represents involuntary movements of the jaw muscles, resulting in tooth grinding and clenching. Generally it occurs during sleep, but occasionally can be present during the day, so called awake bruxism. Bruxism is a common condition, affecting approximately 8% of all people. It is not known what causes bruxism ...	Bruxism	bruxism, botulinum toxin, sleep study	null	2	arm 1: Placebo arm arm 2: Active arm	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: Patients are injected with botulinum toxin type A (BOTOX) 60 units in each masseter muscle and 35 in each temporalis muscle, bilaterally. intervention 2: Placebo comparator	intervention 1: Botulinum toxin type A intervention 2: Placebo arm	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	23	NCT00908050	1COMPLETED	2011-09-01	2009-04-01	Baylor College of Medicine	7OTHER	false	false	false	null	0
[ 3 ]	349	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	null	The purpose of this study is to test whether Fondaparinux is effective and safe to prevent thromboembolic events (like for example strokes) and bleeding events in patients who undergo a normalisation of their heart rhythm disturbance. Fondaparinux will be compared with Heparin and tablets containing Vitamin-K-Antagonis...	null	Fibrillation, Atrial	Cardioversion, Electric Pathological Conditions, Sings and Symptoms Cardiovascular Diseases Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac Pathologic Processes Anticoagulants	null	2	arm 1: None arm 2: None	[ 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Comparison of different drugs intervention 2: Comparison of different drugs intervention 3: Comparison of different drugs	intervention 1: fondaparinux intervention 2: unfractionated heparin intervention 3: Vitamin-K-Antagonist	34	Albi \| N/A \| France \| 2.148 \| 43.9298 Antony \| N/A \| France \| 2.29668 \| 48.75329 Brest \| N/A \| France \| -4.48628 \| 48.39029 Créteil \| N/A \| France \| 2.46569 \| 48.79266 Évecquemont \| N/A \| France \| 1.94425 \| 49.01439 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| F...	344	NCT00911300	1COMPLETED	2011-09-01	2009-08-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 5 ]	963	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.	null	Overactive Bladder	incontinence OAB urgency nocturia	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Fesoterodine 4mg and 8 mg tablets taken daily. intervention 2: Placebo sham 4mg and 8 mg tables taken daily.	intervention 1: Fesoterodine intervention 2: Placebo	112	Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Goodyear \| Arizona \| United States \| -112.35821 \| 33.43532 Litchfield Park \| Arizona \| United States \| -112.35794 \| 33.49337 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \|...	937	NCT00911937	1COMPLETED	2011-09-01	2009-08-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 3 ]	7	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Background: * Surgical resection is the treatment of choice for patients with lung cancer, and cure after resection generally depends on whether lymph nodes are involved. A patient with Stage IIIA (N2) lung cancer has cancer in the lymph nodes involving the center of the chest (mediastinum). * Studies have shown that ...	Background: * Stage IIIA-N2 is considered one of the most therapeutically challenging and controversial subsets of lung cancer. This heterogenous group of patients have tumors which range from minimal N2 (found incidentally during or after surgery) to multi-station bulky N2 disease. The extent of mediastinal involveme...	NSCLC Stage IIIA (N2)	Neoadjuvant Stage IIIA (N2) Cisplatin Gemcitabine Bevacizumab Non-Small Cell Lung Cancer NSCLC	Prot_SAP_000.pdf: Protocol Number: 09-C-0107 Version Date 12/22/10 1 PHASE II STUDY OF NEOADJUVANT GEMCITABINE, CISPLATIN AND BEVACIZUMAB IN STAGE IIIA (N2) NON-SQUAMOUS CELL NON-SMALL CELL LUNG CANCER Abbreviated Title: Neoadjuvant therapy in NSCLC Coordinating Center: Center for Cancer Research ...	1	arm 1: Non-squamous cell non small cell lung cancer treated with 1250 mg/m\^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m\^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m\^2 intravenous, and 100 mg/m\^2 etoposid...	[ 0 ]	5	[ 0, 0, 0, 3, 0 ]	intervention 1: 1250 mg/m\^2 dose for two doses on days 1 and 8 intervention 2: 80 mg/m\^2 on day 1 intervention 3: 7.5 mg/m\^2 on day 1 every 21 days for first two cycles only intervention 4: thoracotomy with lobectomy/pneumonectomy and mediastinal lymph node dissection 4-6 weeks post completion of last cycle of cispl...	intervention 1: Gemcitabine intervention 2: Cisplatin intervention 3: Bevacizumab intervention 4: Surgery intervention 5: Etoposide	2	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067 Zagreb \| N/A \| Croatia \| 15.97798 \| 45.81444	7	NCT00924209	6TERMINATED	2011-09-01	2009-03-01	National Cancer Institute (NCI)	0NIH	true	true	true	https://cdn.clinicaltrials.gov/large-docs/09/NCT00924209/Prot_SAP_000.pdf https://cdn.clinicaltrials.gov/large-docs/09/NCT00924209/ICF_001.pdf	0
[ 5 ]	566	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladder (OAB).	null	Overactive Bladder	Urgency Urinary Incontinence OAB	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Fesoterodine 4 mg and 8 mg intervention 2: Placebo sham 4 mg and 8 mg	intervention 1: Fesoterodine intervention 2: Placebo	125	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Green Valley \| Arizona \| United States \| -110.9937 \| 31.85425 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Phoenix \| Arizona \| Uni...	562	NCT00928070	1COMPLETED	2011-09-01	2009-09-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	WHO: The investigators are recruiting children and young adults to participate in a research study who: 1. Have been diagnosed with Alternating Hemiplegia of Childhood (AHC) 2. Are between the ages of 6 months - 25 years old 3. Have at least three 10-minute-long AHC episodes during a typical week 4. Can commit to 12 w...	null	Alternating Hemiplegia of Childhood	phase I/II study effects of sodium oxybate cohort of 6 children and young adults AHC	null	1	arm 1: * The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC. * Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. ...	[ 0 ]	1	[ 0 ]	intervention 1: dosage is by weight	intervention 1: Sodium Oxybate	1	Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078	6	NCT00931164	1COMPLETED	2011-09-01	2009-08-01	University of Utah	7OTHER	false	false	false	null	0
[ 5 ]	17	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	2DOUBLE	true	0ALL	null	Recent data show that marked cell damage precedes the clinical manifestation of Alzheimer's disease (AD). Hence, targeting populations at risk with pharmacological interventions is a possible strategy to lessen the burden of the disease. Cognitively normal individuals with subjective memory complaints (SMC) manifest bi...	null	Alzheimer's Disease	subjective memory complaints cognitively healthy family history AD	null	2	arm 1: after a period of gradual dose increase from 5 mg/day, participants will be asked to take memantine (20mg/day) for 16 weeks 10 mg in the morning, 10 mg at night arm 2: dose increase to match active drug, after that 1 tablet in the morning, 1 tablet at night, to match active drug	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: participants will be asked to take memantine (20mg/day) for 16 weeks intervention 2: participants will be asked to take 2 tablets per day to match active drug	intervention 1: memantine intervention 2: Placebo	1	New York \| New York \| United States \| -74.00597 \| 40.71427	17	NCT00933608	1COMPLETED	2011-09-01	2009-07-01	NYU Langone Health	7OTHER	false	false	false	null	0
[ 0 ]	77	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	Randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (CPB).	This study proposes a randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (CPB). The study will focus on neonates for a few reasons. Although their post-CPB clinical course is typically more severe and intensive care unit (ICU) care more prolo...	Congenital Heart Disease Disorder of Fetus or Newborn	Cardiopulmonary Bypass (CPB) System Inflammatory Response Low Cardiac Output Syndrome (LCOS) in Neonates Methylprednisolone Cardiopulmonary Bypass (CPB) in Neonates Glucocorticoid Use in Neonatal Cardiac Surgery Steroid	null	2	arm 1: Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose intravenous methylprednisolone (IVMP) prior to heart surgery. arm 2: Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypa...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB)machine in the first month of life that receive ONE doses intravenous methylprednisolone (IVMP) prior to heart surgery.Compare the effects and preoperative and intraoperative IVMP (2 dose steroid)to intraope...	intervention 1: methylprednisolone (IVMP) intervention 2: methylprednisolone (two doses IVMP)	1	Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632	76	NCT00934843	1COMPLETED	2011-09-01	2007-03-01	Medical University of South Carolina	7OTHER	false	false	false	null	0
[ 3 ]	54	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva and gemcitabine, and of gemcitabine monotherapy, as first line treatment of elderly patients, or patients with ECOG performance status of 2, with advanced non-small cell lung cancer.Patients will be randomized to receive either s...	null	Non-Small Cell Lung Cancer		null	2	arm 1: None arm 2: None	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 150mg po on days 15-28 of each 4 week cycle intervention 2: 1250mg/m2/day on days 1 and 8 of each 4 week cycle intervention 3: 1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle	intervention 1: erlotinib [Tarceva] intervention 2: gemcitabine intervention 3: gemcitabine	17	Port Macquarie \| New South Wales \| Australia \| 152.90894 \| -31.43084 Randwick \| New South Wales \| Australia \| 151.24895 \| -33.91439 Sydney \| New South Wales \| Australia \| 151.20732 \| -33.86785 Sydney \| New South Wales \| Australia \| 151.20732 \| -33.86785 Tweed Heads \| New South Wales \| Australia \| 153.5452 \| -28.17671 W...	54	NCT00940875	6TERMINATED	2011-09-01	2009-06-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 3 ]	27	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	true	This randomized phase II trial is studying 4-hydroxytamoxifen to see how well it works compared with tamoxifen citrate in treating women with newly diagnosed ductal breast carcinoma in situ. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use...	This is a randomized, double-blind, placebo-controlled presurgical trial of 0.228% 4-hydroxy-tamoxifen (4-OHT) gel vs. oral tamoxifen (TAM) 20 mg daily. The study population will consist of 112 pre- and postmenopausal women with any grade DCIS, ER positive, non-palpable DCIS with no evidence of invasion found on diagno...	Ductal Breast Carcinoma in Situ Estrogen Receptor-positive Breast Cancer		null	2	arm 1: 4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily. arm 2: Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).	[ 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Oral placebo taken daily for 4-10 weeks. intervention 2: 2mg/breast applied daily in the form of a gel for 4-10 weeks. intervention 3: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks. intervention 4: Placebo gel applied to breasts daily for 4-10 weeks.	intervention 1: oral placebo intervention 2: afimoxifene intervention 3: tamoxifen citrate intervention 4: placebo gel	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	26	NCT00952731	1COMPLETED	2011-09-01	2009-12-01	Northwestern University	7OTHER	false	false	false	null	0
[ 4 ]	1,263	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.	null	Diabetes Mellitus, Type 2		null	2	arm 1: patient receives a tablet with intended final marketed dose arm 2: patient receives a tablet identical to those containing Linagliptin	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Placebo, identical to Linagliptin tablet intervention 2: intended final marketed dose	intervention 1: Placebo intervention 2: Linagliptin	169	Escondido \| California \| United States \| -117.08642 \| 33.11921 Escondido \| California \| United States \| -117.08642 \| 33.11921 Fresno \| California \| United States \| -119.77237 \| 36.74773 Greenbrae \| California \| United States \| -122.5247 \| 37.94854 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Ang...	1,261	NCT00954447	1COMPLETED	2011-09-01	2009-08-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 2 ]	59	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 in Asian cancer patients, and to provide safety data in terms of drug-related adverse events.	null	Neoplasms		null	1	arm 1: Schedule A	[ 0 ]	1	[ 0 ]	intervention 1: Dose level 1	intervention 1: BI 6727	2	Tainan City \| N/A \| Taiwan \| 120.21333 \| 22.99083 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306	59	NCT00969553	1COMPLETED	2011-09-01	2009-08-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 3 ]	13	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, wo...	OBJECTIVES: Primary * Estimate the 1-year progression-free survival rate in patients with stage IIIB, stage IV, or recurrent non-squamous cell non-small cell lung cancer treated with bevacizumab, docetaxel, and gemcitabine hydrochloride. Secondary * Evaluate the median time to progression in patients treated with t...	Lung Cancer	recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer large cell lung cancer	null	1	arm 1: Treatment repeats every 21 days for up to 6 courses.	[ 0 ]	3	[ 2, 0, 0 ]	intervention 1: 15 mg/kg on day 1 of a 21-day cycle intervention 2: 75 mg/m2 on day 1 intervention 3: 900 mg/m2 on days 1, and 8,	intervention 1: bevacizumab intervention 2: docetaxel intervention 3: gemcitabine hydrochloride	4	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Mayfield Heights \| Ohio \| United States \| -81.4579 \| 41.51922	13	NCT00970684	1COMPLETED	2011-09-01	2009-09-01	Nathan Pennell, MD, PhD	7OTHER	false	false	false	null	0
[ 0 ]	74,256	RANDOMIZED	null	1PREVENTION	null	false	0ALL	false	The Randomized Evaluation of Decolonization versus Universal Clearance to Eliminate MRSA (REDUCE MRSA) Trial is a cluster randomized trial of the comparative effectiveness of three strategies to prevent methicillin-resistant Staphylococcus aureus (MRSA) in intensive care units. The three strategies to be evaluated are:...	Baseline data involving 12 months of data for participating hospitals (July 2008 - June 2009) was collected prior to randomization to account for size and ICU baseline prevalence of MRSA in randomization scheme. Randomization occurred at the hospital level. Eligibility survey was conducted to determine exclusion crite...	Methicillin-resistant Staphylococcus Aureus	MRSA infection	null	3	arm 1: Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+ arm 2: Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+ arm 3: Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions...	[ 4, 1, 1 ]	1	[ 0 ]	intervention 1: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)	intervention 1: Chlorhexidine bath and nasal mupirocin	42	Anchorage \| Alaska \| United States \| -149.90028 \| 61.21806 Thousand Oaks \| California \| United States \| -118.83759 \| 34.17056 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Brandenton \| Florida \| United States \| N/A \| N/A Brandon \| Florida \| United States \| -82.28592 \| 27.9378 Fort Lauderdale \| Florida \| Uni...	74,256	NCT00980980	1COMPLETED	2011-09-01	2009-09-01	Harvard Pilgrim Health Care	7OTHER	false	false	false	null	0
[ 2, 3 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Clofarabine is approved by the FDA for the treatment of pediatric patients (1 to 21 years of age) with relapsed or refractory ALL. Alemtuzumab is approved by the FDA for treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients over the age of 18. These drugs have been used to treat patients with leukemia in...	The strategy for treating relapsed and refractory adult ALL patients is through reinduction chemotherapy followed by allogeneic stem cell transplantation, provided that the toxicity of the salvage regimen is acceptable. However, this leukemia is characterized as being highly refractory to standard chemotherapy and ther...	Acute Lymphoblastic Leukemia	cancer lymphoblastic leukemia	null	0	null	null	2	[ 2, 0 ]	intervention 1: 3mg day 1,10mg day 2, 30mg day 3, 30mg day 5, 30mg day 8, then three times per calendar week thereafter for a total 12- 30mg doses intervention 2: Dose Escalation Cycle 1 (30 days or until alemtuzumab completed) Clofarabine 10,20,30 or 40 mg/m2 days 5-9 Cycle 2 and subsequent cycles (administered no m...	intervention 1: Alemtuzumab intervention 2: Clofarabine	3	La Jolla \| California \| United States \| -117.2742 \| 32.84727 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571	0	NCT00983528	6TERMINATED	2011-09-01	2009-09-01	University of California, San Diego	7OTHER	false	false	false	null	0
[ 4 ]	833	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	This study aims to investigate how dapagliflozin can control blood sugar in patients with type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with metformin). The effect of dapagliflozin on weight and blood pressure will also be studied.	null	Type 2 Diabetes	Dapagliflozin DPP IV inhibitor add on study Inadequate control	null	2	arm 1: Dapagliflozin 10 mg tablet arm 2: Matching placebo tablet	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 10 mg tablet, oral, once daily, 48 weeks intervention 2: Matching placebo tablet	intervention 1: Dapagliflozin intervention 2: Placebo	88	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Ozark \| Alabama \| United States \| -85.64049 \| 31.45906 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Chula Vista \| California \| United States \| -117.0842 \| 32.64005 Greenbrae \| California \| United States \| -122.5247 \| 37.94854 Laguna Hills \| Calif...	451	NCT00984867	1COMPLETED	2011-09-01	2009-10-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 0 ]	6	NA	SINGLE_GROUP	0TREATMENT	1SINGLE	false	0ALL	true	The aim of this pilot study is to determine if there are any changes in brain glucose metabolism in the gray matter of patients with Phenylketonuria (PKU) and whether administration of Sapropterin (KUVAN) therapy can improve such deficits.	Phenylketonuria (PKU) is an autosomal recessive disorder resulting from a deficiency of phenylalanine hydroxylase, which converts phenylalanine to tyrosine. Phenylalanine hydroxylase is one of the three aromatic amino acid hydroxylases that utilizes tetrahydrobiopterin (BH4) as cofactor. The published reports indicate ...	Phenylketonuria	PKU BH4 KUVAN PET scan Neurodevelopment	null	1	arm 1: All subjects will receive Sapropterin (KUVAN) therapy at a dose of 20/mk/kg/day for four months.	[ 0 ]	1	[ 0 ]	intervention 1: All subjects will receive 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects will be examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing befo...	intervention 1: Sapropterin	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	6	NCT00986973	1COMPLETED	2011-09-01	2010-03-01	Children's Hospital of Philadelphia	7OTHER	false	false	false	null	0
[ 3, 4 ]	21	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to obtain continuous glucose monitoring (CGM) data from individuals taking Welchol compared to placebo. The CGM data will determine the effect on glucose control of adding Welchol to an anti-diabetic medication regimen.	To understand the effect of the addition of colesevelam HCl to oral agent therapy in individuals with type 2 diabetes on glycemic control by utilizing a novel technology, continuous glucose monitoring with ambulatory glucose profile analysis. To date there are no studies of this compound that have employed continuous g...	Type 2 Diabetes		null	2	arm 1: 3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks. arm 2: Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.	[ 2, 2 ]	2	[ 0, 0 ]	intervention 1: 3.75 grams of colesevelam HCl (6 tablets) intervention 2: None	intervention 1: colesevelam HCl intervention 2: placebo	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	42	NCT00993824	1COMPLETED	2011-09-01	2009-09-01	HealthPartners Institute	7OTHER	false	false	false	null	0
[ 3 ]	53	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this trial was to examine the safety and tolerability, pharmacokinetics of FE 202158 and to assess whether it can stabilize blood pressure and reduce vascular (blood vessel) leakage. FE 202158 had previously been tested in healthy volunteers.	This was a multi-centre, double-blind, randomized, placebo-controlled, parallel group trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of FE 202158 (using three ascending doses) in patients with vasodilatory hypotension in early septic shock, when given as continuous infusion for up ...	Septic Shock	V1a agonist	null	4	arm 1: Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min. FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use. arm 2: Patients in the arm received an intrav...	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 10 ]	intervention 1: FE 202158 at dose 1.25 ng/kg/min infused. intervention 2: FE 202158 at dose 2.5 ng/kg/min infused. intervention 3: FE 202158 at dose 3.75 ng/kg/min infused. intervention 4: Isotonic saline infused.	intervention 1: FE 202158 1.25 intervention 2: FE 202158 2.5 intervention 3: FE 202158 3.75 intervention 4: Placebo	16	Newark \| Delaware \| United States \| -75.74966 \| 39.68372 Springfield \| Massachusetts \| United States \| -72.58981 \| 42.10148 Duluth \| Minnesota \| United States \| -92.10658 \| 46.78327 Camden \| New Jersey \| United States \| -75.11962 \| 39.92595 New York \| New York \| United States \| -74.00597 \| 40.71427 Houston \| Texas \| Un...	52	NCT01000649	1COMPLETED	2011-09-01	2009-11-01	Ferring Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	233	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	1FEMALE	true	The primary purpose of this study is to help answer the following research questions: 1. How teriparatide given using a skin patch (transferred through the skin using the ViaDerm Teriparatide System) compares to teriparatide injected under the skin with a needle (pen injector) affects your bone density (how solid or p...	Teriparatide 20 micrograms (mcg) per day is currently only available as a subcutaneous (SQ) injection and many patients with severe osteoporosis for whom anabolic therapy with teriparatide is appropriate are either unwilling or physically unable to self-inject. The purpose of this Phase 2 study is to identify a transde...	Osteoporosis	Age Related Osteoporosis Senile Osteoporosis	null	4	arm 1: Received 20 micrograms (mcg) subcutaneously once daily in an unblinded manner. arm 2: Received 30 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. arm 3: Received 50 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Par...	[ 1, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Administered subcutaneously once daily for 12 months intervention 2: Administered transdermally, applied once daily for 6 hours over 12 months	intervention 1: Subcutaneous Teriparatide intervention 2: Transdermal Teriparatide	18	Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Pärnu \| N/A \| Estonia \| 24.49711 \| 58.38588 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Tartu \| N/A \| Estonia \| 26.72509 \| 58.38062 Balatonfüred \| N/A \| Hungary \| 17.87187 \| 46.96188 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Debrecen \| N/A \| Hungary \| 21.624...	231	NCT01011556	1COMPLETED	2011-09-01	2009-11-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 0 ]	59	RANDOMIZED	PARALLEL	9OTHER	2DOUBLE	true	0ALL	true	Insomnia and other sleep abnormalities are common, persistent, and associated with relapse in alcohol-dependent patients. The overall, long-term objectives of the proposed research are to investigate the neurophysiologic mechanisms of sleep disturbance that are associated with relapse in patients with alcohol dependenc...	null	Alcohol Dependence Insomnia	Alcoholism Alcohol dependence Insomnia Dim light melatonin onset Gabapentin	null	2	arm 1: After 3 nights in the UM sleep lab and randomization, this arm receives placebo for one week. They then return to the sleep lab for the same procedures. arm 2: After spending 3 baseline nights in the UM sleep lab, alcohol dependent subjects are randomized. This arm receives gabapentin . On nights 1 and 2 of medi...	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: Placebo for 11 days, (one pill at bedtime on nights 1 and 2, 2 pills at bedtime on nights 3-10, and 1 pill at bedtime on night 11, then D/C). They return to the Sleep Lab for polysomnography on nights 8 - 10 of medication so their sleep data can be compared. intervention 2: After spending 3 baseline nig...	intervention 1: Placebo dispensed to subject. intervention 2: Gabapentin dispensed to subject.	1	Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756	59	NCT01014533	1COMPLETED	2011-09-01	2007-05-01	Dr. Kirk Brower	7OTHER	false	false	false	null	0
[ 5 ]	112	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substan...	Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substan...	Smoking Cessation Substance-Related Disorders	methadone maintenance	null	2	arm 1: Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12 arm 2: Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day intervention 2: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily	intervention 1: Varenicline intervention 2: Placebo	1	The Bronx \| New York \| United States \| -73.86641 \| 40.84985	112	NCT01027754	1COMPLETED	2011-09-01	2009-08-01	Albert Einstein College of Medicine	7OTHER	false	false	false	null	0
[ 3 ]	68	RANDOMIZED	PARALLEL	1PREVENTION	3TRIPLE	true	2MALE	true	This is an exploratory mixed-methods research study that compares an efficacious behavioral HIV-prevention intervention (3MV) alone to the behavioral HIV-prevention intervention combined with a biomedical intervention (PrEP). After completing the 3MV behavioral intervention, participants will be randomly assigned to on...	null	HIV	Pre-exposure prophylaxis HIV Prevention Truvada Many Men, Many Voices Emtricitabine Tenofovir disoproxil fumarate Young men who have sex with men HIV Seronegativity	null	3	arm 1: Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention arm 2: Blinded administration of placebo pill; HIV behavioral intervention arm 3: Subjects receive HIV behavioral intervention but no pill.	[ 0, 2, 1 ]	3	[ 0, 0, 5 ]	intervention 1: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks. intervention 2: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks. intervention 3: Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collecte...	intervention 1: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP intervention 2: Placebo intervention 3: Many Men, Many Voices (3MV)	2	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	58	NCT01033942	1COMPLETED	2011-09-01	2009-08-01	University of North Carolina, Chapel Hill	7OTHER	false	false	false	null	0
[ 5 ]	54	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This randomized, double-blind, placebo-controlled study will use Magnetic Resonance Imaging (MRI) to assess the efficacy of tocilizumab plus non-biological DMARD in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to non-biological DMARDS. Patients will be randomized to receive ...	null	Rheumatoid Arthritis		null	2	arm 1: None arm 2: None	[ 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: 8mg/kg (minimal dose 480mg, maximum dose 800mg) iv infusion every 4 weeks for 24 weeks intervention 2: iv every 4 weeks for 24 weeks intervention 3: stable dose at investigator's prescription	intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: placebo intervention 3: non-biological DMARDs	11	Almada \| N/A \| Portugal \| -9.1569 \| 38.67902 Coimbra \| N/A \| Portugal \| -8.41955 \| 40.20564 Coimbra \| N/A \| Portugal \| -8.41955 \| 40.20564 Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 P...	54	NCT01034397	1COMPLETED	2011-09-01	2010-03-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 4 ]	331	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. The purpose of this study is to investigate safety (side effects) asso...	null	Postoperative Pain Abdominal Surgery	Postoperative pain Post-operative pain Opioid Laparoscopic surgery Bupivacaine Local anesthetic	null	3	arm 1: SABER-Bupivacaine arm 2: Bupivacaine HCl arm 3: SABER-Placebo	[ 0, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Injectable Extended Release Solution; SABER-Bupivacaine /Once intervention 2: Injectable Solution; Bupivacaine HCl /Once intervention 3: Injectable Solution; SABER-Placebo/Once	intervention 1: SABER-Bupivacaine intervention 2: Bupivacaine HCl intervention 3: SABER-Placebo	26	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Florence \| Alabama \| United States \| -87.67725 \| 34.79981 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Sheffield \| Alabama \| United S...	305	NCT01052012	1COMPLETED	2011-09-01	2009-12-01	Durect	4INDUSTRY	false	false	false	null	0
[ 4 ]	936	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This multicenter, double-blind, randomized, placebo-controlled study will evaluate the effect of dalcetrapib 600 mg on artherosclerotic disease progression, lipid profile and biomarker profile and long-term safety profile of dalcetrapib in patients with coronary artery disease. Atherosclerotic disease progression will ...	null	Cardiovascular Disease		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Dalcetrapib 600 mg orally once daily intervention 2: Placebo orally once daily	intervention 1: Dalcetrapib intervention 2: Placebo	110	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Torrance \| California \| United States \| -118.34063 \| 33.83585 Boulder \| Colorado \| United States \| -105.27055 \| 40.01499 Greeley \| Colorado \| United States \| -104.70913 \| 40.42331 Littleton ...	936	NCT01059682	6TERMINATED	2011-09-01	2010-01-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 4 ]	495	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	2MALE	false	The purpose of this study is to evaluate the efficacy and safety of dapoxetine compared to placebo in men with premature ejaculation and erectile dysfunction who are currently being treated with a phosphodiesterase-5 inhibitor (ie, sildenafil, vardenafil, or tadalafil) for erectile dysfunction.	Premature ejaculation (PE) and erectile dysfunction (ED) are forms of sexual dysfunction in men. An objective measurement of PE in clinical studies is the intravaginal ejaculatory latency time (IELT), which is the time it takes for a man to ejaculate during sexual intercourse (as measured by stopwatch). This is a multi...	Erectile Dysfunction Sexual Dysfunction	Erectile Dysfunction Sexual Dysfunction Dapoxetine hydrochloride PRILIGY Premature ejaculation Serotonin Uptake Inhibitors Sildenafil (Viagra) Vardenafil (Levitra) Tadalafil (Cialis)	null	2	arm 1: Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + a PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction. arm 2: Placebo tablets identical in appearance to d...	[ 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks. intervention 2: 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for...	intervention 1: Placebo intervention 2: Dapoxetine intervention 3: PDE5I (phosphodiesterase-5 inhibitor)	69	Decatur \| Alabama \| United States \| -86.98334 \| 34.60593 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Englewood \| Colorado \| United States \| -104.98776 \| 39.64777 Aventura \| Florida \| United States \| -80.13921 \| 25.95648 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Gainesville \| Florida \| Un...	495	NCT01063855	1COMPLETED	2011-09-01	2010-04-01	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	4INDUSTRY	false	false	false	null	0
[ 4 ]	600	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	false	Depomed's Gabapentin Extended Release is an investigational, extended release formulation of Gabapentin that is being studied for the treatment of Hot Flashes/Hot Flushes in postmenopausal women	The primary study objective is to assess the efficacy of G-ER dosed at 1800mg daily (600mg AM, 1200mg PM), compared to placebo in reducing the average daily frequency and severity score of moderate to severe hot flashes in postmenopausal women at weeks 4 \& 12 of the efficacy treatment period, compared with baseline.	Hot Flashes	Hot Flushes Vasomotor Symptoms Menopausal Hot Flashes	null	2	arm 1: Active treatment arm 2: Placebo	[ 0, 5 ]	2	[ 0, 0 ]	intervention 1: Gabapentin ER 1800mg daily intervention 2: Sugar pill	intervention 1: Gabapentin Extended Release intervention 2: Placebo	66	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| Uni...	595	NCT01080300	1COMPLETED	2011-09-01	2010-08-01	Depomed	4INDUSTRY	false	false	false	null	0
[ 4 ]	284	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The objective of this study is to evaluate the clinical efficacy and safety of SPM962 in patients with restless legs syndrome (RLS) with once-daily repeated doses of 4.5mg and 6.75mg during a 13-week dose-titration and maintenance period. This is a multi-center, randomized, placebo-controlled, double-blind, 3-armed par...	null	Idiopathic Restless Legs Syndrome		null	3	arm 1: started at 2.25 mg/day to 4.5 mg/day for 13 weeks arm 2: started at 2.25 mg/day to 6.75 mg/day for 13 weeks arm 3: for 13 weeks	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: once a daily transdermal administration started at 2.25 mg/day to 4.5 mg/day for 13 weeks intervention 2: once a daily transdermal administration started at 2.25 mg/day to 6.75 mg/day for 13 weeks intervention 3: once a daily transdermal administration for 13 weeks	intervention 1: SPM 962 intervention 2: SPM 962 intervention 3: Placebo of SPM 962	8	Chubu Region \| N/A \| Japan \| N/A \| N/A Chugoku Region \| N/A \| Japan \| N/A \| N/A Hokkaido Region \| N/A \| Japan \| N/A \| N/A Kansai Region \| N/A \| Japan \| N/A \| N/A Kanto Region \| N/A \| Japan \| N/A \| N/A Kyushu Region \| N/A \| Japan \| N/A \| N/A Shikoku Region \| N/A \| Japan \| N/A \| N/A Tohoku Region \| N/A \| Japan \| N/A \| N/...	284	NCT01084551	1COMPLETED	2011-09-01	2010-02-01	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	0
[ 5 ]	16	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	3TRIPLE	true	0ALL	false	We are studying if putting a gel capsule over a standard HIV drug changes the ability of the body to absorb the drug. This is important because we want to be able to study new HIV drugs against the most common drugs used today and the most common is Sustiva, which is also called efavirenz. We will give you Sustiva ever...	null	HIV HIV Infections	efavirenz Sustiva pharmacokinetics	null	2	arm 1: None arm 2: None	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Subject will take efavirenz for 5 days. intervention 2: Subject will take efavirenz that has been over-encapsulated with a gel capsule for 5 days.	intervention 1: Efavirenz intervention 2: Over-encapsulated efavirenz	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	15	NCT01087814	1COMPLETED	2011-09-01	2010-02-01	University of Minnesota	7OTHER	false	false	false	null	0
[ 2 ]	46	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study will test a new cancer medication to determine if this medication will block blood supply to a tumor and decrease growth of a tumor. This study will also define the safety profile and define the safest dose of this new medication for people who have cancer.	null	Neoplasm	VGEF inhibitor Anti angiogenesis Advanced Solid Tumors	null	10	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None arm 9: None arm 10: None	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	10	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: 0.67mg Capsule Once Daily (Accelerated Dose Escalation) Continuous intervention 2: 1mg Capsule Once Daily (Dose Escalation) Continuous intervention 3: 2mg Capsule Once Daily (Dose Escalation) Continuous intervention 4: 4mg Capsule Once Daily (Dose Escalation) Continuous intervention 5: 6mg Capsule Once ...	intervention 1: PF-00337210 intervention 2: PF-00337210 intervention 3: PF-00337210 intervention 4: PF-00337210 intervention 5: PF-00337210 intervention 6: PF-00337210 intervention 7: PF-00337210 intervention 8: PF-00337210 intervention 9: PF-00337210 intervention 10: PF-00337210	3	Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	46	NCT01105533	1COMPLETED	2011-09-01	2006-05-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 4 ]	137	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for th...	The study will be organized as follows: * Screening Phase * Single-blind Prospective Treatment Phase * Single-blind Continuation Phase (Responder)or Double-blind Randomization Phase (non-Responder) * 30 day Post Treatment Follow-up Assigned Interventions: * Escitalopram monotherapy * Aripiprazole/Escitalopram combin...	Major Depressive Disorder (MDD)	Major Depressive Disorder MDD Depression	null	5	arm 1: Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the Week 1 (end of Week 1) based upon tolerability profile, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8)...	[ 0, 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Escitalopram capsule administered orally, once daily without regard to meals. intervention 2: Aripiprazole capsule administered orally, once daily without regard to meals.	intervention 1: Escitalopram intervention 2: Aripiprazole	53	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Chino \| California \| United States \| -117.68894 \| 34.01223 Riverside \| California \| United States \| -117.39616 \| 33.95335 Torrance \| California \| United States \| -118.34063 \| 33.83585 Hamden \| Connecticut \| United States \| -72.89677 \| 41.39593 Marietta \| Georgia ...	208	NCT01111565	6TERMINATED	2011-09-01	2010-10-04	Otsuka Pharmaceutical Development & Commercialization, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	62	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to investigate the safety, tolerability, pharmacodynamics (how the study medication affects the body) and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time) of an intravenous administration of JNJ-39588146 or pl...	This study will assess the safety, tolerability, pharmacodynamics and pharmacokinetics of JNJ-39588146 or placebo (which looks like the drug being studied but has no active ingredients) in patients with heart failure. This study is being conducted in two parts. Part 1 is a randomized (study drug will be assigned by cha...	Heart Failure	Heart Failure Cardiac Failure	null	2	arm 1: 3 consecutive 1-hour infusions of JNJ-39588146 5, 15, or 30 ng/kg/min or matching placebo arm 2: 1 18-hr infusion of JNJ-39588146 of the highest tolerated dose from Part 1 of the study or matching placebo	[ 0, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: 1-hour infusion of JNJ-39588146 5 ng/kg/min on Day 1 intervention 2: 1-hour infusion of JNJ-39588146 15 ng/kg/min on Day 1 intervention 3: 1-hour infusion of JNJ-39588146 30 ng/kg/min on Day 1 intervention 4: 1-hour infusion of matching placebo on Day 1 intervention 5: 18-hour infusion of JNJ-39588146 o...	intervention 1: JNJ-39588146 5 ng/kg/min intervention 2: JNJ-39588146 15 ng/kg/min intervention 3: JNJ-39588146 30 ng/kg/min intervention 4: Placebo intervention 5: JNJ-39588146 5, 15, or 30 ng/kg/min	9	Aalst \| N/A \| Belgium \| 4.0355 \| 50.93604 B-1070 Bruxelles \| N/A \| Belgium \| N/A \| N/A Genk \| N/A \| Belgium \| 5.50082 \| 50.965 Bad Nauheim \| N/A \| Germany \| 8.73859 \| 50.36463 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1 Bucharest \| N/...	62	NCT01120210	1COMPLETED	2011-09-01	2010-06-01	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	4INDUSTRY	false	false	false	null	0
[ 3 ]	2	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This is an exploratory clinical investigation. The objectives of this study are to evaluate the safety, steady-state pharmacokinetics, and efficacy of metyrosine (Demser®) for the treatment of psychosis in patients with velocardiofacial syndrome (VCFS).	null	Velo-cardio-facial Syndrome Psychosis	Patients with velocardiofacial syndrome and psychosis	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Metyrosine (250 mg capsules) were to be used at all dose levels (administered as multiples of that dosing unit). The starting dose was 250 mg/day of metyrosine. Dose escalation was to be carried out weekly for 8 weeks (up to a maximum of 8 capsules/day \[2000 mg/day if metyrosine\]) with dosage incremen...	intervention 1: Metyrosine intervention 2: Placebo	1	Syracuse \| New York \| United States \| -76.14742 \| 43.04812	2	NCT01127503	6TERMINATED	2011-09-01	2010-06-01	Bausch Health Americas, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	841	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.	This randomized, open-label, multicenter, 2 parallel-group study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with liraglutide. Subjects with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen...	Diabetes Mellitus, Type 2	GSK716155 liraglutide albiglutide open-label	null	2	arm 1: weekly albiglutide subcutaneous injection arm 2: liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.	[ 0, 1 ]	2	[ 2, 0 ]	intervention 1: albiglutide weekly subcutaneous injection intervention 2: liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.	intervention 1: albiglutide intervention 2: liraglutide	173	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Gilbert \| Arizona \| United States \| -111.78903 \| 33.35283 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Searcy \| Arkansas \| United S...	812	NCT01128894	1COMPLETED	2011-09-01	2010-05-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 0 ]	20	RANDOMIZED	CROSSOVER	2DIAGNOSTIC	2DOUBLE	true	1FEMALE	false	The purpose of this study is to assess the effect that Celebrex (a COX-2 inhibitor and non-steroidal anti-inflammatory drug) has on ovulation.	A prospective randomized double-blind crossover study of healthy reproductive-aged (18-35 years old) women with regular cycles, not currently using or needing hormonal contraception, were recruited. Women will undergo ovarian ultrasound and serum hormone monitoring during four menstrual cycles (control cycle, treatment...	Ovulation Luteal Development	Celebrex prostoglandin inhibitor ovulation emergency contraception	null	3	arm 1: Control menstrual cycle arm 2: Pre-LH surge dosing of celecoxib arm 3: Post-LH surge dosing of celecoxib	[ 4, 0, 0 ]	2	[ 0, 0 ]	intervention 1: 400 mg PO daily intermittently based on hormone and ultrasound findings intervention 2: Placebo identical to celecoxib	intervention 1: Celebrex intervention 2: Placebo	1	Portland \| Oregon \| United States \| -122.67621 \| 45.52345	60	NCT01129245	1COMPLETED	2011-09-01	2009-09-01	Oregon Health and Science University	7OTHER	false	false	false	null	0
[ 5 ]	15	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study will examine the safety and effectiveness of ACTHAR Gel, when used to treat 15 patients diagnosed with "treatment resistant nephrotic syndrome." Nephrotic syndrome is a group of symptoms that includes low levels of protein in the blood, swelling of tissue (edema), especially around the eyes, feet and hands;...	The nephrotic syndrome is characterized by heavy proteinuria, edema, hyperlipidemia, and a thrombotic tendency. Membranous nephropathy, focal segmental glomerulosclerosis, resistant minimal change disease, and Immunoglobulin A (IgA) nephropathy (also known as Berger's disease) are the common forms of idiopathic nephrot...	Treatment Resistant Nephrotic Syndrome	Treatment Resistance Nephrotic Syndrome Focal Segmental Glomerulosclerosis lipoid nephrosis Membranous nephropathy IgA nephropathy proteinuria	null	1	arm 1: Patients will be treated with ACTHAR gel starting with 40 units given twice weekly subcutaneously for two weeks, then 80 units given twice weekly subcutaneously afterwards for a period of up to six months.	[ 0 ]	1	[ 0 ]	intervention 1: Patients will be treated with ACTHAR gel starting with 40 units given twice weekly subcutaneously for two weeks, then 80 units given twice weekly subcutaneously afterwards for a period of up to six months.	intervention 1: ACTHAR gel	1	New York \| New York \| United States \| -74.00597 \| 40.71427	15	NCT01129284	1COMPLETED	2011-09-01	2009-12-01	Columbia University	7OTHER	false	false	false	null	0
[ 0 ]	5	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study is designed to evaluate the safety and efficacy of an oral medicine (called apremilast) for treating skin involvement in patients with the disease dermatomyositis.	null	Dermatomyositis		null	1	arm 1: apremilast 20mg bid	[ 0 ]	1	[ 0 ]	intervention 1: Apremilast 20mg PO BID	intervention 1: Apremilast	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	5	NCT01140503	6TERMINATED	2011-09-01	2010-02-01	Stanford University	7OTHER	false	false	false	null	0
[ 0 ]	10	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to develop biomarkers for central nervous system BH4 concentration in children with autism so they can be easily screened to determine if they may benefit from BH4 supplementation. Kuvan is a synthetic form of BH4. BH4 is an enzyme cofactor that is essential for several critical metabolic f...	SUMMARY PURPOSE: The purpose of this study is to develop biomarkers for central nervous system BH4 concentration in children with autism so they can be easily screened to determine if they may benefit from BH4 supplementation. Kuvan is a synthetic form of BH4. BH4 is an enzyme cofactor that is essential for several cr...	Autism Spectrum Disorder		null	1	arm 1: Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.	[ 0 ]	1	[ 0 ]	intervention 1: Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.	intervention 1: sapropterin dihydrochloride	1	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648	10	NCT01141595	1COMPLETED	2011-09-01	2010-07-01	The University of Texas Health Science Center, Houston	7OTHER	false	false	false	null	0
[ 0 ]	78	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	1FEMALE	true	Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.	There are currently 2 intrauterine devices (IUDs) available in the U.S., the copper T380 (paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to tubal sterilization\[1\], with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent y...	Contraception	IUD insertion nulliparous women contraception family planning IUD insertion in nulliparous women	null	2	arm 1: Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit arm 2: Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit intervention 2: Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit	intervention 1: Misoprostol intervention 2: Placebo	1	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749	73	NCT01147497	1COMPLETED	2011-09-01	2010-06-01	Emory University	7OTHER	false	false	false	null	0
[ 4 ]	3,236	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	Primary Objective: * Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation \[AF\] and additi...	The study period per participant was variable depending on the enrollment in the study. A final follow-up visit had to occur within 1 month after the CSED.	Atrial Fibrillation		null	2	arm 1: Dronedarone 400 mg twice a day until the CSED arm 2: Placebo (for Dronedarone) twice a day until the CSED	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Film-coated tablet Oral administration under fed conditions (during breakfast and dinner) intervention 2: film-coated tablet strictly identical in appearance Oral administration under fed conditions (during breakfast and dinner)	intervention 1: Dronedarone intervention 2: Placebo (for Dronedarone)	37	Bridgewater \| New Jersey \| United States \| -74.64815 \| 40.60079 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Macquarie Park \| N/A \| Australia \| 151.12757 \| -33.78105 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Diegem \| N/A \| Belgium \| 4.43354 \| 50.89727 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 Sofia \|...	3,223	NCT01151137	6TERMINATED	2011-09-01	2010-07-01	Sanofi	4INDUSTRY	false	false	false	null	0
[ 3 ]	10	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The primary aim of the study is to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during RHC. Secondary considerations are to confirm that inhaled NO generated by the GeNO nitrosyl delivery system, reduces PVR in patients with reversible PH, contains levels of NO2 well bel...	Investigational product will be administered by qualified study staff in accordance with the procedures described in the protocol and in accordance with the detailed set of instructions supplied with the initial shipment of investigational product. Nitric oxide, 80 ppm in air or oxygen will be administered using the G...	Pulmonary Arterial Hypertension		null	1	arm 1: 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM	[ 0 ]	1	[ 0 ]	intervention 1: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM.	intervention 1: Nitric Oxide	1	Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389	10	NCT01165047	1COMPLETED	2011-09-01	2010-09-01	Wake Forest University Health Sciences	7OTHER	false	false	false	null	0
[ 3 ]	5	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The study objectives of this study are to determine the effects, safety, and pharmacokinetics of bendamustine for multiple myeloma to a regimen of bendamustine and prednisolone.	The study objectives of this study are to determine the effects, safety, and pharmacokinetics of bendamustine for untreated and maladjustment to hematopoietic stem cell transplantation (HSCT) multiple myeloma to a regimen of bendamustine and prednisolone.	Multiple Myeloma	Multiple Myeloma	null	1	arm 1: SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to a...	[ 0 ]	2	[ 0, 0 ]	intervention 1: SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration o...	intervention 1: SyB L-0501 intervention 2: prednisolone	3	Nagoya \| Aichi-ken \| Japan \| 136.90641 \| 35.18147 Fukuoka \| Fukuoka \| Japan \| 130.41667 \| 33.6 Isehara \| Kanagawa \| Japan \| 139.31019 \| 35.39932	5	NCT01179490	6TERMINATED	2011-09-01	2010-09-01	SymBio Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 4 ]	295	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.	A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy	Major Depressive Disorder Depression	Major Depressive Disorder MDD Depression Safety add-on therapy	null	2	arm 1: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID arm 2: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Tablet, oral, twice daily for 8 weeks intervention 2: Tablet, oral, twice daily for 8 weeks	intervention 1: TC-5214 intervention 2: Placebo	66	Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Kutná Hora \| N/A \| Czechia \| 15.26816 \| 49.94839 Litoměřice \| N/A \| Czechia \| 14.1318 \| 50.53348 Pilsen \| N/A \| Czechia \| 13.37759 \| 49.74747 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Praha 10 - Strasnice \| N/A \| Czechia \| N/A \| N/A Tartu \| Estonia \| Estonia \| 26.72509 \| 58...	293	NCT01180400	1COMPLETED	2011-09-01	2010-09-01	AstraZeneca	4INDUSTRY	false	false	false	null	-0
[ 4 ]	917	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides)	null	Facial Rhytides Crow's Feet Lines Glabellar Lines		null	3	arm 1: 44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. arm 2: 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilate...	[ 0, 5, 2 ]	3	[ 2, 2, 0 ]	intervention 1: 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart. intervention 2: 44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's...	intervention 1: onabotulinumtoxinA 24 U intervention 2: onabotulinumtoxinA 44 U intervention 3: normal saline	4	Newport Beach \| California \| United States \| -117.92895 \| 33.61891 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Antibes \| N/A \| France \| 7.12487 \| 43.58127 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437	917	NCT01189760	1COMPLETED	2011-09-01	2010-09-01	Allergan	4INDUSTRY	false	false	false	null	0
[ 3 ]	6	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	null	This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.	null	Endometriosis	Endometriosis Infertility Pain Vaginal Diseases Uterine Diseases	null	3	arm 1: 1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules. arm 2: 1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules arm 3: 1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: Active treatment with a high dose of BGS649 intervention 2: Active treatment with a low dose of BGS649 intervention 3: Placebo treatment to blind study	1	Anaheim \| California \| United States \| -117.9145 \| 33.83529	6	NCT01190475	1COMPLETED	2011-09-01	2010-07-01	Mereo BioPharma	4INDUSTRY	false	false	false	null	0
[ 4 ]	471	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy (SLIT) administered to children and adolescents as allergen-based tablets once daily over a period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication use.	After the screening period, the patients will be administered 300 IR house dust mite allergen based tablets or placebo, once a day, for a period of 36 months with two windows of 8 months and 6 months without treatment. The carry over effect will be evaluated after a treatment free follow up period of 24 months. An ind...	Allergic Rhinitis Due to Dust Mite		null	2	arm 1: 300 IR house dust mites allergen extract tablet arm 2: Placebo tablet	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: One sublingual tablet daily for one year. intervention 2: One sublingual tablet daily for one year.	intervention 1: 300 IR house dust mites allergen extract tablet intervention 2: Placebo tablet	0	null	471	NCT01199133	6TERMINATED	2011-09-01	2009-10-01	Stallergenes Greer	4INDUSTRY	false	false	false	null	0
[ 5 ]	65	RANDOMIZED	PARALLEL	2DIAGNOSTIC	0NONE	false	0ALL	true	A higher degree of platelet inhibition remains the goal of peri-interventional and long-term anti-thrombotic therapy in patients with coronary artery disease. In clinical practice, patients undergoing percutaneous coronary intervention with stent implantation who are already on clopidogrel therapy get re-loaded with cl...	null	Coronary Artery Disease	coronary artery disease percutaneous coronary revascularization prasugrel therapy	null	3	arm 1: Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel arm 2: Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel arm 3: Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel	[ 1, 1, 4 ]	1	[ 0 ]	intervention 1: Prasugrel 10mg, 30mg, or 60mg	intervention 1: Prasugrel	1	Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218	65	NCT01201772	1COMPLETED	2011-09-01	2010-08-01	University of Florida	7OTHER	false	false	false	null	0
[ 5 ]	30	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with neuropathic pain.	Neuropathic pain state is usually refractory to most analgesic regimens and requires polypharmacy for symptomatic relief. Current treatment options for neuropathic pain include both oral and topical medications. Most commonly prescribed oral treatments include antidepressants (eg, amitriptyline, desipramine, and duloxe...	Neuropathic Pain	Pain Neuropathy Neuropathic Pain Hydromorphone	null	1	arm 1: None	[ 1 ]	1	[ 0 ]	intervention 1: Oral hydromorphone extended release, once daily	intervention 1: Hydromorphone	1	Leawood \| Kansas \| United States \| -94.6169 \| 38.96667	30	NCT01207596	1COMPLETED	2011-09-01	2010-09-01	International Clinical Research Institute	7OTHER	false	false	false	null	0
[ 5 ]	251	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the effects of Succinate Metoprolol(Betaloc ZOK®) (95 - 190 mg) on heart rate in the Stable angina patients.	null	Angina Pectoris	angina pectoris chest pain heart rate	null	2	arm 1: None arm 2: None	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure\<100mmHg and heart rate \<45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks intervention 2: Treatment with 95mg for two weeks, and if tolerated an...	intervention 1: Succinate Metoprolol (Betaloc ZOK®) intervention 2: Succinate Metoprolol (Betaloc ZOK®)	10	Beijing \| Beijing Municipality \| China \| 116.39723 \| 39.9075 Guangzhou \| Guangdong \| China \| 113.25 \| 23.11667 Tangshan \| Hebei \| China \| 118.18319 \| 39.64381 Zhengzhou \| Henan \| China \| 113.64861 \| 34.75778 Nanjing \| Jiangsu \| China \| 118.77778 \| 32.06167 Jingzhou \| Liaoning \| China \| 121.32528 \| 41.36028 Shenyang \| L...	251	NCT01213173	1COMPLETED	2011-09-01	2010-10-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 0 ]	238	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.	null	Glaucoma Ocular Hypertension		null	2	arm 1: One drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks. arm 2: One drop of brimonidine tartrate ophthalmic solution (Alphagan®)...	[ 5, 1 ]	4	[ 0, 0, 0, 10 ]	intervention 1: One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks. intervention 2: One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice dail...	intervention 1: brimonidine tartrate/timolol fixed combination ophthalmic solution intervention 2: brimonidine tartrate ophthalmic solution intervention 3: timolol ophthalmic solution intervention 4: fixed combination vehicle	1	Guangzhou \| Guangdong \| China \| 113.25 \| 23.11667	236	NCT01229462	1COMPLETED	2011-09-01	2010-10-01	Allergan	4INDUSTRY	false	false	false	null	0
[ 3 ]	335	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	true	To determine whether higher as compared with lower maintenance doses of clopidogrel can adequately improve the degree of platelet inhibition in carriers of a reduced-function CYP2C19 allele.	Clopidogrel blocks the P2Y12 ADP receptor on platelets and has been shown to reduce cardiovascular events in acute coronary syndrome (ACS) patients.However, inter-patient variability in the pharmacodynamic response to clopidogrel is well recognized, and patients with lesser degrees of platelet inhibition in response to...	Myocardial Infarction Percutaneous Coronary Intervention	Myocardial infarction Percutaneous coronary intervention Clopidogrel Genetics Platelet Function	null	2	arm 1: Clopidogrel for CYP2C19\2 gene carriers arm 2: Clopidogrel for CYP2C19\2 gene NON-carriers	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Clopidogrel 75 mg daily, 150 mg daily, 225 mg daily, and 300 mg daily based on genotype intervention 2: Clopidogrel 75 mg daily, 150 mg daily	intervention 1: Clopidogrel intervention 2: Clopidogrel	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	794	NCT01235351	1COMPLETED	2011-09-01	2010-10-01	The TIMI Study Group	7OTHER	false	false	false	null	0
[ 3 ]	213	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	Following screening, eligible subjects will be enrolled into a 6-week Low Calorie Diet (LCD) lead-in period. Subjects who lose at least 2% of their body weight at the end of the 6-week LCD lead-in period will be randomized to 1 of 2 treatment arms (pramlintide+metreleptin or placebo) to begin a 16-week treatment period...	null	Obesity	Pramlintide Metreleptin Obesity Amylin Takeda	null	2	arm 1: Pramlintide+Metreleptin arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Group A: Subcutaneous Injection once a day (QD): Pramlintide 360 mcg+Metreleptin 5.0 mg for 1 week followed by Pramlintide 360 mcg+Metreleptin 5.0 mg twice a day (BID) for 15 weeks. intervention 2: Group B: Subcutaneous Injection-twice a day (BID): Placebo equivalent volumes to active doses.	intervention 1: Pramlintide+Metreleptin intervention 2: Placebo	18	Greenbrae \| California \| United States \| -122.5247 \| 37.94854 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Winter Park \| Florida \| United States \| -81.33924 \| 28.6 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Baton Rouge \| Louisiana \|...	72	NCT01235741	6TERMINATED	2011-09-01	2011-01-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 3 ]	120	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to evaluate efficacy, safety and tolerability of metadoxine (MG01CI) extended release formulation for the treatment of adults diagnosed with ADHD	This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with ADHD. Eligible subjects will be randomly assigned in a 1:1 ratio to one of two treatment groups, 1400 mg Metadoxine (MG01CI) and Placebo. The study will consist of three periods: a screening period of ...	ADHD	ADHD,Adults,MG01CI,METADOXINE	null	2	arm 1: Eligible subjects will be randomly assigned to receive MG01CI (1,400 mg) arm 2: Eligible subjects will be randomly assigned to receive Placebo (1,400 mg)	[ 0, 2 ]	1	[ 0 ]	intervention 1: MG01CI 1400 mg, that will be taken daily by the patients for a duration of 6 weeks.	intervention 1: Metadoxine (MG01CI)	2	Haifa \| N/A \| Israel \| 34.99928 \| 32.81303 Petah Tikva \| N/A \| Israel \| 34.88747 \| 32.08707	117	NCT01243242	1COMPLETED	2011-09-01	2011-02-01	Alcobra Ltd.	4INDUSTRY	false	false	false	null	0
[ 5 ]	1	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The hypothesis of this study is that symptoms of anxiety, depression and insomnia; and indices of psychosocial function will all improve, while BZ use will decrease significantly during a twelve-week trial period of substituting quetiapine for benzodiazepines.	1.1 Background Numerous patients having depression or anxiety appear to use benzodiazepines chronically and respond incompletely to conventional antidepressants. These patients are more likely to request or incur frequent changes of medication because of non-response, incomplete response or intolerance. The hypothesis ...	Major Depression Generalized Anxiety Disorder	Major Depression Generalized Anxiety Disorder Benzodiazepine Quetiapine	null	1	arm 1: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.	[ 0 ]	1	[ 0 ]	intervention 1: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.	intervention 1: quetiapine	1	New York \| New York \| United States \| -74.00597 \| 40.71427	1	NCT01244711	6TERMINATED	2011-09-01	2008-09-01	Weill Medical College of Cornell University	7OTHER	false	false	false	null	0
[ 5 ]	127	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	0ALL	false	Background: Myofascial pain syndrome (MPS) of the shoulder girdle and cervical region is a common musculoskeletal problem that is often chronic or recurrent. It has demonstrated the effectiveness of different treatments such as exercise, injection but not comparing them with each other. The objective of this research w...	We propose a double blind randomized controlled clinical trial, in different health centers in Medellin. The subjects are patients with myofascial trigger points (MTP) in muscles of the shoulder girdle (levator scapulae, trapezius, infraspinatus) diagnosed by neck ans shoulder pain lasting langer than 6 weeks, and that...	Myofascial Pain Syndrome Pain Myofascial Trigger Point Pain Musculoskeletal Pain	Myofascial pain Trigger points. Lidocaine injection. Physical therapy	null	3	arm 1: Twelve sessions, 3 per week. arm 2: Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose. arm 3: Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.	[ 1, 1, 0 ]	3	[ 10, 0, 10 ]	intervention 1: Twelve sessions (3 per week) intervention 2: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose. intervention 3: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)	intervention 1: Physical therapy intervention 2: Lidocaine injection intervention 3: Lidocaine injection + physical therapy	2	Medellín \| Antioquia \| Colombia \| -75.57151 \| 6.245 Medellín \| Antioquia \| Colombia \| -75.57151 \| 6.245	127	NCT01250184	1COMPLETED	2011-09-01	2009-05-01	Grupo Rehabilitacion en Salud	5NETWORK	false	false	false	null	0
[ 0 ]	74	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Paraffin (kerosene) ingestion in the developing world accounts for a large number of visits to healthcare facilities, especially amongst children. There is no evidence in animals and no good evidence in humans that the use of early antibiotics improves the clinical outcome of paraffin-induced pneumonitis. This randomis...	The average of 100 children per annum attending Red Cross War Memorial Children's Hospital 9RCWMCH) with the diagnosis of kerosene ingestion would give a sample of 200 children over a two-year period, with 100 patients in each group. From a postulated secondary infection rate of 15 to 50% for children not receiving an ...	Kerosene Pneumonitis	pneumonitis paraffin kerosene	null	2	arm 1: Amoxicillin arm 2: Placebo	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Amoxicillin syrup 20-30mg/kg 8 hourly for 5 days intervention 2: Placebo suspension made of water, dextrose and glycerine with a similar taste and appearance to the active comparator. Dose 20-30mg/kg 8 hourly for 5 days	intervention 1: Amoxicillin intervention 2: Placebo	1	Cape Town \| Western Cape \| South Africa \| 18.42322 \| -33.92584	74	NCT01253980	1COMPLETED	2011-09-01	2010-07-01	University of Cape Town	7OTHER	false	false	false	null	0
[ 3, 4 ]	2	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The goal of this clinical research study is to learn if Lipitor (atorvastatin) or fish oil supplements can help to control side effects of the heart that are commonly seen after lung surgery (such as irregular heartbeat). Researchers also want to learn if one of these drugs is more effective than the other at controlli...	The Study Drugs: Atorvastatin is designed to lower cholesterol by blocking its production in the liver. This may help to decrease the chances of having a heart attack or a stroke. Fish oil supplements are designed to lower fat levels in the blood by blocking their production in the liver. This may help to decrease th...	Advanced Cancers	Breast cancer Colorectal cancer Genitourinary cancer Head and neck cancers Lung cancer Melanoma Sarcoma Atorvastatin Lipitor Fish Oil supplement Placebo	null	3	arm 1: 1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery. arm 2: 3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery. arm 3: 4 capsules orally every morning and 3 every evening for 5 days pre-surgery.	[ 0, 0, 2 ]	3	[ 0, 7, 10 ]	intervention 1: 1 capsule by mouth every morning 5 days before surgery, and 9 days after surgery or until discharge. intervention 2: 3 capsules by mouth in the morning and evening 5 days before surgery, and 9 days after surgery or until discharge. intervention 3: Placebo group: 4 capsules by mouth every morning and 3 e...	intervention 1: Atorvastatin intervention 2: Fish Oil Supplement intervention 3: Placebo	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	2	NCT01259284	6TERMINATED	2011-09-01	2011-01-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 5 ]	110	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	false	This study is being conducted to determine if smoking will influence the platelet aggregation inhibition ability of clopidogrel and prasugrel. It will also determine if smoking has any effect on the plasma concentrations of the active metabolite of prasugrel and the active and inactive metabolites of clopidogrel. The ...	Subjects will be stratified according to smoking status prior to being randomized to 1 of the 2 treatment sequences: prasugrel 10 mg daily for 10 days followed by clopidogrel 75 mg daily for 10 days or clopidogrel 75 mg daily for 10 days followed by prasugrel 10 mg daily for 10 days. There will be a 14-day Washout Peri...	Coronary Artery Disease	thienopyridine antiplatelet prasugrel clopidogrel	null	2	arm 1: Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken. arm 2: Clopidogrel 75 mg film-coated ...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken. intervention 2: One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.	intervention 1: Prasugrel intervention 2: Clopidogrel	3	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711	213	NCT01260584	1COMPLETED	2011-09-01	2010-11-01	Daiichi Sankyo	4INDUSTRY	false	false	false	null	0
[ 0 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Hypothesis: The supplementation of Ergocalciferol (Vitamin D2) to those with Vitamin D deficiency in the Chronic Kidney Disease population requiring recombinant human erythropoietin for the treatment of anemia related to kidney disease will reduce the dose of erythropoietin required to maintain a nonanemic state.	null	Chronic Kidney Disease Stages 3-5		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Vitamin D in the form of ergocalciferol will be the drug utilized in the study. This medication is a Vitamin D analog and is normally used in the current study population to help augment those who are deficient in Vitamin D.	intervention 1: Ergocalciferol supplementation	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	6	NCT01263028	6TERMINATED	2011-09-01	2010-08-01	Kaiser Permanente	7OTHER	false	false	false	null	0
[ 0 ]	53	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	Burn patients have extreme pain. Opioids are the main agents used for analgesia. We therefore propose a single center study to fruther assess the efficacy of neuropathic agents in controlling the pain associated with acute thermal injury.	The study was conducted in a 16-bed American Burn Association certified burn unit. Patients age \>18 years old, with at least a 5% burn injury and an expected length of stay (LOS) of 48 hours, were approached for enrollment in this prospective, placebo controlled randomized study. Patients who were pregnant, lactating,...	Pain Burn Injury		null	2	arm 1: Placebo arm 2: Gabapentin	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: On Study day 1: 1200mg (single dose). Study day 2,3: 300mg TID, 900mg daily. Study day 4-7: 600mg TID 1800mg\* daily. Study day 8-11: 800mg TID 2400mg\* daily \[Optional increase to 2400 if pain scores are still 4 on NRS\] Study day 11: 1200mg TID 3600mg\* daily \[Optional increase to 3600 if pain s...	intervention 1: Gabapentin intervention 2: Placebo	1	Iowa City \| Iowa \| United States \| -91.53017 \| 41.66113	53	NCT01265056	1COMPLETED	2011-09-01	2010-02-01	Lucy A Wibbenmeyer	7OTHER	false	false	false	null	0
[ 4 ]	296	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects continued at the same dose and dosing frequency.	null	Diabetes Diabetes Mellitus, Type 2		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs). intervention 2: Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.	intervention 1: insulin degludec/insulin aspart intervention 2: insulin glargine	50	Asahikawa-shi, Hokkaido \| N/A \| Japan \| N/A \| N/A Chigasaki-shi, Kanagawa \| N/A \| Japan \| 139.91667 \| 37.58333 Chuo-ku, Tokyo \| N/A \| Japan \| N/A \| N/A Chuo-ku, Tokyo \| N/A \| Japan \| N/A \| N/A Ebina-shi \| N/A \| Japan \| N/A \| N/A Fukuoka-shi, Fukuoka \| N/A \| Japan \| N/A \| N/A Iruma-shi, Saitama \| N/A \| Japan \| 139.65657...	296	NCT01272193	1COMPLETED	2011-09-01	2011-01-01	Novo Nordisk A/S	4INDUSTRY	false	false	false	null	0
[ 5 ]	179	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This trial is conducted in Asia. The aim of the trial is to compare the effect on glycaemic control of biphasic insulin aspart 30 twice daily with two different dosage split regimens for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a glycosylated haemoglobin A1c (HbA1c) below 7% in ...	null	Diabetes Diabetes Mellitus, Type 2		null	2	arm 1: After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and be...	[ 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Administered subcutaneously (under the skin), twice daily with a dosage of 2/3 and 1/3 total daily dose before breakfast and before dinner, in combination with metformin. intervention 2: Administered subcutaneously (under the skin), twice daily with a split dosage of 1/2 and 1/2 total daily dose before ...	intervention 1: biphasic insulin aspart 30 intervention 2: biphasic insulin aspart 30 intervention 3: metformin	1	Beijing \| Beijing Municipality \| China \| 116.39723 \| 39.9075	179	NCT01278160	1COMPLETED	2011-09-01	2011-01-01	Novo Nordisk A/S	4INDUSTRY	false	false	false	null	0
[ 4 ]	225	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	null	0ALL	null	Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug alone, often a combination of two or more drugs is essential to achieve a sufficient antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009 combination therapy is recommended. In JSH 2009 it is advise...	null	Hypertension		null	2	arm 1: once daily arm 2: once daily	[ 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: once daily intervention 2: once daily intervention 3: once daily intervention 4: once daily	intervention 1: 40 mg telmisartan intervention 2: 5 mg amlodipine intervention 3: 5 mg amlodipine intervention 4: 80 mg telmisartan	8	Chuo-ku,Tokyo \| N/A \| Japan \| N/A \| N/A Hiroshima, Hiroshima \| N/A \| Japan \| N/A \| N/A Itoshima, Fukuoka \| N/A \| Japan \| N/A \| N/A Katsushika-ku, Tokyo \| N/A \| Japan \| N/A \| N/A Osaka, Osaka \| N/A \| Japan \| N/A \| N/A Ota-ku, Tokyo \| N/A \| Japan \| N/A \| N/A Suita, Osaka \| N/A \| Japan \| N/A \| N/A Yokohama, Kanagawa \| N/A...	225	NCT01286558	1COMPLETED	2011-09-01	2011-01-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	-0
[ 3 ]	26	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	This study will be a repeat-dose, double-blind, randomized, placebo controlled, three-way crossover study in patients with persistent bronchial asthma to compare the effect of morning (AM) and evening (PM) dosing with fluticasone furoate (FF)/Vilanterol (VI) inhalation powder on lung function. Following screening there...	This will be a repeat-dose, double-blind, randomized, placebo controlled, three-way crossover study in patients with persistent bronchial asthma to compare the effect of AM and PM dosing with fluticasone furoate (FF)/Vilanterol (VI) inhalation powder(100/25mcg) on lung function. Twenty-four male and female patients wil...	Asthma	Fluticasone furoate Vilanterol Efficacy FEV1 FF/VI Inhalation powder	null	3	arm 1: FF(100mcg)/Vilanterol(25mcg) in the morning (approx 09.00) for 14 days (± 2 days).; placebo in evening (approx 21.00) for 14 days (± 2 days). arm 2: Placebo in morning (approx 09.00) for 14 days (± 2 days); FF(100mcg)/Vilanterol(25mcg) in evening (approx 21.00) for 14 days (± 2 days). arm 3: Placebo given in mor...	[ 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Inhalation powder intervention 2: Inhalation powder intervention 3: Inhalation powder intervention 4: Inhalation powder	intervention 1: FF(100mcg)/Vilanterol(25mcg) AM intervention 2: FF(100mcg)/Vilanterol(25mcg) PM intervention 3: Placebo AM intervention 4: Placebo PM	1	Wellington \| N/A \| New Zealand \| 174.77557 \| -41.28664	72	NCT01287065	1COMPLETED	2011-09-01	2010-10-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0

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