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	LABEL_sum_dosing_errors int64	LABEL_dosing_error_rate float32	LABEL_wilson_label 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_count_Accidental overdose int64	METADATA_count_Intentional overdose int64	METADATA_count_Overdose int64	METADATA_count_Overdose NOS int64	METADATA_wilson_lower_bound float32
[ 3 ]	100	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The objective of the trial was to establish the dose-response relation of sugammadex (Org 25969) given as a reversal agent of rocuronium or vecuronium at 1-2 PTC during sevoflurane anesthesia for Japanese participants.	null	Anesthesia, General		null	10	arm 1: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the second twitch (T2) response to Train-of-four (TOF) stimulation, a single dose of 0.5 mg/kg sugammadex was...	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: After induction of anesthesia an intubation dose of a neuromuscular blocking agent (NMBA) was administered IV: either 0.9 mg/kg rocuronium (arms 1-5) or 0.1 mg/kg vecuronium (arms 6-10). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary....	intervention 1: Sugammadex	0	null	99	0	0	0	NCT00591786	1COMPLETED	2006-10-19	2005-12-05	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	162	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of the study is to compare the effectiveness, safety and pharmacokinetics of sugammadex in participants 65 and over with participants under 65. There is no hypothesis defined for the study.	null	Anesthesia, General		null	3	arm 1: Participants to receive an intravenous (IV) single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, partici...	[ 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: intravenous (IV) single bolus dose of 0.6 mg.kg-1	intervention 1: Sugammadex intervention 2: Rocurium	0	null	150	1	0.006667	1	NCT00474617	1COMPLETED	2006-10-20	2005-12-29	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	1	0	0.001178
[ 4 ]	122	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This study evaluates the safety of medicine on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 56 weeks, and subjects will visit the clinic 16 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.	null	Pulmonary Disease, Chronic Obstructive	Chronic Bronchitis COPD Emphysema	null	0	null	null	1	[ 0 ]	intervention 1: None	intervention 1: fluticasone propionate/salmeterol combination DISKUS	5	Kodaira \| N/A \| Japan \| 139.48508 \| 35.72603 Kyoto \| N/A \| Japan \| 135.75385 \| 35.02107 Osaka \| N/A \| Japan \| 135.50107 \| 34.69379 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 N/A \| N/A \| N/A \| N/A \| N/A	122	0	0	0	NCT00269087	1COMPLETED	2006-10-25	2005-01-28	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	48	NON_RANDOMIZED	SINGLE_GROUP	1PREVENTION	0NONE	false	0ALL	false	This study is requested by PMDA to confirm the efficacy and the safety for HFS.	null	Thromboembolism	Xa factor VTE MOSLL pentasaccharide	null	0	null	null	1	[ 0 ]	intervention 1: None	intervention 1: Fondaparinux	1	N/A \| N/A \| N/A \| N/A \| N/A	48	0	0	0	NCT00320424	1COMPLETED	2006-10-26	2006-02-16	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 5 ]	506	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one inhalation twice daily will be compared to ...	A multicentre, randomised, double-blind, double dummy, parallel group study to compare the salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100mcg twice daily and fluticasone propionate (FLIXOTIDE™) at a dose of 200mcg twice daily, both delivered via a dry powder inhaler (DISKUS™) for 12 weeks ...	Asthma	FLIXOTIDE asthmatics children 4-11 years SERETIDE asthma-control	null	2	arm 1: Fluticasone propionate (FLIXOTIDE™) at a dose of 200μg twice daily arm 2: Salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100μg twice daily	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: 200μg twice daily intervention 2: 50/100μg twice daily	intervention 1: Fluticasone propionate intervention 2: Fluticasone propionate/salmeterol	65	Bruges \| N/A \| Belgium \| 3.22424 \| 51.20892 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Edegem \| N/A \| Belgium \| 4.44504 \| 51.15662 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Aalborg \| N/A \| Denmark \| 9.9187 \| 57.048 Odense \| N/A \| Denmark \| 10.38831 \| 55.39594 Essey-lès-Nancy...	303	0	0	0	NCT00353873	1COMPLETED	2006-10-26	2005-11-18	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	369	RANDOMIZED	PARALLEL	0TREATMENT	null	false	0ALL	false	This study evaluates the effect of medicines for type 2 diabetes and lipids control. This study will require about 6 office visits for lab tests and examinations. All study related medicines and medical examinations will be provided at no cost to the subjects.	null	Diabetes Mellitus, Type 2	Type 2 diabetes Type II	null	0	null	null	1	[ 0 ]	intervention 1: None	intervention 1: GSK523338	85	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Fresno \| California \| United States \| -119.77237 \| 36.74773 Wheat Ridge \| Colorado \| United States \| -105.07721 \| 39.7661 Waterbury \| Connecticut \| United States \| -73.0515 \| 41.55815 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Saint Cloud \| Florida \| ...	369	0	0	0	NCT00256867	1COMPLETED	2006-10-31	2005-08-18	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0	-0
[ 3 ]	38	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The primary study objective was to evaluate the dose-dependent efficacy of eslicarbazepine acetate administered at doses of 600, 1200, and 1800 mg over a 3-week period, compared with placebo, as therapy in patients with acute mania. The secondary objectives of this study were to a) evaluate the safety and tolerability ...	This was a phase II, double-blind, fixed multiple dose, randomised, placebo-controlled, multicentre clinical trial in patients with a diagnosis of bipolar I disorder who experienced an acute manic (including mixed) episode. Patients who met the selection criteria at randomisation visit (V) (V2, Day 1) were randomised t...	BIPOLAR I DISORDER	BIPOLAR I DISORDER, Eslicarbazepine acetate	null	4	arm 1: Eslicarbazepine acetate 1800 mg arm 2: Eslicarbazepine acetate 1200 mg arm 3: Eslicarbazepine acetate 600 mg arm 4: Placebo pills	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets. intervention 2: Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets. intervention 3: Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets. intervention 4: Placebo sugar pills	intervention 1: Eslicarbazepine acetate 1800 mg intervention 2: Eslicarbazepine acetate 1200 mg intervention 3: Eslicarbazepine acetate 600 mg intervention 4: Placebo	0	null	38	1	0.026316	1	NCT01824602	6TERMINATED	2006-11-01	2006-02-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	1	0	0	0.004661
[ 3 ]	104	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	null	The purpose of this study is to determine if E7389 is a safe and effective treatment for advanced/metastatic breast cancer.	The primary objective is to determine the response rate (RR) to E7389 monotherapy administered as an IV bolus of 1.4 mg/m\^2 on Days 1, 8, and 15 of a 28-Day cycle and on Days 1 and 8 of a 21-day cycle in patients with advanced/metastatic breast cancer treated with chemotherapy including an anthracycline and a taxane, ...	Breast Neoplasms	breast neoplasm breast cancer breast tumor	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: The first cohort of subjects were to receive E7389 1.4 mg/m\^2 as an intravenous (IV) bolus on Days 1, 8, and 15 of a 28-day cycle. A second cohort of subjects was added and were to receive E7389 1.4 mg/m\^2 as an IV bolus on Days 1 and 8 of a 21-day cycle.	intervention 1: E7389	16	Jonesboro \| Arkansas \| United States \| -90.70428 \| 35.8423 Deer Park \| California \| United States \| -120.82327 \| 38.68185 La Verne \| California \| United States \| -117.76784 \| 34.10084 Pasadena \| California \| United States \| -118.14452 \| 34.14778 Pomona \| California \| United States \| -117.75228 \| 34.05529 Brooksville \| ...	103	0	0	0	NCT00097721	1COMPLETED	2006-11-01	2004-09-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	460	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	2MALE	true	The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix.	null	Prostate Cancer	Prostate Cancer Androgen ablation therapy	null	3	arm 1: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9. arm 2: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9. arm 3: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.	[ 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9 intervention 2: Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9 intervention 3: Drug: Degarelix subcutaneo...	intervention 1: Degarelix intervention 2: Degarelix intervention 3: Degarelix	56	Homewood \| Alabama \| United States \| -86.80082 \| 33.47177 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Anchorage \| Alaska \| United States \| -149.90028 \| 61.21806 Anaheim \| California \| United States \| -117.9145 \| 33.83529 La Mesa \| California \| United States \| -117.02308 \| 32.76783 Laguna Woods \| Californ...	447	0	0	0	NCT00116753	1COMPLETED	2006-11-01	2005-01-01	Ferring Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 0 ]	10	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	2DOUBLE	false	0ALL	false	To investigate a possible interaction between formoterol and budesonide on GR-translocation and to compare the effect of different doses of Symbicort (80/4.5 and 2x80/4.5 mcg) with the effect of budesonide (200 mcg and 800 mcg) on GR translocation, and to investigate the effect of the study drugs on exhaled NO (bronchi...	Combination therapy with inhaled corticosteroids (ICS) and long-acting β(2)-adrenergic agonists (LABA) is reported to have superior effects on controlling asthma symptoms to ICS alone; however, there is no molecular-based evidence to explain the clinical effects. Here, the effect of the ICS/LABA combination was compare...	Asthma	Asthma Glucocorticoid Long-acting beta2-adrenoceptor Inhaled corticosteroids	null	6	arm 1: placebo arm 2: Oxis(®) 12 μg arm 3: Pulmicort(®) 200 μg arm 4: Pulmicort(®) 800 μg arm 5: single 100/6 μg SYM100 arm 6: double 200/12 μg SYM200	[ 2, 0, 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Dry powder inhaler intervention 2: 12ug intervention 3: Inhaler intervention 4: Combination Inhaler, Symbicort	intervention 1: Placebos intervention 2: Formoterol Inhalant Powder intervention 3: Budesonide Powder intervention 4: Budesonide and Formoterol Product	1	London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	60	0	0	0	NCT00159263	1COMPLETED	2006-11-01	2004-11-01	Imperial College London	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	133	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	null	0ALL	null	To evaluate efficacy and safety of E2014 (2500U, 5000U, 10000U, placebo) in a multicenter, randomized, double-blind, parallel group comparative study by intramuscularly administering to patients with spasmodic torticollis. Primary endpoint for efficacy evaluation is changes in TWSTRS total scores from baseline measured...	null	Cervical Dystonia Spasmodic Torticollis		null	0	null	null	1	[ 0 ]	intervention 1: None	intervention 1: BOTULINUM TOXIN TYPE B	21	Ichihara \| Chiba \| Japan \| 140.08333 \| 35.51667 Kitakyushu \| Fukuoka \| Japan \| 130.85034 \| 33.85181 Sapporo \| Hokkaido \| Japan \| 141.35 \| 43.06667 Sapporo \| Hokkaido \| Japan \| 141.35 \| 43.06667 Kagoshima \| Kagoshima-ken \| Japan \| 130.55 \| 31.56667 Kawasaki \| Kanagawa \| Japan \| 139.71722 \| 35.52056 Sagamihara \| Kanagawa...	130	0	0	0	NCT00165776	1COMPLETED	2006-11-01	2004-06-01	Eisai Co., Ltd.	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 0 ]	101	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	Chronic suppurative otitis media is one of the most common chronic infections in children worldwide. Symptoms include otorrhea, otalgia and hearing loss. In many countries, it is treated primarily with antibiotics; in other countries such as the Netherlands a surgical approach, such as a tonsillectomy, adenoidectomy, p...	Chronic suppurative otitis media is one of the most common chronic infections in children worldwide. Symptoms include otorrhea, otalgia and hearing loss. In many countries it is treated primarily with antibiotics; in other countries such as the Netherlands a surgical approach, such as a tonsillectomy, adenoidectomy, pl...	Chronic Otitis Media		null	2	arm 1: None arm 2: None	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: 18 mg/kg, two times a day intervention 2: None	intervention 1: Sulfamethoxazole-trimethoprim intervention 2: Placebo	1	Utrecht \| Utrecht \| Netherlands \| 5.12222 \| 52.09083	101	0	0	0	NCT00189098	1COMPLETED	2006-11-01	2003-02-01	UMC Utrecht	7OTHER	false	false	false	null	0	0	0	0	0
[ 5 ]	20	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this research study is to analyze the effectiveness and tolerability of a medication, valproate ( Depakote and Depakote ER), in individuals age 50 years and older who have schizophrenia.	It is known that up to 30% of individuals with schizophrenia continue to have symptoms even when treated with current FDA-approved medications intended to treat their schizophrenia. Anticonvulsant medications such as valproate (Depakote and Depakote ER) are known to be effective for related conditions such as bipolar d...	Schizophrenia	Schizophrenia Anticonvulsants Valproic Acid Valproate	null	1	arm 1: All participants received open-label, add-on valproate.	[ 0 ]	1	[ 0 ]	intervention 1: Enrolled individuals received adjunctive, open-label valproate semisodium, initially started as valproate semisodium delayed -release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended- release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, ...	intervention 1: Valproate	1	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	20	0	0	0	NCT00194025	1COMPLETED	2006-11-01	2004-11-01	University Hospitals Cleveland Medical Center	7OTHER	false	false	false	null	0	0	0	0	0
[ 2 ]	4	NA	SINGLE_GROUP	0TREATMENT	2DOUBLE	false	0ALL	false	The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH.	The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH. This study never moved forward due to funding issues.	Hepatitis, Alcoholic	acute alcoholic hepatitis	null	1	arm 1: All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days (20-40 treated, 1-20 placebo) with monthly follow up for 90 days.	[ 0 ]	1	[ 0 ]	intervention 1: daily dosing	intervention 1: pentoxifylline	0	null	0	0	0	0	NCT00205049	6TERMINATED	2006-11-01	2005-03-01	University of Wisconsin, Madison	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	176	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo, administered during 12 weeks, to patients suffering from moderate to severe chronic plaque psoriasis, extended by a 12 to 24 week follow-up.	null	Chronic Plaque Psoriasis	chronic plaque psoriasis, anti TNFα CDP870, Cimzia	null	3	arm 1: Subcutaneous injections of Placebo every 2 weeks arm 2: Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter arm 3: Subcutaneous injections of 400 mg every 2 weeks	[ 2, 0, 0 ]	2	[ 0, 10 ]	intervention 1: * Pharmaceutical Form: solution for injection in pre-filled syringe * Route of Administration: subcutaneous use intervention 2: Matching Placebo to Certolizumab Pegol	intervention 1: Certolizumab Pegol intervention 2: Placebo	15	Besançon \| N/A \| France \| 6.01815 \| 47.24878 Créteil \| N/A \| France \| 2.46569 \| 48.79266 Nice \| N/A \| France \| 7.26608 \| 43.70313 Paris \| N/A \| France \| 2.3488 \| 48.85341 Pierre-Bénite \| N/A \| France \| 4.82424 \| 45.70359 Saint-Etienne \| N/A \| France \| 4.39 \| 45.43389 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Bonn \| ...	175	0	0	0	NCT00245765	1COMPLETED	2006-11-01	2005-10-01	UCB Pharma	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	830	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to compare the efficacy of pitavastatin with that of atorvastatin.	Following a wash-out dietary lead-in period, patients will receive either Atorvastatin or Pitavastatin during 12 weeks, in order to establish the efficacy of pitavastatin in reducing cholesterol levels.	Primary Hypercholesterolemia Dyslipidemia	hypercholesterolemia dyslipidemia kowa KRE pitavastatin NK-104	null	0	null	null	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Pitavastatin intervention 2: Atorvastatin	192	Copenhagen \| N/A \| Denmark \| 12.56553 \| 55.67594 Copenhagen \| N/A \| Denmark \| 12.56553 \| 55.67594 Copenhagen Nv \| N/A \| Denmark \| N/A \| N/A Frederiksberg \| N/A \| Denmark \| 12.53463 \| 55.67938 Hellerup \| N/A \| Denmark \| 12.57093 \| 55.73204 Vejle \| N/A \| Denmark \| 9.5357 \| 55.70927 Helsinki \| N/A \| Finland \| 24.93545 \| 6...	821	0	0	0	NCT00249249	1COMPLETED	2006-11-01	2005-10-01	Kowa Research Europe	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 5 ]	152	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This study hopes to determine the appropriate oral steroid dose for treating children hospitalized with asthma exacerbations. Practice guidelines from different countries recommend a wide range of doses, and the doses used in actual practice vary widely. There is no data on what is the most appropriate dose of predniso...	Practice guidelines for the management of asthma in children universally recommend systemic corticosteroids for the treatment of moderate to severe asthma exacerbations. However, these guidelines vary widely with respect to dose, frequency, method of delivery, and duration of therapy. In actual practice, there is also ...	Asthma	Corticosteroids Treatment Pediatric	null	2	arm 1: High dose prednisolone arm 2: Lower dose prednisolone alternating with placebo	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: 4 mg/kg/day orally divided every 6 hours (maximum 30 mg per dose) intervention 2: 2 mg/kg/day orally divided q 12 (maximum 30mg/dose) alternating with placebo	intervention 1: Prednisolone high dose intervention 2: Prednisolone lower dose	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	152	0	0	0	NCT00257933	1COMPLETED	2006-11-01	2006-02-01	Children's Hospital of Philadelphia	7OTHER	false	false	false	null	0	0	0	0	0
[ 4 ]	34	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	null	The primary efficacy objective of this study is to compare the coefficient of fat absorption (CFA) following oral administration of Aptalis Pharma's (formerly Eurand Pharmaceuticals) pancreatic enzyme product (PEP) capsules and placebo in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI...	This is a randomized, double-blind, placebo-controlled, 2-treatment, crossover, multicenter trial in participants with CF and EPI. The study consists of a screening period (1 to 14 days), a washout period (2 days), a dose titration/stabilization period (6 to 9 days), a blinded randomized treatment period (6 to 7 days),...	Cystic Fibrosis Exocrine Pancreatic Insufficiency	CF Cystic Fibrosis EPI Exocrine Pancreatic Insufficiency Pancreatic Enzyme PEP	null	2	arm 1: None arm 2: None	[ 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule will be given orally daily in first double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6...	intervention 1: EUR-1008 (APT-1008) intervention 2: Placebo intervention 3: Placebo intervention 4: EUR-1008 (APT-1008)	1	Tyler \| Texas \| United States \| -95.30106 \| 32.35126	66	0	0	0	NCT00297167	1COMPLETED	2006-11-01	2006-05-01	Forest Laboratories	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 5 ]	401	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will hope to show that by relieving the participant's nasal symptoms of seasonal allergies using mometasone furoate nasal spray, the participant will obtain a better quality of night-time sleep, which in turn, causes less daytime sleepiness so that he/she can function productively during the day.	null	Seasonal Allergic Rhinitis		null	2	arm 1: Mometasone Furoate Nasal Spray 200 mcg, once daily. arm 2: None	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: MFNS 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg QD), once daily (each morning), for 28 days. intervention 2: Matching placebo nasal spray: 2 sprays per nostril once daily for 28 days	intervention 1: Mometasone Furoate Nasal Spray (MFNS) intervention 2: Placebo	0	null	401	0	0	0	NCT00358527	1COMPLETED	2006-11-01	2006-05-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	392	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study of Vytorin 10/10 (ezetimibe 10 mg with simvastatin 10 mg), Vytorin 10/20 (ezetimibe 10 mg with simvastatin 20 mg), and Vytorin 10/40 (ezetimibe 10 mg with simvastatin 40 mg) compared to placebo administered daily for 8 con...	null	Hypercholesterolemia		null	4	arm 1: Ezetimibe 10 mg with Simvastatin 10 mg arm 2: Ezetimibe 10 mg with Simvastatin 20 mg arm 3: Ezetimibe 10 mg with Simvastatin 40 mg arm 4: None	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Ezetimibe 10 mg with Simvastatin 10 mg once daily for a total of eight weeks intervention 2: Ezetimibe 10 mg with Simvastatin 20 mg once daily for a total of eight weeks intervention 3: Ezetimibe 10 mg with Simvastatin 40 mg once daily for a total of eight weeks intervention 4: Placebo once daily for a ...	intervention 1: ezetimibe with simvastatin intervention 2: Ezetimibe with Simvastatin intervention 3: Ezetimibe with Simvastatin intervention 4: Placebo	0	null	389	0	0	0	NCT00413972	1COMPLETED	2006-11-01	2006-04-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	1,162	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.	null	Asthma		null	2	arm 1: montelukast arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: montelukast 5 mg tablet Once a day (QD) for 8 weeks intervention 2: Placebo to montelukast QD for 8 weeks	intervention 1: montelukast intervention 2: Comparator: Placebo	0	null	1,132	0	0	0	NCT00461032	1COMPLETED	2006-11-01	2006-06-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	59	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	This study was a Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to that of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects with Rheumatoid Arthritis. This Phase II, 6-week blinded study was planned for 60 subjects with moderate to severe ...	The primary objective of this study was to: • Compare the response of CRx-102 plus DMARD therapy to placebo plus DMARD therapy in lowering CRP levels in rheumatoid arthritis subjects. The secondary objectives of this study were to: * Evaluate the changes in inflammatory cytokines in subjects treated with CRx-102 plu...	Rheumatoid Arthritis	Rheumatoid Arthritis RA DMARD CRP	null	2	arm 1: None arm 2: None	[ 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: DMARD therapy can include methotrexate or other DMARD therapy	intervention 1: CRx-102 intervention 2: Placebo intervention 3: DMARD Therapy	0	null	59	0	0	0	NCT00747214	1COMPLETED	2006-11-01	2004-11-01	Zalicus	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 2 ]	60	RANDOMIZED	CROSSOVER	9OTHER	0NONE	true	0ALL	false	The objective of this study was to compare the oral availability of a test product of Mycophenolate Mofetil 250 mg capsule to an equivalent oral dose of the commercially available reference product, CellCept® 250 mg capsule administered to healthy subjects under fed conditions.	Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods	Healthy	Bioequivalence Healthy Subjects	null	2	arm 1: Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period. arm 2: CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 250 mg Capsule intervention 2: 250 mg Capsule	intervention 1: Mycophenolate Mofetil intervention 2: CellCept®	1	Austin \| Texas \| United States \| -97.74306 \| 30.26715	120	0	0	0	NCT00910663	1COMPLETED	2006-11-01	2006-10-01	Teva Pharmaceuticals USA	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	454	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	false	Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist.	Multicenter, randomized, double-blind, placebo-controlled trial evaluating different doses of transdermal estradiol delivered by sray to symptomatic postmenopausal women. The endpoints are the reduction in frequency and severity of hot flushes.	Hot Flashes	Postmenopause Hot Flashes Estradiol Polyestradiol phosphate Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Estrogens Hormones Hormones, Hormone Substitutes Hormone Antagonists	null	6	arm 1: Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator arm 2: Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator arm ...	[ 2, 2, 2, 1, 1, 1 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator intervention 2: Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator intervention 3: Es...	intervention 1: Estradiol transdermal one 90 μL spray intervention 2: Estradiol transdermal spray, two 90 μL sprays intervention 3: Estradiol transdermal three 90 μL sprays intervention 4: Placebo transdermal two 90 μL sprays intervention 5: Placebo transdermal three 90 μL sprays intervention 6: Placebo transdermal one...	43	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Oro Valley \| Arizona \| United States \| -110.96649 \| 32.39091 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United S...	454	0	0	0	NCT01389102	1COMPLETED	2006-11-01	2004-12-01	Lumara Health, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	36	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	null	Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744 CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI 1744 CL. Olodaterol dose 40 mcg was investigated only in the open-label extension part for additional PK assessments which are not de...	null	Pulmonary Disease, Chronic Obstructive		null	6	arm 1: solution for inhalation arm 2: solution for inhalation arm 3: solution for inhalation arm 4: solution for inhalation arm 5: solution for inhalation arm 6: solution for inhalation	[ 0, 0, 0, 0, 0, 2 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: solution for inhalation intervention 2: solution for inhalation intervention 3: solution for inhalation intervention 4: solution for inhalation intervention 5: solution for inhalation intervention 6: solution for inhalation	intervention 1: single dose of 5 mcg intervention 2: single dose of placebo intervention 3: single dose of 40 mcg intervention 4: single dose of 20 mcg intervention 5: single dose of 2 mcg intervention 6: single dose of 10 mcg	1	Heerlen \| N/A \| Netherlands \| 5.98154 \| 50.88365	174	0	0	0	NCT01809262	1COMPLETED	2006-11-01	2005-12-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	161	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	Multicentre, double-blind, randomised, parallel-group, placebo-controlled dose-titration study; depending on clinical efficacy, up-titration of dosage 3 and 6 days after start of treatment; maintenance of individual maximum dose for the rest of the total 3-week treatment period; subsequently, down-titration (according ...	Objectives: The primary objective was to evaluate the dose-dependent efficacy of 2 dose-titration regimens of Eslicarbazepine Acetate (ESL) compared with placebo as therapy in patients with acute mania. The secondary objective was to evaluate the safety and tolerability of 2 dose-titration regimens of Eslicarbazepine...	Bipolar I Disorder		null	3	arm 1: Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response. arm 2: Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical resp...	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response. intervention 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical resp...	intervention 1: Eslicarbazepine Acetate intervention 2: Eslicarbazepine Acetate intervention 3: Placebo	0	null	161	0	0	0	NCT01822678	1COMPLETED	2006-11-01	2005-12-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	310	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is a multi-center, open-label study to evaluate whether participants follow the duration of use instructions for short-term use of alclometasone dipropionate in a population of participants with itchy skin conditions who would use OTC treatments for relief. The study population will be composed of two different co...	Approximately 313 participants who are currently suffering from an itchy skin condition caused by eczema or psoriasis or any occasional itchy skin experiences will be enrolled into the study to get 250 participants who complete the study (at least 100 to each of the cohorts). After evaluation of the study criteria, the...	Eczema Allergy Symptoms Psoriasis Itch	Alclometasone dipropionate Eczema Psoriasis Itch	null	1	arm 1: Alclometasone dipropionate cream 0.05% will be applied by the participants topically on the affected areas per label instructions for 14 days.	[ 0 ]	1	[ 0 ]	intervention 1: Alclometasone dipropionate cream 0.05% (15 g)	intervention 1: Alclometasone dipropionate cream	0	null	306	0	0	0	NCT02075632	1COMPLETED	2006-11-01	2006-09-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	60	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to determine the pathological complete tumor response rate.	null	Rectal Cancer		null	1	arm 1: Eligible participants received capecitabine 1000 milligrams per square meter (mg/m\^2) on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 pri...	[ 0 ]	2	[ 0, 0 ]	intervention 1: Capecitabine is available as 50 mg and 500 mg tablets. It will be administered as a 1000mg/m\^2 bid orally on Days 1-14, and at a dose of 825mg/m\^2 bid on Days 22-35 and 43-56. intervention 2: Oxaliplatin is available in vials containing 50 mg or 100 mg. It will be administered as a oxaliplatin 130mg/m...	intervention 1: Capecitabine intervention 2: Oxaliplatin	6	Basel \| N/A \| Switzerland \| 7.57327 \| 47.55839 Chur \| N/A \| Switzerland \| 9.53287 \| 46.84986 Lucerne \| N/A \| Switzerland \| 8.30635 \| 47.05048 Sankt Gallen \| N/A \| Switzerland \| 9.37477 \| 47.42391 Zurich \| N/A \| Switzerland \| 8.55 \| 47.36667 Zurich \| N/A \| Switzerland \| 8.55 \| 47.36667	60	0	0	0	NCT02694718	1COMPLETED	2006-11-01	2005-03-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	58	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	A study to evaluate the cholesterol-lowering effects of ezetimibe in participants with primary hypercholesterolemia (high cholesterol) after eating a meal that is high in cholesterol. The primary hypothesis is that treatment with ezetimibe 10 mg/day reduces the cholesterol concentration of the chylomicron-containing Sf...	null	Hypercholesterolemia	Primary Hypercholesterolemia	null	2	arm 1: After a 2-week single- blind placebo run-in, participants will receive ezetimibe 10 mg once daily for 4 weeks and then receive placebo once daily for 4 weeks. arm 2: After a 2-week single- blind placebo run-in, participants will receive placebo once daily for 4 weeks and then receive ezetimibe10 mg once daily fo...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: ezetimibe intervention 2: Comparator: placebo	0	null	114	0	0	0	NCT00101439	1COMPLETED	2006-11-08	2005-11-10	Organon and Co	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	131	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	null	This was a prospective, randomized, Phase II, comparative study with a parallel control for evaluating the efficacy and safety of combined treatment of recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH). The combined treatment was administered at the middle of the ...	null	Infertility Ovulation Induction	Reproductive technology, Assisted Recombinant human follicle stimulating hormone (r-hFSH) Recombinant leutinizing hormone (r-hLH) Ovulation induction Infertility	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Subjects will receive subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per d...	intervention 1: Recombinant human follicle stimulating hormone (r-hFSH) intervention 2: Recombinant human luteinizing hormone (r-hLH)	1	Vizcaya \| N/A \| Spain \| N/A \| N/A	131	0	0	0	NCT01110707	1COMPLETED	2006-11-15	2005-01-10	Merck KGaA, Darmstadt, Germany	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	20	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	An evaluation of tablet disintegration and absorption and gastric transit of sumatriptan and naproxen sodium from a TREXIMA tablet and eletriptan from a RELPAX 40mg tablet.	null	Migraine Disorders	Combination product, sumatriptan succinate, naproxen sodium, absorption, pharmacokinetics, disintegration, gastric transit, gastric scintigraphy	null	2	arm 1: open-label active drug arm 2: open-label active drug	[ 5, 5 ]	2	[ 0, 0 ]	intervention 1: sumatriptan/naproxen sodium intervention 2: eletriptan tablets	intervention 1: Combination Product (sumatriptan succinate / naproxen sodium) intervention 2: RELPAX(eletriptan) 40mg Tablet	1	Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869	20	0	0	0	NCT00385008	1COMPLETED	2006-11-24	2006-09-13	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 5 ]	70	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	Eligible subjects will be randomized to receive VALTREX 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days in between.	null	Herpes Labialis	Recurrent Genital Herpes	null	0	null	null	1	[ 0 ]	intervention 1: valacyclovir	intervention 1: valacyclovir	18	Anaheim \| California \| United States \| -117.9145 \| 33.83529 Carmichael \| California \| United States \| -121.32828 \| 38.61713 Fair Oaks \| California \| United States \| -121.27217 \| 38.64463 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Diego \| California \| United States \| -117.16472 \| 32.71571 Boynton...	124	0	0	0	NCT00306293	1COMPLETED	2006-11-27	2006-02-20	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 5 ]	764	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.	null	Relapsing-remitting Multiple Sclerosis		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Subjects will be administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw). intervention 2: Subjects will be administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (...	intervention 1: Rebif® intervention 2: Copaxone®	80	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Diego \| California \| United States \| -117.16472 \| 32.71571 Fort Collins \| Colo...	756	2	0.002646	1	NCT00078338	1COMPLETED	2006-11-28	2004-02-16	EMD Serono	4INDUSTRY	false	false	false	null	1	0	1	0	0.000726
[ 4 ]	29	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	true	The PERCHE trial evaluated the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years. The use of chemotherapy was determined by randomization. The metho...	OBJECTIVES: * Compare ovarian function suppression and tamoxifen or exemestane with vs without adjuvant chemotherapy in premenopausal women with endocrine-responsive resected breast cancer. * Compare the disease-free and overall survival of patients treated with these regimens. * Compare sites of first treatment failu...	Breast Cancer	stage IIIA breast cancer stage I breast cancer stage II breast cancer	null	2	arm 1: Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years. arm 2: Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T)...	[ 0, 0 ]	6	[ 0, 0, 0, 0, 3, 3 ]	intervention 1: Planned duration of chemotherapy: 2 months if an anthracycline is included (e.g., 4 cycles of EC or AC) or 4 months if no anthracycline is given (e.g., 6 cycles of CMF) is recommended. Unless medically contraindicated, an anthracycline-containing regimen using epirubicin should be given. intervention 2:...	intervention 1: chemotherapy intervention 2: exemestane intervention 3: tamoxifen intervention 4: triptorelin intervention 5: oophorectomy intervention 6: ovarian irradiation	6	Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Aviano \| N/A \| Italy \| 12.59472 \| 46.07056 Milan \| N/A \| Italy \| 9.18951 \| 45.46427 Chur \| N/A \| Switzerland \| 9.53287 \| 46.84986 Lausanne \| N/A \| Switzerland \| 6.63282 \| 46.516 Sankt Gallen \| N/A \| Switzerland \| 9.37477 \| 47.42391	29	0	0	0	NCT00066807	6TERMINATED	2006-12-01	2003-08-01	ETOP IBCSG Partners Foundation	5NETWORK	false	false	false	null	0	0	0	0	0
[ 0 ]	300	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine if opening blocked arteries with heart balloons and stents prevents heart rhythm problems in individuals 3 to 28 days after a heart attack.	BACKGROUND: There is now unequivocal evidence that early coronary reperfusion using either thrombolytics or primary angioplasty results in a long-term mortality reduction among individuals who have had a heart attack. The benefit of early reperfusion (less than 6 hours after the heart attack) was initially attributed ...	Cardiovascular Diseases Heart Diseases Myocardial Infarction Coronary Disease Arrhythmia Ventricular Fibrillation	Stents, myocardial infarction	null	2	arm 1: Percutaneous Coronary Intervention (PCI) with angioplasty and stenting of the infarct-related artery and optimal medical therapy arm 2: Optimal medical therapy alone	[ 0, 0 ]	2	[ 3, 0 ]	intervention 1: None intervention 2: Guideline-directed drug therapies after MI	intervention 1: PCI intervention 2: Optimal Medical Therapy	1	Stony Brook \| New York \| United States \| -73.14094 \| 40.92565	300	0	0	0	NCT00119847	1COMPLETED	2006-12-01	2002-09-01	University of Maryland, Baltimore	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	116	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD), in maintaining serum urate levels within clinically acceptable levels in subjects with gout.	Uric acid is the end product of purine degradation in humans. Hyperuricemia, a urate concentration in serum exceeding the limit of urate solubility (approximately 7.0 milligrams per deciliter \[mg/dL\]), is a common biochemical abnormality. Aberrations in any of the multiple mechanisms involved in the production and/or...	Gout	Uric acid xanthine oxidase tophi Drug Therapy	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Febuxostat 40 mg, tablets, orally, once daily, based on serum urate level. intervention 2: Febuxostat 80 mg, tablets, orally, once daily, based on serum urate level. intervention 3: Febuxostat 120 mg, tablets, orally, once daily, based on serum urate level.	intervention 1: Febuxostat intervention 2: Febuxostat intervention 3: Febuxostat	0	null	281	0	0	0	NCT00174941	1COMPLETED	2006-12-01	2001-03-01	Takeda	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 5 ]	117	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to examine whether adjunctive galantamine is effective in the treatment of cognitive impairments in patients with schizophrenia.	Patients with schizophrenia are characterized by a broad range of neurocognitive abnormalities. These include impairments in attention; eye-tracking; visual and verbal memory; working memory; processing speed; and sensory gating, as measured by P50. These impairments are major determinants of poor functional outcome in...	Schizophrenia Schizoaffective Disorder	schizophrenia acetylcholine cognitive impairments attention processing speed sensory gating eye-tracking	null	2	arm 1: galantamine, 24mgs, p.o., qday arm 2: placebo, 3 tablets, p.o., qday	[ 0, 2 ]	1	[ 0 ]	intervention 1: see arm/group description	intervention 1: galantamine	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	86	0	0	0	NCT00176423	1COMPLETED	2006-12-01	2002-05-01	University of Maryland, Baltimore	7OTHER	false	false	false	null	0	0	0	0	0
[ 0 ]	15	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to collect and evaluate information on the use of Depakote Extended Release (ER) and Depacon Intravenous (IV) in patients with cluster headaches. Patients who are currently in a cluster cycle will be treated with 2 consecutive days of IV Depacon followed by oral Depakote ER. Patients will r...	This study will consist of four visits (3 visits if the screening visit and first treatment visit are on the same day). Screening Visit: The screening visit can be performed either before an active cluster period or once the cluster period has already started. If the subject agrees to participate, the study doctor wi...	Cluster Headache		null	1	arm 1: Subjects will be treated in this single arm study with 2 consecutive days of IV Depacon followed by oral Depakote ER for a total of 1000 mg of Depacon and 1000 mg of Depakote ER each day.	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: Depacon IV and Depakote ER	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	15	0	0	0	NCT00203242	1COMPLETED	2006-12-01	2003-07-01	Thomas Jefferson University	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	60	NON_RANDOMIZED	FACTORIAL	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to evaluate three dose levels of a combination tablet and a fixed dose granule formulation of pyronaridine and artesunate (PA) for the treatment of acute uncomplicated falciparum malaria in children.	This is a Phase II, open-label, sequential-group, dose-escalation, single-centre study to study pharmacokinetics, bioavailability comparison of tablets vs. granules, and safety/tolerability of PA in paediatric patients with acute symptomatic uncomplicated P. falciparum malaria. The study population will include 60 pati...	Uncomplicated Plasmodium Falciparum Malaria	malaria P. falciparum artemisinin based combination therapy (ACT) antimalarial pyronaridine artesunate (Pyramax)	null	4	arm 1: Pyronaridine artesunate 6:2 mg/kg. The tablet strength is 48:16 mg oral PA, with the number of tablets depending on body weight. arm 2: Pyronaridine artesunate 9:3 mg/kg. The tablet strength is 72:24 mg oral PA, with the number of tablets depending on body weight. arm 3: Pyronaridine artesunate 12:4 mg/kg. The t...	[ 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: Once a day for 3 days	intervention 1: Pyronaridine-Artesunate	1	Lambaréné \| N/A \| Gabon \| 10.24055 \| -0.7001	59	0	0	0	NCT00331136	1COMPLETED	2006-12-01	2006-06-01	Medicines for Malaria Venture	7OTHER	false	false	false	null	0	0	0	0	0
[ 5 ]	1,452	RANDOMIZED	PARALLEL	1PREVENTION	1SINGLE	false	0ALL	true	Trachoma, an ocular infection caused by C. trachomatis, is the second leading cause of blindness worldwide.Years of repeated infection with C. trachomatis cause the eyelid to scar and contract and ultimately to rotate inward such that eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Healt...	A randomized clinical trial of the effectiveness of a single dose of azithromycin compared to 6 weeks of topical tetracycline, and the added benefit of family-based azithromycin treatment, in preventing recurrence of trichiasis following surgery is proposed. This will provide the evidence base to inform and change the ...	Trichiasis	trichiasis azithromycin trichiasis surgery topical tetracycline	null	3	arm 1: topical tetracycline arm 2: oral azithromycin, single 1g dose to subject arm 3: single oral azithromycin dose to subject and immediate family members	[ 1, 1, 1 ]	2	[ 0, 0 ]	intervention 1: oral antibiotic intervention 2: None	intervention 1: azithromycin intervention 2: topical tetracycline	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	1,452	0	0	0	NCT00347776	1COMPLETED	2006-12-01	2001-08-01	Johns Hopkins University	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	449	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to evaluate the safety, efficacy, and tolerability of azilsartan medoxomil, once daily (QD), in individuals with hypertension.	Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. Data from the Framingham Heart study suggest that the lifetime risk of developing hypertension ...	Hypertension	hypertension blood pressure diastolic blood pressure drug therapy	null	7	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None	[ 0, 0, 0, 0, 0, 1, 2 ]	7	[ 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. intervention 2: Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. intervention 3: Azilsartan medoxomil 20 mg and comparator matching placebo ta...	intervention 1: Azilsartan Medoxomil intervention 2: Azilsartan Medoxomil intervention 3: Azilsartan Medoxomil intervention 4: Azilsartan Medoxomil intervention 5: Azilsartan Medoxomil intervention 6: Olmesartan intervention 7: Placebo	54	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Ozark \| Alabama \| United States \| -85.64049 \| 31.45906 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Carmichael \| California \| United States \| -121.32828 \| 38.61713 Long Beach \| California \|...	445	0	0	0	NCT00362115	1COMPLETED	2006-12-01	2006-05-01	Takeda	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	34	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	1.Study rationale:There is no standard regimen for the advanced and/or metastatic gastric cancer patients who relapsed after adjuvant chemotherapy or failed to first systemic chemotherapy. 2.Primary Objectives:To evaluate overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria and T...	null	Stomach Neoplasms		null	1	arm 1: salvage docetaxel and epirubicin	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: Docetaxel and epirubicin	1	Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	34	0	0	0	NCT00375999	1COMPLETED	2006-12-01	2006-09-01	Yonsei University	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	44	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The main objective of this phase 2a proof-of-concept trial is to assess the efficacy of rotigotine nasal spray in ascending doses in subjects with idiopathic Restless Legs Syndrome.	Each patient of the placebo and rotigotine group performed an Eligibility Assessment, as well 4 treatment days at which subjects performed a repeated 'Suggested Immobilization Test' (SIT) during a 30min pre-dose and a 4 hours post-dose period. During these periods the severity of RLS symptoms in the legs was assessed b...	Restless Legs Syndrome	Rotigotine Rotigotine nasal spray Efficacy, safety and tolerability Restless Legs Syndrome	null	2	arm 1: Subjects receiving a single dose of placebo nasal spray on all 4 treatment days arm 2: Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4	[ 2, 0 ]	2	[ 0, 10 ]	intervention 1: Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution intervention 2: Daily single dose of placebo delivered as single puff of nasal spray solution	intervention 1: Rotigotine Nasal Spray intervention 2: Placebo Nasal Spray	1	Monheim \| N/A \| Germany \| 10.85834 \| 48.84389	158	0	0	0	NCT00389831	1COMPLETED	2006-12-01	2006-08-01	UCB Pharma	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	389	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	true	0ALL	false	Although pyridoxine has been used empirically for the prevention of capecitabine associated hand-foot syndrome (HFS), its efficacy needs to be demonstrated in prospective controlled trials. The investigators therefore performed a prospective randomized double-blind study to determine whether pyridoxine 200 mg/day can p...	Although pyridoxine has been used empirically for the prevention of capecitabine associated HFS, its efficacy needs to be demonstrated in prospective controlled trials. We estimated that the HFS rate with placebo and pyridoxine would be 0.35 and 0.18, respectively, and we therefore calculated that a sample size of 345 ...	Hand-foot Syndrome	hand-foot syndrome capecitabine pyridoxine prevention	null	2	arm 1: one tablet twice per day, which is identical to pyridoxine arm 2: 100 mg twice per day	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: 100mg BID/daily, Per oral intervention 2: placebo 100mg BID/daily, Per oral	intervention 1: Pyridoxine intervention 2: Placebo	0	null	360	0	0	0	NCT00446147	1COMPLETED	2006-12-01	2004-06-01	Asan Medical Center	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	208	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents.	null	Asthma		null	3	arm 1: a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks arm 2: a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks arm 3: Placebo delivered by nebulization twice daily for 6 weeks	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks intervention 2: a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks intervention 3: Placebo delivered by nebulization twice daily for 6 weeks	intervention 1: MAP0010 low dose intervention 2: MAP0010 high dose intervention 3: Placebo	1	San Diego \| California \| United States \| -117.16472 \| 32.71571	205	0	0	0	NCT00697801	1COMPLETED	2006-12-01	2006-07-01	Allergan	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 2 ]	13	RANDOMIZED	CROSSOVER	2DIAGNOSTIC	2DOUBLE	false	0ALL	null	This study will qualify a functional model that can measure central blood pressure and vascular compliance effects through noninvasive means.	null	Hypertension		null	5	arm 1: losartan 100 mg arm 2: ISMN 60 mg arm 3: losartan 100 mg + ISMN 15 mg arm 4: losartan 100 mg + ISMN 60 mg arm 5: Placebo	[ 1, 1, 1, 1, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Single dose losartan 100 mg in one of five treatment periods intervention 2: Single dose ISMN 60 mg in one of five treatment periods intervention 3: Single dose losartan 100 mg and ISMN 15 mg in one of five treatment periods intervention 4: Single dose losartan 100 mg and ISMN 60 mg in one of five treat...	intervention 1: losartan potassium intervention 2: Comparator: isosorbide mononitrate (ISMN) intervention 3: Comparator: losartan + ISMN intervention 4: Comparator: losartan + ISMN intervention 5: Comparator: Placebo	0	null	59	0	0	0	NCT00943852	1COMPLETED	2006-12-01	2006-08-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	76	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	2MALE	false	The primary objective of this study was to determine the appropriate dose of SKY0402 for the management of postoperative pain following inguinal hernia repair. This study evaluated the safety, efficacy, and pharmacokinetics of SKY0402 compared with a 100 mg dose of bupivacaine HCl for the treatment of postoperative pai...	SKY0402 was administered in a dose escalating/de-escalating fashion, with a low starting dose in Cohort 1 that was to be increased or decreased in subsequent cohorts based on safety and analgesic effects. The decision to proceed to the next cohort (i.e., increase or decrease the dose) was made by a Cohort Data Review C...	Inguinal Hernia	Postoperative pain Analgesia	null	2	arm 1: (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402 arm 2: Low dose, low-mid dose, mid-dose, and high dose	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Single dose of SKY0402 administered locally into the surgical wound. intervention 2: Single dose of bupivacaine HCl (100 mg) administered locally into the surgical wound.	intervention 1: SKY0402 intervention 2: Bupivacaine HCl	0	null	76	0	0	0	NCT01203644	1COMPLETED	2006-12-01	2004-12-01	Pacira Pharmaceuticals, Inc	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	58	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The primary objective of this study was to determine the appropriate dose of SKY0402 administered as a nerve block for the management of postoperative pain following bunionectomy.	This Phase 2, multicenter, randomized, double blind, dose escalating/de-escalating study evaluated the safety, efficacy, and pharmacokinetics of a single dose of SKY0402 compared to a single 125 mg dose of bupivacaine HCl for the treatment of postoperative pain in subjects undergoing bunionectomy. Up to 88 subjects we...	Postoperative Pain	Postoperative Pain Bunionectomy Analgesia	null	2	arm 1: Low-dose (175 mg), low-mid dose( 225 mg), and mid-dose (350 mg) arm 2: Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Single dose of SKY0402 administered as a nerve block intervention 2: Single dose of 125 mg administered as a nerve block	intervention 1: SKY0402 intervention 2: Bupivacaine HCl	0	null	58	0	0	0	NCT01206595	1COMPLETED	2006-12-01	2005-03-01	Pacira Pharmaceuticals, Inc	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	33	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	2MALE	true	This study was conceived in order to explain what the investigators previously observed suggesting that lisinopril, a drug normally used to treat patients with high blood pressure and heart failure, may be effective in treating infertile men with low sperm count. The investigators hypothesized, therefore, that the drug...	Introduction. Infertility constitutes the cause for about 16.6% of patients seeking consultations at the primary healthcare level. Male factor infertility accounts for about 50% of all infertility problems. Of this percentage seminal fluid abnormality of unknown cause is common, occurring in up to 60% of males with une...	Oligospermia	Oligospermia Male infertility Lisinopril	null	2	arm 1: Started with Placebo until the crossover. arm 2: Started with Lisinopril until the crossover	[ 2, 0 ]	1	[ 0 ]	intervention 1: The two groups of patients, A and B, were randomly allocated treatments in a double-blind fashion. Group A was started on the coded drug "DY1" while group B was started on the coded drug "DZ2". Both "DY1" and "DZ2" were very identical in appearance. At week 96 the drugs were swopped between the groups s...	intervention 1: Lisinopril	1	Enugu \| Enugu State \| Nigeria \| 7.49883 \| 6.44132	66	0	0	0	NCT01409837	1COMPLETED	2006-12-01	1998-03-01	University Of Nigeria Teaching Hospital	5NETWORK	false	false	false	null	0	0	0	0	0
[ 4 ]	95	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. The dosing period lasts three weeks and starts following a three-week run-in period.	null	Asthma	Asthma Pediatric asthma	null	2	arm 1: ProAir(TM) HFA, Breath Actuated Inhalation Aerosol arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Albuterol 90mcg intervention 2: Placebo	intervention 1: Albuterol intervention 2: Placebo	14	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Huntington Beach \| California \| United States \| -117.99923 \| 33.6603 San Jose \| California \| United States \| -121.89496 \| 37.33939 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 En...	95	0	0	0	NCT00308685	1COMPLETED	2006-12-04	2006-06-10	Teva Branded Pharmaceutical Products R&D, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	127	RANDOMIZED	CROSSOVER	0TREATMENT	null	false	0ALL	false	The objectives of this study are to evaluate and compare patient preference for FF (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration.	null	Rhinitis, Allergic, Perennial	taste questionnaire preference attributes odor after taste scent	null	2	arm 1: 200 micrograms (mcg); an aqueous suspension of microfine FP arm 2: 110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: 200 micrograms (mcg); an aqueous suspension of microfine FP intervention 2: 110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF	intervention 1: fluticasone propionate (FP) intervention 2: fluticasone furoate (FF)	14	Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 Long Beach \| California \| United States \| -118.18923 \| 33.76696 San Diego \| California \| United States \| -117.16472 \| 32.71571 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Lakewood \| Colorado \| United States \| -105.08137 \| 39.70471 Lawrenc...	254	0	0	0	NCT00398476	1COMPLETED	2006-12-04	2006-12-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 5 ]	251	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	Community based study assessing safety and efficacy of levetiracetam in partial onset seizures. The optimal dose in daily clinical practice will be used.	null	Epilepsy, Partial	Epilepsy Partial Onset Seizures Keppra Levetiracetam	null	1	arm 1: Subjects received open-label Levetiracetam.	[ 0 ]	1	[ 0 ]	intervention 1: * Pharmaceutical form: oral tablets * Concentration: 500 mg * Route of administration: Oral use	intervention 1: Levetiracetam	29	Hong Kong \| N/A \| Hong Kong \| 114.17469 \| 22.27832 Hong Kong \| N/A \| Hong Kong \| 114.17469 \| 22.27832 Kwun Tong \| N/A \| Hong Kong \| 114.22176 \| 22.31184 Kuala Lumpur \| N/A \| Malaysia \| 101.68653 \| 3.1412 Kuala Lumpur \| N/A \| Malaysia \| 101.68653 \| 3.1412 Kuala Lumpur \| N/A \| Malaysia \| 101.68653 \| 3.1412 Manila \| N/A \|...	251	0	0	0	NCT00160654	1COMPLETED	2006-12-12	2003-11-24	UCB Pharma	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	100	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The objective of this trial was to establish the dose-response of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch,T1) in Japanese and Caucasian participants. Part A: Japanese Participants	For most surgical procedures a depth of neuromuscular block of 1-2 twitches after TOF-stimulation is sufficient to avoid unwanted muscular activity. At reappearance of T2, the anesthesiologist might decide to either give (another) maintenance dose of rocuronium or vecuronium when surgery continues, to await spontaneous...	Anesthesia, General		null	10	arm 1: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV. arm 2: After induction of anesthesia an intubation dose of 0...	[ 2, 0, 0, 0, 0, 2, 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of s...	intervention 1: sugammadex intervention 2: Placebo	0	null	98	0	0	0	NCT00591409	1COMPLETED	2006-12-18	2006-01-03	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 1 ]	103	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	0NONE	true	0ALL	false	Adipose tissue is an active endocrine organ producing several hormones with circulatory and metabolic effects. In 1994, the hormone leptin was discovered. The lack of this hormone explained extreme obesity in rare patients and parenteral substitution restored body weight and metabolic disturbances. It was however soon ...	Introduction High BMI and particularly fat mass index are associated with increased risk of coronary artery disease and other cardiovascular conditions, but the underlying mechanisms are not well understood. Endothelial dysfunction precedes atherosclerosis and represents an important link between obesity and cardiovasc...	Endothelial Dysfunction Obesity Vasodilation Venous Occlusion Plethysmography		null	3	arm 1: This applies to protocol 1 when 10 healthy men got leptin infused locally in the forearm and forearm blood flow (FBF) was measured. The other forearm was used as the control. arm 2: This applies to protocol 2 when 10 healthy men got either a background infusion of leptin or saline locally in the forearm when mea...	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: This applies only to protocol 2 with two arms (leptin or saline) where four vasodilatators (bradykinin, acetylcholine, sodium nitroprusside and verapamil) were infused concomitantly intervention 2: This applies only to protocol 1 when only leptin was given intervention 3: This applies only to protocol 3	intervention 1: Leptin infusion plus vasodilators in healthy men intervention 2: Leptin infusion in healthy men intervention 3: Vasodilators in CAD patients	2	Umeå \| N/A \| Sweden \| 20.25972 \| 63.82842 Edinburgh \| N/A \| United Kingdom \| -3.19648 \| 55.95206	113	0	0	0	NCT04374500	1COMPLETED	2006-12-20	2006-01-01	Stefan Soderberg	7OTHER	false	false	false	null	0	0	0	0	-0
[ 4 ]	108	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®). Planned treatment duration was up to 3 years. Alkermes terminated th...	From the date of successful completion of Study ALK21-006 (base study \[NCT01218997\])), all subjects, including those who received oral naltrexone during the base study, were given the option to enroll in this extension study. Study investigators ensured that subjects were opioid-free and did not demonstrate evidence...	Alcoholism Opiate Dependence		null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Administered via intramuscular (IM) injection once every 4 weeks. Subjects in this dosing group also received this treatment throughout the base study. intervention 2: Subjects in this dosing group received oral naltrexone 50 mg in the base study, but received only Medisorb naltrexone 380 mg in this ext...	intervention 1: Medisorb naltrexone 380 mg intervention 2: Oral naltrexone to Medisorb naltrexone 380 mg	0	null	108	2	0.018519	1	NCT00156936	6TERMINATED	2007-01-01	2004-08-01	Alkermes, Inc.	4INDUSTRY	false	false	false	null	0	0	0	2	0.005093
[ 3 ]	129	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to assess efficacy and safety of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients. The study will be conducted in 120 agitated schizophrenic patients - either newly admitted to a hospital setting or a research unit for acute agitation or already in hospital fo...	null	Schizophrenia	Agitation Schizophrenia	null	3	arm 1: Inhaled Staccato Placebo, single dose arm 2: Inhaled Staccato Loxapine 5 mg, single dose arm 3: Inhaled Staccato Loxapine 10 mg, single dose	[ 2, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Inhaled Placebo, single dose intervention 2: Inhaled Staccato Loxapine 5 mg, single dose intervention 3: Inhaled Staccato Loxapine 10 mg, single dose	intervention 1: Inhaled Placebo intervention 2: Inhaled Loxapine 5 mg intervention 3: Inhaled Loxapine 10 mg	1	Upland \| California \| United States \| -117.64839 \| 34.09751	129	1	0.007752	1	NCT00369577	1COMPLETED	2007-01-01	2006-08-01	Alexza Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0	0	1	0	0.00137
[ 2 ]	188	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	0ALL	null	This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.	null	Dyslipidemia		null	2	arm 1: MK0524A Source 1 (Phase III manufacturing site) arm 2: MK0524A Source 2 (commercial manufacturing site)	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods. intervention 2: Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 2 in one of two treatment periods.	intervention 1: niacin (+) laropiprant (Source 1) intervention 2: Comparator: niacin (+) laropiprant (Source 2)	0	null	376	26	0.069149	1	NCT00944645	1COMPLETED	2007-01-01	2006-10-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	26	0	0.047623
[ 4 ]	441	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with Type 2 diabetes mellitus.	null	Diabetes Mellitus, Type 2		null	2	arm 1: Sitagliptin 10 mg tablet daily for 54 weeks arm 2: Placebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks	[ 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: sitagliptin 10 mg tablet, once daily for 54 weeks intervention 2: Placebo oral tablet once daily for 24 weeks intervention 3: Pioglitazone 30 mg tablet once daily for 30 weeks	intervention 1: Comparator: Sitagliptin intervention 2: Comparator: Placebo intervention 3: Comparator: Pioglitazone	0	null	441	0	0	0	NCT00106704	1COMPLETED	2007-01-01	2005-03-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 2 ]	73	NON_RANDOMIZED	SEQUENTIAL	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to evaluate the safety and tolerability as well as find the maximum tolerated dose (MTD) for HKI-272. In addition, this study will examine the effects of the study drug on your tumor, and how your body uses and eliminates HKI-272.	null	Breast Neoplasms	Tumors Neratinib HKI-272 Nerlynx	null	8	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None	[ 0, 0, 0, 0, 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: HKI-272	intervention 1: neratinib	5	Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589	72	0	0	0	NCT00146172	1COMPLETED	2007-01-01	2003-11-01	Puma Biotechnology, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 0 ]	10	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	The goal of this clinical research study is to evaluate how well ferumoxtran-10, a new Magnetic Resonance Imaging (MRI) contrast agent, can detect cancer in the pelvic lymph nodes or malignant pelvic lymph nodes.	The contrast agent, ferumoxtran-10, is made of ultra small iron oxide particles (USPIO). Once they are injected through vein, they are taken up mostly by liver, spleen, bone marrow, and lymph nodes. It takes about 24 - 36 hours to reach peak uptake in the lymph nodes. The ability of current imaging techniques to detect...	Bladder Cancer Genitourinary Cancer Prostate Cancer	Bladder Cancer Genitourinary Cancer Prostate Cancer MR Lymphangiography Ferumoxtran-10 SPIO Ultra-small superparamagnetic agent iron oxide	null	2	arm 1: MR lymphangiography using Ferumoxtran-10 contrast agent. arm 2: MR lymphangiography before injecting Ferumoxtran-10 contrast agent.	[ 0, 1 ]	2	[ 0, 3 ]	intervention 1: Intravenous infusion of 2.6 mg/kg of ferumoxtran-10 intervention 2: First MRI examination before ferumoxtran-10 contrast injected and second MRI examination about 24 hours after injection of contrast agent, each MRI taking 20 minutes.	intervention 1: Ferumoxtran-10 (USPIO) intervention 2: MR lymphangiography	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	10	0	0	0	NCT00147238	6TERMINATED	2007-01-01	2005-07-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0	0	0	0	0
[ 5 ]	23	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The levels of lopinavir achieved in the blood following oral ingestion of standard doses of Kaletra (lopinavir/ritonavir) in HIV-infected men was compared with those achieved in HIV-infected women receiving the same dose of the drug.	The association between patient sex and the tolerability of antiretroviral drugs (ARVs) is increasingly being recognized. Several lines of evidence suggest that women are more likely than men to develop side effects to ARVs. On the other hand, it has been generally accepted that the efficacies of the ARVs are similar i...	HIV Infections	Sex differences Pharmacokinetic Lopinavir/ritonavir Treatment Experienced HIV-infection	null	2	arm 1: LPV/r 800/200 mg once daily arm 2: LPV/r 800/200 mg once daily	[ 1, 0 ]	1	[ 0 ]	intervention 1: LPV/r 800/200 mg once daily	intervention 1: LPV/r	1	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749	23	0	0	0	NCT00148759	1COMPLETED	2007-01-01	2005-06-01	Emory University	7OTHER	false	false	false	null	0	0	0	0	0
[ 4 ]	108	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).	Enrolled subjects continued to receive the same dose strength of Medisorb naltrexone (ie, 190 mg or 380 mg) they had received in Study ALK21-003-EXT (NCT01218971). Assigned dose strength (high or low) was not revealed to the subject, the study investigators, or any blinded member of the clinical study team for the dura...	Alcoholism	Alcohol dependence	null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years. intervention 2: Administered via IM injection once every 4 weeks for up to 3.5 years.	intervention 1: Medisorb naltrexone 380 mg intervention 2: Medisorb naltrexone 190 mg	0	null	108	0	0	0	NCT00156923	1COMPLETED	2007-01-01	2003-10-01	Alkermes, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 5 ]	312	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to compare three treatment regimens in patients who have received a liver transplant for end-stage liver disease caused by Chronic Hepatitis C infection.	End-stage liver disease due to Hepatitis C virus (HCV) infection is the most common reason for liver transplantation in the United States. Patients who have HCV will always carry the virus in their body. If patients respond to treatment, the virus is no longer active. This means that although the virus is still present...	End Stage Liver Disease Hepatitis C	Hepatitis C Virus Immunosuppressive Agents	null	3	arm 1: immunosuppressant treatment regimens the intervention is antirejection treatment with the above labeled drugs tacrolimus and cyclosporine arm 2: immunosuppressant treatment regimensthe intervention is antirejection treatment with the above labeled drugs MMF tacrolimus and cyclosporine arm 3: immunosuppressant tr...	[ 1, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: anti-rejection drug intervention 2: anti rejection drug intervention 3: anti rejection drug intervention 4: anti rejection drug	intervention 1: Daclizumub intervention 2: Tacrolimus intervention 3: Cyclosporine intervention 4: MMF	1	Dallas \| Texas \| United States \| -96.80667 \| 32.78306	312	0	0	0	NCT00163657	1COMPLETED	2007-01-01	2002-07-01	Baylor Research Institute	7OTHER	false	false	false	null	0	0	0	0	0
[ 5 ]	75	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	true	This is the first comparison of efficacy of Betaseron and Copaxone for treatment of relapsing forms of MS.	We propose to perform a head to head comparison of Interferon beta and Copaxone for treatment of patients with CIS and RR forms of MS using acute changes on MRI as primary outcome. The study will be performed at the two clinical practice sites of the Multiple Sclerosis Center at University of Medicine and Dentistry New...	Multiple Sclerosis	Multiple Sclerosis Brain Betaseron Copaxone MRI	null	2	arm 1: Betaseron 250 micrograms SQ every other day and Triple-Dose Gadolinium at each MRI arm 2: Copaxone 20 mg daily SQ and Triple-Dose Gadolinium at each MRI	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Betaseron 250 micrograms injected SQ every other day intervention 2: Copaxone 20 mg injected SQ every day (glatiramer acetate)	intervention 1: Betaseron intervention 2: Copaxone	1	Newark \| New Jersey \| United States \| -74.17237 \| 40.73566	75	0	0	0	NCT00176592	1COMPLETED	2007-01-01	2003-01-01	University of Medicine and Dentistry of New Jersey	7OTHER	false	false	false	null	0	0	0	0	0
[ 4 ]	2,038	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.	This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8-week treatment period. This study will compare the efficacy of dexlansoprazole MR (60 mg QD and 90 mg QD) with that of lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast...	Esophagitis, Reflux Esophagitis, Peptic	Erosive Esophagitis	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks. intervention 2: Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks. intervention 3: Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.	intervention 1: Dexlansoprazole MR intervention 2: Dexlansoprazole MR intervention 3: Lansoprazole	140	Alabaster \| Alabama \| United States \| -86.81638 \| 33.24428 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Tucson \| Arizona \| Unit...	2,038	0	0	0	NCT00251693	1COMPLETED	2007-01-01	2005-12-01	Takeda	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	2,054	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.	This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8 week treatment period. This study will compare the efficacy of Dexlansoprazole MR (60 mg and 90 mg) with that of Lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The ...	Esophagitis, Reflux Esophagitis, Peptic	Erosive Esophagitis	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks. intervention 2: Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks. intervention 3: Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.	intervention 1: Dexlansoprazole MR intervention 2: Dexlansoprazole MR intervention 3: Lansoprazole	144	Anniston \| Alabama \| United States \| -85.83163 \| 33.65983 Hueytown \| Alabama \| United States \| -86.99666 \| 33.45122 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Tallassee \| Alabama \| United States \| -85.89329 \| 32.53597 Tuscaloosa \| Alabama \| United States \| -87.56917 \| 33.20984 Tucson \| Arizona \| United ...	2,054	0	0	0	NCT00251719	1COMPLETED	2007-01-01	2005-12-01	Takeda	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	20	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	While new treatments for metastatic and recurrent colorectal cancer have become available over the past several years, this disease remains incurable with a limited life expectancy from the time of diagnosis. New strategies for treatment of disseminated colorectal cancer are needed. Under this proposal, patients with a...	null	Colon Cancer Rectal Cancer	Metastatic colon cancer Metastatic rectal cancer	null	1	arm 1: Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250ug/m\^2 SQ QD with a cap of 500mcg SQ QD	[ 0 ]	1	[ 0 ]	intervention 1: 250ug/m\^2 SQ QD with a cap of 500mcg SQ QD	intervention 1: GM-CSF	1	Orange \| California \| United States \| -117.85311 \| 33.78779	20	0	0	0	NCT00257322	1COMPLETED	2007-01-01	2003-04-01	University of California, Irvine	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	77	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The goal of this trial was to explore the utility of evaluating emphysema progression through CT scans measuring lung density during a 2 year period of weekly infusions of either placebo or human alpha-1-antitrypsin (AAT; Prolastin®). Exacerbation data recorded in patient diaries were also collected. All efficacy data ...	This is a one to one randomized, placebo-controlled, clinical, exploratory study with the aim of collecting information on possible clinical endpoints i.e., the progression of emphysema by lung density measurements with CT scan and frequency of exacerbations that could be used for a subsequent placebo controlled clinic...	Alpha 1-Antitrypsin Deficiency	alpha 1 proteinase inhibitor alpha1 proteinase inhibitor congenital emphysema replacement therapy	null	2	arm 1: Prolastin arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Weekly infusion of 60 mg/kg body weight for 2 years intervention 2: Weekly infusion for 2 years. Albumin (Human) 20% will be diluted with 5% glucose to a final concentration of 2.0%.	intervention 1: Alpha1-Proteinase Inhibitor (Human) intervention 2: Albumin (Human) 20%, United States Pharmacopeia (USP)	3	Hellerup \| N/A \| Denmark \| 12.57093 \| 55.73204 Malmo \| N/A \| Sweden \| 13.00073 \| 55.60587 Birmingham \| England \| United Kingdom \| -1.89983 \| 52.48142	77	0	0	0	NCT00263887	1COMPLETED	2007-01-01	2003-12-01	Grifols Therapeutics LLC	4INDUSTRY	false	false	false	null	0	0	0	0	-0
[ 5 ]	886	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus severity score over the first week of treatment	null	Chronic Idiopathic Urticaria	Chronic Idiopathic Urticaria CUTE Levocetirizine Xyzal®	null	2	arm 1: Levocetirizine, once daily, 4 week duration arm 2: Desloratadine, once daily, 4 week duration	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 5mg oral capsules, once daily, 4 week duration intervention 2: 5mg oral capsules, once daily, 4 week duration	intervention 1: Levocetirizine intervention 2: Desloratadine	80	Bruges \| N/A \| Belgium \| 3.22424 \| 51.20892 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Merksem \| N/A \| Belgium \| 4.44903 \| 51.24623 Sint-Niklaas \| N/A \| Belgium \| 4.1437 \| 51.16509 Woluwe-St-Lamb \| N/A \| Belgium \| N/A \| N/A Bernay \| N/A \| France \| 0.59858 \| 49.08888 Besanço...	886	0	0	0	NCT00264303	1COMPLETED	2007-01-01	2005-12-01	UCB Pharma	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	249	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The objective of this study is to evaluate the safety and efficacy of two investigational drugs (MK-0736 and MK-0916) in lowering blood pressure and body weight in patients with hypertension (high blood pressure). This is an early phase trial and some specific protocol information is proprietary and not publicly avail...	Participants enrolled in the study will be separated into 2 strata based on baseline body mass index (BMI) assessments prior to being randomly assigned to study treatment. Study will include a 24-week treatment period comprised of 2 phases, A and B, each of which will 12 weeks in duration.	Hypertension		null	6	arm 1: Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) arm 2: Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) arm 3: Participants administ...	[ 0, 0, 0, 2, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: MK0736 intervention 2: MK0916 intervention 3: Placebo	0	null	249	0	0	0	NCT00274716	1COMPLETED	2007-01-01	2005-11-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	-0
[ 3 ]	96	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of age and older. In addition, patient delay in seeking care for symptoms results in diagnosis at a more advanced stage than that seen in younger individuals. However, clinical trials on gastric cancer rarely have been available to...	null	Gastric Cancer	Stomach cancer Palliative chemotherapy Capecitabine S-1	null	2	arm 1: None arm 2: None	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: S-1 intervention 2: Capecitabine	9	Goyang-si \| Gyeonggi-do \| South Korea \| 126.835 \| 37.65639 Pyeongchon \| Gyeonggido \| South Korea \| 127.26395 \| 37.92595 Daegu \| N/A \| South Korea \| 128.59111 \| 35.87028 Daegu \| N/A \| South Korea \| 128.59111 \| 35.87028 Incheon \| N/A \| South Korea \| 126.70515 \| 37.45646 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul...	86	0	0	0	NCT00278863	1COMPLETED	2007-01-01	2004-11-01	Asan Medical Center	7OTHER	false	false	false	null	0	0	0	0	0
[ 4 ]	22	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is for compassionate use of nitazoxanide in the treatment of diarrheal disease due to Clostridium difficile infection when the patient has failed previous treatment with metronidazole or vancomycin.	Clostridium difficile is the leading cause of nosocomial diarrheal disease associated with antibiotic therapy. This is a debilitating condition with substantial morbidity and a mortality that may be around 2-3%. There has been an enormous increase in this disease at the VA Medical Center during the past two years, just...	Clostridium Enterocolitis Pseudomembranous Colitis	Clostridium difficile Associated Diarrhea	null	1	arm 1: 500 mg nitazoxanide bid given to patient	[ 5 ]	1	[ 0 ]	intervention 1: 500 mg bid	intervention 1: Nitazoxanide	2	Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328	27	0	0	0	NCT00304356	1COMPLETED	2007-01-01	2004-01-01	Daniel M. Musher MD	1FED	false	false	false	null	0	0	0	0	0
[ 4 ]	291	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIT45 compared to the current standard of care in postpartum patients.	This is an open label Phase III randomized active control study of postpartum patients with anemia. Patients will be randomized to either active control or the investigational agent and followed for up to 6 weeks.	Postpartum Anemia	anemia postpartum	null	2	arm 1: Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly. arm 2: 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly. intervention 2: 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.	intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Ferrous Sulfate tablets	1	Norristown \| Pennsylvania \| United States \| -75.3399 \| 40.1215	289	0	0	0	NCT00354484	1COMPLETED	2007-01-01	2006-05-01	American Regent, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	200	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.	null	Pain, Postoperative	Bunionectomy Bunion surgery Post-operative pain	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 25 mg capsule, every 6 hours intervention 2: Oral placebo capsule, every 6 hours	intervention 1: diclofenac potassium (XP21L) intervention 2: Placebo	4	Austin \| Texas \| United States \| -97.74306 \| 30.26715 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Marcos \| Texas \| United States \| -97.94139 \| 29.88327 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078	200	0	0	0	NCT00375934	1COMPLETED	2007-01-01	2006-09-01	Xanodyne Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	3,095	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Cycloset, a new quick-release oral formulation of bromocriptine mesylate, effectively reduces blood sugar by the proposed mechanism of reversing many of the metabolic alterations associated with insulin resistance and obesity by resetting central (hypothalamic) circadian organization of monoamine neuronal activities. ...	Bromocriptine mesylate, an ergot derivative, is a sympatholytic dopamine D2 receptor agonist that can exert inhibitory effects on serotonin turnover in the central nervous system. It has been proposed that bromocriptine can reverse many of the metabolic alterations associated with insulin resistance and obesity by rese...	Type 2 Diabetes Mellitus	diabetes diabetes mellitus	null	2	arm 1: Usual diabetes therapy plus placebo arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Usual diabetes therapy plus Cycloset intervention 2: Placebo tablet taken orally once in the morning, beginning with one tablet daily, titrated up by 1 tablet each week to a maximum of 6 tablets daily	intervention 1: Cycloset intervention 2: Usual Diabetes Therapy plus placebo	0	null	3,070	0	0	0	NCT00377676	1COMPLETED	2007-01-01	2004-07-01	VeroScience	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	60	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The main objectives of this study are to evaluate the efficacy and safety of combination therapy BMS-201038 (AEGR-733) plus ezetimibe vs. each agent given alone on LDL cholesterol and other lipoproteins over 12 weeks of therapy.	Subjects will participate in this study for approximately 14-17 weeks. This study has 2 periods: 1) a 1-2-week screening period with 2 visits where baseline cholesterol and other characteristics will be evaluated to determine study eligibility. This period also includes a 4-week washout for patients on prior lipid-lowe...	Hypercholesterolemia	Cholesterol	null	0	null	null	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: BMS-201038 (AEGR-733) intervention 2: Ezetimibe	1	Princeton \| New Jersey \| United States \| -74.65905 \| 40.34872	85	0	0	0	NCT00405067	1COMPLETED	2007-01-01	2006-05-01	Aegerion Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	400	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	Staccato Prochlorperazine is being developed to treat patients suffering from acute migraine headaches. In October 2005, we completed a 75 patient, multi-center, double-blind placebo-controlled Phase 2A clinical trial in patients suffering from moderate to severe acute migraine headaches. This Phase 2B clinical trial o...	null	Migraine Headache Aura	Migraine, Staccato Prochlorperazine Migraine headache with or without aura.	null	4	arm 1: Inhaled Staccato Placebo arm 2: Inhaled Staccato Prochlorperazine 5 mg arm 3: Inhaled Staccato Prochlorperazine 7.5 mg arm 4: Inhaled Staccato Prochlorperazine 10 mg	[ 2, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Inhaled Staccato Placebo intervention 2: Inhaled Staccato Prochlorperazine 5 mg intervention 3: Inhaled Staccato Prochlorperazine 7.5 mg intervention 4: Inhaled Staccato Prochlorperazine 10 mg	intervention 1: Inhaled Placebo intervention 2: Inhaled PCZ 5 mg intervention 3: Inhaled PCZ 7.5 mg intervention 4: Inhaled PCZ 10 mg	25	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Santa Monica \| California \| United States \| -118.49138 \| 34.01949 Walnut Creek \| California \| United States \| -122.06496 \| 37.90631 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Fai...	400	0	0	0	NCT00422812	1COMPLETED	2007-01-01	2006-04-01	Alexza Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	181	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	1FEMALE	false	To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.	To compare the efficacy, based on the bone turnover marker (BTM) serum Type I collagen C-telopeptide (CTx), of a 50 mg delayed-release risedronate tablet, administered immediately after a typical breakfast, to that of a 35 mg immediate-release tablet, administered according to labeling instructions (ie, at least 30 min...	Postmenopausal Women		null	4	arm 1: 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks arm 2: 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks arm 3: 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks...	[ 1, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks intervention 2: 35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks intervention 3: 50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks intervention 4:...	intervention 1: risedronate intervention 2: risedronate intervention 3: risedronate intervention 4: risedronate	6	Costa Mesa \| California \| United States \| -117.91867 \| 33.64113 Gainsville \| Florida \| United States \| N/A \| N/A Miami \| Florida \| United States \| -80.19366 \| 25.77427 Honolulu \| Hawaii \| United States \| -157.85833 \| 21.30694 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 San Antonio \| Texas \| United States \| -9...	181	0	0	0	NCT00577720	1COMPLETED	2007-01-01	2006-07-01	Warner Chilcott	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 2 ]	13	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The objective of the study is to determine whether or not inhalation of hypertonic saline will be tolerated by infants with cystic fibrosis and the effect of inhalation on their lung function.	Cystic fibrosis lung disease is characterized by mucous retention which favors secondary bacterial infection and inflammation, which leads to lung damage and ultimately respiratory failure. Classically, therapeutic interventions are aimed to improve mucociliary clearance, to reduce both bacterial load and lower airway ...	Cystic Fibrosis	Cystic Fibrosis Hypertonic Saline Infants	null	1	arm 1: Administration of a single dose of 7% hypertonic saline	[ 0 ]	1	[ 0 ]	intervention 1: 5 ml of 7% saline will be administered via mask with Pari LC Plus nebuliser and a Pari Ultra Ned compressor.	intervention 1: Hypertonic Saline	1	Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	13	0	0	0	NCT00753987	1COMPLETED	2007-01-01	2006-03-01	The Hospital for Sick Children	7OTHER	false	false	false	null	0	0	0	0	0
[ 2 ]	36	RANDOMIZED	CROSSOVER	null	0NONE	true	1FEMALE	false	This study compared the relative bioavailability (rate and extent of absorption) of 0.4 mg/35 mcg Norethindrone and Ethinyl Estradiol Chewable Tablets by Teva Pharmaceuticals, USA with that of 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets manufactured by Warner Chilcott Company, Inc., following a single oral dose (2 \* 0...	null	Bioequivalence	Healthy Subjects	null	2	arm 1: Norethindrone/Ethinyl Estradiol 0.4 mg/35 mcg Chewable Tablets (Teva) arm 2: Ovcon® 35 Fe 0.4 mg/35 mcg Chewable Tablets (Warner Chilcott)	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 0.4 mg/35 mcg Chewable Tablets intervention 2: 0.4 mg/35 mcg Chewable Tablets	intervention 1: Norethindrone/Ethinyl Estradiol intervention 2: Ovcon® 35 Fe	1	Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719	72	0	0	0	NCT01340625	1COMPLETED	2007-01-01	2006-12-01	Teva Pharmaceuticals USA	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 5 ]	1,266	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This is a Phase IIIb/IV, open label, multicentre study of efalizumab (anti cluster of differentiation \[CD\] 11a recombinant human monoclonal antibody) in participants with moderate to severe plaque psoriasis who have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies includ...	null	Psoriasis	Candidates for systemic therapy for psoriasis	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Participants will receive efalizumab 1.0 milligram per kilogram (mg/kg) (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (first treatment \[FT\]). Depending on the response at Week 12, participants could receive additional 8 to 12 weekly injections of e...	intervention 1: Efalizumab - anti-CD11a recombinant human monoclonal antibody	1	Feltham \| N/A \| United Kingdom \| -0.41388 \| 51.4462	1,266	1	0.00079	1	NCT00249808	1COMPLETED	2007-01-25	2004-12-13	Merck KGaA, Darmstadt, Germany	4INDUSTRY	false	false	false	null	1	0	0	0	0.000139
[ 4 ]	182	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	true	The purpose of the trial is to demonstrate a faster recovery from neuromuscular block (NMB) induced with rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with reversal by 70 μg/kg of neostigmine in combination with 14 μg/kg glycopyrrolate.	null	Anesthesia, General		null	4	arm 1: Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 post-tetanic counts (PTC) and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered. arm 2: Partici...	[ 0, 1, 0, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Administered as an intravenous (IV) infusion intervention 2: Administered as an IV infusion intervention 3: Administered as an IV infusion intervention 4: Administered as an IV infusion intervention 5: Administered as an IV infusion	intervention 1: sugammadex intervention 2: neostigmine intervention 3: vecuronium intervention 4: rocuronium intervention 5: glycopyrrolate	0	null	157	0	0	0	NCT00473694	1COMPLETED	2007-01-29	2005-11-28	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	-0
[ 3 ]	58	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	null	Evaluate the effectiveness of adding lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) in the middle of the follicular phase compared to no addition, in infertile women at risk of poor response stimulated with follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) under Gonadotropin Releasi...	null	Ovarian Stimulation	Lutropin alfa Fertilization in vitro Intracytoplasmic sperm injection Reproductive techniques, assisted	null	2	arm 1: Lutropin alfa (r-hLH) will be administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard...	[ 0, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: r-FSH will be administered as specified in the arm description. intervention 2: r-hLH will be administered as specified in the arm description. intervention 3: Analogous GnRH antagonist will be administered as specified in the arm description. intervention 4: r-hCG will be administered as specified in t...	intervention 1: r-FSH intervention 2: r-hLH intervention 3: Analogous GnRH antagonist intervention 4: r-hCG intervention 5: Progesterone	1	Valencia \| N/A \| Spain \| -0.37966 \| 39.47391	58	0	0	0	NCT01112358	1COMPLETED	2007-01-30	2005-12-07	Merck KGaA, Darmstadt, Germany	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	741	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.	null	Diabetes Mellitus, Type 2		null	4	arm 1: Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d ) arm 2: Phase A and B: Oral tablets of sitagliptin 200 mg q.d arm 3: Phase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d. arm 4: Phase A: Oral tablets of placebo matching sitagliptin 2...	[ 1, 1, 2, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks. intervention 2: Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks. intervention 3: Phase A: Placebo matching Sitagliptin 100 mg once a day for ...	intervention 1: Sitagliptin (MK0431) intervention 2: Sitagliptin intervention 3: Placebo intervention 4: Placebo intervention 5: Metformin - Rescue	0	null	741	1	0.00135	1	NCT00087516	1COMPLETED	2007-02-01	2004-06-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	1	0	0.000238
[ 4 ]	325	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.	null	Schizophrenia Bipolar Disorder	Open Label Aripiprazole Bipolar I Disorder, Manic or Mixed Episode	null	1	arm 1: All subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239).	[ 0 ]	1	[ 0 ]	intervention 1: 2 to 30 mg/day orally (2, 5, 10, 15, 20, 25, or 30 mg/day); tablets in strengths of 2, 5, 10, and 15 mg were used to achieve desired doses	intervention 1: Aripiprazole	50	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Costa Mesa \| California \| United States \| -117.91867 \| 33.64113 Fresno \| California \| United States \| -119.77237 \| 36.74773 Orange \| California \| United States \| -117.85311 \| 33.78779 Riverside \| Ca...	325	1	0.003077	1	NCT00102518	1COMPLETED	2007-02-01	2004-09-01	Otsuka Pharmaceutical Development & Commercialization, Inc.	4INDUSTRY	false	false	false	null	0	1	0	0	0.000543
[ 4 ]	296	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.	null	Bipolar Disorder	Aripiprazole Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features	null	3	arm 1: Aripiprazole 10 mg tablet arm 2: Aripiprazole 30 mg tablet arm 3: Placebo	[ 1, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Treatment Arm 1 (10 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, and aripiprazole 10 mg QD as the target dose starting on Day 5. Subjects remained on the 10 mg dose for the remainder of the treatment period Subjects reached their target dose through a forced titra...	intervention 1: Aripiprazole intervention 2: Aripiprazole intervention 3: placebo	53	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 National City \| California \| United States \| -117.0992 \| 32.67811 Orange \| California \| United States \| -117.85311 \| 33.78779 Pasadena \| California \| United States \| -118.14452 \| 34.14778 Sacrament...	294	1	0.003401	1	NCT00110461	1COMPLETED	2007-02-01	2005-03-01	Otsuka Pharmaceutical Development & Commercialization, Inc.	4INDUSTRY	false	false	false	null	1	0	0	0	0.000601
[ 3 ]	52	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The primary purpose of this protocol is to determine the activity of AG 013736 in patients with metastatic renal cell cancer who have received 1 prior cytokine-based therapy.	null	Kidney Neoplasms		null	0	null	null	1	[ 0 ]	intervention 1: None	intervention 1: Vascular Endothelial Growth Factor Receptor [VEGFR] and Platelet-Derived Growth Factor Receptor [PDGFR] inhibitor	9	San Francisco \| California \| United States \| -122.41942 \| 37.77493 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 New York \| New York \| United States \| -74.00597 \| 40.71427 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Philadelphia \| ...	52	0	0	0	NCT00076011	1COMPLETED	2007-02-01	2003-10-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	9	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study will evaluate the effectiveness of the experimental drug, Org 24448, for short-term treatment of depression. It will examine the effects of the drug on symptoms, such as low mood and persistent sadness, poor sleep and appetite, poor motivation and lack of enjoyment of things people normally enjoy, negative t...	Depression is a devastating illness that is estimated to affect 12% to 17% of the population at some point during the lifetime of an individual. Despite the availability of a wide range of antidepressant drugs, 30% to 40% of patients with major depression fail to respond to first-line antidepressant (e.g., selective se...	Depression	Depression Glutamate Ampakine Treatment Memory Major Depressive Disorder AMPA Receptor Activation BDNF	null	2	arm 1: Blinded, active experimental compound arm 2: Blinded placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 250 mg once per day for first week, 250 mg twice per day for second week, 500 mg twice per day for third and fourth weeks, if response minimal or worse at four weeks then 750 mg twice per day for additional weeks intervention 2: Inactive equivalent of 250 mg once per day for first week, 250 mg twice per...	intervention 1: Org 24448 intervention 2: Placebo	2	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067 New York \| New York \| United States \| -74.00597 \| 40.71427	9	0	0	0	NCT00113022	6TERMINATED	2007-02-01	2005-05-01	National Institute of Mental Health (NIMH)	0NIH	false	false	false	null	0	0	0	0	0
[ 4 ]	1,086	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine the long-term safety of febuxostat, once daily (QD), compared to allopurinol in reducing serum urate levels in subjects with gout.	Uric acid is the end product of purine degradation in humans. Hyperuricemia, a urate concentration in serum exceeding the limit of urate solubility (approximately 7.0 mg/dL), is a common biochemical abnormality. Aberrations in any of the multiple mechanisms involved in the production and/or excretion of uric acid may i...	Gout	uric acid xanthine oxidase hyperuricemia tophi Drug Therapy	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Febuxostat 80 mg, tablets, orally, once daily. intervention 2: Febuxostat 120 mg, tablets, orally, once daily. intervention 3: Allopurinol 100 mg or 300 mg, tablets, orally, once daily.	intervention 1: Febuxostat intervention 2: Febuxostat intervention 3: Allopurinol	0	null	1,466	0	0	0	NCT00175019	1COMPLETED	2007-02-01	2003-07-01	Takeda	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	24	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this clinical study (ChAMP - Comparability pharmacokinetics of Alpha-1 Modified Process) is to compare the pharmacokinetic, safety and tolerability of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1 MP) and Prolastin in adult Alpha1-antitrypsin deficient patients. Patients will be infused...	The objective of this study is to demonstrate the pharmacokinetic comparability of Alpha-1 MP to Prolastin® in subjects with Alpha1-antitrypsin deficiency. This study is divided into three 8-week treatment sequences including an initial 8-week double-blind treatment period (with one of the 2 study drugs), a second 8-w...	Alpha 1-Antitrypsin Deficiency	alpha 1-Antitrypsin Deficiency alpha 1-Antitrypsin pulmonary emphysema	null	2	arm 1: Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP arm 2: Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 M...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: alpha-1 proteinase inhibitor (human), 60 mg/kg body weight intervention 2: Prolastin	intervention 1: Alpha-1 MP intervention 2: alpha-1 proteinase inhibitor (human)	8	Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Miami \| Florida \| United States \| -80.19366 \| 25.77427 New York \| New York \| United States \| -74.00597 \| 40.71427 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Philadelphia \| Pennsylvania \| Uni...	48	0	0	0	NCT00295061	1COMPLETED	2007-02-01	2006-05-01	Grifols Therapeutics LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	35	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This study evaluates the safety of plerixafor and other outcomes that are purely exploratory in nature. One other pre-specified outcome is to evaluate an interval of 10-11 hours between dosing with plerixafor and the beginning of apheresis to determine if there will be at least a 2-fold increase in circulating CD34+ ce...	Participants with non-Hodgkin's lymphoma and multiple myeloma who have undergone prior cyto-reductive chemotherapy and are to be autologously transplanted will be treated with a combination of plerixafor and granulocyte colony-stimulating factor (G-CSF) mobilization regimen on the day prior to apheresis. The only chang...	Lymphoma, Non-Hodgkin Multiple Myeloma	Non-Hodgkin's lymphoma Multiple Myeloma Stem cell mobilization	null	2	arm 1: Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for u...	[ 0, 0 ]	1	[ 0 ]	intervention 1: Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and recei...	intervention 1: G-CSF Plus Plerixafor	3	Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Dresden \| N/A \| Germany \| 13.73832 \| 51.05089 Heidelberg \| N/A \| Germany \| 8.69079 \| 49.40768	35	0	0	0	NCT00322842	1COMPLETED	2007-02-01	2004-09-01	Genzyme, a Sanofi Company	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	49	RANDOMIZED	SINGLE_GROUP	0TREATMENT	2DOUBLE	false	2MALE	false	A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the dose-response relationship, and to assess the pharmacokinetics (PK), safety and tolerability of UK-453,061 in asymptomatic HIV infecte...	null	HIV-1		null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Placebo BID, Placebo QD, UK-453,061 10 mg BID, 30 mg BID, 100 mg BID or 500 mg QD for 7 days intervention 2: Placebo BID, Placebo QD, UK-453,061 100 mg QD, 500 mg BID or 750 mg QD for 7 days	intervention 1: UK-453,061 intervention 2: UK-453,061	3	Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Frankfurt am Main \| N/A \| Germany \| 8.68417 \| 50.11552 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073	48	0	0	0	NCT00348673	1COMPLETED	2007-02-01	2006-02-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 5 ]	95	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This is a multicenter, randomized trial to compare the safety and efficacy of two dosing frequencies of Cerezyme® in patients with Gaucher disease who are currently being treated with Cerezyme®. Approximately 90 patients will be randomized in a 2:1 (q4 : q2) ratio to one of two treatment arms at up to 26 study centers...	null	Gaucher Disease, Type 1 Cerebroside Lipidosis Syndrome Glucocerebrosidase Deficiency Disease Glucosylceramide Beta-Glucosidase Deficiency Disease Gaucher Disease, Non-Neuronopathic Form	Type 1 Gaucher Disease Glucocerebrosidase Deficiency Disease	null	2	arm 1: Patients receiving Cerezyme one infusion every 2 weeks (Q2). arm 2: Patients receiving Cerezyme one infusion every 4 weeks (Q4).	[ 5, 5 ]	1	[ 0 ]	intervention 1: Cerezyme doses of 20-60U/kg every 2 weeks (Q2 Arm) or 40-120 U/kg every 4 weeks (Q4 Arm).	intervention 1: Cerezyme	26	Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Coral Springs \| Florida \| United States \| -80.2706 \| 26.27119 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Skokie \| Illinois \| United States \| -87.73339 \| 42.03336 Boston \| M...	190	0	0	0	NCT00364858	1COMPLETED	2007-02-01	2001-12-01	Genzyme, a Sanofi Company	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	215	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	null	Randomized study of PRT054021 40 mg and 15 mg bid vs. enoxaparin 30 mg q12h for the prophylaxis of venous thromboembolic events after unilateral knee replacement surgery.	Approximately 200 patients undergoing unilateral knee replacement will be entered into the study and randomized to receive either enoxaparin 30 mg sq bid, PRT054021 15 mg po bid, or PRT054021 40 mg po bid for 10 to 14 days, at which time patients will undergo venography.	Thromboembolism	Prevention of Venous Thromboembolism	null	3	arm 1: Betrixaban 15 mg oral twice daily for 10 to 14 days arm 2: Betrixaban 40 mg oral twice daily for 10 to 14 days arm 3: Enoxaparin 30 mg administered subcutaneously every 12 hours for 10 to 14 days	[ 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Capsule intervention 2: Administered subcutaneously	intervention 1: Betrixaban intervention 2: Enoxaparin	1	Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884	214	0	0	0	NCT00375609	1COMPLETED	2007-02-01	2006-05-01	Portola Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 2 ]	40	RANDOMIZED	CROSSOVER	null	0NONE	true	1FEMALE	false	The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg norethindrone acetate) Tablets under fed condition...	Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods	Healthy	Bioequivalence Healthy Subjects	null	2	arm 1: Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg arm 2: Activella® (1 mg estradiol/0.5 mg norethindrone acetate) Tablets	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 1 mg/0.5 mg Tablets intervention 2: 1 mg/0.5 mg Tablets	intervention 1: Estradiol/Norethindrone acetate intervention 2: Activella®	1	Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	80	0	0	0	NCT01181726	1COMPLETED	2007-02-01	2007-01-01	Teva Pharmaceuticals USA	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	48	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This Phase 2 study is to determine whether WR279396 with occlusion (a polyurethane dressing) is more effective than WR279396 without occlusion for once daily treatment. Extensive objective and subjective local tolerance data will also be captured during this trial, as well as surrogate markers (parasite loads and amin...	Forty-eight patients (48) with Old World cutaneous leishmaniasis will be randomly allocated to WR279396 treatment once a day for 20 days with an optimized polyurethane dressing (occlusion) (24 patients), or without occlusion (24 patients). All patients will be rescued with the standard of care accepted in Tunisia, if t...	Old World Cutaneous Leishmaniasis	Ointment to treat leishmania skin lesions	null	2	arm 1: 24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing arm 2: 24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing intervention 2: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days	intervention 1: WR279,396 with Tegaderm Dressing intervention 2: WR 279,396 with Gauze and Tape Dressing	1	Tunis \| N/A \| Tunisia \| 10.16579 \| 36.81897	48	0	0	0	NCT01536795	1COMPLETED	2007-02-01	2005-10-01	U.S. Army Medical Research and Development Command	1FED	false	false	false	null	0	0	0	0	0
[ 2 ]	16	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	false	Randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to determine a maximum tolerated dose	This study was designed as a randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to assess the safety and pharmacokinetics of supratherapeutic doses of eslicarbazepine acetate in 32 healthy adult male and female subjects, with 8 subjects per treatment group. In each study group, subje...	Epilepsy	Anticonvulsant	null	3	arm 1: Matching placebo tablets for oral administration arm 2: Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets) arm 3: Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)	[ 2, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Matching placebo tablets for oral administration intervention 2: Eslicarbazepine acetate 600 mg tablets for oral administration intervention 3: Eslicarbazepine acetate 600 mg tablets for oral administration	intervention 1: Placebo intervention 2: BIA 2-093 3000 mg once daily intervention 3: BIA 2-093 3600 mg once daily	1	Miramar \| Florida \| United States \| -80.23227 \| 25.98731	16	0	0	0	NCT01879332	1COMPLETED	2007-02-01	2006-12-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 2 ]	32	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	2MALE	false	Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers	Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers: Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of Topamax (TPM) in last phases; Group B: Pre-treatment with TPM, treatment with TPM and ascending doses of ESL in last phases	Epilepsy		null	2	arm 1: Group A * Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days; * Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days * Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM ...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: BIA 2-093 intervention 2: Topamax	0	null	32	0	0	0	NCT02283814	1COMPLETED	2007-02-01	2007-01-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	5	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Current therapies for Non-Hodgkin's Lymphoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Non-Hodgkin's Lymphoma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston t...	OBJECTIVES: * Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with non-Hodgkin's lymphoma who have failed high-dose chemotherapy and bone marrow transplantation. * Describe the response to, tolerance to, and side effects of this regimen in these patients. Non-Hodgkin's Lym...	Non Hodgkin Lymphoma	Non Hodgkin Lymphoma Recurrent Non Hodgkin Lymphoma Refractory	null	1	arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.	[ 0 ]	1	[ 0 ]	intervention 1: Patients with Non-Hodgkin's Lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.	intervention 1: Antineoplaston therapy (Atengenal + Astugenal)	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	5	0	0	0	NCT00003498	6TERMINATED	2007-02-02	1997-10-13	Burzynski Research Institute	7OTHER	false	false	false	null	0	0	0	0	0
[ 4 ]	701	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.	null	Diabetes Mellitus, Type II	Type 2 Diabetes Mellitus	null	2	arm 1: The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablet...	[ 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104 intervention 2: Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104) intervention 3: Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 10...	intervention 1: Sitagliptin (MK0431) intervention 2: Placebo/Glipizide 5 mg intervention 3: Metformin intervention 4: Pioglitazone	0	null	701	0	0	0	NCT00086515	1COMPLETED	2007-02-02	2004-06-30	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0

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