Split (3)

train · 29.5k rows

FEATURE_phases list	FEATURE_enrollmentCount int64	FEATURE_allocation string	FEATURE_interventionModel string	FEATURE_primaryPurpose class label	FEATURE_masking class label	FEATURE_healthyVolunteers bool	FEATURE_sex class label	FEATURE_oversightHasDmc bool	FEATURE_briefSummary string	FEATURE_detailedDescription string	FEATURE_conditions string	FEATURE_conditionsKeywords string	FEATURE_protocolPdfText string	FEATURE_numArms int64	FEATURE_armDescriptions string	FEATURE_armGroupTypes list	FEATURE_numInterventions int64	FEATURE_interventionTypes list	FEATURE_interventionDescriptions string	FEATURE_interventionNames string	FEATURE_numLocations int64	FEATURE_locationDetails string	LABEL_ct_level_ade_population int64	METADATA_nctId string	METADATA_overallStatus class label	METADATA_completionDate date32	METADATA_startDate date32	METADATA_leadSponsorName string	METADATA_leadSponsorClass class label	METADATA_hasProtocol bool	METADATA_hasSap bool	METADATA_hasIcf bool	METADATA_protocolPdfLinks string	METADATA_wilson_lower_bound float32
[ 3 ]	114	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	null	This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus Herceptin. Patients will be randomized either to...	null	Breast Cancer		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: As prescribed intervention 2: 6mg/kg iv every 3 weeks	intervention 1: Second line chemotherapy intervention 2: trastuzumab [Herceptin]	30	Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47....	109	NCT00444587	1COMPLETED	2011-08-01	2007-03-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	20	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Wegener's granulomatosis (WG) is a rare disease that causes inflammation of blood vessels, or vasculitis. It may involve many different parts of the body, but typically affects the upper and lower respiratory tract and kidneys. The purpose of this study is to determine the safety and effectiveness of the medication aba...	Current standard treatment for WG involves various medications and is based on disease severity. Unfortunately, more than 50% of people experience a relapse after remission, placing them at risk for additional organ damage and medication toxicity. To prevent this, safer and more effective treatments for mild relapses a...	Wegener's Granulomatosis	Vasculitis Relapse Wegener's Treatment	null	1	arm 1: Participants will receive abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter.	[ 0 ]	1	[ 0 ]	intervention 1: A participant's abatacept dose depended on body weight and will remain the same throughout the study: * 500 mg of abatacept for body weight less than 60 kg * 750 mg of abatacept for body weight between 60 and 100 kg * 1000 mg of abatacept for body weight greater than 100 kg Abatacept is administered i...	intervention 1: Abatacept	4	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	20	NCT00468208	1COMPLETED	2011-08-01	2008-02-01	University of Pennsylvania	7OTHER	false	false	false	null	0
[ 3 ]	79	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	false	0ALL	true	This randomized phase II trial is studying how well aspirin works in preventing colorectal cancer in patients at increased risk of colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of aspirin may prevent colorectal cancer.	PRIMARY OBJECTIVE: I. Determine whether acetylsalicylic acid (aspirin) will alter spectral markers (i.e., spectral slope and fractal dimension) in distal colonic mucosa of patients who are at increased risk for the development or recurrence of colorectal cancer. SECONDARY OBJECTIVES: I. Assess the effect of this dru...	Colon Cancer Precancerous Condition Rectal Cancer		null	2	arm 1: Patients receive oral acetylsalicylic acid (aspirin) once daily. arm 2: Patients receive oral placebo once daily.	[ 0, 2 ]	3	[ 0, 0, 10 ]	intervention 1: Given orally intervention 2: Given orally intervention 3: Correlative study	intervention 1: acetylsalicylic acid intervention 2: placebo intervention 3: laboratory biomarker analysis	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	79	NCT00468910	1COMPLETED	2011-08-01	2007-03-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0
[ 3 ]	47	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	The purpose of this study is to assess the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer (a disease in which cells in the prostate gland \[a gland in the male reproductive system found below the bladder and in front of the rectum\] become abnormal and start to grow uncontr...	This is an open-label (all people know the identity of the intervention), single arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the anti-tumor activities and safety of abiraterone acetate in participants with cancer who have failed taxane (doceta...	Prostate Neoplasms	Prostate neoplasms CB7630 Abiraterone acetate Glucocorticoid Prednisone Prednisolone	null	1	arm 1: Abiraterone acetate 1000 milligram (mg) tablet or capsule will be administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Abiraterone acetate 1000 milligram (mg) capsule or tablet will be administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study. intervention 2: Prednisone/prednisolone 5 mg tablet orally twice daily/dexamethasone 0.5 mg tablet orally once daily continuou...	intervention 1: Abiraterone acetate intervention 2: Glucocorticoid	3	San Francisco \| California \| United States \| -122.41942 \| 37.77493 New York \| New York \| United States \| -74.00597 \| 40.71427 Sutton \| N/A \| United Kingdom \| -0.2 \| 51.35	47	NCT00474383	1COMPLETED	2011-08-01	2006-11-01	Cougar Biotechnology, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	122	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will evaluate the efficacy and safety of MabThera monotherapy in patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura (ITP). Patients will receive infusions of MabThera 1000mg i.v. on days 1 and 15. The anticipated time on study treatment is 3-12 months, and the targe...	null	Idiopathic Thrombocytopenic Purpura		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 1000mg iv on days 1 and 15	intervention 1: rituximab [MabThera/Rituxan]	12	Adelaide \| New South Wales \| Australia \| N/A \| N/A Gosford \| New South Wales \| Australia \| 151.34399 \| -33.4244 Randwick \| New South Wales \| Australia \| 151.24895 \| -33.91439 Sydney \| New South Wales \| Australia \| 151.20732 \| -33.86785 Sydney \| New South Wales \| Australia \| 151.20732 \| -33.86785 Westmead \| New South Wa...	122	NCT00475423	1COMPLETED	2011-08-01	2007-05-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 3, 4 ]	82	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	Prospective participants will undergo a screening process at the clinic to determine eligibility. After screening, eligible patients will complete an 8-day inpatient detoxification, followed by a 12-week outpatient phase. Patients will be randomly assigned to one of two conditions (1) Naltrexone + Placebo; (2) Naltrexo...	In the proposed trial heroin-dependent patients undergoing detoxification will be randomly assigned to one of two conditions (1) Naltrexone + Placebo; (2) Naltrexone + Memantine 20 mg bid. Long-acting, injectable form of naltrexone (Vivitrol) will be administered once per month (the total of three injections) while mem...	Opioid Dependence Heroin Dependence	heroin abuse opiate abuse opioid dependence naltrexone memantine	null	2	arm 1: intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO) arm 2: intramuscular injection of Vivitrol 380 mg and Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections) intervention 2: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medica...	intervention 1: Vivitrol intervention 2: memantine	1	New York \| New York \| United States \| -74.00597 \| 40.71427	55	NCT00476242	1COMPLETED	2011-08-01	2008-06-01	New York State Psychiatric Institute	7OTHER	false	false	false	null	0
[ 0 ]	7	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: In animal models, stem cells have been shown to home to the skin and repair the biochemical and structural abnormalities associated with recessive dystrophic epidermolysis bullosa (RDEB) (collagen 7 deficiency). PURPOSE: To determine the safety and effectiveness of stem cell infusion in the treatment of RDE...	OBJECTIVES: Primary * Estimate the incidence of detectable donor-derived collagen type VII at day 100 in patients with epidermolysis bullosa by donor. Secondary * Determine the incidence of transplant-related mortality at day 180 * Determine the incidence of blood chimerism at days 21, 100, 180, 365, and 730 * Dete...	Epidermolysis Bullosa	epidermolysis bullosa dystrophic epidermolysis bullosa	null	1	arm 1: Epidermolysis bullosa patients treated per study regimen with chemotherapy and stem cell transplant.	[ 0 ]	4	[ 0, 0, 0, 3 ]	intervention 1: Day -9 through Day -6: 1.1 mg/kg if \< 12 kg IV every 6 hours; 0.8 mg/kg if \> 12 kg. intervention 2: Day -5 through Day -2: 50 mg/kg IV over 120 min. intervention 3: Day -5 through Day -3: 25 mg/m2 IV over 60 min. intervention 4: allogeneic bone marrow, peripheral stem cell or umbilical cord blood tran...	intervention 1: busulfan intervention 2: cyclophosphamide intervention 3: fludarabine phosphate intervention 4: hematopoietic bone marrow transplantation	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	7	NCT00478244	6TERMINATED	2011-08-01	2007-04-01	Masonic Cancer Center, University of Minnesota	7OTHER	false	false	false	null	0
[ 2, 3 ]	20	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	false	This research is part of a set of studies whose purpose is to test whether tramadol can be used for the treatment of opioid addiction. Tramadol is already available in the United States as a pain medicine marketed as Ultram. It has effects similar to morphine, and it may also have effects similar to other drugs like st...	This is a human laboratory study that tests the effects of tramadol as a step in the possible development of this medication as a new treatment for opioid dependence. Tramadol is a mild/moderate mu agonist opioid currently marketed as an analgesic that has a unique profile of effects. One of the primary metabolites of ...	Opioid Abuse Opioid Addiction Stimulant Abuse Stimulant Addiction	drug discrimination opioid pharmacology behavioral pharmacology human research	null	4	arm 1: oral dose, once per day arm 2: oral dose, once per day arm 3: oral dose, once per day arm 4: oral dose, once per day	[ 1, 2, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: oral dose, once per day intervention 2: oral dose, once per day intervention 3: oral dose, once per day intervention 4: oral dose, once per day	intervention 1: tramadol intervention 2: placebo intervention 3: Hydromorphone intervention 4: Methylphenidate	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	8	NCT00499746	1COMPLETED	2011-08-01	2007-11-01	National Institute on Drug Abuse (NIDA)	0NIH	false	false	false	null	0
[ 3 ]	17	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	2MALE	true	RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving everolimus before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase II trial is studying the side effects and how well...	OBJECTIVES: Primary * To determine the clinical effects of everolimus, in terms of pathologic response (i.e., histologic P0, margin status, or capsular penetration) and surgical outcome, in patients with newly diagnosed localized prostate cancer treated with two different doses of everolimus prior to radical prostate...	Prostate Cancer	adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer stage III prostate cancer	null	2	arm 1: 5mg Everolimus daily continuously for 8 weeks and conventional surgery arm 2: 10mg Everolimus daily continuously for 8 weeks and conventional surgery	[ 0, 1 ]	2	[ 0, 3 ]	intervention 1: Patients will receive arm-specific dosage of Everolimus daily continuously for 8 week intervention 2: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).	intervention 1: Everolimus intervention 2: conventional surgery	1	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	17	NCT00526591	6TERMINATED	2011-08-01	2007-09-01	Jorge A. Garcia, MD	7OTHER	false	false	false	null	0
[ 4 ]	759	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the ...	null	Hepatitis C, Chronic	hepatitis C ribavirin Hepatitis C-related thrombocytopenia thrombopoietin peginterferon alfa-2b platelets	null	2	arm 1: active treatment arm arm 2: placebo control arm	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: double-blind active treatment daily oral administation at dose of 25, 50, 75, or 100 mg intervention 2: double-blind matched placebo control daily oral administration	intervention 1: eltrombopag intervention 2: placebo	227	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Arcadia \| California \| United States \| -118.03534 \| 34.13973 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Los Angeles \| Califor...	1,563	NCT00529568	1COMPLETED	2011-08-01	2007-10-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 3 ]	90	NA	SINGLE_GROUP	9OTHER	0NONE	false	0ALL	true	Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.	null	Head and Neck Cancer Squamous Cell Cancer		null	1	arm 1: Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.	[ 0 ]	1	[ 0 ]	intervention 1: Individual dose titration weekly i.v. doses	intervention 1: Zalutumumab	48	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Loma Linda \| California \| United States \| -117.26115 \| 34.04835 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Fort Wayne \| Indiana \| United ...	90	NCT00542308	1COMPLETED	2011-08-01	2008-01-01	Genmab	4INDUSTRY	false	false	false	null	0
[ 4 ]	896	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	2MALE	true	Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases. * This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo. * ZD4054...	null	Prostate Cancer	Hormone Resistant Prostate Cancer Endothelin A Receptor Antagonist Endothelin A Endothelin A antagonist	null	2	arm 1: ZD4054 10 mg oral tablet once daily arm 2: Matching Placebo, oral tablets once daily	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: ZD4054 10 mg oral tablet once daily intervention 2: Matching placebo oral tablet once daily	intervention 1: ZD4054 intervention 2: Placebo	197	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Greenbrae \| California \| United States \| -122.5247 \| 37.94854 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Palm Springs \| California \| United States \| -116.54529 \| 33.8303 San Mateo \| California \| United States \| -122.32553 \| 37.56299 Norwich ...	593	NCT00554229	1COMPLETED	2011-08-01	2007-11-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 5 ]	205	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will evaluate the efficacy and safety of a first-line regimen of Avastin and XELOX (oxaliplatin + Xeloda) in patients with metastatic cancer of the colon or rectum. Patients will receive 21-day cycles of treatment, comprising Avastin 7.5mg/kg iv on day 1, oxaliplatin 130mg/m2 iv on day 1, and Xelo...	null	Colorectal Cancer		null	1	arm 1: None	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: 7.5mg iv on day 1 of each 3 week cycle intervention 2: 130mg/m2 iv on day 1 of each 3 week cycle intervention 3: 1000mg/m2 po bid on days 1-14 of each 3 week cycle	intervention 1: bevacizumab [Avastin] intervention 2: Oxaliplatin intervention 3: Xeloda	38	Bologna \| N/A \| Italy \| 11.33875 \| 44.49381 Brescia \| N/A \| Italy \| 10.21472 \| 45.53558 Cagliari \| N/A \| Italy \| 9.11917 \| 39.23054 Cagliari \| N/A \| Italy \| 9.11917 \| 39.23054 Caserta \| N/A \| Italy \| 14.33231 \| 41.07262 Catanzaro \| N/A \| Italy \| 16.60086 \| 38.88247 Cefalù \| N/A \| Italy \| 14.02285 \| 38.03856 Fano \| N/A ...	197	NCT00577031	1COMPLETED	2011-08-01	2008-02-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 4 ]	60	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	In pilot study now proposed, we plan to randomly assign 60 opioid dependent patients to the new model, Depot-BNT, or to BNT plus oral naltrexone for a 6-month trial. This will provide initial clinical experience with the new Depot-BNT treatment model, while providing a rigorous test of whether Depot-BNT produces superi...	The clinical trial now proposed will provide an initial test of the feasibility and efficacy of the newly adapted version of Behavioral Naltrexone Therapy for Depot Naltrexone (Depot-BNT). Treatment-seeking opiate-dependent patients will be admitted for inpatient detoxification and induction onto oral naltrexone. Those...	Opiate Dependence Heroin Dependence	Opiate Dependence Heroin Dependence Naltrexone	null	2	arm 1: Depot Naltrexone. Vivitrol (380 mg)given monthly arm 2: Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Mond...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is wha...	intervention 1: depot naltrexone intervention 2: Oral Naltrexone	1	New York \| New York \| United States \| -74.00597 \| 40.71427	60	NCT00577408	1COMPLETED	2011-08-01	2007-09-01	New York State Psychiatric Institute	7OTHER	false	false	false	null	0
[ 3 ]	50	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	true	This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent individuals, who are healthy and are seeking treatment for their substance abuse, will be randomized to receive either atomoxetine (n=25) or a matched-...	null	Substance Abuse	cocaine dependence stimulants	null	2	arm 1: Atomoxetine arm 2: Matched Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Once daily oral dosing intervention 2: Once daily oral dosing - matched placebo	intervention 1: atomoxetine intervention 2: placebo	1	Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869	50	NCT00617201	1COMPLETED	2011-08-01	2007-07-01	Sharon Walsh	7OTHER	false	false	false	null	0
[ 3 ]	111	RANDOMIZED	PARALLEL	9OTHER	3TRIPLE	false	0ALL	true	The purpose of this study is to evaluate the effects of the study medication, memantine (placebo, 20 mg or 40 mg/day) on alcohol drinking behavior in a laboratory setting in which participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. We hypothe...	null	Alcohol Drinking	Alcohol Drinking Memantine	null	3	arm 1: 20 mg memantine arm 2: 40 mg memantine arm 3: None	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Memantine 20 mg once per day for 7 days intervention 2: Memantine 40 mg once per day for 7 days intervention 3: Placebo once per day for 7 days	intervention 1: memantine intervention 2: Memantine intervention 3: Placebo	1	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815	111	NCT00630955	1COMPLETED	2011-08-01	2006-06-01	Yale University	7OTHER	false	false	false	null	0
[ 4 ]	1,240	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.	Data of this trial ("VIEW 2") was pooled with data of a sister trial ("VIEW 1", NCT00509795), and an integrated analyses of the combined data was performed.	Macular Degeneration	Eye diseases Vision Impairment and Blindness Eyes and Vision Seniors Neovascular Age-Related Macular Degeneration (AMD) Retinal Disease	null	4	arm 1: Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. arm 2: Participants received a 2.0 mg dose of Aflibercept Injection ...	[ 1, 0, 0, 0 ]	4	[ 0, 2, 2, 2 ]	intervention 1: Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. intervention 2: Participants received a 2.0 mg dose of Afli...	intervention 1: Ranibizumab intervention 2: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) intervention 3: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) intervention 4: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)	189	Buenos Aires \| Ciudad Auton. de Buenos Aires \| Argentina \| -58.37723 \| -34.61315 Buenos Aires \| Ciudad Auton. de Buenos Aires \| Argentina \| -58.37723 \| -34.61315 Buenos Aires \| Ciudad Auton. de Buenos Aires \| Argentina \| -58.37723 \| -34.61315 Buenos Aires \| Ciudad Auton. de Buenos Aires \| Argentina \| -58.37723 \| -34.61...	1,204	NCT00637377	1COMPLETED	2011-08-01	2008-04-01	Bayer	4INDUSTRY	false	false	false	null	0
[ 5 ]	135	NON_RANDOMIZED	PARALLEL	2DIAGNOSTIC	0NONE	false	0ALL	true	Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial. The aim of this study was to evaluate the safety profile of gadoterate meglumine (Dotarem®) in patients with chroni...	Patients with renal insufficiency not requiring hemodialysis and scheduled to undergo a contrast enhanced MRI or unenhanced MRI examination to specify a diagnosis, were selected for inclusion. Two groups of patients were defined on the basis of the planned imaging procedure selected to obtain a diagnosis: those undergo...	Renal Insufficiency	contrast-induced nephropathy, creatinemia	null	2	arm 1: Patients undergoing Dotarem®-enhanced MRI for diagnostic purposes arm 2: Patients undergoing non-enhanced MRI for diagnostic purposes	[ 0, 5 ]	2	[ 0, 10 ]	intervention 1: Single IV administration before MRI exam intervention 2: non injected MRI	intervention 1: Dotarem®-enhanced MRI intervention 2: non-enhanced MRI	15	Aalst \| N/A \| Belgium \| 4.0355 \| 50.93604 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Roeselare \| N/A \| Belgium \| 3.12269 \| 50.94653 Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 Lille \| N/A \| France \| 3.05858 \| 50.63297 Lyon \| N/A \| France \| 4.84671 \| 45.74846 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| France \|...	114	NCT00650845	1COMPLETED	2011-08-01	2008-01-01	Guerbet	4INDUSTRY	false	false	false	null	0
[ 5 ]	24	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	true	The primary objective of the proposed pilot study is to determine the efficacy of oxymorphone hydrochloride and propoxyphene/acetaminophen combination in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients lumbar spinal stenosis that have clinical symptoms of neuro...	A computer-generated randomization plan was used for assignment of subjects to one of six treatment sequences (4 subjects per sequence): oxymorphone/propoxyphene/placebo, oxymorphone/placebo/propoxyphene, placebo/oxymorphone/propoxyphene, placebo/propoxyphene/oxymorphone, propoxyphene/oxymorphone/placebo, or propoxyphe...	Lumbar Spinal Stenosis		null	6	arm 1: Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit. arm 2: Opana IR, 5mg (o...	[ 0, 0, 0, 0, 0, 0 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit. intervention 2...	intervention 1: opana then darvocet then placebo intervention 2: opana then placebo then darvocet intervention 3: placebo then opana then darvocet intervention 4: Placebo then darvocet then opana intervention 5: Darvocet then opana then placebo intervention 6: Darvocet then placebo then opana	1	Rochester \| New York \| United States \| -77.61556 \| 43.15478	21	NCT00652093	6TERMINATED	2011-08-01	2008-03-01	University of Rochester	7OTHER	false	false	false	null	0
[ 0 ]	24	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	true	Hypothesis: one-dose pamidronate will prevent post-operative bone loss in children at risk for low bone density Plan: children with chronic disease such as CP, spina bifida, etc. will be recruited pre operatively and studied with DXA scan. After surgery, children will be randomized to receive either pamidronate or sal...	Children at risk for post operative bone loss will be studied with preoperative DXA scan of spine and distal femora Preoperative screening with standard labs electrolytes, Ca++, PO4, creatinine, Vit D Following surgery of hip(s) or lower extremities, randomization into treatment with low dose IV pamidronate (one dose...	Osteoporosis Cerebral Palsy Spina Bifida Osteopenia Osteogenesis Imperfecta	pediatric osteoporosis pediatric osteopenia pamidronate post operative osteopenia	null	2	arm 1: Receives pamidronate 1mg/kg once arm 2: receives saline injection 10 cc/kg over 4 hours once post operatively	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: The pamidronate is mixed 1 to 10 (10 cc of saline for each 1 mg pamidronate), with a minimum volume of 50 cc saline. The medication is administered as an IV infusion to run at a rate beginning at 20 cc/hr, adjusting the rate so that the infusion will run over 4 hours. For children \< 8 kg (80cc infusion...	intervention 1: pamidronate intervention 2: saline	1	Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449	20	NCT00655681	1COMPLETED	2011-08-01	2007-09-01	University of New Mexico	7OTHER	false	false	false	null	0
[ 5 ]	14	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This is a 16 week study of the efficacy of quetiapine in treating symptoms of generalized anxiety disorder (GAD) in subjects with comorbid opiate dependence. The study will be conducted in a prospective, randomized, double-blind, and placebo-controlled fashion. Study subjects will be inpatients at a residential drug-tr...	null	Generalized Anxiety Disorder Comorbid Opiate Dependence in Remission Status Post Methadone-Maintenance Treatment	Generalized Anxiety Disorder Opiate Dependence Methadone-Maintenance Drug Addiction Treatment	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Dosage is 50 - 300 mg, once daily, at bedtime.	intervention 1: Quetiapine	1	New York \| New York \| United States \| -74.00597 \| 40.71427	0	NCT00668265	6TERMINATED	2011-08-01	2008-01-01	Beth Israel Medical Center	7OTHER	false	false	false	null	0
[ 3 ]	5	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The goal of this clinical research study is to learn if Revlimid® (lenalidomide), along with standard-of-care steroid treatment you are already receiving, can help to control Chronic Graft-Versus-Host Disease (cGVHD). The safety of this study drug in combination with the steroids will also be studied. Primary Objectiv...	The Study Drug: Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. It may decrease or prevent the growth of cancer cells. Researchers want to find out if lenalidomide can improve the cGVHD and if it can help dec...	Graft-versus-Host Disease	Chronic Graft-versus-Host Disease cGVHD GVHD Lenalidomide Revlimid CC-5013 Stem Cell Transplant Allogeneic hematopoietic stem cell transplantation Allogeneic HSCT HSCT Post-Transplant Prophylactic Immunosuppressive Therapy Steroids Standard-of-care steroid treatment Corticosteroids Prednisone Medrol	null	1	arm 1: Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.	[ 0 ]	1	[ 0 ]	intervention 1: 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.	intervention 1: Lenalidomide	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	5	NCT00675441	6TERMINATED	2011-08-01	2008-04-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 0 ]	25	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	1FEMALE	false	Pregnant women with type 2 diabetes mellitus (T2DM) are at increased risk for miscarriages, birth defects, large infants, and stillbirths. Maintaining blood sugars in the normal range decreases these pregnancy complications. We hypothesize that metformin will achieve similar levels of blood sugar control compared to in...	Pregnant women with type 2 diabetes mellitus (T2DM) are at increased risk for miscarriages, birth defects, large infants, and stillbirths. Maintaining blood sugars in the normal range decreases these pregnancy complications. Currently, insulin is the primary medication used to treat pregnant women with T2DM. However, i...	Pregnancy Complications	Type 2 diabetes mellitus Pregnancy Metformin Insulin Pregnant women	null	2	arm 1: Metformin therapy as prescribed by their health care provider arm 2: Insulin as prescribed by their health care provider	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily intervention 2: Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day	intervention 1: Metformin intervention 2: Insulin (NPH and Regular)	3	Brownsville \| Texas \| United States \| -97.49748 \| 25.90175 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328	21	NCT00678080	1COMPLETED	2011-08-01	2008-09-01	The University of Texas Health Science Center, Houston	7OTHER	false	false	false	null	0
[ 5 ]	25	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	false	We hypothesize that metformin co-administered with olanzapine will be well tolerated and associated with significantly less insulin resistance, weight gain and dyslipidemia as compared to olanzapine plus placebo.	Increased risk of metabolic complications with olanzapine therapy, relative to other antipsychotics, may lead clinicians to avoid its use, despite evidence of greater efficacy. These problems may also pose a therapeutic dilemma for patients who respond well to olanzapine. Metabolic complications negatively impact on mo...	Metabolic Complications	Olanzapine Zyprexa Weight Gain Antipsychotics Metformin Glucophage Bipolar Disorder Schizophrenia Depression Diabetes Side effects Metabolic complications Prevention Treatment Metabolic side effects of olanzapine	null	2	arm 1: Olanzapine plus metformin: olanzapine plus metformin 500 mg titrated up to but no greater than 2,000 mg based upon fasting blood glucose during study visits over six months. arm 2: Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months.	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Drug: Metformin 500 mg po daily titrated up to but no greater than 2000 mg based upon fasting blood glucose during study visits over six months. intervention 2: Drug: Placebo. Subjects will remain on placebo for 6 months.	intervention 1: Metformin intervention 2: Placebo	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	25	NCT00682448	1COMPLETED	2011-08-01	2007-08-01	Rush University Medical Center	7OTHER	false	false	false	null	0
[ 5 ]	33	RANDOMIZED	PARALLEL	9OTHER	2DOUBLE	false	0ALL	true	Primary Objective: To test the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight gain in persons with schizophrenia who are currently taking either drug; measures of the metabolic syndrome will be evaluated as well.	This study is a sixteen week placebo-controlled, double-blind investigation of the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight gain. We will recruit approximately 72 volunteers with the plan of having a final N = 25 in each of the 2 treatment groups. (This number is to allow for nor...	Schizophrenia Schizoaffective Disorder Diabetes Weight Gain	Schizophrenia Schizoaffective Olanzapine Zyprexa Clozapine Clozaril Pramlintide Diabetes Weight Gain Obesity Metabolic Syndrome	null	2	arm 1: Patients will be given the Placebo for injection twice daily arm 2: volunteers are given 180mg of pramlintide, twice daily	[ 5, 5 ]	2	[ 0, 0 ]	intervention 1: 180mg subcutaneous injections, twice daily intervention 2: 180mg subcutaneous injections, twice daily	intervention 1: Pramlintide intervention 2: Placebo	1	Dallas \| Texas \| United States \| -96.80667 \| 32.78306	24	NCT00690235	1COMPLETED	2011-08-01	2007-11-01	University of Texas Southwestern Medical Center	7OTHER	false	false	false	null	0
[ 3 ]	70	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	A multicenter, randomized, patient-masked, sham-controlled evaluation of the safety and effects on visual function of brimonidine intravitreal implant in patients with glaucomatous optic neuropathy. Patients will be followed for up to 1 year.	null	Glaucoma, Open-Angle		null	3	arm 1: 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. arm 2: 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. arm 3: Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study ...	[ 0, 0, 3 ]	3	[ 0, 0, 0 ]	intervention 1: 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. intervention 2: 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. intervention 3: Sham Posterior Segment Drug Delivery system; Applicato...	intervention 1: 400 ug Brimonidine Implant intervention 2: 200 ug Brimonidine Implant intervention 3: Sham (no implant)	2	Artesia \| California \| United States \| -118.08312 \| 33.86585 Tel Aviv \| N/A \| Israel \| 34.78057 \| 32.08088	70	NCT00693485	1COMPLETED	2011-08-01	2008-09-01	Allergan	4INDUSTRY	false	false	false	null	0
[ 5 ]	105	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	To investigate safety and efficacy of single agent sunitinib malate as first-line systemic therapy in Chinese patients with metastatic renal cell carcinoma.	null	Carcinoma, Renal Cell	sunitinib Phase IV metastatic renal cell carcinoma Chinese	null	1	arm 1: single agent sunitinib, single arm	[ 0 ]	1	[ 0 ]	intervention 1: Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.	intervention 1: Sunitinib Malate (SU011248)	11	Guangzhou \| Guangdong \| China \| 113.25 \| 23.11667 Wuhan \| Hubei \| China \| 114.26667 \| 30.58333 Nanjing \| Jiangsu \| China \| 118.77778 \| 32.06167 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Chongqing \| N/A \| China \| 127.13373 \| 45.880...	105	NCT00706706	1COMPLETED	2011-08-01	2008-07-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 0 ]	10	NA	SINGLE_GROUP	2DIAGNOSTIC	0NONE	false	2MALE	true	RATIONALE: Diagnostic procedures, such as MRI and magnetic resonance spectroscopy imaging, may help in learning how well dutasteride works in patients with benign prostatic hypertrophy and low-risk prostate cancer. PURPOSE: This clinical trial is studying MRI and magnetic resonance spectroscopy imaging in patients rec...	OBJECTIVES: Primary * To determine whether there is a decrease in the extent of prostate cancer as measured by endorectal MRI and magnetic resonance spectroscopy imaging in patients with symptomatic benign prostatic hypertrophy and low-risk prostate cancer treated with dutasteride for 6 months. Secondary * To monit...	Nonmalignant Neoplasm Prostate Cancer	adenocarcinoma of the prostate stage IIB prostate cancer stage IIA prostate cancer benign prostatic hyperplasia	null	1	arm 1: Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months	[ 0 ]	1	[ 0 ]	intervention 1: 6 months of dutasteride 3.5 mg daily	intervention 1: dutasteride	1	San Francisco \| California \| United States \| -122.41942 \| 37.77493	10	NCT00706966	1COMPLETED	2011-08-01	2005-06-01	University of California, San Francisco	7OTHER	false	false	false	null	0
[ 0 ]	29	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	true	1. Research question: Does vitamin D reduce the frequency and severity of nocturnal leg cramps in older persons who previously took quinine for leg cramps? 2. Experimental Design: This is a randomized, double blind, placebo controlled study of 70 men and women veterans receiving care at the Madison VA Medical Center(VA...	This is a randomized, double-blind, placebo-controlled trial to determine if oral vitamin D administration reduces the number or severity of nocturnal leg cramps, compared to placebo. Symptom diaries will be used throughout the study to assess frequency and severity of cramps. We will enroll a total of 70 men and women...	Leg Cramps, Nocturnal	Leg cramps vitamin D deficiency	null	2	arm 1: Vitamin D arm arm 2: placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks. intervention 2: After a two-week wash-in, subjects will take a placebo capsule once daily for 10 days, followed by a on...	intervention 1: vitamin d intervention 2: placebo	1	Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	13	NCT00715429	6TERMINATED	2011-08-01	2007-08-01	University of Wisconsin, Madison	7OTHER	false	false	false	null	0
[ 3 ]	34	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes ...	OBJECTIVES: Primary * To screen for an indication that the addition of vandetanib to chemoradiotherapy may prolong disease-free survival as compared to a combination of chemoradiotherapy in patients with resected, high-risk stage III or IV head and neck squamous cell carcinoma. Secondary * To determine whether this...	Head and Neck Cancer	stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage III verrucous carcinoma of the oral cavity stage IV verrucous carcinoma of the oral cavity stage III squamous cell...	null	2	arm 1: Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. arm 2: Patients undergo radiotherapy as in arm I and receive cisplatin IV ov...	[ 1, 0 ]	3	[ 0, 0, 4 ]	intervention 1: Given IV intervention 2: Given orally intervention 3: Patients undergo radiotherapy 5 times a week for up to 6.5 weeks.	intervention 1: cisplatin intervention 2: vandetanib intervention 3: radiation therapy	63	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Duarte \| California \| United States \| -117.97729 \| 34.13945 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Sacramento \| California \| United States \| -121.4944 \| 38.58157 Newark \| D...	29	NCT00720083	6TERMINATED	2011-08-01	2008-11-01	Radiation Therapy Oncology Group	5NETWORK	false	false	false	null	0
[ 3 ]	260	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.	null	Advanced/Metastatic Non-Small Cell Lung Cancer		null	2	arm 1: None arm 2: None	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Intravenous (IV) solutions, ixabepilone, 32 mg/m\^2 intervention 2: IV solutions, paclitaxel, 200 mg/m\^2 intervention 3: Carboplatin (AUC 6) day 1, every 21 days, 6 cycles	intervention 1: Ixabepilone, 32 mg/m^2 intervention 2: Paclitaxel, 200 mg/m^2 intervention 3: Carboplatin (area under the concentration curve [AUC] 6)	33	La Jolla \| California \| United States \| -117.2742 \| 32.84727 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Capital Federal \| Buenos Aires \| Argentina \| N/A \| N/A Capital Federal \| Buenos Aires \| Argentina \| N/A \| N/A Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Bankstown \| New South Wales \| Aust...	191	NCT00723957	1COMPLETED	2011-08-01	2008-12-01	R-Pharm	4INDUSTRY	false	false	false	null	0
[ 3, 4 ]	40	NA	SINGLE_GROUP	7BASIC_SCIENCE	0NONE	true	0ALL	false	This study is being done to find out how much of the drug raltegravir (RGV) gets into cerebrospinal fluid (CSF), compared to how much get into the blood and to find out if normal changes in a certain gene in your body affects how much RGV gets into the CSF.	The multidrug efflux transporter P-glycoprotein (P-gp) is expressed in the blood-brain barrier where it limits entry of substrate drugs into the central nervous system. Raltegravir (MK-0158), a new HIV-1 integrase inhibitor and potentially major addition to the therapeutic armamentarium against HIV, is a substrate for ...	HIV Infections	Raltegravir CSF ABCB1 SNP HIV/AIDS	null	1	arm 1: Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days.	[ 0 ]	1	[ 0 ]	intervention 1: 400mg orally every 12 hours for 7 days	intervention 1: Raltegravir	1	Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589	40	NCT00729924	1COMPLETED	2011-08-01	2008-08-01	Vanderbilt University	7OTHER	false	false	false	null	0
[ 3 ]	40	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	The primary objective of this study is to test the hypothesis that myocardial perfusion heterogeneity, quantified by Markovian Homogeneity analysis of cardiac PET perfusion images, will improve in a quantitative manner after treatment with selective ETA receptor antagonist darusentan 100 mg per day for 2 weeks compared...	This 6-week, Phase 2, randomized, double-blind, crossover, investigator-initiated, single-center study will determine the feasibility of detecting the effect of darusentan 100 mg once daily on the extent of myocardial perfusion heterogeneity in subjects with documented CAD, as measured by cardiac PET imaging. Prior to ...	Coronary Artery Disease Endothelial Dysfunction	atherosclerosis coronary artery disease myocardial perfusion defect endothelial dysfunction endothelin receptor blockade	null	2	arm 1: Group 1 will receive oral darusentan 100mg for 2 weeks during Phase 1 then placebo for 2 weeks during Phase 2. arm 2: Group 2 will receive placebo for 2 weeks during Phase 1 then oral darusentan 100 mg for two weeks during Phase 2	[ 1, 1 ]	1	[ 0 ]	intervention 1: All subjects will receive oral darusentan 100 mg for a total of 2 weeks and placebo for 2 weeks.	intervention 1: darusentan 100 mg	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	20	NCT00738049	1COMPLETED	2011-08-01	2009-06-01	K.Lance Gould	7OTHER	false	false	false	null	0
[ 5 ]	398	RANDOMIZED	PARALLEL	null	4QUADRUPLE	true	0ALL	true	The objective of this study is to monitor liver function tests (blood levels of an indicator of liver function) of healthy people taking the maximum labeled daily dose of acetaminophen compared to people taking placebo for 16 to 40 days. Those people that continue to have normal liver tests after 16 days will have comp...	Acetaminophen use is common and many consumers take 4g/day for longer than 4 days. The use of 4g/day of acetaminophen for more than 4 days causes an asymptomatic ALT elevation in some people. This elevation most likely resolves while continuing treatment, but it is possible that some individuals may go on to develop cl...	Drug Toxicity Healthy	acetaminophen protein adducts drug safety alanine aminotransferase Alanine Amino Transferase	null	2	arm 1: acetaminophen, 4 grams/day (1 gram every 4 hours for 4 doses) arm 2: placebo for acetaminophen 4 grams/day (2 caplets every 4 hours for 4 doses)	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 500 mg caplets; 2 caplets (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days. intervention 2: placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days	intervention 1: acetaminophen intervention 2: placebo	2	Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Denver \| Colorado \| United States \| -104.9847 \| 39.73915	276	NCT00743093	1COMPLETED	2011-08-01	2008-08-01	Denver Health and Hospital Authority	7OTHER	false	false	false	null	0
[ 3 ]	26	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	true	Acute kidney injury is associated with a rise in serum uric acid during cardiovascular surgery and can cause poor blood flow to the kidneys making them vulnerable to kidney injury. We hypothesize that hyperuricemia, particularly if chronic and marked, is a risk factor for acute kidney injury. The preoperative lowering ...	The study will be a prospective, double-blind, placebo-controlled, randomized, clinical trial, initiated and implemented conjointly by the Nephrology and Cardiovascular Surgery Departments at Shands Hospital at the University of Florida in Gainesville, FL. We propose to study whether lowering uric acid provides signifi...	Hyperuricemia	cardiac surgery hyperuricemia	null	2	arm 1: patients receiving rasburicase to lower serum uric acid arm 2: patients will receive a placebo	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Rasburicase (Dose: 7.5mg in 50ml of normal saline administered over 30 minutes) or identical placebo will be administered as an (dosage form)intravenous infusion preoperatively. intervention 2: Placebo drug (color-coded to appear identical to study drug) administered as an (dosage form) intravenous infu...	intervention 1: Rasburicase intervention 2: Placebo	1	Gainesville \| Florida \| United States \| -82.32483 \| 29.65163	26	NCT00756964	1COMPLETED	2011-08-01	2008-10-01	University of Florida	7OTHER	false	false	false	null	0
[ 3 ]	109	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	false	1FEMALE	false	This study is being conducted to evaluate the efficacy of a 91-day extended cycle oral contraceptive compared to placebo for decreasing the frequency and severity of menstrually-related migraine headaches.	null	Migraine	Migraine headache menstrual oral contraceptive Menstrually-Related Migraine Headache	null	2	arm 1: Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks. arm 2: Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, fo...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE. intervention 2: 1 tablet daily to match experimental arm	intervention 1: 91-day Levonorgestrel Oral Contraceptive intervention 2: Placebo	22	La Mesa \| California \| United States \| -117.02308 \| 32.76783 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Washington D.C. \| District of Columbia \| United States \| -77.03637...	106	NCT00781456	1COMPLETED	2011-08-01	2009-01-01	Duramed Research	4INDUSTRY	false	false	false	null	0
[ 3 ]	3	RANDOMIZED	CROSSOVER	0TREATMENT	1SINGLE	false	0ALL	true	PP1- The purpose of this study is to determine whether giving more of the hormone produced by everyone called growth hormone releasing hormone (GHRH) can improve heart function in individuals with congestive heart failure. You must be 50 years old or older, have a diagnosis of congestive heart failure, and have a high ...	PP1- The overall purpose of this study is to evaluate the effects of Growth Hormone Releasing Hormone (GHRH) on cardiac structure and function in subjects aged 50 years and older with a diagnosis of congestive heart failure in a single blinded (to the subject) randomized treatment/placebo study design. They will receiv...	Congestive Heart Failure	CHF	null	1	arm 1: Everyone will receive 12 weeks of GHRH and 12 weeks of Placebo	[ 0 ]	1	[ 0 ]	intervention 1: 12 weeks of drug at max dose of 2mg/day administered in 4 pulses at 11pm, 1am, 3am, and 5am, followed by 6 weeks of washout period, then 12 weeks of placebo or vise versa- 12 weeks of placebo, 6 weeks washout, 12 weeks of drug.	intervention 1: Growth hormone releasing hormone/ placebo	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	0	NCT00791843	1COMPLETED	2011-08-01	2004-03-01	University of Pennsylvania	7OTHER	false	false	false	null	0
[ 0 ]	1	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Epistaxis is a common problem among people of all ages and backgrounds. However, occasionally epistaxis can be severe enough to require emergency room admission. Among the treatment options for epistaxis, nasal packing is the most common approach. This approach requires a return visit to the clinic for removal of the p...	null	Epistaxis	epistaxis	null	2	arm 1: Thrombin-JMI arm 2: Merocel pack	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 5,000 IU, to nasal mucosa via syringe spray applicator intervention 2: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps	intervention 1: Thrombin-JMI intervention 2: Merocel pack	1	Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417	1	NCT00814333	6TERMINATED	2011-08-01	2008-12-01	University of Kansas Medical Center	7OTHER	false	false	false	null	0
[ 3 ]	22	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	To investigate the role of ranibizumab and angiographically-directed peripheral scatter laser therapy in patients with clinically-significant diabetic macular edema (CSME) and peripheral nonperfusion. We propose a novel treatment of CSME in a subgroup of patients defined by a combination of ultrawide-field angiography ...	Diabetic retinopathy is a leading cause of moderate and severe visual loss in developed countries. It is of paramount socioeconomic impact as the prevalence of diabetes is sharply increasing, diabetic macular edema is the leading cause of vision loss in working age patients, it is a significant cause of vision loss in ...	Diabetic Macular Edema	diabetic macular edema	null	2	arm 1: 1. single intravitreal injection of ranibizumab (0.5 mg in 0.1 cc) 2. peripheral laser to areas of retinal nonperfusion on ultra-widefield fluorescein angiography arm 2: 1. single intravitreal injection of triamcinolone acetonide (4.0 mg in 0.1 cc) 2. macular laser per treatment criteria	[ 0, 1 ]	4	[ 0, 3, 0, 3 ]	intervention 1: intravitreal injection of 0.5 mg ranibizumab intervention 2: ultra-widefield fluorescein angiography guided peripheral laser intervention 3: intravitreal injection of 4.0 mg triamcinolone acetonide intervention 4: macular laser to areas of retinal thickening or leakage	intervention 1: intravitreal injection of ranibizumab intervention 2: peripheral laser intervention 3: intravitreal injection of triamcinolone acetonide intervention 4: macular laser	1	Tampa \| Florida \| United States \| -82.45843 \| 27.94752	22	NCT00815360	1COMPLETED	2011-08-01	2008-02-01	Retina Associates of Florida, P.A.	7OTHER	false	false	false	null	0
[ 3 ]	29	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	null	An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a single agent versus lapatinib versus trastuzumab in patients with HER2-positive treatment-naïve Stage IIIa locally advanced breast cancer. Additional information will be obtained on the safety profile and pharmacokinetics of BI...	null	Breast Neoplasms		null	3	arm 1: BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE) arm 2: Lapatinib tablets 1500 mg daily. arm 3: Trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly.	[ 0, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: lapatinib tablets 1500 mg daily intervention 2: BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE) intervention 3: trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly	intervention 1: lapatinib intervention 2: BIBW 2992 intervention 3: trastuzumab	17	Houston \| Texas \| United States \| -95.36327 \| 29.76328 Brasília \| N/A \| Brazil \| -47.92972 \| -15.77972 Cachoeiro de Itapemirim \| N/A \| Brazil \| -41.11278 \| -20.84889 Campo Grande \| N/A \| Brazil \| -54.64639 \| -20.44278 Caxias do Sul \| N/A \| Brazil \| -51.17944 \| -29.16806 Goiânia \| N/A \| Brazil \| -49.25389 \| -16.67861 Ij...	29	NCT00826267	1COMPLETED	2011-08-01	2009-01-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 3 ]	2	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	A Phase II open- labeled, prospective study to determine the efficacy of pre-operative chemotherapy with six cycles of modified FOLFOX 6 followed by total mesorectal excision (TME) followed by an additional six cycles of FOLFOX 6. The objectives of this study are the following: 1. The primary endpoint of this trial i...	Principal Investigator: Peter Kozuch, M.D. Sites: BIMC/SLRHC Introduction A Phase II open- labeled, prospective study to determine the efficacy of pre-operative chemotherapy with six cycles of modified FOLFOX 6 followed by total mesorectal excision (TME) followed by an additional six cycles of FOLFOX 6. The objecti...	Rectal Neoplasms		null	1	arm 1: None	[ 0 ]	2	[ 0, 3 ]	intervention 1: 6 cycles of neo-adjuvant mFOLFOX6 intervention 2: TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.	intervention 1: FOLFOX intervention 2: total mesorectal excision (TME)	2	New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427	2	NCT00832299	6TERMINATED	2011-08-01	2009-01-01	Beth Israel Medical Center	7OTHER	false	false	false	null	0
[ 1 ]	9	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	0NONE	false	0ALL	null	This phase 0 trial is studying whether 2 weeks of cetuximab and dasatinib will change tumor cells in patients with colorectal cancer and liver metastases that can be removed by surgery. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and ...	PRIMARY OBJECTIVES: I. To evaluate the biological effects of cetuximab, dasatinib, or the combination on epidermal growth factor receptor (EGFR)- and Src-signaling pathways in resected colorectal cancer liver metastases. OUTLINE: This is a multicenter study. Patients are initially enrolled in cohort A. Once cohort A ...	Liver Metastases Mucinous Adenocarcinoma of the Colon Mucinous Adenocarcinoma of the Rectum Recurrent Colon Cancer Recurrent Rectal Cancer Signet Ring Adenocarcinoma of the Colon Signet Ring Adenocarcinoma of the Rectum Stage IV Colon Cancer Stage IV Rectal Cancer		null	4	arm 1: Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy. arm 2: Patients receive 400 mg/m\^2 cetuximab IV over 120 minutes on day 1 and 250 mg/m\^...	[ 0, 0, 0, 0 ]	4	[ 2, 0, 3, 10 ]	intervention 1: Given IV intervention 2: Given orally intervention 3: Undergo surgery intervention 4: Correlative studies	intervention 1: cetuximab intervention 2: dasatinib intervention 3: therapeutic conventional surgery intervention 4: laboratory biomarker analysis	2	Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589	9	NCT00835679	6TERMINATED	2011-08-01	2009-12-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0
[ 0 ]	41	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	3TRIPLE	false	0ALL	false	Glutathione is normally present at high levels in the blood and plays an important role in the body's defense against oxidative stress, that is, against the damage caused to the body by several reactive oxygen species produced by the metabolism of most nutrients, including glucose. Glutathione is a small peptide made f...	Forty adolescents with T1D will undergo a measurement of blood glutathione concentration and markers of oxidative stress (plasma protein-bound 3-nitrotyrosine, and urinary 8OH-2-dG, and F2-isoprostane excretion, markers of oxidative damage to protein, DNA and lipids, respectively) while at near normoglycemia, on two se...	Diabetes Mellitus, Type 1	Glutathione	null	2	arm 1: Vitamin C 250 mg; beta-carotene 6 mg; vitamin E 30 mg; selenium 100 mcg; zinc 20 mg arm 2: None	[ 1, 2 ]	3	[ 7, 10, 0 ]	intervention 1: 1 capsule daily with dinner intervention 2: Intensification of diabetes treatment regimen, including education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator intervention 3: Regular Insulin,...	intervention 1: Antioxidant supplement intervention 2: Diabetes treatment intervention 3: Regular Insulin	1	Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218	32	NCT00858273	1COMPLETED	2011-08-01	2008-03-01	Nemours Children's Clinic	7OTHER	false	false	false	null	0
[ 2, 3 ]	8	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Patients will receive neoadjuvant sorafenib (investigational agent) in combination with preoperative external beam conformal radiotherapy (50 Gy in 25 fractions) for localized, large soft tissue sarcomas of the extremity and body wall prior to resection with curative intent. Sorafenib is an FDA-approved targeted agent ...	Patients will receive neoadjuvant sorafenib (investigational agent) in combination with preoperative external beam conformal radiotherapy (50 Gy in 25 fractions) for localized, large soft tissue sarcomas of the extremity and body wall prior to resection with curative intent. Sorafenib is an FDA-approved targeted agent ...	Soft Tissue Sarcoma	Soft tissue sarcoma of the extremity and body wall	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 400mg twice daily	intervention 1: Sorafenib	1	Sacramento \| California \| United States \| -121.4944 \| 38.58157	8	NCT00864032	1COMPLETED	2011-08-01	2009-03-01	University of California, Davis	7OTHER	false	false	false	null	0
[ 2, 3 ]	10	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the safety and tolerability of imatinib mesylate in combination with panitumumab for the treatment of stage IV colorectal cancer that has spread to the liver. It will also assess the whether imatinib mesylate, either alone or in combination with panitumumab, is effective in trea...	Recently, a series of clinical trial outcome reports have shown that KRAS mutations (and to a lesser extent KRAS mutations with BRAF V600E mutation) significantly negatively correlate with response to anti-epidermal growth factor (EGFR) mAbs, such as panitumumab, in metastatic colorectal cancer (mCRC) patients. WT KRAS...	Colorectal Neoplasm Colorectal Cancer	colorectal neoplasm colorectal cancer imatinib mesylate Gleevec Physiological Effects of Drugs panitumumab Vectibix c-kit receptor Receptor Platelet-Derived Growth Factor alpha	null	2	arm 1: Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab. arm 2: Subjects whose initial liver biopsy samples meet certain lab values wi...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Patients will be entered into sequential cohorts with escalating doses of imatinib mesylate. After approximately 28 days of monotherapy treatment with imatinib mesylate, patients will be asked to have a liver biopsy performed (this biopsy is voluntary and is not required for continued participation in t...	intervention 1: Imatinib mesylate and panitumumab intervention 2: Standard-of-care treatment with panitumumab	2	Fairfax \| Virginia \| United States \| -77.30637 \| 38.84622 Falls Church \| Virginia \| United States \| -77.17109 \| 38.88233	6	NCT00867334	1COMPLETED	2011-08-01	2009-06-01	Inova Health Care Services	7OTHER	false	false	false	null	0
[ 0 ]	51	RANDOMIZED	PARALLEL	6HEALTH_SERVICES_RESEARCH	1SINGLE	false	1FEMALE	true	Our hypothesis is that hyperinsulinemia increases the renal clearance of D-chiro-inositol (DCI) in women with polycystic ovary syndrome (PCOS) and that this leads to a reduction in circulating insulin-stimulated D-chiro-inositol-containing inositol phosphoglycan (DCI-IPG) release. To assess the effects of a chronic red...	This protocol focuses on the hypothesis that a deficiency in a putative inositolphosphoglycan (IPG) mediator of insulin action, namely a D-chiro-inositol-containing IPG (DCI-IPG), contributes to the insulin resistance of some women with PCOS. Our interest in this area stems directly from our previous studies, which dem...	Polycystic Ovary Syndrome		null	2	arm 1: Pioglitazone in pill form at 45mg twice per day for 6 months arm 2: Placebo control to arm 1 in pill form identical to treatment form also twice per day for 6 months	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: pioglitazone 45 mg intervention 2: placebo daily	intervention 1: pioglitazone intervention 2: Placebo	2	Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Caracas \| N/A \| Venezuela \| -66.87919 \| 10.48801	51	NCT00868140	6TERMINATED	2011-08-01	2009-02-01	Virginia Commonwealth University	7OTHER	false	false	false	null	0
[ 4 ]	334	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.	This was a Phase 3 multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the inhibition of radiographic progression by adalimumab compared with placebo in adult Japanese patients with early rheumatoid arthritis (RA) who had not been previously treated with methotrexate (MT...	Rheumatoid Arthritis	Rheumatoid Arthritis	null	6	arm 1: Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly. arm 2: Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other ...	[ 2, 0, 0, 0, 0, 0 ]	4	[ 2, 0, 2, 2 ]	intervention 1: Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) intervention 2: Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow) intervention 3: Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after ...	intervention 1: Double-blind adalimumab intervention 2: Double-blind Placebo intervention 3: Open-label Adalimumab intervention 4: Open-labelAdalimumabRescue	88	Anjo \| N/A \| Japan \| 137.08054 \| 34.95828 Aomori \| N/A \| Japan \| 140.73333 \| 40.81667 Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Fuchū \| N/A \| Japan \| 139.48216 \| 35.67452 Fukuoka \| N/A \| Japan \| 130.41667 \|...	660	NCT00870467	1COMPLETED	2011-08-01	2009-03-01	Abbott	4INDUSTRY	false	false	false	null	-0
[ 3 ]	24	RANDOMIZED	CROSSOVER	1PREVENTION	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine if Omega-3 fatty acids reduce seizures and modify cardiac risk factors in people with epilepsy.	Epilepsy is a common and disabling condition, characterized by recurrent seizures. Sudden unexpected death (SUDEP) is a major cause of mortality in people with epilepsy. SUDEP accounts for up to 20% of all cause mortality, and is most common in younger people, especially in their 20's to 40's year olds. In those with d...	Epilepsy	epilepsy cardiac risk factors memory cognition n-3 fatty acids fish oil EPA DHA seizures	null	3	arm 1: Corn Oil Placebo (n-6 fatty acids) arm 2: 2160 mg of EPA + DHA arm 3: 1060 mg of EPA + DHA	[ 2, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: corn oil (n-6 fatty acids) intervention 2: n-3 fatty acids, 1060 mg EPA + DHA intervention 3: n-3 fatty acids, 2160 mg EPA + DHA	intervention 1: Placebo intervention 2: High Dose Fish Oil intervention 3: Low Dose Fish Oil	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	62	NCT00871377	1COMPLETED	2011-08-01	2008-05-01	National Center for Complementary and Integrative Health (NCCIH)	0NIH	false	false	false	null	0
[ 2, 3 ]	67	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This was a multi-institutional, multinational, open-label, single-arm Phase Ib/II study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trastuzumab emtansine (trastuzumab-MCC-DM1) administered by intravenous (IV) infusion in combination with pertuzumab in patients with human epidermal g...	There were 2 phases in the study, a Dose Escalation phase (Phase 1b) and a Dose Expansion phase (Phase 2a). In the Dose Escalation phase, 3 patients were enrolled at the first dose level (3.0 mg/kg trastuzumab emtansine) and and 6 patients were enrolled at the second dose level (3.6 mg/kg trastuzumab emtansine). An add...	Metastatic Breast Cancer	MBC Breast Cancer HER2+ HER2+ breast cancer HER2 positive breast cancer herceptin Trastuzumab emtansine	null	2	arm 1: Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed...	[ 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Trastuzumab emtansine was provided as a single-use lyophilized formulation. intervention 2: Trastuzumab emtansine was provided as a single-use lyophilized formulation. intervention 3: Pertuzumab was provided as a single-use formulation.	intervention 1: Trastuzumab emtansine [Kadcyla] 3.0 mg/kg intervention 2: Trastuzumab emtansine [Kadcyla] 3.6 mg/kg intervention 3: Pertuzumab 420 mg	20	Boca Raton \| Florida \| United States \| -80.0831 \| 26.35869 Deerfield Beach \| Florida \| United States \| -80.09977 \| 26.31841 Maywood \| Illinois \| United States \| -87.84312 \| 41.8792 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Rockville \| Maryland ...	67	NCT00875979	1COMPLETED	2011-08-01	2009-05-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 3 ]	67	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	false	SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is currently available as Sonata as well as several generic formulations. Sonata and its generics induce sleep soon after ingestion. SKP-1041, however, is a formulation that is designed to become active 2-3 hours after ingestion. It is...	Patients will participate in the study for approximately 44 to 56 days, including a 14- to 21-day Screening Period, 4 Treatment Periods each followed by washout periods, and a final Follow-up Visit. Patients will receive their randomly assigned study medication and spend 2 nights in a sleep laboratory, subsequently ret...	Sleep Disorder Primary Insomnia	insomnia middle of the night sleep maintenance	null	4	arm 1: Two placebo tablets administered orally at bedtime for two consecutive nights to each patient per crossover randomized sequence arm 2: One 10 mg SKP-1041 controlled release zaleplon tablet plus one placebo tablet administered orally at bedtime for two consecutive nights to each patient per crossover randomized s...	[ 2, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: tablet at bedtime intervention 2: tablet at bedtime	intervention 1: placebo intervention 2: SKP-1041 (experimental formulation of zaleplon)	0	null	268	NCT00878553	1COMPLETED	2011-08-01	2010-05-01	Somnus Therapeutics, Inc.	4INDUSTRY	false	false	false	null	0
[ 0 ]	18	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	true	The purpose of this study is evaluate the medication vasopressin for its ability to preserve kidney function in patients undergoing liver transplantation.	Renal failure is a common complication of liver disease. Hepatorenal syndrome is caused by a dysfunctional global circulation in the setting of liver disease: Increased flow to the mesenteric circulation is a contributor to decreased blood flow to the kidneys (1). Renal failure often worsens in the perioperative period...	Liver Failure	liver transplantation vasopressin renal function hypotension creatinine urine output diuretics vasopressors hemodynamic stability	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Patients randomly assigned to the experimental arm of the study will receive vasopressin 0.5U/hr IV (20 U vasopressin in 250mL of 0.9% NaCL to infuse at a rate of 6.25mL/hr) via internal jugular catheter. Vasopressin infusion is started at the time of incision and is stopped at the time abdominal closur...	intervention 1: Vasopressin intervention 2: Normal saline placebo	1	Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632	18	NCT00886262	1COMPLETED	2011-08-01	2007-07-01	Medical University of South Carolina	7OTHER	false	false	false	null	0
[ 3 ]	178	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The AC-055B201/MUSIC study is a Phase II study, comparing one dose of ACT-064922 (macitentan) 10 mg with placebo in patients with idiopathic pulmonary fibrosis (IPF). The main study objective is to demonstrate that macitentan positively affects the forced vital capacity (FVC) in comparison with placebo in patients with...	The study included two treatment periods: Period 1 (fixed duration) from randomization up to the primary endpoint evaluation (Month 12 or earlier in case of premature discontinuation of study drug) and Period 2 (variable duration) from the primary endpoint evaluation visit up to the end of study (EOS). EOS occurred whe...	Idiopathic Pulmonary Fibrosis	idiopathic pulmonary fibrosis MUSIC	null	2	arm 1: ACT-064922 tablet (macitentan), 10 mg, once daily arm 2: Matching placebo, once daily	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: ACT-064992 (macitentan) tablet, 10 mg, once daily intervention 2: matching placebo, once daily	intervention 1: ACT-064992 (macitentan) intervention 2: Placebo	53	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Francisco \|...	178	NCT00903331	1COMPLETED	2011-08-01	2009-05-01	Actelion	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	15	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	RATIONALE: Lenalidomide may stop the growth of cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with do...	OBJECTIVES: Phase I - Primary * To determine the maximum tolerated dose of lenalidomide when combined with fixed dose pegylated liposomal doxorubicin hydrochloride in women with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer. Phase II - Define the best overall response induced by lenalido...	Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer	recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer	null	3	arm 1: liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days arm 2: liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days arm 3: liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: ma...	[ 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: administered by mouth at the assigned dose daily for each 28 day cycle intervention 2: administered at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle	intervention 1: Lenalidomide intervention 2: liposomal doxorubicin	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	15	NCT00903630	6TERMINATED	2011-08-01	2009-04-01	Masonic Cancer Center, University of Minnesota	7OTHER	false	false	false	null	0
[ 3 ]	163	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to test the effectiveness and safety of adding cyclophosphamide or lenalidomide to the VD combination in the treatment of patients with multiple myeloma that have achieved a stable response after 4 initial cycles of treatment with VD. Multiple myeloma is the second most common cancer of the...	It has been shown that quality of response corresponds with clinical benefit. Stable disease is not regarded as a satisfactory result of therapy for relapsed and refractory multiple myeloma. However, there is no consensus if, when and how treatment should be continued or changed in the case of stable disease. There ar...	Multiple Myeloma	multiple myeloma bortezomib hematology bone marrow cancer immunoglobulin refractory progression dexamethasone lenalidomide cyclophosphamide	null	4	arm 1: Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 8 arm 2: Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day ...	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 500 mg, p.o daily, days 1, 8 and 15 for cycles 5 to 8 cycles intervention 2: 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 for cycles 1 to 8 intervention 3: 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycles 1 to 8 intervention 4: 10 mg orally daily, days 1-14 for cycles 5 to 8	intervention 1: Cyclophosphamide intervention 2: Bortezomib intervention 3: Dexamethasone intervention 4: Lenalidomide	42	Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 Le Mans \| N/A \| France \| 0.20251 \| 48.0021 Lille \| N/A \| France \| 3.05858 \| 50.63297 Tours \| N/A \| France \| 0.70398 \| 47.39484 Duisburg \| N/A \| Germany \| 6.76516 \| 51.43247 Essen \| N/A \| Germany \| 7.01228 \| 51.45657 Frankfurt (Oder) \| N/A \| Germany \| 14.55062 \| 52.34714 Leip...	163	NCT00908232	1COMPLETED	2011-08-01	2008-05-01	Janssen-Cilag International NV	4INDUSTRY	false	false	false	null	0
[ 4 ]	548	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.	null	Overactive Bladder		null	2	arm 1: OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). arm 2: Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botuli...	[ 0, 5 ]	2	[ 2, 0 ]	intervention 1: OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applic...	intervention 1: onabotulinumtoxinA intervention 2: normal saline	7	Laguna Hills \| California \| United States \| -117.71283 \| 33.61252 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Tübingen \| N/A \| Germany \| 9.05222 \| 48.52266 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 London \| N/A \| United Kingdom \| -0....	544	NCT00910520	1COMPLETED	2011-08-01	2009-09-01	Allergan	4INDUSTRY	false	false	false	null	0
[ 3 ]	4	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	Background: * Melanoma antigen recognized by T-cells (MART-1) and gp100 are two genes found in melanoma cells. An experimental procedure developed for treating patients with advanced melanoma uses these genes and a type of virus to make special cells called anti-MART-1 and anti-gp100 cells, which are designed to destr...	Background: * We have engineered human peripheral blood lymphocyte (PBLs) to express a T-cell receptor (TCR) that recognizes human leukocyte antigens (HLAA\0201) restricted epitopes derived from the gp100 or the MART-1 melanoma antigen. We constructed single retroviral vectors that contain both Alpha and Beta T cel...	Melanoma Skin Cancer	Metastatic Melanoma Tumor Regression Safety Immunotherapy	null	2	arm 1: Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population). One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsi...	[ 0, 0 ]	9	[ 0, 0, 0, 3, 0, 0, 0, 6, 6 ]	intervention 1: Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population). One mg of either the gp100:154-162 or the MART-1:26-35(...	intervention 1: MART-1: 26-35(27L) Peptide intervention 2: Montanide ISA 51 VG intervention 3: gp100:154-162 Peptide intervention 4: Radiation intervention 5: Aldesleukin intervention 6: Fludarabine intervention 7: Cyclophosphamide intervention 8: Anti-gp 100:154 TCR PBL intervention 9: Anti-MART-1 F5 TCR PBL	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	4	NCT00923195	1COMPLETED	2011-08-01	2008-12-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0
[ 3 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study will evaluate the safety, tolerability and efficacy of open-label fluoxetine for three months among patients with pulmonary arterial hypertension.	Idiopathic pulmonary arterial hypertension (PAH) is a life-threatening disorder of uncertain cause that leads to progressive right heart failure and death. Average survival has improved from about 2.8 years in the early 1990s to approximately 5-7 years with current treatments, but most patients will still die of their ...	Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension Pulmonary Hypertension	null	1	arm 1: Fluoxetine will be added starting at 20 mg and titrated as tolerated to 80 mg daily.	[ 5 ]	1	[ 0 ]	intervention 1: Total dose How to take: Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-6 40 mg BID Week 7-12 40mg BID	intervention 1: Fluoxetine	1	Dallas \| Texas \| United States \| -96.80667 \| 32.78306	6	NCT00942708	1COMPLETED	2011-08-01	2009-09-01	University of Texas Southwestern Medical Center	7OTHER	false	false	false	null	0
[ 3 ]	46	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	The purpose of this research study is to test the safety, tolerability, and effectiveness of two chemotherapy drugs, pegylated liposomal doxorubicin (Doxil) and bevacizumab (Avastin). How Doxil is metabolized and excreted from the body will also be studied.	Avastin: Avastin is a humanized monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer). Avastin has been approved for the treatment of colorectal cancer and lung cancer. Avastin is investigational for the treatment of ovarian cancer and has ...	Ovarian Cancer		null	1	arm 1: Patients receive both agents, doxil and Avastin.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1 intervention 2: First agent (Doxil) will be following by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression	intervention 1: Doxil intervention 2: Avastin	3	Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Santa Fe \| New Mexico \| United States \| -105.9378 \| 35.68698 New York \| New York \| United States \| -74.00597 \| 40.71427	46	NCT00945139	1COMPLETED	2011-08-01	2007-03-01	New Mexico Cancer Research Alliance	7OTHER	false	false	false	null	0
[ 3 ]	22	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The current Standard of Care (SOC) for chronic HCV infection, which is pegylated interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is effective in only part of the patients and is often associated with severe adverse effects leading to discontinuation of treatment and dose modification...	null	Hepatitis C Pharmacokinetics		null	4	arm 1: patient to receive a capsule containing low dose of BI 201335 NA/Drug for treatment-naive (TN) patients arm 2: patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-naive (TN )patients arm 3: patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-exper...	[ 0, 0, 0, 2 ]	12	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: ribavirin (RBV) intervention 2: pegylated interferon (PegIFN) alfa-2a intervention 3: pegylated interferon (PegIFN) alfa-2a intervention 4: ribavirin (RBV) intervention 5: Placebo intervention 6: pegylated interferon (PegIFN) alfa-2a intervention 7: ribavirin (RBV) intervention 8: BI 201335 NA high inte...	intervention 1: ribavirin (RBV) intervention 2: pegylated interferon (PegIFN) alfa-2a intervention 3: pegylated interferon (PegIFN) alfa-2a intervention 4: ribavirin (RBV) intervention 5: BI 201335 NA low placebo intervention 6: pegylated interferon (PegIFN) alfa-2a intervention 7: ribavirin (RBV) intervention 8: BI 20...	3	Kurashiki, Okayama \| N/A \| Japan \| N/A \| N/A Minato-ku, Tokyo \| N/A \| Japan \| N/A \| N/A Nishinomiya, Hyogo \| N/A \| Japan \| N/A \| N/A	43	NCT00947349	1COMPLETED	2011-08-01	2009-07-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 3 ]	17	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Protocol HPN-100-005 was the first study of HPN-100 in pediatric subjects with urea cycle disorders (UCDs) and was a fixed-sequence, open-label, switch over study of HPN-100 with a long-term (12 month) safety extension designed to assess the safety of HPN-100 and to prospectively assess its ability to control blood amm...	This was a fixed-sequence, open-label, switch over study of HPN-100 with a long-term (12 month) safety extension part designed to assess the safety of HPN-100 in pediatric subjects and to prospectively assess the ability of HPN-100 to control blood ammonia compared with NaPBA. For those subjects who participated in th...	Urea Cycle Disorders	Urea Cycle Disorder UCD GT4P Buphenyl hyperammonemia sodium phenylbutyrate	null	1	arm 1: 1 week of NaPBA treatment followed by 1 week of HPN-100 treatment.	[ 0 ]	2	[ 0, 0 ]	intervention 1: HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (\~17.4mL) delivers equivalent amount of PBA that 40 tablets of NapBA do. intervention 2: NaPBA tablets for oral administration and NaPBA powder for oral, nas...	intervention 1: HPN-100 intervention 2: NaPBA	8	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 New York \| New York \| United States \| -74.00597 \| 40.71427 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Houston \| Texas \| United States \| -95.36327 \| 29.7632...	17	NCT00947544	1COMPLETED	2011-08-01	2010-03-01	Amgen	4INDUSTRY	false	false	false	null	0
[ 3 ]	51	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine if treatment with omalizumab (Xolair, anti-IgE) can eliminate or reduce symptoms of peanut allergy.	The study will evaluate if omalizumab is an effective treatment for peanut allergy. In addition we will further evaluate the role of allergic cells (mast cells and basophils) and IgE in food allergy.	Food Allergy Peanut Allergy	peanut allergy	null	2	arm 1: Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group. arm 2: Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allerge...	[ 0, 0 ]	1	[ 0 ]	intervention 1: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE	intervention 1: omalizumab	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	14	NCT00949078	1COMPLETED	2011-08-01	2009-07-01	Johns Hopkins University	7OTHER	false	false	false	null	0
[ 3 ]	267	NA	SINGLE_GROUP	1PREVENTION	0NONE	false	0ALL	true	The purpose of this program is to evaluate an effort to provide a comprehensive package of HIV prevention services of which post-exposure prophylaxis (medicines that may help prevent HIV infection after an exposure) can be a part. It will also include risk reduction information and testing for other sexually transmitte...	The Los Angeles County P-QUAD program is a combined effort of County, City, public health, community, academic, and private agencies and individuals in an effort to provide a comprehensive package of HIV prevention services of which PEP can be an integral component. These services are designed to be easily accessible, ...	HIV Prevention HIV Infections	post exposure prophylaxis biomedical prevention HIV seronegativity	null	1	arm 1: This was an open-label demonstration project. Therefore, medications were not blinded and participants were made aware of the regimen they received for PEP.	[ 5 ]	1	[ 0 ]	intervention 1: The preferred regimen will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a creatinine clearance 30-49 mL/min, dosing of Truvada is 1 tablet by mouth every other day. For patients with creatinine cleara...	intervention 1: tenofovir + emtricitabine, lopinavir/ritonavir	2	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223	282	NCT00949234	1COMPLETED	2011-08-01	2010-03-01	University of California, Los Angeles	7OTHER	false	false	false	null	0
[ 3 ]	87	RANDOMIZED	FACTORIAL	0TREATMENT	3TRIPLE	true	0ALL	false	Unfortunately, the investigators still need to assess and identify novel ways to help people quit smoking. Differences between people in terms of how fast they metabolize nicotine influences response to transdermal nicotine patches, the most popular nicotine dependence treatment, and it affects plasma levels of nicotin...	Novel approaches to treating nicotine dependence remain a priority. The transdermal nicotine patch is the most widely used form of tobacco dependence treatment, but only \~1 in 5 smokers who use this treatment achieve cessation. One factor that may contribute to a poor response to transdermal nicotine is inter-individu...	Nicotine Dependence	nicotine dependence nicotine replacement therapy transdermal nicotine nicotine metabolism high dose	null	2	arm 1: 21mg transdermal nicotine + placebo patch arm 2: 42mg transdermal nicotine	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Transdermal nicotine patch (21mg vs. 42mg), 8 weeks intervention 2: placebo patch	intervention 1: Nicoderm CQ transdermal nicotine intervention 2: placebo	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	87	NCT00956943	1COMPLETED	2011-08-01	2009-08-01	University of Pennsylvania	7OTHER	false	false	false	null	0
[ 0 ]	252	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	1FEMALE	true	The investigators propose to perform a prospective randomized control trial to compare the rate of cesarean delivery in women where Oxytocin (OT) is discontinued once active labor begins (5 cm dilation) when compared with women where OT is continued at a maintenance level per the usual protocol. One study group will f...	Oxytocin is the most common agent used to induce and augment labor. Oxytocin injection is approved by the Food and Drug Administration for the initiation or improvement of uterine contractions to achieve vaginal delivery. It is used to induce labor and stimulate or reinforce labor. The relationship of oxytocin and its...	Labor Induction Cesarean Delivery	Induction of labor in term pregnancies Term pregnancy Cesarean delivery	null	2	arm 1: Continuation of oxytocin per protocol once the patient reaches active labor arm 2: Oxytocin will be stopped once the patient reaches active labor	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Continuation of oxytocin once in active labor intervention 2: Oxytocin will be stopped once in active labor	intervention 1: Oxytocin intervention 2: Oxytocin discontinuation	1	Allentown \| Pennsylvania \| United States \| -75.49018 \| 40.60843	252	NCT00957593	1COMPLETED	2011-08-01	2009-02-01	Lehigh Valley Hospital	7OTHER	false	false	false	null	0
[ 0 ]	4	RANDOMIZED	SINGLE_GROUP	0TREATMENT	2DOUBLE	false	0ALL	false	Facial lacerations are a commonly encountered problem in the emergency department. Despite this, few original articles have been written concerning the management of lacerations of the lip which communicate with the oral cavity. Specifically, no study has been able to definitively show whether the use of antibiotics fo...	Facial lacerations are commonly encountered problem in trauma and emergency room patients. Soft tissue trauma of the face can cause significant psychological impact. Wound care and the need to minimize scarring is particularly important in this region. There have been many studies evaluating the management of soft tiss...	Through-and-through Lip Lacerations		null	2	arm 1: keflex 500mg twice a day for five days arm 2: placebo 500mg twice a day for five days	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: keflex 500 mg BID 5 days intervention 2: placebo BID for five days	intervention 1: keflex intervention 2: placebo	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	4	NCT00957827	6TERMINATED	2011-08-01	2009-08-01	University of Pennsylvania	7OTHER	false	false	false	null	0
[ 4 ]	446	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment. The primary objective is to assess the effects of lixisenatide ...	The study comprises 3 periods: * An up to 14-week screening period, which includes an up to 2-week screening phase and a 12-week run-in phase with introduction and titration of insulin glargine on top of metformin +/-TZDs. * At the end of the run-in phase, patients whose HbA1c (centralized assay) is greater than or eq...	Type 2 Diabetes Mellitus		null	2	arm 1: 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24. arm 2: 2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.	[ 0, 2 ]	6	[ 0, 0, 0, 1, 0, 0 ]	intervention 1: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 3: Dose to be adjusted to maintain a fasting SMPG between 100 and 80 mg/dL (5.6 and 4.4 m...	intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Insulin glargine intervention 4: Pen auto-injector intervention 5: Metformin intervention 6: Thiazolidinedione (TZD)	140	Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Mountain Home \| Arkansas \| United States \| -92.38516 \| 36.33534 Concord \| California \| United States \| -122.03107 \| 37.97798 Greenbrae \| Calif...	446	NCT00975286	1COMPLETED	2011-08-01	2009-10-01	Sanofi	4INDUSTRY	false	false	false	null	0
[ 4 ]	2,561	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal function.	null	Iron Deficiency Anemia Impaired Renal Function	IDA	null	2	arm 1: 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg arm 2: 5 doses of 200 mg for a total cumulative dose of 1000 mg	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg intervention 2: 5 doses of 200 mg for a total cumulative dose of 1000 mg	intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Iron Sucrose (Venofer)	1	Norristown \| Pennsylvania \| United States \| -75.3399 \| 40.1215	2,561	NCT00981045	1COMPLETED	2011-08-01	2009-08-01	American Regent, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	396	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or as monotherapy in Asian patients with visual impairment due to Diabetic Macular Edema (DME).	null	Diabetic Macular Edema	DME Diabetic macula edema ranibizumab REVEAL	null	3	arm 1: Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser. arm 2: Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser. arm 3: Active laser treatment plus sham intravitreal injections.	[ 0, 0, 1 ]	4	[ 0, 3, 0, 3 ]	intervention 1: Ranibizumab 0.5 mg intravitreal injection at day 1, month 1 and month 2. If stable vision not reached at month 3, one injection per month continued until stable vision was reached. Intravitreal injections re-initiated if needed. intervention 2: Active laser treatment administered at day 1. Subsequent la...	intervention 1: Ranibizumab intervention 2: Laser photocoagulation intervention 3: Sham ranibizumab intervention 4: Sham laser photocoagulation	35	Beijing \| N/A \| China \| 116.39723 \| 39.9075 Changsha \| N/A \| China \| 112.97087 \| 28.19874 Chengdu \| N/A \| China \| 104.06667 \| 30.66667 Chongqing \| N/A \| China \| 106.55771 \| 29.56026 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Hangzhou \| N/A \| China \| 120.16142 \| 30.29365 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 We...	393	NCT00989989	1COMPLETED	2011-08-01	2009-09-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 4 ]	127	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms in patients with active rheumatoid arthritis (RA) who are incomplete responders to MTX.	null	Rheumatoid Arthritis	CDP870 Korea CIMZIA	null	2	arm 1: None arm 2: None	[ 2, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Given every 2 weeks until Week22 (SC) intervention 2: 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week 22(SC) intervention 3: Received treatment with Methotrexate(MTX)for at least 24 weeks prior to the Baseline Visit. The dose and route of administration of M...	intervention 1: Placebo of CDP870 intervention 2: CDP870 200mg intervention 3: Methotrexate	15	Daegu \| N/A \| South Korea \| 128.59111 \| 35.87028 Daegu \| N/A \| South Korea \| 128.59111 \| 35.87028 Daejeon \| N/A \| South Korea \| 127.38493 \| 36.34913 Inchon \| N/A \| South Korea \| 126.6251 \| 35.55479 Kwangju \| N/A \| South Korea \| 127.1279 \| 36.9122 Pusan \| N/A \| South Korea \| 128.3681 \| 36.3809 Seoul \| N/A \| South Korea ...	127	NCT00993317	1COMPLETED	2011-08-01	2009-10-01	Korea Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	0
[ 3 ]	10	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine safety and tolerability of the treatment with lithium in Multiple System Atrophy. Moreover, clinical symptoms, neuronal loss, quality of life and depressive symptoms, will be considered to further investigate the effect of lithium therapy.	Patients will be progressively enrolled in the study and undergo a screening visit to test for inclusion/exclusion criteria. Patients will then be randomized to receive either Lithium carbonate or placebo. Patients will visit study center at 2, 4, 8, 12, 24, 36 and 48 weeks, for endpoint and laboratory assessments.	Multiple System Atrophy	MSA Lithium Lithium carbonate MSA-P MSA-C	null	2	arm 1: None arm 2: Placebo comparator	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day. intervention 2: None	intervention 1: Lithium Carbonate intervention 2: Placebo	1	Napoli \| N/A \| Italy \| 14.5195 \| 40.87618	9	NCT00997672	6TERMINATED	2011-08-01	2009-10-01	Federico II University	7OTHER	false	false	false	null	0
[ 4 ]	43	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	false	Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. RP103 is a formulation of...	This is a multi-center, open-label, randomized, cross-over study to determine whether steady-state, twice a day treatment with Cysteamine Bitartrate Delayed-release Capsules(RP103) results in comparable depletion of white blood cell (WBC) cystine levels compared to the existing four times a day cysteamine treatment. It...	Cystinosis	cystinosis cysteamine inheritable disease orphan disease CTNS protein, human metabolic disease nephropathic cystinosis	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Run-in Period (Weeks 1, 2, 3) and Period 1 (Weeks 4, 5, 6) or Period 2 (Weeks 7, 8, 9); Immediate crossover to opposite treatment than taken during Period 1: Every 6H, supplied in 150 and 50mg capsules/Duration of Treatment: 3 weeks each period used intervention 2: Period 1 (Weeks 4, 5, 6) or Period 2 ...	intervention 1: Cystagon® (Cysteamine Bitartrate) intervention 2: Cysteamine Bitartrate Delayed-release Capsules (RP103)	8	Stanford \| California \| United States \| -122.16608 \| 37.42411 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Lyon \| N/A \| France \| 4.84671 \| 45.74846 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| F...	84	NCT01000961	1COMPLETED	2011-08-01	2010-06-01	Amgen	4INDUSTRY	false	false	false	null	0
[ 3 ]	116	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	This study is investigating how N-Acetylcysteine (NAC), an over-the-counter medication, will reduce marijuana use when combined with Contingency Management, a behavioral treatment. It is hypothesized that marijuana dependent adolescents who are treated with NAC will use less marijuana during treatment when compared to ...	This protocol involves investigation of N-Acetylcysteine (NAC) as a pharmacological treatment for cannabis dependence in adolescents. While recent advances have been made in psychosocial treatments for cannabis dependent adolescents, minimal work has been done to investigate the potential adjunctive role for pharmacoth...	Cannabis Dependence		null	2	arm 1: None arm 2: None	[ 1, 2 ]	3	[ 0, 0, 5 ]	intervention 1: 1200 mg twice daily for 8 weeks intervention 2: 2 capsules twice daily for 8 weeks intervention 3: rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule	intervention 1: N-Acetylcysteine intervention 2: placebo intervention 3: Contingency Management	1	Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632	116	NCT01005810	1COMPLETED	2011-08-01	2009-09-01	Medical University of South Carolina	7OTHER	false	false	false	null	0
[ 5 ]	21	RANDOMIZED	CROSSOVER	null	4QUADRUPLE	true	0ALL	false	People who have hayfever or allergic rhinitis often complain about eye symptoms associated with their nasal symptoms. How people with hayfever develop eye symptoms is not clear. The purpose of this study is to better understand the generation of eye symptoms in patients with allergic rhinitis. We have previously shown ...	We performed a randomized, double-blind, double-dummy, placebo-controlled, four-way crossover study in 21 subjects with seasonal allergic rhinitis studied out of season. Healthy patients, between 18 and 50 years of age, came to the Nasal Physiology Laboratory at The University of Chicago for screening, where they compl...	Seasonal Allergic Rhinitis		null	4	arm 1: Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order: * fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL) * PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO), * FF nasal spray and olopat...	[ 5, 5, 5, 5 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 2 puffs of PL nasal spray (from GlaxoSmithKline) in each nostril once a day for 1 week intervention 2: 2 puffs of FF nasal spray in each nostril once a day for 1 week intervention 3: 1 drop of placebo eye drops (lubricant eye drops with active ingredients 0.3% glycerin) in each eye once a day for 1 week...	intervention 1: PL nasal spray intervention 2: fluticasone furoate (FF) intervention 3: PL eye drops intervention 4: olopatadine (OLO)	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	83	NCT01007253	1COMPLETED	2011-08-01	2009-11-01	University of Chicago	7OTHER	false	false	false	null	0
[ 4 ]	781	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	This study will establish the safety and tolerability of suvorexant (MK-4305) when administered for up to 14 months. Participants will be randomized to receive suvorexant or placebo for a 12-month double-blind (DB) Treatment Phase. Participants who complete the 12-month DB Treatment Phase will enter a 2-month DB Random...	null	Insomnia		null	2	arm 1: After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the Treatment Phase. arm 2: After a 1-week single-blind placebo run-in, participants received dose-match...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Oral tablet (30 mg and 10 mg), administered daily before bedtime intervention 2: Oral tablet, administered daily before bedtime	intervention 1: Suvorexant intervention 2: Dose-matched Placebo to Suvorexant	0	null	2,042	NCT01021813	1COMPLETED	2011-08-01	2009-12-10	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 5 ]	160	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	2DOUBLE	true	1FEMALE	true	Sevoflurane is an FDA-approved anesthetic drug commonly used for anesthesia during second trimester abortion procedures. It has a few advantages, including ease of use by the anesthesia provider. However, the literature suggests that when used in doses higher than those used at Oregon Health \& Science University (OHSU...	This study seeks to examine the bleeding complications associated with use of sevoflurane in general anesthesia regimens for second trimester abortion procedures and assess anesthesia providers' use and beliefs regarding possible risks associated with newer inhalational agents such as sevoflurane in this setting. Parti...	Blood Loss Anesthesia	Sevoflurane anesthesia abortion blood loss	null	2	arm 1: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure. arm 2: Subject receives standard of care drug regimens for anesthesia with this procedure.	[ 1, 2 ]	2	[ 0, 10 ]	intervention 1: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure. intervention 2: Subject only standard of care drug regimens for anesthesia with this procedure.	intervention 1: Sevoflurane intervention 2: No Sevoflurane	2	Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345	160	NCT01048658	1COMPLETED	2011-08-01	2009-09-01	Oregon Health and Science University	7OTHER	false	false	false	null	0
[ 4 ]	51	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	OPC-41061 will be orally administered at 7.5 mg/day for 7 days to cirrhosis patients with ascites despite having received conventional diuretic therapy. Based on the change in body weight, on Day 7 it will be decided whether to continue administration at the same dose or to increase the dose, and then OPC-41061 will be...	null	Cirrhosis	Cirrhosis ascites Tolvaptan OPC-41061	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: OPC-41061 tablets will be orally administered once daily after breakfast at 7.5 mg on Day 1 to 7 and at either 7.5 or 15 mg on Day 8 to 14.	intervention 1: OPC-41061	6	Chubu Region \| N/A \| Japan \| N/A \| N/A Chugoku Region \| N/A \| Japan \| N/A \| N/A Kanto Region \| N/A \| Japan \| N/A \| N/A Kinki Region \| N/A \| Japan \| N/A \| N/A Kyushu Region \| N/A \| Japan \| N/A \| N/A Tohoku Region \| N/A \| Japan \| N/A \| N/A	51	NCT01048788	1COMPLETED	2011-08-01	2009-12-01	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	0
[ 3 ]	64	RANDOMIZED	SINGLE_GROUP	0TREATMENT	2DOUBLE	false	0ALL	false	Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100 mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg active sofosbuvir (3 placebo tablets) and 200 mg a...	null	Hepatitis C	Chronic Hepatitis C infection Genotype 1 HCV GT1 GT 1	null	4	arm 1: Participants received sofosbuvir 100 mg (1 x 100 mg tablet) and placebo to match sofosbuvir (3 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) arm 2: Participants received sofosbuvir 200 mg (2 x 100 mg tablets) and placebo to match sofosbuvir (2 tablets) for 28 days (baseline to Day...	[ 0, 0, 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Sofosbuvir tablet(s) administered orally once daily intervention 2: Placebo to match sofosbuvir administered orally once daily intervention 3: Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection. intervention 4: Ribavirin (RBV) tablets were administered orall...	intervention 1: Sofosbuvir intervention 2: Placebo intervention 3: PEG intervention 4: RBV	7	San Francisco \| California \| United States \| -122.41942 \| 37.77493 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Seattle \| Was...	63	NCT01054729	1COMPLETED	2011-08-01	2010-01-01	Gilead Sciences	4INDUSTRY	false	false	false	null	0
[ 4 ]	281	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The primary objective of the study is to determine the efficacy of Asacol™ 4.8 g/day (800 mg tablets) to induce clinical and endoscopic remission after 6 weeks of treatment compared to placebo in subjects with active ulcerative colitis (UC).	The 800 mg Asacol™ tablets from Tillotts Pharma AG are being marketed in over 30 countries, mainly in Europe and Asia. Approved dosages for the treatment of active UC are between 2.4 and 4.8 g/day in analogy to the approved 400 mg dosage form. The present trial is planned to generate efficacy data to support the safe u...	Ulcerative Colitis	Mesalamine Asacol Ulcerative colitis induction therapy acute disease mild to moderate Active Ulcerative Colitis (mild to moderate)	null	2	arm 1: 4.8g Mesalamin (800mg tablet) arm 2: 4.8g Placebo to Mesalamin (800 mg tablet)	[ 0, 2 ]	1	[ 0 ]	intervention 1: 4.8g/day, 800 mg tablets	intervention 1: Mesalamin	31	Homyel \| N/A \| Belarus \| 30.9754 \| 52.4345 Minsk \| N/A \| Belarus \| 27.56653 \| 53.90019 Minsk \| N/A \| Belarus \| 27.56653 \| 53.90019 Minsk \| N/A \| Belarus \| 27.56653 \| 53.90019 Minsk \| N/A \| Belarus \| 27.56653 \| 53.90019 Vitebsk \| N/A \| Belarus \| 30.2049 \| 55.1904 Hyderabad \| Andhrapradesh \| India \| 78.45636 \| 17.38405 H...	281	NCT01059344	1COMPLETED	2011-08-01	2009-11-01	Tillotts Pharma AG	4INDUSTRY	false	false	false	null	0
[ 5 ]	490	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This purpose of this study is to assess the safety of ustekinumab in psoriasis patients who receive ustekinumab following an inadequate response to methotrexate therapy. The study will provide information for doctors on how to manage the transfer from methotrexate to the biologic agent ustekinumab. The study is designe...	Only limited data exist to guide physicians on transitioning patients onto biologic agents once conventional systemic agents have been found to be inadequate. Most Phase III regulatory studies for biologics, including ustekinumab, required washout periods of between one and three months between previous therapies and t...	Psoriasis	Psoriasis Ustekinumab Stelara Methotrexate Biologic	null	2	arm 1: Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0). arm 2: Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexat...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Patients weighting ≤ 100 kg will receive ustekinumab 45 mg at Weeks 0, 4 and 16. Patients who achieve a PASI 75 response at Week 28 and 40 will continue receiving ustekinumab 45 mg at Week 28 and 40. Patients who fail to achieve PASI 75 response at Week 28 will receive ustekinumab 90 mg at Week 28 and 4...	intervention 1: Ustekinumab intervention 2: Methotrexate	76	Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Pleven \| N/A \| Bulgaria \| 24.61667 \| 43.41667 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Aarhus \| N/A \| Denmark \| 10.21076 \| 56.15674 Roskilde \|...	489	NCT01059773	1COMPLETED	2011-08-01	2009-10-01	Janssen-Cilag International NV	4INDUSTRY	false	false	false	null	0
[ 3 ]	21	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	0ALL	false	Brittle nail syndrome (BNS) refers to nails that exhibit splitting, raggedness (fraying of the distal edge), and peeling (lamellar onychoschizia).(1) This is a common problem, affecting approximately 20% of women, with higher prevalence among the elderly.(2) A number of factors have been proposed as possible causes of ...	Brittle nail syndrome (BNS) is a heterogeneous abnormality, characterized by increased fragility of the nail plate. About 20% of the population is affected by brittle nails and women are affected twice as frequently as men. (2). The diagnostic criteria for brittle nails are not well defined but most authors agree in at...	Brittle Nail Syndrome	brittle nail	null	2	arm 1: apply 2 drops to 2 target nails under occlusion daily for 20 weeks arm 2: apply to target nails daily under occlusion daily for 20 weeks	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: apply 2 drops to 2 target fingernails under occlusion daily intervention 2: apply 2 drops to 2 target fingernails under occlusion daily for 20 weeks	intervention 1: topical cyclosporine ophthalmic suspension 0.05% intervention 2: vehicle	1	Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132	21	NCT01064830	1COMPLETED	2011-08-01	2010-02-01	University of North Carolina, Chapel Hill	7OTHER	false	false	false	null	0
[ 5 ]	42	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have an Event related potential (ERP) (a type of electroencephalogram \[EEG\]) study. After the baseline EEG, children will be randomized t...	All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have an Event related potential (ERP) (a type of electroencephalogram \[EEG\]) study. After the baseline EEG, children will be randomized t...	Attention Deficit Disorder With Hyperactivity	Attention Deficit Disorder with Hyperactivity Guanfacine Event Related Potentials	null	2	arm 1: Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets). arm 2: Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind ...	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Guanfacine is an alpha-2A agonist which is given one a day. the dose range is 1-4 mg. It is a tablet. intervention 2: Table that match the 1 mg Guanfacine Extended Release Tablet. They are dosed once a day.	intervention 1: Guanfacine Extended Release intervention 2: Placebo	1	San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	29	NCT01069523	1COMPLETED	2011-08-01	2010-03-01	The University of Texas Health Science Center at San Antonio	7OTHER	false	false	false	null	0
[ 2, 3 ]	43	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The primary objective of phase 1 of this study is to establish the recommended phase II dose (RP2D). The primary objective of phase 2 of this study is to evaluate the safety and efficacy of bendamustine at the recommended pediatric dose for the treatment of pediatric patients with relapsed or refractory acute leukemia.	null	Leukemia		null	1	arm 1: Bendamustine 90 or 120 mg/m\^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: Bendamustine	50	Orange \| California \| United States \| -117.85311 \| 33.78779 San Diego \| California \| United States \| -117.16472 \| 32.71571 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Detroit \| M...	43	NCT01088984	1COMPLETED	2011-08-01	2010-08-01	Teva Branded Pharmaceutical Products R&D, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	338	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia.	null	Functional Dyspepsia	dyspepsia rabeprazole Japan	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks. intervention 2: Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks. intervention 3: Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks. intervention 4: Rabeprazole Placebo ta...	intervention 1: Rabeprazole intervention 2: Rabeprazole intervention 3: Rabeprazole intervention 4: Placebo	46	Nagoya \| Aichi-ken \| Japan \| 136.90641 \| 35.18147 Akita \| Akita \| Japan \| 140.11667 \| 39.71667 Chikushino-shi \| Fukuoka \| Japan \| 130.5156 \| 33.49631 Fukuoka \| Fukuoka \| Japan \| 130.41667 \| 33.6 Kitakyushu \| Fukuoka \| Japan \| 130.85034 \| 33.85181 Gifu \| Gifu \| Japan \| 136.76039 \| 35.42291 Maebashi \| Gunma \| Japan \| 139...	338	NCT01089543	1COMPLETED	2011-08-01	2010-04-01	Eisai Co., Ltd.	4INDUSTRY	false	false	false	null	0
[ 4 ]	324	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks.	null	Hypertension		null	2	arm 1: combination therapy arm 2: Monotherapy	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: combination therapy intervention 2: monotherapy intervention 3: combination therapy	intervention 1: Telmisartan80mg+Amlodipine5mg intervention 2: amlodipine 5mg intervention 3: Telmisartan80mg+Amlodipine 5mg	16	Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Changchun \| N/A \| China \| 125.32278 \| 43.88 Changsha \| N/A \| China \| 112.97087 \| 28.19874 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Hangzhou \| N/A \| China \| 120.16142 \| 30.29365 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Shangh...	324	NCT01103960	1COMPLETED	2011-08-01	2010-07-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 5 ]	31	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	2DOUBLE	false	0ALL	false	Blood-Oxygen-Level-Dependent (BOLD) responses to painful mechanical stimulation of the OA knee following treatment with four consecutive doses (at 8 hour intervals) on giving sustained released paracetamol treatment or placebo will be compared. The fMRI and pain assessments will occur approximately 2-5 hours after taki...	The objective of this study is to investigate if functional magnetic response imaging (fMRI) can detect the effects of a known pain medicine at over-the-counter doses in people with osteoarthritis (OA) of the knee. The fMRI is a harmless and painless technique that is used in the current study to collect images of brai...	Osteoarthritis, Knee	osteoarthritis pain paracetamol Blood-Oxygen-Level-Dependent functional magnetic resonance imaging	null	2	arm 1: Two 665 mg sustained release paracetamol caplets administered orally with water. arm 2: Two placebo caplets administered orally with water.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 665 mg sustained release paracetamol caplets intervention 2: Placebo caplets	intervention 1: Paracetamol intervention 2: Placebo	1	Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879	87	NCT01105936	1COMPLETED	2011-08-01	2010-09-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 2 ]	72	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	false	The 5-milligram (mg) dose of prasugrel in low body weight (LBW) patients with coronary artery disease produces a pharmacodynamic response within the same therapeutic range as 10-mg dose in higher body weight (HBW) patients.	null	Coronary Artery Disease	Platelet function	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 1, 1 ]	2	[ 0, 0 ]	intervention 1: Administered orally, daily for 12 days intervention 2: Administered orally, daily for 12 days	intervention 1: prasugrel intervention 2: clopidogrel	6	Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Dublin \| N/A \| Ireland \| -6.24889 \| 53.33306 Nieuwegein \| N/A \| Netherlands \| 5.08056 \| 52.02917 Lund \| N/A \| Sweden \| 13.19321 \| 55.70584 Uppsala \| N/A \| Sweden \| 17.63889 \| 59.85882	210	NCT01107925	1COMPLETED	2011-08-01	2010-03-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 5 ]	42	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this 16-week research study is to determine whether a drug called memantine hydrochloride (memantine) has the potential to help improve memory and other cognitive abilities of young adults with Down syndrome (DS). Memantine (Namenda®) is a drug approved by the Food and Drug Administration (FDA) for patie...	Down syndrome, which is the result of the trisomy of Chromosome 21, is the most common genetically defined cause of intellectual disabilities. The estimated number of people with Down syndrome in the United States is approximately 300,000, and this figure is expected to continue increasing due to projected increases in...	Down Syndrome	Down syndrome Trisomy 21 Pattern Recognition Memory (PRM) Paired Associates Learning (PAL) California Verbal Learning Test (CVLT) Test of Reception of Grammar (TROG-II) Peabody Picture Vocabulary Test (PPVT-III) Scales of Independent Behavior revised (SIB-R)	null	2	arm 1: The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 \& 10 mg/d divided dose week three, 10mg/BID week four). arm 2: These are identically-looking pills to the ones in the Memantine Arm	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 \& 10 mg/d divided dose week three, 10mg/BID week four). intervention 2: These are identically-looking pills to those in the Memantine Arm.	intervention 1: Memantine intervention 2: Placebo	1	Aurora \| Colorado \| United States \| -104.83192 \| 39.72943	38	NCT01112683	1COMPLETED	2011-08-01	2008-07-01	University of Colorado, Denver	7OTHER	false	false	false	null	0
[ 3 ]	49	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose is to assess the safety of Lacosamide in subjects with uncontrolled Primary Generalized Tonic-Clonic (PGTC) seizures with Idiopathic Generalized Epilepsy.	null	Epilepsy	Primary Generalized Tonic-Clonic (PGTC) Seizures Absence Seizures Myoclonic Seizures Idiopathic Generalized Epilepsy (IGE)	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosa...	intervention 1: Lacosamide	25	Alabaster \| Alabama \| United States \| -86.81638 \| 33.24428 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Atlanta \| Georgi...	49	NCT01118949	1COMPLETED	2011-08-01	2010-05-01	UCB BIOSCIENCES, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	37	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	1SINGLE	false	0ALL	null	This study assessed the interaction between single and multiple doses of aliskiren (150 mg and 300 mg) and furosemide (60 mg) in patients with heart failure.	null	Heart Failure	Heart failure, aliskiren, furosemide, diuretic efficacy, interaction	null	3	arm 1: Treatment period 1 (Day 1 to Day 7): All eligible patients received 60 mg furosemide, 150 mg placebo of aliskiren, and 300 mg placebo aliskiren once daily. arm 2: Treatment Period 2 (Day 8 to day 17): Patients received 60 mg furosemide, 150 mg aliskiren and 300 mg placebo once daily. arm 3: Treatment Period 3 (D...	[ 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Aliskiren 150 mg tablet intervention 2: Furosemide 60 mg commercially-available tablets intervention 3: Matching placebo for aliskiren 150 mg and 300 mg intervention 4: Aliskiren 300 mg tablet	intervention 1: Aliskiren 150 mg intervention 2: Furosemide 60 mg intervention 3: Placebo for Aliskiren intervention 4: Aliskiren 300 mg	2	Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Vilnius \| N/A \| Lithuania \| 25.2798 \| 54.68916	101	NCT01125514	1COMPLETED	2011-08-01	2010-05-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 4 ]	152	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The primary objective of this study is to demonstrate superiority of single treatment of GSK1358820 (hereinafter, referred to as BOTOX®) over placebo in terms of the efficacy of treatment with BOTOX® 50 U in each axilla (100 U in total for each patient) as intradermal injections based on gravimetric assessment (measure...	null	Hyperhidrosis	Neuromuscular Agents Botulinum Toxin Type A Sweating Sweat Gland Disease Axillary Hyperhidrosis Skin Disease	null	2	arm 1: Onabotulinum toxin type A arm 2: Placebo	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Onabotulinum toxin type A intervention 2: Placebo	intervention 1: GSK1358820 intervention 2: Placebo	14	Aichi \| N/A \| Japan \| 130.62158 \| 32.51879 Kanagawa \| N/A \| Japan \| 139.91667 \| 37.58333 Miyagi \| N/A \| Japan \| 128.18236 \| 26.62566 Saitama \| N/A \| Japan \| 139.65657 \| 35.90807 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Tokyo \| N/A \| Ja...	218	NCT01128738	1COMPLETED	2011-08-01	2010-04-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 5 ]	285	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.	null	Acne		null	2	arm 1: Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks arm 2: Topical Gel Vehicle applied topically once daily for 12 weeks	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: daily topical application for 12 weeks intervention 2: daily topical application for 12 weeks	intervention 1: adapalene/benzoyl peroxide intervention 2: Topical Gel Vehicle	25	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 San Diego \| California \| United States \| -117.16472 \| 32.71571 Santa Rosa \| California \| United States \| -122.71443 \| 38.44047 Miramar \| Florida \| United States \| -80.23227 \| 25.98731 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Louisville \| K...	285	NCT01138735	1COMPLETED	2011-08-01	2010-06-01	Galderma R&D	4INDUSTRY	false	false	false	null	0
[ 0 ]	9	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	The purpose of this study is to provide eribulin to patients with advanced breast cancer who have no other treatment options and therapy is requested by an Investigator.	This compassionate use program will consist of a Pretreatment Phase and a Treatment Phase. Patients with locally advanced or metastatic breast cancer who fulfill the eligibility criteria may be treated. Safety data will be collected, but a minimal amount of other data will also be collected.	Breast Cancer	Advanced breast cancer refractory to all commercially available therapies	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Eribulin Mesylate: A dose of 1.4 mg/m\^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.	intervention 1: Eribulin Mesylate	5	La Verne \| California \| United States \| -117.76784 \| 34.10084 Nyack \| New York \| United States \| -73.91791 \| 41.09065 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Bismarck \| North Dakota \| United States \| -100.78374 \| 46.80833 Dallas \| Texas \| United States \| -96.80667 \| 32.78306	9	NCT01142661	1COMPLETED	2011-08-01	2010-08-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	20	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The two co-primary objectives of this study are to assess in Japanese patients with severe sepsis and/or septic shock: 1) the safety and tolerability of two different doses of intravenous AZD9773 and 2) the PK of AZD9773. The secondary objective is to make a preliminary assessment of the pharmacodynamics of two differ...	null	Severe Sepsis Septic Shock	TNF neutralisation	null	2	arm 1: AZD9773 250 units/kg (1 infusion) + 50 units/kg (9 infusions) (Dose Cohort 1): AZD9773 500 units/kg (1 infusion) + 100 units/kg (9 infusions) (Dose Cohort 2) arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: A single loading dose followed by 9 maintenance doses; doses to be given every 12 hours over a period of 5 days intervention 2: Intravenous infusion of a saline solution	intervention 1: AZD9773 intervention 2: Placebo	7	Sapporo \| Hokkaido \| Japan \| 141.35 \| 43.06667 Kobe \| Hyōgo \| Japan \| 135.183 \| 34.6913 Kumamoto \| Kumamoto \| Japan \| 130.69181 \| 32.80589 Osaka \| Osaka \| Japan \| 135.50107 \| 34.69379 Sumiyoshi-ku \| Osaka \| Japan \| N/A \| N/A Hachiōji \| Tokyo \| Japan \| 139.32389 \| 35.65583 Ohta-ku \| Tokyo \| Japan \| N/A \| N/A	20	NCT01144624	1COMPLETED	2011-08-01	2010-07-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 4 ]	66	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	To confirm that the combination therapy of rufinamide has superior efficacy compared to placebo in patients with Lennox-Gastaut syndrome.	null	Lennox-Gastaut Syndrome	Epilepsy Seizures	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined b...	intervention 1: Rufinamide (E2080) intervention 2: Placebo	23	Nagoya \| Aichi-ken \| Japan \| 136.90641 \| 35.18147 Matsuyama \| Ehime \| Japan \| 132.76574 \| 33.83916 Fukuoka \| Fukuoka \| Japan \| 130.41667 \| 33.6 Hiroshima \| Hiroshima \| Japan \| 132.45 \| 34.4 Sapporo \| Hokkaido \| Japan \| 141.35 \| 43.06667 Kobe \| Hyōgo \| Japan \| 135.183 \| 34.6913 Yokohama \| Kanagawa \| Japan \| 139.65 \| 35....	59	NCT01146951	1COMPLETED	2011-08-01	2010-06-01	Eisai Limited	4INDUSTRY	false	false	false	null	0
[ 3 ]	94	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	null	Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for the compliance and convenience of the patient in comparison to placebo. Further the rationale is to evaluate efficacy and safety of ti...	null	Asthma		null	3	arm 1: two actuations delivered via Respimat® inhaler arm 2: two actuations delivered via Respimat® inhaler arm 3: N/A (two actuations of placebo) delivered via Respimat® inhaler	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: 2.5 µg (two actuations of 1.25 µg) delivered via Respimat® inhaler intervention 2: N/A (two actuations of placebo) delivered via Respimat® inhaler intervention 3: 5 µg (two actuations of 2.5 µg) delivered via Respimat® inhaler	intervention 1: Tiotropium 2.5 µg b.i.d intervention 2: Placebo intervention 3: Tiotropium 5 µg q.d.	15	Linz \| N/A \| Austria \| 14.28611 \| 48.30639 Schlüsslberg \| N/A \| Austria \| 13.87161 \| 48.21861 Thalheim bei Wels \| N/A \| Austria \| 14.03333 \| 48.15 Wels \| N/A \| Austria \| 14.03333 \| 48.16667 Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Kyjov \| N/A \| Czechia \| 17.12253 \| 49.01018 Kohtla-Järve \| N/A \| Estonia \| 27.27306 \| 5...	272	NCT01152450	1COMPLETED	2011-08-01	2010-07-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 3, 4 ]	36	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to 24 hours in the neon...	null	Sedation	Initially intubated and mechanically ventilated neonates	null	3	arm 1: Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr. arm 2: Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr. arm 3: Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion intervention 2: Per package insert, N-PASS scores and investigator discretion. intervention 3: None	intervention 1: Midazolam intervention 2: Fentanyl/Morphine intervention 3: Dexmedetomidine	18	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Stanford \| California \| United States \| -122.16608 \| 37.42411 ...	36	NCT01159262	1COMPLETED	2011-08-01	2010-07-01	Hospira, now a wholly owned subsidiary of Pfizer	4INDUSTRY	false	false	false	null	0
[ 2 ]	30	NA	SINGLE_GROUP	null	0NONE	false	0ALL	false	The purpose of this study is to characterize the pharmacokinetics (PK) of single-dose ORF tablets in pediatric patients aged 6 to 16 years, inclusive.	null	Opioid Analgesia	Pediatric Post-operative Nonsurgical patients Opioid	null	1	arm 1: ORF Tablets	[ 0 ]	1	[ 0 ]	intervention 1: Oxycodone hydrochloride controlled-release (ORF) tablets (10 mg, 15 mg or 20 mg) taken every 12 hours	intervention 1: Oxycodone hydrochloride controlled-release (ORF) tablets	17	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Palo Alto \| California \| United States \| -122.14302 \| 37.44188 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Ann Arbor \| Michigan \| U...	30	NCT01160614	1COMPLETED	2011-08-01	2010-07-01	Purdue Pharma LP	4INDUSTRY	false	false	false	null	0
[ 0 ]	10	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	true	2MALE	true	The investigators are attempting to demonstrate a decrease in the frequency and severity of sedation-induced respiratory arrhythmias(central and obstructive apneas) with pharmacological pre-treatment in this pilot project and then eventually to understand the mechanisms behind this decrease. The efficacy and mechanisms...	One of the most serious side effects of drugs administered for sedation is untoward respiratory events. The relative prevalence of such events is thought to be high, occurring in up to 41% of patients in some cohorts. Many specific drugs and combinations have been recommended for moderate sedation, particularly when pr...	Upper Airway Obstruction	Breathing Sedation	null	4	arm 1: We are attempting to demonstrate a decrease in the frequency and severity of sedation-induced respiratory arrhythmias (central and obstructive apneas) with pharmacological pre-treatment in this pilot project and then eventually to understand the mechanisms behind this decrease. The efficacy and mechanisms of the...	[ 0, 2, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Physostigmine is a centrally acting acetylcholinesterase inhibitor that has been proposed as a treatment for sleep disordered breathing. It is currently FDA approved and used commonly by Anesthesiologists in the post anesthetic setting to reverse confusion caused by central anticholinergic medication ef...	intervention 1: Physostigmine intervention 2: Oxygen intervention 3: Placebo	1	Rochester \| New York \| United States \| -77.61556 \| 43.15478	40	NCT01171118	1COMPLETED	2011-08-01	2009-08-01	University of Rochester	7OTHER	false	false	false	null	0
[ 3 ]	259	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of acute exacerbation of schizophrenia during a 4-week inpatient treatment period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for PF-02545920 compared to risperidone and placebo ...	null	Schizophrenia	schizophrenia acute exacerbation inpatient	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 2, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 5 mg tablet every 12 hours for 28 days intervention 2: 15 mg tablet every 12 hours for 28 days intervention 3: One tablet/capsule every 12 hours for 28 days intervention 4: 3 mg capsule every 12 hours for 28 days	intervention 1: PF-02545920 intervention 2: PF-02545920 intervention 3: Placebo intervention 4: Risperidone	46	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Escondido \| California \| United States \| -117.08642 \| 33.11921 Escondido \| California \| United States \| -117.08642 \| 33.11921 Garden Grove \| California \| United States \| -117.94145 \| 33.77391 Long B...	258	NCT01175135	1COMPLETED	2011-08-01	2010-10-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 3 ]	148	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to determine the daily dose of mesalamine granules that will provide adequate relief from symptoms of IBS with diarrhea.	null	Irritable Bowel Syndrome With Diarrhea	IBS Diarrhea IBS-D Irritable Bowel Syndrome Abdominal pain Bloating	null	3	arm 1: None arm 2: None arm 3: None	[ 2, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: placebo capsules once daily for 12 weeks intervention 2: 750 mg mesalamine granules once daily for 12 weeks intervention 3: 1500 mg mesalamine granules once daily for 12 weeks	intervention 1: Placebo intervention 2: Mesalamine Granules 750 mg intervention 3: Mesalamine Granules 1500 mg	20	Sherwood \| Arkansas \| United States \| -92.22432 \| 34.81509 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Bristol ...	148	NCT01177410	1COMPLETED	2011-08-01	2010-07-01	Bausch Health Americas, Inc.	4INDUSTRY	false	false	false	null	0

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