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
[ 5 ]	156	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	false	The purpose of this study is to evaluate the effect of pioglitazone on bone metabolism in postmenopausal women with impaired fasting glucose.	The World Health Organization has estimated that 30% of all women aged over 50 years (postmenopausal) have osteoporosis according to a definition of Bone Mineral Density at any site being more than 2.5 standard deviations below the mean for young healthy adult women. A known risk factor for development of osteoporosis...	Bone Metabolism	Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus Lipoatrophic Postmenopausal	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks. intervention 2: Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.	intervention 1: Pioglitazone intervention 2: Placebo	34	Greenbrae \| California \| United States \| -122.5247 \| 37.94854 Los Banos \| California \| United States \| -120.84992 \| 37.05828 San Diego \| California \| United States \| -117.16472 \| 32.71571 Walnut Creek \| California \| United States \| -122.06496 \| 37.90631 West Hills \| California \| United States \| -118.64398 \| 34.19731 La...	156	NCT00708175	1COMPLETED	2011-02-01	2008-05-01	Takeda	4INDUSTRY	false	false	false	null	0
[ 4 ]	496	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to basal insulin with or without metformin over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when ad...	Patients who complete the 24-week main double-blind treatment would undergo a variable double-blind extension treatment, which ends for all patients at approximately the scheduled date of Week 76 visit (Visit 25) for the last randomized patients.	Diabetes Mellitus, Type 2	hyperglycemia, GLP-1, metformin, insulin	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 the end of treatment. 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 the end ...	[ 0, 2 ]	5	[ 0, 0, 0, 0, 1 ]	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 kept stable. intervention 4: Metformin if given to be continued at stable d...	intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Basal Insulin intervention 4: Metformin intervention 5: Pen auto-injector	15	Bridgewater \| New Jersey \| United States \| -74.64815 \| 40.60079 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 Laval \| N/A \| Canada \| -73.692 \| 45.56995 Santiago \| N/A \| Chile \| -70.64827 \| -33.45694 Cairo \| N/A \| Egypt \| 31.24967 \| 30.06263 Paris \| N/A \| France \| 2.3488 \| 48.85341 Berlin \| N/A \| Germany \| 13.41053 \| ...	495	NCT00715624	1COMPLETED	2011-02-01	2008-07-01	Sanofi	4INDUSTRY	false	false	false	null	0
[ 0 ]	71	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	Our goals for this study involve using intravenous lidocaine as it is normally used in the Stanford Pain Management Center to assess the effect of intravenous lidocaine on chronic pain. Studies have been done determining the efficacy of intravenous lidocaine for treating pain but little research has been done to determ...	Each patient will receive an intravenous infusion of lidocaine. Drug will be infused using a computer-controlled paradigm. This paradigm allows increasing plasma concentrations in a step-wise manner, keeping the concentration during each infusion step constant. Plasma concentrations will be increased gradually from 0 t...	Pain		null	1	arm 1: Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 µg/ml.	[ 0 ]	1	[ 0 ]	intervention 1: Intravenous lidocaine administered up to 5 µg/ml.	intervention 1: Intravenous lidocaine	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	71	NCT00725504	1COMPLETED	2011-02-01	2008-09-01	Stanford University	7OTHER	false	false	false	null	0
[ 5 ]	210	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This 2 arm study will compare the efficacy and safety of CellCept, combined with low or standard dose tacrolimus plus corticosteroids, in patients with kidney transplants. Patients will be randomized into one of 2 groups to receive either 1)CellCept 2.0g/day po bid + tacrolimus 10-12ng/mL followed by a maintenance dose...	null	Kidney Transplantation		null	2	arm 1: Participants received mycophenolate mofetil (MMF) 0.75 to (-) 1 gram (g), orally (PO), twice daily (BID) from Day 0 through Month 12. Participants also received tacrolimus 0.1-0.15 milligrams per kilogram (mg/kg), PO, BID to reach a target trough dose of 8-10 nanograms per milliliter (ng/mL) from Day 0 through M...	[ 1, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 0.75-1 g PO BID from Day 0 through Month 12 intervention 2: Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8-10 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 7-10 ng/mL in Month 3 and continued through Month 12. intervention 3: Initial ...	intervention 1: mycophenolate mofetil intervention 2: tacrolimus, standard dose intervention 3: tacrolimus, low dose intervention 4: corticosteroids	6	Beijing \| N/A \| China \| 116.39723 \| 39.9075 Fuzhou \| N/A \| China \| 119.30611 \| 26.06139 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Nanjing \| N/A \| China \| 118.77778 \| 32.06167 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Zhejiang \| N/A \| China \| 108.78745 \| 22.4143	210	NCT00758602	1COMPLETED	2011-02-01	2008-09-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 3, 4 ]	58	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	true	0ALL	true	The purpose of this study is to determine whether reducing inflammation in blood vessels with an aspirin-like drug called salsalate will improve blood vessel function.	To test the hypothesis that inhibition of I \[kappa\] B kinase \[beta\] (IĸKβ), an inflammatory mediator, by high dose salsalate, will restore insulin-mediated endothelium-dependent vasodilation in subjects with atherosclerosis.	Atherosclerosis	vascular inflammation endothelium-dependent flow-mediated blood vessel function	null	2	arm 1: In this crossover study, this group was randomly allocated therapy with salsalate first, a 4 week washout, then 4 weeks of placebo therapy in a double-blinded fashion. arm 2: In this crossover study, this group was randomly allocated therapy with placebo first, a 4 week washout, then 4 weeks of salsalate therapy...	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 1.5 grams orally 3 times daily intervention 2: matching placebo	intervention 1: salsalate intervention 2: placebo	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	116	NCT00760019	1COMPLETED	2011-02-01	2005-08-01	Brigham and Women's Hospital	7OTHER	false	false	false	null	0
[ 4 ]	209	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	A study to test the safety and effect of twice daily raltegravir in a diverse cohort of patients currently infected with human immunodeficiency virus (HIV), where at least 50% are African American and at least 25% are female, either having received antiretroviral drugs before or not.	null	Human Immunodeficiency Virus		null	1	arm 1: raltegravir	[ 0 ]	1	[ 0 ]	intervention 1: 400 mg tablets taken twice daily. Total treatment period is 48 weeks.	intervention 1: Comparator: raltegravir	0	null	206	NCT00764946	1COMPLETED	2011-02-01	2008-10-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 3 ]	39	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	To assess the efficacy of oral aliskiren as a therapy for diabetic macular edema	null	Diabetic Macular Edema	Diabetes Macular edema Aliskiren Diabetic retinopathy Diabetes mellitus type 1 Diabetes mellitus type 2	null	2	arm 1: Aliskiren 300 mg once daily for 12 weeks arm 2: Matching placebo once daily for 12 weeks	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 300 mg once daily intervention 2: Matching placebo once daily	intervention 1: Aliskiren intervention 2: Placebo	12	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts...	39	NCT00768040	6TERMINATED	2011-02-01	2008-09-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 4 ]	494	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to evaluate its safety, and to evaluate its effect on development of pulmonary hypertension, quality of life, and dyspnea (shortness of breath...	null	Idiopathic Pulmonary Fibrosis	idiopathic pulmonary fibrosis interstitial lung disease ambrisentan	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Ambrisentan (5mg or 10 mg tablet) was administered orally once daily. intervention 2: Placebo to match ambrisentan was administered orally once daily.	intervention 1: Ambrisentan intervention 2: Placebo	185	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Diego \| C...	492	NCT00768300	6TERMINATED	2011-02-01	2008-12-01	Gilead Sciences	4INDUSTRY	false	false	false	null	0
[ 0 ]	3	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide and prednisone, work in ...	OUTLINE: * Induction therapy: Patients receive rituximab IV and cyclophosphamide IV over 30 minutes on day 1, bortezomib IV on days 1 and 8, and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients then proc...	Lymphoma Follicular Lymphoma Marginal Zone Lymphoma	stage III grade 1 follicular lymphoma stage IV grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage IV grade 2 follicular lymphoma stage III marginal zone lymphoma stage IV marginal zone lymphoma	null	1	arm 1: Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP): * Rituximab * Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles * Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles * Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21...	[ 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Administered intravenously during induction and maintenance therapy per protocol. intervention 2: Administered intravenously per protocol. intervention 3: Administered intravenously per protocol. intervention 4: Administered orally (PO) per protocol.	intervention 1: Rituximab intervention 2: Bortezomib intervention 3: Cyclophosphamide intervention 4: Prednisone	1	Miami \| Florida \| United States \| -80.19366 \| 25.77427	3	NCT00772668	6TERMINATED	2011-02-01	2009-09-25	University of Miami	7OTHER	false	false	false	null	0
[ 5 ]	58	NON_RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	To determine whether one glaucoma eye drop is less likely to cause changes to the surface of the eye (conjunctiva) than another. The two different prostaglandins are Xalatan and Travatan Z.	Two groups will be entered into this study: group 1 will be naive to treatment and group 2 will be using Xalatan for at least one month before enrollment. Both groups will be using one drop at bedtime of Xalatan in the right eye and one drop at bedtime of Travatan Z in the left eye. Both of these drops are presently on...	Glaucoma	glaucoma impression cytology ocular surface changes prostaglandins	null	2	arm 1: Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye. arm 2: Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.	[ 5, 5 ]	2	[ 0, 0 ]	intervention 1: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime intervention 2: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime	intervention 1: Xalatan intervention 2: Travatan Z	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	58	NCT00798694	1COMPLETED	2011-02-01	2008-11-01	Wills Eye	7OTHER	false	false	false	null	0
[ 0 ]	105	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The investigators propose the present study with the following aims: * to determine whether early patent ductus arteriosus (PDA) treatment with ibuprofen treatment at the onset of clinical symptoms is superior to late ibuprofen treatment only when symptoms of a hemodynamically significant PDA are present in the evolut...	Study terminated when intravenous (IV) ibuprofen withdrawn for both clinical and research use.	Patent Ductus Arteriosus	Patent ductus arteriosus Respiratory outcome	null	2	arm 1: Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to "early treatment" will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive u...	[ 0, 5 ]	2	[ 0, 10 ]	intervention 1: IBUPROFEN SCHEDULE: initial dose 10 mg/kg, then 2 doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy is blinded. At PDA diagnosis, infants randomized to "early treatment" receive blinded ibuprofen. Infants randomized to "late treatment" receive blinded placebo. Hemodynamically sign...	intervention 1: Early ibuprofen intervention 2: Late ibuprofen expectant group (placebo)	1	Miami \| Florida \| United States \| -80.19366 \| 25.77427	105	NCT00802685	6TERMINATED	2011-02-01	2007-11-01	University of Miami	7OTHER	false	false	false	null	0
[ 4 ]	1,886	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	false	The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.	null	Menopause Osteoporosis	Postmenopausal Women Bazedoxifene/Conjugated Estrogens	null	5	arm 1: bazedoxifene 20 mg/conjugated estrogens 0.45 mg arm 2: bazedoxifene 20 mg/conjugated estrogens 0.625 mg arm 3: bazedoxifene 20 mg arm 4: Prempro arm 5: Placebo	[ 0, 0, 0, 1, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: One capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year. intervention 2: One capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year. intervention 3: One capsule, bazedoxifene 20 mg (over-encapsulated), once...	intervention 1: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg intervention 2: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg intervention 3: bazedoxifene 20 mg intervention 4: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg intervention 5: Placebo	178	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Glendale \| Arizona \| United States \| -112.18599 \| 33.53865 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Peoria \| Arizona \| United State...	1,843	NCT00808132	1COMPLETED	2011-02-01	2009-01-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 3 ]	70	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	This Phase IIB proof-of-concept study would examine the effects of an investigational product called N-acetylcysteine (NAC) on the basic processes that cause inflammation in CF lung disease. We hope to learn more about the causes of lung disease in cystic fibrosis by studying the characteristics of the inflammation in ...	null	Cystic Fibrosis		null	2	arm 1: Placebo was administered oral tablet TID for 24 weeks. arm 2: Participants received 900 mg of oral N-acetylcysteine TID for 24 weeks.	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: N-acetylcysteine (NAC) intervention 2: Placebo	11	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Stanford \| California \| United States \| -122.16608 \| 37.42411 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 New York \| New Yo...	70	NCT00809094	1COMPLETED	2011-02-01	2008-11-01	Stanford University	7OTHER	false	false	false	null	0
[ 5 ]	56	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This study is designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with major depressive disorder (MDD) based on the change from baseline to Week 8/end-of-study in the CDRS-R total...	null	Depressive Disorder	paroxetine selective serotonin reuptake inhibitor CDRS-R children and adolescents	null	2	arm 1: paroxetine 10-40mg/day arm 2: matched placebo to paroxetine	[ 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 1 or 2 tablet(s) once a day intervention 2: 1 tablet once a day intervention 3: 2 tablets once a day intervention 4: 1 tablet once a day	intervention 1: paroxetine 10mg tablet intervention 2: paroxetine 20mg tablet intervention 3: matched placebo to paroxetine 10mg intervention 4: matched placebo to paroxetine 20mg	33	Aichi \| N/A \| Japan \| 130.62158 \| 32.51879 Aichi \| N/A \| Japan \| 130.62158 \| 32.51879 Aichi \| N/A \| Japan \| 130.62158 \| 32.51879 Aichi \| N/A \| Japan \| 130.62158 \| 32.51879 Fukui \| N/A \| Japan \| 135.54836 \| 34.84214 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Fukuoka \| N/A \| Japan \|...	56	NCT00812812	6TERMINATED	2011-02-01	2009-03-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 0 ]	11	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Patients with bipolar disorder have one of the highest rates of nicotine dependence and one of the lowest quit rates. Varenicline has been shown in previous trials to be effective for smoking cessation, but has not been studied in subjects with bipolar disorder. This 12-week open label trial will be conducted to assess...	Varenicline, a nicotinic acetylcholine receptor partial agonist, has been shown in two placebo-controlled trials to be efficacious for smoking cessation. Given the high prevalence of nicotine dependence in bipolar disorder and the high prevalence of sub-syndromal and syndromal depressive symptoms in bipolar disorder, t...	Smoking Bipolar Disorder Depression	Smoking Bipolar Disorder Depression	null	1	arm 1: Open-label; subjects will receive a behavioral intervention in addition to Varenicline.	[ 0 ]	1	[ 0 ]	intervention 1: Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.	intervention 1: Varenicline	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	9	NCT00813800	1COMPLETED	2011-02-01	2009-01-01	Mark Frye	7OTHER	false	false	false	null	0
[ 3 ]	10	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	Vulvodynia is characterized by persistent vulvar pain, which often occurs upon touch or pressure. The cause of vulvodynia is unknown but is presumed to involve many factors. Some of these factors may include altered immune response, infections, altered vaginal acid-base balance, allergic reactions and psychosexual diso...	CC-10004 is a well-tolerated, selective PDE4 inhibitor with a demonstrated inhibitory effect on inflammatory mediators and is under development for the treatment of inflammatory and immune mediated conditions. This is an open-label, one arm, phase II study at William Beaumont Hospital. Twenty female subjects aged 18 o...	Vulvodynia	vulvodynia pelvic pain vulvar pain	null	1	arm 1: Study drug CC-10004 20mg taken orally twice a day.	[ 0 ]	1	[ 0 ]	intervention 1: CC-10004 20 mg. twice a day for 12 weeks	intervention 1: CC-10004	1	Royal Oak \| Michigan \| United States \| -83.14465 \| 42.48948	9	NCT00814632	1COMPLETED	2011-02-01	2008-12-01	Kenneth Peters, MD	7OTHER	false	false	false	null	0
[ 4 ]	326	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3 controlled trial to establish the efficacy and safety of conversion from maintenance immunosuppressive therapy with Prograf® capsules (tacrolimus, Astellas Pharma US, Inc., Deerfield, IL) twice daily to maintenance immunotherapy wi...	This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3 controlled trial to establish the efficacy and safety of conversion from maintenance immunosuppressive therapy with Prograf capsules (tacrolimus, Astellas Pharma US, Inc., Deerfield, IL) twice daily to maintenance immunotherapy wit...	Renal Failure	kidney transplantation renal transplantation maintenance immunosuppression tacrolimus Prevention of acute allograft rejection	null	2	arm 1: LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK) arm 2: Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets. intervention 2:...	intervention 1: LCP-Tacro intervention 2: Prograf	1	San Diego \| California \| United States \| -117.16472 \| 32.71571	324	NCT00817206	1COMPLETED	2011-02-01	2008-12-01	Veloxis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	22	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	We want to learn if dasatinib will make triple negative breast cancers smaller. We also hope that we can learn more about what makes triple negative breast cancers grow. We believe this information will help us to predict which patients will benefit from taking this drug or other drugs like it. This study is a "neoadj...	Women who have been recently diagnosed with a type of breast cancer called "triple negative", and have not yet received any type of treatment (surgery, radiation therapy, etc.) for breast cancer are among the patient population this study will seek. "Triple negative" means breast cancer is not estrogen receptor positiv...	Breast Cancer	Breast Cancer	null	1	arm 1: Dasatinib / Sprycel 100 mg	[ 0 ]	1	[ 0 ]	intervention 1: pill form, 100 mg daily	intervention 1: Dasatinib	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	22	NCT00817531	6TERMINATED	2011-02-01	2008-12-01	Baylor Breast Care Center	7OTHER	false	false	false	null	0
[ 3 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	The hypothesis of this clinical research study is to discover if the study drug RAD001 can shrink or slow the growth of Estrogen Receptor/Progesterone Receptor (ER/PR) negative or Human Epidermal growth factor Receptor 2 (Her2 Neu) negative breast cancer. The safety of RAD001 will also be studied. Patients physical sta...	RAD001 is an orally administered cell cycle inhibitor with antitumor activity. RAD001, like Rapamycin, binds with high affinity to an intracellular immunophilin, FKBP12 and this complex specifically interacts with the mammalian target of rapamycin (mTOR) protein kinase, inhibiting downstream events such as the initiati...	Breast Cancer	Breast cancer metastatic breast triple negative ER/PR negative Her2 Neu negative	null	1	arm 1: RAD001-10 mg by mouth once everyday	[ 0 ]	1	[ 0 ]	intervention 1: RAD 001-10 mg by mouth once everyday	intervention 1: RAD 001	1	Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592	4	NCT00827567	6TERMINATED	2011-02-01	2009-04-01	Milton S. Hershey Medical Center	7OTHER	false	false	false	null	0
[ 5 ]	101	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	true	This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their ...	null	Smoking	smoking relapse withdrawal	null	2	arm 1: 52-week varenicline therapy + individual smoking cessation counseling arm 2: 13 weeks of varenicline therapy + individual smoking cessation counseling	[ 0, 1 ]	3	[ 0, 0, 5 ]	intervention 1: Extension of 1 mg twice daily treatment to 52 weeks intervention 2: Double-blind switch to placebo after 12 weeks of open-label therapy intervention 3: Brief (\<10 minutes) smoking cessation counseling delivered at clinic visits	intervention 1: varenicline intervention 2: varenicline intervention 3: Individual smoking cessation counseling	2	Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389	67	NCT00828113	1COMPLETED	2011-02-01	2009-01-01	University of Wisconsin, Madison	7OTHER	false	false	false	null	0
[ 5 ]	106	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The investigators hypothesize that low-dose dietary supplementation with omega-3 fish oil will improve disease activity and endothelial function in Systemic Lupus Erythematosus (SLE) patients.	Patients with SLE have a fifty-fold increased risk of myocardial infarction. This risk is not totally explained by traditional cardiovascular risk factors. In a previous double-blind study of atorvastatin in SLE, there was no reduction in surrogate measures of coronary artery disease (coronary calcium, coronary IMT, ca...	Systemic Lupus Erythematosus	SLE atherosclerosis omega-3	null	2	arm 1: 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters); flow-mediated dilation of the brachial artery arm 2: corn starch; flow-mediated dilation of the brachial artery	[ 1, 2 ]	3	[ 0, 1, 10 ]	intervention 1: Omega-3-acid ethyl esters (Lovaza) 3 gram once a day for 12 weeks intervention 2: flow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks intervention 3: 3 capsules qd for 12weeks	intervention 1: Omega-3 intervention 2: flow-mediated dilation of the brachial artery intervention 3: corn starch	2	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	85	NCT00828178	1COMPLETED	2011-02-01	2009-02-01	Michelle Petri M.D.,MPH	7OTHER	false	false	false	null	0
[ 4 ]	19	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	An open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for treatment of subjects with ITP who have previously been enrolled in the eltrombopag trial TRA108109 (NCT00540423).	null	Idiopathic Thrombocytopenic Purpura Purpura, Thrombocytopenic, Idiopathic	eltrombopag thrombopoietin receptor agonist ITP blood platelet	null	1	arm 1: Eltrombopag oral tablets once daily	[ 0 ]	1	[ 0 ]	intervention 1: Eltrombopag oral tablets once daily	intervention 1: Eltrombopag oral tablets	6	Gifu \| N/A \| Japan \| 136.76039 \| 35.42291 Hiroshima \| N/A \| Japan \| 132.45 \| 34.4 Ibaraki \| N/A \| Japan \| 135.56828 \| 34.81641 Osaka \| N/A \| Japan \| 135.50107 \| 34.69379 Osaka \| N/A \| Japan \| 135.50107 \| 34.69379 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895	19	NCT00828750	1COMPLETED	2011-02-01	2008-05-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 4 ]	106	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study will assess the safety and efficacy of the long-term use of pregabalin at doses up to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study A0081208 (NCT00830167).	null	Fibromyalgia		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Dosage: 300-450 mg/day (150-225 mg twice daily), oral administration, Treatment duration: 52 weeks	intervention 1: pregabalin (Lyrica)	19	Yotukaidou \| Chiba \| Japan \| N/A \| N/A Matuyama-si \| Ehime \| Japan \| N/A \| N/A Iiduka \| Fukuoka \| Japan \| N/A \| N/A Kobe \| Hyōgo \| Japan \| 135.183 \| 34.6913 Mito \| Ibaraki \| Japan \| 140.45 \| 36.35 Morioka \| Iwate \| Japan \| 141.15 \| 39.7 Yokohama \| Kanagawa \| Japan \| 139.65 \| 35.43333 Tsu \| Mie-ken \| Japan \| 136.51667 \|...	106	NCT00830128	1COMPLETED	2011-02-01	2009-07-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0
[ 2 ]	185	NON_RANDOMIZED	SINGLE_GROUP	null	0NONE	true	0ALL	false	This study assesses the effects of voriconazole, 200 mg, administered twice daily (BID), on the steady-state pharmacokinetics of atazanavir administered as atazanavir/ritonavir, 300/100 mg once daily (QD), in healthy participants with functional CYP2C19 alleles. The study also reviews the effects of atazanavir/ritonavi...	null	Human Immunodeficiency Virus Type 1 (HIV-1) HIV Infections		null	5	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None	[ 1, 1, 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Treatment A: Participants with functional CYP2C19 alleles (EM) received oral tablets of voriconazole, 400 mg, twice daily (BID), on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a light meal. Treatment C: EM participants received atazanavir/ritonavir, 300/100 ...	intervention 1: Voriconazole intervention 2: Atazanavir intervention 3: Ritonavir	2	Cypress \| California \| United States \| -118.03729 \| 33.81696 Nijmegen \| N/A \| Netherlands \| 5.85278 \| 51.8425	93	NCT00833482	1COMPLETED	2011-02-01	2009-09-01	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	0
[ 3 ]	33	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the antiviral activity as measured by the change in viral load from baseline in the 14 days following initiation of treatment with 4 different dose regimens of TMC310911 co-administered with ritonavir.	This is an open-label (all people know the identity of the intervention) and randomized (study medication assigned by chance) study in treatment-naive human immunodeficiency virus type 1 (HIV-1)-infected participants (participants who had not been treated with a therapeutic HIV vaccine within 1 year prior to enrollment...	Human Immunodeficiency Virus Type 1	Human immunodeficiency virus type 1 HIV-1 HIV-1 treatment-naive TMC310911 Protease inhibitor Ritonavir Antiviral Activity HIV Infections Treatment Naive	null	4	arm 1: TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 arm 2: TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 arm 3: TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 arm 4: TMC310911 300 mg + ritonavir 100 mg once daily on Days 1 to 14	[ 0, 0, 0, 0 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: TMC310911 75 mg twice daily orally (by mouth) on Days 1 to 14. intervention 2: TMC310911 150 mg twice daily orally (by mouth) on Days 1 to 14 intervention 3: TMC310911 300 mg twice daily orally (by mouth) on Days 1 to 14 intervention 4: TMC310911 300 mg once daily orally (by mouth) on Days 1 to 14 inter...	intervention 1: TMC310911 75 mg twice daily intervention 2: TMC310911 150 mg twice daily intervention 3: TMC310911 300 mg twice daily intervention 4: TMC310911 300 mg once daily intervention 5: Ritonavir 100 mg twice daily intervention 6: Ritonavir 100 mg once daily	3	Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Frankfurt \| N/A \| Germany \| 10.53333 \| 49.68333 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073	33	NCT00838162	1COMPLETED	2011-02-01	2009-06-01	Tibotec Pharmaceuticals, Ireland	4INDUSTRY	false	false	false	null	0
[ 4 ]	2,091	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy	null	Asthma	Asthma Symbicort Turbuhaler	null	2	arm 1: Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed arm 2: Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 160/4.5 µg intervention 2: 0.4 mg	intervention 1: Symbicort Turbuhaler intervention 2: Terbutaline Turbuhaler	109	Buenos Aires \| Argentina \| Argentina \| -58.37723 \| -34.61315 Capital Federal \| Buenos Aires \| Argentina \| N/A \| N/A Mar del Plata \| Buenos Aires \| Argentina \| -57.5562 \| -38.00042 Monte Grande \| Buenos Aires \| Argentina \| -58.46592 \| -34.8194 Quilmes \| Buenos Aires \| Argentina \| -58.25454 \| -34.72065 Rosario \| Santa Fe...	2,091	NCT00839800	1COMPLETED	2011-02-01	2009-02-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 3 ]	50	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	true	0ALL	null	This randomized phase II trial is studying how well sulindac works in preventing melanoma in healthy participants who are at increased risk of melanoma. Sulindac may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether sulindac is more effective than a place...	PRIMARY OBJECTIVE: I. To determine sulindac and metabolite levels in healthy participants with atypical nevi and benign nevus at increased risk for melanoma treated with sulindac versus placebo. SECONDARY OBJECTIVES: I. To assess the effects of sulindac on apoptosis in atypical nevi of these participants. II. To as...	Precancerous Condition		null	2	arm 1: Participants receive oral sulindac twice daily for 8 weeks arm 2: Participants receive oral placebo twice daily for 8 weeks	[ 0, 2 ]	3	[ 0, 10, 10 ]	intervention 1: Given orally intervention 2: Inactive agent intervention 3: Correlative studies	intervention 1: sulindac intervention 2: placebo intervention 3: laboratory biomarker analysis	2	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Stanford \| California \| United States \| -122.16608 \| 37.42411	50	NCT00841204	1COMPLETED	2011-02-01	2009-02-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0
[ 3 ]	4	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine the value of adding IMC-A12 to irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC).	The purpose of this study is to determine the value of adding IMC-A12 to irinotecan + cetuximab in improving progression-free survival (PFS) at 18 weeks from the date of randomization for participants with metastatic Kirsten Rat Sarcoma (K-RAS) wild-type CRC that has progressed on an oxaliplatin/bevacizumab-containing ...	Colon Cancer Rectal Cancer	Tumors Antibodies, Monoclonal Colorectal Neoplasms Metastatic K-RAS Wild-Type Carcinoma of the Colon or Rectum	null	2	arm 1: Participants in Treatment Group 1 will receive intravenous infusions of Cetuximab 500 milligrams per square meter (mg/m²) and Irinotecan 180 mg/m². arm 2: Participants in Treatment Group 2 will receive intravenous infusions of Cetuximab 500 mg/m², IMC-A12 10 milligrams/kilogram (mg/kg) and Irinotecan 180 mg/m².	[ 1, 0 ]	3	[ 2, 0, 2 ]	intervention 1: Cetuximab 500 mg/m² every 14 days until disease progression or participant intolerance intervention 2: 180 mg/m² every 14 days until disease progression or participant intolerance intervention 3: IMC-A12 10 mg/kg every 14 days until disease progression or participant intolerance	intervention 1: Cetuximab intervention 2: Irinotecan intervention 3: IMC-A12 (cixutumumab)	3	Vallejo \| California \| United States \| -122.25664 \| 38.10409 Greenville \| North Carolina \| United States \| -77.36635 \| 35.61266 Scranton \| Pennsylvania \| United States \| -75.6649 \| 41.40916	4	NCT00845039	6TERMINATED	2011-02-01	2009-05-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 3 ]	74	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study (28851) is a long-term follow-up study of subjects enrolled in ATAMS study 28063 (NCT00642902). The aim of this study is to monitor the safety and tolerability of atacicept administered for up to 5 years to subjects with relapsing multiple sclerosis (RMS). This extension study consists of two parts. Part A ...	null	Relapsing Multiple Sclerosis		null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Subjects who received atacicept 25 milligram (mg) subcutaneously (SC) as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study will continue with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination o...	intervention 1: Atacicept 25 mg intervention 2: Atacicept 75 mg intervention 3: Atacicept 150 mg intervention 4: Atacicept 150 mg	47	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Northbrook \| Illinois \| United States \| -87.82895 \| 42.12753 East Lansing \| Michigan \| United States \| -84.48387 \| 42.73698 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Nashville \| Tenn...	70	NCT00853762	6TERMINATED	2011-02-01	2009-03-01	EMD Serono	4INDUSTRY	false	false	false	null	0
[ 4 ]	44	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	The main objective of the study is to determine whether glatiramer acetate 20 mg once daily reduces the amount of axonal loss in the optic nerve after a first event of acute optic neuritis compared to placebo patients and to generate data supporting the potential neuroprotective effect of glatiramer acetate in a human ...	null	Optic Neuritis		null	2	arm 1: Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months. arm 2: Participants received placebo subcutaneous injection once a day for up to 6 months.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 20 mg injected daily subcutaneously intervention 2: injected daily subcutaneously	intervention 1: Glatiramer Acetate intervention 2: placebo	0	null	40	NCT00856635	1COMPLETED	2011-02-01	2009-02-01	Teva Branded Pharmaceutical Products R&D, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	27	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Prospective, open-label, controlled (active comparator), randomized study of 8 weeks follow-up for the evaluation of the efficacy of extended release quetiapine (quetiapine XR) versus Sertraline in addition to previous mood stabilizer treatment (lithium or valproate at stable and clinically therapeutic blood levels) in...	null	Bipolar Disorder Bipolar Depression	Bipolar disorder Bipolar depression quetiapine sertraline	null	2	arm 1: Lithium or valproate at stable doses within seric therapeutic levels arm 2: Lithium or valproate at stable doses within seric therapeutic levels	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length. Quetiapine XR was initiated at 50 mg/day and titrated to 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, and flexible doses of 300 to 600 mg/d from day 5 to the end of the study. interve...	intervention 1: Extended release quetiapine (quetiapine XR) intervention 2: Sertraline intervention 3: adequate mood stabilizer	4	Vitoria-Gasteiz \| Basque Country \| Spain \| -2.67268 \| 42.84998 Santander \| Cantabria \| Spain \| -3.80444 \| 43.46472 Zamora \| Castille and León \| Spain \| -5.74456 \| 41.50633 Vigo \| Galicia \| Spain \| -8.72264 \| 42.23282	27	NCT00857584	1COMPLETED	2011-02-01	2009-05-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 3 ]	2	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving clofarabine together with cytarabine may kill more cancer cells. PURPOSE: This pilot phase II trial is studying how...	PRIMARY OBJECTIVES: I. To test the ability of clofarabine + ara-C (cytarabine) to eliminate minimal residual (MRD) in acute myeloid leukemia (AML) patients whose bone marrows exhibit complete remission by morphology. SECONDARY OBJECTIVES: I. To determine the duration of complete remission after this treatment to min...	Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Recurrent Ad...		null	1	arm 1: Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.	[ 0 ]	3	[ 0, 0, 2 ]	intervention 1: Given IV intervention 2: Given IV intervention 3: Given SC	intervention 1: clofarabine intervention 2: cytarabine intervention 3: filgrastim	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	2	NCT00863434	6TERMINATED	2011-02-01	2009-02-01	University of Washington	7OTHER	false	false	false	null	0
[ 3 ]	1,359	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this study is to evaluate the efficacy and safety of multiple doses of tanezumab administered every 8 weeks in treating chronic low back pain. Tanezumab is a monoclonal antibody directed against human nerve growth factor.	null	Low Back Pain	randomized controlled trial monoclonal antibody nerve growth factor naproxen	null	5	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None	[ 0, 0, 0, 1, 2 ]	10	[ 2, 0, 2, 0, 2, 0, 2, 0, 2, 0 ]	intervention 1: 2 IV administrations of tanezumab 20 mg at an 8 week interval intervention 2: Oral placebo for naproxen twice a day for 16 weeks intervention 3: 2 IV administrations of tanezumab 10 mg at an 8 week interval intervention 4: Oral placebo for naproxen twice a day for 16 weeks intervention 5: 2 IV administr...	intervention 1: Tanezumab 20 mg IV intervention 2: Placebo for naproxen intervention 3: Tanezumab 10 mg IV intervention 4: Placebo for naproxen intervention 5: Tanezumab 5 mg IV intervention 6: Placebo for naproxen intervention 7: Placebo for tanezumab intervention 8: Naproxen intervention 9: Placebo for tanezumab inte...	135	Anniston \| Alabama \| United States \| -85.83163 \| 33.65983 Anniston \| Alabama \| United States \| -85.83163 \| 33.65983 Anniston \| Alabama \| United States \| -85.83163 \| 33.65983 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Hueytown \| Alabama \| United States \| -86.99666 \| 33.45122 Huntsville \| Alabama \| Unite...	1,347	NCT00876187	1COMPLETED	2011-02-01	2009-06-15	Pfizer	4INDUSTRY	false	false	false	null	0
[ 4 ]	40	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Ambrisentan is an endothelin receptor antagonist used for the treatment of pulmonary hypertension (PH). Based on research suggesting a role for endothelin-1 in the pathogenesis of idiopathic pulmonary fibrosis (IPF) and the poor prognosis for patients with IPF who are also diagnosed with PH, this study was designed to ...	null	Idiopathic Pulmonary Fibrosis Pulmonary Hypertension	Idiopathic Pulmonary Fibrosis Pulmonary Hypertension PH IPF Ambrisentan ERA Endothelin Receptor Antagonist Cardiovascular	null	2	arm 1: Participants were randomized to receive ambrisentan treatment at an initial dose of 5 mg for 4 weeks, followed by ambrisentan at the target dose of 10 mg for an additional 52 weeks arm 2: Participants were randomized to receive placebo to match ambrisentan for 48 weeks, then transition to ambrisentan treatment a...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Ambrisentan (5 mg or 10 mg tablet) administered orally once daily. intervention 2: Placebo to match ambrisentan administered orally once daily.	intervention 1: Ambrisentan intervention 2: Placebo	85	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Davis \| California \| United States \| -121.74052 \| 38.54491 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Francisc...	40	NCT00879229	6TERMINATED	2011-02-01	2009-07-01	Gilead Sciences	4INDUSTRY	false	false	false	null	0
[ 3 ]	12	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	true	The prevalence of severely obese children is on the rise. Behavioral therapies for weight loss are successful in some, but others need more aggressive approaches such as drug therapy. In addition, up to 25% of severely obese children have impaired glucose tolerance (IGT), which places them at significantly elevated ris...	This will be a randomized, open-label, controlled, crossover clinical trial in 12 patients. All patients will receive exenatide and undergo the control phase. Following baseline testing, participants will be randomly assigned to treatment order: therapy (exenatide) or control (lifestyle modification). Half (n = 6) will...	Obesity, Morbid	Obesity Impaired Glucose Tolerance Children	null	2	arm 1: Exenatide arm 2: Control - no intervention	[ 0, 4 ]	1	[ 0 ]	intervention 1: Exenatide, subcutaneous injection, 10 mcg, twice per day	intervention 1: Exenatide	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	22	NCT00886626	1COMPLETED	2011-02-01	2009-05-01	University of Minnesota	7OTHER	false	false	false	null	0
[ 3 ]	6	NA	SINGLE_GROUP	4SUPPORTIVE_CARE	0NONE	false	0ALL	false	RATIONALE: Fosaprepitant dimeglumine, palonosetron hydrochloride, and dexamethasone may help lessen or prevent nausea and vomiting caused by cisplatin in patients with head and neck cancer undergoing chemotherapy and radiation therapy. PURPOSE: This phase II trial is studying how well fosaprepitant dimeglumine togethe...	PRIMARY OBJECTIVES: I. To determine the complete response rate of anti-emetic therapy based on a single dose of intravenous fosaprepitant with multiple cycles of high dose cisplatin (complete response is defined as no emesis or rescue nausea medications needed in the 120 hours following cisplatin infusion). SECONDARY...	Nausea and Vomiting Stage III Squamous Cell Carcinoma of the Hypopharynx Stage III Squamous Cell Carcinoma of the Larynx Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity Stage III Squamous Cell Carcinoma of the Nasopharynx Stage III Squamous Cell Carcinoma of the Oropharynx Stage IV Squamous Cell Carcinoma ...		null	1	arm 1: Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients also undergo radiotherapy once daily 5 days a week for up to 7 weeks. Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients then receive oral dexam...	[ 0 ]	7	[ 0, 0, 0, 0, 10, 5, 4 ]	intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV and orally intervention 5: Ancillary studies intervention 6: Ancillary studies intervention 7: Undergo radiotherapy	intervention 1: fosaprepitant dimeglumine intervention 2: cisplatin intervention 3: palonosetron hydrochloride intervention 4: dexamethasone intervention 5: Functional Living Index-Emesis Questionnaire intervention 6: Emesis Diary intervention 7: Radiotherapy	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	6	NCT00895245	6TERMINATED	2011-02-01	2009-02-01	University of Washington	7OTHER	false	false	false	null	0
[ 3 ]	479	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	false	0ALL	true	This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.	null	Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass		null	3	arm 1: Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute. arm 2: Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute...	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute intervention 2: Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute intervention 3: Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute	intervention 1: catridecacog intervention 2: catridecacog intervention 3: placebo	32	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Allentown \| Pennsylvania \| United States \| -75.49018 \| 40.60843 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Providence \| ...	409	NCT00914589	1COMPLETED	2011-02-01	2009-07-01	Novo Nordisk A/S	4INDUSTRY	false	false	false	null	0
[ 3 ]	27	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication), safety and antiviral activity to support dose recommendations by body weight of darunavir with low-dose ritonavir (DRV/rtv), in combination with other antiretroviral drugs (ARVs), in treatment-experienced Human immunod...	This is an open-label (all people know the identity of the intervention), study to evaluate the pharmacokinetics, safety and antiviral activity. Approximately 24 HIV-1 infected children will be enrolled in this study. The study consists of a 4-week screening period, a 48-week treatment period, and a 4-week follow-up pe...	Human Immunodeficiency Virus 1	Human immunodeficiency virus 1 HIV-1 Darunavir Ritonavir Norvir	null	1	arm 1: Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and \<20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Befo...	[ 0 ]	2	[ 0, 0 ]	intervention 1: Darunavir oral suspension (100 mg/mL) will be administered as 20 mg per kg body weight twice daily for children weighing between 10 and \<20 kg before dose adjustment. Darunavir oral suspension will be administered 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg ...	intervention 1: Darunavir intervention 2: Ritonavir	8	Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Rio de Janeiro \| N/A \| Brazil \| -43.18223 \| -22.90642 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 Chennai \| N/A \| India \| 80.27847 \| 13.08784 Kilifi \| N/A \| Kenya \| 39.84992 \| -3.63045 Durban \| N/A \| South Africa \| 31.0292 \| -29.8579 Johannesburg \| N/A \| South ...	21	NCT00919854	1COMPLETED	2011-02-01	2009-09-01	Tibotec Pharmaceuticals, Ireland	4INDUSTRY	false	false	false	null	0
[ 3 ]	123	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	In addition to the blood pressure lowering effects of aliskiren, it may have beneficial effects on blocking the so called RAAS (renin-angiotensin-aldosterone system) at the tissue level. An increase of angiotensin II is associated with progression of heart failure. Although the use of ACE-inhibitors in heart failure sh...	null	Heart Failure	Heart failure Systolic Aliskiren Ramipril Angiotensin II Ang II Plasma Renin Activity PRA Plasma Renin Concentration PR, brain natriuretic peptide BNP urinary aldosterone Escape Pharmacokinetic PK	null	3	arm 1: In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up...	[ 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Aliskiren 150 mg once daily up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site intervention 2: 2.5 mg , 5.0 mg or 10 mg once daily intervention 3: matching placebo to aliskiren in double blind phase intervention 4: Matching placebo...	intervention 1: aliskiren intervention 2: ramipril intervention 3: Placebo to aliskiren intervention 4: Placebo to ramipril	16	Bad Krozingen \| N/A \| Germany \| 7.7 \| 47.91667 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Göttingen \| N/A \| Germany \| 9.93228 \| 51.53443 Jena \| N/A \| Germany \| 11.5899 \| 50.92878 München \| N/A \| Germany \| 13.31243 \| 51.60698 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Lubl...	123	NCT00923156	1COMPLETED	2011-02-01	2009-05-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	10	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	Left ventricular assist devices (LVADs) are one treatment option for people with congestive heart failure. This study will evaluate the safety of injecting mesenchymal precursor cells (MPCs) into the heart during LVAD implantation surgery and examine if injecting MPCs into the heart is effective at improving heart func...	Congestive heart failure is a major health problem and recent estimates indicate that end-stage heart failure with a 2-year mortality rate of 70-80% affects over 60,000 people in the United States each year. For these patients, treatment options are extremely limited. Less than 3,000 heart transplants are available eac...	Heart Failure	Mesenchymal Precursor Cells Left Ventricular Assist Device LVAD Congestive Heart Failure Stem Cells	null	2	arm 1: Participants will receive intramyocardial injections of cryoprotective media alone (placebo). arm 2: Participants will receive intramyocardial injections of low dose (25 million) or higher dose (75 million) MPCs in sequential cohorts.	[ 3, 0 ]	2	[ 2, 0 ]	intervention 1: Participants will receive intramyocardial injections of low dose (25 million) or higher dose (75 million) MPCs (in sequential cohorts). intervention 2: Participants will receive intramyocardial injections of cryoprotective media (placebo).	intervention 1: Mesenchymal Precursor cells (RevascorTM) intervention 2: Cryoprotective media alone	17	San Diego \| California \| United States \| -117.16472 \| 32.71571 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Oak Lawn \| Illinois \| United States \| -87.75811 \| 41.71087 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756...	10	NCT00927784	6TERMINATED	2011-02-01	2009-08-01	Icahn School of Medicine at Mount Sinai	7OTHER	false	false	false	null	0
[ 0 ]	400	NA	SINGLE_GROUP	7BASIC_SCIENCE	0NONE	true	0ALL	true	The purpose of this study is to determine genetic factors that affect responses to niacin therapy and endotoxemia in healthy volunteers.	Niacin is a vitamin that has beneficial effects on cholesterol (a type of fat in the blood) when used in high doses. Different people respond differently to cholesterol lowering doses of niacin, some people have a side effect termed flushing (similar to a hot flash) while others do not and some people have more pronoun...	Healthy Volunteers		null	1	arm 1: All subjects are expected to have the same interventions- Niacin and Endotoxin.	[ 0 ]	1	[ 0 ]	intervention 1: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).	intervention 1: Immediate Release Niacin, Extended Release Niacin, Endotoxin	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	400	NCT00953667	1COMPLETED	2011-02-01	2007-06-01	University of Pennsylvania	7OTHER	false	false	false	null	0
[ 4 ]	391	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to assess the efficacy, the quality of life, and the safety of multiple dosing atomoxetine in Asian adult subjects with attention deficit/hyperactivity disorder (ADHD).	The treatment will be initiated at the lowest dosage 40 milligrams per day (mg/day), and it will be titrated up to 80 mg/day. Patients who are unable to tolerate a dose of at least 80 mg/day through the end of this study will be discontinued. The dosage will be titrated up to a maximum of 120 mg/day.	Attention Deficit Hyperactivity Disorder	ADHD	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 40-120 milligrams (mg) taken by mouth, once daily for 10 weeks. intervention 2: Taken by mouth, once daily for 10 weeks.	intervention 1: Atomoxetine intervention 2: Placebo	24	Aichi \| N/A \| Japan \| 130.62158 \| 32.51879 Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Fukushima \| N/A \| Japan \| 140.46667 \| 37.75 Hokkaido \| N/A \| Japan \| N/A \| N/A Hyōgo \| N/A \| Japan \| 144.43333 \| 43.36667 Kanagawa \| N/A \| Japan \| 139.91667 \| 37.58333 Kumamoto \| N/A \| Japan \| 130.69181 \| 32.80589 Kyoto \| N/A \| Japan \| 13...	388	NCT00962104	1COMPLETED	2011-02-01	2009-08-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 0 ]	2	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine the tolerability and side effects of oral sorafenib in combination with intrathecal DepoCyt.	After an Ommaya reservoir has been placed in the patient's head, the patient will receive DepoCyt through that reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Patients will also receive oral sorafenib at 400 mg twice a day throughout the treatment co...	Neoplastic Meningitis	Neurologic Oncology Neoplastic Meningitis from solid tumors Brain and Nervous System Breast Cancer	null	1	arm 1: This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400...	[ 0 ]	2	[ 0, 0 ]	intervention 1: Patients were to receive DepoCyt through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses. intervention 2: Patients received oral sorafenib at 400 mg twice a day	intervention 1: DepoCyt intervention 2: Sorafenib	1	Tampa \| Florida \| United States \| -82.45843 \| 27.94752	2	NCT00964743	6TERMINATED	2011-02-01	2009-08-01	H. Lee Moffitt Cancer Center and Research Institute	7OTHER	false	false	false	null	0
[ 3, 4 ]	474	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. This study was conducted as a phase IIb study and continued with further enrollment as a phase III study.	null	Bacterial Conjunctivitis		null	2	arm 1: 0.6% ophthalmic suspension arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Besifloxacin 0.6% administered into the study eye two times a day for three days. intervention 2: Vehicle administered to the study eye two times a day for three days.	intervention 1: Besifloxacin intervention 2: Vehicle (Placebo)	1	Rochester \| New York \| United States \| -77.61556 \| 43.15478	464	NCT00972777	1COMPLETED	2011-02-01	2009-10-01	Bausch & Lomb Incorporated	4INDUSTRY	false	false	false	null	0
[ 3 ]	24	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	null	This open-label, randomized, parallel arm study will evaluate the effect of capecitabine administered concurrently with WBRT and as maintenance therapy in participants with breast cancer and newly diagnosed brain metastases. Participants will be randomized to receive either capecitabine with 10 days standard WBRT, or W...	null	Breast Cancer		null	2	arm 1: Participants will receive 3000 centi-Gray (cGy) WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants will be followed during the treat...	[ 1, 0 ]	3	[ 4, 0, 0 ]	intervention 1: 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction). intervention 2: 825 mg/m\^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by 1000 mg/m\^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2. intervention 3: The choice of standard of...	intervention 1: WBRT intervention 2: Capecitabine intervention 3: Standard of Care	16	Arras \| N/A \| France \| 2.78186 \| 50.29301 Beuvry \| N/A \| France \| 2.68541 \| 50.51674 Béziers \| N/A \| France \| 3.21402 \| 43.34122 Bobigny \| N/A \| France \| 2.45012 \| 48.90982 Dijon \| N/A \| France \| 5.01667 \| 47.31667 Le Mans \| N/A \| France \| 0.20251 \| 48.0021 Lille \| N/A \| France \| 3.05858 \| 50.63297 Lyon \| N/A \| France ...	23	NCT00977379	6TERMINATED	2011-02-01	2009-08-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 2 ]	13	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to describe the Central Nervous System exposure of maraviroc in HIV-1 infected subjects receiving a stable antiretroviral regimen, including maraviroc, at steady state.	15 HIV-1 infected subjects currently receiving stable antiretroviral therapy will be recruited. At study entry, within 14 days of screening procedures, subjects will commence maraviroc dosed at 150 mg twice daily. For the rest of study period antiretroviral therapy will comprise: * Truvada™ one tablet once daily at 09...	HIV Infections	treatment experienced	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 150mg twice daily	intervention 1: Maraviroc	1	London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	12	NCT00982878	1COMPLETED	2011-02-01	2009-09-01	Imperial College London	7OTHER	false	false	false	null	0
[ 0 ]	26	RANDOMIZED	CROSSOVER	0TREATMENT	1SINGLE	false	0ALL	true	Methylphenidate may improve sleep in children with ADHD. By leaving Daytrana (methylphenidate) patch for a longer time then 9 hours, many children report short sleep latencies and better quality of sleep.	Once the optimal dose of Daytrana that controlled the ADHD symptoms is established. The patch will be removed 1, 2, and 3 hours before bed time in a random fashion, at weekly intervals, and parents will keep a sleep diary. 25 patients will be enrolled in order to obtain statistical significance.	Attention Deficit Hyperactivity Disorder INSOMNIA	daytrana sleep latency adhd rating scales ADHD	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Daytrana patch 10-30 mg administered once daily for 9hr intervention 2: Daytrana 10-30 mg worn once daily for 10 hr wear intervention 3: Daytrana 10-30 mg worn once daily for 11 hr intervention 4: Daytrana 10-30 mg worn once daily for 12 hrs	intervention 1: Daytrana intervention 2: Daytrana intervention 3: Daytrana intervention 4: Daytrana	1	Springfield \| Missouri \| United States \| -93.29824 \| 37.21533	26	NCT00989950	1COMPLETED	2011-02-01	2009-12-01	Cox Health Systems	7OTHER	false	false	false	null	0
[ 3 ]	109	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin) injections at different doses of BIM 23A760 on growth hormone and insulin-like growth factor-1 levels in patients with acromegaly after 6 months of treatment.	null	Acromegaly		null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.	intervention 1: BIM 23A760	23	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Rio de Janeiro \| N/A \| Brazil \| -43.18223 \| -22....	176	NCT00994214	6TERMINATED	2011-02-01	2009-10-01	Ipsen	4INDUSTRY	false	false	false	null	0
[ 3 ]	14	NA	SINGLE_GROUP	6HEALTH_SERVICES_RESEARCH	0NONE	true	0ALL	true	This is a molecular imaging research study designed to examine how much nicotine gets into the brain before and after vaccination with NicVAX, a nicotine vaccine developed by Nabi Biopharmaceuticals. NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine designed as an aid to smoking cessation and long-term ...	The purpose of the present study is to examine the occupancy of brain β2-containing nicotinic acetylcholine receptors (β2-nAChR) by nicotine both at baseline and following administration of a nicotine vaccine. The number of brain β2-nAChR and the amount of nicotine occupancy both before and after vaccination will be me...	Nicotine Dependence	Nicotine, SPECT, vaccine, receptor	null	1	arm 1: There is only one arm to the study. All subjects will receive NicVax, \[123I\]5-I-A-85380,and Nicotine bitartrate.	[ 0 ]	3	[ 2, 4, 0 ]	intervention 1: 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies intervention 2: up to 10 mCi of \[123I\]5-IA-85380, I.V. on each of two SPECT Scan days intervention 3: 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days	intervention 1: NicVAX intervention 2: [123I]5-IA-85380 intervention 3: Nicotine bitartrate	1	West Haven \| Connecticut \| United States \| -72.94705 \| 41.27065	14	NCT00996034	1COMPLETED	2011-02-01	2009-09-01	Yale University	7OTHER	false	false	false	null	0
[ 4 ]	1,090	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	true	The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.	null	Sexual Dysfunctions, Psychological		null	2	arm 1: flibanserin 100mg po qd arm 2: placebo 1 tab po qd	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: patients will be randomized to flibanserin or placebo in a double-blind manner intervention 2: patients will be randomized to flibanserin or placebo in a double-blind manner	intervention 1: Flibanserin intervention 2: Placebo	75	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Encinitas \| California \| Unit...	1,090	NCT00996164	1COMPLETED	2011-02-01	2009-10-01	Sprout Pharmaceuticals, Inc	4INDUSTRY	false	false	false	null	0
[ 4 ]	478	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	The purpose of this study is to evaluate the efficacy of adding methotrexate to etanercept compared with etanercept monotherapy as measured by the percentage of participants achieving a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at Week 24.	null	Psoriasis	Etanercept Methotrexate Psoriasis	null	2	arm 1: Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, a...	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Methotrexate tablets over-encapsulated for blinding intervention 2: 1 mL for subcutaneous injection intervention 3: Matching placebo to methotrexate capsules	intervention 1: Methotrexate intervention 2: Etanercept intervention 3: Placebo	0	null	478	NCT01001208	1COMPLETED	2011-02-01	2009-11-01	Amgen	4INDUSTRY	false	false	false	null	0
[ 4 ]	79	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	3TRIPLE	false	0ALL	null	This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.	null	Asthma	Severe asthma, non-atopic, omalizumab	null	2	arm 1: Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. arm 2: Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Omalizumab was supplied in 5mL vials with solution for subcutaneous injection. intervention 2: Placebo was supplied in vials with solution for subcutaneous injection.	intervention 1: omalizumab intervention 2: Placebo	10	Arnaud de Villeneuve \| N/A \| France \| N/A \| N/A Béthune \| N/A \| France \| 2.64003 \| 50.52965 Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 Clamart \| N/A \| France \| 2.26692 \| 48.80299 Lyon \| N/A \| France \| 4.84671 \| 45.74846 Nantes \| N/A \| France \| -1.55336 \| 47.21725 Paris \| N/A \| France \| 2.3488 \| 48.85341 Strasbourg \| ...	41	NCT01007149	1COMPLETED	2011-02-01	2009-09-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	530	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The primary aim is to evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in TD2M Patients	null	Type II Diabetes Mellitus	Type II Diabetes Mellitus metformin glipizide	null	7	arm 1: AZD1656 arm 2: AZD1656 arm 3: AZD1656 arm 4: AZD1656 arm 5: AZD1656 arm 6: None arm 7: Glipizide administered to 1 group of patients	[ 0, 0, 0, 0, 0, 2, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Different doses of AZD1656 administered to 5 groups of patients intervention 2: AZD1656 placebo and glipizide placebo administered to 1 group of patients intervention 3: Glipizide administered to 1 group of patients	intervention 1: AZD1656 intervention 2: Placebo intervention 3: Glipizide	77	Temuco \| Región de la Araucanía \| Chile \| -72.59738 \| -38.73628 Brentwood \| TN \| Chile \| N/A \| N/A Santiago \| N/A \| Chile \| -70.64827 \| -33.45694 Temuco \| N/A \| Chile \| -72.59738 \| -38.73628 Dresden \| Saxony \| Germany \| 13.73832 \| 51.05089 Brentwood \| TN \| Germany \| N/A \| N/A Aschaffenburg \| N/A \| Germany \| 9.15214 \| 4...	523	NCT01020123	1COMPLETED	2011-02-01	2009-10-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 3 ]	326	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	This was a cross-over, polysomnography (PSG) study to test the safety, tolerability and effectiveness of different doses of MK-6096 in the treatment of participants with primary insomnia. The primary efficacy hypothesis was that at least one dose of MK-6096 is superior to placebo in improving sleep efficiency (SE) as m...	null	Primary Insomnia		null	8	arm 1: Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Da...	[ 0, 0, 0, 0, 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: MK-6096 2.5 mg or 5 mg tablets equaling 2.5 mg dose, 5 mg dose, 10 mg dose, or 20 mg dose (depending upon allocation) were taken daily before bedtime for 4 weeks. intervention 2: Dose-matched placebo tablets to MK-6096 were taken daily before bedtime during 2-week single-blind run-in, for 4 weeks as a t...	intervention 1: MK-6096 intervention 2: Dose-matched Placebo to MK-6096	0	null	1,272	NCT01021852	1COMPLETED	2011-02-01	2009-11-30	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 5 ]	61	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	Study Hypothesis: The administration of 200 mg doxycycline once a day for 7 days after regenerative periodontal therapy of infrabony defects improves the results of therapy (clinical vertical attachment gains \[CAL-V\], bony fill) and reduces postoperative flap dehiscence and defect exposure. In each of 90 patients on...	Patients From April 2007 until February 2009 all patients undergoing periodontal treatment at the Department of Periodontology, Center of Dental, Oral, and Maxillofacial Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt/Main and the Section of Periodontology, Department of Conservative Dentistry, Clinic...	Periodontitis	periodontal regeneration radiographic bone fill infrabony defects randomized placebo-controlled clinical trial guided tissue regeneration, periodontal	null	2	arm 1: The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects * modified/simplified papilla preservation flap; scaling * Prefgel/Emdogain * 0.12% chlorhexidine gluconate solution * Ibuprofen 400 mg (if necessary) * 1% chlorhexidine gl...	[ 0, 2 ]	7	[ 0, 0, 3, 2, 0, 0, 0 ]	intervention 1: The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects. intervention 2: The patients of the doxycycline group will take 200 mg placebo once a day for 7 days after regenerative therapy of an infrabony defects. interventi...	intervention 1: Doxycycline intervention 2: Placebo intervention 3: modified/simplified papilla preservation flap; scaling intervention 4: Prefgel/Emdogain intervention 5: 0.12% chlorhexidine gluconate solution intervention 6: Ibuprofen 400 mg (if necessary) intervention 7: 1% chlorhexidine gluconate gel (if necessary)	2	Frankfurt am Main \| N/A \| Germany \| 8.68417 \| 50.11552 Heidelberg \| N/A \| Germany \| 8.69079 \| 49.40768	61	NCT01030666	6TERMINATED	2011-02-01	2007-04-01	Peter Eickholz	7OTHER	false	false	false	null	0
[ 5 ]	103	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	A 3-week, multi-center, open-label, randomized, active-control, parallel-group study to compare effects of Nateglinide and Acarbose on postprandial glucose fluctuation in Chinese drug-naive patients type 2 diabetes mellitus (T2DM). In this study, participants in different groups took Nateglinide at a dose of 120 mg ora...	null	Diabetes Mellitus, Type 2	Diabetes Mellitus, Type 2 Nateglinide Acarbose glucose fluctuation	null	2	arm 1: Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily. arm 2: Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily. intervention 2: Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.	intervention 1: Nateglinide intervention 2: Acarbose	3	Hangzhou \| N/A \| China \| 120.16142 \| 30.29365 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Shanghai \| N/A \| China \| 121.45806 \| 31.22222	103	NCT01030952	1COMPLETED	2011-02-01	2009-12-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	25	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This was a double-blinded, randomized, vehicle-controlled study in sporadic superficial BCC (sBCC) and nodular BCC (nBCC) patients which consisted of a 21-day screening period, a treatment period of 6 weeks (topical 0.75% LDE225 cream application b.i.d) ending with post treatment biopsies, as safety visit one week afte...	null	Sporadic Superficial and Nodular Skin Basal Cell Carcinomas	Basal cell carcinomas, sporadic, superficial and nodular, skin	null	2	arm 1: Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks. arm 2: Participants topically applied matching placebo cream twice daily for 6 weeks.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 0.75% cream intervention 2: matching placebo cream to 0.75% LDE225 cream	intervention 1: LDE225 0.75% intervention 2: Vehicle	4	Benowa \| Queensland \| Australia \| 153.38583 \| -28.0077 Woolloongabba \| Queensland \| Australia \| 153.03655 \| -27.48855 Graz \| N/A \| Austria \| 15.45 \| 47.06667 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849	25	NCT01033019	6TERMINATED	2011-02-01	2009-12-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 0 ]	23	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	false	The objectives of this study are to assess the effects of 4 g/d prescription omega-3 acid ethyl esters (POM3), compared with a placebo, on indices of insulin sensitivity and secretion, as well as aspects of the fasting and postprandial lipid and lipoprotein profiles, in subjects with hypertriglyceridemia.	This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2 (Week 0), subjects meeting all entry criteria will be randomized to one of two treatment sequences: placebo or POM3 for the first 6 week phase followed by the study product they did not receive during the first phase (POM3 or pl...	Hypertriglyceridemia		null	2	arm 1: POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment arm 2: Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 4 g/day intervention 2: matching placebo capsule, 4 g/day	intervention 1: POM3 intervention 2: Placebo	1	Addison \| Illinois \| United States \| -87.98896 \| 41.9317	46	NCT01034540	1COMPLETED	2011-02-01	2010-03-01	Provident Clinical Research	7OTHER	false	false	false	null	0
[ 3 ]	233	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	null	The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week treatment in patients with COPD.	null	Pulmonary Disease, Chronic Obstructive		null	8	arm 1: low dose inhaled olodaterol orally once daily from the Respimat inhaler arm 2: low dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily arm 3: low dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily arm 4: low...	[ 0, 0, 0, 0, 0, 0, 0, 0 ]	7	[ 0, 0, 0, 0, 0, 0, 1 ]	intervention 1: olodaterol (BI 1744) low intervention 2: low tiotropium bromide intervention 3: olodaterol (BI 1744) high intervention 4: medium tiotropium bromide intervention 5: high tiotropium bromide intervention 6: Placebo intervention 7: Respimat inhaler	intervention 1: olodaterol (BI 1744) low intervention 2: low tiotropium bromide intervention 3: olodaterol (BI 1744) high intervention 4: medium tiotropium bromide intervention 5: high tiotropium bromide intervention 6: Placebo intervention 7: Respimat	33	Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Grimsby \| Ontario \| Canada \| -79.56631 \| 43.20011 Mississauga \| Ontario \| Canada \| -79.6583 \| 43.5789 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Point Claire \| Quebec \| Canada \| N/A \| N/A Québec \| Queb...	879	NCT01040403	1COMPLETED	2011-02-01	2010-01-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 0 ]	72	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	true	1FEMALE	false	The purpose of this study is to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications in subjects undergoing minimally invasive urogynecologic surgery.	See above	Functional Disorder of Intestine	Urogynecology	null	2	arm 1: Docusate is the standard of care regimen arm 2: Docusate, Miralax, Metamucil wafers, Bisacodyl suppository	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Docusate 100mg BID intervention 2: Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID	intervention 1: Docusate intervention 2: Bowel medications	1	Rochester \| New York \| United States \| -77.61556 \| 43.15478	72	NCT01044212	1COMPLETED	2011-02-01	2009-11-01	University of Rochester	7OTHER	false	false	false	null	0
[ 2 ]	36	RANDOMIZED	PARALLEL	null	0NONE	false	0ALL	false	The purpose of this study is to assess the pharmacokinetics and safety of dexlansoprazole, once daily (QD), in pediatric subjects with symptomatic Gastroesophageal Reflux Disease.	Gastroesophageal Reflux Disease (GERD) is a condition of several causes resulting in the backward flow of gastric contents into the esophagus through the lower esophageal sphincter. The prevalence of GERD in the pediatric population is increasingly becoming recognized and documented. It is a disease that may persist th...	Gastroesophageal Reflux	Gastroesophageal Reflux Erosive Esophagitis Pharmacokinetics Pediatrics Drug Therapy	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days. intervention 2: Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days intervention 3: Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days	intervention 1: Dexlansoprazole intervention 2: Dexlansoprazole intervention 3: Dexlansoprazole	4	Anaheim \| California \| United States \| -117.9145 \| 33.83529 Miami Garden \| Florida \| United States \| N/A \| N/A Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711	36	NCT01045096	1COMPLETED	2011-02-01	2010-03-01	Takeda	4INDUSTRY	false	false	false	null	0
[ 4 ]	702	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering high fasting triglyceride levels in patients with high risk for cardiovascular disease and fasting triglyceride levels ≥ 200 and \< 500 mg/dL.	null	Hypertriglyceridemia	hypertriglyceridemia omega-3 fatty acids statin triglycerides lipids EPA docosahexaenoic acid fish fatty acids fibrates niacin lipid atorvastatin Lovaza simvastatin lovastatin pravastatin fluvastatin rosuvastatin Trilipix Vytorin Simcor Niaspan ezetimibe Zetia ethyl-EPA ethyl icosapentate Crestor Zocor Lipitor LDL HDL ...	null	3	arm 1: None arm 2: None arm 3: None	[ 2, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks intervention 2: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks intervention 3: Placebo 4 capsules/day for 12 weeks	intervention 1: AMR101 (ethyl icosapentate) - 4 g/day intervention 2: AMR101 (ethyl icosapentate) - 2 g/day intervention 3: Placebo	80	Muscle Shoals \| Alabama \| United States \| -87.66753 \| 34.74481 Scottsboro \| Alabama \| United States \| -86.03415 \| 34.67231 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Burbank \| California \|...	702	NCT01047501	1COMPLETED	2011-02-01	2009-12-01	Amarin Pharma Inc.	4INDUSTRY	false	false	false	null	-0
[ 5 ]	480	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	Study Comparing Discontinuation Symptoms in subjects with Major Depressive Disorder treated for 24 Weeks with Open-label 50 mg Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR)	null	Major Depressive Disorder		null	3	arm 1: None arm 2: None arm 3: None	[ 1, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: DVS SR 50 mg Reference Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase. intervention 2: DVS SR 25 mg Taper Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of th...	intervention 1: Desvenlafaxine Succinate Sustained-Release Formulation 50 mg intervention 2: Desvenlafaxine Succinate Sustained-Release Formulation 25 mg intervention 3: Placebo	0	null	841	NCT01056289	1COMPLETED	2011-02-01	2010-03-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 3 ]	7	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Cancer results from multiple mutations which cause cells to grow uncontrolled. It therefore may be necessary to inhibit several oncogenic targets to affect cancer cell growth. Studies have shown that panobinostat (LH589) causes a wide range of effect on endothelial cells that lead to inhibition of tumor angiogenesis (a...	null	Pancreatic Cancer	insulinoma cancer of pancreas neoplasms, pancreas alpha-cell tumor glucagonoma beta-cell tumor somatostatinoma	null	1	arm 1: Pancreatic cancer patients who received treatment with bortezomib and panobinostat after progressing on gemcitabine.	[ 0 ]	2	[ 0, 0 ]	intervention 1: 1.3 mg/m\^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period intervention 2: 20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period	intervention 1: Bortezomib intervention 2: Panobinostat	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	7	NCT01056601	6TERMINATED	2011-02-01	2010-09-01	Masonic Cancer Center, University of Minnesota	7OTHER	false	false	false	null	0
[ 5 ]	600	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	0ALL	true	The purpose of this study is to compare Nulytely (or Trilyte) with a Gatorade and Miralax combination for cleaning out the colon before colonoscopy. A laxative pill called Bisacodyl may also be used with the Gatorade and Miralax to see if it helps with the clean out process. We are trying to find out if either of these...	null	Preparation for Colonoscopy		null	3	arm 1: Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy. arm 2: Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64...	[ 1, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Gatorade 64 oz (1/2 gallon), Miralax 306 g to be consumed the day before your colonoscopy as follows: Miralax 51 g at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM. intervention 2: Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before ...	intervention 1: Gatorade/Miralax intervention 2: NuLytely intervention 3: Bisacodyl intervention 4: Placebo	1	Downers Grove \| Illinois \| United States \| -88.01117 \| 41.80892	600	NCT01063049	1COMPLETED	2011-02-01	2010-02-01	Gastroenterology Services, Ltd.	7OTHER	false	false	false	null	0
[ 3 ]	125	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).	null	Chronic Plaque-type Psoriasis	Moderate to severe chronic plaque-type psoriasis AIN457 dermatology	null	5	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None	[ 0, 0, 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: AIN457 intervention 2: Placebo	19	San Diego \| California \| United States \| -117.16472 \| 32.71571 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Lake Oswego \| Oregon \| United States \| -122.67065 \| 45.42067 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Halifax \| Nova Sc...	125	NCT01071252	1COMPLETED	2011-02-01	2010-03-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	30	RANDOMIZED	PARALLEL	2DIAGNOSTIC	1SINGLE	false	0ALL	true	Growing research from independent laboratories provide an association between mycobacteria and sarcoidosis. More recent immunologic and molecular studies demonstrate immune responses to mycobacteria virulence factors. The purpose of this study is to assess if administration of anti-mycobacterial drug therapy will aid i...	Independent molecular and immunologic investigations strengthen the association between mycobacterial antigens and sarcoidosis pathogenesis. Molecular analysis of sarcoidosis granulomas reveals the presence of Mycobacterium tuberculosis complex (MTB) DNA and proteins that are significantly absent from granulomatous con...	Sarcoidosis	sarcoidosis mycobacteria cutaneous lesions	null	2	arm 1: The Antibiotic Regimen consists of Levaquin 750 mg loading on day 1, then 500 mg po QD and Ethambutol 15-25 mg/kg for a maximum of 1200mg QD and Azithromycin 500mg on day 1, then 250 mg po QD and Rifampin 5-10 mg/kg for a maximum of 300mg po QD. All four drugs are given concomitantly. arm 2: The placebo regimen...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg QD Azithromycin 500mg on day 1, then 250 mg po QD Rifampin 5-10 mg/kg for a maximum of 300mg po QD All four drugs are given concomitanly intervention 2: lactose control tablets; one for each antibiotic wit...	intervention 1: Antibiotic Regimen intervention 2: Placebo Regimen	1	Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589	30	NCT01074554	1COMPLETED	2011-02-01	2010-02-01	Vanderbilt University	7OTHER	false	false	false	null	0
[ 0 ]	1	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	false	RATIONALE: Giving chemotherapy and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they will hel...	PRIMARY OBJECTIVES: I. The percentage of normal donors who collect at least 2 x 10\^6 CD34 cells/kg recipient weight on day 1 after administration of combined filgrastim and plerixafor. SECONDARY OBJECTIVES: I. Measuring CD34+ cells/ul in peripheral blood of donors 11, 15, 24 and 36 hours post dosing. II. Tolerance...	Accelerated Phase Chronic Myelogenous Leukemia Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid ...		null	1	arm 1: Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose...	[ 0 ]	4	[ 0, 2, 3, 3 ]	intervention 1: Given SC intervention 2: Given SC intervention 3: Infusion of peripheral blood stem cells intervention 4: Infusion of hematopoietic stem cells	intervention 1: plerixafor intervention 2: filgrastim intervention 3: peripheral blood stem cell transplantation intervention 4: allogeneic hematopoietic stem cell transplantation	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	1	NCT01076270	6TERMINATED	2011-02-01	2010-06-01	Fred Hutchinson Cancer Center	7OTHER	false	false	false	null	0
[ 5 ]	40	NON_RANDOMIZED	SINGLE_GROUP	7BASIC_SCIENCE	0NONE	true	0ALL	false	The primary objective of this study is to compare the pharmacokinetic profiles of colchicine and its primary metabolites in plasma and urine following a single 0.6 mg oral dose of colchicine in healthy adults with normal renal function, in patients with mild, moderate or severe renal impairment, and in patients with en...	40 male and female subjects will be enrolled in the study and stratified into one of five groups based on their renal status as determined from creatinine clearance (CrCL) estimated using the serum creatinine (sCR) and the Cockcroft-Gault and Modified Diet in Renal Disease (MDRD) equations as follows: Treatment group 1...	Pharmacokinetics		null	5	arm 1: Healthy participants with normal renal function (Creatinine Clearance \[CrCl\] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1. arm 2: Participants with mild renal impairment (estimated Glomerular Filtration Rate \[eGFR\] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1. arm...	[ 0, 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: Colchicine tablets	intervention 1: Colchicine	1	Cypress \| California \| United States \| -118.03729 \| 33.81696	40	NCT01084278	1COMPLETED	2011-02-01	2010-05-01	Takeda	4INDUSTRY	false	false	false	null	0
[ 3 ]	14	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The goal of the proposed study is to evaluate the efficacy and safety of dronabinol in individuals with obsessive-compulsive disorder (OCD) or the obsessive-compulsive spectrum disorders, trichotillomania (TTM) or pathological skin picking (PSP). Fifteen patients with OCD, TTM, or PSP will receive 12 weeks of open-labe...	The study consists of twelve weeks of open-label dronabinol. All eligible study subjects will be started on open-label dronabinol 2.5mg/day for 3 weeks. The dose will be increased to 5mg/day at visit 2 (Week 3), to10mg/day at visit 3 (Week 6), and to 15mg/day at Visit 4 (Week 9) unless clinical improvement is attained ...	Trichotillomania Obsessive Compulsive Disorder	Skin Picking OCD Trichotillomania Pathological Skin Picking	null	1	arm 1: Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks	[ 0 ]	1	[ 0 ]	intervention 1: 2.5mg-15mg by mouth once a day for twelve-weeks	intervention 1: Dronabinol	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	14	NCT01093976	1COMPLETED	2011-02-01	2010-04-01	University of Chicago	7OTHER	false	false	false	null	0
[ 5 ]	62	RANDOMIZED	PARALLEL	null	4QUADRUPLE	true	0ALL	true	This study is being done to evaluate the effects of pregabalin, a drug approved for anticonvulsive therapy and for neuropathic pain, on colonic and sensory functions in healthy individuals. The specific study hypotheses were as follows: 1) pregabalin increases sensation thresholds, decreases sensation ratings, and inc...	The treatment of patients with irritable bowel syndrome and chronic abdominal pain is advancing with several effective options for symptoms related to bowel dysfunction and bloating/distension. However, there are no approved or effective centrally or peripherally acting visceral analgesics. Pregabalin has been proposed...	Healthy	pregabalin motor sensation colon pain gas	null	3	arm 1: Subjects randomized to this arm received a single dose of pregabalin 75 mg orally arm 2: Subjects randomized to this arm received a single dose of pregabalin 200 mg orally arm 3: Subjects randomized to this arm received a single dose of placebo medication orally	[ 0, 0, 2 ]	3	[ 0, 0, 10 ]	intervention 1: FDA approved medication (capsules) at 75 mg and 200 mg doses intervention 2: Placebo capsules intervention 3: Polyethylene glycol electrolyte solution bowel preparation	intervention 1: Pregabalin intervention 2: Placebo intervention 3: Bowel preparation	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	60	NCT01094808	1COMPLETED	2011-02-01	2010-03-01	Mayo Clinic	7OTHER	false	false	false	null	0
[ 4 ]	13	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to explore the impact of Ziprasidone HCl on the distribution of metabolic syndrome (MS) risk factors in a population of Bipolar patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.	The trial was terminated prematurely on December 14, 2010, due to inability to recruit the planned number of subjects and shifting organizational priorities. The decision to terminate the trial was not based on any safety or efficacy concerns.	Bipolar Disorder	Ziprasidone Bipolar Disorder Metabolic Syndrome	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40-160 mg total daily dose) for up to 1 year.	intervention 1: Ziprasidone HCL (oral)	10	Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Penticton \| British Columbia \| Canada \| -119.58584 \| 49.48062 Winnipeg \| Manitoba \| Canada \| -97.14704 \| 49.8844 Winnipeg \| Manitoba \| Canada \| -97.14704 \| 49.8844 Halifax \| Nova Scotia \| Canada \| -63.57688 \| 44.64269 ...	13	NCT01113541	6TERMINATED	2011-02-01	2010-07-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	2	RANDOMIZED	SINGLE_GROUP	0TREATMENT	4QUADRUPLE	true	1FEMALE	true	This protocol is a controlled study of estradiol therapy in early postmenopausal women with and without frequent hot flashes that will be used to determine whether hot flashes are an important intermediary in the generation of menopause-associated depression.	SPECIFIC AIMS (Research Objectives) To define the relative effects of hot flashes and changes in estradiol on mood in postmenopausal women: Hypotheses: 1. Estrogen treatment has a similar therapeutic effect on mood in women with and without frequent hot flashes 2. Estradiol levels correlate with improvement in mood	Menopausal Depression		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: Oral estradiol 1.0 mg/day for four weeks. intervention 2: Placebo control matched to estradiol tablets. Daily dosing for one month.	intervention 1: Estradiol intervention 2: Placebo control	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	2	NCT01126801	6TERMINATED	2011-02-01	2010-05-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0
[ 3 ]	190	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	PF-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which is involved in the pathway that causes inflammation and pain. The purpose of this study is to test how effective, safe and tolerated PF-04191834 is in patients with osteoarthritis of the knee by itself or with naproxen, particul...	This study has been terminated in response to a reported serious adverse event (SAE). The sponsor's assessment of the limited data available at the time of the initial SAE report was that the SAE may alter the potential benefit - risk profile of the study medication.	Osteoarthritis, Knee	Cross-over safety efficacy tolerability osteoarthritis knee pain	null	4	arm 1: PF-04191834 600 mg BID dose followed by matched placebo plus naproxen placebo. arm 2: Placebo followed by 600 mg BID dose of PF-04191834 plus naproxen placebo. arm 3: PF-04191834 600 mg BID + Naproxen 500 mg BID followed by Naproxen 500 mg BID plus PF-04191834 placebo arm 4: Naproxen 500 mg BID followed by PF-04...	[ 0, 0, 0, 0 ]	12	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: 100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks intervention 2: Matching PF-04191834 placebo tablets to be administered BID for two weeks intervention 3: Matching naproxen placebo tablets to be administered BID for 4 weeks intervention 4: Matching PF-04191834 placeb...	intervention 1: PF-04191834 intervention 2: PF-04191834 placebo intervention 3: Naproxen placebo intervention 4: PF-04191834 placebo intervention 5: PF-04191834 intervention 6: Naproxen placebo intervention 7: PF-04191834 intervention 8: Naproxen intervention 9: PF-04191834 placebo intervention 10: Naproxen interventio...	31	Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Carmichael \| California \| United States \| -121.32828 \| 38.61713 Fair Oaks \| California \|...	324	NCT01147458	6TERMINATED	2011-02-01	2010-07-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 3 ]	12	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is an open-label, Phase II Clinical Trial of Aplidin® (plitidepsin) in Patients with Primary Myelofibrosis and post polycythemia vera/essential thrombocythemia (Post-PV/ET) Myelofibrosis.	This trial tries to assess response rate (ORR) of plitidepsin in patients with: primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF). Besides, the study results will allow to evaluate the effect of plitidepsin on bone marrow (BM) o...	Myelofibrosis	Aplidin Plitidepsin Myelofibrosis Pharma Mar	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Aplidin® (plitidepsin) lyophilized powder and solvent for concentrate for solution for infusion. (2 mg plitidepsin vial and 4 ml ampoule). Plitidepsin will be administered at 5 mg/m2 intravenously diluted to a total volume of 250 ml in 0.9% saline or 5% dextrose solution on Day 1 and 15 every four week...	intervention 1: APLIDIN (plitidepsin)	2	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 Florence \| N/A \| Italy \| 11.24626 \| 43.77925	12	NCT01149681	1COMPLETED	2011-02-01	2010-07-01	PharmaMar	4INDUSTRY	false	false	false	null	0
[ 5 ]	50	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	null	Tracheal extubation can be associated with hyperdynamic circulatory response. The investigators examined the effect of maintaining a remifentanil infusion on the cardiovascular response during extubation in propofol-remifentanil sedated patients after surgery.	null	Tracheal Extubation	safety and efficacy of maintaining a remifentanil infusion during extubation in propofol-remifentanil sedated patients after surgery	null	2	arm 1: stopping of propofol and remifentanil infusion arm 2: stopping of propofol and maintenance of remifentanil infusion	[ 4, 1 ]	1	[ 0 ]	intervention 1: Control group : stopping of propofol and remifentanil infusion Remifentanil group : stopping of propofol and maintenance of remifentanil infusion	intervention 1: Remifentanil	1	Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	50	NCT01152515	1COMPLETED	2011-02-01	2010-05-01	Severance Hospital	7OTHER	false	false	false	null	0
[ 4 ]	108	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	null	The ability for patients with COPD to exercise is limited due to the deterioration of their lung function. NVA237 is being developed to treat COPD. This study is designed to look at how well NVA237 improves the ability to exercise in patients with moderate to severe COPD.	null	Chronic Obstructive Pulmonary Disease	NVA237 COPD bronchodilator exercise endurance	null	2	arm 1: Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days Period 2: Matching placebo via NEOHALER inhaler device for 21 days The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. Salbut...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 50 μg via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily intervention 2: Matching placebo via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily	intervention 1: NVA237 intervention 2: Placebo	10	Spartanburg \| South Carolina \| United States \| -81.93205 \| 34.94957 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Frankfurt \| N/A \| Germany \| 10.53333 \| 49.68333 Mainz \| N/A \| Germany \| 8.2791 \| 49.98419 Mannheim \| N/A \| Germany \| 8.46694 \| 49.4891 Wiesbaden \| N/A \| Germany \| 8.24932 \| 50.08258 Woehrendamm \| N/A \| Germa...	204	NCT01154127	1COMPLETED	2011-02-01	2010-06-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 4 ]	286	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	null	Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.	null	Purulent Bacterial Conjunctivitis		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2 intervention 2: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6	intervention 1: T1225 intervention 2: Tobramycin	1	Clermont-Ferrand \| N/A \| France \| 3.08682 \| 45.77969	286	NCT01155999	1COMPLETED	2011-02-01	2008-12-01	Laboratoires Thea	4INDUSTRY	false	false	false	null	0
[ 0 ]	36	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study is being conducted to find out if the use of inhaled corticosteroids has an affect on upper airway (UAW) collapsibility and sleep apnea risk. An inhaled corticosteroid is a common asthma controller medication like Flovent. Sleep apnea or sleep deprived breathing (SDB) is when someone stops breathing for a sh...	To address this hypothesis, we specifically aim is to determine the effects of 16 weeks of treatment with inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 880 mcg twice daily, on: Specific Aim 1: UAW collapsibility, as measured by Pcrit during NREM sleep; Specific Aim 2: Severity of obstructive S...	Lung Disease	asthma sleep apnea	null	2	arm 1: The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs B...	[ 4, 1 ]	1	[ 0 ]	intervention 1: The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg ...	intervention 1: FP 220 mcg 2 puffs BID	1	Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	18	NCT01184118	1COMPLETED	2011-02-01	2009-03-01	University of Wisconsin, Madison	7OTHER	false	false	false	null	0
[ 2 ]	42	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will investigate the safety, tolerability, and pharmacokinetics of new formulation of bimatoprost following topical application in patients with alopecia. Two formulations of bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be investigated in Part 2. Part 2 will begin af...	null	Alopecia Alopecia, Androgenetic Baldness		null	3	arm 1: bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17. arm 2: bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17. arm 3: bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17. intervention 2: bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17. intervention 3: bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-...	intervention 1: bimatoprost Formulation A intervention 2: bimatoprost Formulation B intervention 3: bimatoprost Formulation C	1	Tempe \| Arizona \| United States \| -111.90931 \| 33.41477	42	NCT01189279	1COMPLETED	2011-02-01	2010-10-01	Allergan	4INDUSTRY	false	false	false	null	0
[ 3 ]	223	RANDOMIZED	FACTORIAL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain and...	null	Cataract		null	4	arm 1: OMS302 Solution arm 2: OMS302 Mydriatic Solution arm 3: OMS302 Anti-inflammatory Solution arm 4: Balanced Salt Solution (BSS) Solution	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None	intervention 1: OMS302 Solution intervention 2: OMS302 Mydriatic Solution intervention 3: OMS302 Anti-inflammatory Solution intervention 4: Balanced Salt Solution (BSS) Solution	24	Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Glendale \| Arizona \| United States \| -112.18599 \| 33.53865 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Parker \| Colorado \| United States \| -104.76136 \| 39.5186 Largo \| Florida \| ...	222	NCT01193127	1COMPLETED	2011-02-01	2010-07-01	Omeros Corporation	4INDUSTRY	false	false	false	null	0
[ 4 ]	260	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to compare the safety and efficacy of Oral Osmotic Therapeutic System (OROS) hydromorphone hydrochloride (HCl) with controlled-release oxycodone HCl in participants with cancer-related pain.	This is a double-blind (a medical research study in which neither the researchers nor the participants know what treatment the participants is receiving), randomized (study drug is assigned by chance), multi-center (when more than one hospital or medical school team work on a medical research study), comparative, paral...	Pain	Pain Hydromorphone hydrochloride Oxycodone hydrochloride	null	2	arm 1: OROS Hydromorphone HCl will be administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titrationphase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioid dose. arm 2: Oxycodone HCl will be administered in dose of 10, 20, 30 and 40 m...	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Hydromorphone HCl will be administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of Titration phase and 28 days of Maintenance phase. Starting dose will be based on participant's previous daily opioid dose. intervention 2: Oxycodone HCl will be administered in dose of 10, 2...	intervention 1: Hydromorphone HCl intervention 2: Oxycodone HCl CR intervention 3: Placebo	12	Beijing \| N/A \| China \| 116.39723 \| 39.9075 Chengdu \| N/A \| China \| 104.06667 \| 30.66667 Fuzhou \| N/A \| China \| 119.30611 \| 26.06139 Guangdong \| N/A \| China \| 129.33635 \| 42.76832 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Hangzhou \| N/A \| China \| 120.16142 \| 30.29365 Hefei \| N/A \| China \| 117.28083 \| 31.86389 Nanchan...	254	NCT01205126	1COMPLETED	2011-02-01	2009-12-01	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	4INDUSTRY	false	false	false	null	0
[ 0 ]	50	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	1FEMALE	true	The purpose of this study is to evaluate if a paracervical block containing 1% lidocaine administered prior to IUD insertion reduces insertion pain. The hypothesis is that women receiving paracervical analgesia will experience less pain during IUD insertion than those who do not receive such analgesia.	null	Pain Control for Intrauterine Device Insertions	intrauterine device local anesthetic	null	2	arm 1: None arm 2: None	[ 0, 4 ]	1	[ 0 ]	intervention 1: 1% Lidocaine	intervention 1: Lidocaine	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	50	NCT01207401	1COMPLETED	2011-02-01	2010-07-01	Northwestern University	7OTHER	false	false	false	null	0
[ 2 ]	33	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study is a multicenter, nonrandomized, open-label, dose-escalation with intra-patient dose-escalation, Phase 1 study of intravenous LY2523355 to determine the dose of LY2523355 that can be safely administered to participants with acute leukemia. Part A and Part B are dose escalation of two schedules in participant...	null	Acute Leukemia	Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Chronic Myelogenous Leukemia,Blast Crisis	null	2	arm 1: Starting dose was 2 milligrams per meter squared (mg/m\^2) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle. arm 2: Starting dose was 8 milligrams per meter squared (mg/m\^2) administered by a 1-hour IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.	[ 0, 0 ]	1	[ 0 ]	intervention 1: Administered as a 1-hour IV infusion for at least 2 cycles. Cycle length is 21 days. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.	intervention 1: LY2523355	5	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Houston \| Texas \| United States \| -95.36327 \| 29.76328	42	NCT01214655	6TERMINATED	2011-02-01	2008-06-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 2 ]	18	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	false	The purpose of this study is to determine how warfarin might affect LY2216684 and how giving LY2216684 might affect warfarin in the body. Information about any side effects that may occur will also be collected.	null	Major Depressive Disorder		null	1	arm 1: Period 1: Single 10-milligram (mg) warfarin oral dose on Day 1; Washout Period of at least 14 days; Period 2: 18-mg LY2216684 oral dose, once daily on Days 1 to 12, with single 10-mg warfarin oral dose coadministered on Day 3.	[ 0 ]	2	[ 0, 0 ]	intervention 1: 10-mg warfarin oral dose intervention 2: 18-mg LY2216684 oral dose	intervention 1: Warfarin intervention 2: LY2216684	1	Dallas \| Texas \| United States \| -96.80667 \| 32.78306	50	NCT01263119	1COMPLETED	2011-02-01	2010-12-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 2 ]	16	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	0ALL	null	Relative bioavailability of BI 10773 given alone and together with verapamil	null	Healthy		null	2	arm 1: single dose BI 10773 arm 2: single dose BI 10773 + single dose verapamil	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: single dose verapamil intervention 2: single dose BI 10773 intervention 3: single dose BI 10773	intervention 1: Verapamil intervention 2: BI 10773 intervention 3: BI 10773	1	Biberach \| N/A \| Germany \| 8.03333 \| 48.33333	32	NCT01276301	1COMPLETED	2011-02-01	2011-01-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 2 ]	20	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	0ALL	null	This is a Phase 1, single-center, open-label, randomized, 3-period, 2-sequence crossover study of cobimetinib in healthy participants to evaluate the effect of the proton-pump inhibitor (PPI) rabeprazole on the relative bioavailability of cobimetinib in healthy participants when administered in the fed or fasted states...	null	Healthy Volunteer		null	2	arm 1: Treatment A in Period 1: One 20-mg tablet of cobimetinib will be administered orally with 240 milliliters (mL) room temperature water after at least an 8-hour fast. Treatment B in Period 2: 20 mg oral rabeprazole will be administered once daily for 4 days starting on Day -4. On Day 1, 20 mg rabeprazole will be a...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast or approximately 30 minutes after starting the standardized FDA high-fat meal. intervention 2: Rabeprazole 20 mg will be administered orally once daily for 4 days starting on Day ...	intervention 1: Cobimetinib intervention 2: Rabeprazole	0	null	57	NCT01277718	1COMPLETED	2011-02-01	2011-01-01	Genentech, Inc.	4INDUSTRY	false	false	false	null	0
[ 2 ]	28	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	1SINGLE	true	0ALL	null	This study will be an open-label, randomized, two-treatment, two-period, two-sequence crossover study to evaluate the bioequivalence of the amlodipine component of Boehringer Ingelheim Pharma GmbH \& Co. KGs 80 mg telmisartan/10 mg amlodipine fixed dose combination tablet to the corresponding mono-component amlodipine ...	null	Hypertension		null	2	arm 1: Telmisartan/Amlodipine medium fixed dose combination tablet once daily. arm 2: Amlodipine Monocomponent 10mg tablet once daily	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Combination Tablet intervention 2: Active Comparator	intervention 1: Telmisartan/Amlodipine Combination Tablet intervention 2: Amlodipine Monocomponent	1	Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	54	NCT01278797	1COMPLETED	2011-02-01	2011-01-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 4 ]	712	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The objective of the study is to evaluate the efficacy and safety of a single oral dose of two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than either single ingredient alone in subjects with post...	null	Pain, Postoperative	Naproxen sodium Diphenhydramine	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose intervention 2: Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose intervention 3: Participants received two Napr...	intervention 1: Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) intervention 2: Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) intervention 3: Naproxen sodium 440 mg (BAYH6689) intervention 4: DPH 50 mg	2	Austin \| Texas \| United States \| -97.74306 \| 30.26715 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078	712	NCT01280591	1COMPLETED	2011-02-01	2010-10-01	Bayer	4INDUSTRY	false	false	false	null	0
[ 3 ]	37	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	2DOUBLE	false	0ALL	true	The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of recurrent aphthous stomatitis (RAS)	Recurrent aphthous stomatitis (RAS) is the most painful oral lesion with a considerable prevalence . The most common aphthous ulcer treatments include applying topical agents such as antibiotics, Non Steroidal Anti Inflammatory Drugs (NSAIDs) to immunosuppressants. The mixture of Diphenhydramine and Aluminum MgS suspe...	Aphthous Stomatitis	Aphthous Stomatitis Ibuprofen treatment efficacy	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 3 times daily for 3 days intervention 2: 3 times daily for 3 days	intervention 1: Ibuprofen, Diphenhydramine and Aluminium MgS intervention 2: Diphenhydramine and Aluminium MgS	2	Qazvin \| Qazvin Province \| Iran \| 50.0041 \| 36.26877 Qazvin \| Qazvin Province \| Iran \| 50.0041 \| 36.26877	31	NCT01293968	1COMPLETED	2011-02-01	2010-11-01	Qazvin University Of Medical Sciences	7OTHER	false	false	false	null	0
[ 4 ]	269	RANDOMIZED	FACTORIAL	0TREATMENT	0NONE	false	0ALL	false	This study evaluated two chemotherapy regimens with and without the addition of interferon in patients with advanced or recurrent melanoma.	null	Malignant Melanoma Recurrent Melanoma		null	4	arm 1: combination chemotherapy without interferon arm 2: combination chemotherapy with interferon arm 3: single agent dacarbazine without interferon arm 4: single agent dacarbazine plus interferon	[ 0, 0, 1, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 900 mg / m2 every 3 weeks intervention 2: 100 mg / m2 every 3 weeks intervention 3: 5 M units every 3 weeks	intervention 1: Dacarbazine intervention 2: Fotemustine intervention 3: Interferon Alfa-2b	0	null	252	NCT01359956	1COMPLETED	2011-02-01	2002-04-01	National Cancer Institute, Naples	7OTHER	false	false	false	null	0
[ 5 ]	30	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	false	Inflammation related to cytokine release is known to occur with surgery. The cytokine IL6, a major marker of inflammation is known to increase during total joint replacement surgery. IL6 has been found to be elevated postoperatively in patients with hip fractures and has been linked to mental status changes and possibl...	null	Postoperative Inflammatory Response	Bilateral total knee replacement cytokine desmosine	null	2	arm 1: Hydrocortisone 100 mg IV Q 8hrs x3 arm 2: Saline IV Q8hr x3	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times intervention 2: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times	intervention 1: Hydrocortisone intervention 2: Saline	1	New York \| New York \| United States \| -74.00597 \| 40.71427	30	NCT01399268	1COMPLETED	2011-02-01	2009-02-01	Hospital for Special Surgery, New York	7OTHER	false	false	false	null	0
[ 0 ]	518	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	This is a randomized double blind 2x2 factorial controlled trial to evaluate efficacy tolerability of low strength Polycap versus two doses of low strength Polycap in patients with stable cardiovascular disease in reducing blood pressure and LDL. To evaluate the tolerability and safety of low dose potassium supplement...	Mean change in blood pressure between those taking 2capsules of the polycap versus one Difference in Rates of early discontinuation between 2 capsules of polycap versus one Rates of reported adverse effects among those taking the polycap	Ischemic Heart Disease Ischemic Stroke Peripheral Vascular Disease Type 2 Diabetes Mellitus		null	2	arm 1: Single dose polycap without pottasium arm 2: Double Dose polycap with potassium	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin intervention 2: 2 Capsules of low strength polycap with 30mEq of Potassium	intervention 1: Single Dose Polycap intervention 2: Double dose Polycap	0	null	518	NCT01404078	1COMPLETED	2011-02-01	2010-04-01	St. John's Research Institute	7OTHER	false	false	false	null	0
[ 5 ]	96	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	Gastrografin is a radiopaque contrast agent for the gastrointestinal tract (GIT) which can be applied orally or rectally. In neonatal intensive care, Gastrografin is used to detect otherwise radiologically invisible perforations or an insufficient GIT anastomosis after surgery. Furthermore it is used for the treatment ...	In premature infants the establishment of proper gastrointestinal function is challenging and often associated with delayed meconium passage. Meconium evacuation depends on gestational age and birthweight: the more immature an infant is, the later meconium passage starts and the longer meconium passage lasts. The mean ...	Meconium Ileus Very Low Birth Weight Infant	VLBW infant Meconium Enteral nutrition Meconium passage	null	2	arm 1: infants receive 3ml/kg Gastrografin + 6ml/kg sterile water arm 2: infants receive 9ml/kg sterile water	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Patients will receive 3ml Gastrografin + 6ml sterile water/kg as a single dose via a nasogastric tube during the first 24 hours of life. intervention 2: Patients will receive 9ml/kg sterile water as a single dose via a nasogastric tube during the first 24 hours of life.	intervention 1: Gastrografin intervention 2: Sterile water	0	null	96	NCT01515696	1COMPLETED	2011-02-01	2007-10-01	Nadja Haiden,MD	7OTHER	false	false	false	null	0
[ 5 ]	281	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The removal of smooth, percutaneous pins (Perc Pins), which are used for fracture fixation, occurs once adequate bone healing has taken place. At the Stollery Children's Hospital (SCH), this frequently performed procedure is currently done without anesthetic, making it a painful and uncomfortable experience for the chi...	null	Pain	Patients aged 3 to 16 years presenting for removal of smooth percutaneous interosseus pins after orthopeadic surgery	null	2	arm 1: Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing arm 2: This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Te...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 4% Liposomal Lidocaine intervention 2: Tubes were visually identical to the Liposomal Lidocaine tubes.	intervention 1: Liposomal Lidocaine intervention 2: Placebo	0	null	281	NCT01542125	1COMPLETED	2011-02-01	2008-09-01	University of Alberta	7OTHER	false	false	false	null	0
[ 3 ]	45	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This phase II trial is studying how well docetaxel given together with cisplatin and pegfilgrastim followed by erlotinib hydrochloride works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth...	PRIMARY OBJECTIVES: I. To determine if this regimen improves the time-to-progression for patients with advanced non-small cell lung cancer (NSCLC) compared to historical controls. SECONDARY OBJECTIVES: I. To assess response rate and median survival. II. To evaluate tumor biomarkers that could predict response and su...	Adenocarcinoma of the Lung Adenosquamous Cell Lung Cancer Bronchoalveolar Cell Lung Cancer Large Cell Lung Cancer Non-small Cell Lung Cancer Recurrent Non-small Cell Lung Cancer Squamous Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer		null	1	arm 1: Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgra...	[ 0 ]	8	[ 0, 2, 0, 10, 6, 10, 6, 0 ]	intervention 1: Given IV intervention 2: Given SC intervention 3: Given PO intervention 4: Optional correlative study intervention 5: Correlative study intervention 6: Correlative study intervention 7: Correlative study intervention 8: Given IV	intervention 1: cisplatin intervention 2: pegfilgrastim intervention 3: erlotinib hydrochloride intervention 4: laboratory biomarker analysis intervention 5: polymorphism analysis intervention 6: pharmacogenomic studies intervention 7: genetic linkage analysis intervention 8: docetaxel	1	Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986	44	NCT01557959	1COMPLETED	2011-02-01	2007-07-01	Wake Forest University Health Sciences	7OTHER	false	false	false	null	0
[ 4 ]	40	NA	SINGLE_GROUP	2DIAGNOSTIC	1SINGLE	false	0ALL	false	Re-read of brain amyloid scans acquired in previous AV-45 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).	null	Alzheimer's Disease	Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging	null	1	arm 1: Seven practicing nuclear medicine physicians with no prior training in reading scans from florbetapir-PET, or other amyloid imaging agents.	[ 0 ]	1	[ 0 ]	intervention 1: IV injection, 370MBq (10mCi), single dose (intervention for Study A05 participants, source of scans for this study)	intervention 1: florbetapir F 18	0	null	0	NCT01565382	1COMPLETED	2011-02-01	2011-02-01	Avid Radiopharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 0 ]	10	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	This is a single center, open-label, split-face, prospective study of ten to fifteen subjects seeking vascular laser therapy for the treatment of mild to moderate rosacea. Subjects will be screened for eligibility for vascular laser therapy outside of the confines of this protocol. Once approved for laser, subjects wil...	This is a single center, open-label, split-face, prospective study of ten to fifteen subjects seeking vascular laser therapy for the treatment of mild to moderate rosacea. Subjects will be screened for eligibility for vascular laser therapy outside of the confines of this protocol. Once approved for laser, subjects wil...	Rosacea	Rosacea, Laser, Finacea Gel, Azelaic Acid,	null	2	arm 1: Azelaic acid 15% twice daily on half the face for 6 weeks, plus laser treatment with Nd:Yag laser once at 2 weeks. arm 2: laser treatment on all face once at 2 weeks with no azelaic acid on one side of the face	[ 0, 1 ]	2	[ 0, 1 ]	intervention 1: 15% gel on half the face, twice daily, 6 weeks intervention 2: Treatment with Nd:Yag laser , once at Week 2.	intervention 1: Azelaic acid intervention 2: Nd:Yag laser	1	Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986	20	NCT01631656	1COMPLETED	2011-02-01	2010-07-01	Wake Forest University Health Sciences	7OTHER	false	false	false	null	0
[ 4 ]	320	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to compare the efficacy and safety of extended release (ER) tramadol hydrochloride (HCl)/acetaminophen with immediate release (IR) tramadol HCl/acetaminophen in participants with moderate to severe (very serious, life threatening) postoperative pain.	This study is a randomized (study drug assigned by chance), multicenter (when more than 1 hospital or medical school team work on a medical research study), active-controlled, parallel group (each group of participants will be treated at the same time), double-blind (neither physician nor participant knows the treatmen...	Pain, Postoperative	Pain, Postoperative Tramadol Hydrochloride Acetaminophen Ultracet	null	2	arm 1: Participants will be administered 2 oral tablets of extended release (ER) tramadol HCl (75 milligram \[mg\])/acetaminophen (650 mg) and 2 tablets of placebo matching to immediate release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matching to IR tramadol HCl/ace...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 2 tablets of ER (tramadol HCl \[75 mg\]/acetaminophen \[650 mg\]) will be administered at 0, 12, 24 and 36 hours intervention 2: 2 tablets of IR (tramadol HCl \[37.5 mg\]/acetaminophen \[325 mg\]) at 0, 6, 12, 18, 24, 30, 36 and 42 hours	intervention 1: Tramadol HCl/Acetaminophen ER intervention 2: Tramadol HCl/Acetaminophen IR	0	null	314	NCT01814878	1COMPLETED	2011-02-01	2009-11-01	Janssen Korea, Ltd., Korea	4INDUSTRY	false	false	false	null	-0
[ 3 ]	18	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with docetaxel...	OBJECTIVES: Primary * To determine the proportion of patients achieving a 50% reduction in serum PSA from baseline in patients with androgen-independent prostate cancer (AIPC) receiving sorafenib tosylate and docetaxel. Secondary * To estimate the progression-free survival of patients with AIPC. * To quantify the n...	Prostate Cancer	adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer	null	1	arm 1: All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks	[ 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: docetaxel intervention 2: sorafenib tosylate	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	17	NCT00589420	1COMPLETED	2011-02-02	2007-07-27	Abramson Cancer Center at Penn Medicine	7OTHER	false	false	false	null	0

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